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amendment list, 23 June 2026

Monitoring and controlling drug precursors and repealing Regulations (EC) No 273/2004 and (EC) No 111/2005

Document CJ75-AM-790130 · (COM(2025)0747 – 2025/0384(COD))

Committee on International Trade Committee on Civil Liberties, Justice and Home Affairs

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Amendment 36

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 1

Text proposed by the CommissionAmendment
(1) The United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances adopted in Vienna on 19 December 1988 ('the UN Convention') is part of the worldwide effort to combat the production and trafficking of illicit drugs. The Union concluded the UN Convention by means of Council Decision 90/611/EEC3 .(1) The United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances adopted in Vienna on 19 December 1988 ('the UN Convention') is part of the worldwide effort to combat the production and trafficking of illicit drugs and thus forms the basis for the regulation of chemical precursors. The Union concluded the UN Convention by means of Council Decision 90/611/EEC3 .
3 (3)Council Decision of 22 October 1990 concerning the conclusion, on behalf of the European Economic Community, of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (OJ L 326, 24.11.1990, p. 56, ELI: http://data.europa.eu/eli/dec/1990/611/oj).3 (3)Council Decision of 22 October 1990 concerning the conclusion, on behalf of the European Economic Community, of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (OJ L 326, 24.11.1990, p. 56, ELI: http://data.europa.eu/eli/dec/1990/611/oj).

Or. en

Amendment 37

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 2

Text proposed by the CommissionAmendment
(2) Article 12 of the UN Convention requires the Parties thereto to take the measures they deem appropriate to prevent the diversion of substances which are included in the tables annexed to the Convention and used for the purpose of the illicit manufacture of drugs (drug precursors). The adoption of rules to monitor and control these drug precursors was implemented in the Union by Regulation (EC) No 273/2004 of the European Parliament and of the Council4 , regarding the control and monitoring measures within the internal market; and Council Regulation (EC) No 111/20055 on trade between the Union and third countries.(2) Article 12 of the UN Convention requires the Parties thereto to take the measures they deem appropriate to prevent the diversion of substances which are included in the tables annexed to the Convention and used for the purpose of the illicit manufacture of drugs (drug precursors) obliging them to submit to the establishment of a monitoring system . The adoption of rules to monitor and control these drug precursors was implemented in the Union by Regulation (EC) No 273/2004 of the European Parliament and of the Council4 , regarding the control and monitoring measures within the internal market; and Council Regulation (EC) No 111/20055 on trade between the Union and third countries. Close cooperation must be established with the INCB (International Narcotics Control Board).
4 (4)Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (OJ L 47, 18.2.2004, ELI: http://data.europa.eu/eli/reg/2004/273/oj).4 (4)Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (OJ L 47, 18.2.2004, ELI: http://data.europa.eu/eli/reg/2004/273/oj).
5 (5)Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors (OJ L 22, 26.1.2005, ELI: http://data.europa.eu/eli/reg/2005/111/oj).5 (5)Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors (OJ L 22, 26.1.2005, ELI: http://data.europa.eu/eli/reg/2005/111/oj).

Or. en

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Amendment 38

Saskia Bricmont

Proposal for a regulation

Recital 2 a (new)

Text proposed by the CommissionAmendment
(2a) As recognised in the EU Drugs Strategy and EUDA mandate, drug policy should be multidimensional and include both public health and security perspectives. Policy responses at both EU and Member State level should include measures combatting illegal trade in drug precursors as well as public health measures, harm reduction policies for people who use drugs, and preventive actions aimed at reducing drug demand and related harms.

Or. en

Amendment 39

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Recital 3

Text proposed by the CommissionAmendment
(3) The Evaluation of the Union drug precursor regulations(6) has shown that additional action with regard to designer precursors is necessary. Designer precursors are substances closely related to controlled drug precursors, with no known legitimate use, and which evade the controls set out in Regulations (EC) No 273/2004 and 111/2005. Those Regulations have been conceived to address the diversion of traditional drug precursors from licit channels towards the illicit manufacture of drugs, and do not include specific rules addressing designer precursors. The evaluation also pointed out to the need to take a holistic approach in regulating drug precursors, to ensure consistency with recent policy developments at Union level against drug trafficking. Recent developments include the EU Drugs Strategy and Action Plan, the adoption of Regulation (EU) 2023/1322(7) on the European Union Drugs Agency, the European Digital Strategy and the adoption of Regulation (EU) 2022/2399(8).(3) The Evaluation of the Union drug precursor regulations(6) has shown that additional action with regard to designer precursors is necessary. Designer precursors are substances closely related to controlled drug precursors, with no known legitimate use, and which evade the controls set out in Regulations (EC) No 273/2004 and 111/2005. Those Regulations have been conceived to address the diversion of traditional drug precursors from licit channels towards the illicit manufacture of drugs, and do not include specific rules addressing designer precursors. The evaluation also pointed out to the need to modernise the regulatory framework for drug precursors in order to respond to new forms of circumvention of existing controls. Recent developments include the EU Drugs Strategy and Action Plan, the adoption of Regulation (EU) 2023/1322(7) on the European Union Drugs Agency, the European Digital Strategy and the adoption of Regulation (EU) 2022/2399(8).
(6) (6)Report from the Commission to the European Parliament and the Council of 30.11.2020 - Evaluation of the EU drug precursors regulations (COM/2020/768 final).(6) (6)Report from the Commission to the European Parliament and the Council of 30.11.2020 - Evaluation of the EU drug precursors regulations (COM/2020/768 final).
(7) (7)Regulation (EU) 2023/1322 of the European Parliament and of the Council of 27 June 2023 on the European Union Drugs Agency (EUDA) and repealing Regulation (EC) No 1920/2006 (OJ L 166, 30.6.2023, p. 6., ELI: http://data.europa.eu/eli/reg/2023/1322/oj).(7) (7)Regulation (EU) 2023/1322 of the European Parliament and of the Council of 27 June 2023 on the European Union Drugs Agency (EUDA) and repealing Regulation (EC) No 1920/2006 (OJ L 166, 30.6.2023, p. 6., ELI: http://data.europa.eu/eli/reg/2023/1322/oj).
(8) (8)Regulation (EU) 2022/2399 of the European Parliament and of the Council of 23 November 2022 establishing the European Union Single Window Environment for Customs and amending Regulation (EU) No 952/2013 (OJ L 317, 9.12.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/2399/oj).(8) (8)Regulation (EU) 2022/2399 of the European Parliament and of the Council of 23 November 2022 establishing the European Union Single Window Environment for Customs and amending Regulation (EU) No 952/2013 (OJ L 317, 9.12.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/2399/oj).

Or. sk

Justification

The term ‘holistic approach’ has no clear legal content and does not provide sufficient guidance for the interpretation of the Regulation. The recital should more precisely identify the specific problem, which is the emergence of new design precursors and the need for more effective monitoring of their use.

Amendment 40

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Recital 4

Text proposed by the CommissionAmendment
(4) Drug precursor controls are a crucial component of drug supply reduction policy as outlined in the EU Drugs Strategy 2021-2025(9). Furthermore, the EU Drugs Action Plan 2021-2025(10) highlights the need to address the challenge posed by designer precursors. Additionally, the 2023 EU Roadmap to fight drug trafficking and organised crime(11) stresses the need to set out innovative ways to speed up and broaden the current approach to regulating drug precursors in response to new methods of illicit drug production. Equally, as part of the new EU Drugs Strategy and EU Action Plan against drug trafficking, announced in Protect EU: a European Internal Security Strategy(12), the EU will boost operational efforts to stop the inflow of drug precursors, including designer precursors.(4) Drug precursor controls are a crucial component of efforts to curb the illicit production of and trafficking in drugs. Furthermore, there is a need to address the challenge posed by designer precursors. There is a need to set out effective and appropriate mechanisms to speed up and broaden the current approach to regulating drug precursors in response to new methods of illicit drug production. The EU should boost operational efforts to stop the inflow of drug precursors, including designer precursors.
(9) (9)Council Conclusions on the EU Drugs Strategy 2021-2025, 14178/20, 18 December 2020.
(10) (10)Communication COM (2020) 606 final of 24.7.2020 from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions - EU Agenda and Action Plan on Drugs 2021-2025.
(11) (11)Communication COM (2023) 641 final of 18.10.2023 from the Commission to the European Parliament and the Council on the EU roadmap to fight drug trafficking and organised crime.
(12) (12)Communication COM(2025) 148 final of 1.4.2025 from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on ProtectEU: a European Internal Security Strategy.

Or. sk

Justification

The recital should justify the need for the proposed regulation based on specific problems related to the production of illegal drugs. References to several strategies, action plans and policy communications are not essential to explain the purpose of the regulation and their deletion improves the clarity of the text.

Amendment 41

Brando Benifei, Evin Incir

Proposal for a regulation

Recital 5

Text proposed by the CommissionAmendment
(5) Therefore, new rules on drug precursors should be adopted, to better address the developments in the illicit manufacture of drugs, and in particular, the proliferation of designer precursors. These new rules would also give effect to the obligations deriving from Article 12 of the UN Convention.(5) Therefore, new rules on drug precursors should be adopted, to better address the developments in the illicit manufacture of drugs, and in particular, the proliferation of designer precursors, both online and offline. These new rules would also give effect to the obligations deriving from Article 12 of the UN Convention.

Or. en

Amendment 42

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 5 a (new)

Text proposed by the CommissionAmendment
(5a) The administrative simplification and digitalisation provided for in this Regulation should not result in a disproportionate reduction in the ability of the competent authorities to monitor intra-Union movements of drug precursors which present a high risk of diversion towards the illicit manufacture of drugs. It is therefore appropriate to adopt proportionate traceability and risk-analysis tools, while respecting the proper functioning of the internal market.

Or. en

Amendment 43

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Recital 6

Text proposed by the CommissionAmendment
(6) In order to streamline current procedures and to reduce administrative burden, Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005 should also be merged into one Regulation. That should also facilitate the free movement of chemicals in the internal market. This Regulation should apply without prejudice to other Union legislation applicable to the substances contained in drug precursors covered by this Regulation, such as Regulation (EC) No 1907/2006(13), Regulation (EC) No 1272/2008(14) or Regulation (EU) 2019/1148(15). It should also apply without prejudice to the obligations of Member States to set out national rules on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking in accordance with Council Framework Decision 2004/757/JHA(16). This Regulation should not apply to customs, police, armed forces and laboratories of competent authorities in the Member States when they are acting within the scope of their official duties, as the risk of diversion of drug precursors in such cases is minimal. The possession and use of drug precursors by pharmacies and veterinary dispensaries within the scope of their regular activities should also be exempt from the scope of the Regulation, as such operators are already subject to strict rules under Union and national legislation. The possibility of setting out simplified formalities for specific external traders, such as pharmacies and dispensaries of veterinary products, should be maintained to reduce the administrative burden for operators with a low risk profile.(6) In order to streamline current procedures and to reduce administrative burden, Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005 should also be merged into one Regulation. That should also facilitate the free movement of chemicals in the internal market, while also ensuring a high level of protection of public safety and the effective prevention of the misuse of drug precursors for the illicit manufacture of drugs. This Regulation should apply without prejudice to other Union legislation applicable to the substances contained in drug precursors covered by this Regulation, such as Regulation (EC) No 1907/2006(13), Regulation (EC) No 1272/2008(14) or Regulation (EU) 2019/1148(15). It should also apply without prejudice to the obligations of Member States to set out national rules on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking in accordance with Council Framework Decision 2004/757/JHA(16). This Regulation should not apply to customs, police, armed forces and laboratories of competent authorities in the Member States when they are acting within the scope of their official duties, as the risk of diversion of drug precursors in such cases is minimal. The possession and use of drug precursors by pharmacies and veterinary dispensaries within the scope of their regular activities should also be exempt from the scope of the Regulation, as such operators are already subject to strict rules under Union and national legislation. The possibility of setting out simplified formalities for specific external traders, such as pharmacies and dispensaries of veterinary products, should be maintained to reduce the administrative burden for operators with a low risk profile.
(13) (14)Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).(13) (14)Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).
(14) (15)Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, ELI: http://data.europa.eu/eli/reg/2008/1272/oj).(14) (15)Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, ELI: http://data.europa.eu/eli/reg/2008/1272/oj).
(15) (16)Regulation (EU) 2019/1148 of the European Parliament and of the Council of 20 June 2019 on the marketing and use of explosives precursors, amending Regulation (EC) No 1907/2006 and repealing Regulation (EU) No 98/2013 (OJ L 186, 11.7.2019,ELI: http://data.europa.eu/eli/reg/2019/1148/oj).(15) (16)Regulation (EU) 2019/1148 of the European Parliament and of the Council of 20 June 2019 on the marketing and use of explosives precursors, amending Regulation (EC) No 1907/2006 and repealing Regulation (EU) No 98/2013 (OJ L 186, 11.7.2019,ELI: http://data.europa.eu/eli/reg/2019/1148/oj).
16 (17)Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking (OJ L 335, 11.11.2004, p. 8, ELI: http://data.europa.eu/eli/dec_framw/2004/757/oj).16 (17)Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking (OJ L 335, 11.11.2004, p. 8, ELI: http://data.europa.eu/eli/dec_framw/2004/757/oj).

Or. sk

Justification

The free movement of chemicals must be balanced with appropriate measures to protect public safety and combat organised crime linked to the production of synthetic drugs.

Amendment 44

Brando Benifei, Evin Incir

Proposal for a regulation

Recital 6

Text proposed by the CommissionAmendment
(6) In order to streamline current procedures and to reduce administrative burden, Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005 should also be merged into one Regulation. That should also facilitate the free movement of chemicals in the internal market. This Regulation should apply without prejudice to other Union legislation applicable to the substances contained in drug precursors covered by this Regulation, such as Regulation (EC) No 1907/200613 , Regulation (EC) No 1272/200814 or Regulation (EU) 2019/114815 . It should also apply without prejudice to the obligations of Member States to set out national rules on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking in accordance with Council Framework Decision 2004/757/JHA16 . This Regulation should not apply to customs, police, armed forces and laboratories of competent authorities in the Member States when they are acting within the scope of their official duties, as the risk of diversion of drug precursors in such cases is minimal. The possession and use of drug precursors by pharmacies and veterinary dispensaries within the scope of their regular activities should also be exempt from the scope of the Regulation, as such operators are already subject to strict rules under Union and national legislation. The possibility of setting out simplified formalities for specific external traders, such as pharmacies and dispensaries of veterinary products, should be maintained to reduce the administrative burden for operators with a low risk profile.(6) In order to streamline current procedures and to reduce administrative burden, Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005 should also be merged into one Regulation. That should also facilitate the free movement of chemicals in the internal market and address the challenge of preventing the use of drug precursors in the illicit manufacture of drugs. This Regulation should apply without prejudice to other Union legislation applicable to the substances contained in drug precursors covered by this Regulation, such as Regulation (EC) No 1907/200613 , Regulation (EC) No 1272/200814 or Regulation (EU) 2019/114815 . It should also apply without prejudice to the obligations of Member States to set out national rules on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking in accordance with Council Framework Decision 2004/757/JHA16 . This Regulation should not apply to customs, police, armed forces and laboratories of competent authorities in the Member States when they are acting within the scope of their official duties, as the risk of diversion of drug precursors in such cases is minimal. The possession and use of drug precursors by pharmacies and veterinary dispensaries within the scope of their regular activities should also be exempt from the scope of the Regulation, as such operators are already subject to strict rules under Union and national legislation. The possibility of setting out simplified formalities for specific external traders, such as pharmacies and dispensaries of veterinary products, should be maintained to reduce the administrative burden for operators with a low risk profile.
13 (14) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).13 (14) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).
14 (15)Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, ELI: http://data.europa.eu/eli/reg/2008/1272/oj).14 (15)Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, ELI: http://data.europa.eu/eli/reg/2008/1272/oj).
15 (16)Regulation (EU) 2019/1148 of the European Parliament and of the Council of 20 June 2019 on the marketing and use of explosives precursors, amending Regulation (EC) No 1907/2006 and repealing Regulation (EU) No 98/2013 (OJ L 186, 11.7.2019,ELI: http://data.europa.eu/eli/reg/2019/1148/oj).15 (16)Regulation (EU) 2019/1148 of the European Parliament and of the Council of 20 June 2019 on the marketing and use of explosives precursors, amending Regulation (EC) No 1907/2006 and repealing Regulation (EU) No 98/2013 (OJ L 186, 11.7.2019,ELI: http://data.europa.eu/eli/reg/2019/1148/oj).
16 (17)Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking (OJ L 335, 11.11.2004, p. 8, ELI: http://data.europa.eu/eli/dec_framw/2004/757/oj).16 (17)Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking (OJ L 335, 11.11.2004, p. 8, ELI: http://data.europa.eu/eli/dec_framw/2004/757/oj).

Or. en

Amendment 45

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 6

Text proposed by the CommissionAmendment
(6) In order to streamline current procedures and to reduce administrative burden, Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005 should also be merged into one Regulation. That should also facilitate the free movement of chemicals in the internal market. This Regulation should apply without prejudice to other Union legislation applicable to the substances contained in drug precursors covered by this Regulation, such as Regulation (EC) No 1907/200613 , Regulation (EC) No 1272/200814 or Regulation (EU) 2019/114815 . It should also apply without prejudice to the obligations of Member States to set out national rules on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking in accordance with Council Framework Decision 2004/757/JHA16 . This Regulation should not apply to customs, police, armed forces and laboratories of competent authorities in the Member States when they are acting within the scope of their official duties, as the risk of diversion of drug precursors in such cases is minimal. The possession and use of drug precursors by pharmacies and veterinary dispensaries within the scope of their regular activities should also be exempt from the scope of the Regulation, as such operators are already subject to strict rules under Union and national legislation. The possibility of setting out simplified formalities for specific external traders, such as pharmacies and dispensaries of veterinary products, should be maintained to reduce the administrative burden for operators with a low risk profile.(6) In order to streamline current procedures and to reduce administrative burden, Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005 should also be merged into one Regulation. That should also facilitate the free movement of chemicals in the internal market. This Regulation should apply without prejudice to other Union legislation applicable to the substances contained in drug precursors covered by this Regulation, such as Regulation (EC) No 1907/200613 , Regulation (EC) No 1272/200814 or Regulation (EU) 2019/114815 . It should also apply without prejudice to the obligations of Member States to set out national rules on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking in accordance with Council Framework Decision 2004/757/JHA16 . This Regulation should not apply to customs, police, armed forces and laboratories of competent authorities in the Member States when they are acting within the scope of their official duties, as the risk of diversion of drug precursors in such cases is minimal and is adequately controlled through existing internal control measures. The possession and use of drug precursors by pharmacies and veterinary dispensaries within the scope of their regular activities should also be exempt from the scope of the Regulation, as such operators are already subject to strict rules under Union and national legislation. The possibility of setting out simplified formalities for specific external traders, such as pharmacies and dispensaries of veterinary products, should be maintained to reduce the administrative burden for operators with a low risk profile.
13 (14) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).13 (14) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).
14 (15)Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, ELI: http://data.europa.eu/eli/reg/2008/1272/oj).14 (15)Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, ELI: http://data.europa.eu/eli/reg/2008/1272/oj).
15 (16)Regulation (EU) 2019/1148 of the European Parliament and of the Council of 20 June 2019 on the marketing and use of explosives precursors, amending Regulation (EC) No 1907/2006 and repealing Regulation (EU) No 98/2013 (OJ L 186, 11.7.2019,ELI: http://data.europa.eu/eli/reg/2019/1148/oj).15 (16)Regulation (EU) 2019/1148 of the European Parliament and of the Council of 20 June 2019 on the marketing and use of explosives precursors, amending Regulation (EC) No 1907/2006 and repealing Regulation (EU) No 98/2013 (OJ L 186, 11.7.2019,ELI: http://data.europa.eu/eli/reg/2019/1148/oj).
16 (17)Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking (OJ L 335, 11.11.2004, p. 8, ELI: http://data.europa.eu/eli/dec_framw/2004/757/oj).16 (17)Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking (OJ L 335, 11.11.2004, p. 8, ELI: http://data.europa.eu/eli/dec_framw/2004/757/oj).

Or. en

Amendment 46

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 6 a (new)

Text proposed by the CommissionAmendment
(6a) The illicit diversion and trafficking of drug precursors have evolved significantly in recent years, notably through the rapid emergence of new synthetic drugs, non-scheduled drug precursors lacking legally binding obligations, sophisticated methods of chemical concealment and transformation and the increased use of online platforms and cross-border supply chains. Those developments have substantially changed the nature, scale and complexity of the drug phenomenon within the Union and require a coherent, modern and adaptable legal framework. In that context, it is key for Council Framework Decision 2004/757/JHA to be reassessed and, where appropriate, revised in order to ensure that the Union legal framework remains effective, proportionate and fit for purpose in addressing current and emerging challenges related to illicit drug manufacture, illicit drug trafficking and the illicit diversion of drug precursors. Enhanced alignment between this Regulation and the criminal law provisions of the Member States, as coordinated within the Union framework, would strengthen the protection of public health and security across the Union.

Or. en

Amendment 47

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 7

Text proposed by the CommissionAmendment
(7) Scheduled drug precursors consist of or contain substances covered by the annexes to this Regulation. The annexes should include all the substances already covered by Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005. Such substances are either covered by the UN Convention or are placed under control at Union level, in response to specific risks of diversion identified in the Union. To facilitate their free movement in the internal market and their external trade, harmonised rules should be set out to enable national authorities to control and monitor legitimate trade effectively, with a view to avoiding their diversion towards the illicit manufacture of drugs, without creating disproportionate administrative burdens. As is the case under the current rules, operators should continue to have the obligation to notify suspicious transactions. This is an important source of information for competent authorities to discover illicit activities. The obligation should be extended to significant disappearances and thefts, as such incidents could also indicate possible diversion towards the illicit manufacture of drugs. Similarly, operators should maintain their obligation to keep the documentation regarding transactions of scheduled drug precursors. To increase the possibility for competent authorities to gather evidence concerning illicit activities, the obligation to keep documentation should be extended to operators using scheduled drug precursors of the highest risk and the documentation should be kept for a longer period of time.(7) Scheduled drug precursors consist of or contain substances covered by the annexes to this Regulation. The annexes should include all the substances already covered by Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005. Such substances are either covered by the UN Convention or are placed under control at Union level, in response to specific risks of diversion identified in the Union. To facilitate their free movement in the internal market and their external trade, harmonised rules should be set out to enable national authorities to control and monitor licit trade effectively and where appropriate, ensure the traceability of transactions, with a view to avoiding their diversion by criminal networks towards the illicit manufacture of drugs, without creating disproportionate administrative burdens.
Continuous and structured dialogue with the competent authorities of third countries, in particular those identified as presenting a high risk of diversion and trafficking, should be maintained with the support/ assistance of the European Union Drugs Agency (‘the Agency’), in collaboration with UNODC (United Nations Office on Drugs and Crime), and relevant international bodies, in order to strengthen monitoring, information exchange and cooperation aimed at preventing the diversion of drug precursors for the illicit manufacture of drugs, while identifying and addressing unnecessary obstacles to licit trade.
As is the case under the current rules, operators should continue to have the obligation to notify suspicious transactions. This is an important source of information for competent authorities to discover illicit activities. The obligation should be extended to significant disappearances and thefts, as such incidents could also indicate possible diversion towards the illicit manufacture of drugs. Similarly, operators should maintain their obligation to keep the documentation regarding transactions of scheduled drug precursors. To increase the possibility for competent authorities to gather evidence concerning illicit activities, the obligation to keep documentation should be extended to operators using scheduled drug precursors of the highest risk and the documentation should be kept for a longer period of time.

Or. en

Amendment 48

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Recital 7

Text proposed by the CommissionAmendment
(7) Scheduled drug precursors consist of or contain substances covered by the annexes to this Regulation. The annexes should include all the substances already covered by Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005. Such substances are either covered by the UN Convention or are placed under control at Union level, in response to specific risks of diversion identified in the Union. To facilitate their free movement in the internal market and their external trade, harmonised rules should be set out to enable national authorities to control and monitor legitimate trade effectively, with a view to avoiding their diversion towards the illicit manufacture of drugs, without creating disproportionate administrative burdens. As is the case under the current rules, operators should continue to have the obligation to notify suspicious transactions. This is an important source of information for competent authorities to discover illicit activities. The obligation should be extended to significant disappearances and thefts, as such incidents could also indicate possible diversion towards the illicit manufacture of drugs. Similarly, operators should maintain their obligation to keep the documentation regarding transactions of scheduled drug precursors. To increase the possibility for competent authorities to gather evidence concerning illicit activities, the obligation to keep documentation should be extended to operators using scheduled drug precursors of the highest risk and the documentation should be kept for a longer period of time.(7) Scheduled drug precursors consist of or contain substances covered by the annexes to this Regulation. The annexes should include all the substances already covered by Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005. Such substances are either covered by the UN Convention or are placed under control at Union level, in response to specific risks of diversion identified in the Union. To facilitate their free movement in the internal market and their external trade, harmonised rules should be set out to enable national authorities to control and monitor legitimate trade effectively, with a view to avoiding their diversion towards the illicit manufacture of drugs, without creating disproportionate administrative burdens, particularly for small and medium-sized enterprises and operators with a low risk profile. As is the case under the current rules, operators should continue to have the obligation to notify suspicious transactions. This is an important source of information for competent authorities to discover illicit activities. The obligation should be extended to significant disappearances and thefts, as such incidents could also indicate possible diversion towards the illicit manufacture of drugs. Similarly, operators should maintain their obligation to keep the documentation regarding transactions of scheduled drug precursors. To increase the possibility for competent authorities to gather evidence concerning illicit activities, the obligation to keep documentation should be extended to operators using scheduled drug precursors of the highest risk and the documentation should be kept for a longer period of time.

Or. sk

Justification

Control measures should be proportionate to the risk. When implementing the Regulation, it is appropriate to take into account the special position of small and medium-sized enterprises and entities for which an increased risk of drug precursor misuse has not been identified.

Amendment 49

Brando Benifei, Evin Incir

Proposal for a regulation

Recital 7

Text proposed by the CommissionAmendment
(7) Scheduled drug precursors consist of or contain substances covered by the annexes to this Regulation. The annexes should include all the substances already covered by Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005. Such substances are either covered by the UN Convention or are placed under control at Union level, in response to specific risks of diversion identified in the Union. To facilitate their free movement in the internal market and their external trade, harmonised rules should be set out to enable national authorities to control and monitor legitimate trade effectively, with a view to avoiding their diversion towards the illicit manufacture of drugs, without creating disproportionate administrative burdens. As is the case under the current rules, operators should continue to have the obligation to notify suspicious transactions. This is an important source of information for competent authorities to discover illicit activities. The obligation should be extended to significant disappearances and thefts, as such incidents could also indicate possible diversion towards the illicit manufacture of drugs. Similarly, operators should maintain their obligation to keep the documentation regarding transactions of scheduled drug precursors. To increase the possibility for competent authorities to gather evidence concerning illicit activities, the obligation to keep documentation should be extended to operators using scheduled drug precursors of the highest risk and the documentation should be kept for a longer period of time.(7) Scheduled drug precursors consist of or contain substances covered by the annexes to this Regulation. The annexes should include all the substances already covered by Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005. Such substances are either covered by the UN Convention or are placed under control at Union level, in response to specific risks of diversion identified in the Union. To facilitate their free movement in the internal market and their external trade, harmonised rules should be set out to enable national authorities to control and monitor legitimate trade effectively, with a view to avoiding their diversion towards the illicit manufacture of drugs, without creating disproportionate administrative burdens for legitimate operators. As is the case under the current rules, operators should continue to have the obligation to notify suspicious transactions. This is an important source of information for competent authorities to discover illicit activities. The obligation should be extended to significant disappearances and thefts, as such incidents could also indicate possible diversion towards the illicit manufacture of drugs. Similarly, operators should maintain their obligation to keep the documentation regarding transactions of scheduled drug precursors. To increase the possibility for competent authorities to gather evidence concerning illicit activities, the obligation to keep documentation should be extended to operators using scheduled drug precursors of the highest risk and the documentation should be kept for a longer period of time.

Or. en

Amendment 50

Sebastian Tynkkynen

Proposal for a regulation

Recital 7

Text proposed by the CommissionAmendment
(7) Scheduled drug precursors consist of or contain substances covered by the annexes to this Regulation. The annexes should include all the substances already covered by Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005. Such substances are either covered by the UN Convention or are placed under control at Union level, in response to specific risks of diversion identified in the Union. To facilitate their free movement in the internal market and their external trade, harmonised rules should be set out to enable national authorities to control and monitor legitimate trade effectively, with a view to avoiding their diversion towards the illicit manufacture of drugs, without creating disproportionate administrative burdens. As is the case under the current rules, operators should continue to have the obligation to notify suspicious transactions. This is an important source of information for competent authorities to discover illicit activities. The obligation should be extended to significant disappearances and thefts, as such incidents could also indicate possible diversion towards the illicit manufacture of drugs. Similarly, operators should maintain their obligation to keep the documentation regarding transactions of scheduled drug precursors. To increase the possibility for competent authorities to gather evidence concerning illicit activities, the obligation to keep documentation should be extended to operators using scheduled drug precursors of the highest risk and the documentation should be kept for a longer period of time.(7) Scheduled drug precursors consist of or contain substances covered by the annexes to this Regulation. The annexes should include all the substances already covered by Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005. Such substances are either covered by the UN Convention or are placed under control at Union level, in response to specific risks of diversion identified in the Union. To facilitate their free movement in the internal market and their external trade, harmonised rules should be set out to enable national authorities to control and monitor legitimate trade effectively, with a view to avoiding their diversion towards the illicit manufacture of drugs, without creating disproportionate administrative burdens. As is the case under the current rules, operators should continue to have the obligation to notify suspicious transactions immediately. This is an important source of information for competent authorities to discover illicit activities. The obligation should be extended to significant disappearances and thefts, as such incidents could also indicate possible diversion towards the illicit manufacture of drugs. Similarly, operators should maintain their obligation to keep the documentation regarding transactions of scheduled drug precursors. To increase the possibility for competent authorities to gather evidence concerning illicit activities, the obligation to keep documentation should be extended to operators using scheduled drug precursors of the highest risk and the documentation should be kept for a longer period of time.

Or. fi

Amendment 51

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 8

Text proposed by the CommissionAmendment
(8) This Regulation should lay down specific obligations for online marketplaces with respect to reporting suspicious transactions with scheduled drug precursors that take place on their websites or that use their computing services, once they have become aware of information leading to such a suspicion. The obligations on online marketplaces under this Regulation should not amount to a general monitoring obligation.(8) This Regulation should lay down specific obligations for online marketplaces with respect to the identification and reporting suspicious transactions with scheduled drug precursors that take place on their websites or that use their computing services, once they have become aware of information leading to such a suspicion. In view of the increasing use of online services for the marketing and sale of drug precursors, providers of online marketplaces should take appropriate and proportionate measures to prevent the diversion and illicit trade of drug precursors through their services, including by establishing mechanisms enabling the detection and reporting of suspicious transactions. The obligations on online marketplaces under this Regulation should not amount to a general monitoring obligation. Providers designated as very large online platforms or very large online search engines pursuant to Regulation (EU) 2022/2065 should, where relevant to the functioning and use of their services, take into account risks related to the diversion and illicit trade of drug precursors in the risk assessments carried out pursuant to Article 34 of that Regulation and adopt reasonable, proportionate and effective mitigation measures pursuant to Article 35 thereof. The implementation of those obligations should ensure coherence with Regulation (EU) 2022/2065 and should not impose additional general monitoring obligations.

Or. en

Amendment 52

Brando Benifei, Evin Incir

Proposal for a regulation

Recital 8

Text proposed by the CommissionAmendment
(8) This Regulation should lay down specific obligations for online marketplaces with respect to reporting suspicious transactions with scheduled drug precursors that take place on their websites or that use their computing services, once they have become aware of information leading to such a suspicion. The obligations on online marketplaces under this Regulation should not amount to a general monitoring obligation.(8) This Regulation should lay down specific obligations for online marketplaces with respect to reporting suspicious transactions with scheduled drug precursors that take place on their websites or that use their computing services, once they have become aware of information leading to such a suspicion. The obligations on online marketplaces under this Regulation should not amount to a general monitoring obligation. In line with Regulation (…) establishing the Union Customs Code and the European Union Customs Authority, providers of online marketplaces should be deemed to be the importers for distance sales. To close the regulatory gap before the revised Union Customs Code takes effect, those providers should appoint a responsible person established in the Union, empowered to represent them in all matters relating to the application of this Regulation.

Or. en

Amendment 53

Saskia Bricmont

Proposal for a regulation

Recital 8

Text proposed by the CommissionAmendment
(8) This Regulation should lay down specific obligations for online marketplaces with respect to reporting suspicious transactions with scheduled drug precursors that take place on their websites or that use their computing services, once they have become aware of information leading to such a suspicion. The obligations on online marketplaces under this Regulation should not amount to a general monitoring obligation.(8) This Regulation should lay down specific obligations for online marketplaces with respect to reporting suspicious transactions with scheduled drug precursors that take place on their websites or that use their computing services, once they have become aware of information leading to such a suspicion. The obligations on online marketplaces under this Regulation should not amount to a general monitoring obligation. For the sake of clarity, as long as they are covered by the definition of importers under the modernised Union Customs Code, online marketplaces are subject to the obligations on external traders set out in this Regulation.

Or. en

Amendment 54

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Recital 8

Text proposed by the CommissionAmendment
(8) This Regulation should lay down specific obligations for online marketplaces with respect to reporting suspicious transactions with scheduled drug precursors that take place on their websites or that use their computing services, once they have become aware of information leading to such a suspicion. The obligations on online marketplaces under this Regulation should not amount to a general monitoring obligation.(8) This Regulation should lay down specific obligations for online marketplaces with respect to reporting suspicious transactions with scheduled drug precursors that take place on their websites or that use their computing services, once they have become aware of information leading to such a suspicion. The obligations on online marketplaces under this Regulation should not amount to a general monitoring obligation, nor an obligation to actively seek facts or circumstances indicating illegal activity.

Or. sk

Justification

Online marketplace operators should not be held liable for content or transactions of which they have no knowledge. Obligations should only arise after specific information about a possible violation of legal regulations has been obtained.

Amendment 55

Sebastian Tynkkynen

Proposal for a regulation

Recital 8

Text proposed by the CommissionAmendment
(8) This Regulation should lay down specific obligations for online marketplaces with respect to reporting suspicious transactions with scheduled drug precursors that take place on their websites or that use their computing services, once they have become aware of information leading to such a suspicion. The obligations on online marketplaces under this Regulation should not amount to a general monitoring obligation.(8) This Regulation should lay down specific obligations for online marketplaces with respect to reporting suspicious transactions with scheduled drug precursors that take place on their websites or that use their computing services, once they have become aware of information leading to such a suspicion. The obligations on online marketplaces under this Regulation should not amount to a general monitoring obligation, unless the national authority deems it necessary.

Or. fi

Amendment 56

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 8 a (new)

Text proposed by the CommissionAmendment
(8a) This Regulation shall apply to scheduled drug precursors throughout their life cycle, including where such precursors are discarded, surrendered, returned or transferred for disposal, recovery or final treatment, until they are irreversibly rendered unusable and non-recoverable as drug precursors. In order to ensure traceability and prevent diversion at the end of the supply chain, operators involved in the collection, destruction or downstream treatment of scheduled drug precursors should be subject to appropriate registration and record-keeping requirements.

Or. en

Amendment 57

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 9

Text proposed by the CommissionAmendment
(9) Category 1 drug precursors should be subject to strict control rules as they contain substances playing a key role in the illicit manufacture of drugs, but also with important legitimate uses which increases the risk of diversion from licit channels. Operators making available on the market, importing, exporting, performing intermediary activities, possessing or using such drug precursors should continue to be required to hold a licence, as this offers national authorities the possibility to make a thorough check of their legitimate intentions before the activity can be performed. Where fees are levied at national level for obtaining a licence, Member States should adjust such fees in order to safeguard the competitiveness of small and medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC17 . The existing obligation of operators to verify that their customers also hold a licence should be maintained, as it proved to be an efficient way of verifying the reliability of such customers. However, the obligation to obtain customer declarations should no longer be maintained, as it leads to administrative burden without clear benefits in terms of facilitating the identification of suspicious transactions. It is also important to maintain the existing obligation of operators trading in Category 1 drug precursors to secure premises, and to extend it to operators using such drug precursors, given their high risk of diversion.(9) Category 1 drug precursors should be subject to strict control and monitoring rules as they contain substances playing a key role in the illicit manufacture of drugs, but also with important legitimate uses which increases the risk of diversion from licit channels. Operators making available on the market, importing, exporting, performing intermediary activities, possessing or using such drug precursors should continue to be required to hold a licence, as this offers national authorities the possibility to make a thorough check of their legitimate intentions before the activity can be performed. Where fees are levied at national level for obtaining a licence, Member States should adjust such fees in order to safeguard the competitiveness of small and medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC17 thereby avoiding disproportionate administrative burdens for those enterprises. In order to promote a consistent application of such reductions across the Union and enhance legal certainty for economic operators, guidance should be developed on the application of fee reductions for small and medium-sized enterprises, including the possible use of graduated approaches reflecting the size category of the enterprise and objective and transparent criteria related to the administrative workload associated with the processing of applications. The existing obligation of operators to verify that their customers also hold a licence should be maintained, as it proved to be an efficient way of verifying the reliability of such customers. However, the obligation to obtain customer declarations should no longer be maintained, as it leads to administrative burden without clear benefits in terms of facilitating the identification of suspicious transactions. It is also important to maintain the existing obligation of operators trading in Category 1 drug precursors to secure premises, and to extend it to operators using such drug precursors, given their high risk of diversion.
17 (18)Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises, C(2003) 1422 (OJ L 124, 20.5.2003, pp. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).17 (18)Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises, C(2003) 1422 (OJ L 124, 20.5.2003, pp. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).

Or. en

Amendment 58

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Recital 9

Text proposed by the CommissionAmendment
(9) Category 1 drug precursors should be subject to strict control rules as they contain substances playing a key role in the illicit manufacture of drugs, but also with important legitimate uses which increases the risk of diversion from licit channels. Operators making available on the market, importing, exporting, performing intermediary activities, possessing or using such drug precursors should continue to be required to hold a licence, as this offers national authorities the possibility to make a thorough check of their legitimate intentions before the activity can be performed. Where fees are levied at national level for obtaining a licence, Member States should adjust such fees in order to safeguard the competitiveness of small and medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC(17). The existing obligation of operators to verify that their customers also hold a licence should be maintained, as it proved to be an efficient way of verifying the reliability of such customers. However, the obligation to obtain customer declarations should no longer be maintained, as it leads to administrative burden without clear benefits in terms of facilitating the identification of suspicious transactions. It is also important to maintain the existing obligation of operators trading in Category 1 drug precursors to secure premises, and to extend it to operators using such drug precursors, given their high risk of diversion.(9) Category 1 drug precursors should be subject to strict control rules as they contain substances playing a key role in the illicit manufacture of drugs, but also with important legitimate uses which increases the risk of diversion from licit channels. Operators making available on the market, importing, exporting, performing intermediary activities, possessing or using such drug precursors should continue to be required to hold a licence, as this offers national authorities the possibility to make a thorough check of their legitimate intentions before the activity can be performed. Where fees are levied at national level for obtaining a licence, Member States should adjust such fees in order to safeguard the competitiveness of small and medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC17, whereas the amount of fees should be proportionate to the actual administrative costs associated with issuing and managing the permit. The existing obligation of operators to verify that their customers also hold a licence should be maintained, as it proved to be an efficient way of verifying the reliability of such customers. However, the obligation to obtain customer declarations should no longer be maintained, as it leads to administrative burden without clear benefits in terms of facilitating the identification of suspicious transactions. It is also important to maintain the existing obligation of operators trading in Category 1 drug precursors to secure premises, and to extend it to operators using such drug precursors, given their high risk of diversion.
(17) (18)Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises, C(2003) 1422 (OJ L 124, 20.5.2003, pp. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).(17) (18)Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises, C(2003) 1422 (OJ L 124, 20.5.2003, pp. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).

Or. sk

Justification

Authorisation regimes must not impose a disproportionate financial burden on economic operators. Fees should reflect real administrative costs and should not constitute an additional regulatory burden.

Amendment 59

Sebastian Tynkkynen

Proposal for a regulation

Recital 9

Text proposed by the CommissionAmendment
(9) Category 1 drug precursors should be subject to strict control rules as they contain substances playing a key role in the illicit manufacture of drugs, but also with important legitimate uses which increases the risk of diversion from licit channels. Operators making available on the market, importing, exporting, performing intermediary activities, possessing or using such drug precursors should continue to be required to hold a licence, as this offers national authorities the possibility to make a thorough check of their legitimate intentions before the activity can be performed. Where fees are levied at national level for obtaining a licence, Member States should adjust such fees in order to safeguard the competitiveness of small and medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC(17). The existing obligation of operators to verify that their customers also hold a licence should be maintained, as it proved to be an efficient way of verifying the reliability of such customers. However, the obligation to obtain customer declarations should no longer be maintained, as it leads to administrative burden without clear benefits in terms of facilitating the identification of suspicious transactions. It is also important to maintain the existing obligation of operators trading in Category 1 drug precursors to secure premises, and to extend it to operators using such drug precursors, given their high risk of diversion.(9) Category 1 drug precursors should be subject to strict control rules as they contain substances playing a key role in the illicit manufacture of drugs, but also with important legitimate uses which increases the risk of diversion from licit channels. Operators making available on the market, importing, exporting, performing intermediary activities, possessing or using such drug precursors should continue to be required to hold a licence, as this offers national authorities the possibility to make a thorough check of their legitimate intentions before the activity can be performed. Where fees are levied at national level for obtaining a licence, Member States should adjust such fees in order to safeguard the competitiveness of small and medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC(17). The existing obligation of operators to verify that their customers also hold a licence should be maintained, as it proved to be an efficient way of verifying the reliability of such customers. However, the obligation to obtain customer declarations should no longer be maintained, unless the national authority deems it absolutely necessary, as it leads to administrative burden without clear benefits in terms of facilitating the identification of suspicious transactions. It is also important to maintain the existing obligation of operators trading in Category 1 drug precursors to secure premises, and to extend it to operators using such drug precursors, given their high risk of diversion.
(17) (18)Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises, C(2003) 1422 (OJ L 124, 20.5.2003, pp. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).(17) (18)Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises, C(2003) 1422 (OJ L 124, 20.5.2003, pp. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).

Or. fi

Amendment 60

Brando Benifei, Evin Incir

Proposal for a regulation

Recital 9 a (new)

Text proposed by the CommissionAmendment
(9a) The misuse of legitimate e-commerce services may facilitate the diversion of drug precursors towards illicit drug manufacture. Given the high risk posed by Category 1 drug precursors, providers of online marketplaces facilitating distance contracts for their sale should verify, through the centralised electronic system, that the operators involved hold valid licences. This targeted, automated verification is proportionate, entails limited additional cost, limits data processing to what is necessary, and does not amount to a general monitoring obligation.

Or. en

Amendment 61

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 10

Text proposed by the CommissionAmendment
(10) Category 2 drug precursors are precursors which, even though frequently used in the illicit production of drugs, are traded in significant quantities in the internal market and external trade and have extensive legitimate uses. While the risk of diversion is significant, strict control measures would be very cumbersome both for the industry and for the national authorities, with limited added value for the identification of suspicious activities. Therefore, the control and monitoring measures under this Regulation should be focused only on the external trade. To reduce the administrative burden, obligations for external traders should be limited to registering their activities, without the requirement of approval by national authorities.(10) Category 2 drug precursors are precursors which, even though frequently used in the illicit production of drugs, are traded in significant quantities in the internal market and external trade and have extensive legitimate uses. While the risk of diversion is significant, strict control measures could impose a substantial administrative and operational burden on economic operators and national authorities, without being fully proportionate to the level of risk and the objectives of detecting illicit activities. Therefore, the control and monitoring measures under this Regulation should be proportionate to the level of risk and focused on operations presenting an increased risk of diversion. To reduce the administrative burden, obligations for external traders concerned should be based on a registration system. In exceptional and duly justified circumstances involving emerging substances that may present a significant risk of diversion towards the illicit manufacture of drugs, Member States should also be able to adopt temporary and proportionate safeguard measures pending the adoption of measures at Union level.

Or. en

Amendment 62

Jaroslav Bžoch

Proposal for a regulation

Recital 10

Text proposed by the CommissionAmendment
(10) Category 2 drug precursors are precursors which, even though frequently used in the illicit production of drugs, are traded in significant quantities in the internal market and external trade and have extensive legitimate uses. While the risk of diversion is significant, strict control measures would be very cumbersome both for the industry and for the national authorities, with limited added value for the identification of suspicious activities. Therefore, the control and monitoring measures under this Regulation should be focused only on the external trade. To reduce the administrative burden, obligations for external traders should be limited to registering their activities, without the requirement of approval by national authorities.(10) Category 2 drug precursors are precursors which, even though frequently used in the illicit production of drugs, are traded in significant quantities in the internal market and external trade and have extensive legitimate uses. While the risk of diversion is significant, strict control measures would be very cumbersome for the industry. Therefore, the control and monitoring measures under this Regulation should be proportionate to allow for the identification of suspicious activities without creating an additional administrative burden for the operators. The main focus of the control and monitoring measures related to category 2 drug precursors should be on the external trade. However, in view of the significant risk of diversion, competent national authorities should also be allowed to continue monitoring the intra-Union movements of category 2 drug precursors. To reduce the administrative burden, obligations for external traders should be limited to registering their activities, without the requirement of approval by national authorities.

Or. en

Amendment 63

Sebastian Tynkkynen

Proposal for a regulation

Recital 10

Text proposed by the CommissionAmendment
(10) Category 2 drug precursors are precursors which, even though frequently used in the illicit production of drugs, are traded in significant quantities in the internal market and external trade and have extensive legitimate uses. While the risk of diversion is significant, strict control measures would be very cumbersome both for the industry and for the national authorities, with limited added value for the identification of suspicious activities. Therefore, the control and monitoring measures under this Regulation should be focused only on the external trade. To reduce the administrative burden, obligations for external traders should be limited to registering their activities, without the requirement of approval by national authorities.(10) Category 2 drug precursors are precursors which, even though frequently used in the illicit production of drugs, are traded in significant quantities in the internal market and external trade and have extensive legitimate uses. While the risk of diversion is significant, strict control measures would be very cumbersome both for the industry and for the national authorities, with limited added value for the identification of suspicious activities. Therefore, the control and monitoring measures under this Regulation should be focused only on the external trade, unless the national authority also deems it essential to monitor internal trade. To reduce the administrative burden, obligations for external traders should be limited to registering their activities, without the requirement of approval by national authorities.

Or. fi

Amendment 64

Brando Benifei, Evin Incir

Proposal for a regulation

Recital 10

Text proposed by the CommissionAmendment
(10) Category 2 drug precursors are precursors which, even though frequently used in the illicit production of drugs, are traded in significant quantities in the internal market and external trade and have extensive legitimate uses. While the risk of diversion is significant, strict control measures would be very cumbersome both for the industry and for the national authorities, with limited added value for the identification of suspicious activities. Therefore, the control and monitoring measures under this Regulation should be focused only on the external trade. To reduce the administrative burden, obligations for external traders should be limited to registering their activities, without the requirement of approval by national authorities.(10) Category 2 drug precursors are precursors which, even though frequently used in the illicit production of drugs, are traded in significant quantities in the internal market and external trade and have extensive legitimate uses. Since the risk of diversion is significant for certain category 2 drug precursors, strict control measures and registration continue to be needed for these certain category 2 drug precursors. For the rest of category 2 drug precursors, the control and monitoring measures under this Regulation should be focused only on the external trade. To reduce the administrative burden, obligations for external traders should be limited to registering their activities, without the requirement of approval by national authorities.

Or. en

Amendment 65

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Recital 11

Text proposed by the CommissionAmendment
(11) Category 3 drug precursors should be introduced to address the particularities and high risks for use in illicit drug production associated with designer precursors, which play a significant role in the illicit manufacture of drugs, as demonstrated by their high proportion in the number of seizures in the recent years, and do not have any known legitimate use other than research and innovation. Such precursors do not follow the traditional pattern of diversion from licit channels towards the illicit manufacture of drugs. In support of the fight against the production and trafficking of illicit drugs, it is therefore important to ban them from: being made available on the market; import; export; intermediary activities; and their use or possession.(11) Category 3 drug precursors should be introduced to address the particularities and high risks for use in illicit drug production associated with designer precursors, which play a significant role in the illicit manufacture of drugs, as demonstrated by their high proportion in the number of seizures in the recent years, and do not have any known legitimate use on a commercial or industrial scale other than research and innovation. Such precursors do not follow the traditional pattern of diversion from licit channels towards the illicit manufacture of drugs. In support of the fight against the production and trafficking of illicit drugs, it is therefore important to ban them from: being made available on the market; import; export; intermediary activities; and their use or possession, except for activities carried out for the purposes of scientific research, development or forensic analysis under the supervision of the competent authorities.

Or. sk

Justification

The proposed regulation primarily clarifies the scope of legitimate use of the substances in question and increases legal certainty in their categorisation. Furthermore, a complete ban could disproportionately impact legitimate scientific research and innovation activities. The exception for controlled research allows for maintaining a high level of protection against misuse while respecting the needs of the scientific community.

Amendment 66

Sebastian Tynkkynen

Proposal for a regulation

Recital 11

Text proposed by the CommissionAmendment
(11) Category 3 drug precursors should be introduced to address the particularities and high risks for use in illicit drug production associated with designer precursors, which play a significant role in the illicit manufacture of drugs, as demonstrated by their high proportion in the number of seizures in the recent years, and do not have any known legitimate use other than research and innovation. Such precursors do not follow the traditional pattern of diversion from licit channels towards the illicit manufacture of drugs. In support of the fight against the production and trafficking of illicit drugs, it is therefore important to ban them from: being made available on the market; import; export; intermediary activities; and their use or possession.(11) Category 3 drug precursors should be introduced to address the particularities and high risks for use in illicit drug production associated with designer precursors, which play a significant role in the illicit manufacture of drugs, as demonstrated by their high proportion in the number of seizures in the recent years, and do not have any known legitimate use other than research and innovation. Such precursors do not follow the traditional pattern of diversion from licit channels towards the illicit manufacture of drugs. In support of the fight against the production and trafficking of illicit drugs, it is therefore important to ban them from: being made available on the market; import; export; intermediary activities; and their use, possession or unlicensed production.

Or. fi

Amendment 67

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 12

Text proposed by the CommissionAmendment
(12) However, as Category 3 drug precursors can be used in research and innovation and other legitimate uses may be discovered after the inclusion of various substances in the annex to this Regulation, it is important to set out rules allowing operators to perform activities with such precursors. Should small quantities of designer precursors be needed for research and innovation, operators should be required to file a prior notification to the competent authority in the Member State where they are established. That will encourage research and innovation by not imposing costly and lengthy formalities for transactions of low quantities and therefore low risk. Should operators need Category 3 drug precursors in higher quantities or for legitimate purposes other than research and innovation, they should then be required to obtain a licence in accordance with the provisions for Category 1 drug precursors, as the risks are similar.(12) However, as Category 3 drug precursors can be used in research and innovation and other legitimate uses may be discovered after the inclusion of various substances in the annex to this Regulation, it is important to set out rules allowing operators to perform activities with such precursors. Should small quantities of designer precursors be needed for research and innovation, operators should be required to file a prior notification to the competent authority in the Member State where they are established. That will encourage research and innovation by not imposing costly and lengthy formalities for transactions of low quantities and therefore low risk. Should operators need Category 3 drug precursors in higher quantities or for legitimate purposes other than research and innovation, they should then be required to obtain a licence equivalent to the licence under in accordance with the provisions for Category 1 drug precursors, as the risks are similar.

Or. en

Amendment 68

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 13

Text proposed by the CommissionAmendment
(13) As new designer precursors can be easily created by modifying the chemical structure of substances placed under control, it is important that this Regulation is adapted to cater for the introduction of both a list of substances identified individually and of groups of substances identified in a generic way in Category 3 drug precursors. Whenever a group of substances is included in a generic way, an exemption list should be provided to exclude individual substances that are part of this group but for which a legitimate use other than research and innovation has been identified and which are not included in either Category 1 or Category 2 drug precursors.(13) As new designer precursors can be easily created by modifying the chemical structure of substances placed under control, it is important that this Regulation is adapted to cater for the introduction of both a list of substances identified individually and of groups of substances identified in a generic way in Category 3 drug precursors to prevent circumvention through chemical structure modification while preserving legitimate uses and the proportionality of the control system. Whenever a group of substances is included in a generic way, an exemption list should be provided to exclude individual substances that are part of this group but for which a legitimate use other than research and innovation has been identified and which are not included in either Category 1 or Category 2 drug precursors.

Or. en

Amendment 69

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Recital 13

Text proposed by the CommissionAmendment
(13) As new designer precursors can be easily created by modifying the chemical structure of substances placed under control, it is important that this Regulation is adapted to cater for the introduction of both a list of substances identified individually and of groups of substances identified in a generic way in Category 3 drug precursors. Whenever a group of substances is included in a generic way, an exemption list should be provided to exclude individual substances that are part of this group but for which a legitimate use other than research and innovation has been identified and which are not included in either Category 1 or Category 2 drug precursors.(13) As new designer precursors can be easily created by modifying the chemical structure of substances placed under control, it is important that this Regulation is adapted to cater for the introduction of both a list of substances identified individually and of groups of substances identified in a generic way in Category 3 drug precursors. Whenever a group of substances is included in a generic way, an exemption list should be provided to exclude individual substances that are part of this group but for which a legitimate use other than research and innovation has been identified and which are not included in either Category 1 or Category 2 drug precursors, on the basis of a scientifically sound and transparent risk assessment.

Or. sk

Justification

The inclusion of substances in generically defined groups should be accompanied by a transparent and scientifically sound assessment to avoid unintentionally restricting legitimate economic or research activities.

Amendment 70

Benoit Cassart, Sophie Wilmès, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 13 a (new)

Text proposed by the CommissionAmendment
(13a) Particular attention should be paid to substances that are not yet scheduled but have been identified by the Union monitoring, early-warning or risk-assessment mechanisms as presenting a risk of diversion for the illicit manufacture of drugs. Operators should be encouraged to cooperate with the competent authorities in reporting suspicious transactions involving such substances.

Or. en

Amendment 71

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Recital 14

Text proposed by the CommissionAmendment
(14) The requirement for obtaining import and export authorisations should be removed and replaced by quantity management, comprising quantity notification by operators and automatic verifications by customs authorities for import and export. That should reduce the administrative burden for external traders, whilst at the same time maintaining strict controls of drug precursors entering or leaving the customs territory of the Union and ensuring continued fulfilment of the UN Convention by the Union and its Members States.(14) The requirement for obtaining import and export authorisations should be removed and replaced by quantity management, comprising quantity notification by operators and automatic verifications by customs authorities for import and export. That should reduce the administrative burden for external traders, whilst at the same time maintaining strict controls of drug precursors entering or leaving the customs territory of the Union and ensuring continued fulfilment of the UN Convention by the Union and its Members States, while Member States should be able to maintain or introduce additional control measures where an identified increased risk exists.

Or. sk

Justification

Risk profiles may differ between Member States. National authorities should be able to respond to specific security threats.

Amendment 72

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 14

Text proposed by the CommissionAmendment
(14) The requirement for obtaining import and export authorisations should be removed and replaced by quantity management, comprising quantity notification by operators and automatic verifications by customs authorities for import and export. That should reduce the administrative burden for external traders, whilst at the same time maintaining strict controls of drug precursors entering or leaving the customs territory of the Union and ensuring continued fulfilment of the UN Convention by the Union and its Members States.(14) The requirement for obtaining import and export authorisations should be removed and replaced by quantity management, comprising prior quantity notification by operators risk-based customs controls for import and export, supported by digital monitoring and automated analysis tools. That should reduce the administrative burden for external traders, whilst at the same time maintaining strict controls of drug precursors entering or leaving the customs territory of the Union and ensuring continued fulfilment of the UN Convention by the Union and its Members States.

Or. en

Amendment 73

Sophie Wilmès, Benoit Cassart, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 15

Text proposed by the CommissionAmendment
(15) In accordance with Article 12(10) of the UN Convention, the effectiveness and practicability of pre-export notifications is fully recognised. However, exports to non-Member States participating in the Union Single Market and exports to countries where an international agreement waives the pre-export notification, should be exempt from the pre-export notification obligation.(15) In accordance with Article 12(10) of the UN Convention, the effectiveness and practicability of pre-export notifications is fully recognised. In order to ensure that this mechanism remains efficient and does not create unnecessary administrative burdens or lead to the accumulation of pending notifications and delays in legitimate trade, the period granted to the country of destination to reply should be limited. In the absence of any indication from the competent authorities of the country of destination that the export operation may be intended for the illicit manufacture of narcotic drugs or psychotropic substances, the competent authorities of the Member State of export should be able to authorise the export after the expiry of that period.

Or. en

Amendment 74

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Recital 15

Text proposed by the CommissionAmendment
(15) In accordance with Article 12(10) of the UN Convention, the effectiveness and practicability of pre-export notifications is fully recognised. However, exports to non-Member States participating in the Union Single Market and exports to countries where an international agreement waives the pre-export notification, should be exempt from the pre-export notification obligation.(15) In accordance with Article 12(10) of the UN Convention, the effectiveness and practicability of pre-export notifications is fully recognised. However, exports to non-Member States participating in the Union Single Market and exports to countries where an international agreement waives the pre-export notification, should be exempt from the pre-export notification obligation, provided that this does not reduce the level of protection against the misuse of drug precursors and that equivalent control mechanisms are ensured.

Or. sk

Justification

Exemptions from the pre-export notification regime should be conditional on maintaining an appropriate level of control. The aim is to ensure that the simplification of administrative procedures does not lead to the creation of weaknesses in the drug precursor monitoring system.

Amendment 75

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 16

Text proposed by the CommissionAmendment
(16) To enforce this Regulation effectively, it is important to enable competent authorities to request proof of licit purposes for drug precursors entering the customs territory of the Union.(16) To enforce this Regulation effectively, it is important to enable competent authorities to request based on a risk-based approach, evidence justifying the lawful purpose of drug precursors entering the customs territory of the Union.

Or. en

Amendment 76

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 17

Text proposed by the CommissionAmendment
(17) It is essential to step up efforts for raising the awareness of legitimate operators to the risks associated with non-scheduled precursors, to support them in identifying suspicious transactions and notifying them on voluntary basis. Thus, extensive information on drug precursors, including non-scheduled ones, and a tool to help determine the scope of scheduled designer precursors, will be made available through a Drug Precursors Information Repository.(17) It is essential to step up efforts for raising the awareness of legitimate operators to the risks associated with non-scheduled precursors, to support them in identifying suspicious transactions and notifying them on voluntary basis. Thus, extensive information on drug precursors, including non-scheduled ones, and a tool to help determine the scope of scheduled designer precursors, will be made available through a Drug Precursors Information Repository. Special attention should be paid to SMEs to avoid a disproportionate burden and the risk of over-reporting, which could overwhelm the competent authorities and affect the effectiveness of the system.

Or. en

Amendment 77

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Recital 17

Text proposed by the CommissionAmendment
(17) It is essential to step up efforts for raising the awareness of legitimate operators to the risks associated with non-scheduled precursors, to support them in identifying suspicious transactions and notifying them on voluntary basis. Thus, extensive information on drug precursors, including non-scheduled ones, and a tool to help determine the scope of scheduled designer precursors, will be made available through a Drug Precursors Information Repository.(17) It is essential to step up efforts for raising the awareness of legitimate operators to the risks associated with non-scheduled precursors, to support them in identifying suspicious transactions and notifying them on voluntary basis. Thus, extensive information on drug precursors, including non-scheduled ones, and a tool to help determine the scope of scheduled designer precursors, will be made available through a Drug Precursors Information Repository, while the use of such tools should not create any new legal obligations for economic operators beyond those laid down in this Regulation.

Or. sk

Justification

Databases and support tools can help with compliance, but they should not create new obligations or legal uncertainty for economic operators without an explicit legal basis in the Regulation.

Amendment 78

Brando Benifei, Evin Incir

Proposal for a regulation

Recital 17

Text proposed by the CommissionAmendment
(17) It is essential to step up efforts for raising the awareness of legitimate operators to the risks associated with non-scheduled precursors, to support them in identifying suspicious transactions and notifying them on voluntary basis. Thus, extensive information on drug precursors, including non-scheduled ones, and a tool to help determine the scope of scheduled designer precursors, will be made available through a Drug Precursors Information Repository.(17) It is essential to step up efforts for raising the awareness of legitimate operators to the risks associated with non-scheduled precursors, to support them in identifying suspicious transactions and notifying them. Thus, extensive information on drug precursors, including non-scheduled ones, and a tool to help determine the scope of scheduled designer precursors, will be made available through a Drug Precursors Information Repository.

Or. en

Amendment 79

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Recital 18

Text proposed by the CommissionAmendment
(18) The Drug Precursors Information Repository should be developed, maintained, and kept up to date by the European Union Drugs Agency and should replace the existing Voluntary Monitoring List. The Repository should contain comprehensive information on scheduled and non-scheduled drug precursors, and their legitimate and illicit uses, to support operators in identifying suspicious transactions and Member States and the Commission in identifying new trends in the illicit production of drugs.(18) The Drug Precursors Information Repository should be developed, maintained, and kept up to date by the European Union Drugs Agency in close cooperation with the competent authorities of the Member States and taking into account information provided by economic operators and the scientific community and should replace the existing Voluntary Monitoring List. The Repository should contain comprehensive information on scheduled and non-scheduled drug precursors, and their legitimate and illicit uses, to support operators in identifying suspicious transactions and Member States and the Commission in identifying new trends in the illicit production of drugs, whereas the information contained in the database should be informative in nature and should not, in itself, create any new legal obligations or alter the legal status of substances under this Regulation.

Or. sk

Justification

Identifying new trends in the field of design precursors requires the use of expertise from Member States, scientific institutions and the economic operators concerned.

Amendment 80

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 18

Text proposed by the CommissionAmendment
(18) The Drug Precursors Information Repository should be developed, maintained, and kept up to date by the European Union Drugs Agency and should replace the existing Voluntary Monitoring List. The Repository should contain comprehensive information on scheduled and non-scheduled drug precursors, and their legitimate and illicit uses, to support operators in identifying suspicious transactions and Member States and the Commission in identifying new trends in the illicit production of drugs.(18) The Drug Precursors Information Repository should be developed, maintained, and kept up to date by the European Union Drugs Agency and should replace the existing Voluntary Monitoring List. The Repository should contain comprehensive information on scheduled and non-scheduled drug precursors, and their legitimate and illicit uses, to support operators in identifying suspicious transactions and Member States and the Commission in identifying new trends in the illicit production of drugs. The Agency should carry out these missions in compliance with the responsibilities of the competent national authorities and by ensuring effective coordination between the national and Union levels.

Or. en

Amendment 81

Saskia Bricmont

Proposal for a regulation

Recital 18 a (new)

Text proposed by the CommissionAmendment
(18a) Effective prevention of the diversion of drug precursors and the timely detection of emerging trafficking methods require a strong analytical, operational and scientific contribution at Union level. In accordance with its mandate, the European Union Drugs Agency (‘the Agency’) is best placed to support the implementation of this Regulation by providing risk assessments, strategic and operational analysis, early warning and trend monitoring, technical and scientific expertise, training activities, and support for information exchange and cooperation among competent national authorities and with relevant Union bodies and international partners. In order to ensure the effective and sustainable fulfilment of those tasks, the Agency should be provided with adequate and predictable financial and human resources, commensurate with the responsibilities entrusted to it under this Regulation and the evolving challenges posed by the illicit diversion and trafficking of drug precursors. The Commission and the Member States should therefore ensure that the Agency is able to contribute effectively to the objectives of this Regulation.

Or. en

Amendment 82

Evin Incir, Brando Benifei

Proposal for a regulation

Recital 19

Text proposed by the CommissionAmendment
(19) Member States should organise regular training to raise awareness on the risks of diversion of drug precursors and the significant role which operators can play in the fight against the illicit manufacture of drugs.(19) Member States should organise regular and specialised training for competent authorities, as well as awareness-raising activities for operators, on the risks of diversion of drug precursors and the significant role which operators can play in the fight against the illicit manufacture of drugs. Member States should, where appropriate, involve civil society actors in these efforts, given their role in prevention, early identification of risks, and outreach to vulnerable groups.

Or. en

Amendment 83

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Recital 19

Text proposed by the CommissionAmendment
(19) Member States should organise regular training to raise awareness on the risks of diversion of drug precursors and the significant role which operators can play in the fight against the illicit manufacture of drugs.(19) Member States should organise regular training, proportionate to the identified risks and to the needs of the economic operators concerned, to raise awareness on the risks of diversion of drug precursors and the significant role which operators can play in the fight against the illicit manufacture of drugs.

Or. sk

Justification

Training activities should be based on the principle of proportionality and take into account the real level of risk in individual Member States and sectors.

Amendment 84

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 19

Text proposed by the CommissionAmendment
(19) Member States should organise regular training to raise awareness on the risks of diversion of drug precursors and the significant role which operators can play in the fight against the illicit manufacture of drugs.(19) Member States should organise regular training to exchange best practices and raise awareness on the risks of diversion of drug precursors and the significant role which operators can play in the fight against the illicit manufacture of drugs.

Or. en

Amendment 85

Giuseppe Antoci

Proposal for a regulation

Recital 19 a (new)

Text proposed by the CommissionAmendment
(19a) Awareness-raising and training activities provided for by this Regulation should into take account the needs of both economic operators and health and social services that work with drug users. Harm reduction programmes, addiction treatment services and organisations that provide healthcare to vulnerable individuals together form an important prevention network and can play a supplementary role in identifying the misuse of precursors. The controls provided for by this Regulation should not, therefore, serve to limit such services from availing themselves of the substances they need to perform their legitimate activities or from carrying out their work effectively to safeguard public health.

Or. it

Amendment 86

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 19 a (new)

Text proposed by the CommissionAmendment
(19a) The prevention of the diversion of drug precursors from licit trade requires close cooperation and effective synergies between Member States, the Commission and the relevant Union agencies, acting within the limits of their respective mandates. The exchange of information and expertise on emerging trends, suspicious patterns and methods of diversion, together with appropriate feedback mechanisms, should contribute to strengthening risk assessment, identifying vulnerabilities in supply chains and supporting the effective implementation of this Regulation. Cooperation with third countries should also be promoted in a coherent and coordinated manner, ensuring consistency between relevant Union instruments, international agreements and the activities of the Union bodies involved.

Or. en

Amendment 87

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 20

Text proposed by the CommissionAmendment
(20) Mutual assistance between Member States and between Member States and the Commission should be reinforced, in particular by recourse to Council Regulation (EC) No 515/97(18) .(20) Mutual assistance between Member States and between Member States and the Commission should be reinforced to improve the prevention, detection, and prosecution of the diversion of drug precursors. This enhanced cooperation should enable a faster and more comprehensive exchange of relevant information and greater coherence in the actions taken. To this end, the framework established by Council Regulation (EC) No 515/97(18), which facilitates mutual administrative assistance and operational cooperation between competent authorities, should be used where appropriate.
18 (19)Council Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs and agricultural matters (OJ L 82, 22.3.1997, p. 1, ELI: http://data.europa.eu/eli/reg/1997/515/oj).

Or. en

Amendment 88

Benoit Cassart, Sophie Wilmès, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 21

Text proposed by the CommissionAmendment
(21) To prevent the diversion of drug precursors towards the illicit manufacturing of drugs, national authorities and customs authorities should be empowered to seize and confiscate both scheduled and non-scheduled drug precursors, if there are reasonable grounds or evidence that the drug precursor is intended for illicit use.(21) To prevent the diversion of drug precursors towards the illicit manufacturing of drugs, national authorities and customs authorities should be empowered to seize and confiscate both scheduled and non-scheduled drug precursors, if there are reasonable and documented grounds, supported by factual, objective and verifiable evidence that the drug precursor is intended for illicit use. These measures are applied in a manner proportionate to the nature of the substance, the strength of the evidence, and the risk of diversion. In the case of non-scheduled drug precursors, the authorities prioritize temporary detention, the duration of which may not exceed seven working days, to allow for the necessary checks without unduly disrupting legitimate trade.

Or. en

Amendment 89

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Recital 21

Text proposed by the CommissionAmendment
(21) To prevent the diversion of drug precursors towards the illicit manufacturing of drugs, national authorities and customs authorities should be empowered to seize and confiscate both scheduled and non-scheduled drug precursors, if there are reasonable grounds or evidence that the drug precursor is intended for illicit use.(21) To prevent the diversion of drug precursors towards the illicit manufacturing of drugs, national authorities and customs authorities should be empowered to seize and confiscate both scheduled and non-scheduled drug precursors, if there are reasonable grounds or evidence that the drug precursor is intended for illicit use, in accordance with the principle of proportionality and the relevant procedural safeguards laid down in Union and national law.

Or. sk

Justification

The power of seizure and confiscation constitutes a significant interference with property rights. It is therefore appropriate to explicitly emphasise the need to respect the principle of proportionality and procedural guarantees.

Amendment 90

Sebastian Tynkkynen

Proposal for a regulation

Recital 21

Text proposed by the CommissionAmendment
(21) To prevent the diversion of drug precursors towards the illicit manufacturing of drugs, national authorities and customs authorities should be empowered to seize and confiscate both scheduled and non-scheduled drug precursors, if there are reasonable grounds or evidence that the drug precursor is intended for illicit use.(21) To prevent the diversion of drug precursors towards the illicit manufacturing of drugs, national authorities and customs authorities should have the powers to seize and confiscate both scheduled and non-scheduled drug precursors, if they consider it justified.

Or. fi

Amendment 91

Brando Benifei, Evin Incir

Proposal for a regulation

Recital 22

Text proposed by the CommissionAmendment
(22) To ensure the correct application of this Regulation, Member States should lay down rules on penalties applicable for infringement of this Regulation, which should be effective, dissuasive and proportionate.(22) Member States should confer on their competent authorities the power to impose and implement effective, proportionate and dissuasive penalties in cases where the economic operator has failed to comply with this regulation. The rules on penalties should be established by Member States, giving due regard to elements such as the gravity and duration of the infringement, previous infringements by the economic operator, the degree of cooperation with competent authorities and any other mitigating or aggravating factor applicable to the circumstances of the particular case. The Commission should issue guidance for Member States on the method for calculating financial penalties and the thresholds applicable.

Or. en

Amendment 92

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 22

Text proposed by the CommissionAmendment
(22) To ensure the correct application of this Regulation, Member States should lay down rules on penalties applicable for infringement of this Regulation, which should be effective, dissuasive and proportionate.(22) To ensure the correct application of this Regulation, Member States should lay down rules on penalties applicable for infringement of this Regulation, which should be effective, dissuasive and proportionate. These rules and sanctions must be closely coordinated at EU level to prevent criminal "forum shopping," whereby criminal networks exploit disparities in treatment between Member States. To this end, customs and national authorities are required to share, in real time via the EU information system, any blocking, seizure, or detected infringement measures, in order to prevent the immediate redirection of suspicious shipments to another point of entry into the single market.

Or. en

Amendment 93

Saskia Bricmont

Proposal for a regulation

Recital 22

Text proposed by the CommissionAmendment
(22) To ensure the correct application of this Regulation, Member States should lay down rules on penalties applicable for infringement of this Regulation, which should be effective, dissuasive and proportionate.(22) To ensure the correct application of this Regulation, this Regulation should set criteria for penalties to ensure harmonisation and avoid differences among Member States regulatory framework. Member States should follow up on those standards to lay down rules on penalties applicable for infringement of this Regulation, which should be effective, dissuasive and proportionate.

Or. en

Amendment 94

Georgiana Teodorescu

Proposal for a regulation

Recital 22

Text proposed by the CommissionAmendment
(22) To ensure the correct application of this Regulation, Member States should lay down rules on penalties applicable for infringement of this Regulation, which should be effective, dissuasive and proportionate.(22) To ensure the correct application of this Regulation, Member States, in accordance with the principles of subsidiarity and proportionality, should lay down rules on penalties applicable for infringement of this Regulation, which should be effective, dissuasive and proportionate.

Or. en

Amendment 95

Brando Benifei, Evin Incir

Proposal for a regulation

Recital 23

Text proposed by the CommissionAmendment
(23) The annual reporting obligation for operators should be removed, as it has not been proven to be the most efficient measure in the identification of suspicious activities, while being very burdensome for the industry. Instead, the efforts of national authorities should be increased in reporting, without delay, significant seizures of drug precursors. This would ensure that national authorities from other Member States can better target their controls.deleted

Or. en

Amendment 96

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 23

Text proposed by the CommissionAmendment
(23) The annual reporting obligation for operators should be removed, as it has not been proven to be the most efficient measure in the identification of suspicious activities, while being very burdensome for the industry. Instead, the efforts of national authorities should be increased in reporting, without delay, significant seizures of drug precursors. This would ensure that national authorities from other Member States can better target their controls.(23) The annual reporting obligation for operators should be removed, as it has not been proven to be the most efficient measure in the identification of suspicious activities, while being very burdensome for the industry. Instead, the efforts of national authorities should be increased in reporting, without undue delay, significant seizures of drug precursors. This would ensure that national authorities from other Member States can better target their controls, particularly to prevent strategies for circumventing or redirecting shipments.

Or. en

Amendment 97

Evin Incir, Brando Benifei

Proposal for a regulation

Recital 23

Text proposed by the CommissionAmendment
(23) The annual reporting obligation for operators should be removed, as it has not been proven to be the most efficient measure in the identification of suspicious activities, while being very burdensome for the industry. Instead, the efforts of national authorities should be increased in reporting, without delay, significant seizures of drug precursors. This would ensure that national authorities from other Member States can better target their controls.(23) The annual reporting obligation for operators should be removed, as it has not been proven to be the most efficient measure in the identification of suspicious activities, while being very burdensome for the industry. Instead, reporting by national authorities should be strengthened in order to improve the timely detection of significant seizures of drug precursors and to support the effective targeting of controls across Member States. Such reporting should also support the monitoring, evaluation and review of this Regulation.

Or. en

Amendment 98

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 24

Text proposed by the CommissionAmendment
(24) Following the Union’s obligations of reporting in Article 12(12) of the UN Convention and Resolutions of the United Nations Economic and Social Council 1995/20 on measures to strengthen international cooperation to prevent diversion of substances included in table I of the UN Convention and used in the illicit manufacture of stimulants and other psychotropic substances and 49/3 strengthening systems for the control of precursor chemicals used in the manufacture of synthetic drugs, the Commission should draw up an annual report to be sent to the International Narcotics Control Board.(24) Following the Union’s obligations of reporting in Article 12(12) of the UN Convention and Resolutions of the United Nations Economic and Social Council 1995/20 on measures to strengthen international cooperation to prevent diversion of substances included in table I of the UN Convention and used in the illicit manufacture of stimulants and other psychotropic substances and 49/3 strengthening systems for the control of precursor chemicals used in the manufacture of synthetic drugs, the Commission should draw up an annual report to be sent to the International Narcotics Control Board. This report is based on centralised operational data from the Union, ensuring transparent and comprehensive transmission of seizure trends recorded on the single market.

Or. en

Amendment 99

Saskia Bricmont

Proposal for a regulation

Recital 25

Text proposed by the CommissionAmendment
(25) A centralised electronic system should be established to digitalise all the procedures set out in this Regulation. The system should allow operators to fulfil their obligations laid down in this Regulation and competent authorities to make their decisions on the implementation of this Regulation and perform their reporting obligations. The system should also facilitate the communication by the Commission of information requested under the UN Convention. The enforcement of drug precursors entering or leaving the Customs territory of the Union under this Regulation should be facilitated by the interconnection between that electronic system and the ‘EU Single Window Environment for Customs’. In addition, the Commission should explore with the United Nations to possibly interconnect the electronic system with the United Nations system for the reporting of incidents with precursors or other tools, to avoid double reporting and facilitate the international cooperation. The Agency should have access to the information in the electronic system to facilitate the implementation of its mandate under Regulation (EU) 2023/1322 and the development and update of the Drug Precursors Information Repository.(25) A centralised electronic system should be established to digitalise all the procedures set out in this Regulation. The system should allow operators to fulfil their obligations laid down in this Regulation and competent authorities to make their decisions on the implementation of this Regulation and perform their reporting obligations. The system should also facilitate the communication by the Commission of information requested under the UN Convention. The enforcement of drug precursors entering or leaving the Customs territory of the Union under this Regulation should be facilitated by the interconnection between that electronic system and the ‘EU Single Window Environment for Customs’. In addition, the Commission should explore with the United Nations to possibly interconnect the electronic system with the United Nations system for the reporting of incidents with precursors or other tools, to avoid double reporting and facilitate the international cooperation. The Agency should have access to the information in the electronic system to facilitate the implementation of its mandate under Regulation (EU) 2023/1322 and the development and update of the Drug Precursors Information Repository. The electronic system shall be designed to ensure that data available therein is protected from unauthorised access and other threats to its integrity and security, which constitutes a public interest. In the context of tasks related to the development, hosting, operation and maintenance, and any related data processing on the electronic system, any supplier and other service provider, and any subcontractor, shall ensure reliability, security and independence from influence of governments of third countries.

Or. en

Amendment 100

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 25

Text proposed by the CommissionAmendment
(25) A centralised electronic system should be established to digitalise all the procedures set out in this Regulation. The system should allow operators to fulfil their obligations laid down in this Regulation and competent authorities to make their decisions on the implementation of this Regulation and perform their reporting obligations. The system should also facilitate the communication by the Commission of information requested under the UN Convention. The enforcement of drug precursors entering or leaving the Customs territory of the Union under this Regulation should be facilitated by the interconnection between that electronic system and the ‘EU Single Window Environment for Customs’. In addition, the Commission should explore with the United Nations to possibly interconnect the electronic system with the United Nations system for the reporting of incidents with precursors or other tools, to avoid double reporting and facilitate the international cooperation. The Agency should have access to the information in the electronic system to facilitate the implementation of its mandate under Regulation (EU) 2023/1322 and the development and update of the Drug Precursors Information Repository.(25) A centralised electronic system should be established to digitalise all the procedures set out in this Regulation. The system should allow operators to fulfil their obligations laid down in this Regulation and competent authorities to make their decisions on the implementation of this Regulation and perform their reporting obligations. The system should also facilitate the communication by the Commission of information requested under the UN Convention. The enforcement of drug precursors entering or leaving the Customs territory of the Union under this Regulation should be facilitated by the automatic interconnection between that electronic system and the ‘EU Single Window Environment for Customs’ to ensure immediate data interoperability between Member States. In addition, the Commission should explore with the United Nations to possibly interconnect the electronic system with the United Nations system for the reporting of incidents with precursors or other tools, to avoid double reporting and facilitate the international cooperation. The Agency should have access to the information in the electronic system to facilitate the implementation of its mandate under Regulation (EU) 2023/1322 and the development and update of the Drug Precursors Information Repository. The development and operation of this electronic system must guarantee the absolute protection of confidential data and trade secrets of economic operators, in accordance with Directive (EU) 2016/943. Access to sensitive commercial and industrial information must be strictly limited to the competent authorities on a need-to-know basis, and robust security protocols must be deployed to prevent any unauthorized access or data leakage.

Or. en

Amendment 101

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Recital 25

Text proposed by the CommissionAmendment
(25) A centralised electronic system should be established to digitalise all the procedures set out in this Regulation. The system should allow operators to fulfil their obligations laid down in this Regulation and competent authorities to make their decisions on the implementation of this Regulation and perform their reporting obligations. The system should also facilitate the communication by the Commission of information requested under the UN Convention. The enforcement of drug precursors entering or leaving the Customs territory of the Union under this Regulation should be facilitated by the interconnection between that electronic system and the ‘EU Single Window Environment for Customs’. In addition, the Commission should explore with the United Nations to possibly interconnect the electronic system with the United Nations system for the reporting of incidents with precursors or other tools, to avoid double reporting and facilitate the international cooperation. The Agency should have access to the information in the electronic system to facilitate the implementation of its mandate under Regulation (EU) 2023/1322 and the development and update of the Drug Precursors Information Repository.(25) A centralised electronic system should be established to digitalise all the procedures set out in this Regulation. The system should allow operators to fulfil their obligations laid down in this Regulation and competent authorities to make their decisions on the implementation of this Regulation and perform their reporting obligations. The system should also facilitate the communication by the Commission of information requested under the UN Convention. The enforcement of drug precursors entering or leaving the Customs territory of the Union under this Regulation should be facilitated by the interconnection between that electronic system and the ‘EU Single Window Environment for Customs’. In addition, the Commission should explore with the United Nations to possibly interconnect the electronic system with the United Nations system for the reporting of incidents with precursors or other tools, provided that adequate protection of the confidential business information and financial interests of economic operators is maintained, to avoid double reporting and facilitate the international cooperation. The Agency should have access to the information in the electronic system to facilitate the implementation of its mandate under Regulation (EU) 2023/1322 and the development and update of the Drug Precursors Information Repository.

Or. sk

Justification

International data exchange must respect the need to protect sensitive commercial information.

Amendment 102

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 25 a (new)

Text proposed by the CommissionAmendment
(25a) Given the sensitive nature of the information processed in the electronic system established under this Regulation, including information relating to operators, trade flows and the movement of scheduled drug precursors, it is essential to ensure a high level of security, confidentiality and resilience of that system. As is the case for customs systems, the protection of such information constitutes an important public interest, requiring that the electronic system remain under the effective control of the Union and be safeguarded against unauthorised access, unlawful disclosure and undue influence from third countries. The design, operation and procurement of the electronic system should therefore contribute to the Union's digital sovereignty, including by reducing strategic dependencies, ensuring the security of the supply chain and facilitating interoperability and portability.

Or. en

Amendment 103

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 26

Text proposed by the CommissionAmendment
(26) Any processing of personal data under this Regulation should be carried out in compliance with the provisions of Regulation (EU) 2016/67919 or Regulation (EU) 2018/172520 of the European Parliament and of the Council, within their respective scope of application.(26) Any processing of personal data under this Regulation should be carried out in compliance with the provisions of Regulation (EU) 2016/67919 or Regulation (EU) 2018/172520 of the European Parliament and of the Council, within their respective scope of application. Economic operators and individuals have a right to access and quickly rectify their data, as well as accelerated legal remedies to challenge any unjustified blocking or seizure of their goods.
19 (20)Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/679/oj).19 (20)Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/679/oj).
20 (21)Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39, ELI: http://data.europa.eu/eli/reg/2018/1725/oj).20 (21)Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39, ELI: http://data.europa.eu/eli/reg/2018/1725/oj).

Or. en

Amendment 104

Sophie Wilmès, Benoit Cassart, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 26 a (new)

Text proposed by the CommissionAmendment
(26a) For the purposes of this Regulation, in relation to drug precursors and transactions involving drug precursors, “reasonable grounds” should be understood as referring to objective, factual and verifiable elements which, assessed in light of the circumstances of the individual case, would lead a diligent operator or competent authority to suspect that a drug precursor may be intended for the illicit manufacture of drugs. Such grounds can be derived, inter alia, from the nature, quantity or combination of substances ordered, unusual transaction patterns, inconsistencies in the information provided by the customer, atypical methods of payment, transport or delivery, the refusal to provide information required under this Regulation, or information communicated by competent authorities, the Agency or relevant Union or international bodies. The assessment of reasonable grounds should be carried out on a case-by-case basis and in a proportionate manner, taking into account the legitimate commercial and industrial uses of the substances concerned.

Or. en

Amendment 105

Giuseppe Antoci

Proposal for a regulation

Recital 26 a (new)

Text proposed by the CommissionAmendment
(26a) In order to ensure that this Regulation is implemented in a proportionate manner without imposing excessive burdens on legitimate non-profit operators, the procedures and requirements of this Regulation should take into account the specific characteristics of healthcare facilities, harm reduction services, non-profit organisations and public research bodies. Despite operating in compliance with stringent national and Union legislative frameworks, these entities often have limited resources at their disposal and carry out activities in the general public health interest. The competent authorities should therefore adopt a proportionate approach towards operators of this kind, including taking into account their actual risk profile and the purpose of their activities.

Or. it

Amendment 106

Evin Incir, Brando Benifei

Proposal for a regulation

Recital 26 a (new)

Text proposed by the CommissionAmendment
(26a) In order to ensure the effective and uniform application of this Regulation throughout the Union, Member States should ensure that enforcement measures and penalties are effective, proportionate and dissuasive. Significant disparities in enforcement may create vulnerabilities that can be exploited for the diversion of drug precursors and may undermine the proper functioning of the internal market and the protection of public health.

Or. en

Amendment 107

Sebastian Tynkkynen

Proposal for a regulation

Recital 27

Text proposed by the CommissionAmendment
(27) In order to amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty of the Functioning of the European Union should be delegated to the Commission to add or remove substances from the categories of drug precursors, where necessary as a matter of urgency. Given the particularities of designer precursors which are close chemical relatives of scheduled drug precursors and can be easily created, the Commission should have the possibility to add designer precursors also by including groups of substances, identified in a generic way and, where needed, to exclude individual substances part of such groups which have legitimate uses other than research and innovation and which are not to be included in a different category. However, the Commission should not add groups of substances in Category 1 or Category 2 drug precursors, unless this is necessary to fulfil the obligations under the UN Convention. In addition, the Commission should be empowered to amend non-essential elements set out in the annexes concerning licences, registrations, prior notifications, quantity management related to import and export, pre-export notifications, demonstration of licit purposes, determining the criteria for suspicion on intention of use in the illicit manufacture of drugs, transitional measures and reporting. It is of particular importance that the Commission carry out appropriate consultations during the preparatory work for the adoption of delegated acts, including at expert level and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(21). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.(27) In order to amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty of the Functioning of the European Union should be delegated to the Commission to add or remove substances from the categories of drug precursors, where necessary as a matter of urgency. This authorisation will not restrict the right of Member States to regulate the scheduling of substances more stringently than at Union level. Given the particularities of designer precursors which are close chemical relatives of scheduled drug precursors and can be easily created, the Commission should have the possibility to add designer precursors also by including groups of substances, identified in a generic way and, where needed, to exclude individual substances part of such groups which have legitimate uses other than research and innovation and which are not to be included in a different category. However, the Commission should not add groups of substances in Category 1 or Category 2 drug precursors, unless this is necessary to fulfil the obligations under the UN Convention. In addition, the Commission should be empowered to amend non-essential elements set out in the annexes concerning licences, registrations, prior notifications, quantity management related to import and export, pre-export notifications, demonstration of licit purposes, determining the criteria for suspicion on intention of use in the illicit manufacture of drugs, transitional measures and reporting. Member States will in any event have the right to regulate the scheduling of substances and any measures relating thereto independently and more stringently than the Union’s minimum requirements. It is of particular importance that the Commission carry out appropriate consultations during the preparatory work for the adoption of delegated acts, including at Member State and expert level and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(21). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
(21) (22)OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.(21) (22)OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.

Or. fi

Amendment 108

Benoit Cassart, Sophie Wilmès, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 27

Text proposed by the CommissionAmendment
(27) In order to amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty of the Functioning of the European Union should be delegated to the Commission to add or remove substances from the categories of drug precursors, where necessary as a matter of urgency. Given the particularities of designer precursors which are close chemical relatives of scheduled drug precursors and can be easily created, the Commission should have the possibility to add designer precursors also by including groups of substances, identified in a generic way and, where needed, to exclude individual substances part of such groups which have legitimate uses other than research and innovation and which are not to be included in a different category. However, the Commission should not add groups of substances in Category 1 or Category 2 drug precursors, unless this is necessary to fulfil the obligations under the UN Convention. In addition, the Commission should be empowered to amend non-essential elements set out in the annexes concerning licences, registrations, prior notifications, quantity management related to import and export, pre-export notifications, demonstration of licit purposes, determining the criteria for suspicion on intention of use in the illicit manufacture of drugs, transitional measures and reporting. It is of particular importance that the Commission carry out appropriate consultations during the preparatory work for the adoption of delegated acts, including at expert level and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making21 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.(27) In order to amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty of the Functioning of the European Union should be delegated to the Commission to add or remove substances from the categories of drug precursors, where necessary as a matter of urgency. Given the particularities of designer precursors which are close chemical relatives of scheduled drug precursors and can be easily created, the Commission should have the possibility to add designer precursors also by including groups of substances, identified in a generic way and, where needed, to exclude individual substances part of such groups which have legitimate uses other than research and innovation and which are not to be included in a different category. In exercising this power, the Commission ensures that a balanced approach is maintained, rigorously assessing the economic impact on the legitimate chemical sector so that the necessary fight against drug trafficking does not disproportionately disrupt the Union's industrial supply chains. However, the Commission should not add groups of substances in Category 1 or Category 2 drug precursors, unless this is necessary to fulfil the obligations under the UN Convention. In addition, the Commission should be empowered to amend non-essential elements set out in the annexes concerning licences, registrations, prior notifications, quantity management related to import and export, pre-export notifications, demonstration of licit purposes, determining the criteria for suspicion on intention of use in the illicit manufacture of drugs, transitional measures and reporting. It is of particular importance that the Commission carry out appropriate consultations during the preparatory work for the adoption of delegated acts, including at expert level and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making21 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
21 (22)OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.21 (22)OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.

Or. en

Amendment 109

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Recital 27

Text proposed by the CommissionAmendment
(27) In order to amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty of the Functioning of the European Union should be delegated to the Commission to add or remove substances from the categories of drug precursors, where necessary as a matter of urgency. Given the particularities of designer precursors which are close chemical relatives of scheduled drug precursors and can be easily created, the Commission should have the possibility to add designer precursors also by including groups of substances, identified in a generic way and, where needed, to exclude individual substances part of such groups which have legitimate uses other than research and innovation and which are not to be included in a different category. However, the Commission should not add groups of substances in Category 1 or Category 2 drug precursors, unless this is necessary to fulfil the obligations under the UN Convention. In addition, the Commission should be empowered to amend non-essential elements set out in the annexes concerning licences, registrations, prior notifications, quantity management related to import and export, pre-export notifications, demonstration of licit purposes, determining the criteria for suspicion on intention of use in the illicit manufacture of drugs, transitional measures and reporting. It is of particular importance that the Commission carry out appropriate consultations during the preparatory work for the adoption of delegated acts, including at expert level and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(21). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.(27) In order to amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty of the Functioning of the European Union should be delegated to the Commission to add or remove substances from the categories of drug precursors, where necessary as a matter of urgency. The delegated powers should be limited to technical and scientific updates necessary to take into account new developments in the field of drug precursors and should not lead to substantial changes in the rights and obligations of economic operators. Given the particularities of designer precursors which are close chemical relatives of scheduled drug precursors and can be easily created, the Commission should have the possibility to add designer precursors also by including groups of substances, identified in a generic way on the basis of a transparent scientific risk assessment and after consultation with relevant scientific and industry stakeholders and, where needed, to exclude individual substances part of such groups which have legitimate uses other than research and innovation and which are not to be included in a different category. However, the Commission should not add groups of substances in Category 1 or Category 2 drug precursors, unless this is necessary to fulfil the obligations under the UN Convention. In addition, the Commission should be empowered to amend non-essential elements set out in the annexes concerning licences, registrations, prior notifications, quantity management related to import and export, pre-export notifications, demonstration of licit purposes, transitional measures and reporting. It is of particular importance that the Commission carry out appropriate consultations during the preparatory work for the adoption of delegated acts, including at expert level and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(21). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
(21) (22)OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.(21) (22)OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.

Or. sk

Justification

Article 290 TFEU allows only non-essential elements of a legislative act to be amended. The essential obligations of economic operators should remain subject to the regular legislative process. The next section suggests taking into account that generic definitions can have a significant impact on research, industry and trade. Their introduction should be based on sound scientific assessment. Finally, it is proposed to delete the passage from the original proposal, since the criteria on the basis of which trade may be restricted or an intervention may be carried out against an economic operator constitute an essential element of the legislation and should be adopted by the legislator.

Amendment 110

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Recital 28

Text proposed by the CommissionAmendment
(28) Implementing powers should be conferred on the Commission in order to determine the implementing arrangements for the electronic system. These arrangements should include technical requirements and procedures for the implementation of the main obligations set out in this Regulation, such as obtaining a licence, filing a registration or prior-notification, or those linked to quantity notification and customs verification. These arrangements should also include the rules for the protection, safety and security of personal data. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council22 .(28) Implementing powers should be conferred on the Commission in order to determine the implementing arrangements for the electronic system. These arrangements should include technical requirements and procedures for the implementation of the main obligations set out in this Regulation, such as obtaining a licence, filing a registration or prior-notification, or those linked to quantity notification and customs verification. These technical arrangements must be designed in such a way as to minimize the administrative burden and ensure the system's accessibility for all operators, including small and medium-sized enterprises (SMEs). These arrangements should also include the rules for the protection, safety and security of personal data. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council22 .
22 (1)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, pp. 13, ELI: http://data.europa.eu/eli/reg/2011/182/oj).22 (1)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, pp. 13, ELI: http://data.europa.eu/eli/reg/2011/182/oj).

Or. en

Amendment 111

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Recital 28

Text proposed by the CommissionAmendment
(28) Implementing powers should be conferred on the Commission in order to determine the implementing arrangements for the electronic system. These arrangements should include technical requirements and procedures for the implementation of the main obligations set out in this Regulation, such as obtaining a licence, filing a registration or prior-notification, or those linked to quantity notification and customs verification. These arrangements should also include the rules for the protection, safety and security of personal data. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(22).(28) Implementing powers should be conferred on the Commission in order to determine the implementing arrangements for the electronic system. These arrangements should include technical requirements and procedures for the implementation of the main obligations set out in this Regulation, such as obtaining a licence, filing a registration or prior-notification, or those linked to quantity notification and customs verification. These arrangements should also include the rules for the protection, safety and security of personal data. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(22) without altering the scope of the rights and obligations laid down in this Regulation.
(22) (1)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, pp. 13, ELI: ELI: http://data.europa.eu/eli/reg/2011/182/oj).(22) (1)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, pp. 13, ELI: ELI: http://data.europa.eu/eli/reg/2011/182/oj).

Or. sk

Justification

It is proposed to clarify and emphasise that implementing acts should regulate technical aspects of the implementation of the Regulation and should not create new substantive obligations.

Amendment 112

Saskia Bricmont

Proposal for a regulation

Recital 28 a (new)

Text proposed by the CommissionAmendment
(28a) Given the rapidly evolving nature of illicit drug manufacture and the increasing use of new non-scheduled substances and designer precursors by criminal networks, there can be a delay between the identification of an emerging precursor threat and the entry into force of Union measures applicable to that substance. In order to avoid regulatory gaps capable of creating serious risks to public security and public health, Member States should be able, under specific conditions and on a temporary basis, to adopt proportionate national safeguard measures pending action at Union level. Coordination with the Commission and the Agency is essential to ensuring consistency, information exchange and the proper functioning of the internal market.

Or. en

Amendment 113

Jaroslav Bžoch

Proposal for a regulation

Recital 31

Text proposed by the CommissionAmendment
(31) The application of this Regulation should be deferred with the time needed to establish the electronic system needed for its implementation.(31) The application of this Regulation should be deferred with the time needed to establish the electronic system needed for its implementation. The electronic system should be established and put into service in a timely manner allowing operators to comply with this Regulation without unnecessary administrative costs while safeguarding the free movement of goods in the internal market.

Or. en

Amendment 114

Evin Incir, Brando Benifei

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the CommissionAmendment
1. This Regulation establishes harmonised rules for the monitoring and control of the making available on the market, import, export, possession, and use of drug precursors and of intermediary activities involving drug precursors with a view to ensuring their free movement in the internal market and preventing their availability for the illicit manufacture of drugs.1. This Regulation establishes harmonised rules for the monitoring and control of the making available on the market, import, export, possession, and use of drug precursors and of intermediary activities involving drug precursors with a view to ensuring their free movement in the internal market and preventing their diversion and availability for the illicit manufacture of drugs, thereby contributing to the protection of public health and safety and to the reduction of drug-related harm.

Or. en

Amendment 115

Saskia Bricmont

Proposal for a regulation

Article 1 – paragraph 2 a (new)

Text proposed by the CommissionAmendment
2a. This Regulation shall apply without prejudice to the Union Customs Code.

Or. en

Amendment 116

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 2 – paragraph 1 – point 1

Text proposed by the CommissionAmendment
(1) ‘drug precursor’ means a substance that can be used for the illicit manufacture of drugs, as well as mixtures, organisms and substances which occur in nature containing such substances;(1) ‘drug precursor’ means a substance that can be reasonably and demonstrably used for the illicit manufacture of drugs, as well as mixtures, organisms and substances which occur in nature containing such substances;

Or. sk

Justification

It increases legal certainty and reduces the risk of unduly extensive interpretation.

Amendment 117

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 2 – paragraph 1 – point 8

Text proposed by the CommissionAmendment
(8) ‘designer precursor’ means a drug precursor which is a substance or a mixture containing a substance which is a close chemical relative of a substance covered by Annex I or Annex I and which does not have any known legitimate use except research and innovation;(8) ‘designer precursor’ means a drug precursor which is a substance or a mixture containing a substance which is a close chemical relative of a substance covered by Annex I or Annex II and which does not have any known legitimate use except research and innovation or another documented scientific, pharmaceutical or industrial use;

Or. sk

Justification

Future legitimate uses may arise after the substance has been included.

Amendment 118

Jaroslav Bžoch

Proposal for a regulation

Article 2 – paragraph 1 – point 11

Text proposed by the CommissionAmendment
(11) ‘making available on the market' means any supply of a drug precursor for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;(11) ‘making available on the market' means any supply of a drug precursor for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge, including through digital channels;

Or. en

Amendment 119

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 2 – paragraph 1 – point 13 a (new)

Text proposed by the CommissionAmendment
(13a) (14) "collection’ means the receipt, taking back, gathering, sorting or consolidation of scheduled drug precursors from one or more operators for the purpose of transport, storage, destruction or downstream treatment;

Or. en

Amendment 120

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 2 – paragraph 1 – point 13 b (new)

Text proposed by the CommissionAmendment
(13b) (15) "destruction" means any physical, chemical or other operation by which scheduled drug precursors are irreversibly rendered unusable and non-recoverable as drug precursors for legitimate trade or for the illicit manufacture of drugs;

Or. en

Amendment 121

Sophie Wilmès, Benoit Cassart, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 2 – paragraph 1 – point 13 c (new)

Text proposed by the CommissionAmendment
(13c) (16) "downstream treatment" means any operation, other than collection or destruction, carried out on scheduled drug precursors or on materials containing such precursors after they have been discarded, surrendered, returned or transferred for disposal, recovery or final treatment, including storage, sorting, separation, concentration, dilution, neutralisation, transformation, recovery, recycling or disposal

Or. en

Amendment 122

Jaroslav Bžoch

Proposal for a regulation

Article 2 – paragraph 1 – point 24

Text proposed by the CommissionAmendment
(24) ‘provider of an online marketplace’ means a provider of an online platform within the meaning of Article 3, point (i), of Regulation (EU) 2022/206528 that allows consumers or operators to conclude distance contracts with traders for the sale of scheduled drug precursors;(24) ‘provider of an online marketplace’ means a provider of an online platform within the meaning of Article 3, point (i), of Regulation (EU) 2022/206528 that allows consumers or operators to conclude distance contracts with traders for the sale of scheduled or non-scheduled drug precursors;
28 (31)Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L 277, 27.10.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/2065/oj).28 (31)Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L 277, 27.10.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/2065/oj).

Or. en

Amendment 123

Georgiana Teodorescu

Proposal for a regulation

Article 2 – paragraph 1 – point 25

Text proposed by the CommissionAmendment
(25) ‘intermediary' means any natural or legal person arranging the purchase and sale or supply of scheduled drug precursor, where the goods subsequently will be imported or exported and aiming to obtain an agreement between two parties or to do so through acting on behalf of at least one of these parties without taking these drug precursors into their possession or taking control of the carrying out of such transaction; this definition shall also pertain to any activity involving purchase and sale or supply of scheduled drug precursors without these precursors being introduced into the Union customs territory;(25) ‘intermediary' means any natural or legal person, acting as a broker, arranging the purchase and sale or supply of scheduled drug precursor, where the goods subsequently will be imported or exported and aiming to obtain an agreement between two parties or to do so through acting on behalf of at least one of these parties without taking these drug precursors into their possession or taking control of the carrying out of such transaction; this definition shall also pertain to any activity involving purchase and sale or supply of scheduled drug precursors without these precursors being introduced into the Union customs territory; this definition excludes natural or legal persons who provide technical services, general transport operations, logistics, financial or payment processing services, and the provision of general digital infrastructure by online platforms as defined in Article 3, point (i), of Regulation (EU) 2022/2065, provided that such services, operations, logistics and provision of infrastructure are not aimed at obtaining an agreement for the underlying chemical trade transaction and do not know the final purpose of the transaction.

Or. en

Justification

In line with the EU Digital Services Act (DSA) principles, general online marketplaces, communication platforms, or standard shipping lines should not be turned into de facto chemical oversight bodies unless they are actively brokering and structuring the sale of the precursors. This amendment ensures liability falls squarely on the actual commercial decision-maker (the broker) rather than the passive channel of transit. With a broad and vague definition, courts in different Member States could interpret it differently. This fractures the internal market and creates massive compliance confusion for European distributors.

Amendment 124

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 2 – paragraph 1 – point 34

Text proposed by the CommissionAmendment
(34) ‘suspicious transaction’ means any transaction concerning drug precursors for which there are reasonable grounds for suspecting that the drug precursors concerned are intended for the illicit manufacture of drugs;(34) ‘suspicious transaction’ means any transaction concerning drug precursors for which there are objective and verifiable facts indicating that the drug precursors concerned are intended for the illicit manufacture of drugs;

Or. sk

Justification

It increases legal certainty for economic operators and reduces the risk of arbitrary interpretation.

Amendment 125

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 3 – paragraph 2

Text proposed by the CommissionAmendment
2. This Regulation shall also apply to non-scheduled drug precursors which are substances that can be used for the illicit manufacture of drugs, and mixtures containing such substances, unless the condition in paragraph 1, point (b)(i) is met.2. This Regulation shall also apply to non-scheduled drug precursors which are substances that can be demonstrably and proportionately used for the illicit manufacture of drugs, and mixtures containing such substances, unless the condition in paragraph 1, point (b)(i) is met.

Or. sk

Justification

The proposal increases legal predictability and limits the risk of extensive interpretation.

Amendment 126

Georgiana Teodorescu

Proposal for a regulation

Article 3 – paragraph 3 a (new)

Text proposed by the CommissionAmendment
3a. research, industrial and innovation facilities, in order to ensure that scientific environments and technological development are not disproportionately affected by administrative bottlenecks.

Or. en

Justification

Strict regulatory frameworks must be balanced against the strategic importance of European scientific progress. Clear and functional exceptions ensure that R&D ecosystems are not crippled by slow bureaucratic approvals.

Amendment 127

Sebastian Tynkkynen

Proposal for a regulation

Article 4 – paragraph 1

Text proposed by the CommissionAmendment
Unless otherwise provided for in this Regulation or in other legal acts the Union, Member States shall not prohibit, restrict or hinder making available on the market of scheduled drug precursors by operators complying with this Regulation on grounds related to monitoring the legitimate trade for the prevention of the illicit manufacture of drugs.Unless otherwise provided for in this Regulation or in other legal acts the Union, Member States shall not prohibit, restrict or hinder making available on the market of scheduled drug precursors by operators complying with this Regulation on grounds related to monitoring the legitimate trade for the prevention of the illicit manufacture of drugs, unless the authorities of the Member States deem it absolutely necessary.

Or. fi

Amendment 128

Brando Benifei, Evin Incir

Proposal for a regulation

Article 5 – paragraph 1 – point b a (new)

Text proposed by the CommissionAmendment
(ba) Category 2A drug precursors:
(i) drug precursors containing or consisting of substances covered by Part Ia, of Annex II.

Or. en

Amendment 129

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 5 – paragraph 1 – point c

Text proposed by the CommissionAmendment
(c) Category 3 drug precursors containing or consisting of substances covered by Annex III which are designer precursors with no known legitimate use except research and innovation at the moment of their scheduling. The substances covered by Annex III shall be either listed individually or identified in a generic way by listing groups of substances. Individual substances included in such a group that have a legitimate use other than research and innovation and that are not included in Annex I or Annex II, shall be exempted from Category 3 and listed in Part II, Section 2, of Annex III.(c) Category 3 drug precursors containing or consisting of substances covered by Annex III which are designer precursors with no known legitimate use except research and innovation at the moment of their scheduling. The substances covered by Annex III shall be either listed individually or identified in a generic way by listing groups of substances. Individual substances included in such a group that have a legitimate use other than research and innovation and that are not included in Annex I or Annex II, shall be exempted from Category 3 and listed in Part II, Section 2, of Annex III.
When a classification by group is envisaged, it should be accompanied by a set of clear and structured reference information, made available in the Drug Precursor Information Repository, including lists of the substances concerned and, where available, their corresponding CAS numbers. Where no CAS number exists, the Commission shall request the assignment of a CAS number before adopting the delegated act.

Or. en

Amendment 130

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 5 – paragraph 1 – point c

Text proposed by the CommissionAmendment
(c) Category 3 drug precursors containing or consisting of substances covered by Annex III which are designer precursors with no known legitimate use except research and innovation at the moment of their scheduling. The substances covered by Annex III shall be either listed individually or identified in a generic way by listing groups of substances. Individual substances included in such a group that have a legitimate use other than research and innovation and that are not included in Annex I or Annex II, shall be exempted from Category 3 and listed in Part II, Section 2, of Annex III.(c) Category 3 drug precursors containing or consisting of substances covered by Annex III which are designer precursors with no known legitimate use except research and innovation at the moment of their scheduling. The substances covered by Annex III shall be either listed individually or identified in a generic way by listing groups of substances. Individual substances included in such a group that have a legitimate use other than research and innovation and that are not included in Annex I or Annex II, shall be exempted from Category 3 and listed in Part II, Section 2, of Annex III. The Commission regularly reviews whether substances classified in Category 3 have acquired new legitimate scientific, pharmaceutical or industrial uses.

Or. sk

Justification

Category 3 is not intended to be a permanent list. Chemical and pharmaceutical developments can create new legitimate uses.

Amendment 131

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 5 – paragraph 3

Text proposed by the CommissionAmendment
3. Scheduled drug precursors, which are mixtures containing substances covered by Annex III above the concentration threshold set out in that annex, organisms or substances which occur in nature containing such substances, and in addition containing substances covered by Annex II shall be subject to the requirements for Category 3 drug precursors.3. Scheduled drug precursors, which are mixtures containing substances covered by Annex III above the concentration threshold set out in that annex, organisms or substances which occur in nature containing such substances, and in addition containing substances covered by Annex II shall be subject to the requirements for Category 3 drug precursors, unless the competent authority determines otherwise on the basis of documented legitimate use.

Or. sk

Justification

The proposal allows for appropriate flexibility for mixtures containing substances with proven legitimate uses.

Amendment 132

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 6 – paragraph 2

Text proposed by the CommissionAmendment
2. Operators shall, further to a reasoned request, provide competent authorities or customs authorities with the information and documentation necessary to demonstrate that they fulfilled their obligations based on this Regulation, without delay, in a machine-readable and structured way, using open standards, transferred through a secure communication channel without vendor lock-in.2. Operators shall, further to a reasoned request, provide competent authorities or customs authorities with the information and documentation essential and proportionate to demonstrate that they fulfilled their obligations based on this Regulation, without delay, in a machine-readable and structured way, using open standards, transferred through a secure communication channel without vendor lock-in. The competent authorities shall ensure the protection of confidential business information obtained pursuant to this paragraph.

Or. sk

Justification

In the first part, the proposal emphasises that the principle of proportionality requires authorities to request only the information necessary for the performance of their tasks. In the second part, it then stresses that operators may provide sensitive commercial data, including data on supply chains and customers.

Amendment 133

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 6 – paragraph 2

Text proposed by the CommissionAmendment
2. Operators shall, further to a reasoned request, provide competent authorities or customs authorities with the information and documentation necessary to demonstrate that they fulfilled their obligations based on this Regulation, without delay, in a machine-readable and structured way, using open standards, transferred through a secure communication channel without vendor lock-in.2. Operators shall, further to a reasoned request, provide competent authorities or customs authorities with the information and documentation necessary to demonstrate that they fulfilled their obligations based on this Regulation, without undue delay, in a machine-readable and structured way, using open standards, transferred through a secure communication channel without vendor lock-in.

Or. en

Amendment 134

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 6 – paragraph 2 a (new)

Text proposed by the CommissionAmendment
2a. The processing and transmission of these documents are carried out in strict compliance with trade secrecy, in accordance with applicable Union legislation.

Or. en

Amendment 135

Sophie Wilmès, Benoit Cassart, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 6 – paragraph 3

Text proposed by the CommissionAmendment
3. Operators shall cooperate with those authorities, upon request, on any action taken to eliminate the risks of diversion of scheduled drug precursors towards the illicit manufacture of drugs.3. Operators shall cooperate fully and proactively with those authorities on any action taken to eliminate the risks of diversion of scheduled drug precursors towards the illicit manufacture of drugs.

Or. en

Amendment 136

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 6 – paragraph 3 a (new)

Text proposed by the CommissionAmendment
3a. The obligations under this Article shall be implemented in accordance with the principle of proportionality and shall not result in a disproportionate administrative or financial burden on operators.

Or. sk

Justification

The proposal aims to strengthen proportionality in the exercise of control powers.

Amendment 137

Saskia Bricmont

Proposal for a regulation

Article 6 – paragraph 3 a (new)

Text proposed by the CommissionAmendment
3a. Operators shall cooperate with the European Union Drugs Agency.

Or. en

Amendment 138

Benoit Cassart, Sophie Wilmès, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 7 – paragraph 1 – point a

Text proposed by the CommissionAmendment
(a) the name of the substance covered by Annex I, Annex II or Annex III, or, in the case of a mixture or a an organism or a substance which occurs in nature, their name and the name of the substance covered by Annex I, Annex II or Annex III, contained in the mixture, organism or substance which occurs in nature; for import, export or intermediary activities, the name shall be followed by the term 'DRUG PRECURSOR';(a) the name of the substance covered by Annex I, Annex II or Annex III, or, in the case of a mixture or a an organism or a substance which occurs in nature, this name is associated, where available, with its CAS number ; their name and the name of the substance covered by Annex I, Annex II or Annex III, contained in the mixture, organism or substance which occurs in nature; this name is associated, where available, with its CAS number ; for import, export or intermediary activities, this classification is numerically integrated into the standardised identifier, and the name is followed by the term 'DRUG PRECURSOR';

Or. en

Amendment 139

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 7 – paragraph 1 – point b

Text proposed by the CommissionAmendment
(b) the quantity of the substance covered by Annex I, Annex II or Annex III and, in the case of a mixture, an organism or a substance which occurs in nature, the quantity or the percentage of any such substance contained therein; and(b) the quantity and weight of the substance covered by Annex I, Annex II or Annex III and, in the case of a mixture, an organism or a substance which occurs in nature, the quantity or the percentage of any such substance contained therein; and

Or. en

Amendment 140

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 7 – paragraph 2

Text proposed by the CommissionAmendment
2. Operators shall keep the documentation referred to in paragraph 1 for a period of 5 years from the end of the calendar year in which the transaction took place.2. Operators shall keep the documentation referred to in paragraph 1 for a period of minimum 5 years from the end of the calendar year in which the transaction took place and must be readily available for inspection by the competent authorities upon request.

Or. en

Amendment 141

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 7 – paragraph 2

Text proposed by the CommissionAmendment
2. Operators shall keep the documentation referred to in paragraph 1 for a period of 5 years from the end of the calendar year in which the transaction took place.2. Operators shall keep the documentation referred to in paragraph 1 for a period of 5 years from the end of the calendar year in which the transaction took place, unless Union or national law requires a longer retention period.

Or. sk

Amendment 142

Sophie Wilmès, Benoit Cassart, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 8 – paragraph 1

Text proposed by the CommissionAmendment
1. Operators shall report to the competent authorities immediately suspicious transactions, significant disappearances and thefts of scheduled drug precursors. Where providers of online marketplaces become aware of any information regarding suspicious transactions, significant disappearances, and thefts of scheduled drug precursors, they shall immediately report that information to the competent authorities.1. Operators shall report to the competent authorities without undue delay suspicious transactions, significant disappearances or/and thefts of scheduled drug precursors as well as of non-scheduled drug precursors, where there are reasonable grounds to suspect their use in the illicit manufacture of drugs. Where providers of online marketplaces become aware of any information regarding suspicious transactions, significant disappearances, and thefts of scheduled drug precursors or non-scheduled drug precursors, they shall immediately report that information to the competent authorities.
Providers of online marketplaces shall take appropriate and proportionate measures to prevent the diversion and illicit trade of drug precursors through their services. Such measures shall include mechanisms enabling the detection and reporting of suspicious transactions.

Or. en

Amendment 143

Mika Aaltola

Proposal for a regulation

Article 8 – paragraph 1

Text proposed by the CommissionAmendment
1. Operators shall report to the competent authorities immediately suspicious transactions, significant disappearances and thefts of scheduled drug precursors. Where providers of online marketplaces become aware of any information regarding suspicious transactions, significant disappearances, and thefts of scheduled drug precursors, they shall immediately report that information to the competent authorities.1. Operators shall report to the competent authorities immediately suspicious transactions, significant disappearances and thefts of scheduled drug precursors.

Or. en

Amendment 144

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 8 – paragraph 1

Text proposed by the CommissionAmendment
1. Operators shall report to the competent authorities immediately suspicious transactions, significant disappearances and thefts of scheduled drug precursors. Where providers of online marketplaces become aware of any information regarding suspicious transactions, significant disappearances, and thefts of scheduled drug precursors, they shall immediately report that information to the competent authorities.1. Operators shall report to the competent authorities immediately suspicious transactions, significant disappearances, and thefts of scheduled drug precursors, determined on the basis of objective and transparent criteria laid down pursuant to this Regulation. Where providers of online marketplaces become aware of any information, in the course of their normal activities, regarding suspicious transactions, significant disappearances, and thefts of scheduled drug precursors, they shall immediately report that information to the competent authorities.

Or. sk

Justification

In the first part, the proposal draws attention to the fact that the concept of ‘significant quantity’ is not defined. Uniform criteria will ensure legal certainty and uniform application of the Regulation in all Member States. In the second part, the proposal specifies the scope of the obligation and confirms that the provision does not establish a general obligation of monitoring.

Amendment 145

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 8 – paragraph 1 a (new)

Text proposed by the CommissionAmendment
1a. Providers designated as very large online platforms or very large online search engines pursuant to Regulation (EU) 2022/2065 shall take into account risks related to the diversion and illicit trade of drug precursors in the risk assessments carried out pursuant to Article 34 of that Regulation, where relevant to the functioning and use of their services. and shall adopt reasonable, proportionate and effective mitigation measures pursuant to Article 35 of that Regulation.

Or. en

Amendment 146

Benoit Cassart, Sophie Wilmès, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 8 – paragraph 2 – point a

Text proposed by the CommissionAmendment
(a) the name of the substance covered by Annex I, Annex II or Annex III;(a) the name of the substance covered by Annex I, Annex II or Annex III and where available, its CAS number ;

Or. en

Amendment 147

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 8 – paragraph 2 – point b

Text proposed by the CommissionAmendment
(b) the quantity of the substance;(b) the quantity and the weight of the substance;

Or. en

Amendment 148

Saskia Bricmont

Proposal for a regulation

Article 8 – paragraph 2 – point c

Text proposed by the CommissionAmendment
(c) the names and addresses of the operators involved in the supply chain.(c) the names and addresses of the operators involved in the supply chain and of their responsible officers. .

Or. en

Amendment 149

Evin Incir, Brando Benifei

Proposal for a regulation

Article 8 – paragraph 2 – subparagraph 1 (new)

Text proposed by the CommissionAmendment
Member States shall ensure that reporting in good faith under this provision shall not give rise to civil, administrative or criminal liability for the reporting operator, marketplace provider, or natural person reporting on their behalf.

Or. en

Amendment 150

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 9 – paragraph 2

Text proposed by the CommissionAmendment
2. When considering whether to grant a licence, the competent authorities shall take into account the conditions set out in Annex IV regarding the competence and integrity of the applicant. The licence shall be refused if there are reasonable grounds for doubting the suitability and reliability of the operator or its responsible officer.2. When considering whether to grant a licence, the competent authorities shall take into account the conditions set out in Annex IV regarding the competence and integrity of the applicant. The licence shall be refused if there are reasonable grounds for doubting the suitability and reliability of the operator or its responsible officer, provided that such a decision is duly reasoned and is subject to effective review under national law.

Or. sk

Justification

The terms ‘suitability’ and ‘reliability’ are broad. Refusal of authorisation should therefore be duly justified and reviewable in order to ensure legal certainty for economic operators.

Amendment 151

Saskia Bricmont

Proposal for a regulation

Article 9 – paragraph 2

Text proposed by the CommissionAmendment
2. When considering whether to grant a licence, the competent authorities shall take into account the conditions set out in Annex IV regarding the competence and integrity of the applicant. The licence shall be refused if there are reasonable grounds for doubting the suitability and reliability of the operator or its responsible officer.2. When considering whether to grant a licence, the competent authorities shall take into account the conditions set out in Annex IV regarding the competence and integrity of the applicant and the information related to the economic operator stored in the Customs Data hub. The licence shall be refused if there are reasonable grounds for doubting the suitability and reliability of the operator or its responsible officer.

Or. en

Amendment 152

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 9 – paragraph 3

Text proposed by the CommissionAmendment
3. The licence shall include the information set out in Annex IV and shall be granted for a period not exceeding three years, unless the operator requests it for a shorter time period.3. The licence shall include the information set out in Annex IV and shall be granted for a period not exceeding three years, unless the operator requests it for a shorter time period and provided that the conditions for granting the licence remain fulfilled. However, for economic operators demonstrating a sustained record of compliance, this period may be extended to five years or the renewal of the licence may be subject to a simplified electronic procedure.

Or. en

Amendment 153

Sophie Wilmès, Benoit Cassart, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 9 – paragraph 4

Text proposed by the CommissionAmendment
4. The competent authorities may grant simplified licences for an unlimited time period, subject to the conditions set out in Annex IV.4. The competent authorities may in principle grant simplified licences for an unlimited time period but may be suspended or revoked by the competent authorities, subject to the conditions set out in Annex IV.

Or. en

Amendment 154

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 9 – paragraph 6

Text proposed by the CommissionAmendment
6. The licence may be suspended or revoked by the competent authorities whenever the conditions under which the licence was granted are no longer fulfilled or where there are reasonable grounds for suspecting that there is a risk of diversion of scheduled drug precursors towards the illicit manufacture of drugs.6. The licence may be suspended or revoked by the competent authorities whenever the conditions under which the licence was granted are no longer fulfilled or where there are reasonable grounds for suspecting that there is a risk of diversion of scheduled drug precursors towards the illicit manufacture of drugs. Before a decision is taken to suspend or revoke the permit, the operator shall be given the opportunity to comment, except where such postponement could seriously jeopardise the purpose of the measure.

Or. sk

Justification

The proposal aims to strengthen the procedural rights of the entities concerned and underline the respect for the rights of the defence without restricting the possibility of acting in urgent cases.

Amendment 155

Brando Benifei, Evin Incir

Proposal for a regulation

Article 9 – paragraph 6

Text proposed by the CommissionAmendment
6. The licence may be suspended or revoked by the competent authorities whenever the conditions under which the licence was granted are no longer fulfilled or where there are reasonable grounds for suspecting that there is a risk of diversion of scheduled drug precursors towards the illicit manufacture of drugs.6. The licence shall be suspended or revoked by the competent authorities whenever the conditions under which the licence was granted are no longer fulfilled or where there are reasonable grounds for suspecting that there is a risk of diversion of scheduled drug precursors towards the illicit manufacture of drugs.

Or. en

Amendment 156

Evin Incir, Brando Benifei

Proposal for a regulation

Article 9 – paragraph 6 a (new)

Text proposed by the CommissionAmendment
6a. The diversion of drug precursors towards the illicit manufacture of drugs has significant consequences for public health across the Union. The increased availability of synthetic drugs contributes to drug-related deaths, serious health harms and the exploitation of vulnerable persons, including women and children. Preventing the diversion of drug precursors therefore constitutes not only a matter of public security but also an important element of the Union's efforts to protect public health and reduce drug-related harm.

Or. en

Amendment 157

Saskia Bricmont

Proposal for a regulation

Article 9 – paragraph 7

Text proposed by the CommissionAmendment
7. External traders that import, export, or perform intermediary activities with Category 1 drug precursors in quantities not exceeding the quantity thresholds set out in Annex I over one calendar year shall be subject to the obligations applicable under Article 15.deleted

Or. en

Amendment 158

Evin Incir, Brando Benifei

Proposal for a regulation

Article 9 – paragraph 8

Text proposed by the CommissionAmendment
8. The competent authorities may require operators to pay a fee for processing the application for a licence. Where a fee is levied, competent authorities shall adjust the level of the fee set for small and medium-sized enterprises. Such a fee shall be levied in a non-discriminatory manner and shall not exceed the cost of processing the application.8. The competent authorities may require operators to pay a fee for processing the application for a licence. Where a fee is levied, it shall be proportionate, transparent and non-discriminatory, and shall not exceed the cost of processing the application. Competent authorities shall provide for reduced fees for micro, small and medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC, and may waive the fee entirely where justified by the size, turnover or economic capacity of the applicant. The fee shall be waived for universities, public research organisations, non-profit research institutes, public-health laboratories and recognised forensic laboratories, where the drug precursors are used exclusively for documented scientific, medical, forensic or public-health research. The level of any fee shall not constitute a barrier to independent research, early-warning activities or public-interest scientific innovation.

Or. en

Amendment 159

Giuseppe Antoci

Proposal for a regulation

Article 9 – paragraph 8

Text proposed by the CommissionAmendment
8. The competent authorities may require operators to pay a fee for processing the application for a licence. Where a fee is levied, competent authorities shall adjust the level of the fee set for small and medium-sized enterprises. Such a fee shall be levied in a non-discriminatory manner and shall not exceed the cost of processing the application.8. The competent authorities may require operators to pay a fee for processing the application for a licence. The fee may be reduced or waived in the case of universities, public research institutes, public health services, harm reduction services and non-profit organisations that work in the field of public health or the treatment of addictions, provided that the drug precursors are used exclusively for the purposes of scientific or medical research or for activities that are carried out in the public interest and not for commercial purposes. Where a fee is levied, competent authorities shall adjust the level of the fee set for small and medium-sized enterprises. Such a fee shall be levied in a non-discriminatory manner and shall not exceed the cost of processing the application.

Or. it

Amendment 160

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 9 – paragraph 8

Text proposed by the CommissionAmendment
8. The competent authorities may require operators to pay a fee for processing the application for a licence. Where a fee is levied, competent authorities shall adjust the level of the fee set for small and medium-sized enterprises. Such a fee shall be levied in a non-discriminatory manner and shall not exceed the cost of processing the application.8. The competent authorities may require operators to pay a fee for processing the application for a licence. Where a fee is levied, competent authorities shall adjust the level of the fee set for small and medium-sized enterprises. Such a fee shall be levied in a non-discriminatory manner, shall not exceed the cost of processing the application and shall not constitute an undue barrier to market access for small and medium-sized enterprises.

Or. sk

Justification

The proposal supports the competitiveness of SMEs and at the same time meets the objective of reducing administrative and financial burdens.

Amendment 161

Sophie Wilmès, Benoit Cassart, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 9 – paragraph 8

Text proposed by the CommissionAmendment
8. The competent authorities may require operators to pay a fee for processing the application for a licence. Where a fee is levied, competent authorities shall adjust the level of the fee set for small and medium-sized enterprises. Such a fee shall be levied in a non-discriminatory manner and shall not exceed the cost of processing the application.8. The competent authorities may require operators to pay a fee for processing the application for a licence. Where a fee is levied, competent authorities shall apply reduced and proportionates based on their size and turnover set for small and medium-sized enterprises. Such a fee shall be levied in a non-discriminatory manner and shall not exceed the cost of processing the application.

Or. en

Amendment 162

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 9 – paragraph 8 a (new)

Text proposed by the CommissionAmendment
8a. The Commission shall issue guidelines on the application of fee reductions for small and medium-sized enterprises, including on graduated reduction models reflecting the size category of the enterprise, in accordance with Commission Recommendation 2003/361/EC, and on the objective and transparent criteria that may be taken into account for the purpose of reflecting administrative workload associated with the processing of applications.

Or. en

Amendment 163

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 10 – paragraph 1

Text proposed by the CommissionAmendment
1. Operators referred to in Article 9(1) shall appoint a responsible officer established in the Union empowered to represent them in matters relating to the application of this Regulation.1. Operators referred to in Article 9(1) shall appoint a responsible officer established in the Union empowered to represent them in matters relating to the application of this Regulation. This function may also be performed by a person who simultaneously performs other management or compliance functions within the operator.

Or. sk

Justification

The proposal maintains the obligation to designate a responsible person, but at the same time clarifies that it is not a requirement to create a new independent job position. Many small and medium-sized businesses already have staff responsible for regulatory compliance or internal control. Allowing this function to be performed within existing structures reduces administrative costs without undermining the objectives of the Regulation.

Amendment 164

Brando Benifei, Evin Incir

Proposal for a regulation

Article 10 – paragraph 1 a (new)

Text proposed by the CommissionAmendment
1a. Where a provider of an online marketplace facilitates distance sales of scheduled drug precursors imported from third countries into the Union, that provider shall be deemed to be the importer.
Such providers shall appoint a responsible person established in the Union empowered to represent them in matters relating to the application of this Regulation.

Or. en

Amendment 165

Benoit Cassart, Sophie Wilmès, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 11 – paragraph 1

Text proposed by the CommissionAmendment
Operators making available on the market, importing, exporting, or performing intermediary activities with Category 1 drug precursors shall ensure that the name of the substance covered by Annex I is indicated on the packaging or its label, or, in case of products supplied in bulk, in the accompanying documents.Operators making available on the market, importing, exporting, or performing intermediary activities with Category 1 drug precursors shall ensure that the name of the substance covered by Annex I as well as the corresponding CAS number, where available are indicated on the packaging or its label, or, in case of products supplied in bulk, in the accompanying documents.

Or. en

Amendment 166

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 12 – paragraph 2

Text proposed by the CommissionAmendment
2. The operators referred to in paragraph 1 shall keep the documentation for a period of 5 years from the end of the calendar year in which the specific drug precursor was possessed for the last time.2. The operators referred to in paragraph 1 shall keep the documentation for a period of minimum 5 years from the end of the calendar year in which the specific drug precursor was possessed for the last time and must be readily available for inspection by the competent authorities upon request.

Or. en

Amendment 167

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 13 – paragraph 1

Text proposed by the CommissionAmendment
Operators shall make available on the market Category 1 drug precursors only after having verified that the other operators involved in such a transaction hold a valid licence.Operators shall make available on the market Category 1 drug precursors only after having verified through an automated consultation of the Union's centralised electronic system that the other operators involved in such a transaction hold a valid licence.

Or. en

Amendment 168

Brando Benifei, Evin Incir

Proposal for a regulation

Article 13 a (new)

Text proposed by the CommissionAmendment
Article13 a
Verification of operators by providers of online marketplaces
Providers of online marketplaces shall allow operators to conclude distance contracts for the sale of Category 1 drug precursors only after having verified, through the centralised electronic system referred to in Article 35, that the operators involved in such a contract hold a valid licence.

Or. en

Amendment 169

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 14 – paragraph 1

Text proposed by the CommissionAmendment
Operators shall take adequate measures to secure business premises and the places of use against the unauthorised removal of Category 1 drug precursors.Operators shall take adequate and proportionate measures, based on the size of their structure, the nature of their activities and the volumes of substances held to secure business premises and the places of use against the unauthorised removal of Category 1 drug precursors. The Commission shall issue guidelines specifying such measures.

Or. en

Amendment 170

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 14 – paragraph 1

Text proposed by the CommissionAmendment
Operators shall take adequate measures to secure business premises and the places of use against the unauthorised removal of Category 1 drug precursors.Operators shall take adequate measures to secure business premises and the places of use against the unauthorised removal of Category 1 drug precursors, and such measures must be proportionate to the nature of the activity carried out, the quantity of drug precursors concerned and the level of the identified risk.

Or. sk

Justification

The Commission proposal uses the term ‘adequate measures’ without specifying the criteria against which proportionality is to be assessed. Adding essential factors to be taken into account by competent authorities increases legal certainty and promotes the uniform application of the Regulation in the Member States. At the same time, it is ensured that security requirements correspond to the actual level of risk and do not impose disproportionate obligations on entities working with limited quantities of precursors.

Amendment 171

Saskia Bricmont

Proposal for a regulation

Article 15 – paragraph 1 – introductory part

Text proposed by the CommissionAmendment
1. External traders engaged in import, export or intermediary activities involving Category 2 drug precursors shall register information on their activities with the competent authority in the Member State where they are established. This obligation shall not apply to:1. External traders engaged in import, export or intermediary activities involving Category 2 drug precursors shall register information on their activities with the competent authority in the Member State where they are established.

Or. en

Amendment 172

Saskia Bricmont

Proposal for a regulation

Article 15 – paragraph 1 – point a

Text proposed by the CommissionAmendment
(a) direct customs representatives, carriers and transporters when acting solely in those capacities;deleted

Or. en

Amendment 173

Saskia Bricmont

Proposal for a regulation

Article 15 – paragraph 1 – point b

Text proposed by the CommissionAmendment
(b) Category 2 drug precursors transhipped, placed under temporary storage, stored in a free zone, or leaving the customs territory of the Union by a re-export notification.deleted

Or. en

Amendment 174

Saskia Bricmont

Proposal for a regulation

Article 15 – paragraph 3

Text proposed by the CommissionAmendment
3. By way of derogation from paragraph 2, a registration may be valid for an unlimited period of time, subject to the conditions set out in Annex V.deleted

Or. en

Amendment 175

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 15 – paragraph 5

Text proposed by the CommissionAmendment
5. The competent authority in the Member State of establishment of the external trader may order the external trader to suspend or cease the activities covered by the registration, where the registration does not comply with this Regulation; the conditions declared are no longer fulfilled; or, where there are reasonable grounds for suspecting that there is a risk of diversion of the scheduled drug precursors towards the illicit manufacture of drugs.5. The competent authority in the Member State of establishment of the external trader may order the external trader to suspend or cease the activities covered by the registration, where the registration does not comply with this Regulation, the conditions declared are no longer fulfilled; or, where there are reasonable grounds for suspecting that there is a risk of diversion of the scheduled drug precursors towards the illicit manufacture of drugs. Before such a decision is taken, the foreign trade operator shall be given the opportunity to comment, except where such postponement could seriously jeopardise the purpose of the measure.

Or. sk

Justification

A decision to suspend or terminate an activity can have significant economic consequences. It is therefore appropriate to ensure that the entity concerned has the opportunity to be heard before a decision is taken, while preserving the possibility of immediate intervention in urgent cases.

Amendment 176

Brando Benifei, Evin Incir

Proposal for a regulation

Article 15 – paragraph 5

Text proposed by the CommissionAmendment
5. The competent authority in the Member State of establishment of the external trader may order the external trader to suspend or cease the activities covered by the registration, where the registration does not comply with this Regulation; the conditions declared are no longer fulfilled; or, where there are reasonable grounds for suspecting that there is a risk of diversion of the scheduled drug precursors towards the illicit manufacture of drugs.5. The competent authority in the Member State of establishment of the external trader shall order the external trader to suspend or cease the activities covered by the registration, where the registration does not comply with this Regulation; the conditions declared are no longer fulfilled; or, where there are reasonable grounds for suspecting that there is a risk of diversion of the scheduled drug precursors towards the illicit manufacture of drugs.

Or. en

Amendment 177

Mika Aaltola

Proposal for a regulation

Article 15 – paragraph 5 a (new)

Text proposed by the CommissionAmendment
5a. For Category 2 drug precursors presenting a high risk of diversion towards the illicit manufacture of drugs, which are listed in Annex II, Part III, operators shall be subject to electronic notification allowing for the monitoring of intra-Union movements, to ensure an adequate level of traceability and to prevent diversion towards the illicit.

Or. en

Amendment 178

Sophie Wilmès, Benoit Cassart, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 15 – paragraph 7 – subparagraph 1 (new)

Text proposed by the CommissionAmendment
Registration of collectors, destroyers and downstream operators
1. Operators engaged in the collection, destruction or downstream treatment of scheduled drug precursors shall register information on those activities with the competent authority in the Member State where they are established before carrying out such activities.
2. The registration shall include at least the identity of the operator, the place where the activities are carried out, the categories and quantities of scheduled drug precursors concerned and, where applicable, the method of destruction or downstream treatment used.
3. The operators referred to in paragraph 1 shall, without delay, record in the electronic system the receipt, transfer, destruction or downstream treatment of the scheduled drug precursors concerned and shall upload or make available documentary evidence thereof, including, where appropriate, certificates of destruction, transport documents, photographs or equivalent records enabling traceability.
4. The information and evidence referred to in paragraph 3 shall be kept for a period of 5 years from the end of the calendar year in which the activity took place.
5. The competent authority in the Member State of establishment may order the operator to suspend or cease the activities covered by the registration where the registration does not comply with this Regulation, the declared conditions are no longer fulfilled, or where there are reasonable grounds for suspecting that there is a risk of diversion of the scheduled drug precursors towards the illicit manufacture of drugs.

Or. en

Amendment 179

Jaroslav Bžoch

Proposal for a regulation

Article 15 a (new)

Text proposed by the CommissionAmendment
Article 15 a
Notification obligation
For Category 2 drug precursors presenting a high risk of diversion, operators shall be subject to notification via the electronic system on intra-Union movements of these precursors.

Or. en

Amendment 180

Brando Benifei, Evin Incir

Proposal for a regulation

Chapter 2 – Section 3 a (new)

Text proposed by the CommissionAmendment
3a Category 2A drug precursors
Article 15a
Registration
1. Operators making available on the market Category 2 (a) drug precursors exceeding the quantity thresholds set out in Annex II shall obtain registration from the competent authorities of the Member State in which they are established before placing on the market scheduled substances of category 2A of Annex II.
2. Any operator holding a registration shall supply scheduled substances of category 2A of Annex II only to other operators who also hold a registration.
3. When considering whether to grant registration, the competent authorities shall take into account, in particular, the competence and integrity of the applicant. They shall refuse registration if there are reasonable grounds for doubting the suitability and reliability of the applicant or of the officer responsible for the trade in scheduled substances. They may suspend or revoke registration where there are reasonable grounds for believing that the holder is no longer a fit and proper person to hold a registration, or that the conditions under which registration was granted are no longer fulfilled.

Or. en

Amendment 181

Georgiana Teodorescu

Proposal for a regulation

Article 17 – paragraph 2

Text proposed by the CommissionAmendment
2. Operators intending to make available on the market, import, export, possess, use, or perform intermediary activities involving Category 3 drug precursors for research and innovation in quantities not exceeding the maximum quantity threshold set out in Part I of Annex III shall notify their intended activities over a period of maximum six months to the competent authority in the Member State where they are established, 5 days before the first transaction or possession. This obligation does not apply to direct customs representatives, carriers and other transporters acting solely in that capacity.2. Operators intending to make available on the market, import, export, possess, use, or perform intermediary activities involving Category 3 drug precursors for research and innovation in quantities not exceeding the maximum quantity threshold set out in Part I of Annex III shall notify their intended activities over a period of maximum six months to the competent authority in the Member State where they are established, 5 days before the first transaction or possession. This obligation does not apply to direct customs representatives, carriers and other transporters acting solely in that capacity. For such transactions, the prior notification procedure shall be simplified, streamlined, and fully digitalised in order to avoid excessive administrative and bureaucratic burden on operators.

Or. en

Justification

While the tracking of synthetic precursors is highly supported to address evolving illicit drug markets, minor transactions should not trigger heavy bureaucratic bottlenecks that penalize these small operators.

Amendment 182

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 17 – paragraph 4

Text proposed by the CommissionAmendment
4. The competent authority may request additional information and perform inspections to check the accuracy of the information provided, including the use of drug precursors for research and innovation.4. The competent authority may request additional information and perform inspections to check the accuracy of the information provided, including the use of drug precursors for research and innovation. Such controls must be proportionate to the scope of the activities notified and the level of risk identified.

Or. sk

Justification

The proposal leaves the necessary control powers to the competent authorities, but at the same time ensures that the scope of controls corresponds to the actual risk and the scale of the activities carried out.

Amendment 183

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 17 – paragraph 5

Text proposed by the CommissionAmendment
5. The competent authority of the Member State of establishment of the operator may order the operator to suspend or cease the activities covered by the prior notification, where the prior notification does not comply with this Regulation; the conditions declared are no longer fulfilled; or, there are reasonable grounds for suspecting that there is a risk of diversion of the Category 3 drug precursor towards the illicit manufacture of drugs.5. The competent authority of the Member State of establishment of the operator may order the operator to suspend or cease the activities covered by the prior notification, where the prior notification does not comply with this Regulation, the conditions declared are no longer fulfilled; or, there are reasonable grounds for suspecting that there is a risk of diversion of the Category 3 drug precursor towards the illicit manufacture of drugs. Before such a decision is taken, the operator shall be given the opportunity to comment, except where such postponement could seriously jeopardise the purpose of the measure.

Or. sk

Justification

The same procedural guarantees should apply to the prior notification regime as to the registration or authorisation regime. This strengthens legal certainty and predictability of decision-making.

Amendment 184

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 18 – paragraph 1

Text proposed by the CommissionAmendment
By way of further derogation from Article 16(1), operators may make available on the market, import, export, perform intermediary activities, possess or use Category 3 drug precursors for research and innovation in quantities exceeding the maximum quantity threshold set out in Part I of Annex III or for other legitimate use, provided they obtain a licence in accordance with Article 9(1), (2) and (3). Article 9(5), (6) and (8) shall also apply to that licence.By way of further derogation from Article 16(1), operators may make available on the market, import, export, perform intermediary activities, possess or use Category 3 drug precursors for research and innovation in quantities exceeding the maximum quantity threshold set out in Part I of Annex III or for other legitimate use, provided they obtain a licence in accordance with Article 9(1), (2) and (3). Article 9(5), (6) and (8) shall also apply to that licence. When assessing applications, the competent authorities shall take into account the scientific, research, pharmaceutical or industrial purpose of the intended use.

Or. sk

Justification

The regulation itself allows for the legitimate use of Category 3 substances. It is therefore appropriate to explicitly state that these legitimate purposes are to be taken into account in the authorisation procedure.

Amendment 185

Mika Aaltola

Proposal for a regulation

Article 18 – paragraph 1

Text proposed by the CommissionAmendment
By way of further derogation from Article 16(1), operators may make available on the market, import, export, perform intermediary activities, possess or use Category 3 drug precursors for research and innovation in quantities exceeding the maximum quantity threshold set out in Part I of Annex III or for other legitimate use, provided they obtain a licence in accordance with Article 9(1), (2) and (3). Article 9(5), (6) and (8) shall also apply to that licence.By way of further derogation from Article 16(1), operators may make available on the market, import, export, perform intermediary activities, possess or use Category 3 drug precursors for research and innovation in quantities exceeding the maximum quantity threshold set out in Part I of Annex III , provided they obtain a licence in accordance with Article 9(1), (2) and (3). Article 9(5), (6) and (8) shall also apply to that licence.

Or. en

Amendment 186

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 19 – paragraph 1

Text proposed by the CommissionAmendment
1. Operators referred to in Article 17 or Article 18 shall make available on the market Category 3 drug precursors only after having verified that the operators involved in the transaction have made a prior notification or hold a licence in accordance with Article 17 or Article 18 respectively.1. Operators referred to in Article 17 or Article 18 shall make available on the market Category 3 drug precursors only after having verified through an automated check in the European Union’s centralised electronic system that the operators involved in the transaction have made a prior notification or hold a licence in accordance with Article 17 or Article 18 respectively.

Or. en

Amendment 187

Benoit Cassart, Sophie Wilmès, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 19 – paragraph 4

Text proposed by the CommissionAmendment
4. External traders importing, exporting or performing intermediary activities with Category 3 drug precursors in accordance with Article 17 and Article 18 shall ensure that the name of the substance covered by Annex III is indicated on the packaging or its label, or, in case of products supplied in bulk, on the accompanying documents.4. External traders importing, exporting or performing intermediary activities with Category 3 drug precursors in accordance with Article 17 and Article 18 shall ensure that the name of the substance covered by Annex III and its CAS number or standardised structural formula are clearly indicated on the packaging or its label, or, in case of products supplied in bulk, on the accompanying documents.

Or. en

Amendment 188

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 20 – paragraph 1

Text proposed by the CommissionAmendment
1. The importer shall notify the competent authority of the total quantity of the intended imports for each substance covered by Annex I or Annex II over a specified time period before the first import. The quantity of substances imported during that time period shall not exceed the quantities notified.1. The importer shall notify the competent authority of the total quantity of the intended imports for each substance covered by Annex I or Annex II over a specified time period before the first import. The quantity of substances imported during that time period shall not exceed the quantities notified. The competent authority shall allow for appropriate updating of the notified quantities during the relevant period, where the changes are duly justified by legitimate commercial or production needs.

Or. sk

Justification

Business needs, production schedules, and supply chains can change throughout the year. The possibility to update the notified quantities increases the flexibility of the system without weakening the control by the competent authorities.

Amendment 189

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 20 – paragraph 1

Text proposed by the CommissionAmendment
1. The importer shall notify the competent authority of the total quantity of the intended imports for each substance covered by Annex I or Annex II over a specified time period before the first import. The quantity of substances imported during that time period shall not exceed the quantities notified.1. The importer shall notify the competent authority of the total quantity of the intended imports for each substance covered by Annex I or Annex II over a specified time period before the first import. The quantity of substances imported during that time period shall not exceed the quantities notified, taken into to account for variations arising from transport conditions and industrial weighing processes.

Or. en

Amendment 190

Sophie Wilmès, Benoit Cassart, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the CommissionAmendment
1. All exports of Category 1 drug precursors and exports of Category 2 drug precursors to certain countries of destination, as referred to in Chapter 2 of Annex VII, shall be preceded by a pre-export notification by the competent authorities of the Member State concerned to the competent authorities of the country of destination.1. All exports of Category 1 drug precursors and exports of Category 2 drug precursors to certain countries of destination, as referred to in Chapter 2 of Annex VII, shall be preceded by a pre-export notification by the competent authorities of the Member State concerned to the competent authorities of the country of destination.
The country of destination shall be allowed a period of 7 working days to reply, the end of which the export operation may be authorised by the competent authorities of the Member State of export, if no advice from the competent authorities of the country of destination is received indicating that this export operation might be intended for the illicit manufacture of narcotic drugs or psychotropic substances.

Or. en

Amendment 191

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 22 – paragraph 1

Text proposed by the CommissionAmendment
1. The exporter shall notify the competent authority of the total quantity of the intended exports for each substance covered by Annex I or Annex II in a specified time period before the first export. The quantity of substances exported during that time period shall not exceed the quantity notified.1. The exporter shall notify the competent authority of the total quantity of the intended exports for each substance covered by Annex I or Annex II in a specified time period before the first export. The quantity of substances exported during that time period shall not exceed the quantity notified. The competent authority shall allow for appropriate updating of the notified quantities during the relevant period, where the changes are duly justified by legitimate commercial or production needs.

Or. sk

Justification

The same rules should apply to both imports and exports. Allowing the updating of notified quantities takes into account the real functioning of international trade while maintaining full traceability of the movement of precursors.

Amendment 192

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 22 – paragraph 1

Text proposed by the CommissionAmendment
1. The exporter shall notify the competent authority of the total quantity of the intended exports for each substance covered by Annex I or Annex II in a specified time period before the first export. The quantity of substances exported during that time period shall not exceed the quantity notified.1. The exporter shall notify the competent authority of the total quantity of the intended exports for each substance covered by Annex I or Annex II in a specified time period before the first export. The quantity of substances exported during that time period shall not exceed the quantity notified, taken into account for variations arising from transport conditions and industrial weighing processes;

Or. en

Amendment 193

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 22 – paragraph 2

Text proposed by the CommissionAmendment
2. Paragraph 1 shall also apply for exports of substances covered by Annex III, subject to the conditions set out in Article 17 or Article 18.2. Paragraph 1 shall also apply for exports of substances covered by Annex III, subject to the conditions set out in Article 17 or Article 18. However, exports by public research institutes and university centres involving research quantities below the thresholds set out in Annex III are exempt from this dual notification requirement.

Or. en

Amendment 194

Benoit Cassart, Sophie Wilmès, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 22 – paragraph 6

Text proposed by the CommissionAmendment
6. Following the notification referred to in Article 21(1) and Article 21(2), the competent authorities or the customs authorities of the Member States may prevent the export if an objection, indicating that this export might be intended for the illicit manufacture of drugs, is received from the competent authorities or customs authorities of the country of destination.6. Following the notification referred to in Article 21(1) and Article 21(2), the competent authorities or the customs authorities of the Member States may prevent the export if an objection, indicating that this export might be intended for the illicit manufacture of drugs, is received from the competent authorities or customs authorities of the country of destination within the strict 7-business-day deadline referred to in Article 21(5).

Or. en

Amendment 195

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 23 – paragraph 2

Text proposed by the CommissionAmendment
2. The importer, exporter or holder of a transit procedure as referred to in paragraph 1 shall provide or make available to customs authorities either: proof of possession of a valid licence as referred to in Article 9 or Article 18; registration as referred to Article 9(7) or Article 15; or prior notification as referred to in Article 17, including, where applicable, the proof of notification of quantities in accordance with Articles 20 and 22.2. The importer, exporter or holder of a transit procedure as referred to in paragraph 1 shall provide or make available electronically to customs authorities via the EU Single Window environment for Customs, either : proof of possession of a valid licence as referred to in Article 9 or Article 18; registration as referred to Article 9(7) or Article 15; or prior notification as referred to in Article 17, including, where applicable, the proof of notification of quantities in accordance with Articles 20 and 22.

Or. en

Amendment 196

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 23 – paragraph 4

Text proposed by the CommissionAmendment
4. In addition to paragraph 3, the customs authorities shall verify that the quantities are within the thresholds notified in Article 20 and Article 22 before releasing substances for free circulation, temporary admission, end use, outward processing, export or re-export where a re-export declaration is submitted.4. In addition to paragraph 3, the customs authorities shall verify that the quantities are within the thresholds notified in Article 20 and Article 22 taken into to account for variations arising from transport conditions and industrial weighing processes before releasing substances for free circulation, temporary admission, end use, outward processing, export or re-export where a re-export declaration is submitted.

Or. en

Amendment 197

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 23 – paragraph 6

Text proposed by the CommissionAmendment
6. The verification referred to in paragraph 3 and paragraph 4 shall be done electronically and automatically via the interconnection referred to in Article 35(5) from the date that interconnection is operational.6. The verification referred to in paragraph 3 and paragraph 4 shall be done electronically and automatically via the interconnection referred to in Article 35(5) from the date that interconnection is operational. Until the interconnection referred to in Article 35 is operational, or where the electronic system or that interconnection is temporarily unavailable, the verifications referred to in paragraphs 3 and 4 shall be carried out through the electronic system by other secure electronic means or, where necessary, through fallback procedures established by the implementing act referred to in Article 35(…). Those fallback procedures shall ensure business continuity, traceability of checks and an equivalent level of control

Or. en

Amendment 198

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 24 – paragraph 1

Text proposed by the CommissionAmendment
Where a scheduled drug precursor enters into the customs territory of the Union for transhipment, placement in temporary storage or storage in a free zone for licit purposes, the operator shall demonstrate those licit purposes in accordance with Chapter 4 of Annex VII, upon request by the competent authorities or the customs authorities.Where a scheduled drug precursor enters into the customs territory of the Union for transhipment, placement in temporary storage or storage in a free zone for licit purposes, the operator shall demonstrate those licit purposes in accordance with Chapter 4 of Annex VII, upon request by the competent authorities or the customs authorities. This request is primarily generated automatically based on the risk analysis built into the Union’s centralised electronic system, to ensure the uniform application of border controls and to prevent any logistical circumvention strategies.

Or. en

Amendment 199

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 24 – paragraph 1

Text proposed by the CommissionAmendment
Where a scheduled drug precursor enters into the customs territory of the Union for transhipment, placement in temporary storage or storage in a free zone for licit purposes, the operator shall demonstrate those licit purposes in accordance with Chapter 4 of Annex VII, upon request by the competent authorities or the customs authorities.Where a scheduled drug precursor enters into the customs territory of the Union for transhipment, placement in temporary storage or storage in a free zone for licit purposes, the operator shall demonstrate those licit purposes in accordance with Chapter 4 of Annex VII, upon request by the competent authorities or the customs authorities. Such a request must be proportionate and based on objective facts justifying the need for verification.

Or. sk

Justification

The obligation to demonstrate a legitimate purpose is justified, but should be applied on the basis of a risk-based approach. This avoids placing an undue burden on legitimate economic operators.

Amendment 200

Saskia Bricmont

Proposal for a regulation

Article 25 – paragraph 1

Text proposed by the CommissionAmendment
1. By [OP please add date: 3 years after entry into force of this Regulation] the Agency shall establish a Drug Precursors Information Repository (‘Repository’).1. By [OP please add date: 18 months after entry into force of this Regulation] the Agency shall establish a Drug Precursors Information Repository (‘Repository’).

Or. en

Amendment 201

Benoit Cassart, Sophie Wilmès, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 25 – paragraph 2 – point a

Text proposed by the CommissionAmendment
(a) general description of the substance and its chemical properties;(a) general description of the substance and its chemical properties including, where available, its CAS number and, in the case of newly designed substances, their standardised structural chemical formula;

Or. en

Amendment 202

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 25 – paragraph 2 – point c a (new)

Text proposed by the CommissionAmendment
(ca) information on how to recognise and notify suspect transactions;

Or. en

Amendment 203

Georgiana Teodorescu

Proposal for a regulation

Article 25 – paragraph 2 – point c a (new)

Text proposed by the CommissionAmendment
(ca) information on the volumes present on the market;

Or. en

Justification

The register shall additionally contain an automated functionality to aggregate and track the total volumes of each scheduled substance present, imported, exported, or placed on the internal market. These volume data aggregates shall be updated continuously to enable competent national authorities and the European Union Drugs Agency to conduct macro-level risk analysis and monitor trends in chemical supply chains.

Amendment 204

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 25 – paragraph 2 – point c b (new)

Text proposed by the CommissionAmendment
(cb) information on emerging threats, diversion trends and best practices related to the monitoring and handling of such substance ;

Or. en

Amendment 205

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 25 – paragraph 2 – point c c (new)

Text proposed by the CommissionAmendment
(cc) information related to drug production incidents, including clandestine laboratories, synthetic drugs and new psychoactive substances, collected through a European database to be developed by the Agency in cooperation with affected Member States;

Or. en

Amendment 206

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 25 – paragraph 2 – point c d (new)

Text proposed by the CommissionAmendment
(cd) other information which may be deemed useful.

Or. en

Amendment 207

Sophie Wilmès, Benoit Cassart, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 25 – paragraph 3

Text proposed by the CommissionAmendment
3. If substances are as a group of substances identified in a generic way in accordance with Article 37(1), the Repository referred to in paragraph 1 shall include an indicative list of the most relevant individual substances covered by the group of substances and a specific function allowing operators to check if a specific substance is to be considered as being part of the group.3. If substances are as a group of substances identified in a generic way in accordance with Article 37(1), the Repository referred to in paragraph 1 shall include an exhaustive list of the most relevant individual substances covered by the group of substances together with their corresponding CAS numbers where available and a specific function allowing operators to check if a specific substance is to be considered as being part of the group.

Or. en

Amendment 208

Mika Aaltola

Proposal for a regulation

Article 25 – paragraph 3

Text proposed by the CommissionAmendment
3. If substances are as a group of substances identified in a generic way in accordance with Article 37(1), the Repository referred to in paragraph 1 shall include an indicative list of the most relevant individual substances covered by the group of substances and a specific function allowing operators to check if a specific substance is to be considered as being part of the group.3. If substances are as a group of substances identified in a generic way in accordance with Article 37(1), the Repository referred to in paragraph 1 shall include an indicative list of the most relevant individual substances along with their respective CAS registry numbers covered by the group of substances and a specific function allowing operators to check if a specific substance is to be considered as being part of the group.

Or. en

Amendment 209

Evin Incir, Brando Benifei

Proposal for a regulation

Article 25 – paragraph 4

Text proposed by the CommissionAmendment
4. The information referred to in paragraph 2, points (a) and (b) and the specific function referred to in paragraph 3 shall be publicly available and free of charge.4. The information referred to in paragraph 2, points (a) and (b), where disclosure does not compromise public security, criminal investigations, commercial confidentiality or the prevention of diversion, point (c), as well as the specific function referred to in paragraph 3, shall be publicly available, free of charge and accessible in a user-friendly format. Member States and the Agency shall ensure that public-health authorities and harm-reduction services designated or recognised by Member States have facilitated access to non-sensitive information referred to in point (c) for the purposes of public-health monitoring and early warning.

Or. en

Amendment 210

Brando Benifei, Evin Incir

Proposal for a regulation

Article 25 – paragraph 4

Text proposed by the CommissionAmendment
4. The information referred to in paragraph 2, points (a) and (b) and the specific function referred to in paragraph 3 shall be publicly available and free of charge.4. The information referred to in paragraph 2, points (a), (b) and (c) regarding trends and risks, and the specific function referred to in paragraph 3 shall be publicly available and free of charge.

Or. en

Amendment 211

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 25 – paragraph 6

Text proposed by the CommissionAmendment
6. The Agency shall maintain and keep the Repository up to date.6. The Agency shall maintain and keep the Repository up to date promptly and without undue delay. Relevant stakeholders, including representatives of the chemical industry, and Union agencies, including Europol, may support the Agency in the development and updating of such information.

Or. en

Amendment 212

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 25 – paragraph 6

Text proposed by the CommissionAmendment
6. The Agency shall maintain and keep the Repository up to date.6. The Agency shall maintain and keep the Repository up to date. The Agency will ensure regular updating of the information and transparent indication of the date of its last revision.

Or. sk

Justification

The database is intended to serve as a reference source for both economic operators and public authorities. It is therefore important that users are able to verify that the information on which they rely when fulfilling their obligations is up to date.

Amendment 213

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 25 – paragraph 6 a (new)

Text proposed by the CommissionAmendment
6a. The Agency shall ensure the involvement of relevant stakeholders, including representatives of the chemical industry, in the development and implementation of the Drug Precursor Information Repository.

Or. en

Amendment 214

Evin Incir, Brando Benifei

Proposal for a regulation

Article 26 – paragraph 1

Text proposed by the CommissionAmendment
1. Member States shall ensure that law enforcement authorities and customs authorities are provided with training, such as risk management training, to detect, in the course of their duties, scheduled or non-scheduled drug precursors that may be used in the illicit manufacture of drugs, and to react in a timely and appropriate manner to a suspicious activity.1. Member States shall ensure that law enforcement authorities and customs authorities are provided with training, such as risk management training, to detect, in the course of their duties, scheduled or non-scheduled drug precursors that may be used in the illicit manufacture of drugs, and to react in a timely and appropriate manner to a suspicious activity. Such training shall also include, where appropriate, information on emerging diversion trends, including synthetic drug precursors and other new psychoactive substances, as well as the public health risks associated with the illicit manufacture and use of drugs. Moreover, such training shall include, where relevant, indicators of forced labour and labour exploitation linked to illicit drug production or supply chains.

Or. en

Amendment 215

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 26 – paragraph 1

Text proposed by the CommissionAmendment
1. Member States shall ensure that law enforcement authorities and customs authorities are provided with training, such as risk management training, to detect, in the course of their duties, scheduled or non-scheduled drug precursors that may be used in the illicit manufacture of drugs, and to react in a timely and appropriate manner to a suspicious activity.1. Member States shall ensure that law enforcement authorities and customs authorities are provided with regular and up to date training, detection equipment, risk assessment capacities and the use of the latest technologies, such as risk management training, to detect, in the course of their duties, scheduled or non-scheduled drug precursors that may be used in the illicit manufacture of drugs, and to react in a timely and appropriate manner to a suspicious activity. CEPOL shall support Member States in the development and delivery of such training.

Or. en

Amendment 216

Saskia Bricmont

Proposal for a regulation

Article 26 – paragraph 1

Text proposed by the CommissionAmendment
1. Member States shall ensure that law enforcement authorities and customs authorities are provided with training, such as risk management training, to detect, in the course of their duties, scheduled or non-scheduled drug precursors that may be used in the illicit manufacture of drugs, and to react in a timely and appropriate manner to a suspicious activity.1. Member States shall ensure that law enforcement authorities and customs authorities are provided with training, such as risk management training, to detect, in the course of their duties, scheduled or non-scheduled drug precursors that may be used in the illicit manufacture of drugs, and to react in a timely and appropriate manner to a suspicious activity. Training should be based inter alia on the experience and expertise of the Agency.

Or. en

Amendment 217

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 26 – paragraph 1 a (new)

Text proposed by the CommissionAmendment
1a. The Commission shall ensure that relevant e-learning and training materials related to drug precursors are regularly updated and made available to competent authorities, customs authorities and relevant stakeholders.

Or. en

Amendment 218

Giuseppe Antoci

Proposal for a regulation

Article 26 – paragraph 2

Text proposed by the CommissionAmendment
2. Member States shall organise, at least once a year, awareness-raising actions for operators making available on the market, importing, exporting, performing intermediary activities, possessing or using drug precursors.2. Member States shall organise, at least once a year on the basis of scientific evidence and harm-reduction principles, awareness-raising actions for operators making available on the market, importing, exporting, performing intermediary activities, possessing or using drug precursors. These actions shall be devised in such a way as to take into account the specific characteristics of the different sectors involved, including health and social services that work in the area of addiction and harm reduction.

Or. it

Amendment 219

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 26 – paragraph 2

Text proposed by the CommissionAmendment
2. Member States shall organise, at least once a year, awareness-raising actions for operators making available on the market, importing, exporting, performing intermediary activities, possessing or using drug precursors.2. Member States shall organise, at least once a year, awareness-raising actions for operators making available on the market, importing, exporting, performing intermediary activities, possessing or using drug precursors with the participation where appropriate, of relevant stakeholders, including representatives of the chemical industry and other relevant sectors.

Or. en

Amendment 220

Evin Incir, Brando Benifei

Proposal for a regulation

Article 26 – paragraph 2

Text proposed by the CommissionAmendment
2. Member States shall organise, at least once a year, awareness-raising actions for operators making available on the market, importing, exporting, performing intermediary activities, possessing or using drug precursors.2. Member States shall organise, at least once a year, awareness-raising actions for operators making available on the market, importing, exporting, performing intermediary activities, possessing or using drug precursors. Such activities shall also address the risks of diversion into illicit drug markets and their wider societal and public health impacts.

Or. en

Amendment 221

Georgiana Teodorescu

Proposal for a regulation

Article 26 – paragraph 2 a (new)

Text proposed by the CommissionAmendment
2a. To ensure a uniform and consistent application of this Regulation across the Union, the Agency, in close cooperation with the Commission and national competent authorities, shall develop a harmonised European training framework. That framework shall include standardised curricula, best-practice guidelines, and joint operational training modules. Those modules shall specifically address the detection of emerging synthetic and designer precursors, risk-based inspection methodologies, and the use of the central IT system.

Or. en

Justification

Chemical traffickers exploit the paths of least resistance. If one Member State’s competent authorities lack the specialized technical knowledge to spot sophisticated diversion methods, that state becomes a target gateway for illicit trade. Standardizing the training ensures a high, baseline shield across all EU external borders and internal market zones.

Amendment 222

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 26 – paragraph 2 a (new)

Text proposed by the CommissionAmendment
2a. The Commission, in cooperation with Member States, Europol and CEPOL, shall facilitate the exchange of guidance, expertise and best practices related to the detection and dismantling of clandestine laboratories, including the safe handling, transport and disposal of seized chemicals and equipment.

Or. en

Amendment 223

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 26 – paragraph 3

Text proposed by the CommissionAmendment
3. Operators shall be responsible for providing information to their personnel on the obligations of the operators under this Regulation and for raising personnel awareness in this regard.3. Operators shall be responsible for providing information to their personnel on the obligations of the operators under this Regulation and for raising personnel awareness in this regard. To minimize the administrative burden on small and medium-sized enterprises (SMEs), the relevant authorities provide operators with free, standardised online training tools and modules.

Or. en

Amendment 224

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 26 – paragraph 3 a (new)

Text proposed by the CommissionAmendment
3a. Enhanced cooperation and synergies
1. Member States, the Commission and the relevant Union agencies shall, within the limits of their respective mandates, ensure close cooperation and promote synergies in order to prevent the diversion of drug precursors from the licit trade.
Such cooperation shall include the exchange of relevant information and expertise on emerging trends, suspicious patterns and methods of diversion, as well as feedback mechanisms aimed at strengthening risk assessment, improving the identification of vulnerabilities in the supply chain and supporting the effective implementation of this Regulation.
Member States, the Commission, Europol and the European Union Drugs Agency shall, in accordance with their respective mandates, promote cooperation with third countries, as appropriate, to facilitate the exchange of information and best practices related to the prevention of the diversion of drug precursors from licit trade. Such cooperation shall be pursued in a coherent and coordinated manner, ensuring consistency between the relevant Union instruments, international agreements and the activities of the Union bodies involved.

Or. en

Amendment 225

Saskia Bricmont

Proposal for a regulation

Article 26 a (new)

Text proposed by the CommissionAmendment
Article 26 a
Guidelines
1. The Commission shall, in close cooperation with the Member States and, where appropriate, relevant Union agencies and bodies, develop and publish guidelines by June 2027 to support the consistent, effective and proportionate application of this Regulation.
2. The guidelines referred to in paragraph 1 shall aim to facilitate a high degree of harmonisation in the interpretation and practical application of the obligations laid down in this Regulation, while taking into account national operational specificities and evolving criminal methodologies.
3. The guidelines may include, where appropriate, practical examples, indicators and recommendations relating, in particular, to:
(a) the assessment of reasonable grounds for suspicion under this Regulation;
(b) criteria and indicative thresholds for identifying significant seizures and suspicious transactions;
(c) examples of legitimate purposes for the placing on the market, possession, import, export or use of scheduled substances and mixtures containing such substances;
(d) “other legitimate uses” permitting the use of Category 3 precursors and synthetic precursors outside the fields of research and innovation;
(e) examples of conduct that can constitute a breach or a circumvention of this Regulation;
(f) the appropriate level of penalties;
(g) operational measures relating to the detention, seizure and disposal of scheduled substances and mixtures containing such substances;
(h) operational measures and best practices for securing premises, facilities and storage locations involving scheduled substances and mixtures containing such substances;
(i) risk assessment and risk management measures;
(j) the exchange of information and cooperation between competent authorities and economic operators;
(k) best practices for monitoring, detection and enforcement activities.
4. The Commission shall periodically review and, where appropriate, update the guidelines, taking into account technological developments, emerging trafficking patterns, relevant jurisprudence and operational experience gained by the Member States.

Or. en

Amendment 226

Giuseppe Antoci

Proposal for a regulation

Article 26 a (new)

Text proposed by the CommissionAmendment
Article 26 a
Guidelines
1. The Commission shall, in close cooperation with the Member States and, where appropriate, the relevant Union agencies and bodies, draw up and publish guidelines to support the consistent, effective and proportionate application of this Regulation.
2. The guidelines referred to in paragraph 1 shall seek to ensure the greatest possible degree of harmonisation in the interpretation and practical application of the requirements laid down in this Regulation, while taking into account the specific features of national practices and evolving criminal methodologies.
3. The guidelines may include, where appropriate, practical examples, indicators and recommendations such as, in particular:
(a) specific guidance designed to ensure that the controls provided for by this Regulation do not impose excessive constraints on health services, harm reduction services, non-profit organisations and research institutes that use precursors for public interest purposes;
(b) the proportionality of control measures for operators with low risk profiles, with due regard for the nature and purpose of their activities.
4. When drawing up the guidelines referred to in paragraph 1, the Commission shall systematically consult with the competent authorities of the Member States, associations of economic operators, civil society organisations working in the field of public health, addiction treatment and harm reduction, and the representatives of public research institutes. The Commission shall ensure that these consultations are conducted transparently, in a timely fashion and on an equal footing with the consulting parties.
5. The Commission shall review these guidelines regularly and update them where appropriate.

Or. it

Amendment 227

Saskia Bricmont

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the CommissionAmendment
1. Each Member State shall designate the competent authority or authorities responsible for ensuring the application of this Regulation and shall inform the Commission, the other Member States and the Agency thereof.1. Each Member State shall designate the competent authority or authorities responsible for ensuring the application of this Regulation and shall inform the Commission, the other Member States and the Agency thereof. Each Member State shall cooperate with the Agency.

Or. en

Amendment 228

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 27 – paragraph 2

Text proposed by the CommissionAmendment
2. For the purposes of applying this Regulation, the provisions of Regulation (EC) No 515/97 shall apply with the necessary adaptations. The competent authorities designated under paragraph 1 shall act as competent authorities within the meaning of Article 2(2) of Regulation (EC) No 515/97.2. For the purposes of applying this Regulation, the provisions of Regulation (EC) No 515/97 shall apply with the necessary adaptations. The competent authorities designated under paragraph 1 shall act as competent authorities within the meaning of Article 2(2) of Regulation (EC) No 515/97. These authorities exchange operational information and risk profiles in an automated and instantaneous manner via the centralised electronic system referred to in this regulation, without prejudice to traditional mutual assistance procedures.

Or. en

Amendment 229

Mika Aaltola

Proposal for a regulation

Article 27 – paragraph 2 – subparagraph 1 (new)

Text proposed by the CommissionAmendment
3a. In order to facilitate the effective implementation and enforcement of this Regulation, the Commission shall, as appropriate, cooperate and exchange information with the authorities of third countries, international organisations, business organisations and other relevant stakeholders.
3b. International cooperation with the authorities of third countries shall take place in a structured way, for example in the context of international bodies such as the International Narcotics Control Board (INCB), the World Customs Organization (WCO) and via bilateral agreements on cooperation regarding the control of precursors.
3c. International cooperation may involve the exchange of information, best practices, information on decisions to control precursors and operational expertise.

Or. en

Amendment 230

Mika Aaltola

Proposal for a regulation

Article 27 – paragraph 2 a (new)

Text proposed by the CommissionAmendment
2a. 1. The European Union Customs Authority (EUCA), established pursuant to Regulation (EC) 2023/0156, shall exercise the following coordination functions in respect of drug precursor controls:
(a) coordinating cross-border enforcement actions involving the competent authorities and customs administrations of two or more Member States in cases of suspected or confirmed drug precursor diversion;
(b) monitoring and analysing the sanction records held in the drug precursors electronic system pursuant to Article 31 and reporting annually to the Commission; (c) issuing guidance on the consistent interpretation of mitigating and aggravating circumstances under Article 31 to reduce enforcement divergence between Member States;
(d) facilitating and supporting joint operational taskforces with Europol and EUDA.
2. EUCA shall act as the Union focal point for drug precursor enforcement cooperation with third-country customs authorities and with international organisations including the WCO and INCB.
3. Appropriate financial and human resources shall be ensured to EUCA for the implementation of these tasks as foreseen in Regulation (EC) 2023/0156

Or. en

Amendment 231

Saskia Bricmont

Proposal for a regulation

Article 27 – paragraph 2 a (new)

Text proposed by the CommissionAmendment
2a. In view of achieving the general objective of this Regulation, the Commission, the customs authorities, and the EU Customs Authority may exchange and share data processed, in a systematic and automated manner, in accordance with this Regulation [...] with customs authorities and other authorities of third countries for the purpose of customs cooperation. The exchange will take place in accordance with Article 244 of the Union Customs Code and may concern, in particular, the following categories of data:
(a) data elements included in decisions taken by the customs authorities or similar decisions taken in third countries;
(b) data elements included in declarations, licences and notifications;
(c) data on risks identified, findings made, and results obtained by the customs authorities of the Member States or the Commission, on the one hand, and the authorities of third countries competent for customs matters, on the other, in the course of performing their risk analysis and controls.

Or. en

Amendment 232

Saskia Bricmont

Proposal for a regulation

Article 27 – paragraph 2 b (new)

Text proposed by the CommissionAmendment
2b. In view of achieving the general objective of this Regulation, without prejudice to the budgetary autonomy of the Member States, Member States shall ensure sufficient human and financial resources for the effective application of the measures set out in this Regulation.

Or. en

Amendment 233

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 28 – paragraph 1

Text proposed by the CommissionAmendment
1. Competent authorities shall carry out controls to determine if operators fulfil the obligations laid down in this Regulation. When there is reason to believe that a drug precursor might be diverted towards the illicit manufacture of drugs, the competent authority shall perform additional controls without delay under the conditions set out in Article 29 and Article 30.1. Competent authorities shall carry out controls to determine if operators fulfil the obligations laid down in this Regulation. When there is reason to believe that a drug precursor might be diverted towards the illicit manufacture of drugs, the competent authority shall perform additional controls without delay under the conditions set out in Article 29 and Article 30. Controls shall be carried out on the basis of a risk-based approach and shall be proportionate to the nature, scale and risk profile of the activities concerned.

Or. sk

Justification

A risk-based approach is a standard element of modern regulation and allows for more efficient use of public resources while limiting unnecessary administrative burdens for low-risk entities.

Amendment 234

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 28 – paragraph 1

Text proposed by the CommissionAmendment
1. Competent authorities shall carry out controls to determine if operators fulfil the obligations laid down in this Regulation. When there is reason to believe that a drug precursor might be diverted towards the illicit manufacture of drugs, the competent authority shall perform additional controls without delay under the conditions set out in Article 29 and Article 30.1. Competent authorities shall carry out controls to determine if operators fulfil the obligations laid down in this Regulation. When there are reasonable grounds, based on objective and factual elements that a drug precursor might be diverted towards the illicit manufacture of drugs, the competent authority shall perform additional controls without delay under the conditions set out in Article 29 and Article 30.

Or. en

Amendment 235

Georgiana Teodorescu

Proposal for a regulation

Article 28 – paragraph 1 a (new)

Text proposed by the CommissionAmendment
1a. Strengthening controls is essential, provided that such controls shall be strictly risk-based and coordinated systematically between national competent authorities to avoid administrative and operational overlaps. Authorities shall utilise the central IT system and the repository to cross-reference data before initiating on-site inspections. Operators shall not be subject to duplicate requests for information or verification procedures by different domestic or Union authorities for the same underlying transaction or timeframe, unless justified by an immediate, substantiated risk of diversion of drug precursors.

Or. en

Justification

If an enterprise has already submitted its volume data, trade invoices, and operator information into the Central IT system, it is an inefficient use of public resources for two separate entities (e.g., Customs and Chemical Security Inspectorates) to request the exact same paperwork in separate audits.

Amendment 236

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 28 – paragraph 2

Text proposed by the CommissionAmendment
2. The competent authorities shall respect the principles of confidentiality and of professional and commercial secrecy and shall protect personal data in accordance with Union and national law.2. The competent authorities shall respect the principles of confidentiality and of professional and commercial secrecy and shall protect personal data in accordance with Union and national law, particularly when accessing, copying, or processing the operator's computer data during inspections.

Or. en

Amendment 237

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 28 – paragraph 3

Text proposed by the CommissionAmendment
3. Member States shall ensure that the competent authorities have the resources necessary to ensure the proper administration of their tasks under this Regulation.3. Member States shall ensure that the competent authorities have the resources - financial, human and technological - necessary to ensure the proper administration of their tasks under this Regulation.

Or. en

Amendment 238

Evin Incir, Brando Benifei

Proposal for a regulation

Article 28 a (new)

Text proposed by the CommissionAmendment
Article 28a
Any natural or legal person directly and adversely affected by a decision or measure adopted under this Regulation shall have the right to an effective remedy before a competent judicial or independent administrative authority, in accordance with national and EU law. To this end, Member States shall ensure that any such decision or measure is reasoned, proportionate and notified without undue delay to the person concerned. Information on the available remedies and applicable time limits shall be communicated together with the decision or measure.

Or. en

Amendment 239

Sophie Wilmès, Benoit Cassart, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 29 – paragraph 1

Text proposed by the CommissionAmendment
Competent authorities may seize scheduled drug precursors for up to 30 days subject to the conditions set out under national law, to verify the identification of the drug precursors and compliance with this Regulation.Competent authorities may seize scheduled drug precursors for up to 7 days subject to the conditions set out under national law, to verify the identification of the drug precursors and compliance with this Regulation.
Where justified by the complexity of the verification or by the need to prevent an imminent risk of diversion, the period referred to in paragraph 1 may be extended once for an additional period not exceeding 15 days, subject to the conditions set out under national law.

Or. en

Amendment 240

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 29 – paragraph 1

Text proposed by the CommissionAmendment
Competent authorities may seize scheduled drug precursors for up to 30 days subject to the conditions set out under national law, to verify the identification of the drug precursors and compliance with this Regulation.Competent authorities may seize scheduled drug precursors for up to 30 days subject to the conditions set out under national law, to verify the identification of the drug precursors and compliance with this Regulation. If the reasons for the seizure cease to exist before the expiry of the aforementioned period, the seized drug precursors shall be released without delay.

Or. sk

Justification

The seizure shall serve solely for the performance of the necessary checks. If the reasons for its duration no longer exist, further restrictions on the handling of goods are not justified.

Amendment 241

Saskia Bricmont

Proposal for a regulation

Article 29 – paragraph 1 a (new)

Text proposed by the CommissionAmendment
Where the competent authorities are unable to comply with the time-limit for taking a decision including where such a delay is due to ongoing consultations with other competent authorities or international bodies, they shall inform the applicant of that fact before the expiry of that time-limit, stating the reasons and indicating the further period of time which they consider necessary in order to take a decision. Except where otherwise provided, that further period of time shall not exceed 30 calendar days.

Or. en

Amendment 242

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 30 – paragraph 2

Text proposed by the CommissionAmendment
2. The competent authorities of each Member State shall prohibit the introduction of non-scheduled drug precursors into the customs territory of the Union or their departure from it where there is sufficient evidence that those drug precursors are intended for the illicit manufacture of drugs.2. The competent authorities of each Member State shall prohibit the introduction of non-scheduled drug precursors into the customs territory of the Union or their departure from it where there is sufficient evidence that those drug precursors are intended for the illicit manufacture of drugs. The Commission shall issue guidelines specifying the criteria and indicators to be taken into account when assessing whether sufficient evidence exists under this paragraph.

Or. en

Amendment 243

Saskia Bricmont

Proposal for a regulation

Article 30 – paragraph 5

Text proposed by the CommissionAmendment
5. The period of temporary detention referred to in paragraph 4 shall not exceed 30 days.5. The period of temporary detention referred to in paragraph 4 shall not exceed 30 days. Where the competent authorities are unable to comply with the time-limit for taking a decision including where such a delay is due to ongoing consultations with other competent authorities or international bodies, they shall inform the applicant of that fact before the expiry of that time-limit, stating the reasons and indicating the further period of time which they consider necessary in order to take a decision. Except where otherwise provided, that further period of time shall not exceed 30 calendar days.

Or. en

Amendment 244

Sophie Wilmès, Benoit Cassart, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 30 – paragraph 5

Text proposed by the CommissionAmendment
5. The period of temporary detention referred to in paragraph 4 shall not exceed 30 days.5. The period of temporary detention referred to in paragraph 4 shall not exceed 7 days.
Without prejudice to paragraph 5, the period of temporary detention can be extended by an additional period of temporary detention, when the customs authorities have reasonable grounds to do so. The additional period of temporary detention shall not exceed 15 days.

Or. en

Amendment 245

Brando Benifei, Evin Incir

Proposal for a regulation

Article 30 – paragraph 5

Text proposed by the CommissionAmendment
5. The period of temporary detention referred to in paragraph 4 shall not exceed 30 days.5. The period of temporary detention referred to in paragraph 4 shall not exceed 30 days; in duly justified cases, the period of time may be extended for 30 additional days

Or. en

Amendment 246

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 30 – paragraph 6 – point b

Text proposed by the CommissionAmendment
(b) entering the business premises of operators in order to obtain evidence of irregularities;(b) entering the business premises of operators in order to obtain evidence of irregularities in strict compliance with trade secrets and national legal procedures;

Or. en

Amendment 247

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 30 – paragraph 7

Text proposed by the CommissionAmendment
7. When determining if there is suspicion that scheduled or non-scheduled drug precursors are intended to be used in the illicit manufacture of drugs, customs authorities or competent authorities shall use the criteria laid out in Chapter 5 of Annex VII. Should the criteria laid out in chapter 5, point 8 (b), of Annex VII be fulfilled the external trader importing, exporting, or performing intermediary activities with the non-scheduled substance shall be required to prove that the substance is destined for legitimate use.7. When determining if there is suspicion that scheduled or non-scheduled drug precursors are intended to be used in the illicit manufacture of drugs, customs authorities or competent authorities shall use the criteria laid out in Chapter 5 of Annex VII. Should the criteria laid out in chapter 5, point 8 (b), of Annex VII be fulfilled the external trader importing, exporting, or performing intermediary activities with the non-scheduled substance shall be required to prove that the substance is destined for legitimate use. This proof is provided in a simplified manner through the electronic transmission, via the Union’s centralised system, of the end-user’s certified declaration of use or any equivalent commercial document.

Or. en

Amendment 248

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 30 – paragraph 8

Text proposed by the CommissionAmendment
8. For the purpose of preventing specific risks of diversion of drug precursors stored in free zones and under temporary storage as well as in other sensitive areas, such as customs warehouses, Member States shall ensure that effective controls are applied to activities carried out in these areas at every stage, and that the controls are no less stringent than those applied in the other parts of the customs territory.8. For the purpose of preventing specific risks of diversion of drug precursors stored in free zones and under temporary storage as well as in other sensitive areas, such as customs warehouses, Member States shall ensure that effective controls are applied to activities carried out in these areas at every stage, and that the controls are no less stringent than those applied in the other parts of the customs territory. When organising these controls, Member States shall take into account the principles of effectiveness, proportionality and risk management.

Or. sk

Justification

The same level of protection does not require the same intensity of controls in all cases. A risk-based approach allows for more effective targeting of control capacities on the riskiest operations.

Amendment 249

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 30 – paragraph 8 a (new)

Text proposed by the CommissionAmendment
8a. Safeguard clause
Where a Member State identifies an emerging substance, including a non-scheduled drug precursor or combination of substances, that may be used for the illicit manufacture of drugs and gives rise to serious concerns regarding the risk of diversion, it may, pending the adoption of measures at Union level, take proportionate and temporary precautionary measures in accordance with Union law.
The Member State concerned shall immediately notify the Commission and the European Union Drugs Agency of the measures taken and provide the reasons supporting its assessment, together with any relevant scientific, technical or operational information available.
The Commission shall examine, without undue delay, whether further action at Union level is appropriate under this Regulation, including, where necessary, through the use of the powers conferred upon it by this Regulation.
Any measures adopted pursuant to this Article shall be limited in scope and duration to what is strictly necessary and shall not constitute a means of arbitrary discrimination or a disguised restriction on trade within the internal market.

Or. en

Amendment 250

Saskia Bricmont

Proposal for a regulation

Article 30 a (new)

Text proposed by the CommissionAmendment
Article 30a
Safeguard clause
1. Where a Member State identifies an emerging substance, including a non-scheduled drug precursor or combination of substances, that may be used for the illicit manufacture of drugs and which poses a serious or imminent threat to public security, public health or public safety, and where no delegated act adopted pursuant to this Regulation has yet entered into force in relation to that substance, the Member State may adopt temporary national measures which are necessary and proportionate to prevent the diversion, trafficking or illicit use of that substance.
2. The measures referred to in paragraph 1 may include restrictions concerning the manufacture, import, export, placing on the market, possession, distribution, transport or use of the substance concerned, as well as enhanced monitoring, reporting or registration obligations for operators.
3. The Member State referred to in paragraph 1 shall immediately notify the Commission and the Agency of the measures adopted pursuant to that paragraph, together with the reasons justifying those measures and any available scientific, technical or intelligence information supporting the assessment of the threat.
4. The Commission shall, without undue delay, assess whether the substance concerned should be made subject to measures at Union level, including through the adoption of a delegated act pursuant to this Regulation. The European Commission should duly notify the other Member States in order for them to also immediately put in place temporary measures.
5. Measures adopted pursuant to paragraph 1 shall be temporary in nature and shall remain applicable only until the relevant Union measures enter into force or until the Member State determines that the threat no longer justifies their maintenance. Such measures shall comply with Union law and shall not constitute a means of arbitrary discrimination or a disguised restriction on trade within the internal market.

Or. en

Amendment 251

Evin Incir, Brando Benifei

Proposal for a regulation

Article 30 a (new)

Text proposed by the CommissionAmendment
Article 30a
Management of seized and detained drug precursors
1. Member States shall take the necessary measures to ensure the adequate management of drug precursors seized or detained under Article 29 or Article 30, including secure storage and chain of custody, so as to prevent diversion, theft and risks to workers, public health and the environment.
2. Drug precursors not retained pursuant to a final administrative decision under national law upon expiry of the period referred to in Article 29 or Article 30 shall be returned immediately. The person concerned shall have the effective possibility to challenge the seizure, detention or any decision under this Article before a court, in accordance with Article 28A.
3. Drug precursors retained pursuant to a final administrative decision shall be destroyed, irreversibly converted or otherwise disposed of in an environmentally sound manner, in accordance with Union and national waste legislation, unless their further retention is necessary for evidential, forensic, research or other public-interest purposes.

Or. en

Amendment 252

Brando Benifei, Evin Incir

Proposal for a regulation

Article 31 – paragraph 2

Text proposed by the CommissionAmendment
The penalties provided for shall be effective, proportionate and dissuasive.The penalties provided for shall be effective, proportionate and dissuasive.
Competent authorities shall ensure that the penalties referred to in paragraph 1 give due regard to the following, as applicable:
(a) the gravity and duration of the infringement;
(b) any relevant previous infringements by the economic operator;
(c) the degree of cooperation with the competent authorities;
(d) any other mitigating or aggravating factor applicable to the circumstances of the case, such as financial benefits, gains or losses avoided, directly or indirectly, from the infringement.

Or. en

Amendment 253

Saskia Bricmont

Proposal for a regulation

Article 31 – paragraph 2

Text proposed by the CommissionAmendment
The penalties provided for shall be effective, proportionate and dissuasive.The penalties provided for shall be effective, proportionate and dissuasive. The penalties shall include temporary exclusion for a maximum period of 12 months from public procurement processes and from access to public funding, including tendering procedures, grants and concessions, and temporary prohibition from placing or making available on the market or exporting relevant substances and mixtures.

Or. en

Amendment 254

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 31 – paragraph 2

Text proposed by the CommissionAmendment
The penalties provided for shall be effective, proportionate and dissuasive.The penalties provided for shall be effective, proportionate and dissuasive, with Member States, when determining them, taking into account the nature, gravity, duration and recurrence of the infringement, as well as the degree of cooperation of the entity concerned with the competent authorities.

Or. sk

Justification

The draft regulation sets out a general requirement of proportionality of sanctions, but does not provide any criteria for its application. Adding essential factors will support a more consistent and predictable application of sanctioning regimes across Member States.

Amendment 255

Mika Aaltola

Proposal for a regulation

Article 31 – paragraph 2

Text proposed by the CommissionAmendment
The penalties provided for shall be effective, proportionate and dissuasive.The penalties referred to in paragraph 1 shall be effective, proportionate and dissuasive.

Or. en

Amendment 256

Mika Aaltola

Proposal for a regulation

Article 31 – paragraph 2 – subparagraph 1 (new)

Text proposed by the CommissionAmendment
3. Member States shall ensure that when deciding whether to impose a penalty and deciding on the type or severity thereof due regard shall be given to the following: (a) whether infringements are committed intentionally or negligently;
(b) the nature, gravity, repetition and duration of the infringement;
(c) the impact on the financial and other security and safety interests of the Union and of Member States;
(d) the degree of cooperation with the competent authorities in order to remedy the infringement and mitigate the possible adverse effects of the infringement;
(e) any relevant previous infringement;
(f) any other mitigating or aggravating circumstances of the case, in accordance with national law,
4. The following acts or omissions shall constitute infringements for the purposes of this Regulation, subject to sanctions:
(a) failure by a licensed operator to submit a pre-export, export or import notification as required under this Regulation;
(b) submission by an operator of false, incomplete or materially misleading information in a precursor notification, licence application or registration;
(c) trading in scheduled or designer precursors without holding a valid licence or registration required under this Regulation;
(d) failure by an operator to report a suspicious transaction or disappearance of scheduled substances or theft where reporting is required;
5. Member States may define additional infringements related to the obligations under this Regulation beyond those listed in paragraph 3, subject to notification to the Commission.
6. Clerical and minor errors shall not constitute an infringement under paragraph 3 unless committed intentionally or as the result of obvious negligence. Infringements attributable to force majeure, including documented IT system failures beyond the operator's or carrier's control, shall not give rise to sanctions.
7. Penalties shall include where appropriate:
(a) a pecuniary charge;
(b) revocation, suspension or amendment of a licence or registration granted under this Regulation;
(c) confiscation of the goods concerned;
(d) a warning

Or. en

Amendment 257

Saskia Bricmont

Proposal for a regulation

Article 31 – paragraph 2 a (new)

Text proposed by the CommissionAmendment
Without prejudice to the right of Member States to provide for and impose criminal sanctions, Member States shall lay down rules on pecuniary sanctions and administrative measures. Member States shall ensure that, when determining the type and level of pecuniary sanctions or administrative measures, competent authorities take into account all relevant circumstances, including where applicable:
(a) the gravity and the duration of the infringement;
(b) the number of instances the infringement was repeated;
(c) the degree of responsibility of the natural or legal person held responsible;
(d) the financial strength of the natural or legal person held responsible, including in light of its total turnover or annual income;
(e) the benefit derived from the breach by the natural or legal person held responsible, insofar as it can be determined;
(f) the losses to third parties caused by the infringement, insofar as they can be determined;
(g) the level of cooperation of the natural or legal person held responsible with the competent authority;
(h) previous infringements by the natural or legal person held responsible.
Member States shall ensure that the maximum pecuniary sanctions that can be imposed amount at least to twice the amount of the benefit derived from the infringement where that benefit can be determined, or at least EUR 1 000 000, whichever is higher. For Member States whose currency is not the euro, the value referred to in the first subparagraph shall be the corresponding value in the national currency on [OP please add: date of entry into force of this Regulation].

Or. en

Amendment 258

Mika Aaltola

Proposal for a regulation

Article 31 – paragraph 3

Text proposed by the CommissionAmendment
Member States shall notify the Commission of those rules and of any subsequent amendment affecting them.Member States shall notify the Commission of those rules and of any subsequent amendment affecting them, including by recording their decisions through the electronic system referred to in Article 35. The Commission shall publish a comparative overview of Member States’ penalty regimes and report to the European Parliament and Council on enforcement convergence every three years.

Or. en

Amendment 259

Saskia Bricmont

Proposal for a regulation

Article 31 – paragraph 3

Text proposed by the CommissionAmendment
Member States shall notify the Commission of those rules and of any subsequent amendment affecting them.Member States shall by [OP please add date: 3 years after the date of entry into force of this Regulation] notify the Commission of those rules on penalties together with their legal basis and shall notify it, without delay, and of any subsequent amendment affecting them.

Or. en

Amendment 260

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 31 – paragraph 3 a (new)

Text proposed by the CommissionAmendment
The Commission may issue guidelines on the determination of penalties and minimum levels applicable to serious infringements under this Regulation.

Or. en

Amendment 261

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 32 – paragraph 1

Text proposed by the CommissionAmendment
The competent authorities and customs authorities shall report information on seizures of drug precursors and information on the implementation of this Regulation subject to the conditions set out in Annex VIII.The competent authorities and customs authorities shall report information without undue delay on seizures of drug precursors by electronic means via the Union’s centralised electronic system and information on the implementation of this Regulation subject to the conditions set out in Annex VIII. This automated sharing takes place without undue delay in real time as soon as the offense or significant seizure is detected, to enable the immediate configuration of common risk profiles at the Union’s borders.

Or. en

Amendment 262

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 32 – paragraph 1

Text proposed by the CommissionAmendment
The competent authorities and customs authorities shall report information on seizures of drug precursors and information on the implementation of this Regulation subject to the conditions set out in Annex VIII.The competent authorities and customs authorities shall report information on seizures of drug precursors and information on the implementation of this Regulation subject to the conditions set out in Annex VIII. The notification shall ensure the protection of trade secrets, confidential business information and personal data in accordance with Union law.

Or. sk

Justification

The exchange of information is essential for the effective enforcement of the Regulation. At the same time, it is necessary to explicitly ensure the protection of confidential business information and personal data that may be part of the reported data.

Amendment 263

Evin Incir, Brando Benifei

Proposal for a regulation

Article 32 – paragraph 1 – subparagraph 1 (new)

Text proposed by the CommissionAmendment
Member States shall transmit to the Commission, on an annual basis, aggregated information on the implementation of this Regulation, based on data reported pursuant to Annex VIII. The Commission shall use that information to monitor the implementation of this Regulation and shall make a Union-wide overview of those data available.

Or. en

Amendment 264

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 33 – paragraph 1

Text proposed by the CommissionAmendment
1. Where the information referred to in Article 32 concerns significant seizures of non-scheduled drug precursors, the competent authority or customs authority shall notify the Commission, the Agency and other Member States without delay.1. Where the information referred to in Article 32 concerns significant seizures of non-scheduled drug precursors, the competent authority or customs authority shall notify the Commission, the Agency and other Member States without undue delay and by electronic means via the Union’s centralised electronic system.

Or. en

Amendment 265

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 33 – paragraph 1

Text proposed by the CommissionAmendment
1. Where the information referred to in Article 32 concerns significant seizures of non-scheduled drug precursors, the competent authority or customs authority shall notify the Commission, the Agency and other Member States without delay.1. Where the information referred to in Article 32 concerns significant seizures of non-scheduled drug precursors, the competent authority or customs authority shall notify the Commission, the Agency and other Member States without delay. The Commission, in cooperation with the Agency, will issue guidelines to promote a uniform interpretation of the concept of ‘significant’.

Or. sk

Justification

The term ‘significant’ is not further defined in the proposal. Common guidelines would help ensure uniform application practice across Member States without the need to introduce rigid thresholds into the Regulation itself.

Amendment 266

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 33 – paragraph 1 a (new)

Text proposed by the CommissionAmendment
1a. The Commission shall adopt implementing acts specifying the thresholds and criteria for determining significant seizures of non-scheduled drug precursors for the purposes of this Article.

Or. en

Amendment 267

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 33 – paragraph 2

Text proposed by the CommissionAmendment
2. The competent authority of a Member State shall inform the Commission, the Agency and the competent authorities of other Member States without delay, if it receives a request for a licence for a Category 3 drug precursor in accordance with Article 18.2. The competent authority of a Member State shall without undue delay and through the Union’s centralised electronic system inform the Commission, the Agency and the competent authorities of other Member States without delay, if it receives a request for a licence for a Category 3 drug precursor in accordance with Article 18 or if it refuses, suspends, or revokes such a licence to prevent any circumvention strategies or forum shopping.

Or. en

Amendment 268

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 34 – paragraph 1 a (new)

Text proposed by the CommissionAmendment
The Commission shall forward this final report to the European Parliament and the Council.

Or. en

Amendment 269

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 34 – paragraph 1 b (new)

Text proposed by the CommissionAmendment
This report is prepared on a consolidated basis using operational data and statistics automatically centralized within the Union’s electronic system by the competent authorities, thereby ensuring the completeness and reliability of the information provided without imposing an additional annual reporting burden on operators.

Or. en

Amendment 270

Evin Incir, Brando Benifei

Proposal for a regulation

Article 35 – paragraph 1

Text proposed by the CommissionAmendment
1. The Commission shall establish and maintain a centralised electronic system for the submission, storage, processing, decision-making, and exchange of information for the monitoring and control of drug precursors in accordance with this Regulation.1. The Commission shall establish and maintain a centralised electronic system for the submission, storage, processing, decision-making, and exchange of information for the monitoring and control of drug precursors in accordance with this Regulation. The Commission shall also establish contingency procedures ensuring that competent authorities, customs authorities and operators can continue to perform their diversion-prevention obligations in the event of a system outage, cyber incident or hybrid-threat activity targeting the system.

Or. en

Amendment 271

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 35 – paragraph 2 – point a – point vi a (new)

Text proposed by the CommissionAmendment
(via) record collection, destruction and downstream treatment activities and upload or make available documentary evidence thereof in accordance with the newly proposed Article;

Or. en

Amendment 272

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 35 – paragraph 2 – point a – point vi b (new)

Text proposed by the CommissionAmendment
(vib) The electronic system shall be designed in a user-friendly and proportionate manner to minimise administrative burden, in particular for small and medium-sized enterprises.

Or. en

Amendment 273

Brando Benifei, Evin Incir

Proposal for a regulation

Article 35 – paragraph 2 – point b a (new)

Text proposed by the CommissionAmendment
(ba) To enable providers of online marketplaces to verify in accordance with Article 13a that the operators involved in a transaction hold a valid licence;

Or. en

Amendment 274

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 35 – paragraph 2 – point d a (new)

Text proposed by the CommissionAmendment
(da) provide user-friendly digital functionalities facilitating compliance and administrative procedures, including standardised templates, automated completeness and consistency checks, the possibility to attach supporting documents, tools to verify end-use declarations, dashboards enabling operators and competent authorities to monitor the status of requests and licences, and secure communication functionalities for the exchange of follow-up questions and additional information.

Or. en

Amendment 275

Brando Benifei, Evin Incir

Proposal for a regulation

Article 35 – paragraph 3

Text proposed by the CommissionAmendment
3. The functions referred to in paragraph 2, points (a)(i), (ii), (iii), (iv) and (v), points (b), (c) and (d) shall be operational at the latest 18 months after the entry into force of the implementing act referred to in paragraph 8.3. The functions referred to in paragraph 2, points (a)(i), (ii), (iii), (iv) and (v), points (b), (c) and (d) shall be operational at the latest 12 months after the entry into force of the implementing act referred to in paragraph 8.

Or. en

Amendment 276

Saskia Bricmont

Proposal for a regulation

Article 35 – paragraph 3

Text proposed by the CommissionAmendment
3. The functions referred to in paragraph 2, points (a)(i), (ii), (iii), (iv) and (v), points (b), (c) and (d) shall be operational at the latest 18 months after the entry into force of the implementing act referred to in paragraph 8.3. The functions referred to in paragraph 2, points (a)(i), (ii), (iii), (iv) and (v), points (b), (c) and (d) shall be operational at the latest 12 months after the entry into force of the implementing act referred to in paragraph 8.

Or. en

Amendment 277

Saskia Bricmont

Proposal for a regulation

Article 35 – paragraph 4

Text proposed by the CommissionAmendment
4. The functions referred to in paragraph 2, point (a)(vi) shall be operational at the latest 6 years after the entry into force of the implementing act referred to in paragraph 8.4. The functions referred to in paragraph 2, point (a)(vi) shall be operational at the latest 2 years after the entry into force of the implementing act referred to in paragraph 8.

Or. en

Amendment 278

Sophie Wilmès, Benoit Cassart, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 35 – paragraph 4

Text proposed by the CommissionAmendment
4. The functions referred to in paragraph 2, point (a)(vi) shall be operational at the latest 6 years after the entry into force of the implementing act referred to in paragraph 8.4. The functions referred to in paragraph 2, point (a)(vi) shall be operational at the latest 3 years after the entry into force of the implementing act referred to in paragraph 8.

Or. en

Amendment 279

Brando Benifei, Evin Incir

Proposal for a regulation

Article 35 – paragraph 4

Text proposed by the CommissionAmendment
4. The functions referred to in paragraph 2, point (a)(vi) shall be operational at the latest 6 years after the entry into force of the implementing act referred to in paragraph 8.4. The functions referred to in paragraph 2, point (a)(vi) shall be operational at the latest 2 years after the entry into force of the implementing act referred to in paragraph 8.

Or. en

Amendment 280

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 35 – paragraph 5

Text proposed by the CommissionAmendment
5. The Commission shall interconnect the electronic system referred to in paragraph 1 with the EU Single Window Environment for Customs established by Regulation (EU) 2022/2399 for the purpose of enabling the performance of the verifications referred to in Article 23(3) and Article 23(4) at the latest 6 years from the entry into force of the implementing act referred to in paragraph 8 of this Article.5. The Commission shall interconnect the electronic system referred to in paragraph 1 with the EU Single Window Environment for Customs established by Regulation (EU) 2022/2399 for the purpose of enabling the performance of the verifications referred to in Article 23(3) and Article 23(4) at the latest 3 years from the entry into force of the implementing act referred to in paragraph 8 of this Article.
The Commission shall interconnect the electronic system referred to in paragraph 1 with the EU Single Window Environment for Customs established by Regulation (EU) 2022/2399 for the purpose of enabling the performance of the verifications referred to in Article 23(3) and Article 23(4), by the date referred to in paragraph 3.

Or. en

Amendment 281

Mika Aaltola

Proposal for a regulation

Article 35 – paragraph 5

Text proposed by the CommissionAmendment
5. The Commission shall interconnect the electronic system referred to in paragraph 1 with the EU Single Window Environment for Customs established by Regulation (EU) 2022/2399 for the purpose of enabling the performance of the verifications referred to in Article 23(3) and Article 23(4) at the latest 6 years from the entry into force of the implementing act referred to in paragraph 8 of this Article.5. For the purpose of enabling the performance of the verifications referred to in Article 23(3) and Article 23(4), the Commission shall interconnect the electronic system referred to in paragraph 1 with the EU Single Window Environment for Customs established by Regulation (EU) 2022/2399 for the purpose of enabling the performance of the verifications referred to in Article 23(3) and Article 23(4) at the latest 6 years from the entry into force of the implementing act referred to in paragraph 8 of this Article and with the EU Customs Data Hub established by Regulation (EC) 2023/0156 at the latest 2 years from the entry into force where possible.

Or. en

Amendment 282

Saskia Bricmont

Proposal for a regulation

Article 35 – paragraph 5

Text proposed by the CommissionAmendment
5. The Commission shall interconnect the electronic system referred to in paragraph 1 with the EU Single Window Environment for Customs established by Regulation (EU) 2022/2399 for the purpose of enabling the performance of the verifications referred to in Article 23(3) and Article 23(4) at the latest 6 years from the entry into force of the implementing act referred to in paragraph 8 of this Article.5. The Commission shall interconnect the electronic system referred to in paragraph 1 with the EU Single Window Environment for Customs established by Regulation (EU) 2022/2399 for the purpose of enabling the performance of the verifications referred to in Article 23(3) and Article 23(4) at the latest 3 years from the entry into force of the implementing act referred to in paragraph 8 of this Article.

Or. en

Amendment 283

Brando Benifei, Evin Incir

Proposal for a regulation

Article 35 – paragraph 5

Text proposed by the CommissionAmendment
5. The Commission shall interconnect the electronic system referred to in paragraph 1 with the EU Single Window Environment for Customs established by Regulation (EU) 2022/2399 for the purpose of enabling the performance of the verifications referred to in Article 23(3) and Article 23(4) at the latest 6 years from the entry into force of the implementing act referred to in paragraph 8 of this Article.5. The Commission shall interconnect the electronic system referred to in paragraph 1 with the EU Single Window Environment for Customs established by Regulation (EU) 2022/2399 for the purpose of enabling the performance of the verifications referred to in Article 23(3) and Article 23(4) at the latest 2 years from the entry into force of the implementing act referred to in paragraph 8 of this Article.

Or. en

Amendment 284

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 35 – paragraph 6

Text proposed by the CommissionAmendment
6. The Commission may, in cooperation with the United Nations, interconnect the system referred to in paragraph 1 with the systems of the United Nations for incidents reporting or other United Nations systems for drug precursors.6. The Commission shall ensure, in cooperation with the United Nations, the effective interoperability and, where technically feasible, the real-time exchange of information between the system referred to in paragraph 1 and the relevant United Nations systems for drug precursor incident reporting in order to avoid delays in the transmission of actionable information. Access shall be role-based and limited to the data strictly necessary for the performance of those tasks.

Or. en

Amendment 285

Brando Benifei, Evin Incir

Proposal for a regulation

Article 35 – paragraph 7

Text proposed by the CommissionAmendment
7. The Commission, the Agency, the competent authorities and the operators shall have access to the data in the electronic system needed for performing their tasks under this Regulation7. The Commission, the Agency, the competent authorities, the operators, and providers of online marketplaces shall have access to the data in the electronic system needed for performing their tasks under this Regulation

Or. en

Amendment 286

Georgiana Teodorescu

Proposal for a regulation

Article 35 – paragraph 7 a (new)

Text proposed by the CommissionAmendment
7a. The roll-out of the central IT system shall follow a realistic, phased timeline. Full implementation shall be conditional upon comprehensive operational testing and verified interoperability with existing national infrastructures, ensuring that the transition does not cause operational disruptions for national competent authorities or operators.

Or. en

Justification

Digital transformation should optimize workflows, not break them. Forcing data migration onto un-tested systems risks severe disruptions to external trade and internal market oversight.

Amendment 287

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 35 – paragraph 8

Text proposed by the CommissionAmendment
8. By [OP please add date: 18 months after the entry into force of this Regulation], the Commission shall adopt an implementing act establishing implementing arrangements for the development and operation of the electronic system, including technical specifications and the procedures to be followed for the implementation of Articles 6, 8, 9, 13, 15, 17, 18, 19(1), 20, 21, 22, 23, 32, 33 and 34.8. By [OP please add date: 18 months after the entry into force of this Regulation], the Commission shall adopt an implementing act establishing implementing arrangements for the development and operation of the electronic system, including technical specifications and the procedures to be followed for the implementation of Articles 6, 8, 9, 13, 15, 17, 18, 19(1), 20, 21, 22, 23, 32, 33 and 34.
That implementing act shall also lay down fallback procedures in the event of system or interconnection failure, user management and access rights, data categories, retention periods, logging requirements, cybersecurity requirements, and the safeguards necessary to ensure compliance with Regulations (EU) 2016/679 and (EU) 2018/1725.

Or. en

Amendment 288

Saskia Bricmont

Proposal for a regulation

Article 35 – paragraph 8

Text proposed by the CommissionAmendment
8. By [OP please add date: 18 months after the entry into force of this Regulation], the Commission shall adopt an implementing act establishing implementing arrangements for the development and operation of the electronic system, including technical specifications and the procedures to be followed for the implementation of Articles 6, 8, 9, 13, 15, 17, 18, 19(1), 20, 21, 22, 23, 32, 33 and 34.8. By [OP please add date: 12 months after the entry into force of this Regulation], the Commission shall adopt an implementing act establishing implementing arrangements for the development and operation of the electronic system, including technical specifications and the procedures to be followed for the implementation of Articles 6, 8, 9, 13, 15, 17, 18, 19(1), 20, 21, 22, 23, 32, 33 and 34.

Or. en

Amendment 289

Mika Aaltola

Proposal for a regulation

Article 35 – paragraph 9 – subparagraph 1 (new)

Text proposed by the CommissionAmendment
10. The system shall be designed to be fully interoperable with other electronic systems, including the Import Control System 2 (ICS2), the Automated Export System (AES), the EU Customs Data Hub, the EU Single Window Environment for Customs and the Information and Communication System for Market Surveillance (ICSMS). The Commission shall by means of delegated acts establish interoperability standards for national systems and the interface between the drug precursors electronic system and these parallel systems within 18 months of entry into force of this Regulation.
11. During the transitional period referred to in Articles 41 to 45 and Annex VII, the Commission shall assess the feasibility of using existing Union customs digital infrastructure, including the Import Control System 2 (ICS2) and the Automated Export System (AES), as well as electronic systems that will start being implemented at an earlier stage, such as the EU Customs Data Hub, to frontload some of the requirements for external trade for the registration, submission and exchange of information relating to drug precursor consignments to accelerate the implementation of this Regulation.
12. Pending the interconnection of the drug precursors electronic system with the Single Window Environment for Customs, Member States that have deployed functional national electronic systems for precursor notifications shall be authorised to operate those systems as of the date of entry into force of this Regulation, provided they meet interoperability standards established by the Commission by implementing acts.
13. The Commission shall carry out appropriate consultations during the preparatory work for the establishment of the electronic system and its interoperability with other electronic systems, including at expert level including Trade Contact Group. Those consultations shall be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

Or. en

Amendment 290

Saskia Bricmont

Proposal for a regulation

Article 35 a (new)

Text proposed by the CommissionAmendment
Article 35a
Digital sovereignty
1. The electronic system shall be designed to ensure that data available therein is protected from unauthorised access and other threats to its integrity and security, which constitutes a public interest. The electronic system, excluding telecommunication transmission infrastructure, shall be solely controlled and administered by the Commission or the EU Customs Authority and the Agency according to a working arrangement establishing operational cooperation. It shall be located within the territory of the European Union.
2. In the context of tasks related to the development, hosting, operation and maintenance, and any related data processing on the electronic system:
(a) Any supplier and other service provider, and any subcontractor, shall ensure reliability, security and independence from influence of governments of third countries and shall not be directly or indirectly subject to any law, including executive orders, of a third country that may require the disclosure of the electronic system data to any authorities of that country. For critical services, including any data-related activities, the contracting authority may require a security clearance.
(b) Any supplier, other service provider, and any subcontractor shall be legally established in the Union and not controlled, directly or indirectly, by any undertaking of a third country as defined in Article 2(7) Regulation (EU) 2019/452.
3. The contracting authority for the electronic system may at any time require any suppliers, tenderers, sub-contractors and any other service providers, to provide evidence of the measures that they have in place to prevent any unauthorised disclosure of data from the electronic system, including documentation that they fulfil the obligations set out in paragraph 2a with regard to independence and non-disclosure, and of the fact that they ensure the reliability, security and independence from influence of governments of third countries.
4. The security of the supply-chain of all IT components, hardware and software shall be ensured to the greatest extent possible. Any suppliers, sub-contractors and any other service providers may be required by the contracting authority for the electronic system to provide evidence in this regard.
5. Where the contracting authority for the electronic system has reason to believe that the measures taken by any suppliers, tenderers, subcontractors or any other service providers to ensure their obligations under paragraphs 2-4 of this Article, are insufficient, or that the evidence provided by them under this Article is not wholly reliable, the contracting authority for the electronic system may take measures under the contract or in a procurement process it deems necessary to remedy the situation, including the suspension or termination in part or in full of the contract and exclusion from the procurement process. This shall be without prejudice to other additional remedial rights the contracting authority for the electronic system may have established under the relevant contract or under other provisions in force.
6. Unless provided for in this Regulation or in an international agreement by which the Union is bound, data processed in the electronic system shall not be transferred or made available to a third country, to an international organization or to natural or legal persons established outside the territory of the Union.
7. The electronic system shall be designed to the highest extent possible to avoid pre-commercial, commercial, technical, contractual and organisational obstacles that discourage, impede or prevent the contracting authority from transferring or porting data, applications, or digital assets to another service provider, or their use in an interoperable environment.

Or. en

Justification

Based on an article of the Regulation of the European Parliament and of the Council

establishing the Union Customs Code and the European Union Customs Authority, and repealing Regulation (EU) No 952/2013.

Amendment 291

Sophie Wilmès, Benoit Cassart, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 36 – paragraph 3

Text proposed by the CommissionAmendment
3. Access to personal data shall be limited to duly authorised staff of the Commission and other Union bodies, competent authorities and customs authorities to the extent necessary for the performance of their tasks under this Regulation. Those Union bodies and authorities shall ensure the confidentiality and integrity of such data and protect them against unauthorised access, use or disclosure, in accordance with the applicable Union data protection rules.3. Access to personal data shall be limited to duly authorised staff of the Commission and other Union bodies, competent authorities and customs authorities to the extent necessary for the performance of their tasks under this Regulation. Those Union bodies and authorities shall ensure the confidentiality and integrity of such data and protect them against unauthorised access, use or disclosure, in accordance with the applicable Union data protection rules.
The electronic system shall ensure logging of access and changes, traceability of actions, data integrity, business continuity and secure exchange of information between competent authorities, customs authorities and operators.

Or. en

Amendment 292

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 36 – paragraph 3

Text proposed by the CommissionAmendment
3. Access to personal data shall be limited to duly authorised staff of the Commission and other Union bodies, competent authorities and customs authorities to the extent necessary for the performance of their tasks under this Regulation. Those Union bodies and authorities shall ensure the confidentiality and integrity of such data and protect them against unauthorised access, use or disclosure, in accordance with the applicable Union data protection rules.3. Access to personal data shall be limited to duly authorised staff of the Commission and other Union bodies, competent authorities and customs authorities to the extent necessary for the performance of their tasks under this Regulation. Those Union bodies and authorities shall ensure the confidentiality and integrity of such data and protect them against unauthorised access, use or disclosure, in accordance with the applicable Union data protection rules. Each access to personal data must be recorded and must be capable of being verified retrospectively.

Or. sk

Justification

In large centralised information systems, it is necessary to ensure not only access restriction, but also full traceability. Such a solution increases the protection of data subjects and supports compliance with data protection rules.

Amendment 293

Sophie Wilmès, Benoit Cassart, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 36 – paragraph 3 a (new)

Text proposed by the CommissionAmendment
3a. Digital sovereignty
1. The electronic system shall be designed to ensure that data available therein is protected from unauthorised access and other threats to its integrity and security, which constitutes a public interest. The electronic system infrastructure, excluding telecommunication transmission infrastructure, shall be solely controlled and administered by the Commission and shall be located within the territory of the European Union.
2. In the context of tasks related to the development, hosting, operation and maintenance, and any related data processing on the electronic system:
(a) Any supplier and other service provider, and any subcontractor, shall ensure reliability, security and independence from influence of governments of third countries and shall not be directly or indirectly subject to any law, including executive orders, of a third country that may require the disclosure of the electronic system to any authorities of that country. For critical services, including any data-related activities, the contracting authority may require a security clearance.
(b) Any supplier, other service provider, and any subcontractor shall be legally established in the Union and not controlled, directly or indirectly, by any undertaking of a third country as defined in Article 2(7) Regulation (EU) 2019/452.
3. The contracting authority for the electronic system may at any time require any suppliers, tenderers, sub-contractors and any other service providers, to provide evidence of the measures that they have in place to prevent any unauthorised disclosure of data from the electronic system, including documentation that they fulfil the obligations set out in paragraph 2a with regard to independence and non-disclosure, and of the fact that they ensure the reliability, security and independence from influence of governments of third countries.
4. The security of the supply-chain of all IT components, hardware and software shall be ensured to the greatest extent possible. Any suppliers, sub-contractors and any other service providers may be required by the contracting authority for the electronic system to provide evidence in this regard.
5. Where the contracting authority for the electronic system has reason to believe that the measures taken by any suppliers, tenderers, subcontractors or any other service providers to ensure their obligations under paragraphs 2-4 of this Article, are insufficient, or that the evidence provided by them under this Article is not wholly reliable, the contracting authority for the electronic system may take measures under the contract or in a procurement process it deems necessary to remedy the situation, including the suspension or termination in part or in full of the contract and exclusion from the procurement process. This shall be without prejudice to other additional remedial rights the contracting authority for the electronic system may have established under the relevant contract or under other provisions in force.
6. The data processed in the electronic system shall not be transferred or made available to a third country, to an international organization or to natural or legal persons established outside the territory of the Union.
7. The electronic system shall be designed to the highest extent possible to avoid pre-commercial, commercial, technical, contractual and organisational obstacles that discourage, impede or prevent the contracting authority from transferring or porting data, applications, or digital assets to another service provider, or their use in an interoperable environment.

Or. en

Amendment 294

Mika Aaltola

Proposal for a regulation

Article 37 – paragraph 1

Text proposed by the CommissionAmendment
1. The Commission is empowered to adopt delegated acts in accordance with Article 38 amending Annex I, Annex II and Annex III to adapt those Annexes to new trends in diversion of drug precursors or to align them with any amendment to the tables annexed to the UN Convention, by adding or removing substances and adapting existing entries. The Commission may only add substances identified individually to Annex I or Annex II, unless otherwise required to align those Annexes with the tables annexed to the UN Convention. The Commission may add substances in Annex III either identified individually or in a generic way. When adding substances in a generic way, the Commission shall clearly identify the group of substances and, if applicable, the individual substances which are to be exempted from the control and monitoring measures for scheduled drug precursors.1. The Commission is empowered to adopt delegated acts in accordance with Article 38 amending Annex I, Annex II and Annex III to adapt those Annexes to new trends in diversion of drug precursors or to align them with any amendment to the tables annexed to the UN Convention, by adding or removing substances and adapting existing entries. The Commission may only add substances identified individually to Annex I or Annex II, unless otherwise required to align those Annexes with the tables annexed to the UN Convention. The Commission shall identify the applicable CAS number for each substance listed in Annex I or Annex II, where available. Where a CAS number has not yet been assigned, the Commission shall request its assignment before the delegated act is adopted. The Commission may add substances in Annex III either identified individually or in a generic way. When adding substances in a generic way, the Commission shall clearly identify the group of substances and, if applicable, the individual substances which are to be exempted from the control and monitoring measures for scheduled drug precursors.

Or. en

Amendment 295

Sophie Wilmès, Benoit Cassart, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 37 – paragraph 1

Text proposed by the CommissionAmendment
1. The Commission is empowered to adopt delegated acts in accordance with Article 38 amending Annex I, Annex II and Annex III to adapt those Annexes to new trends in diversion of drug precursors or to align them with any amendment to the tables annexed to the UN Convention, by adding or removing substances and adapting existing entries. The Commission may only add substances identified individually to Annex I or Annex II, unless otherwise required to align those Annexes with the tables annexed to the UN Convention. The Commission may add substances in Annex III either identified individually or in a generic way. When adding substances in a generic way, the Commission shall clearly identify the group of substances and, if applicable, the individual substances which are to be exempted from the control and monitoring measures for scheduled drug precursors.1. The Commission is empowered to adopt delegated acts in accordance with Article 38 amending Annex I, Annex II and Annex III to adapt those Annexes to new trends in diversion of drug precursors or to align them with any amendment to the tables annexed to the UN Convention, by adding or removing substances and adapting existing entries. For each substance newly added to Annex I or Annex II, the Commission shall indicate the corresponding CAS number, where available. The Commission may only add substances identified individually to Annex I or Annex II, unless otherwise required to align those Annexes with the tables annexed to the UN Convention. The Commission may add substances in Annex III either identified individually or in a generic way. When adding substances in a generic way, the Commission shall clearly identify the group of substances and, if applicable, the individual substances which are to be exempted from the control and monitoring measures for scheduled drug precursors.

Or. en

Amendment 296

Saskia Bricmont

Proposal for a regulation

Article 37 – paragraph 1

Text proposed by the CommissionAmendment
1. The Commission is empowered to adopt delegated acts in accordance with Article 38 amending Annex I, Annex II and Annex III to adapt those Annexes to new trends in diversion of drug precursors or to align them with any amendment to the tables annexed to the UN Convention, by adding or removing substances and adapting existing entries. The Commission may only add substances identified individually to Annex I or Annex II, unless otherwise required to align those Annexes with the tables annexed to the UN Convention. The Commission may add substances in Annex III either identified individually or in a generic way. When adding substances in a generic way, the Commission shall clearly identify the group of substances and, if applicable, the individual substances which are to be exempted from the control and monitoring measures for scheduled drug precursors.1. By [6 months before the date of application of this Regulation] at the latest, the Commission shall is empowered to adopt delegated acts in accordance with Article 38 amending Annex I, Annex II and Annex III to adapt those Annexes to new trends in diversion of drug precursors or to align them with any amendment to the tables annexed to the UN Convention, by adding or removing substances and adapting existing entries. The Commission may only add substances identified individually to Annex I or Annex II, unless otherwise required to align those Annexes with the tables annexed to the UN Convention. The Commission may add substances in Annex III either identified individually or in a generic way. When adding substances in a generic way, the Commission shall clearly identify the group of substances and, if applicable, the individual substances which are to be exempted from the control and monitoring measures for scheduled drug precursors.

Or. en

Amendment 297

Mika Aaltola

Proposal for a regulation

Article 37 – paragraph 1 – subparagraph 1 (new)

Text proposed by the CommissionAmendment
6. Highlights the role of the European Union Drugs Agency (EUDA), pursuant to Article 14 of Regulation (EU) 2023/1322, in assessing drug precursors and preparing threat assessment reports. Notes that such assessments may provide the basis for the Commission to adopt delegated acts under this Regulation.

Or. en

Amendment 298

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 37 – paragraph 4

Text proposed by the CommissionAmendment
4. The Commission is empowered to adopt delegated acts amending Annex IV, Annex V, Annex VI, Annex VII, Annex VIII and Annex IX to adapt the general conditions and other technical rules for: licences; registrations; prior notifications; quantity notifications for import or export; pre-export notifications; the criteria to determine the licit purposes of the transaction referred to in Article 24; determining the criteria for suspicion on intention of use in the illicit manufacture of drugs as referred to in Article 30(7); reporting obligations; and transitional measures.4. The Commission is empowered to adopt delegated acts amending Annex IV, Annex V, Annex VI, Annex VII, Annex VIII and Annex IX to adapt exclusively the technical and implementing elements for: licences; registrations; prior notifications; quantity notifications for import or export; pre-export notifications; the criteria to determine the licit purposes of the transaction referred to in Article 24; determining the criteria for suspicion on intention of use in the illicit manufacture of drugs as referred to in Article 30(7); reporting obligations; and transitional measures. Delegated acts may not change the essential obligations of controllers or extend the scope of this Regulation.

Or. sk

Justification

Delegated acts are intended to amend non-essential elements of a legal act. It is appropriate to explicitly confirm that new substantive obligations cannot be introduced or the scope of regulation extended through delegated acts without a proper legislative process.

Amendment 299

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 37 – paragraph 5

Text proposed by the CommissionAmendment
5. When adopting delegated acts in accordance with this Article, the Commission shall take into account both the risk of diversion of drug precursors for the production and manufacture of illicit drugs and the impact on legitimate trade.5. When adopting delegated acts in accordance with this Article, the Commission shall take into account both the risk of diversion of drug precursors for the production and manufacture of illicit drugs and the impact on legitimate trade. To that end, the Commission shall carry out a preliminary economic impact assessment and shall consult, in accordance with the Better Regulation principles, relevant stakeholders, including expert groups of the Member States, representatives of the chemical industry and academic research institutions.

Or. en

Amendment 300

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 37 – paragraph 5

Text proposed by the CommissionAmendment
5. When adopting delegated acts in accordance with this Article, the Commission shall take into account both the risk of diversion of drug precursors for the production and manufacture of illicit drugs and the impact on legitimate trade.5. When adopting delegated acts in accordance with this Article, the Commission shall take into account both the risk of diversion of drug precursors for the production and manufacture of illicit drugs and the impact on legitimate trade, the competitiveness of economic operators and the administrative burden, particularly for small and medium-sized enterprises.

Or. sk

Justification

The regulation of precursors must ensure a high level of protection against misuse, but at the same time must not impose an undue burden on legitimate economic activities. The assessment of impacts on SMEs is in line with the principles of better regulation.

Amendment 301

Sebastian Tynkkynen

Proposal for a regulation

Article 37 – paragraph 5 a (new)

Text proposed by the CommissionAmendment
5a. No provision of this legislation shall deprive Member States of the right to schedule chemical substances as drug precursors at the national level.

Or. fi

Amendment 302

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 38 – paragraph 4

Text proposed by the CommissionAmendment
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. The Commission shall make the draft delegated act and the underlying technical and scientific justification available to the Member States in good time before the consultation begins.

Or. sk

Justification

Effective consultation presupposes that Member States have sufficient time to assess the proposal and have access to the evidence on which the Commission bases its decision.

Amendment 303

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 39 – paragraph 1

Text proposed by the CommissionAmendment
1. Delegated acts amending Annex I, Annex II and Annex III adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.1. Delegated acts amending Annex I, Annex II and Annex III adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. The Commission shall demonstrate in particular the existence of an imminent and serious risk to public security or public health which justifies the use of the urgency procedure.

Or. sk

Justification

The urgency procedure constitutes an exception to the standard exercise of delegated powers. It is therefore appropriate to specify the circumstances in which this procedure may be used.

Amendment 304

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 40 – paragraph 2 a (new)

Text proposed by the CommissionAmendment
2a. The European Union Drugs Agency (EUDA) participates in the work of the Committee as an observer and shall provide technical expertise. Representatives of from the chemical industry, small and medium-sized enterprises, and university research centres may be invited to participate as observers or experts, as appropriate, to provide an input on assess the operational and economic impact of the measures under consideration.

Or. en

Amendment 305

Saskia Bricmont

Proposal for a regulation

Article 41 – title

Text proposed by the CommissionAmendment
ReviewEvaluation and review

Or. en

Amendment 306

Saskia Bricmont

Proposal for a regulation

Article 41 – paragraph 1

Text proposed by the CommissionAmendment
By [OP please add date: 10 years from the date of application of this Regulation], the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation. The report shall contain an assessment of how this Regulation is achieving its objectives.By 31 December 2030 and every 3 years thereafter, the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation. The report shall contain an evaluation of how this Regulation is achieving its objectives, in terms of public health and legitimate use of drug precursors. The evaluation shall in particular include an assessment of
(a) the evolution of licit and illicit manufacture, trade and use of drug precursors and drug designers;
(b) the categorisation of substances and mixtures; the quality of the collaboration between competent authorities;
(c) the appropriateness of sanctions;
(c) safeguard measures taken by the Member States;
(d) the role of online market platforms;
(e) financial and human resources of the national competent authorities.
Where the Commission considers it appropriate, the report shall be accompanied by a legislative proposal for the amendment of the relevant provisions of this Regulation.

Or. en

Amendment 307

Evin Incir, Brando Benifei

Proposal for a regulation

Article 41 – paragraph 1

Text proposed by the CommissionAmendment
By [OP please add date: 10 years from the date of application of this Regulation], the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation. The report shall contain an assessment of how this Regulation is achieving its objectives.By 5 years from the date of application of this Regulation, the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation and every five years thereafter. The report shall contain an assessment of how this Regulation is achieving its objectives and its uniform application across the Union. The effectiveness of this Regulation in preventing the diversion of drug precursors may also be an indicator in the assessment.

Or. en

Amendment 308

Erik Kaliňák, Katarína Roth Neveďalová

Proposal for a regulation

Article 41 – paragraph 1

Text proposed by the CommissionAmendment
By [OP please add date: 10 years from the date of application of this Regulation], the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation. The report shall contain an assessment of how this Regulation is achieving its objectives.By five years from the date of application of this Regulation, the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation. This report shall contain an assessment of how this Regulation is achieving its objectives, its impact on the fight against illicit drug production, the administrative burden on economic operators and the functioning of the electronic system referred to in Article 35.

Or. sk

Justification

A ten-year period is too long, given the rapid developments in synthetic drugs, designer precursors and digital tools. An earlier assessment will allow for the identification of potential shortcomings and an appropriate response to the development of the situation.

Amendment 309

Brando Benifei, Evin Incir

Proposal for a regulation

Article 41 – paragraph 1

Text proposed by the CommissionAmendment
By [OP please add date: 10 years from the date of application of this Regulation], the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation. The report shall contain an assessment of how this Regulation is achieving its objectives.By 5 years from the date of application of this Regulation, the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation and every 5 years thereafter. The report shall contain an assessment of how this Regulation is achieving its objectives and its uniform application across the Union.

Or. en

Amendment 310

Sophie Wilmès, Benoit Cassart, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 41 – paragraph 1

Text proposed by the CommissionAmendment
By [OP please add date: 10 years from the date of application of this Regulation], the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation. The report shall contain an assessment of how this Regulation is achieving its objectives.By [OP please add date: 5 years from the date of application of this Regulation], the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation. The report shall contain an assessment of how this Regulation is achieving its objectives.

Or. en

Amendment 311

Benoit Cassart, Sophie Wilmès, Dan Barna, Hilde Vautmans, Fabienne Keller

Proposal for a regulation

Article 41 – paragraph 1 a (new)

Text proposed by the CommissionAmendment
This evaluation shall, in particular, assess both the effectiveness of customs controls and digital interconnectivity in reducing the diversion of drug precursors, and the economic and administrative impact of the Regulation on small and medium-sized enterprises, legitimate trade, and scientific research and innovation activities. By way of derogation from paragraph 1, within three years of the date of application of this Regulation, the Commission shall submit an interim evaluation report to the European Parliament and to the Council, with a particular focus on the operational deployment of the centralised electronic system, the interoperability of national customs systems tools, and the adequacy of administrative simplification measures granted to small and medium-sized enterprises as well as to university research centres.

Or. en

Amendment 312

Saskia Bricmont

Proposal for a regulation

Article 43 – paragraph 1

Text proposed by the CommissionAmendment
1. Licences, special licences, registrations and special registrations issued under Regulation (EC) No 273/2004 or Regulation (EC) No 111/2005 before [OP please add date: 3 years after the date of entry into force of this Regulation] shall be valid until their expiry date or until [OP please add date: 4 years after the date of entry into force of this Regulation] whichever is soonest.1. Licences, special licences, registrations and special registrations issued under Regulation (EC) No 273/2004 or Regulation (EC) No 111/2005 before [OP please add date: 18 months after the date of entry into force of this Regulation] shall be valid until their expiry date or until [OP please add date: 4 years after the date of entry into force of this Regulation] whichever is soonest.

Or. en

Amendment 313

Saskia Bricmont

Proposal for a regulation

Article 43 – paragraph 2

Text proposed by the CommissionAmendment
2. Licences and special licences for which an application is made before [OP please add date: 3 years after the date of entry into force of this Regulation] based on Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005 shall be granted in accordance with those Regulations and be valid until maximum [OP please add date: 4 years after the date of entry into force of this Regulation].2. Licences and special licences for which an application is made before [OP please add date: 18 months after the date of entry into force of this Regulation] based on Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005 shall be granted in accordance with those Regulations and be valid until maximum [OP please add date: 4 years after the date of entry into force of this Regulation].

Or. en

Amendment 314

Saskia Bricmont

Proposal for a regulation

Article 43 – paragraph 4

Text proposed by the CommissionAmendment
4. Import and export authorisations issued under Regulation (EC) No 111/2005 before [OP please add date: 3 years after the date of entry into force of this Regulation] shall be valid until their expiry date.4. Import and export authorisations issued under Regulation (EC) No 111/2005 before [OP please add date: 18 months after the date of entry into force of this Regulation] shall be valid until their expiry date.

Or. en

Amendment 315

Saskia Bricmont

Proposal for a regulation

Article 43 – paragraph 5

Text proposed by the CommissionAmendment
5. Import and export authorisations applied for under Regulation (EC) No 111/2005 but not issued before [OP please add date: 3 years after the date of entry into force of this Regulation] shall be deemed to have been applied for under the conditions set out in Annex IX.5. Import and export authorisations applied for under Regulation (EC) No 111/2005 but not issued before [OP please add date: 18 months after the date of entry into force of this Regulation] shall be deemed to have been applied for under the conditions set out in Annex IX.

Or. en

Amendment 316

Saskia Bricmont

Proposal for a regulation

Article 45 – paragraph 2

Text proposed by the CommissionAmendment
It shall apply from [OP please add date: 3 years after the date of entry into force of this Regulation].It shall apply from [OP please add date: 18 months after the date of entry into force of this Regulation].

Or. en

Amendment 317

Mika Aaltola

Proposal for a regulation

Annex VII – subheading 5 a (new)

Text proposed by the CommissionAmendment
Online marketplaces 1. Operators of online marketplaces, within the meaning of Regulation (EU) 2022/2065 (Digital Services Act), that facilitate the sale of scheduled or designer precursors by third-party sellers shall: (a) verify, prior to listing, that sellers hold a valid licence or registration under this Regulation; (b) suspend or remove listings where a seller cannot demonstrate a valid authorisation; and (c) report to the competent authority any seller listed without a valid authorisation that is found to have offered scheduled substances for sale. Online marketplace operators that fail to comply with this Article shall be subject to the penalties applicable to operators under this Regulation. 2. Where providers of online marketplaces become aware of any information regarding suspicious transactions, significant disappearances, and thefts of scheduled drug precursors, they shall immediately report that information to the competent authorities.

Or. en

Amendment 318

Mika Aaltola

Proposal for a regulation

Annex VII – point 7 – paragraph 1 – point b

Text proposed by the CommissionAmendment
(b) the quantity of the substance and, in the case of a mixture, or an organism or a substance which occurs in nature, the quantity, and, if available, the percentage of any substance covered by Annex I, Annex II or Annex III contained therein;(b) the quantity of the substance and, in the case of a mixture, or an organism or a substance which occurs in nature, the quantity, and, if available, the percentage of any substance covered by Annex I, Annex II or Annex III contained therein; exporters may indicate, in a single notification, the concentration range of all mixtures containing a specific scheduled substance exported during a period of 180 calendar days, where the competent authorities are satisfied that this will not result in any risk of diversion of scheduled drug precursors.

Or. en