amendment list, 28 July 2026
On the proposal for a regulation of the European Parliament and of the Council Amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements
Document CJ14-AM-791051 · (COM(2025)1030 – C100359/2025 – 2025/0410(COD))
Committee on the Environment, Climate and Food Safety Committee on Agriculture and Rural Development
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Text 1,848 paragraphs
Amendment 1124
Katarína Roth Neveďalová, Erik Kaliňák
Proposal for a regulation
Article 1 – paragraph 1 – point 33 a (new)
Regulation (EC) No 1107/2009
Article 53
| Present text | Amendment |
|---|---|
| Article 53 is changed as follows | |
| Article 53 | "Article 53 |
| Emergency situations in plant protection | Emergency authorisations |
| 1. By way of derogation from Article 28, in special circumstances a Member State may authorise, for a period not exceeding 120 days, the placing on the market of plant protection products, for limited and controlled use, where such a measure appears necessary because of a danger which cannot be contained by any other reasonable means. | 1. By way of derogation from Article 28 a Member State may authorise, for a period not exceeding one growing season for a specific crop/pest/disease combination, |
| a) the placing on the market and the use of plant protection products, not authorised in a member state; | |
| b) the use of authorised plant protection product beyond the scope of existing authorisation; | |
| c) the placing on the market and use of treated seeds or plant propagating material | |
| if such a measure appears necessary because of a danger which cannot be contained by any other reasonable means. | |
| 2. Emergency authorisation pursuant to paragraph 1 may also apply for the use of the plant protection products for which the conditions of approval of the active substance contained in the plant protection product do not allow authorisation such use pursuant to Article 28. | |
| 3. In case of emergency authorisation pursuant of paragraph 2 risk reduction measures and consumer risk assessment shall ensure an acceptable risk to human health and the environment. | |
| The Member State concerned shall immediately inform the other Member States and the Commission of the measure taken, providing detailed information about the situation and any measures taken to ensure consumer safety. | 4. The Member State concerned shall in 30 days from issuing of emergency authorisation inform the other Member States and the Commission of the measure taken, providing detailed information about the agronomic situation and any measures taken to ensure consumer and environmental safety. |
| 5. A Member State may grant an emergency authorization for a specific crop/pest/disease based on an emergency authorization issued by another Member State in the same zone, provided that the occurrence of the pest or disease for which the authorization was granted has been confirmed. | |
| 2. The Commission may ask the Authority for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within 1 month of the date of the request. | 6. The Commission may ask the Authority for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within 1 month of the date of the request. |
| 3. If necessary, a decision shall be taken, in accordance with the regulatory procedure referred to in Article 79(3), as to when and under what conditions the Member State: | 7. If necessary, a decision shall be taken, in accordance with the regulatory procedure referred to in Article 79(3), as to when and under what conditions the Member State: |
| (a) may or may not extend the duration of the measure or repeat it; or | (a) may or may not extend the duration of the measure or repeat it; or |
| (b) shall withdraw or amend its measure. | (b) shall withdraw or amend its measure. |
| 4. Paragraphs 1 to 3 shall not apply to plant protection products containing or composed of genetically modified organisms unless such release has been accepted in accordance with Directive 2001/18/EC. | 8. Paragraphs 1 to 6 shall not apply to plant protection products containing or composed of genetically modified organisms unless such release has been accepted in accordance with Directive 2001/18/EC. " |
Or. en
(32009R1107)
Amendment 1125
Alexander Bernhuber
Proposal for a regulation
Read the rest (1,836 paragraphs)
Article 1 – paragraph 1 – point 33 a (new)
Regulation (EC) No 1107/2009
Article 53
| Present text | Amendment |
|---|---|
| Article 53 is replaced by the following | |
| Article 53 Emergency situations in plant protection | "Article 53 Emergency situations in plant protection |
| 1. By way of derogation from Article 28, in special circumstances a Member State may authorise, for a period not exceeding 120 days, the placing on the market of plant protection products, for limited and controlled use, where such a measure appears necessary because of a danger which cannot be contained by any other reasonable means. | 1. By way of derogation from Article 28, in special circumstances a Member State may authorise, for a period not exceeding 120 days, the placing on the market of plant protection products, for limited and controlled use, where such a measure appears necessary because of a danger which cannot be contained by any other reasonable means. |
| The Member State concerned shall immediately inform the other Member States and the Commission of the measure taken, providing detailed information about the situation and any measures taken to ensure consumer safety. | The Member State concerned shall immediately inform the other Member States and the Commission of the measure taken, providing detailed information about the situation and any measures taken to ensure consumer safety. |
| 1a. Notwithstanding the restrictions laid down in Implementing Regulations (EU) 2018/783, 2018/784 and 2018/785, a Member State may grant an emergency authorisation under paragraph 1 of this Article for seed treatment uses of the active substances referred to in those Regulations, where: | |
| (a) the Member State has officially delimited areas in which multi-annual phytosanitary monitoring demonstrates systematic exceedance of the Economic Damage Threshold for endemic soil pests; | |
| (b) no effective alternative plant protection means are available to address the identified danger; and | |
| (c) the use is strictly limited to seed treatment and is subject to appropriate risk mitigation measures. | |
| 2. The Commission may ask the Authority for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within 1 month of the date of the request. | 2. The Commission may ask the Authority for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within 1 month of the date of the request. |
| 3. If necessary, a decision shall be taken, in accordance with the regulatory procedure referred to in Article 79(3), as to when and under what conditions the Member State: | 3. If necessary, a decision shall be taken, in accordance with the regulatory procedure referred to in Article 79(3), as to when and under what conditions the Member State: |
| (a) may or may not extend the duration of the measure or repeat it; or | (a) may or may not extend the duration of the measure or repeat it; or |
| (b) shall withdraw or amend its measure. | (b) shall withdraw or amend its measure. |
| 4. Paragraphs 1 to 3 shall not apply to plant protection products containing or composed of genetically modified organisms unless such release has been accepted in accordance with Directive 2001/18/EC. | 4. Paragraphs 1 to 3 shall not apply to plant protection products containing or composed of genetically modified organisms unless such release has been accepted in accordance with Directive 2001/18/EC. |
| 4a. An extension of an authorisation granted by a Member State for a specific crop / plant protection product / pest or disease combination, subject to the prior establishment by that Member State of appropriate risk management measures and application techniques, shall also be immediately effective in all Member States within the same zone. " |
Or. en
(32009R1107)
Amendment 1126
Daniel Buda, Dan-Ştefan Motreanu
Proposal for a regulation
Article 1 – paragraph 1 – point 33 a (new)
Regulation (EC) No 1107/2009
Article 53 – paragraph 1a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| In Article 53, the following paragraph 1a is added: | |
| 1a. By way of derogation from paragraph 1 and without prejudice to the objectives of Implementing Regulations (EU) 2018/783, (EU) 2018/784 and (EU) 2018/785, Member States may grant an emergency authorisation for the use of the active substances referred to in those Regulations to treat seeds, where such an emergency authorisation is explicitly permitted under this paragraph. Such an emergency authorisation may only be granted if all of the following requirements are met: | |
| (a) the Member State has officially demarcated areas where multi-year plant protection monitoring shows systematic exceedance of the economic threshold level by endemic soil pests; | |
| (b) no affordable and at least equally effective alternative means of plant protection are available to combat the identified risk; | |
| (c) use is strictly limited to seed treatment, is geographically limited to the demarcated areas, is time-limited in accordance with paragraph 1, and is subject to appropriate risk mitigation measures. For the purposes of this paragraph, emergency authorisations granted in accordance with the requirements of this paragraph shall be deemed compatible with Implementing Regulations (EU) 2018/783, (EU) 2018/784 and (EU) 2018/785. |
Or. ro
Justification
Propunerea de introducere a unui nou alineat (1a) nu restrânge și nu substituie dreptul statelor membre prevăzut la art. 53, ci clarifică și operationalizează exercitarea acestuia în cazul specific al tratamentului semințelor în zone cu presiune endemică documentată, prin stabilirea unei derogări explicite la nivelul regulamentului-cadru, în condiții strict delimitate și controlabile.Articolul 53 alineatul (1a) este complementar articolului 49 alineatele (3)(a)–(b). În timp ce articolul 49 instituie o cale structurală și permanentă pentru gestionarea zonelor cu presiune endemică documentată, articolul 53 alineatul (1a) asigură o cale de urgență temporară, limitată la 120 de zile, destinată gestionării situațiilor fitosanitare acute, până la implementarea efectivă a mecanismului structural.Necesitatea acestei clarificări rezultă și din practica națională: în perioada 2019–2024, România a acordat autorizații de urgență în temeiul articolului 53 pentru tratamentul semințelor, ca răspuns la presiunea endemică a dăunătorilor de sol și în lipsa unor alternative eficiente. Hotărârea C-162/21 a creat o vulnerabilitate juridică pentru această practică, vulnerabilitate pe care prezentul alineat o remediază în mod explicit.
Amendment 1127
Céline Imart, Emmanouil Kefalogiannis
Proposal for a regulation
Article 1 – paragraph 1 – point 33 a (new)
Regulation (EC) No 1107/2009
Article 53 – paragraph 1 – subparagraph 2 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| Article 53 is amended as follows: | |
| 2a (new) in paragraph 1, the following subparagraph shall be added after the first subparagraph: | |
| By way of derogation from the first subparagraph, where a plant health hazard that cannot be tackled by other means affects a given crop and there is no substitution solution available that is technically effective and economically viable, the Member State may grant a temporary multi-annual authorisation for that specific use. Such an authorisation shall be granted for a maximum period of five years, subject to an annual re-assessment, and only where: | |
| (a) it is established that there is no alternative; | |
| (b) the use in question is subject to restrictions as well as monitoring and traceability conditions; | |
| (c) the Member State has put in place a national plan for research or for deploying alternative solutions; and | |
| (d) the risk-management measures required to protect human health, animal health and the environment have been implemented. | |
| (b) the following paragraph is inserted: | |
| 1b. The authorisation referred to in the second subparagraph of paragraph 1 shall lapse when the need in question has been fully covered by substitution solutions that are technically effective and economically viable for the use in question. |
Or. fr
(32009R1107)
Amendment 1128
Laurence Trochu
Proposal for a regulation
Article 1 – paragraph 1 – point 33 a (new)
Regulation (EC) No 1107/2009
Article 53 – paragraph 1 – subparagraph 1a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| Article 53 is amended as follows: | |
| (a) the following subparagraph is inserted after the first subparagraph: | |
| By way of derogation from the first subparagraph, where a plant health hazard that cannot be tackled by other means affects a given crop and there is no substitution solution available that is technically effective and economically viable, the Member State may grant a temporary multi-annual authorisation for that specific use. | |
| Such an authorisation shall be granted for a maximum period of five years, subject to an annual re-assessment, and only where: | |
| (a) it is established that there is no alternative; | |
| (b) the use in question is subject to restrictions as well as monitoring and traceability conditions; | |
| (c) the Member State has put in place a national or regional plan for research or for deploying alternative solutions; | |
| (d) the risk-management measures required to protect human health, animal health and the environment have been implemented. | |
| (b) the following paragraph is inserted: | |
| 1b. The authorisation referred to in the second subparagraph of paragraph 1 shall lapse when the need in question has been fully covered by substitution solutions that are technically effective and economically viable for the use in question. |
Or. fr
Amendment 1129
Georgiana Teodorescu
Proposal for a regulation
Article 1 – paragraph 1 – point 33 a (new)
Regulation (EC) No 1107/2009
Article 53 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1a By way of derogation from paragraph 1, and without prejudice to the objectives of Implementing Regulations (EU) 2018/783, 2018/784 and 2018/785, Member States may grant an emergency authorisation for seed treatment uses of the active substances referred to in those Regulations, where such emergency authorisation is explicitly permitted under this paragraph. Such emergency authorisation may be granted only where all of the following conditions are met: | |
| a) the Member State has officially delimited areas in which multi-annual phytosanitary monitoring demonstrates a systematic exceedance of the Economic Damage Threshold for endemic soil pests; | |
| (b) no effective alternative plant protection means are available to address the identified danger; | |
| (c) the use is strictly limited to seed treatment, geographically restricted to the delimited areas, limited in time in accordance with paragraph 1, and subject to appropriate risk mitigation measures. | |
| For the purposes of this paragraph, emergency authorisations granted in accordance with the conditions set out herein shall be considered compatible with Implementing Regulations (EU) 2018/783, 2018/784 and 2018/785. |
Or. en
Justification
The proposed amendment introducing a new paragraph (1a) to Article 53 clarifies and operationalizes the right of Member States to grant emergency authorizations for a maximum of 120 days, addressing the legal uncertainty arising from the CJEU judgment in Case C-162/21. This measure does not replace the general framework of Article 53; instead, it establishes an explicit, strictly controlled derogation within the basic regulation for seed treatments in regions with documented endemic pressures. It acts as a necessary complement to the structural solutions proposed under Article 49(3)(a)-(b). While Article 49 establishes a permanent long-term framework, Article 53(1a) provides the temporary safety net required to manage acute phytosanitary crises until the structural pathway is fully implemented, eliminating current legal vulnerabilities.
Amendment 1130
Paulo do Nascimento Cabral
Proposal for a regulation
Article 1 – paragraph 1 – point 33 a (new)
Regulation (EC) No 1107/2009
Article 53 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. Notwithstanding the restrictions laid down in Implementing Regulations (EU) 2018/783, 2018/784 and 2018/785, a Member State may grant an emergency authorisation under paragraph 1 of this Article for seed treatment uses of the active substances referred to in those Regulations, where: | |
| (a) the Member State has officially delimited areas in which multi-annual phytosanitary monitoring demonstrates systematic exceedance of the Economic Damage Threshold for endemic soil pests; | |
| (b) no effective alternative plant protection means are available to address the identified danger; and | |
| (c) the use is strictly limited to seed treatment and is subject to appropriate risk mitigation measures. |
Or. en
Amendment 1131
Gheorghe Cârciu, Dan Nica, Ştefan Muşoiu, Vasile Dîncu, Andi Cristea, Dragoş Benea, Gabriela Firea
Proposal for a regulation
Article 1 – paragraph 1 – point 33 a (new)
Regulation (EC) No 1107/2009
Article 53 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1a Member States may grant emergency authorisations for seed treatment uses involving active substances covered by Regulations (EU) 2018/783, 2018/784 and 2018/785 where there are officially designated areas with documented, systematic exceedances of the economic threshold for pest infestation, no effective alternatives are available, and the use is strictly limited to seed treatment. |
Or. en
Amendment 1132
Ivan David, Anja Arndt, Volker Schnurrbusch, Marc Jongen
Proposal for a regulation
Article 1 – paragraph 1 – point 33 a (new)
Regulation (EC) No 1107/2009
Article 53 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| in Article 53, a new paragraph 1a is inserted: | |
| 1a. Following the notification by the Member State requesting authorisation for a limited and controlled emergency use, the Commission shall adopt a decision, according to the regulatory procedure referred to in Article 79(3), making the same derogation use automatically applicable in all Member States. |
Or. en
Amendment 1133
Krzysztof Hetman, Elżbieta Katarzyna Łukacijewska, Adam Jarubas
Proposal for a regulation
Article 1 – paragraph 1 – point 33 a (new)
Regulation (EC) No 1107/2009
Article 53 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (33a) In Article 53, a new paragraph 1a is added: | |
| 1a. Another Member State from the same zone may grant an appropriate emergency authorisation based on that detailed information, tailored to reflect its specific national requirements. |
Or. en
Amendment 1134
Paulo do Nascimento Cabral
Proposal for a regulation
Article 1 – paragraph 1 – point 33 b (new)
Regulation (EC) No 1107/2009
Article 53 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. By way of derogation from the first subparagraph, where a phytosanitary danger that cannot be controlled by other means affects a given crop and no technically effective and economically viable alternative solution is available, the Member State may grant, for that specific use, a temporary multiannual authorisation. | |
| Such authorisation shall be granted for a maximum period of five years, subject to annual review, and only where: | |
| (a) the absence of alternatives has been demonstrated; | |
| (b) the use is subject to limitation, monitoring and traceability measures; | |
| (c) a national or regional research or deployment plan for alternative solutions has been established; and | |
| (d) the risk mitigation measures necessary to protect human health, animal health and the environment are applied |
Or. en
Amendment 1135
Ivan David, Anja Arndt, Volker Schnurrbusch, Marc Jongen
Proposal for a regulation
Article 1 – paragraph 1 – point 33 d (new)
Regulation (EC) No 1107/2009
Article 53 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (33d) in Article 53, a new paragraph 1a is inserted : | |
| 1a. Notwithstanding the restrictions laid down in Implementing Regulations (EU) 2018/783, 2018/784 and 2018/785, a Member State may grant an emergency authorisation under paragraph 1 of this Article for seed treatment uses of the active substances referred to in those Regulations, where: | |
| (a) the Member State has officially delimited areas in which multi-annual phytosanitary monitoring demonstrates systematic exceedance of the Economic Damage Threshold for endemic soil pests; | |
| (b) no effective alternative plant protection means are available to address the identified danger; and | |
| (c) the use is strictly limited to seed treatment and is subject to appropriate risk mitigation measures." |
Or. en
Justification
Derogation for seed – to Article 49. If a pathology (pest or disease) spreads in one territory, means that the climate and growing conditions are the same of the territory where the pathology originates. It prevents an uncontrolled use of this option and in any case the Member State can require – where necessary – appropriate risk management measures.
Amendment 1136
Ivan David, Anja Arndt, Volker Schnurrbusch, Marc Jongen
Proposal for a regulation
Article 1 – paragraph 1 – point 33 b (new)
Regulation (EC) No 1107/2009
Article 53 – paragraph 3 – introductory part
| Present text | Amendment |
|---|---|
| (33b) In Article 53, paragraph 3, the introductory part is replaced by the following: | |
| 3. If necessary, a decision shall be taken, in accordance with the regulatory procedure referred to in Article 79(3), as to when and under what conditions the Member State: | 3. If necessary, the Commission shall supplement the decision referred to in paragraph 1 a, based on the opinion of the Authority. |
Or. en
(32009R1107)
Amendment 1137
Veronika Vrecionová
Proposal for a regulation
Article 1 – paragraph 1 – point 33 a (new)
Regulation (EC) No 1107/2009
Article 53 – paragraph 3a (new)
| Present text | Amendment |
|---|---|
| (33a) in Article 53, a new paragraph 3a is inserted: | |
| - | 3a. A Member State may grant an emergency authorization for a specific crop, pest or disease based on an emergency authorization issued by another Member State, provided that the occurrence of the pest or disease for which the authorization was granted has been confirmed. |
Or. en
Justification
This amendment would facilitate a rapid response to emergency plant protection situations by allowing Member States to rely on emergency authorisations already granted elsewhere. It would reduce administrative burden, increase transparency and improve efficiency for both authorities and applicants.
Amendment 1138
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 1 – paragraph 1 – point 33 a (new)
Regulation (EC) No 1107/2009
Article 53 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (33a) in Article 53, a new paragraph 4a is inserted: | |
| 4a. Emergency authorisations granted by one Member State shall not automatically apply in other Member States. Any extension shall require an independent scientific assessment demonstrating that the conditions set out in Article 53 are fulfilled for the territory concerned. |
Or. en
Amendment 1139
Mireia Borrás Pabón, Raffaele Stancanelli, Jorge Buxadé Villalba
Proposal for a regulation
Article 1 – paragraph 1 – point 33 a (new)
Regulation (EC) No 1107/2009
Article 53 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (33a) in Article 53, a new paragraph 4a is inserted: | |
| 4a. An extension of an authorisation granted by a Member State for a specific Crop / Pesticide / Pest or Disease combination, subject to the prior establishment by that Member State of appropriate risk management measures and application techniques, shall be immediately effective in all Member States within the same zone. |
Or. en
Justification
Justification: if a pathology (pest or disease) spreads in one territory, means that the climate and growing conditions are the same of the territory where the pathology originates. It prevents an uncontrolled use of this option and in any case the Member State can require – where necessary – appropriate risk management measures.
Amendment 1140
Ivan David, Anja Arndt, Volker Schnurrbusch, Marc Jongen
Proposal for a regulation
Article 1 – paragraph 1 – point 33 c (new)
Regulation (EC) No 1107/2009
Article 53 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| In Article 53, a new paragraph 4 a is inserted : | |
| 4a. An extension of an authorisation granted by a Member State for a specific Crop / Pesticide / Pest or Disease combination, subject to the prior establishment by that Member State of appropriate risk management measures and application techniques, shall be immediately effective in all Member States. |
Or. en
Amendment 1141
Flavio Tosi, Massimiliano Salini, Salvatore De Meo
Proposal for a regulation
Article 1 – paragraph 1 – point 33 a (new)
Regulation (EC) No 1107/2009
Article 53 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. An extension of an authorisation granted by a Member State for a specific Plant Protection Product, subject to the prior establishment by that Member State of appropriate risk management measures and application techniques, shall be immediately effective in all Member States within the same zone. |
Or. en
Justification
The spread of a pest or disease to another territory indicates that comparable climatic and growing conditions exist. This amendment aims to prevent the uncontrolled use of this option while allowing Member States to require appropriate risk management measures where necessary.
Amendment 1142
Anja Hazekamp, Per Clausen, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
Proposal for a regulation
Article 1 – paragraph 1 – point 33 a (new)
Regulation (EC) No 1107/2009
Article 57 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (33a) A new Article 57a is inserted: | |
| Article 57a: Export restrictions | |
| 1. The export of active substances for which an application has been refused, not-renewed or revoked shall be prohibited. | |
| 2. The export of plant protection products, containing active substances for which an application has been refused, not-renewed or revoked shall be prohibited. |
Or. en
Amendment 1143
Bert-Jan Ruissen
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59
| Text proposed by the Commission | Amendment |
|---|---|
| (34) [...] | deleted |
Or. en
Justification
Maintain the current regulatory framework for data protection.
Amendment 1144
Andreas Glück, Jan-Christoph Oetjen
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59
| Text proposed by the Commission | Amendment |
|---|---|
| (34) [...] | deleted |
Or. en
Justification
The proposal to tie protection periods to the first authorization date risks reducing the effective protection duration in later-authorising Member States. This creates uncertainty for data generators and discourages investment in innovation, particularly for renewals, reviews, minor uses and smaller markets.
Amendment 1145
Stefan Köhler, Norbert Lins, Andrea Wechsler, Lena Düpont
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59
| Text proposed by the Commission | Amendment |
|---|---|
| (34) [...] | deleted |
Or. en
Amendment 1146
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez, Juan Ignacio Zoido Álvarez
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59
| Text proposed by the Commission | Amendment |
|---|---|
| (34) [...] | deleted |
Or. en
Justification
The current regulatory framework governing data protection for Plant Protection Products (PPPs) should be maintained. Article 59 should be kept in its current form.
Amendment 1147
Carmen Crespo Díaz, Susana Solís Pérez, Esther Herranz García, Dolors Montserrat
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59
| Text proposed by the Commission | Amendment |
|---|---|
| (34) [...] | deleted |
Or. es
Amendment 1148
Mireia Borrás Pabón, Jorge Buxadé Villalba
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59
| Text proposed by the Commission | Amendment |
|---|---|
| 34) [...] | deleted |
Or. en
Justification
The current regulatory framework governing data protection for Plant Protection Products (PPPs) should be maintained. The Commission's proposal leads to unintended consequences, including the weakening of effective data protection periods. Reducing protection would lower incentives for R&D companies to innovate and to invest in generating high-quality safety data, which is essential for the development and approval (or renewal of approval) of safe and effective PPPs across the EU Member States.
Amendment 1149
Jessica Polfjärd
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59
| Text proposed by the Commission | Amendment |
|---|---|
| 34) [...] | deleted |
Or. en
Amendment 1150
Jessica Polfjärd
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59
| Text proposed by the Commission | Amendment |
|---|---|
| 34) [...] | deleted |
Or. en
Amendment 1151
Jessica Polfjärd
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Test and study reports shall benefit from Union-wide data protection under the conditions laid down in this Article. | deleted |
Or. en
Amendment 1152
Asger Christensen
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Test and study reports shall benefit from Union-wide data protection under the conditions laid down in this Article. | deleted |
Or. en
Justification
The current regulatory framework governing data protection for Plant Protection Products (PPPs) should be maintained. The Commission's proposal leads to unintended consequences, including the weakening of effective data protection periods. Reducing protection would lower incentives for R&D companies to innovate and to invest in generating high-quality safety data, which is essential for the development and approval (or renewal of approval) of safe and effective PPPs across the EU Member States.
Amendment 1153
Jessica Polfjärd
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Data protection may be granted to test and study reports concerning the active substance, safener or synergist, adjuvants and the plant protection product as referred to in Article 8(2) when they are submitted to a Member State by an applicant for authorisation under this Regulation, (‘the first applicant’), provided that those test and study reports were: | deleted |
| (a) necessary for the authorisation or for an amendment of the authorisation in order to allow the use on another crop; and | |
| (b) certified as compliant with the principles of good laboratory practice or of good experimental practice. |
Or. en
Amendment 1154
Gheorghe Cârciu, Biljana Borzan, Dan Nica, Ştefan Muşoiu, Vasile Dîncu, Andi Cristea, Dragoş Benea, Gabriela Firea
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 2 – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Data protection may be granted to test and study reports concerning the active substance, safener or synergist, adjuvants and the plant protection product as referred to in Article 8(2) when they are submitted to a Member State by an applicant for authorisation under this Regulation, (‘the first applicant’), provided that those test and study reports were: | 2. Data protection shall be granted to test and study reports concerning the active substance, safener or synergist, adjuvants and the plant protection product as referred to in Article 8(2) when they are submitted to a Member State by an applicant for authorisation under this Regulation, (‘the first applicant’), provided that those test and study reports were: |
Or. en
Amendment 1155
Jessica Polfjärd
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 2 – point a
| Text proposed by the Commission | Amendment |
|---|---|
| (a) necessary for the authorisation or for an amendment of the authorisation in order to allow the use on another crop; and | deleted |
Or. en
Amendment 1156
Jessica Polfjärd
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 2 – point b
| Text proposed by the Commission | Amendment |
|---|---|
| (b) certified as compliant with the principles of good laboratory practice or of good experimental practice. | deleted |
Or. en
Amendment 1157
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 2 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Paragraph 2 shall not restrict public access to information pursuant to Regulation (EC) No 1049/2001 and Article 63 of this Regulation. |
Or. en
Amendment 1158
Jessica Polfjärd
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 3
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Data protection shall be granted to the test and study reports referred to in paragraph 2 where the first applicant has requested it at the time of submitting the dossier and has provided to the Member State concerned, for each test or study report, the information referred to in point (f) of Article 8(1) and in point (d) of Article 33(3) as well as confirmation that a period of data protection under this Regulation has never been granted anywhere in the Union. | deleted |
Or. en
Amendment 1159
Stefan Köhler, Norbert Lins, Andrea Wechsler, Lena Düpont
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 3a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. Where test and study reports considered necessary for the approval of a new active substance have not been included in a dossier for the authorisation of a plant protection product containing that active substance in a Member State for a period of 10 years from the date of approval of the active substance, data protection for those test and study reports shall no longer apply in that Member State. |
Or. en
Amendment 1160
Stefan Köhler, Norbert Lins, Andrea Wechsler, Lena Düpont
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 3b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 3b. The Authority and the Member States shall establish and manage a common database of test and study reports on an active substance, safener or synergist which were necessary and relied upon by a Member State for the renewal or review of an authorisation and are eligible for data protection. |
Or. en
Amendment 1161
Jessica Polfjärd
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 4
| Text proposed by the Commission | Amendment |
|---|---|
| 4. If the first applicant does not request data protection to be granted for a test or study report submitted for the first time in a dossier under this Regulation, it shall not be data protected and it could be used for the benefit of any subsequent applicants. | deleted |
Or. en
Amendment 1162
Sander Smit, Jessika van Leeuwen
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. If test and study reports considered necessary to approve a new active substance have not been included – for a period of ten years from the date on which that active substance was approved – in an authorisation dossier for a plant protection product containing that active substance in a Member State, data protection shall no longer apply to those test and study reports in the Member State concerned. |
Or. nl
Justification
If the test and study reports required to approve a substance are not used in an authorisation dossier in a Member State for ten years, those reports will no longer benefit from data protection. This is a proportionate sunset provision: if the information has remained unused for a decade, the owners will no longer be able to rely on it to exclude new suppliers, which will increase availability at a fair cost, especially in smaller Member States.
Amendment 1163
Asger Christensen
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. Where test and study reports considered necessary for the approval of a new active substance have not been included in a dossier for the authorisation of a plant protection product containing that active substance in a Member State for a period of 10 years from the date of approval of the active substance, data protection for those test and study reports shall no longer apply in that Member State. |
Or. en
Justification
The current regulatory framework governing data protection for Plant Protection Products (PPPs) should be maintained. The Commission's proposal leads to unintended consequences, including the reduction of effective data protection periods. Weakening protection would lower incentives for companies to innovate and to invest in generating high-quality safety data, which is essential for the development and approval (or renewal of approval) of safe and effective PPPs across the EU Member States.
Amendment 1164
Jessica Polfjärd
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 5
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where a test or study report is protected, it may not be used by any Member State for the benefit of other applicants for authorisation of plant protection products, safeners or synergists and adjuvants, except as provided in Article 62 or in Article 80, or where: | deleted |
| (a) the applicant has submitted a letter of access; or | |
| (b) any period of data protection granted for the test and study reports under this Regulation has expired. |
Or. en
Amendment 1165
Jessica Polfjärd
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 5 – point a
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the applicant has submitted a letter of access; or | deleted |
Or. en
Amendment 1166
Jessica Polfjärd
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 5 – point b
| Text proposed by the Commission | Amendment |
|---|---|
| (b) any period of data protection granted for the test and study reports under this Regulation has expired. | deleted |
Or. en
Amendment 1167
Jessica Polfjärd
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 6
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The period of data protection shall be 10 years starting from the date of the authorisation in the first Member State granting an authorisation based on a dossier including the test or study report. That period is extended to 13 years for plant protection products covered by Article 47. | deleted |
Or. en
Amendment 1168
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59– paragraph 6
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The period of data protection shall be 10 years starting from the date of the authorisation in the first Member State granting an authorisation based on a dossier including the test or study report. That period is extended to 13 years for plant protection products covered by Article 47. | 6. The period of data protection shall be 10 years starting from the date of the authorization or provisional authorization under Article 30 in the first Member State granting an authorization or provisional authorization based on a dossier including the tests or study reports. That period is extended to 13 years for plant protection products covered by Article 47. |
Or. en
Amendment 1169
Katarína Roth Neveďalová, Erik Kaliňák
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59– paragraph 6
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The period of data protection shall be 10 years starting from the date of the authorisation in the first Member State granting an authorisation based on a dossier including the test or study report. That period is extended to 13 years for plant protection products covered by Article 47. | 6. The period of data protection shall be 13 years starting from the date of the authorisation in the first Member State granting an authorisation based on a dossier including the test or study report. That period is extended to 15 years for plant protection products covered by Article 47. |
Or. en
Amendment 1170
Waldemar Buda, Anna Zalewska
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59– paragraph 6
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The period of data protection shall be 10 years starting from the date of the authorisation in the first Member State granting an authorisation based on a dossier including the test or study report. That period is extended to 13 years for plant protection products covered by Article 47. | 6. The period of data protection shall be 13 years from the date of the first authorisation granted by a Member State on the basis of a dossier containing the test or study report. That period shall be15 years for plant protection products covered by Article 47. |
Or. en
Amendment 1171
Krzysztof Hetman, Elżbieta Katarzyna Łukacijewska, Adam Jarubas
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59– paragraph 6
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The period of data protection shall be 10 years starting from the date of the authorisation in the first Member State granting an authorisation based on a dossier including the test or study report. That period is extended to 13 years for plant protection products covered by Article 47. | 6. The period of data protection shall be 13 years from the date of the first authorisation granted by a Member State on the basis of a dossier containing the test or study report. |
| That period shall be 15 years for plant protection products covered by Article 47. |
Or. en
Amendment 1172
Krzysztof Hetman, Elżbieta Katarzyna Łukacijewska, Adam Jarubas
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59– paragraph 6 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 6a. The Commission shall establish and maintain a Union platform enabling the uploading of a list of tests and study reports recognized as protected under this Regulation. The platform shall be publicly accessible |
Or. en
Amendment 1173
Waldemar Buda, Anna Zalewska
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59– paragraph 6 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 6a. The Commission shall establish and maintain a Union platform enabling the uploading of a list of tests and study reports recognized as protected under this Regulation. The platform shall be publicly accessible. |
Or. en
Amendment 1174
Krzysztof Hetman, Elżbieta Katarzyna Łukacijewska, Adam Jarubas
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59– paragraph 6 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 6b. Member States shall draw up and upload a list of tests and study reports recognized as protected into the platform referred to in paragraph 6a within three months from the date on which the relevant authorisation of a plant protection product or the decision amending that authorisation becomes final |
Or. en
Amendment 1175
Waldemar Buda, Anna Zalewska
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59– paragraph 6 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 6b. Member States shall draw up and upload a list of tests and study reports recognized as protected into the platform referred to in paragraph 6a within three months from the date on which the relevant authorisation of a plant protection product or the decision amending that authorisation becomes final. |
Or. en
Amendment 1176
Krzysztof Hetman, Elżbieta Katarzyna Łukacijewska, Adam Jarubas
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59– paragraph 6 c (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 6c. The Commission shall, by means of implementing acts, lay down the detailed rules concerning the functioning of the platform referred to in paragraph 6a, including the format and conditions for access to the information to be uploaded by Member States. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(3). |
Or. en
Amendment 1177
Waldemar Buda, Anna Zalewska
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59– paragraph 6 c (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 6c. The Commission shall, by means of implementing acts, lay down the detailed rules concerning the functioning of the platform referred to in paragraph 6a, including the format and conditions for access to the information to be uploaded by Member States. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(3). |
Or. en
Amendment 1178
Jessica Polfjärd
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 7
| Text proposed by the Commission | Amendment |
|---|---|
| 7. The period of data protection shall be extended by three months for each extension of authorisation for minor uses on a different crop/pest combination as defined in Article 51(1), except where the extension of authorisation is based on extrapolation, if the applications for such extensions are made by the authorisation holder at the latest five years after the date referred to in paragraph 5. | deleted |
Or. en
Amendment 1179
Jessica Polfjärd
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 8
| Text proposed by the Commission | Amendment |
|---|---|
| 8. The same data protection rules as for the first authorisation shall also be granted to test and study reports submitted by third parties for the purpose of extension of authorisation for minor uses as referred to in Article 51(1). | deleted |
Or. en
Amendment 1180
Jessica Polfjärd
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59– paragraph 9
| Text proposed by the Commission | Amendment |
|---|---|
| 9. Data protection shall be granted to test and study reports necessary for the renewal or review of an authorisation. The period for data protection shall be 30 months from the first renewal of the authorisation granted in accordance with Article 43 in any Member State or from the first conclusion of a review conducted in accordance with Article 44 in any Member State. The first to fifth paragraphs shall apply mutatis mutandis. | deleted |
Or. en
Amendment 1181
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59– paragraph 9
| Text proposed by the Commission | Amendment |
|---|---|
| 9. Data protection shall be granted to test and study reports necessary for the renewal or review of an authorisation. The period for data protection shall be 30 months from the first renewal of the authorisation granted in accordance with Article 43 in any Member State or from the first conclusion of a review conducted in accordance with Article 44 in any Member State. The first to fifth paragraphs shall apply mutatis mutandis. | 9. Data protection shall be granted to test and study reports necessary for the renewal of approval or targeted reassessment of an active substance, safener or synergist. The period for data protection shall be 42 months in all EU Member States, starting at the date of active substance renewal or confirmation of approval, set in the implementing acts under Article 20 and Article 18a. respectively. |
| In addition, data protection shall also be granted to test and study reports necessary for the renewal or review of an authorisation. The period for data protection shall be 30 months from the first renewal of the authorisation granted in accordance with Article 43 in any Member State or from the first conclusion of a review conducted in accordance with Article 44 in any Member State. The first to fifth paragraphs shall apply mutatis mutandis. |
Or. en
Amendment 1182
Biljana Borzan, Christophe Clergeau, Gheorghe Cârciu, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59– paragraph 9
| Text proposed by the Commission | Amendment |
|---|---|
| 9. Data protection shall be granted to test and study reports necessary for the renewal or review of an authorisation. The period for data protection shall be 30 months from the first renewal of the authorisation granted in accordance with Article 43 in any Member State or from the first conclusion of a review conducted in accordance with Article 44 in any Member State. The first to fifth paragraphs shall apply mutatis mutandis. | 9. Data protection shall be granted to test and study reports necessary for the renewal or review of an authorisation. The period for data protection shall be 30 months from the first renewal of the authorisation granted in accordance with Article 43 in any Member State or from the first conclusion of a review conducted in accordance with Article 44 in any Member State. The first to fifth paragraphs shall apply mutatis mutandis. Data protection granted under this paragraph shall not result in successive or overlapping periods of protection for the same test or study report. |
Or. en
Justification
Data protection should provide appropriate incentives for investment while ensuring that protection periods remain predictable and proportionate. Clarifying that renewal or review data cannot generate successive or overlapping periods of protection for the same test or study report improves legal certainty, facilitates fair competition and reduces unnecessary administrative burdens.
Amendment 1183
Jessica Polfjärd
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59– paragraph 10
| Text proposed by the Commission | Amendment |
|---|---|
| 10. The total period of data protection may not exceed 13 years. For plant protection products covered by Article 47 the total period of data protection may not exceed 15 years. | deleted |
Or. en
Amendment 1184
Asger Christensen, Christine Singer
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 10 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 10a. The Authority and the Member States shall establish and manage a common database of test and study reports on an active substance, safener or synergist which were necessary and relied upon by a Member State for the renewal or review of an authorisation and are eligible for data protection. |
Or. en
Justification
According to the Commission, “the current data protection regime is highly complex and lacks transparency in terms of when data protection for a given test or study report expires in the different Member States, in particular for studies or tests used for renewals of approvals or review of authorisation”.
Amendment 1185
Jessica Polfjärd
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 11
| Text proposed by the Commission | Amendment |
|---|---|
| 11. Detailed rules for the implementation of this Article may be established in accordance with the procedure referred to in Article 79(3).; | deleted |
Or. en
Amendment 1186
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 1 – paragraph 1 – point 34
Regulation (EC) No 1107/2009
Article 59 – paragraph 11a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 11a. Detailed rules shall ensure that data protection does not extend beyond information strictly necessary to protect investment in generating test and study reports and shall not prevent the sharing of non-confidential scientific information. |
Or. en
Amendment 1187
Flavio Tosi, Massimiliano Salini, Salvatore De Meo
Proposal for a regulation
Article 1 – paragraph 1 – point 34 a (new)
Regulation (EC) No 1107/2009
Article 65 – paragraph 3 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (34a) in Article 65, a new paragraph 3a is inserted: | |
| 3a. The labels of plant protection products shall include specific instructions for nursery production. Where biomass, planting density, or phenological stages differ significantly from adult crops in open fields, dosages shall be expressed in canopy volume units, per number of specimens, or per leaf area unit, in addition to or as an alternative to the dosage per hectare, to ensure treatment efficacy and compliance within digital record-keeping systems. |
Or. en
Justification
Modern nursery management requires product labels that reflect current practices. This amendment provides the legal basis for alternative dosing metrics, ensuring the accurate functioning of the EU-wide digital farm registry system.
Amendment 1188
Sakis Arnaoutoglou
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, except for plant protection products containing as active substances only biocontrol substances, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. | Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, for at least three years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and dose of application, the area and the crop where the plant protection product was used. For plant protection products containing as active substances only biocontrol substances, Member States shall ensure that this obligation may be fulfilled through a simplified standard format proportionate to the risks concerned. |
Or. en
Justification
Records of plant-protection product use are essential for traceability, environmental monitoring, water-quality investigations, the evaluation of exposure and the identification of unexpected effects on crops or non-target organisms. Removing the obligation entirely for biocontrol products would create a significant information gap precisely when their use is expected to increase. A simplified standard format would substantially reduce the administrative burden on farmers while preserving the minimum information required by competent authorities, researchers, drinking-water operators and residents. Digital tools may be made available, but farmers without adequate connectivity or digital capacity should retain access to a simple paper-based option.
Amendment 1189
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, except for plant protection products containing as active substances only biocontrol substances, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. | Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. |
Or. fr
Amendment 1190
Sirpa Pietikäinen
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, except for plant protection products containing as active substances only biocontrol substances, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. | Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. |
Or. en
Amendment 1191
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Thomas Bajada, Mohammed Chahim
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, except for plant protection products containing as active substances only biocontrol substances, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. | Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. |
Or. en
Justification
Record-keeping is essential to ensure traceability, facilitate monitoring and support the evaluation of the real-life performance and safety of plant protection products, including biocontrol products. Simplification should not remove information that is important for post-market oversight and regulatory decision-making.
Amendment 1192
Manuela Ripa
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, except for plant protection products containing as active substances only biocontrol substances, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. | Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. |
Or. en
Amendment 1193
Katri Kulmuni, Elsi Katainen, Benoit Cassart, Stefan Köhler, Asger Christensen, Martin Hojsík
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, except for plant protection products containing as active substances only biocontrol substances, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. | Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. |
Or. en
Justification
Record keeping is an integral part of integrated pest management. It is a tool for the user of plant protection products enabling analyses of the effect of the applications after the season, which further on will help in the planning of coming seasons. These analyses are important also after the use of biocontrol substances, so the obligation to keep records for these products should be kept in the legislation.
Amendment 1194
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, except for plant protection products containing as active substances only biocontrol substances, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. | Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. |
Or. en
Amendment 1195
Alexander Bernhuber
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, except for plant protection products containing as active substances only biocontrol substances, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. | Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. |
Or. en
Amendment 1196
Anja Hazekamp, Per Clausen, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, except for plant protection products containing as active substances only biocontrol substances, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. | Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 15 years. Professional users of plant protection products shall, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. |
Or. en
Amendment 1197
Mireia Borrás Pabón, Raffaele Stancanelli, Jorge Buxadé Villalba
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, except for plant protection products containing as active substances only biocontrol substances, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. | Producers, Cooperative of producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, except for plant protection products containing as active substances only biocontrol substances, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. |
Or. en
Justification
-Cooperative of producers are subjects recognized as “producer” by the EU law. This option is a great simplification for the single producers members of a cooperative;
-It is illogic to exempt biocontrol substances from the record-keeping obligation. They are by definition “PPPs” and it is fundamental for following the use’s trends.
-PPPs data are sensitive and the delivery in aggregated and anonymized form is sufficient for statistical purposes.
Amendment 1198
Flavio Tosi, Massimiliano Salini, Salvatore De Meo
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, except for plant protection products containing as active substances only biocontrol substances, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. | Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products or the cooperatives to which they belong shall, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the day and the dose of application, the area and the crop where the plant protection product was used. |
Or. en
Amendment 1199
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, except for plant protection products containing as active substances only biocontrol substances, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used. | Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products or or cooperatives of which such professional users are members, shall keep records of the plant protection products they use for at least three years. Those records shall include the name of the plant protection product, the day of application, the dose of application, and the area and crop on which the plant protection product was use |
Or. en
Amendment 1200
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| They shall make the relevant information contained in these records available to the competent authority on request. Third parties such as the drinking water industry, retailers or residents, may request access to this information by addressing the competent authority | deleted |
Or. en
Justification
Access to highly sensitive information should be limited to specific and motivated cases.
Amendment 1201
Flavio Tosi, Massimiliano Salini, Salvatore De Meo
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| They shall make the relevant information contained in these records available to the competent authority on request. Third parties such as the drinking water industry, retailers or residents, may request access to this information by addressing the competent authority | deleted |
Or. en
Amendment 1202
Alexander Bernhuber
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| They shall make the relevant information contained in these records available to the competent authority on request. Third parties such as the drinking water industry, retailers or residents, may request access to this information by addressing the competent authority | They shall make the relevant information contained in these records available to the competent authority on request. Third parties such as the drinking water industry, retailers or residents, may request access to this information by addressing the competent authority: |
| - In case of a regulatory inspection carried out by the competent authority | |
| - For the purpose of compiling agricultural statistics | |
| - If there is a reasonable suspicion of a risk to human health or to the environment Third parties such as the drinking water industry, retailers or residents may request access to this information by addressing the competent authority. | |
| Anonymisation and aggregation of the data sets will be granted. |
Or. en
Amendment 1203
Mireia Borrás Pabón, Raffaele Stancanelli, Gilles Pennelle, Anne-Sophie Frigout, Jorge Buxadé Villalba
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| They shall make the relevant information contained in these records available to the competent authority on request. Third parties such as the drinking water industry, retailers or residents, may request access to this information by addressing the competent authority | They shall make the relevant information contained in these records available to the competent authority on request. |
| Anonymization and aggregation of the data sets will be granted. | |
| Third parties such as the drinking water industry, may request access to this information by addressing the competent authority | |
| The competent authorities shall provide access to such information in accordance with applicable national or Union law’. |
Or. en
Justification
-Cooperative of producers are subjects recognized as “producer” by the EU law. This option is a great simplification for the single producers members of a cooperative;
-It is illogic to exempt biocontrol substances from the record-keeping obligation. They are by definition “PPPs” and it is fundamental for following the use’s trends.
-PPPs data are sensitive and the delivery in aggregated and anonymized form is sufficient for statistical purposes.
-It is illogic to allow “retailers” to access the PPPs use records. Retail sector is today acting as an independent safety agency, imposing MRL and/or additional private parameters. The Producers have to comply with the EU and National requirements only.
Amendment 1204
Céline Imart, Emmanouil Kefalogiannis
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| They shall make the relevant information contained in these records available to the competent authority on request. Third parties such as the drinking water industry, retailers or residents, may request access to this information by addressing the competent authority. | They shall make the relevant information contained in these records available to the competent authority: |
| (i) in the event of a regulatory inspection carried out by the competent authority; | |
| (ii) for the purpose of compiling agricultural statistics; | |
| (iii) in the event of a reasonable suspicion of risk to human health or to the environment. | |
| Anonymisation and aggregation of the data sets shall be guaranteed. |
Or. fr
Amendment 1205
Flavio Tosi, Massimiliano Salini, Salvatore De Meo
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1 – subparagraph 3
| Text proposed by the Commission | Amendment |
|---|---|
| Third parties such as the drinking water industry, retailers or residents may request access to this information by addressing the competent authority. | deleted |
Or. en
Amendment 1206
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67– paragraph 1 – subparagraph 3
| Text proposed by the Commission | Amendment |
|---|---|
| Third parties such as the drinking water industry, retailers or residents may request access to this information by addressing the competent authority. | deleted |
Or. en
Amendment 1207
Mireia Borrás Pabón, Raffaele Stancanelli, Jorge Buxadé Villalba
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67– paragraph 1 – subparagraph 3
| Text proposed by the Commission | Amendment |
|---|---|
| Third parties such as the drinking water industry, retailers or residents may request access to this information by addressing the competent authority. | Third parties such as the drinking water industry, may request access to this information by addressing the competent authority. |
Or. en
Amendment 1208
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Upon request by the competent authority, professional users shall make the relevant information contained in these records available to the competent authority: | |
| (a) in the case of a regulatory inspection carried out by the competent authority; | |
| (b) for the purpose of compiling agricultural statistics; | |
| (c) where there are reasonable grounds to suspect a risk to human health or the environment, as identified by an accredited scientific institution. |
Or. en
Amendment 1209
Flavio Tosi, Massimiliano Salini, Salvatore De Meo
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1 – subpargaraph 4
| Text proposed by the Commission | Amendment |
|---|---|
| The competent authorities shall provide access to such information in accordance with applicable national or Union law. | Upon request by the competent authority, professional users shall make the relevant information contained in those records available: |
| (a) in the event of a regulatory inspection carried out by the competent authority; | |
| (b) for the purpose of compiling agricultural statistics; | |
| (c) where there are reasonable grounds to suspect a risk to human health or the environment, as identified by an accredited scientific institution. |
Or. en
Amendment 1210
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) 1107/2009
Article 67 – paragraph 1 – subparagraph 4
| Text proposed by the Commission | Amendment |
|---|---|
| The competent authorities shall provide access to such information in accordance with applicable national or Union law. | Third parties may request access to such information through the competent authority upon a duly justified request. The competent authority shall grant access only where such access is provided for under applicable Union or national law and is necessary and proportionate. |
Or. en
Amendment 1211
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
–Article 67 – paragraph 1 – subparagraph 4a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| In Article 67, paragraph 1, a new subparagraph 4a is added: | |
| 4a. Member states shall support users of PPPs to keep digital records of use in line with paragraph 1 of this article. In designing their NRP plans and the agricultural chapters thereof, Member States may access community budget lines for digitisation and if appropriate precision application for this purpose, in addition to EU funds awarded for innovation, advisory services, investments, and support for disadvantages resulting from certain mandatory requirements, which shall all be considered as compatible with the obligation in paragraph 1. Member states may also access additional funds from the EIB to implement digital record keeping into farm management applications, and to intergrate and make interoperable such platforms with existing structures, including IACS and exsiting food retailer platforms. |
Or. en
Amendment 1212
Stefan Köhler, Norbert Lins, Andrea Wechsler, Lena Düpont
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1 – subparagraph 4 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| In Article 67, paragraph 1, a new subparagraph 4a is added: | |
| Mandatory information on the phenological development stage ('BBCH stage') of the treated crop, the time of application, the user and the authorisation number of the plant protection product used is not required. Member States may not require additional mandatory information in addition to the record-keeping requirements laid down in this Regulation, provided that such information does not directly contribute to consumer, user, environmental or enforcement protection. Corresponding regulations at EU level should be amended accordingly. |
Or. en
Amendment 1213
Marta Wcisło
Proposal for a regulation
Article 1 – paragraph 1 – point 35 a (new)
Regulation (EC) No 1107/2009
Article 67 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (35a) in Article 67, a new paragraph 4a is added: | |
| 4a. Member States shall ensure that minor errors or omissions in records kept pursuant to this Article may be corrected by professional users within 30 calendar days of their notification by the competent authority, without the imposition of penalties, provided that such errors or omissions do not prevent the effective control of the use of plant protection products. |
Or. en
Amendment 1214
Waldemar Buda, Anna Zalewska
Proposal for a regulation
Article 1 – paragraph 1 – point 35 a (new)
Regulation (EC) No 1107/2009
Article 67 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (35a) In Article 67, a new paragraph 4a is added: | |
| '4a. Member States may exempt certain professional users from certain requirements relating to the keeping of records of the plant protection products they use, as stipulated pursuant to paragraph 4, taking into account the size of the farm, the quantity of plant protection products used or the specific nature of the production, provided that such exemption does not affect the control of the use of plant protection products' |
Or. en
Amendment 1215
Krzysztof Hetman, Elżbieta Katarzyna Łukacijewska, Adam Jarubas
Proposal for a regulation
Article 1 – paragraph 1 – point 35a (new)
Regulation (EC) No 1107/2009
Article 67 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (35a) in Article 67, a new paragraph 4a is added: | |
| 4a. Member States may exempt certain professional users from certain requirements relating to the keeping of records of the plant protection products they use, as stipulated pursuant to paragraph 4, taking into account the size of the farm, the quantity of plant protection products used or the specific nature of the production, provided that such exemption does not affect the control of the use of plant protection products. |
Or. en
Amendment 1216
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 1 – paragraph 1 – point 36
Regulation (EC) No 1107/2009
Article 68
| Text proposed by the Commission | Amendment |
|---|---|
| (36) Article 68 is deleted. | deleted |
Or. en
Amendment 1217
Anja Hazekamp, Per Clausen, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
Proposal for a regulation
Article 1 – paragraph 1 – point 36
Regulation (EC) No 1107/2009
Article 68
| Text proposed by the Commission | Amendment |
|---|---|
| (36) Article 68 is deleted. | deleted |
Or. en
Amendment 1218
Sirpa Pietikäinen
Proposal for a regulation
Article 1 – paragraph 1 – point 36
Regulation (EC) No 1107/2009
Article 68
| Text proposed by the Commission | Amendment |
|---|---|
| (36) Article 68 is deleted. | deleted |
Or. en
Justification
Monitoring and controls are essential for the implementation of a Regulation and should therefore remain.
Amendment 1219
Christophe Clergeau
Proposal for a regulation
Article 1 – paragraph 1 – point 36
Regulation (EC) No 1107/2009
Article 68
| Text proposed by the Commission | Amendment |
|---|---|
| (36) Article 68 is deleted. | deleted |
Or. en
Amendment 1220
Manuela Ripa
Proposal for a regulation
Article 1 – paragraph 1 – point 36
Regulation (EC) No 1107/2009
Article 68
| Text proposed by the Commission | Amendment |
|---|---|
| (36) Article 68 is deleted. | (36) Member States shall submit to the Commission by 31 August each year a report, for the previous year, on the scope and the outcome of the official controls performed in order to verify compliance with this Regulation. |
Or. en
Amendment 1221
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 1 – paragraph 1 – point 36 a (new)
Regulation (EC) No 1107/2009
Article 68 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (36a) a new Article 68a is added: | |
| ‘Article 68a Post-market monitoring | |
| Member States shall establish and implement coordinated national monitoring programmes to assess levels of pesticides, active substances, relevant metabolites and degradation products and other residues of plant protection products in humans and the environment in accordance with applicable Union legislation and established scientific methodologies. | |
| Monitoring programmes shall contribute to the early identification of potential risks arising from real-world exposure, including cumulative, combined and long-term exposure to multiple pesticides. Member States shall evaluate monitoring results against protection goals established under this Regulation or other applicable Union legislation. | |
| Where monitoring data indicate that exposure levels may exceed these protection goals, Member States shall ensure that further investigations are carried out, including targeted environmental monitoring or epidemiological studies, as appropriate. Member States shall ensure that such monitoring results are communicated without delay to the Commission and the Authority. | |
| To ensure the effective implementation of the polluter-pays principle, the costs associated with monitoring programmes and any additional studies required under this Article shall be borne by approval holders or applicants. Member States shall ensure that such monitoring programmes and studies are commissioned and managed by the competent authorities and monitoring and studies shall be conducted by independent public or scientific bodies, ensuring transparency, scientific integrity and public trust. Monitoring results generated pursuant to this Article shall be made publicly available without undue delay, subject to the protection of personal data and confidential information in accordance with this Regulation. | |
| Where monitoring carried out under this Article identifies exposure levels in humans or the environment that indicate a potential exceedance of established protection goals, or reveals evidence of harmful effects associated with the use of an active substance or plant protection product, the Commission shall, within six months of the identification of such results assess whether the approval criteria laid down in Article 4 continue to be fulfilled and, where appropriate, initiate a review in accordance with Article 21 or identify active substances or groups of active substances structurally or functionally related for which a renewal procedure shall be conducted. in accordance with Article 18. | |
| The Commission shall adopt implementing acts establishing harmonised requirements for the design, methodology, quality assurance, reporting and publication of monitoring programmes referred to in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(3).’ |
Or. en
Amendment 1222
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 1 – paragraph 1 – point 36 b (new)
Regulation (EC) No 1107/2009
Article 74 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| (36b) in Article 74, paragraph 1 is replaced by the following: | |
| 1. Member States may recover the costs associated with any work they carry out within the scope of this Regulation, by means of fees or charges. | ‘1. Member States shall recover the costs associated with any work they carry out within the scope of this Regulation, by means of fees or charges.’ |
Or. en
(32009R1107)
Amendment 1223
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 1 – paragraph 1 – point 36 c (new)
Regulation (EC) No 1107/2009
Article 74 – paragraph 2 – point ba (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (36c) in Article 74, paragraph 2, a new point (ba) is added: | |
| ‘(ba) are harmonised across Member States in accordance with a fee grid established by the Commission no later than one year after the entry into force of this Regulation.’ |
Or. en
(32009R1107)
Amendment 1224
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 1 – paragraph 1 – point 36 d (new)
Regulation (EC) No 1107/2009
Article 74 – paragraph 2a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (36d) in Article 74, a new paragraph 2a is added: | |
| ‘2a. Fees and charges collected from applicants shall be ring-fenced and exclusively used to cover the costs of work related to pesticide risk assessment.’ |
Or. en
(32009R1107)
Amendment 1225
Daniel Buda, Dan-Ştefan Motreanu
Proposal for a regulation
Article 1 – paragraph 1 – point 36 a (new)
Regulation (EC) No 1107/2009
Article 78a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 36a. A new Article 78a is inserted: | |
| Article 78a | |
| Exercise of the Delegation | |
| 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. | |
| 2. The Commission is empowered to adopt delegated acts amending Annex I in order to adjust the demarcation of zones and, where appropriate, establish subzones, on the basis of scientific and technical criteria, having regard in particular to changes in climatic, agronomic, soil and environmental conditions. | |
| 3. The delegation of power referred to in Article 22c may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. | |
| 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. | |
| 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. | |
| 6. A delegated act adopted pursuant to Article 40a shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. |
Or. ro
Amendment 1226
Stefan Köhler, Norbert Lins, Andrea Wechsler, Lena Düpont
Proposal for a regulation
Article 1 – paragraph 1 – point 36 a (new)
Regulation (EC) No 1107/2009
Article 80a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (36a) In Regulation (EC) 1107/2009 the following Article 80a (new) is added: | |
| Transitional provisions on the introduction of permanent active substance authorisations | |
| 1. The permanent approvals of active substances provided for in Articles 5, 14(2) and 27a shall also apply to active substances the approval of which is subject to a pending renewal procedure at the date of entry into force of those amendments, provided that: | |
| (a) the last completed EFSA assessment did not raise any critical concerns within the meaning of the approval criteria set out in Article 4; | |
| (b) there is no new scientific evidence suggesting a substantiated assumption of increased risk; and | |
| (c) there are no specific safety concerns, substantiated by a Member State or EFSA, which preclude an indefinite authorisation. | |
| 2. Within 12 months of the entry into force of this amendment, the Commission shall, by means of implementing acts in accordance with the procedure referred to in Article 79(3), establish the list of active substances to which paragraph 1 applies. For active substances not included in this list, the non-inclusion shall be publicly justified. The pending renewal procedure will continue in accordance with the provisions in force before the amendment. | |
| 3. Pending the publication of the implementing act referred to in paragraph 2, the approvals of the active substances concerned shall be deemed to be renewed. Article 17 remains unaffected. |
Or. en
Amendment 1227
Veronika Vrecionová
Proposal for a regulation
Article 1 – paragraph 1 – point 36 a (new)
Regulation (EC) No 1107/2009
Article 82 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (36a) in Article 82, a new paragraph 1a is added: | |
| 1a. By [one year after the date of entry into force of this Regulation], the Commission shall submit to the European Parliament and to the Council an evaluation of the impact and consequences of the abolition of the zonal system for the authorisation of plant protection products under this Regulation, including its impacts on the functioning of the zone itself, existing work-sharing arrangements, Member State capacity, pending applications, the effects on the efficiency, consistency and duration of authorisation procedures, the availability of plant protection products, in particular for minor uses, innovation, the functioning of the internal market, administrative burden for applicants and competent authorities, and the level of protection of human and animal health and the environment. The evaluation shall, where appropriate, be accompanied by legislative proposals. |
Or. en
Amendment 1228
Veronika Vrecionová
Proposal for a regulation
Article 1 – paragraph 1 – point 36 b (new)
Regulation (EC) No 1107/2009
Article 82 – paragraph 1 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (36b) In Article 82, a new paragraph 1b is added: | |
| 1b. By [two years after the date of entry into force of this Regulation], and annually thereafter, the Commission shall submit to the European Parliament and to the Council a report on the average time required to complete the procedures concluded during the preceding calendar year under this Regulation, distinguishing at least between: | |
| (a) approval of active substances, broken down by category of active substance, including biocontrol substances, low-risk active substances, basic substances and other active substances; and | |
| (b) authorisation of plant protection products, broken down by products containing biocontrol substances, low-risk active substances and other active substances. | |
| Where the report shows that the average duration of any of the procedures referred to in the first subparagraph exceeds three years, the Commission shall identify the main causes of the delays and, within six months of the publication of the report, present measures to reduce the average duration of those procedures to three years or less. |
Or. en
Amendment 1229
Veronika Vrecionová
Proposal for a regulation
Article 1 – paragraph 1 – point 36 c (new)
Regulation (EC) No 1107/2009
Article 82 – paragraph 1 c (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (36c) In Article 82, a new paragraph 1c is added: | |
| 1c. By [three years after the date of entry into force of this Regulation], and every seven years thereafter, the Commission shall carry out an evaluation of this Regulation and submit a report on its main findings to the European Parliament and to the Council. The evaluation shall assess, in particular, whether this Regulation has contributed to: | |
| - reducing the average duration of approval and authorisation procedures; | |
| - ensuring a high level of protection of human and animal health and the environment; | |
| - facilitating innovation, in particular for biocontrol substances, low-risk active substances and other biological plant protection solutions; | |
| - improving the availability and variety of safe and effective plant protection products for farmers across the Union; | |
| - improving the efficiency, consistency and predictability of authorisation procedures across Member States; | |
| - reducing unnecessary administrative and regulatory burdens for applicants and competent authorities while preserving a high level of protection; | |
| - ensuring the timely availability of plant protection products addressing minor uses and emergency plant health needs, where appropriate. |
Or. en
Amendment 1230
Alexander Bernhuber
Proposal for a regulation
Article 1 – paragraph 1 – point 36 a (new)
Regulation (EC) No 1107/2009
Annex II – article 3 – paragraph 6 – subparagraph 5
| Present text | Amendment |
|---|---|
| (36a) In Annex II, Article 3, paragraph 6, subparagraph 5 is replaced by the following | |
| Annex II, Article 3, paragraph 6, subparagraph 5 | "Annex II, Article 3, paragraph 6, subparagraph 5 |
| An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not considered to have endocrine disrupting properties that may cause adverse effect in humans, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005. | An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as endocrine disruptor category 1. unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is acceptable according to risk-evaluation procedure negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005. " |
Or. en
(32009R1107)
Amendment 1231
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 1 – paragraph 1 -point 36 a (new)
Regulation (EC) No 1107/2009
Annex II – point 4
| Present text | Amendment |
|---|---|
| (36a) in Annex II, point 4 is replaced by the following: | |
| 4. Candidate for substitution | "4. Candidate for substitution |
| An active substance shall be approved as a candidate for substitution pursuant to Article 24 where any of the following conditions are met: | An active substance shall be approved as a candidate for substitution pursuant to Article 24 where any of the following conditions are met: |
| —its ADI, ARfD or AOEL is significantly lower than those of the majority of the approved active substances within groups of substances/use categories, | —its ADI, ARfD or AOEL is significantly lower than those of the majority of the approved active substances within groups of substances/use categories, |
| —it meets two of the criteria to be considered as a PBT substance, | —it meets two of the criteria to be considered as a PBT substance, |
| —it meets two of the criteria to be considered as a PMT substance, | |
| —it meets the OECD definition of poly- and per- fluoroalkyl substances, it meets the OECD definition of poly- and per- fluoroalkyl substances, | |
| —it poses a risk to non-target terrestrial vertebrates, to non-target terrestrial organisms other than vertebrates including bees or to aquatic organisms for some use or risk assessment scenarios, | |
| —there are reasons for concern linked to the nature of the critical effects (such as developmental neurotoxic or immunotoxic effects) which, in combination with the use/exposure patterns, amount to situations of use that could still cause concern, for example, high potential of risk to groundwater; even with very restrictive risk management measures (such as extensive personal protective equipment or very large buffer zones), | —there are reasons for concern linked to the nature of the critical effects (such as developmental neurotoxic or immunotoxic effects) which, in combination with the use/exposure patterns, amount to situations of use that could still cause concern, for example, high potential of risk to groundwater; even with very restrictive risk management measures (such as extensive personal protective equipment or very large buffer zones), |
| —it contains a significant proportion of non-active isomers, | —it contains a significant proportion of non-active isomers, |
| —it is or is to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogen category 1A or 1B, if the substance has not been excluded in accordance with the criteria laid down in point 3.6.3, | —it is or is to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogen category 1A or 1B, if the substance has not been excluded in accordance with the criteria laid down in point 3.6.3, |
| —it is or is to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 1A or 1B if the substance has not been excluded in accordance with the criteria laid down in point 3.6.4, | —it is or is to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 1A or 1B if the substance has not been excluded in accordance with the criteria laid down in point 3.6.4, |
| —it is or is to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 2 or carcinogen category 2. | |
| —if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information, reviewed by the Authority, it is considered to have endocrine disrupting properties that may cause adverse effects in humans if the substance has not been excluded in accordance with the criteria laid down in point 3.6.5. | —if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information, reviewed by the Authority, it is considered to have endocrine disrupting properties that may cause adverse effects in humans if the substance has not been excluded in accordance with the criteria laid down in point 3.6.5. " |
Or. en
(32009R1107)
Justification
Candidates for substitution are the most hazardous active substances approved in the EU and constitute one of the few categories that would retain limited approval for seven years under the Commission’s proposal. However, the criteria used to identify these substances were established in 2011 and have not been updated to reflect important regulatory and scientific developments, notably the introduction of the PMT and vPvP hazard classes under the CLP Regulation. Expanding the criteria is therefore necessary to ensure that the substitution is aligned with these latest developments.
Amendment 1232
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 1 – paragraph 1 – point 36 b (new)
Regulation (EC) No 1107/2009
Annex II – point 5
| Present text Text proposed by the Commission | Amendment |
| (36b) In Annex II, point 5 is replaced by the following: | |
| 5. Low-risk active substances | "5. Low-risk active substances |
| An active substance shall not be considered of low risk where it is or has to be classified in accordance with Regulation (EC) No 1272/2008 as at least one of the following: | An active substance shall not be considered of low risk where it is or has to be classified in accordance with Regulation (EC) No 1272/2008 as at least one of the following: |
| —carcinogenic, | — carcinogenic category 1A, 1B or 2; |
| —mutagenic, | — mutagenic category 1A, 1B or 2; |
| —toxic to reproduction, | — toxic to reproduction category 1A, 1B or 2; |
| —sensitising chemicals, | — skin sensitiser category 1; |
| —very toxic or toxic, | — serious damage to eye category 1; |
| —explosive, | — respiratory sensitiser category 1; |
| —corrosive. | — acute toxicity category 1, 2 or 3; |
| It shall also not be considered as of low risk if: | — specific Target Organ Toxicant, category 1 or 2; |
| —persistent (half-life in soil is more than 60 days), | — hazardous to the aquatic environment, acute category 1 or chronic category 1, 2, 3 or 4; |
| —bioconcentration factor is higher than 100, | — explosive; skin corrosive, category 1A, 1B or 1C; |
| —it is deemed to be an endocrine disrupter, or | It shall also not be considered as of low risk if: |
| —it has neurotoxic or immunotoxic effects. | — it is persistent or very persistent in any relevant environmental compartment, including where the half-life in soil, water, sediment or groundwater exceeds the applicable persistence criteria established under Union legislation; |
| — it has a potential for bioaccumulation or biomagnification, including where the bioconcentration factor, bioaccumulation factor or biomagnification potential exceeds the applicable thresholds established under Union legislation; | |
| — it is deemed to be an endocrine disrupter for humans or non-target organisms in accordance with Union criteria for the identification of endocrine-disrupting properties; | |
| — it has neurotoxic or immunotoxic effects or shows indications of such effects based on available scientific evidence; " |
Or. en
(32009R1107)
Amendment 1233
Alexander Bernhuber
Proposal for a regulation
Article 1 – paragraph 1 – point 36 b (new)
Regulation (EC) No 1107/2009
Annex II – Article 3 – paragraph 8 – subparagraph 2
| Present text | Amendment |
|---|---|
| (36b) In Annex II, Article 3, paragraph 8, subparagraph 2 is replaced by the following | |
| Annex II, Article 3, paragraph 8, subparagraph 2 | "Annex II, Article 3, paragraph 8, subparagraph 2 |
| An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines, it is not considered to have endocrine disrupting properties that may cause adverse effects on non-target organisms unless the exposure of non-target organisms to that active substance in a plant protection product under realistic proposed conditions of use is negligible. | An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as endocrine disruptor category 1. unless the exposure of non-target organisms to that active substance in a plant protection product under realistic proposed conditions of use is negligible. " |
Or. en
(32009R1107)
Amendment 1234
Ivan David
Proposal for a regulation
Article 1 – paragraph 1 – point 36 a (new)
Regulation (EC) No 1107/2009
Annex I
| Amendment | |
| Definition of zones for the authorisation of plant protection products as referred to in Article 3(17) Zone A — North The following Member States belong to this zone: Denmark, Estonia, Latvia, Lithuania, Finland, Sweden Zone B — Centre The following Member States belong to this zone: Belgium, Czech Republic, Germany, Ireland, Luxembourg, Hungary, Netherlands, Austria, Poland, Romania, Slovenia, Slovakia, United Kingdom Zone C — South The following Member States belong to this zone: Bulgaria, Greece, Spain, France, Italy, Cyprus, Malta, Portugal | deleted |
Or. en
Justification
Cutt of criteria could play an important simplification role in procedures before year 2009 and some time afterwards, when present legislation has been designed and plenty of active ingredients across crops and pathogens were available. Nowadays, there is already now significant lack of crop protections tools especially in some indication and it is not admittable any more to continue with preventive cut off approach without proper risk analysis, including all possible risk mitigation tools. Also, independent smart crop protection system contributes significantly to minimize risk, especially for operators. At least cut-off “criteria set in appendix II under 3.6.2., 3.6.3., 3.6.4., 3.6.5. and 3.7. need to be changed to real risks evaluation. Cut-off principle is not compliant with the risk assessment in other areas. Present situation with very limited crop protection tools differs substantially from the situation when “cut off” have been introduced. Nowadays there are many new tools available aiming to minimize or avoid risks by using new and precise application technologies, techniques and machinery.
Amendment 1235
Ivan David
Proposal for a regulation
Article 1 – paragraph 1 – point 36 b (new)
Regulation (EC) No 1107/2009
Annex II – paragraph 3 – subparagraph 6 – point 2
| Amendment | |
| 3.6.2. An active substance, safener or synergist shall only be approved if, on the basis of assessment of higher tier genotoxicity testing carried out in accordance with the data requirements for the active substances, safeners or synergists and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as mutagen category 1A or 1B. | deleted |
Or. en
Justification
Cutt of criteria could play an important simplification role in procedures before year 2009 and some time afterwards, when present legislation has been designed and plenty of active ingredients across crops and pathogens were available. Nowadays, there is already now significant lack of crop protections tools especially in some indication and it is not admittable any more to continue with preventive cut off approach without proper risk analysis, including all possible risk mitigation tools. Also, independent smart crop protection system contributes significantly to minimize risk, especially for operators. At least cut-off “criteria set in appendix II under 3.6.2., 3.6.3., 3.6.4., 3.6.5. and 3.7. need to be changed to real risks evaluation. Cut-off principle is not compliant with the risk assessment in other areas. Present situation with very limited crop protection tools differs substantially from the situation when “cut off” have been introduced. Nowadays there are many new tools available aiming to minimize or avoid risks by using new and precise application technologies, techniques and machinery.
Amendment 1236
Ivan David
Proposal for a regulation
Article 1 – paragraph 1 – point 36 c (new)
Regulation (EC) No 1107/2009
Annex II – paragraph 3 – subparagraph 6 – point 3
| Amendment | |
| 3.6.3. An active substance, safener or synergist shall only be approved, if, on the basis of assessment of carcinogenicity testing carried out in accordance with the data requirements for the active substances, safener or synergist and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogen category 1A or 1B, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with Article 18(1)(b) of Regulation (EC) No 396/2005. | deleted |
Or. en
Justification
Cutt of criteria could play an important simplification role in procedures before year 2009 and some timeafterwards , when present legislation has been designed and plenty of active ingredients across crops and pathogens were available. Nowadays, there is already now significant lack of crop protections tools especially in some indication and it is not admittable any more to continue with preventive cut off approach without proper risk analysis, including all possible risk mitigation tools. Also independent smart crop protection system contribute significantly to minimize risk, especially for operators. At least cut-off “criteria set in appendix II under 3.6.2., 3.6.3., 3.6.4. , 3.6.5. and 3.7.need to be changed to real risks evaluation. Cut-off principle is not compliant with the risk assessment in other areas. Present situation with very limited crop protection tools differs substantially from the situation when “cut off” have been introduced. Nowadays there are many new tools available aiming to minimize or avoid risks by using new and precise application technologies, techniques and machinery.
Amendment 1237
Ivan David
Proposal for a regulation
Article 1 – paragraph 1 – point 36 d (new)
Regulation (EC) No 1107/2009
Annex II – paragraph 3 – subparagraph 6 – point 4
| Amendment | |
| 3.6.4. An active substance, safener or synergist shall only be approved if, on the basis of assessment of reproductive toxicity testing carried out in accordance with the data requirements for the active substances, safeners or synergists and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 1A or 1B, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005. | deleted |
Or. en
Justification
Cutt of criteria could play an important simplification role in procedures before year 2009 and some timeafterwards , when present legislation has been designed and plenty of active ingredients across crops and pathogens were available. Nowadays, there is already now significant lack of crop protections tools especially in some indication and it is not admittable any more to continue with preventive cut off approach without proper risk analysis, including all possible risk mitigation tools. Also independent smart crop protection system contribute significantly to minimize risk, especially for operators. At least cut-off “criteria set in appendix II under 3.6.2., 3.6.3., 3.6.4. , 3.6.5. and 3.7.need to be changed to real risks evaluation. Cut-off principle is not compliant with the risk assessment in other areas. Present situation with very limited crop protection tools differs substantially from the situation when “cut off” have been introduced. Nowadays there are many new tools available aiming to minimize or avoid risks by using new and precise application technologies, techniques and machinery.
Amendment 1238
Ivan David
Proposal for a regulation
Article 1 – paragraph 1 – point 36 e (new)
Regulation (EC) No 1107/2009
Annex II – paragraph 3 – subparagraph 6 – point 5
| Amendment | |
| 3.6.5. An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not considered to have endocrine disrupting properties that may cause adverse effect in humans, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005. | deleted |
Or. en
Justification
Cutt of criteria could play an important simplification role in procedures before year 2009 and some time afterwards, when present legislation has been designed and plenty of active ingredients across crops and pathogens were available. Nowadays, there is already now significant lack of crop protections tools especially in some indication and it is not admittable any more to continue with preventive cut off approach without proper risk analysis, including all possible risk mitigation tools. Also, independent smart crop protection system contributes significantly to minimize risk, especially for operators. At least cut-off “criteria set in appendix II under 3.6.2., 3.6.3., 3.6.4., 3.6.5. and 3.7. need to be changed to real risks evaluation. Cut-off principle is not compliant with the risk assessment in other areas. Present situation with very limited crop protection tools differs substantially from the situation when “cut off” have been introduced. Nowadays there are many new tools available aiming to minimize or avoid risks by using new and precise application technologies, techniques and machinery.
Amendment 1239
Ivan David
Proposal for a regulation
Article 1 – paragraph 1 – point 36 f (new)
Regulation (EC) No 1107/2009
Annex II – paragraph 3 – subparagraph 7
| Present text | Amendment |
|---|---|
| 3.7. Fate and behaviour in the environment | deleted |
Or. en
(32009R1107)
Justification
Cutt of criteria could play an important simplification role in procedures before year 2009 and some time afterwards, when present legislation has been designed and plenty of active ingredients across crops and pathogens were available. Nowadays, there is already now significant lack of crop protections tools especially in some indication and it is not admittable any more to continue with preventive cut off approach without proper risk analysis, including all possible risk mitigation tools. Also independent smart crop protection system contribute significantly to minimize risk, especially for operators. At least cut-off “criteria set in appendix II under 3.6.2., 3.6.3., 3.6.4. , 3.6.5. and 3.7.need to be changed to real risks evaluation. Cut-off principle is not compliant with the risk assessment in other areas. Present situation with very limited crop protection tools differs substantially from the situation when “cut off” have been introduced. Nowadays there are many new tools available aiming to minimize or avoid risks by using new and precise application technologies, techniques and machinery. Present system do not take into consideration real extent of applied amounts of the active ingredients in the context of whole agricultural area. There is general requirement for agricultural crops diversification in EU strategies on the one site, but lack of sufficiently effective plant protection products (active ingredients) is the most significant barrier for growing of these commodities. New approach should take into consideration also acreage of the crop and real number of treatments in longer time horizon within whole crop rotation system. Many of these crops are grown only on very small areas only once in a 5 or 7 years on the same plot. Although, there might be some negative characteristics (what are now subject of cut off) real negative impact in large agricultural systems is marginal.
Instead of flat preventive cut off approach– specifically needs for such minor crops should be taken into consideration in – evaluating the realistic impacts.
Amendment 1240
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| Article 1a | |
| Evaluation and legislative proposal for a standalone biocontrol framework | |
| By 31 December 2028, the Commission shall submit an evaluation report to the European Parliament and the Council assessing the appropriateness of the existing legislative framework for biological control products. This evaluation shall specifically assess the implementation and impact of the biocontrol measures introduced under Regulation (EU)1107/2009 and the food and feed safety simplification package, with an emphasis on time periods to put these products on the market. | |
| The time periods should be comparable with other major agricultural regions while maintaining a strong assessment ensuring a high level of protection of human health, animal health and the environment. The evaluation referred to in paragraph 1 shall analyse: | |
| (a) data requirements, approval criteria, and assessment methodologies; | |
| (b) the efficiency of approval and authorisation procedures, including mutual recognition; and | |
| (c) the structural limitations of evaluating biological products within a framework primarily designed for conventional chemical substances. | |
| When appropriate, the report shall be accompanied by a legislative proposal for a standalone regulation on biocontrol. This proposal shall establish tailored procedures for the assessment, approval, and authorisation of biological solutions, and shall evaluate the conditions under which a centralised authorisation approach may apply. |
Or. en
Amendment 1241
Anja Hazekamp, Per Clausen, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
Proposal for a regulation
Article 2 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| (1) Article 14(2) of Regulation (EC) No 1107/2009 as amended by [OP: please insert the reference of this Regulation] shall, following completion of the renewal procedure, also apply to active substances for which an application for renewal of approval has been submitted before [date of entry force of this Regulation]. | deleted |
Or. en
Amendment 1242
Andreas Glück, Jan-Christoph Oetjen, Christine Singer
Proposal for a regulation
Article 2 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| (1) Article 14(2) of Regulation (EC) No 1107/2009 as amended by [OP: please insert the reference of this Regulation] shall, following completion of the renewal procedure, also apply to active substances for which an application for renewal of approval has been submitted before [date of entry force of this Regulation]. | (1) Article 14(2) of Regulation (EC) No 1107/2009 as amended by [OP: please insert the reference of this Regulation] shall also apply to active substances for which an application for renewal of approval has been submitted before [date of entry force of this Regulation], unless the draft assessment report according to Article 11 of Regulation (EC) No 1107/2009 or the previous approval decision suggest possible non-compliance with Article 14 (2) (a-c) of Regulation (EC) No 1107/2009. In these cases, completion of the renewal procedure shall be a precondition for granting approval for an unlimited period. |
| If these conditions are not met, approval for an unlimited period shall be granted and the active substances shall be considered with priority for the work programmes according to Articles 18 and 18a of Regulation (EC) No 1107/2009 as amended by [OP: please insert the reference of this Regulation]. |
Or. en
Justification
Persistent backlogs in renewal procedures continue to impede farmers' access to essential innovations and will take years to resolve, despite the welcomed move toward unlimited approvals . This amendment optimizes regulatory oversight by prioritising finalized assessments for substances where concerns are identified, while managing other cases through the existing work programme. This approach ensures a comprehensive safety overview while focusing finite resources on substantiated, science-based risks.
Amendment 1243
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët, Viktória Ferenc
Proposal for a regulation
Article 2 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| Article 2a | |
| Review | |
| By no later than two years after the date of entry into force of this Regulation and every two years thereafter, the Commission shall submit to the European Parliament and to the Council a report assessing the impact of this Regulation on: | |
| (a) the effectiveness of the approval, renewal and authorisation procedures for plant protection substances and products; | |
| (b) the availability of plant protection substances and products; | |
| (c) the operations and differences in practice between the approval agencies and the national agencies, and the effectiveness of their relationship through the mutual-recognition procedures and zone-based authorisation schemes; | |
| (d) the development of biocontrol solutions. | |
| If this assessment reveals that the objectives pursued by this Regulation have not been achieved, particularly if there is no significant improvement in meeting the deadlines, in the availability of plant protection solutions, in the operation of mutual recognition or in the zone-based procedures, the Commission must, within a period of six months, submit draft legislation with a view to revising Regulation (EC) No 1107/2009 and adopting additional simplification measures. |
Or. fr
Amendment 1244
Benoit Cassart, Gerben-Jan Gerbrandy, Christine Singer, Pascal Canfin, Olivier Chastel, Charles Goerens, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni, Stine Bosse
Proposal for a regulation
Article 2 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| Article 2a | |
| Review clause concerning Regulation (EC) No 1107/2009 | |
| By 5 years after the entry into force of this Regulation, the Commission shall carry out an evaluation of the implementation and effectiveness of this amended Regulation and submit a report on its findings to the European Parliament and the Council. | |
| The evaluation shall, in particular, assess: | |
| (a) whether it is appropriate to establish a dedicated legislative framework for biocontrol substances; | |
| (b) the effect of unlimited approval period for active substances introduced in articles 5 and 14 in particular its impact on the workload on the Authority and the national competent authorities, farmer’s access to plant protection products, the environnement and human health. | |
| The report shall be accompanied by a legislative proposal if appropriate. |
Or. en
Amendment 1245
Sander Smit, Jessika van Leeuwen
Proposal for a regulation
Article 2 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| No later than one year after the entry into force of this Regulation and every three years thereafter the Commission shall publish a report assessing: (a) the active substances and plant protection products whose approval is expected to expire within the next five years; (b) the potential consequences for plant protection, including the impact on specific crops, on pest and disease control and on agricultural productivity; (c) the availability and effectiveness of alternative solutions, including biocontrol, low-risk substances, resistant varieties, breeding innovations, precision farming and mechanical or other non-chemical techniques. If the report identifies significant gaps in plant protection for which no adequate alternatives are available, the Commission shall take appropriate measures to facilitate the development and availability of solutions. Such measures may involve prioritising the assessment of relevant applications, promoting research and innovation, and supporting the development of alternative plant protection approaches. |
Or. nl
Amendment 1246
Charles Goerens
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point a a (new)
Regulation (EC) No 396/2005
Article 3 – paragraph 2 – subparagraph 1a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (aa) In Article 3, paragraph 2, a new subparagraph 1a is added: | |
| 1a. When considering paragraph 2, point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, or does not meet criteria 3.8.3 of that Annex, the Commission shall carry out an impact assessment prior to the preparation of the Regulation referred to in paragraph 1 of this Article. An MRL based on an existing CXL or a GAP implemented in a third country can be set or maintained if considered appropriate in the light of the outcome of this impact assessment and where that MRL does not represent a major contribution to consumer exposure. In other cases, the MRL shall be established in accordance with Article 18(1)(b) or, where appropriate, Article 16. The results of the impact assessment and a draft Regulation shall be presented to the Committee referred to in Article 45(1) without delay and at the latest within six months upon receipt of the scientific opinion of the Authority referred to in Article 43 or, where appropriate, six months before the expiry of the maximum grace period established at the adoption of a Regulation under Regulation (EC) No 1107/2009 non-approving, non-renewing or withdrawing the approval of an active substance meeting one or more of the properties or criteria referred to in the first subparagraph. This paragraph shall not apply for MRLs applicable to active substances approved in the Union, including in accordance with the derogation set out in Article 4(7) of Regulation (EC) No 1107/2009. |
Or. en
Amendment 1247
Mireia Borrás Pabón, Raffaele Stancanelli, Gilles Pennelle, Anne-Sophie Frigout, Jorge Buxadé Villalba
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point c
Regulation (EC) No 396/2005
Article 3 – paragraph 2 – point g
| Text proposed by the Commission | Amendment |
|---|---|
| (c) point (g) is deleted; | (c) point (g) is replaced by the following: |
| (g) Prohibited active substance’ means an active substance whose approval has been withdrawn, not renewed or refused in the Union for reasons relating to the protection of human health, animal health or the environment.” |
Or. en
Justification
The proposal should clearly specify that when an active substance has been withdrawn or not renewed due to concerns for human or animal health or the environment, the MRL set on the basis of a CXL or GAP applied in a third country must be revoked and set at 0,01 mg/kg or at a value similar to the one established at EU level..
Amendment 1248
Alexander Bernhuber
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point c a (new)
Regulation (EC) No 396/2005
Article 3 – paragraph 2 – point j a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) in Article 3, paragraph 2, a new point ja is added: | |
| (ja) ‘unapproved active substance’ means an active substance which is not approved or no longer approved under Regulation (EC) No 1107/2009; |
Or. de
Amendment 1249
Alexander Bernhuber
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point c b (new)
Regulation (EC) No 396/2005
Article 3 – paragraph 2 – point j b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (cb) in Article 3, paragraph 2, a new point jb is added: | |
| (jb) ‘particularly hazardous active substance’ means an active substance with one or more of the properties referred to in No 3.6.2-3.6.5, 3.7.1-3.7.3 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009; |
Or. de
Amendment 1250
Alexander Bernhuber
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point c c (new)
Regulation (EC) No 396/2005
Article 3 – paragraph 2 – point j c (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (cc) in Article 3, paragraph 2, a new point jc is added: | |
| (jc) ‘period of non-use’ means a continuous period of three years during which no Member State has granted an authorisation under Article 53 of Regulation (EC) No 1107/2009 for an unapproved active substance. |
Or. de
Amendment 1251
Carlo Fidanza, Michele Picaro, Nicola Procaccini, Francesco Ventola
Proposal for a regulation
Article 3 – paragraph 1 – point 1 a (new)
Regulation (EC) No 396/2005
Article 6 – paragraph 2
| Presnt text | Amendment |
| (1a) In Article 6, paragraph 2 is replaced by the following: | |
| 2. All parties demonstrating, through adequate evidence, a legitimate interest in health, including civil society organisations, as well as commercially interested parties such as manufacturers, growers, importers and producers of products covered by Annex I may also submit an application to a Member State in accordance with Article 7. | 2. All parties demonstrating, through adequate evidence, a legitimate interest in health, including civil society organisations, as well as commercially interested parties such as manufacturers, growers and producers of products covered by Annex I may also submit an application to a Member State in accordance with Article 7. |
Or. en
(32005R0396)
Justification
Ban of Import tolerances: In order to implement reciprocity of standards for products imported in the EU with the international trade, it is essential to stop granting any import tolerance that establish MRL for active substances no more authorized in the EU.
Amendment 1252
Raffaele Stancanelli, Silvia Sardone, Isabella Tovaglieri, Ton Diepeveen
Proposal for a regulation
Article 3 – paragraph 1 – point 2 – introductory part
Regulation (EC) No 396/2005
Article 6 – paragraph 4
| Text proposed by the Commission | Amendment |
|---|---|
| (2) In Article 6, paragraph (4) is replaced by the following: | (2) deleted |
| 4. Applications for setting an MRL based on a GAP implemented in a third country shall be submitted to rapporteur Member States designated pursuant to Regulation (EC) No 1107/2009. If no such rapporteur has been designated, applications shall be made to Member States designated by the Commission in accordance with the procedure referred to in Article 45(2) of this Regulation at the request of the applicant. Such applications shall be made in accordance with Article 7 of this Regulation.; |
Or. en
Amendment 1253
Carlo Fidanza, Michele Picaro, Nicola Procaccini, Francesco Ventola, Waldemar Buda
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Regulation (EC) No 396/2005
Article 6 – paragraph 4
| Text proposed by the Commission | Amendment |
|---|---|
| (2) In Article 6, paragraph (4) is replaced by the following: | (2) deleted |
| 4. Applications for setting an MRL based on a GAP implemented in a third country shall be submitted to rapporteur Member States designated pursuant to Regulation (EC) No 1107/2009. If no such rapporteur has been designated, applications shall be made to Member States designated by the Commission in accordance with the procedure referred to in Article 45(2) of this Regulation at the request of the applicant. Such applications shall be made in accordance with Article 7 of this Regulation.; |
Or. en
Justification
In order to implement reciprocity of standards for products imported in the EU with the international trade, it is essential to stop granting any import tolerance that establish MRL for active substances no more authorized in the EU.
Amendment 1254
Alexander Bernhuber
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Regulation (EC) No 396/2005
Article 6 – paragraph 4 – subparagraph 1a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (4a) Applications under subparagraph 1 shall be inadmissible if they relate to a particularly hazardous active substance or if a period of non-use has commenced for the relevant unapproved active substance. |
Or. de
Amendment 1255
Raffaele Stancanelli, Silvia Sardone, Isabella Tovaglieri, Anne-Sophie Frigout, Marie-Luce Brasier-Clain, Gilles Pennelle, Ton Diepeveen
Proposal for a regulation
Article 3 – paragraph 1 – point 2 a (new)
Regulation (EC) No 396/2005
Article 6 – paragraph 2
| Present text | Amendment |
|---|---|
| (2a) In Article 6, paragraph 2 is replaced by the following: | |
| 2. All parties demonstrating, through adequate evidence, a legitimate interest in health, including civil society organisations, as well as commercially interested parties such as manufacturers, growers, importers and producers of products covered by Annex I may also submit an application to a Member State in accordance with Article 7. | '2. All parties demonstrating, through adequate evidence, a legitimate interest in health, including civil society organisations, as well as commercially interested parties such as manufacturers, growers and producers of products covered by Annex I may also submit an application to a Member State in accordance with Article 7.'; |
Or. en
(32005R0396)
Amendment 1256
Mireia Borrás Pabón, Raffaele Stancanelli, Gilles Pennelle, Anne-Sophie Frigout, Jorge Buxadé Villalba
Proposal for a regulation
Article 3 – paragraph 1 – point 2 a (new)
Regulation (EC) No 396/2005
Article 6 – paragraph 4a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (2a) In Article 6, a new paragraph 4a is added: | |
| "4a. Applications for setting an MRL based on a GAP implemented in a third country shall not be admissible in respect of prohibited active substances.” |
Or. en
Justification
The proposal should clearly specify that when an active substance has been withdrawn or not renewed due to concerns for human or animal health or the environment, the MRL set on the basis of a CXL or GAP applied in a third country must be revoked and set at 0,01 mg/kg or at a value similar to the one established at EU level.
Amendment 1257
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 3 – paragraph 1 – point 3 a (new)
Regulation (EC) No 396/2005
Article 14 – paragraph 1a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (3a) in Article 14, a new paragraph 1a is inserted: | |
| '1a. By way of derogation from paragraph 1, where an active substance is not approved, or where its approval is withdrawn or not renewed pursuant to Regulation (EC) No 1107/2009, the corresponding maximum residue levels shall be amended by the Commission to the value referred to in Article 18(1)(b). The Commission shall adopt the necessary measures within three months of the date on which the decision on non-approval, withdrawal or non-renewal becomes applicable. No separate opinion of the Authority under this Regulation shall be required for that purpose.’ |
Or. en
Amendment 1258
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| (a) In paragraph (2), a new subparagraph is added: | deleted |
| ‘- ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; ’ |
Or. en
Amendment 1259
Andreas Glück, Jan-Christoph Oetjen
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| (a) In paragraph (2), a new subparagraph is added: | deleted |
| ‘- ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; ’ |
Or. en
Justification
The existing risk-based Maximum Residue Level (MRL) framework already provides robust consumer protection by setting science-based limits for hazardous substances. Furthermore, the current proposal has sparked significant criticism from trade partners and undermines the EU's commitment to a rules-based multilateral trading system. At the least, the Commission should await the outcome of the impact assessment launched in November 2025 that will consider the impact of changes to the MRL framework on the EU’s competitive position and the international implications.
Amendment 1260
Asger Christensen, Christine Singer
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | deleted |
Or. en
Amendment 1261
Asger Christensen, Christine Singer
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | - Where the active substance is not approved in the Union and has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country shall first be assessed in accordance with this Regulation. |
| Where the assessment referred to in the first subparagraph shows that the MRL does not present an unacceptable risk to consumers, the Commission shall set or maintain the MRL in accordance with this Regulation. | |
| An MRL referred to in the first subparagraph may be subsequently revoked and set in accordance with Article 18(1)(b) only by means of a separate measure and only where a prior, comprehensive and published assessment demonstrates that such revocation and setting at the limit of quantification is necessary and proportionate. | |
| That assessment shall examine, at least: | |
| (a) whether the measure would create a risk of disruption to the availability of food or feed products in the Union, including agricultural commodities, feed materials, processed products or its raw materials, and products with limited alternative sources of supply; | |
| (b) whether the measure would have disproportionate adverse effects on farmers, food and feed business operators, processors, importers, consumers, or the competitiveness of the Union agri-food sector; | |
| (c) whether the measure would affect the resilience, diversification or affordability of Union food and feed supply chains; | |
| (d) whether the measure is compatible with the Union’s obligations under international agreements, including the WTO Agreement on the Application of Sanitary and Phytosanitary Measures, and takes due account of relevant international standards, including Codex maximum residue limits; | |
| (e) whether the measure would have disproportionate effects on producers in third countries, in particular where the products concerned comply with MRLs assessed as safe for consumers under this Regulation; | |
| (f) whether the same objective could be achieved through a measure that is less trade-restrictive or less disruptive for food and feed supply chains. | |
| The assessment referred to in the third subparagraph shall be made public and available for consultation and comment before the adoption of the measure. It shall take into account the cumulative effects of the proposed measure on relevant substances, commodities, origins, supply chains and sectors. Any measure adopted pursuant to this subparagraph shall include appropriate deferral periods and shall apply only to products produced after the date of application of that measure. |
Or. en
Justification
This amendment ensures that the scientific and risk-based logic of Regulation 396/2005 remains the starting point for Codex- and third-country GAP-based MRLs. Such MRLs should continue to be assessed first on the basis of consumer safety. Where the assessment shows that the MRL does not present an unacceptable consumer risk, the MRL should be set or maintained under Regulation 396/2005.
Amendment 1262
Céline Imart, Emmanouil Kefalogiannis
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| — ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | — ‘By way of derogation from paragraph 2, where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 or does not fulfil the criteria laid down in points 3.8.3 or 3.10 of this Annex, according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of the Regulation, a MRL shall be set in accordance with Article 18(1)(b) or Article 16 of this Regulation. |
| In order to avoid any risk of disruption to supply chains in the sectors that currently depend on imports (such as animal feed), derogations must be envisaged, subject to the implementation of plans aiming at least to reduce this high dependency, with the aim of progressing towards food sovereignty in the long term and wherever possible. | |
| By way of derogation from the deadline laid down in Article 14(1), the Commission shall submit to the committee referred to in Article 45(1) the outcome of the impact assessment as well as, where relevant, a draft regulation, without delay and no later than six months following: | |
| (i) an assessment carried out under Article 43 of this Regulation finding that the substance in question has one or more of the properties referred to in the first subparagraph; or | |
| (ii) expiry of the maximum grace period set when a regulation was adopted under Regulation (EC) No 1107/2009 refusing approval, not renewing the approval, or withdrawing the approval for an active substance that has one or more of the properties or which does not fulfil one or more of the criteria referred to in the first subparagraph. | |
| This paragraph shall not apply to MRLs relating to products in respect of which the use of plant protection products containing the active substance has been authorised in the Union in accordance with the derogation provided for in Article 4(7) of Regulation (EC) No 1107/2009. | |
| The following new paragraph 2b is inserted: | |
| 2b. Where it is necessary to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs referred to in Article 14 may envisage transitional measures allowing the placing or remaining on the market in the Union of products that were compliant with the MRLs applicable at the time of their placing on the market or at the time of their placing into storage after production. The burden of proving the date on which the products were placed on the market or placed into storage after production shall fall on the food business operator. |
Or. fr
Amendment 1263
Carmen Crespo Díaz, Susana Solís Pérez, Esther Herranz García, Dolors Montserrat, Juan Ignacio Zoido Álvarez
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| — ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | — ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. |
| Where an MRL has been set on the basis of a limit in the Codex or good agricultural practice in a third country, that limit must first be assessed in accordance with this Regulation and on the basis of consumer safety. | |
| Where such an assessment confirms that the MRL does not pose an unacceptable risk to consumers, the Commission may maintain or modify it under this Regulation. | |
| Any decision to reduce that limit to the limit of quantification must be based on an a priori assessment on a case-by-case basis, and must be properly published, proportionate and supported by objective, scientific criteria. Such an assessment must in particular analyse its impact on food safety, the availability of food and feed, the competitiveness of the Union’s agri-food sector, the reciprocity of production conditions, the resilience of the supply chains, affordability for consumers, and compliance with the Union’s international obligations. | |
| Such an assessment must be made public before the measure is adopted, and must take account of the cumulative impact on the substances, products, origins, supply chains and sectors that are affected. All measures that are adopted must provide for adequate, proportionate implementation and transition periods wherever there are viable alternatives, so that European agri-food sectors have a guarantee of their production and competitiveness; |
Or. es
Amendment 1264
Pascal Canfin, Yvan Verougstraete
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | - ‘By way of derogation from point (e), an MRL that has been set on the basis of a CXL or of a GAP implemented in a third country shall be revoked and set at the relevant limit of quantification in accordance with Article 18(1)(b) where the active substance concerned is not approved, or is no longer approved, under Regulation (EC) No 1107/2009 and where, according to the latest available evaluation under that Regulation or to a specific evaluation carried out in accordance with Article 43 of this Regulation, at least one of the following conditions is met: |
| (a) where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 | |
| (b) the toxicological data package for the active substance does not meet the data requirements applicable under Regulation (EC) No 1107/2009 at the time of the most recent evaluation; | |
| (c) the use of the active substance contributes to an environmental problem of a systemic and global nature, including, inter alia, harm to pollinators, persistence in the environment or long-range transboundary effects.' | |
| By way of derogation from the third subparagraph, the Commission may, following a specific evaluation in accordance with Article 43 and on a case-by-case basis, set or maintain an MRL above the limit of quantification, in accordance with Article 16, only where both of the following cumulative conditions are met: | |
| (a) no risk to consumers has been identified or is suspected; | |
| (b) setting the MRL at the limit of quantification would have a disproportionate negative impact on the functioning of the internal market or on the security of the food or feed supply in the Union. | |
| Any MRL set pursuant to this subparagraph shall be renewable following a new evaluation, and shall be made public together with the reasons justifying the derogation. |
Or. en
Amendment 1265
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mathilde Androuët
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| — By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. | — By way of derogation from paragraph 2, point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 or does not fulfil criterion 3.8.3 or 3.10 of this Annex, according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of this Regulation, a MRL shall be set in accordance with Article 18(1)(b) or Article 16 of this Regulation. In order to avoid any risk of disruption to supply chains in the sectors that currently depend on imports, derogations must be put in place, subject to the implementation of plans aiming to reduce this high dependency, with the aim of striving for food sovereignty wherever possible. By way of derogation from the duration laid down in Article 14(1), the Commission shall submit to the committee referred to in Article 45(1) the outcome of the impact assessment and, where relevant, the draft regulation, without delay and no later than six months following: |
| (i) an assessment under Article 43 of this Regulation finding that the substance in question displays one or more of the properties referred to in the first subparagraph; or | |
| (ii) expiry of the maximum grace period set when a regulation was adopted under Regulation (EC) No 1107/2009 refusing approval, not renewing it, or withdrawing the approval for an active substance that has one or more of the properties or criteria referred to in the first subparagraph. This paragraph shall not apply to MRLs applying to products in respect of which the use of plant protection products containing the active substance is authorised in the Union in accordance with the derogation provided for in Article 4(7) of Regulation (EC) No 1107/2009. |
Or. fr
Amendment 1266
Bert-Jan Ruissen
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment taking account of, in particular: |
| a) The Union import-dependency regarding the targeted agricultural commodities; | |
| b) The specificities and needs of the EU food and feed supply chain, especially in cases of crises or geopolitical disorders; | |
| c) The competitive position of all EU actors in the food and feed supply chain on the EU and export markets; | |
| d) Legal requirements in place to meet phytosanitary requirements related to quarantine pests when importing or exporting to third countries and to address emerging risks; | |
| e) European Union legal requirements which are in pace to meet phytosanitary standards for quarantine pests when importing form non-European countries, considering emerging risks; | |
| f) The compatibility of the measures with the WTO rules. |
Or. en
Amendment 1267
Benoit Cassart, Gerben-Jan Gerbrandy, Christine Singer, Olivier Chastel, Billy Kelleher, Barry Cowen, Elsi Katainen, Katri Kulmuni
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, 3.8.2, 3.8.3 or 3.10 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, the Commission shall carry out an impact assessment taking into account the impact on farmers and their competitiveness, the food and feed chain, the environment and human health prior to the preparation of the Regulation referred to in paragraph 1 of this Article. |
| For food intended for human consumption, an MRL based on an existing CXL or a GAP implemented in a third country shall be established in accordance with Article 18(1)(b) or, where appropriate, Article 16. | |
| For feed, an MRL based on an existing CXL or a GAP implemented in a third country may be established in accordance with Article 18(1)(b) or where appropriate, article 16 if the impact assessment referred to in subparagraph 1 demonstrates that such measure will not create disproportionate disruptions in the feed supply chain provided that residues in feed will not result in residues for food intended for human consumption taking into account scientific knowledge. |
Or. en
Amendment 1268
Flavio Tosi, Massimiliano Salini, Salvatore De Meo
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment, taking into account, in particular: |
| (a) the Union’s dependence on imports of the agricultural commodities concerned; | |
| (b) the specific characteristics and requirements of the Union food and feed supply chain, including its resilience in crisis situations or in the event of geopolitical disruptions; | |
| (c) the impact on the competitiveness of all actors throughout the Union food and feed supply chain, both on the Union market and in export markets; | |
| (d) the consistency of such measures with WTO rules. |
Or. en
Justification
The impact assessment should specify the key elements to be considered before lowering MRLs to the limit of quantification, ensuring that the effects on all actors of the EU food and feed supply chain are properly assessed.
Amendment 1269
Raffaele Stancanelli, Silvia Sardone, Isabella Tovaglieri, Mireia Borrás Pabón, Roman Haider
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | - By way of derogation from paragraph 2, where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 or does not meet criteria 3.8.3 or 3.10 of that Annex, according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL is set in accordance with Article 18(1)(b) or Article 16 of this Regulation. Where the setting of such an MRL gives rise to indications of significant disruption in the supply chain for certain products, as notified by food business operators, farmers or producers' organisations, or by a Member State, the Commission may, within six months of receipt of such notification, carry out an impact assessment. Where that assessment confirms a significant disruption in the supply chain of the products concerned, the Commission may, where appropriate, submit a draft Regulation establishing a specific MRL for the active substance concerned, limited to those products identified as affected by the assessment. ; |
Or. en
Amendment 1270
Stefan Köhler, Norbert Lins, Andrea Wechsler, Lena Düpont
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be reviewed and, in compliance with WTO and SPS requirements, be set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. The impact assessment shall take into account especially the following criteria: |
| (a) a risk assessment carried out by the Authority, | |
| (b) the impact on EU Member States as well as on third countries, | |
| (c) the needs of the entire food and feed chain. | |
| The provisions in the second subparagraph will be reviewed as soon as the general impact assessment initiated under the Vision for Agriculture and Food is available.‘ |
Or. en
Amendment 1271
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment taking account of, in particular: |
| (a) The Union import- dependency regarding the targeted agricultural commodities; | |
| (b) The specificities and needs of the EU food and feed supply chain, especially in cases of crises or geopolitical disorders; | |
| (c) The competitive position of all EU actors of the food and feed supply chain on the EU and export markets; | |
| (d) The compatibility of the measures with the WTO rules.; |
Or. en
Amendment 1272
Sander Smit, Jessika van Leeuwen
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| — ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | — ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment, taking into account in particular: (a) the Union’s dependency on imports of the agricultural raw materials concerned; (b) the specific characteristics and needs of the EU’s food and feed chain, in particular in the event of crises or geopolitical disruptions; (c) the competitive position of all actors in the EU’s food and feed chain on the EU and export markets; (d) the compatibility of the measures with WTO rules.’ |
Or. nl
Justification
This article sets out the factors that have to be considered before an import MRL is reduced to technical zero (import dependency, specific characteristics of the chain and sensitivity to crises, competitive position and WTO compatibility).
Amendment 1273
Asger Christensen, Christine Singer
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment taking account of, in particular: |
| (a) The Union import- dependency regarding the targeted agricultural commodities; | |
| (b) The specificities and needs of the EU food and feed supply chain, especially in cases of crises or geopolitical disorders; | |
| (c) The competitive position of all EU actors of the food and feed supply chain on the EU and export markets; | |
| (d) The compatibility of the measures with the WTO rules.; |
Or. en
Amendment 1274
Anja Hazekamp, Per Clausen, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | - ‘By way of derogation from point (e), where the active substance is not approved for use in the Union in accordance with Regulation (EC) No 1107/2009, the MRL will be set at LOD. |
Or. en
Amendment 1275
Martine Kemp
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | - In relation to paragraph 2 (e), the Commission shall carry out an impact assessment prior to the preparation of the Regulation referred to in paragraph 1 of this Article, where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009. Codex Alimentarius standards or Good Agricultural Practices can serve as a basis for an MRL and can be maintained if considered appropriate in the light of the impact assessment. In other cases, an MRL shall be established in accordance with this regulation without delay and at the latest within six months upon receipt of the scientific opinion of the Authority. This paragraph shall not apply for MRLs applicable to active substances approved in the Union, including in accordance with the derogation set out in Article 4(7) of Regulation (EC) No 1107/2009. |
Or. en
Justification
For coherence purposes, and in order not to undermine the efforts already undertaken within the Union aiming at ensuring a high level of protection of human health and the environment, it is important to apply a stringent approach to residues in imported products, in compliance with international obligations. The aim is enhanced consumer health protection and fair competition for farmers. Impact assessment required to justify the maintenance or establishment of an import MRL which must not contribute to significant consumer exposure and tight deadline for the impact assessment and draft regulation.
Amendment 1276
Laurence Trochu
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| — ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | — ‘By way of derogation from point (e), where the active substance has not been approved in the Union in accordance with Regulation (EC) No 1107/2009 owing to one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to that Regulation, or where its approval has been withdrawn or not renewed on grounds related to the protection of human health, animal health or the environment, the MRL applicable to the products concerned that have been placed on the market in the Union, including imported products, shall be set, within a maximum period of twelve months from the date of the decision to withdraw or not renew the active substance, to the limit of quantification in accordance with Article 18(1)(b), unless a scientific assessment demonstrates that another level guarantees an equivalent level of protection for consumers and the environment.’ |
Or. fr
Amendment 1277
Mireia Borrás Pabón, Raffaele Stancanelli, Jorge Buxadé Villalba
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | - ‘By way of derogation from point (e), where the active substance has been withdrawn or not renewed in the UE due to concerns for human or animal health or the environment pursuant to Regulation (EC) No 1107/2009a MRL that has been set based on a CXL or a GAP implemented in a third country shall be revoked and set in accordance with Article 18(1)(b) |
Or. en
Justification
The proposal should clearly specify that when an active substance has been withdrawn or not renewed due to concerns for human or animal health or the environment, the MRL set on the basis of a CXL or GAP applied in a third country must be revoked and set at 0,01 mg/kg or at a value similar to the one established at EU level..
Amendment 1278
Paulo do Nascimento Cabral
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment, including competiveness between EU and third countries agricultural production; |
Or. en
Amendment 1279
Carlo Fidanza, Michele Picaro, Nicola Procaccini, Francesco Ventola, Waldemar Buda
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | - ‘By way of derogation from paragraph 2, point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 or does not meet criteria 3.8.3 or 3.10 of that Annex, in accordance with the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL is set in accordance with Article 18(1)(b) or Article 16 of this Regulation; if considered appropriate an impact assessment can be carried out based on a notification in accordance with the second subparagraph. |
Or. en
Justification
Ban of Import tolerances. In order to implement reciprocity of standards for products imported in the EU with the international trade, it is essential to stop granting any import tolerance that establish LMR for active substances no more authorized in the EU.
Amendment 1280
Alexander Bernhuber
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country will be revoked and set in accordance with Article 18(1)(b) or Article 16. The Commission establishes the relevant regulation in a matter of twelve months after the relevant properties were evalueted and set. ; |
Or. en
Amendment 1281
Biljana Borzan, Christophe Clergeau, Gheorghe Cârciu, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, a MRL that has been set based on a CXL or a GAP implemented in a third country can be revoked and set in accordance with Article 18(1)(b) or Article 16 if considered appropriate in the light of the outcome of an impact assessment. ; | - ‘By way of derogation from point (e), where the active substance has one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, the MRL shall be set in accordance with Article 18(1)(b), unless a different level is demonstrated to ensure an equivalent level of protection of human health on the basis of a scientific assessment carried out by the Authority.; |
Or. en
Justification
For substances with the most hazardous properties, consumer protection should remain the primary consideration. MRLs should, as a rule, be lowered to the limit of quantification unless a scientific assessment demonstrates that another level provides an equivalent level of protection of human health.
Amendment 1282
Jérémy Decerle
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (a) in Article 14, paragraph 2, a new subparagraph 2a is added: | |
| ‘2a. By way of derogation from point (e), an MRL based on a CXL or a GAP implemented in a third country may not be established and an MRL must be set in accordance with Article 18(1), point (b), or Article 16, where the active substance displays one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, according to the latest available evaluation under Regulation (EC) No 1107/2009 or to a specific evaluation in accordance with Article 43 of Regulation (EC) No 396/2005, including in cases where the data available are insufficient to exclude such properties, or where use of the active substance constitutes a systemic environmental problem on a global scale, other than: | |
| − for products in respect of which the use of plant protection products containing the active substance is authorised in the Union in accordance with the derogation provided for in Article 4(7) of Regulation (EC) No 1107/2009; or | |
| − where it emerges from a case-by-case evaluation, taking account of any legitimate factors that are appropriate, that failure to set the MRL in question would have a disproportionately negative impact on the food or feed supply or on the functioning of the internal market, on condition that the latter scientific evaluation concludes that there is no risk to consumer safety.’ |
Or. fr
Justification
This amendment introduces the general principle of a systematic reduction in MRLs to the limit of detection, within a maximum period of six months, for active substances that are no longer approved in the European Union, either because of a particular risk (especially an exclusion criterion) or because the toxicology file has not been updated (especially with regard to these exclusion criteria).
Amendment 1283
Carlo Fidanza, Michele Picaro, Nicola Procaccini, Francesco Ventola, Waldemar Buda
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (a) in Article 14, paragraph 2, a new subparagraph 2a is added: | |
| 2a. "Where the setting of an MRL referred to in the first subparagraph gives rise to indications of disruption in the supply chain for certain products, as notified by food business operators, by farmers or producers organisations, or by a Member States, the Commission may, within six months of receipt of such notification carry out an impact assessment. Where that assessment confirms a significant disruption in the supply chain of the products concerned, the Commission may, where appropriate, submit a draft Regulation establishing a specific MRL for the active substance concerned limited to those products identified as affected by the assessment. ;" |
Or. en
Justification
In order to implement reciprocity of standards for products imported in the EU with the international trade, it is essential to stop granting any import tolerance that establish LMR for active substances no more authorized in the EU.
Amendment 1284
Alexander Bernhuber
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (a) in Article 14, paragraph 2, a new subparagraph 2a is added: | |
| 2a. "Following the adoption of an implementing act pursuant to Regulation (EC) No 1107/2009 providing that the approval of an active substance is not granted, is not renewed or is withdrawn, the Commission shall, without undue delay and in any event within 36 months, review the corresponding maximum residue levels established under this Regulation." |
Or. en
Amendment 1285
Christine Singer
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a a (new)
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – subparagraph 2b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (aa) In Article 14, paragraph 2, a new subparagraph 2b is inserted: | |
| “2b. Substances which may be detectable in food or feed even without the use of a plant protection product (multi-source substances, such as, in particular, AMPA, bromide and copper) shall be labelled as such. For these substances, the Commission shall establish permanent MRLs in accordance with Article 14, taking into account naturally occurring background levels and unavoidable trace levels resulting from other authorised uses.” |
Or. en
Justification
The amendment addresses the fact that, for certain multi-source substances, analytical findings may result from natural background levels or other sources and therefore do not necessarily provide clear evidence of the use of a plant protection product. Introducing a specific designation for such substances and establishing permanent MRLs that take their multiple potential sources into account would therefore enhance legal clarity, ensure consistent enforcement and support a scientifically sound assessment, particularly for food and feed.
Amendment 1286
Raffaele Stancanelli, Silvia Sardone, Isabella Tovaglieri, Roman Haider
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point a a (new)
Regulation (EC) No 396/2005
Article 14 – paragraph 2 – point e
| Text proposed by the Commission | Amendment |
|---|---|
| (aa) In Article 14, paragraph 2, point (e) is deleted. |
Or. en
Amendment 1287
Sakis Arnaoutoglou
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point b
Regulation (EC) No 396/2005
Article 14 – paragraph 2a – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 14 may establish transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRL was applicable. | Where it is necessary in order to allow for the normal marketing, processing and consumption of products with extended shelf lives, the regulations setting or modifying MRLs provided for in Article 14 may establish, in a harmonised manner throughout the Union and for a maximum period of eighteen months from the date of application of the new maximum residue levels, transitional measures allowing products that had already been placed on the market or placed into storage after production and were compliant with the maximum residue levels applicable at that time to remain on the market. |
| Where the new lower maximum residue level has been established on grounds of safety concern, including newly identified toxicological data, revised exposure assessments or the application of updated hazard criteria, such transitional measures shall be limited to the minimum period strictly necessary for the withdrawal of the products concerned and shall not permit their continued placing on the market. |
Or. en
Justification
Transitional measures may be justified for processed products and other products with long shelf lives in order to avoid unnecessary destruction of legally produced stocks. However, their duration must be clearly defined and applied uniformly throughout the Union to prevent products subject to different residue standards from remaining on the internal market for indeterminate periods. An eighteen-month ceiling provides legal predictability for producers and operators. Where an MRL is lowered because of a newly identified health risk, consumer protection must prevail and the transitional period must be limited to the time strictly necessary for withdrawal. This combines the harmonisation and level-playing-field concerns raised by agricultural organisations with the safety safeguards requested by consumer organisations.
Amendment 1288
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point b
Regulation (EC) No 396/2005
Article 14 – paragraph 2a – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 14 may establish transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRL was applicable. | Where it is necessary in order to allow for the normal marketing, processing and consumption of products with extended shelf lives, the regulations setting or modifying MRLs provided for in Article 14 may establish transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRL was applicable. Where the new lower MRL has been established on grounds of safety concern, including newly identified toxicological data, revised exposure assessments, or the application of updated hazard criteria, such transitional measures shall be limited to the minimum period strictly necessary to withdraw non-compliant products from the market and shall not permit the continued placing on the market of such products. |
Or. en
Amendment 1289
Niels Flemming Hansen
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point b
Regulation (EC) No 396/2005
Article 14 – paragraph 2a – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 14 may establish transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRL was applicable. | Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 14 may establish transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRL was applicable. Where the new lower MRL has been established on grounds of safety concern, including newly identified toxicological data, revised exposure assessments, or the application of updated hazard criteria, such transitional measures shall be limited to the minimum period strictly necessary to withdraw non-compliant products from the market and shall not permit the continued placing on the market of such products. |
Or. en
Amendment 1290
Krzysztof Hetman, Elżbieta Katarzyna Łukacijewska, Adam Jarubas
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point b
Regulation (EC) No 396/2005
Article 14 – paragraph 2a – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 14 may establish transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRL was applicable. | Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 14 shall establish transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRL was applicable, at least until the date of minimum durability. The burden of proving when the products were placed on the market or placed into storage after production shall be borne by the food business operator. |
Or. en
Amendment 1291
Mathilde Androuët
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point b
Regulation (EC) No 396/2005
Article 14 – paragraph 2a – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 14 may establish transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRL was applicable. | Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 14 may, using a harmonised one-zone approach for the Union and for a maximum duration of eighteen months from the date of entry into force of the new MRLs, establish transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRL was applicable. |
Or. fr
Amendment 1292
Biljana Borzan, Christophe Clergeau, Gheorghe Cârciu, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Thomas Bajada, Mohammed Chahim
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point b
Regulation (EC) No 396/2005
Article 14 – paragraph 2a – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 14 may establish transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRL was applicable. | Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 14 may establish transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRL was applicable, provided that those products do not present an unacceptable risk to human health, as established on the basis of the latest available scientific evidence. |
Or. en
Justification
Transitional measures should facilitate market adaptation without compromising consumer safety. Products presenting an unacceptable risk to human health should not benefit from transitional arrangements.
Amendment 1293
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point b
Regulation (EC) No 396/2005
Article 14 – paragraph 2a – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 14 may establish transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRL was applicable. | Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 14 may establish, in a harmonised manner throughout the Union and for a maximum period of eighteen months from the entry into force of the new maximum residue levels, transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRL was applicable. |
Or. en
Amendment 1294
Céline Imart, Emmanouil Kefalogiannis
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point b
Regulation (EC) No 396/2005
Article 14 – paragraph 2a – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 14 may establish transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRL was applicable. | Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 14 may, for a maximum duration of eighteen months from the date of entry into force of the new MRLs, establish transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRL was applicable. |
Or. fr
Amendment 1295
Anja Hazekamp, Per Clausen, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point b
Regulation (EC) No 396/2005
Article 14 – paragraph 2a – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 14 may establish transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRL was applicable. | Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 14 may establish transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRL was applicable. These measures will not allow placing or remaining on the market for more than 6 months. |
Or. en
Amendment 1296
Krzysztof Hetman, Elżbieta Katarzyna Łukacijewska, Adam Jarubas
Proposal for a regulation
Article 3 – paragraph 1 – point 4 – point b a (new)
Regulation (EC) No 396/2005
Article 14 – paragraph 2b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) In Article 14, a new paragraph 2b is inserted: | |
| 2b. Paragraph 2(a) applies to products whose ingredients within the meaning of Regulation (EU) No 1169/2011 at the time of these ingredients’ placing on the market or at the time of their placing into storage after production were compliant with the MRLs applicable or to which no MRL was applicable. |
Or. en
Amendment 1297
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 3 – paragraph 1 – point 5
Regulation (EC) No 396/2005
Article 15 – paragraph 1 – point c
| Text proposed by the Commission | Amendment |
|---|---|
| (5) In Article 15, paragraph (1), point (c) is deleted. | deleted |
Or. en
Amendment 1298
Sakis Arnaoutoglou
Proposal for a regulation
Article 3 – paragraph 1 – point 5
Regulation (EC) No 396/2005
Article 15 – paragraph 1 – point c
| Text proposed by the Commission | Amendment |
|---|---|
| (5) In Article 15, paragraph (1), point (c) is deleted. | deleted |
Or. en
Justification
Article 15(1), point (c), classifies maximum residue levels established in the circumstances referred to in Article 16 as temporary MRLs. Deleting that provision would change the legal status of MRLs based on monitoring data from temporary to permanent. Such limits frequently concern residues of substances that are no longer authorised in the Union but remain present in food or the environment because of historical or persistent contamination. Maintaining their temporary status ensures that those limits remain subject to periodic scrutiny and are not treated as permanently acceptable contamination levels. The amendment therefore preserves the precautionary character of the existing framework and the incentive to reduce residue levels over time.
Amendment 1299
Sakis Arnaoutoglou
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Regulation (EC) No 396/2005
Article 16
| Text proposed by the Commission | Amendment |
|---|---|
| (6) Article 16 is replaced by the following: | deleted |
| ‘Article 16 | |
| Procedure for setting MRLs in certain circumstances | |
| 1. The Commission may adopt a Regulation under Article 14(1) setting a MRL to be included in Annex III in the following circumstances: | |
| (a) in exceptional cases, in particular where pesticide residues may arise as a result of environmental or other contamination or from uses of plant protection products pursuant to Regulation (EC) No 1107/2009; or | |
| (b) where the products concerned constitute a minor component of the diet of consumers, and do not constitute a major part of the diet of relevant subgroups, and, where relevant, of animals; or | |
| (c) for honey; or | |
| (d) for herbal infusions; or | |
| (e) where essential uses of plant protection products have been identified by a Decision to delete an active substance from, or not to include an active substance in, Annex I to Directive 91/414/EEC; or | |
| (f) where new products, product groups and/or parts of products have been included in Annex I, and one or more Member States so request, in order to allow any scientific studies necessary for supporting an MRL to be undertaken and evaluated, provided that no unacceptable safety concerns for the consumer have been identified. | |
| 2. The inclusion of MRLs as referred to in paragraph 1 shall be based on the opinion of the Authority, monitoring data and an assessment demonstrating that there are no unacceptable risks to consumers or animals.;’ |
Or. en
Justification
The existing Article 16 provides a specific procedure for setting temporary MRLs on the basis of monitoring data and requires their review within a specified period not exceeding ten years. The Commission proposal would remove that mandatory periodic review and rely instead on the possibility of an ad hoc review under Article 43. An ad hoc review is reactive and does not provide the same regulatory guarantee as a systematic reassessment at predetermined intervals. Scientific knowledge concerning long-term exposure, toxicity and cumulative effects may evolve even where measured residue levels remain stable. The existing review obligation should therefore be maintained to ensure that monitoring-based MRLs continue to reflect current scientific evidence and remain protective of consumers and the environment.
Amendment 1300
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Regulation 396/2005
Article 16
| Text proposed by the Commission | Amendment |
|---|---|
| (6) Article 16 is replaced by the following: | deleted |
| ‘Article 16 | |
| Procedure for setting MRLs in certain circumstances | |
| 1. The Commission may adopt a Regulation under Article 14(1) setting a MRL to be included in Annex III in the following circumstances: | |
| (a) in exceptional cases, in particular where pesticide residues may arise as a result of environmental or other contamination or from uses of plant protection products pursuant to Regulation (EC) No 1107/2009; or | |
| (b) where the products concerned constitute a minor component of the diet of consumers, and do not constitute a major part of the diet of relevant subgroups, and, where relevant, of animals; or | |
| (c) for honey; or | |
| (d) for herbal infusions; or | |
| (e) where essential uses of plant protection products have been identified by a Decision to delete an active substance from, or not to include an active substance in, Annex I to Directive 91/414/EEC; or | |
| (f) where new products, product groups and/or parts of products have been included in Annex I, and one or more Member States so request, in order to allow any scientific studies necessary for supporting an MRL to be undertaken and evaluated, provided that no unacceptable safety concerns for the consumer have been identified. | |
| 2. The inclusion of MRLs as referred to in paragraph 1 shall be based on the opinion of the Authority, monitoring data and an assessment demonstrating that there are no unacceptable risks to consumers or animals.;’ |
Or. en
Amendment 1301
Anja Hazekamp, Per Clausen, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Regulation (EC) No 396/2005
Article 16
| Text proposed by the Commission | Amendment |
|---|---|
| (6) Article 16 is replaced by the following: | (6) Article 16 is deleted |
Or. en
Amendment 1302
Alexander Bernhuber
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Regulation (EC) No 396/2005
Article 16 – paragraph 2a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. When preparing an opinion under this Regulation concerning an active substance referred to in Article 14, the Authority shall take account of the scientific findings underlying the implementing act adopted pursuant to Regulation (EC) No 1107/2009 insofar as those findings are relevant for the assessment carried out under this Regulation. |
Or. en
Amendment 1303
Christophe Clergeau, Claire Fita, Eric Sargiacomo
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Regulation (EC) No 396/2005
Article 16 – paragraph 2a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. When a substance is not approved under Regulation (EC) No 1107/2009, the MRLs for that substance shall be set at the default values and included in Annex V. |
Or. en
Amendment 1304
Christophe Clergeau, Claire Fita, Eric Sargiacomo
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Regulation (EC) No 396/2005
Article 16 – paragraph 2b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 2b. The revocation or withdrawal of approval of a substance under Regulation (EC) No 1107/2009 shall automatically trigger the adjustment of any existing MRLs exceeding the default values. Such adjustment shall occur without the need for a separate scientific opinion from the Authority. |
Or. en
Amendment 1305
Sakis Arnaoutoglou
Proposal for a regulation
Article 3 – paragraph 1 – point 7
Regulation (EC) No 396/2005
Article 18 – paragraph 1a – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 18 may establish appropriate transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRLs was applicable. | Where it is necessary in order to allow for the normal marketing, processing and consumption of products with extended shelf lives, the regulations setting or modifying MRLs provided for in Article 14 may establish, in a harmonised manner throughout the Union and for a maximum period of eighteen months from the date of application of the new maximum residue levels, appropriate transitional measures allowing products that had already been placed on the market or placed into storage after production and were compliant with the maximum residue levels applicable at that time to remain on the market. |
| Where the new lower maximum residue level has been established on grounds of safety concern, including newly identified toxicological data, revised exposure assessments or the application of updated hazard criteria, such transitional measures shall be limited to the minimum period strictly necessary for the withdrawal of the products concerned and shall not permit their continued placing on the market. |
Or. en
Justification
The provision governing compliance with MRLs must be consistent with the conditions applying when transitional measures are established under Article 14. Without an explicit Union-wide maximum duration, Member States and operators could apply transitional arrangements differently, leading to unequal treatment and distortions of competition. The same safeguard is also required where an MRL reduction is based on health or safety concerns: products exceeding the new protective limit should not continue to be placed on the market merely because they complied with an earlier standard.
Amendment 1306
Mireia Borrás Pabón, Raffaele Stancanelli, Jorge Buxadé Villalba
Proposal for a regulation
Article 3 – paragraph 1 – point 7
Regulation (EC) No 396/2005
Article 18a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 18 may establish appropriate transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRLs was applicable. | a new Article 18a is inserted: |
| "18a. Automatic regulatory coherence | |
| 1. Where an active substance is no longer authorised in the Union for reasons relating to human health, animal health or the environment, the Commission shall, without delay: (a) withdraw any existing import tolerance or MRL set on the basis of a CXL or GAP applied in a third country (b) include the substance in a dedicated Annex listing prohibited active substances without eligibility for import tolerance or MRL set on the basis of a CXL or GAP applied in a third country (c) ensure that official controls at the border include specific verification of compliance with the MRLs applicable to prohibited active substance’. Imported products that do not comply with these requirements shall not be placed on the Union market.” |
Or. en
Justification
The proposal should clearly specify that when an active substance has been withdrawn or not renewed due to concerns for human or animal health or the environment, the MRL set on the basis of a CXL or GAP applied in a third country must be revoked and set at 0,01 mg/kg or at a value similar to the one established at EU level..
Amendment 1307
Mathilde Androuët
Proposal for a regulation
Article 3 – paragraph 1 – point 7
Regulation (EC) No 396/2005
Article 18 – paragraph 1a – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 18 may establish appropriate transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRLs was applicable. | Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 18 may, using a harmonised one-zone approach for the Union and for a maximum duration of eighteen months from the date of entry into force of the new MRLs, establish appropriate transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRLs was applicable. |
Or. fr
Amendment 1308
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
Proposal for a regulation
Article 3 – paragraph 1 – point 7
Regulation (EC) No 396/2005
Article 18 – paragraph 1a – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 18 may establish appropriate transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRLs was applicable. | Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 18 may establish, in a harmonised manner throughout the Union and for a maximum period of eighteen months from the entry into force of the new maximum residue levels, appropriate transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRLs was applicable. |
Or. en
Amendment 1309
Céline Imart, Emmanouil Kefalogiannis
Proposal for a regulation
Article 3 – paragraph 1 – point 7
Regulation (EC) No 396/2005
Article 18 – paragraph 1a – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 18 may establish appropriate transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRLs was applicable. | Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 18 may, for a maximum duration of eighteen months from the date of entry into force of the new MRLs, establish appropriate transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRLs was applicable. |
Or. fr
Amendment 1310
Anja Hazekamp, Per Clausen, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
Proposal for a regulation
Article 3 – paragraph 1 – point 7
Regulation (EC) No 396/2005
Article 18 – paragraph 1a – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 18 may establish appropriate transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRLs was applicable. | Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying MRLs provided for in Article 18 may establish appropriate transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the MRLs applicable or to which no MRLs was applicable. These measures will not allow placing or remaining on the market for more than 6 months. |
Or. en
Amendment 1311
Alexander Bernhuber
Proposal for a regulation
Article 3 – paragraph 1 – point 7 a (new)
Regulation (EC) No 396/2005
Article 18 – paragraph 1aa (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (7a) In Article 18, a new paragraph 1aa is inserted: | |
| "1aa. Where official controls carried out pursuant to Regulation (EU) 2017/625 reveal repeated findings indicating a recurring pattern of non-compliance with this Regulation in relation to residues of an active substance referred to in Article 14 in imported food or feed, the Member State concerned may adopt provisional enforcement measures necessary to ensure compliance with this Regulation pending Union action. | |
| 2. The Member State shall immediately notify the Commission and the other Member States of the measures adopted and the scientific and technical reasons supporting them. | |
| 3. The Commission shall examine the notification without undue delay and, where appropriate, adopt implementing acts laying down coordinated Union measures. | |
| 4. Measures adopted pursuant to this Article shall be proportionate, non-discriminatory and limited to what is necessary to ensure compliance with this Regulation." |
Or. en
Amendment 1312
Alexander Bernhuber
Proposal for a regulation
Article 3 – paragraph 1 – point 7 b (new)
Regulation (EC) No 396/2005
Article 18a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (7b) a new Article 18a is inserted: | |
| ‘Article 18a Automatic adjustment of maximum levels according to use in the Union | |
| (1) The Commission, with the support of the Authority, shall continuously monitor whether and in which Member States authorisations pursuant to Article 53 of Regulation (EC) No 1107/2009 exist or have been granted for unapproved active substances. Member States shall notify any such authorisation to the Commission without delay. | |
| (2) If a period of non-use has commenced for an unapproved active substance, the Commission shall set the maximum levels for this active substance in Annexes II and III at the LOD by means of a Regulation in line with the procedure referred to in Article 45(2). Article 18(1)(b) shall apply mutatis mutandis. The Regulation shall be adopted within 12 months of the end of the period of non-use, and shall provide for an appropriate transitional period of at least six months. | |
| (3) If, after the setting of maximum levels under paragraph 2, a Member State grants another authorisation under Article 53 of Regulation (EC) No 1107/2009 for the relevant active substance, the Commission shall reinstate the maximum level which applied immediately before the maximum level set pursuant to paragraph 2, without undue delay and at the latest within three months, provided that the Authority has not identified any unacceptable risks for consumers or animals. The reinstatement shall take place by means of a Regulation in line with the procedure referred to in Article 45(2) and shall apply equally to products produced in the Union and imported products. | |
| (4) If the authorisation under paragraph 3 expires and a new period of non-use commences, paragraph 2 shall apply mutatis mutandis. | |
| (5) Paragraphs 3 and 4 shall not apply to particularly hazardous active substances. In the case of these latter, the maximum level set under paragraph 2 or Article 14(2) shall remain permanently at the LOD. | |
| (6) The Commission shall maintain a publicly accessible register indicating, for each unapproved active substance, the status of authorisations under Article 53 of Regulation (EC) No 1107/2009, the start and end of a period of non-use and any maximum levels set under paragraph 2 as well as any reinstatement under paragraph 3, together with the respective dates. The register shall be updated at least quarterly. |
Or. de
Amendment 1313
Céline Imart, Emmanouil Kefalogiannis
Proposal for a regulation
Article 3 – paragraph 1 – point 7 a (new)
Regulation (EC) No 396/2005
Article 18a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (7a) The following Article is inserted: | |
| ‘Article 18a. Fast-track procedure for minor uses and production in the outermost regions | |
| 1. The Commission shall lay down a fast-track procedure for setting or modifying the maximum limits applicable to residues for minor uses and for production in the outermost regions as referred to in Article 349 of the Treaty on the Functioning of the European Union. | |
| 2. Such procedure shall allow a decision to be made within a maximum period of twelve months from the date of receipt of a complete application. | |
| 3. For the purposes of this Article, data from local or regional tests, including where these are co-financed by public funds, may be taken into account provided that they are scientifically valid and relevant to the risk assessment. | |
| 4. The Commission may adopt implementing acts laying down implementing rules for the application of this Article.’ |
Or. fr
Amendment 1314
Laurence Trochu
Proposal for a regulation
Article 3 – paragraph 1 – point 7 a (new)
Regulation (EC) No 396/2005
Article 18a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (7a) The following Article 18a is inserted: | |
| Fast-track procedure for minor uses and production in the outermost regions | |
| 1. The Commission shall lay down a fast-track procedure for setting or modifying the maximum limits applicable to residues for minor uses and for production in the outermost regions as referred to in Article 349 of the Treaty on the Functioning of the European Union. | |
| 2. Such procedure shall allow a decision to be made within a maximum period of twelve months from the date of receipt of a complete application. | |
| 3. For the purposes of this Article, data from local or regional tests, including where these are co-financed by public funds, may be taken into account provided that they are scientifically valid and relevant to the risk assessment. | |
| 4. The Commission may adopt implementing acts laying down implementing rules for the application of this Article. |
Or. fr
Amendment 1315
Paulo do Nascimento Cabral
Proposal for a regulation
Article 3 – paragraph 1 – point 7 a (new)
Regulation (EC) No 396/2005
Article 18a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (7a) a new Article 18a is inserted: | |
| "Article 18a (new) - Accelerated procedure for minor uses and produce from the Outermost Regions | |
| 1. The Commission shall establish an accelerated procedure for setting or modifying maximum residue levels applicable to minor uses and to produce from the Outermost Regions referred to in Article 349 of the Treaty on the Functioning of the European Union. | |
| 2. This procedure shall enable a decision to be adopted within a maximum period of 12 months from the date of receipt of a complete application. | |
| 3. For the purposes of this Article, data from local or regional trials, including trials co-financed by public funds, may be taken into account, provided that those data are scientifically reliable and relevant to the risk assessment. | |
| 4. The Commission may adopt implementing acts laying down detailed rules for the application of this Article." |
Or. en
Amendment 1316
Alexander Bernhuber
Proposal for a regulation
Article 3 – paragraph 1 – point 7 b (new)
Regulation (EC) No 396/2005
Article 30 – paragraph 1 – subparagraph 1a (new)
| Present text | Amendment |
|---|---|
| (7b) in Article 30, paragraph 1, a new subparagraph 1a is added: | |
| ‘The national control programmes shall provide for the proportion of samples originating from imports to be no less than the share of consumption of the respective product group in the relevant Member State accounted for by imports. In the case of active substances for which a maximum level has been set at the LOD in line with Article 18a(2) or Article 14(2), the control programmes shall provide for increased sampling of imports from third countries where continued use of the relevant active substance is permitted.’ |
Or. de
(32009R1107)
Amendment 1317
Alexander Bernhuber
Proposal for a regulation
Article 3 – paragraph 1 – point 8
Regulation (EC) No 396/2005
Article 31 – paragraph 1 – point ba (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (8) in Article 31, paragraph 1, a new point ba is inserted: | |
| (ba) the number of import samples and their outcomes, broken down by product group, country of origin and active substance, in particular for active substances with a maximum level set in line with Article 18a(2); |
Or. de
Amendment 1318
Tilly Metz, Anna Strolenberg
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 3 – paragraph 1 – point 9
Regulation (EC) No 396/2005
Article 43 – paragraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Commission may review maximum residue levels established under this Regulation at any time in the light of new scientific and technical knowledge, taking into account the scientific opinion referred to in paragraph 1 where appropriate. . | 2. The Commission shall review maximum residue levels established under this Regulation without undue delay at any time in the light of new scientific and technical knowledge, including independent peer-reviewed scientific evidence, monitoring data, biomonitoring data, and information on cumulative and mixture effects, taking into account the scientific opinion referred to in paragraph 1 where appropriate. |
| The Commission shall initiate such a review where new scientific evidence indicates that an existing maximum residue level may no longer ensure a high level of protection of human health, animal health or the environment, in accordance with the precautionary principle. | |
| The Authority shall make publicly available, without undue delay and subject to the applicable rules on confidentiality, the scientific evidence, methodologies and reasoning underpinning the scientific opinions referred to in this Article. |
Or. en
Amendment 1319
Biljana Borzan, Christophe Clergeau, Gheorghe Cârciu, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim
Proposal for a regulation
Article 3 – paragraph 1 – point 9
Regulation (EC) No 396/2005
Article 43 – paragraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Commission may review maximum residue levels established under this Regulation at any time in the light of new scientific and technical knowledge, taking into account the scientific opinion referred to in paragraph 1 where appropriate. . | 2. The Commission may review maximum residue levels established under this Regulation at any time in the light of new scientific and technical knowledge, taking into account the scientific opinion referred to in paragraph 1 where appropriate. Existing maximum residue levels shall continue to be subject to periodic review in accordance with this Article, taking into account the latest scientific and technical knowledge, monitoring data, biomonitoring evidence and new toxicological information. |
Or. en
Justification
Periodic review of maximum residue levels is essential to ensure that they continue to reflect the latest scientific knowledge and exposure data. Monitoring results, biomonitoring evidence and new toxicological information should be systematically taken into account to ensure a high level of consumer protection and to allow regulatory decisions to respond to evolving scientific evidence.
Amendment 1320
Anja Hazekamp, Per Clausen, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
Proposal for a regulation
Article 3 – paragraph 1 – point 9
Regulation (EC) No 396/2005
Article 43 – paragraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Commission may review maximum residue levels established under this Regulation at any time in the light of new scientific and technical knowledge, taking into account the scientific opinion referred to in paragraph 1 where appropriate. . | 2. The Commission may review maximum residue levels established under this Regulation at any time in the light of new scientific and technical knowledge, and shall do so without delay when new evidence indicates risks to human, animal or environmental health, taking into account the scientific opinion referred to in paragraph 1 where appropriate. . |
Or. en
Amendment 1321
Jérémy Decerle
Proposal for a regulation
Article 3 – paragraph 1 – point 9
Regulation (EC) No 396/2005
Article 43 – paragraph 2a and 2b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (9) in Article 43, new paragraphs 2a and 2b are inserted: | |
| 2a. The Commission shall review the MRLs applicable to an active substance without delay following withdrawal of the authorisation for that active substance. Such review shall take account of the latest applicable data requirements and, where relevant, the scientific opinion referred to in paragraph 1. | |
| 2b. The decision made by the Commission regarding reviews referred to in paragraphs 2 and 3 shall be adopted in accordance with Article 14 of this Regulation. |
Or. fr
Justification
This amendment introduces the general principle of a systematic reduction in MRLs to the limit of detection, within a maximum period of six months, for active substances that are no longer approved in the European Union, either because of a particular risk (especially an exclusion criterion) or because the toxicology file has not been updated (especially with regard to these exclusion criteria).
Amendment 1322
Alexander Bernhuber
Proposal for a regulation
Article 3 – paragraph 1 – point 9
Regulation (EC) No 396/2005
Article 43 – subparagraph 3a(new)
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall present to the European Parliament and the Council a report on the application of Article 18a, commencing three years after the entry into force of Article 18a and every three years thereafter. The report shall, in particular, contain details of the active substances affected, the impacts on the competitiveness of agricultural holdings in the Union, the impacts on the availability of plant protection products, trade flows and the outcomes of import controls. |
Or. de
Amendment 1323
Tilly Metz
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 4
Regulation (EU) No 528/2012
Articles 4, 10, 12, 13, 14a, 15a, 44 and 46
| Text proposed by the Commission | Amendment |
|---|---|
| Article 4 | deleted |
| Amendments to Regulation (EU) No 528/2012 |
Or. en
Justification
Periodic review is essential to detect harmful substances, especially taking into account relatively new product type specific guidelines on exposure assessment. Periodic reassessment also ensures that the responsibility for demonstrating safety remains with the companies placing substances on the market, consistent with the polluter-pays principle. Weakening this system risks shifting the burden of identifying harmful properties onto public authorities and publicly funded researchers, effectively transferring costs from industry to taxpayers.
Amendment 1324
Paulo do Nascimento Cabral
Proposal for a regulation
Article 4 – paragraph 1 – point 1
Regulation (EU) No 528/2012
Article 3 – paragraph 1 – point k a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. in Article 3, paragraph 1, a new point ka is inserted: | |
| "(ka) biocidal use for sanitary purposes in an agricultural environment" means the use of a biocidal product in an agricultural environment or its immediate surroundings where the principal objective is the prevention or reduction of a proven risk to human or animal health, including zoonotic risks, significant allergenic risks or contamination of food by hygiene pests or mechanical vectors, and not the phytopharmaceutical protection of plants or the optimisation of agricultural production. |
Or. en
Amendment 1325
Laurence Trochu
Proposal for a regulation
Article 4 – paragraph 1 – point 1 a (new)
Regulation (EU) No 528/2012
Article 3 – paragraph 1 – point ka (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (1a) In Article 3(1), the following point (ka) is added: | |
| (ka) ‘biocide use for health purposes in an agricultural environment’ means the use of a biocidal product in an agricultural environment or in its immediate surroundings where the main objective is to prevent or reduce a proven health risk to humans or animals, including zoonotic risks, significant allergenic risks or the contamination of food by hygiene pests or mechanical vectors, and not preventative plant protection or the optimisation of agricultural output.’ |
Or. fr
Amendment 1326
Céline Imart, Stefan Köhler, Emmanouil Kefalogiannis
Proposal for a regulation
Article 4 – paragraph 1 – point 1 a (new)
Regulation (EU) No 528/2012
Article 3 – paragraph 1 – point ka (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (1a) in Article 3(1), the following point is added: | |
| (ka) biocide use for health purposes in an agricultural environment means the use of a biocidal product in an agricultural environment or in its immediate surroundings where the main objective is to prevent or reduce a proven health risk to humans or animals, including zoonotic risks, significant allergenic risks or the contamination of food by hygiene pests or mechanical vectors, and not preventative plant protection or the optimisation of agricultural output. |
Or. fr
(32012R0528)
Amendment 1327
Anja Hazekamp, Per Clausen, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
Proposal for a regulation
Article 4 – paragraph 1 – point 1
Regulation (EU) No 528/2012
Article 4 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| (1) in Article 4, paragraph 1 is replaced by the following: | deleted |
| ‘1. An active substance shall be approved if at least one biocidal product containing that active substance may be expected to meet the criteria laid down in Article 19(1), point (b), taking into account the factors set out in Article 19(2) and (5). | |
| Approvals shall be for an unlimited time except for active substances that are identified as candidates for substitution in accordance with Article 10 or where the conditions of approval, for duly justified reasons, specify the expiry date of the approval in accordance with paragraph 3 of this Article. An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years.;’ |
Or. en
Amendment 1328
Christophe Clergeau, Biljana Borzan
Proposal for a regulation
Article 4 – paragraph 1 – point 1
Regulation (EU) No 528/2012
Article 4 – paragraph 1 – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| An active substance shall be approved if at least one biocidal product containing that active substance may be expected to meet the criteria laid down in Article 19(1), point (b), taking into account the factors set out in Article 19(2) and (5). | An active substance shall be approved for an initial period not exceeding 15 years if at least one biocidal product containing that active substance may be expected to meet the criteria laid down in Article 19(1), point (b), taking into account the factors set out in Article 19(2) and (5). |
Or. en
Amendment 1329
Christophe Clergeau, Biljana Borzan
Proposal for a regulation
Article 4 – paragraph 1 – point 1
Regulation (EU) No 528/2012
Article 4 – paragraph 1 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| Approvals shall be for an unlimited time except for active substances that are identified as candidates for substitution in accordance with Article 10 or where the conditions of approval, for duly justified reasons, specify the expiry date of the approval in accordance with paragraph 3 of this Article. An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years.; | An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years.; |
Or. en
Amendment 1330
Christophe Clergeau, Biljana Borzan
Proposal for a regulation
Article 4 – paragraph 1 – point 1
Regulation (EU) No 528/2012
Article 4 – paragraph 1 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| Approvals shall be for an unlimited time except for active substances that are identified as candidates for substitution in accordance with Article 10 or where the conditions of approval, for duly justified reasons, specify the expiry date of the approval in accordance with paragraph 3 of this Article. An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years.; | Approvals shall be for an unlimited time for active substances listed in Annex I in accordance with Article 28. An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years.; |
Or. en
Amendment 1331
Asger Christensen
Proposal for a regulation
Article 4 – paragraph 1 – point 1
Regulation (EU) No 528/2012
Article 4 – paragraph 1 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| Approvals shall be for an unlimited time except for active substances that are identified as candidates for substitution in accordance with Article 10 or where the conditions of approval, for duly justified reasons, specify the expiry date of the approval in accordance with paragraph 3 of this Article. An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years.; | Unlimited approvals shall be the default for biocidal active substances unless specific hazard-based concerns justify time limitation and for active substances that are identified as candidates for substitution in accordance with Article 10 or where the conditions of approval, for duly justified reasons, specify the expiry date of the approval in accordance with paragraph 3 of this Article. An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years.; |
Or. en
Justification
Unlimited approvals reduce unnecessary regulatory burden and allow authorities and industry tofocus on genuinely novel or higher-risk solutions. By linking exceptions to hazard-based concernsrather than undefined "certain exceptions", the amendment provides a clearer, science-based approach for determining when time limits are warranted. This ensures both regulatory efficiencyand robust protection for human and planetary health.
Amendment 1332
Anna Strolenberg
Proposal for a regulation
Article 4 – paragraph 1 – point 1
Regulation (EU) No 528/2012
Article 4 – paragraph 1 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| Approvals shall be for an unlimited time except for active substances that are identified as candidates for substitution in accordance with Article 10 or where the conditions of approval, for duly justified reasons, specify the expiry date of the approval in accordance with paragraph 3 of this Article. An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years.; | An active substance shall be approved for an initial period not exceeding 10 years if at least one biocidal product containing that active substance may be expected to meet the criteria laid down in Article 19(1), point (b), taking into account the factors set out in Article 19(2) and (5). Approvals shall be for an unlimited time for Annex I substances. An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years.; |
Or. en
Amendment 1333
Radan Kanev
Proposal for a regulation
Article 4 – paragraph 1 – point 1
Regulation (EC) No 1107/2009
Article 4 – paragraph 1 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| Approvals shall be for an unlimited time except for active substances that are identified as candidates for substitution in accordance with Article 10 or where the conditions of approval, for duly justified reasons, specify the expiry date of the approval in accordance with paragraph 3 of this Article. An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years.; | Approvals shall be for an initial period not exceeding 10 years except for active substances that are identified as candidates for substitution in accordance with Article 10 or where the conditions of approval, for duly justified reasons, specify the expiry date of the approval in accordance with paragraph 3 of this Article. An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years.; |
Or. en
Justification
Status quo
Amendment 1334
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
Proposal for a regulation
Article 4 – paragraph 1 – point 1
Regulation (EU) No 528/2012
Article 4 – paragraph 1 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| Approvals shall be for an unlimited time except for active substances that are identified as candidates for substitution in accordance with Article 10 or where the conditions of approval, for duly justified reasons, specify the expiry date of the approval in accordance with paragraph 3 of this Article. An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years.; | Approvals shall be for an unlimited time except for active substances that are identified as candidates for substitution in accordance with Article 10 or where the conditions of approval, for duly justified reasons, specify the expiry date of the approval in accordance with paragraph 3 of this Article. An active substance that falls under Article 5 may only be approved for an initial period not exceeding ten years.; |
Or. en
Amendment 1335
Stefan Köhler, Norbert Lins, Andrea Wechsler, Lena Düpont
Proposal for a regulation
Article 4 – paragraph 1 – point 1
Regulation (EU) No 528/2012
Article 4 – paragraph 1 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| Approvals shall be for an unlimited time except for active substances that are identified as candidates for substitution in accordance with Article 10 or where the conditions of approval, for duly justified reasons, specify the expiry date of the approval in accordance with paragraph 3 of this Article. An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years.; | Approvals shall be for an unlimited time except for active substances that are identified as candidates for substitution in accordance with Article 10 or where the conditions of approval, for duly justified reasons, specify the expiry date of the approval in accordance with paragraph 3 of this Article. An active substance that falls under Article 5 may only be approved for an initial period not exceeding ten years.; |
Or. en
Amendment 1336
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
Proposal for a regulation
Article 4 – paragraph 1 – point 1
Regulation (EU) No 528/2012
Article 4 – paragraph 1 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| Approvals shall be for an unlimited time except for active substances that are identified as candidates for substitution in accordance with Article 10 or where the conditions of approval, for duly justified reasons, specify the expiry date of the approval in accordance with paragraph 3 of this Article. An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years.; | Approvals shall be for an unlimited time except for active substances that are identified as candidates for substitution in accordance with Article 10 or where the conditions of approval, for duly justified reasons, specify the expiry date of the approval in accordance with paragraph 3 of this Article. An active substance that falls under Article 5 may only be approved for an initial period not exceeding ten years.; |
Or. en