report parliamentary committee draft, 19 June 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-PR-789113 · (COM(2025)1030 – C100359/2025 – 2025/0410(COD))
Committee on the Environment, Climate and Food Safety Committee on Agriculture and Rural Development · Rapporteur: Michele Picaro, Herbert Dorfmann
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Draft european parliament legislative resolution 533 paragraphs
(COM(2025)1030 – C100359/2025 – 2025/0410(COD))
(Ordinary legislative procedure: first reading)
The European Parliament,
–having regard to the Commission proposal to Parliament and the Council (COM(2025)1030),
–having regard to Article 294(2) and Article 43(2), Article 114, Article 168(4)(b) and Article 192(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C100359/2025),
–having regard to Article 294(3) of the Treaty on the Functioning of the European Union,
–having regard to the opinion of the European Economic and Social Committee of 29 April 2026 ,
–having regard to Rule 60 of its Rules of Procedure,
–having regard to the report of the Committee on the Environment, Climate and Food Safety and the Committee on Agriculture and Rural Development (A100000/2026),
1.Adopts its position at first reading hereinafter set out;
2.Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;
3.Instructs its President to forward its position to the Council, the Commission and the national parliaments.
Read the rest (521 paragraphs)
Amendment 1
Proposal for a regulation
Recital 8
| Text proposed by the Commission | Amendment |
|---|---|
| (8) The risk assessment of biocontrol substances requires specific technical knowledge, and some Member States do not have enough experts specialised in this type of assessment. As a result, some applicants for approval of biocontrol substances face difficulties in finding a rapporteur Member State. In order to increase capacity for the assessment of new biocontrol substances, it should be possible for the European Food Safety Authority (“the Authority”) to assume the role of the rapporteur Member State for the assessment of applications for approval and the Authority’s resources should be increased accordingly. The Authority should put in place appropriate safeguards to ensure independence of the subsequent peer review and to avoid any possible conflict of interests for the experts involved at the different stages of the assessment. | (8) The risk assessment of biocontrol substances requires specific technical knowledge, and some Member States do not have enough experts specialised in this type of assessment. As a result, some applicants for approval of biocontrol substances face difficulties in finding a rapporteur Member State, leading to procedural delays and constraints in the assessment process. In order to increase capacity for the assessment of new biocontrol substances, it should be possible for the European Food Safety Authority (“the Authority”) to assume the role of the rapporteur Member State for the assessment of applications for approval and the Authority’s resources should be increased accordingly. The Authority should put in place appropriate safeguards to ensure independence of the subsequent peer review and to avoid any possible conflict of interests for the experts involved at the different stages of the assessment. |
Or. en
Amendment 2
Proposal for a regulation
Recital 10 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (10a) In order to facilitate the effective uptake of biocontrol substances and ensure that farmers across the Union can access and deploy such solutions under comparable conditions, it is appropriate to provide for the possibility of targeted financial support under the Common Agricultural Policy. Such support should accompany the transition towards more sustainable crop protection systems and contribute to a level playing field in the internal market, while ensuring coherence with the objectives of the Common Agricultural Policy. |
Or. en
Amendment 3
Proposal for a regulation
Recital 16 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (16a) Agricultural land plays a fundamental role in ensuring the production of food, feed and raw materials and is essential for the Union’s food security, competitiveness and strategic autonomy. Plant protection products contribute to safeguarding agricultural production and should support the sustainable use of agricultural land for these purposes. |
Or. en
Amendment 4
Proposal for a regulation
Recital 16 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (16b) In exceptional circumstances, the non-approval or non-renewal of an active substance may have disproportionate consequences for agricultural viability, food production or food security compared to the risks arising from its use. This may occur where endemic soil pests cause recurrent crop losses, effective alternatives are unavailable and seed treatment remains the only technically viable preventive measure. In such cases, approval or renewal should be possible, provided that appropriate risk mitigation measures are applied. |
Or. en
Amendment 5
Proposal for a regulation
Recital 16 c (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (16c) The efficacy and risk assessment of active substances should adequately reflect the diversity of agronomic, climatic and environmental conditions across the Union. Where an intended use concerns biogeographical regions with specific pedoclimatic conditions not covered by the rapporteur Member State, relevant Member States, competent authorities and research institutes should be consulted to ensure that regional specificities, scientific expertise and available monitoring data are duly taken into account and that any data gaps are identified before the completion of the peer review. |
Or. en
Amendment 6
Proposal for a regulation
Recital 16 d (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (16d) Minor crops and minor uses often face limited availability of authorised plant protection products due to the high costs and administrative burden associated with generating the data required for authorisation. To improve the availability of plant protection solutions for those crops and uses, those costs and administrative requirements should be minimised, and the Commission should support the generation of the necessary data and authorisations of the such plant protection products for minor uses. |
Or. en
Amendment 7
Proposal for a regulation
Recital 23 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (23a) Nursery production and the floriculture sector represent a fundamental pillar of the Union's agricultural economy, ensuring the supply of healthy, high-quality plant reproductive material essential for food security, sustainable agricultural production, and urban biodiversity. The technical specificities of nursery production - including high planting density, the smaller size of plant specimens, and cultivation in protected environments or containers - differ substantially from open-field conditions. These differences often render standard dosage instructions reported in current authorizations technically inaccurate or inapplicable for nursery settings. |
Or. en
Amendment 8
Proposal for a regulation
Recital 23 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (23b) The implementation of digital record-keeping systems interconnected with official farm files should be consistent with label authorizations and actual field use. Without such consistency, nursery growers face a legal impossibility to protect their crops from phytosanitary threats, even when chemically suitable active substances are available on the market. It is therefore important to ensure that nursery production is recognized as a distinct cultural category. Authorization procedures and the labelling of plant protection products should account for its unique biological, technical, and economic characteristics to ensure the sector's continued viability and competitiveness. |
Or. en
Amendment 9
Proposal for a regulation
Recital 27 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (27a) To ensure a level playing field between Union producers and those in third countries, and to uphold the Union’s high environmental and health objectives, it is necessary to further develop the principle of reciprocity in production standards. The Commission shall, following the completion of the ongoing impact assessment launched in November 2025, evaluate the necessity of establishing a formal definition and framework for reciprocity. This framework should ensure that imported products are subject to requirements equivalent to those applicable in the Union, particularly regarding the use of pesticides with global environmental impacts, such as those affecting biodiversity and the climate, in accordance with the Union's international obligations. |
Or. en
Amendment 10
Proposal for a regulation
Recital 37
| Text proposed by the Commission | Amendment |
|---|---|
| (37) Therefore, to ensure the good functioning of the internal market and provide legal certainty to food and feed business operators, food and feed products obtained using a GMM as production strain and from which the GMM has been removed should not fall within the scope of Regulation (EC) No 1829/2003 even if residues of the GMM are present in the food or feed, provided that they are limited to non-viable cells, that the presence thereof is minimized through reasonable attempts to remove them and have no technological effect on the final food or feed. In particular, in order to ensure that reasonable attempts to remove residues have been made, it should be required that they have been carried out in accordance with good manufacturing practices as those used in similar food and feed products to minimize the presence of residues. | (37) Therefore, to ensure the good functioning of the internal market, provide legal certainty to food and feed business operators and to support innovation and technological progress in the agri-food and biotechnology sectors, food and feed products obtained using a GMM as production strain and from which the GMM has been removed should not fall within the scope of Regulation (EC) No 1829/2003 even if residues of the GMM are present in the food or feed, provided that they are limited to non-viable cells, that the presence thereof is minimized through reasonable attempts to remove them and have no technological effect on the final food or feed. In particular, in order to ensure that reasonable attempts to remove residues have been made, it should be required that they have been carried out in accordance with good manufacturing practices as those used in similar food and feed products to minimize the presence of residues. |
Or. en
Amendment 11
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a
Regulation (EC) No 1107/2009
Article 3 – point 17
| Text proposed by the Commission | Amendment |
|---|---|
| ‘17. ´zone´ means a group of Member States as defined in Annex I. | ‘17. ´zone´ means a group of Member States as defined in Annex I. |
| For the purpose of use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order to prevent the entry into, and spread within, the Union, of pests listed in accordance with Articles 5(2), 30(1), 32(3), 37(2) of Regulation (EU) 2016/2031 and for plant protection products containing as active substances only biocontrol or low-risk active substances, the zone means all zones defined in Annex I.; | For the purpose of use in greenhouses, for all minor crops, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order to prevent the entry into, and spread within, the Union, of pests listed in accordance with Articles 5(2), 30(1), 32(3), 37(2) of Regulation (EU) 2016/2031 for plant protection products to be used for application by such unmanned aircraft systems in accordance with Directive 2009/128/EC and for plant protection products containing as active substances only biocontrol or low-risk active substances, the zone means all zones defined in Annex I. |
Or. en
Amendment 12
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point c
Regulation (EC) No 1107/2009
Article 3 – point 35 – point b
| Text proposed by the Commission | Amendment |
|---|---|
| (b) inorganic substances as occurring in nature, with the exception of heavy metals and their salts or | (b) inorganic substances as occurring in nature, or |
Or. en
Amendment 13
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point d a (new)
Regulation (EC) No 1107/2009
Article 3 – point 36 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (da) the following point is added: | |
| ‘36a ‘nursery production’: means the activity of multiplication, grafting, and rearing of plants, including plant reproductive material, ornamental plants, cut flowers, young fruit trees, and vegetable seedlings, whether in open fields or under protected conditions. This activity is characterized by a high planting density per unit area and by plant biometric and phenological parameters that substantially differ from those of crops intended for food, fruit, or industrial production in their adult stage.’ |
Or. en
Amendment 14
Proposal for a regulation
Article 1 – paragraph 1 – point 2 a (new)
Regulation (EC) No 1107/2009
Article 4 – paragraph 1
| Present text | Amendment |
|---|---|
| (2a) in Article 4 paragraph 1 is replaced by the following: | |
| 1. An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3. | "1. An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, including a risk assessment based on the availability of risk management measures with particular regard to application techniques, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3. |
| The assessment of the active substance shall first establish whether the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are satisfied. If these criteria are satisfied the assessment shall continue to establish whether the other approval criteria set out in points 2 and 3 of Annex II are satisfied. |
Or. en
(32009R1107)
Amendment 15
Proposal for a regulation
Article 1 – paragraph 1 – point 2 b (new)
Regulation (EC) No 1107/2009
Article 4 – paragraph 3 – subparagraph 1 – introductory part
| Present text | Amendment |
|---|---|
| (2b) in Article 4 (3), subparagraph 1, the introductory part is replaced by the following : | |
| 3. A plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements: | "3. A plant protection product, following an application in accordance with good plant protection practices and taking into account realistic conditions of use, including a risk assessment based on the availability of risk management measures with particular regard to application techniques, shall meet the following requirements: |
Or. en
(32009R1107)
Amendment 16
Proposal for a regulation
Article 1 – paragraph 1 – point 2 c (new)
Regulation (EC) No 1107/2009
Article 4 – paragraph 3 – subparagraph 1 – point a
| Present text | Amendment |
|---|---|
| (2c) in Article 4(3), in the first subparagraph, point (a) is replaced by the following : | |
| (a)it shall be sufficiently effective; | a) shall ensure a sufficiently high level of efficacy; |
Or. en
(32009R1107)
Amendment 17
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Regulation (EC) No 1107/2009
Article 4 – paragraph 7 – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure, within 3 months of EFSA conclusion, an active substance is necessary to effectively control a serious danger to plant health, or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period ensuring that those essential uses are not lost where no viable options exist. |
Or. en
Amendment 18
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Regulation (EC) No 1107/2009
Article 4 – paragraph 7 – subparagraph 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| The application referred to in the first subparagraph shall be submitted during the approval process by the applicant for approval and/or by official or scientific bodies involved in agricultural activities and/or by professional agricultural organisations. |
Or. en
Amendment 19
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Regulation (EC) No 1107/2009
Article 4 – paragraph 7 – subparagraph 1 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| Decisions on derogations should be taken on the base of a socio-economic and agro-economic assessment including efficacy, impact of pests on farmers yield and risks for cross-resistance. |
Or. en
Amendment 20
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Regulation (EC) No 1107/2009
Article 4 – paragraph 7 – subparagraph 1 c (new)
| Text proposed by the Commission | Amendment |
|---|---|
| The use of the active substance shall be subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
Or. en
Amendment 21
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Regulation (EC) No 1107/2009
Article 4 – paragraph 7 – subparagraph 3
| Text proposed by the Commission | Amendment |
|---|---|
| Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health or plant production in their territory identified pursuant to the first subparagraph.’; | deleted |
Or. en
Amendment 22
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Regulation (EC) No 1107/2009
Article 4 – paragraph 7– subparagraph 3 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| This paragraph shall also apply to active substances for which an application for renewal of approval has been submitted before [date of entry into force of this Regulation]. |
Or. en
Amendment 23
Proposal for a regulation
Article 1 – paragraph 1 – point 5 a (new)
Regulation (EC) No 1107/2009
Article 7 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (5a) in Article 7 the following paragraph 1a is inserted: | |
| ‘ The evaluation of the application for the approval of an active substance shall be completed within a period not exceeding 18 months from the date of submission of a complete dossier. ‘ |
Or. en
Amendment 24
Proposal for a regulation
Article 1 – paragraph 1 – point 6 – point a
Regulation (EC) No 1107/2009
Article 11 – paragraph 1a
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances. | 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances. Where the intended use of an active substance concerns biogeographical regions with specific pedoclimatic conditions not covered by the rapporteur Member State, the rapporteur Member State shall coordinate with the Member States whose territory includes those biogeographical regions to ensure that: |
| (a) efficacy assessments reflect the full range of conditions under which the product is intended to be used within the Union; | |
| (b) region-specific data gaps are identified and addressed before completion of the peer review; | |
| (c) competent authorities and research institutes from Member States hosting unique biogeographical regions are consulted as part of the assessment procedure. |
Or. en
Amendment 25
Proposal for a regulation
Article 1 – paragraph 1 – point 10
Regulation (EC) No 1107/2009
Article 18 – paragraph 1 – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. | The Commission may periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. |
Or. en
Amendment 26
Proposal for a regulation
Article 1 – paragraph 1 – point 10
Regulation (EC) No 1107/2009
Article 18 – paragraph 1 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. | The identification of the active substances concerned shall take into account broad-ranging indications of significant safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. |
Or. en
Amendment 27
Proposal for a regulation
Article 1 – paragraph 1 – point 10
Regulation (EC) No 1107/2009
Article 18 – paragraph 1 – subparagraph 3
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable. | The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable in case of indication of safety concerns. |
Or. en
Amendment 28
Proposal for a regulation
Article 1 – paragraph 1 – point 10
Regulation (EC) No 1107/2009
Article 18 – paragraph 2 – point c a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) specify which guidance documents are to be considered by applicants at the time of submission; and |
Or. en
Amendment 29
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Regulation (EC) No 1107/2009
Article 18 a – paragraph 2 – point c
| Text proposed by the Commission | Amendment |
|---|---|
| (c) set out the scope of the targeted reassessment for the active substances concerned, and indicate the specific data requirements that apply and, where relevant, the guidance documents and/or scientific opinions that shall be used; and | (c) set out the scope of the targeted reassessment for the active substances concerned, and indicate the specific data requirements that apply and, where relevant, the guidance documents and/or scientific opinions that shall exclusively be used; and |
Or. en
Amendment 30
Proposal for a regulation
Article 1 – paragraph 1 – point 13
Regulation (EC) No 1107/2009
Article 20 – paragraph 2 – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed two years for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. |
Or. en
Amendment 31
Proposal for a regulation
Article 1 – paragraph 1 – point 13
Regulation (EC) No 1107/2009
Article 20 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; | In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.’; |
Or. en
Amendment 32
Proposal for a regulation
Article 1 – paragraph 1 – point 15
Regulation (EC) No 1107/2009
Article 23 – paragraph 2 – point c
| Text proposed by the Commission | Amendment |
|---|---|
| (c) is not an approved active substance for use in plant protection products at the time of the submission of the application for approval as basic substance and no application for an approval as an active substance is under assessment at that moment; | (c) if a registered active substance qualifies by definition as a basic substance, it shall be included in the catalogue of basic substances and simultaneously removed from the list of active substances. |
Or. en
Amendment 33
Proposal for a regulation
Article 1 – paragraph 1 – point 16 a (new)
Regulation (EC) No 1107/2009
Article 24 – paragraph 1
| Present text | Amendment |
|---|---|
| (16a) in Article 24, paragraph 1 is replaced by the following: | |
| 1. An active substance complying with the criteria provided for in Article 4 shall be approved, for a period not exceeding seven years, as a candidate for substitution if it meets one or more of the additional criteria laid down in point 4 of Annex II. By way of derogation from Article 14(2), the approval may be renewed once or more for periods not exceeding seven years. | “1. An active substance complying with the criteria provided for in Article 4 shall be approved, for a period not exceeding fifteen years, as a candidate for substitution if it meets one or more of the additional criteria laid down in point 4 of Annex II. By way of derogation from Article 14(2), the approval may be renewed once or more for periods not exceeding fifteen years on the basis of a socio-economic and agro-economic assessment including for instance efficacy, impact of pests on farmers yield, and risks for cross- resistance. |
Or. en
(32009R1107)
Amendment 34
Proposal for a regulation
Article 1 – paragraph 1 – point 16 b (new)
Regulation (EC) No 1107/2009
Article 24 – paragraph 2 a (new)
| Present text | Amendment |
|---|---|
| (16b) in Article 24, the following paragraph is added: | |
| 2a. Before withdrawing or not renewing the approval of an active substance approved as a candidate for substitution, the Commission shall assess whether alternative substances or methods are available that provide an equivalent level of effectiveness and are economically viable for farmers. Such an assessment shall take into account agronomic needs, the availability of alternatives across different climatic zones, and the potential impacts on agricultural production. ” |
Or. en
(32009R1107)
Amendment 35
Proposal for a regulation
Article 1 – paragraph 1 – point 17
Regulation (EC) No 1107/2009
Article 27a – paragraph 1 – point d
| Text proposed by the Commission | Amendment |
|---|---|
| (d) active substances for which a procedure for the renewal of approval is ongoing on [OP: please insert the date of entry into force of this Regulation]. | deleted |
Or. en
Amendment 36
Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point b
Regulation (EC) No 1107/2009
Article 28 – paragraph 2 – point f
| Text proposed by the Commission | Amendment |
|---|---|
| (f) placing on the market and use of seeds and other plant reproductive material treated with plant protection products authorised for that use in at least one Member State.; | (f) treatment of seeds, placing on the market and use of treated seeds and other treated plant reproductive material with plant protection products authorised for that use in at least one Member State.; |
Or. en
Amendment 37
Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point b a (new)
Regulation (EC) No 1107/2009
Article 28 – paragraph 2 – point f a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) the following point is added: | |
| (fa) The use of products for treating seeds intended exclusively for export to third countries, in accordance with the legislation of the destination country, where the protection of human health in seed treatment facilities is ensured through clearly defined and appropriate risk-mitigation measures for workers and bystanders, consistent with internationally recognised principles and relevant OECD guidance.; |
Or. en
Amendment 38
Proposal for a regulation
Article 1 – paragraph 1 – point 18 a (new)
Regulation (EC) No 1107/2009
Article 29 – paragraph 3
| Present text | Amendment |
|---|---|
| (18a) Article 29 paragraph 3 is replaced by the following: | |
| 3. Compliance with the requirements set out in point (b) and points (e) to (h) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in question and representative of the conditions prevailing in the zone where the product is intended to be used. | "3. Compliance with the requirements set out in point (b) and points (e) to (h) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in question and representative of the conditions prevailing in the zone where the product is intended to be used, including a risk assessment based on the availability of risk management measures with particular regard to application techniques. |
Or. en
(32009R1107)
Amendment 39
Proposal for a regulation
Article 1 – paragraph 1 – point 18 a (new)
Regulation (EC) No 1107/2009
Article 29 – paragraph 3 – subparagraph 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| Member States shall take into account all available risk mitigation measures when assessing whether the requirements are met. |
Or. en
(32009R1107)
Amendment 40
Proposal for a regulation
Article 1 – paragraph 1 – point 18 a (new)
Regulation (EC) No 1107/2009
Article 29 – paragraph 3 – subparagraph 1 b (new)
| Present text | Amendment |
|---|---|
| Where the intended area of use of a plant protection product includes biogeographical regions with specific pedoclimatic conditions not represented in the tests conducted by the rapporteur Member State, supplementary efficacy and risk data collected under the conditions of those regions shall be required as part of the authorisation dossier. |
Or. en
(32009R1107)
Amendment 41
Proposal for a regulation
Article 1 – paragraph 1 – point 18 a (new)
Regulation (EC) No 1107/2009
Article 29 – paragraph 3 – subparagraph 1 c (new)
| Present text | Amendment |
|---|---|
| Such supplementary data shall be taken into account in the authorisation decision and in any mutual recognition procedure under Article 40. |
Or. en
(32009R1107)
Amendment 42
Proposal for a regulation
Article 1 – paragraph 1 – point 18 a (new)
Regulation (EC) No 1107/2009
Article 29 – paragraph 3 – subparagraph 1 d (new)
| Present text | Amendment |
|---|---|
| This requirement applies in particular to biogeographical regions present in only one Member State of the Union, where specific pedoclimatic stress conditions — including elevated temperatures, drought periods or endemic soil pest pressure — may significantly affect product performance and efficacy compared to the conditions under which the standard tests were conducted. " |
Or. en
(32009R1107)
Amendment 43
Proposal for a regulation
Article 1 – paragraph 1 – point 19
Regulation (EC) No 1107/2009
Article 30 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more biocontrol active substances not yet approved, provided that | 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more biocontrol active substances not yet approved, provided that the dossier is admissible in accordance with Article 9 and the Rapporteur Member State has finalised the draft assessment report in accordance with Article 11 concluding that the not yet approved biocontrol active substances in the plant protection product are expected to satisfy the requirements of Article 4(2) and Article 4(3); |
| (a) the dossier is admissible in accordance with Article 9 and the Rapporteur Member State has finalised the draft assessment report in accordance with Article 11 concluding that the not yet approved biocontrol active substances in the plant protection product are expected to satisfy the requirements of Article 4(2) and Article 4(3); | |
| (b) the Member State concludes that all active substances in the plant protection product comply with the criteria of point 5 of Annex II or qualify as biocontrol active substance and that the uses of the plant protection product for which provisional authorisations are granted satisfy the requirements of Article 29(1)(b) to (h); | |
| (c) where relevant, maximum residue levels have been established in accordance with Regulation (EC) No 396/2005. | |
| The implementation of paragraph 1 shall not undermine the provisional authorisations for plant protection products containing an active substance not yet approved. |
Or. en
Amendment 44
Proposal for a regulation
Article 1 – paragraph 1 – point 19 a (new)
Regulation (EC) No 1107/2009
Article 31 – paragraph 4 – point i a (new)
| Present text | Amendment |
|---|---|
| (19a) in Article 31 (4) the following point is added: | |
| (ia) where applicable, the specific conditions, application methods, and dosages for nursery production, ensuring that such parameters are proportionate to planting density and plant size, clearly distinguishing them from dosages for open-field crops. |
Or. en
(32009R1107)
Amendment 45
Proposal for a regulation
Article 1 – paragraph 1 – point 20
Regulation (EC) No 1107/2009
Article 32 – paragraph 1 – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The period of authorisation shall be laid down in the authorisation. | 1. The period of authorisation shall be laid down in the authorisation. Authorisations shall be for an unlimited time if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval period, and it has been assessed according to this Regulation considering the latest assessments underlying the approvals of the active substances, safeners, and synergists contained in the product. |
Or. en
Amendment 46
Proposal for a regulation
Article 1 – paragraph 1 – point 20
Regulation (EC) No 1107/2009
Article 32 – paragraph 1 – subparagraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| Without prejudice to Article 44, the duration of an authorisation shall be set for a period: | Without prejudice to Article 44, the duration of an authorisation shall be set for a period not exceeding 1 year from the date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product concerned and thereafter for as long as the active substances, safeners and synergists contained in the plant protection product are approved. |
| (a) not exceeding 15 years if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, | |
| (b) not exceeding 1 year from the earliest date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product concerned. |
Or. en
Amendment 47
Proposal for a regulation
Article 1 – paragraph 1 – point 20
Regulation (EC) No 1107/2009
Article 32 – paragraph 1 – subparagraph 3 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| Where no expiry date is set for an active substance (unlimited approval), the re-evaluation of the plant protection product should take place no later than one year after the re-evaluation of the active substance. |
Or. en
Amendment 48
Proposal for a regulation
Article 1 – paragraph 1 – point 21
Regulation (EC) No 1107/2009
Article 33 – paragraph 2 – point b
| Text proposed by the Commission | Amendment |
|---|---|
| (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order to prevent the entry into, and spread within, the Union, of pests listed in accordance with Articles 5(2), 30(1), 32(3) and 37(2) of Regulation (EU) 2016/2031 and for a plant protection product containing as active substances only biocontrol or low-risk active substances, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request.; | (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order to prevent the entry into, and spread within, the Union, of pests listed in accordance with Articles 5(2), 30(1), 32(3) and 37(2) of Regulation (EU) 2016/2031 for plant protection products to be applied by such unmanned aircraft systems in accordance with Directive 2009/128/EC and for a plant protection product containing as active substances only biocontrol or low-risk active substances, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request.; |
Or. en
Amendment 49
Proposal for a regulation
Article 1 – paragraph 1 – point 22
Regulation (EC) No 1107/2009
Article 36 – paragraph 1 – subparagraph 1a
| Text proposed by the Commission | Amendment |
|---|---|
| For the active substances, safeners and synergists contained in the plant protection product, Member States shall rely on the last assessment conducted at EU level unless it considers that an update is necessary in the light of the current scientific and technical knowledge. In this case the Member State shall request the Commission to act under Articles 18, 18a or 21.; | For the active substances, safeners and synergists contained in the plant protection product, Member States shall rely on the last assessment conducted at EU level, in particular on EFSA Conclusions and agreed List of Endpoints supporting the (renewal of) approval. When a Member State considers that an update is necessary in the light of the current scientific and technical knowledge, the Member State shall request the Commission to act under Articles 18, 18a or 21. However, such request will follow a separate procedure and shall not suspend, postpone or withdraw the examination of the application for authorization of the plant protection product.; |
Or. en
Amendment 50
Proposal for a regulation
Article 1 – paragraph 1 – point 22 a (new)
Regulation (EC) No 1107/2009
Article 36 – paragraph 3
| Present text | Amendment |
|---|---|
| (22a) in Article 36(3), the first subparagraph is replaced by the following: | |
| 3. By way of derogation from paragraph 2 and subject to Community law, appropriate conditions may be imposed with respect to the requirements referred to in Article 31(3) and (4) and other risk mitigation measures deriving from specific conditions of use. | "3. By way of derogation from paragraph 2 and subject to Community legislation, Member States may take into account the available risk mitigation measures in order to apply specific conditions of use appropriate to the requirements referred to in Article 31(3) and (4). |
Or. en
(32009R1107)
Amendment 51
Proposal for a regulation
Article 1 – paragraph 1 – point 22 b (new)
Regulation (EC) No 1107/2009
Article 36 – paragraph 3
| Present text | Amendment |
|---|---|
| Where the concerns of a Member State relating to human or animal health or the environment cannot be controlled by the establishment of the national risk mitigation measures referred to in the first subparagraph, a Member State may refuse authorisation of the plant protection product in its territory if, due to its specific environmental or agricultural circumstances, it has substantiated reasons to consider that the product in question still poses an unacceptable risk to human or animal health or the environment. | (22b) in Article 36(3), the second subparagraph is deleted; |
Or. en
(32009R1107)
Amendment 52
Proposal for a regulation
Article 1 – paragraph 1 – point 23
Regulation (EC) No 1107/2009
Article 37 – paragraph 5
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. | 5. Where the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. |
Or. en
Amendment 53
Proposal for a regulation
Article 1 – paragraph 1 – point 23
Regulation (EC) No 1107/2009
Article 37 – paragraph 6
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. | 6. The Member State examining the application shall give, where feasible, priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. |
Or. en
Amendment 54
Proposal for a regulation
Article 1 – paragraph 1 – point 24
Regulation (EC) No 1107/2009
Article 40 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under comparable agricultural practices in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases: | 1. When an authorisation is granted to an applicant by a Member State in accordance with Article 29, such authorisation for the same plant protection product, the same use and under comparable agricultural practices is automatically granted to all Member State of the same zone under the mutual recognition procedure. |
| (a) the authorisation was granted by a Member State (reference Member State) which belongs to the same zone and the authorised plant protection product is placed on the market in the reference Member State; | |
| (b) the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made is not used for the purpose of mutual recognition in another Member State within the same zone and the authorised plant protection product is placed on the market in the reference Member State; | |
| By way of derogation, automatic mutual recognition is also granted in the following cases: | |
| (c) the authorisation was granted by a Member State for use in greenhouses, as post-harvest treatment, for treatment of empty rooms or containers used for storing plant or plant products, for seed treatment, for uses that are solely and explicitly needed in order to apply the provisions of Regulation (EU) 2016/2031 or for plant protection products containing as active substances only biocontrol active substances regardless of the zone to which the reference Member State belongs and the authorised plant protection product is placed on the market in the reference Member State. | (a) the authorisation was granted by a Member State for use in greenhouses, as post-harvest treatment, for treatment of empty rooms or containers used for storing plant or plant products, for seed treatment, for uses that are solely and explicitly needed in order to apply the provisions of Regulation (EU) 2016/2031 or for plant protection products containing as active substances only biocontrol active substances regardless of the zone to which the reference Member State belongs and the authorised plant protection product is placed on the market in the reference Member State. |
| (b) in case of seed treatment, automatic mutual recognition will be granted if the plant protection product is authorised in at least one EU Member State for seed treatment in professional facilities. |
Or. en
Amendment 55
Proposal for a regulation
Article 1 – paragraph 1 – point 24
Regulation (EC) No 1107/2009
Article 40 – paragraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where a plant protection product is not authorised in a Member State because no application for an authorisation has been submitted in that Member State, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply for an authorisation for the same plant protection product, the same use and under the same agricultural practices in that Member State under the mutual recognition procedure referred to in paragraph 1.; | 2. Where a plant protection product is not authorised in a Member State because the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply for an authorisation for the same plant protection product, the same use and under the same agricultural practices in that Member State under the mutual recognition procedure referred to in paragraph 1.’; |
Or. en
Amendment 56
Proposal for a regulation
Article 1 – paragraph 1 – point 31
Regulation (EC) No 1107/2009
Article 46 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Where a Member State withdraws or amends an authorisation or does not renew it, as a result of a Regulation adopted pursuant to Article 20(1) or as a result of a Regulation adopted pursuant to Article 21(3), Member States shall set a grace period within the limits of the maximum grace period set by the Commission on the basis of Article 20(2), unless the Commission has prohibited the setting of such a grace period on the basis of Article 20(2) . | 1. Where a Member State withdraws or amends an authorisation or does not renew it, as a result of a Regulation adopted pursuant to Article 20(1) or as a result of a Regulation adopted pursuant to Article 21(3), Member States shall set the maximum grace period set by the Commission on the basis of Article 20(2), unless the Commission has prohibited the setting of such a grace period on the basis of Article 20(2). |
Or. en
Amendment 57
Proposal for a regulation
Article 1 – paragraph 1 – point 31
Regulation (EC) No 1107/2009
Article 46 – paragraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned.; | 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 1 year for the sale and the distribution and an additional maximum of 2 years for the disposal, storage, and use of existing stocks of the plant protection products concerned.; |
Or. en
Amendment 58
Proposal for a regulation
Article 1 – paragraph 1 – point 31
Regulation (EC) No 1107/2009
Article 46 – paragraph 2 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Products for agricultural input produced using such active substances before the entering into force of the new provisions can be marketed up to the end of the stocks. |
Or. en
Amendment 59
Proposal for a regulation
Article 1 – paragraph 1 – point 32
Regulation (EC) No 1107/2009
Article 49 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a use of a plant protection product. | 1. Treated seeds and plant reproductive material are not to be considered a plant protection product. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a precision application use of a plant protection product. |
Or. en
Amendment 60
Proposal for a regulation
Article 1 – paragraph 1 – point 32
Regulation (EC) No 1107/2009
Article 49 – paragraph 6
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Without prejudice to other Union legislation concerning the labelling of seeds and plant reproductive material, the label and documents accompanying the treated seeds and plant reproductive material shall include the name of the plant protection product with which they were treated, its authorisation number and the Member State which authorised it, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Regulation (EC) No 1272/2008 and, where applicable, risk mitigation measures set out in the authorisation for that product. | 6. Without prejudice to other Union legislation concerning the labelling of seeds and plant reproductive material, the label and documents accompanying the treated seeds and plant reproductive material shall include the name of the plant protection product with which they were treated, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Regulation (EC) No 1272/2008 and, where applicable, risk mitigation measures set out in the authorisation for that product. |
Or. en
Amendment 61
Proposal for a regulation
Article 1 – paragraph 1 – point 33 – point a
Regulation (EC) No 1107/2009
Article 51 – paragraph 2 – point c a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| "(ca) The competent authorities shall support the bodies referred to in paragraph 1, other than the authorisation holder, in obtaining the documents and data necessary for the authorisation. In these cases, derogation should be allowed for the generation of data required for authorisation." |
Or. en
Amendment 62
Proposal for a regulation
Article 1 – paragraph 1 – point 33 – point c
Regulation (EC) No 1107/2009
Article 51 – paragraph 7
| Text proposed by the Commission | Amendment |
|---|---|
| 7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product for minor uses in accordance with Article 40(1) even if the uses in the reference Member State are not minor uses. Member States shall authorise such uses in accordance with Article 41.; | 7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product for minor uses in accordance with Article 40(1) even if the uses in the reference Member State are not minor uses. Member States shall authorise such uses in accordance with Article 41. Competent authorities shall support professional agricultural organisations and professional users for authorisation of minor uses; |
Or. en
Amendment 63
Proposal for a regulation
Article 1 – paragraph 1 – point 33 a (new)
Regulation (EC) No 1107/2009
Article 53 – paragraph 1 a (new)
| Test proposed by the Commission | Amendment |
| (33a) in Article 53, the following paragraph 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 belonging to the same zone as the Member State requesting the authorisation. |
Or. en
(32009R1107)
Amendment 64
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(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, as to when and under what conditions the Member States of the same climatic zone: |
Or. en
(32009R1107)
Amendment 65
Proposal for a regulation
Article 1 – paragraph 1 – point 33 c (new)
Regulation (EC) No 1107/2009
Article 53 – paragraph 4 a (new)
| Text proposaed by the Commission | Amendment |
| (33c) in Article 53, the following paragraph is added: | |
| 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
(32009R1107)
Amendment 66
Proposal for a regulation
Article 1 – paragraph 1 – point 34 a (new)
Regulation (EC) No 1107/2009
Article 65 – paragraph 3 a (new)
| Present text | Amendment |
|---|---|
| (34a) in Article 65, the following paragraph is added: | |
| "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
(32009R1107)
Amendment 67
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1 – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. 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. | 1. Producers, cooperatives 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, 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. Upon request of the competent authority, professional users shall make the relevant information contained in these records available to the competent authority: |
| a) In case of a regulatory inspection carried out by the competent authority; | |
| b) For the purpose of compiling agricultural statistics; | |
| c) If there is a reasonable suspicion of a risk to human health or to the environment. |
Or. en
Amendment 68
Proposal for a regulation
Article 1 – paragraph 1 – point 35
Regulation (EC) No 1107/2009
Article 67 – paragraph 1 – subparagraph 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| In the case described under point b) of this paragraph, anonymisation and aggregation of the data sets will be granted. |
Or. en
Amendment 69
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. | deleted |
Or. en
Amendment 70
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 |
|---|---|
| The competent authorities shall provide access to such information in accordance with applicable national or Community law. | deleted |
Or. en
Amendment 71
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]. |
Or. en
Amendment 72
Proposal for a regulation
Article 6 – paragraph 1 – point 9
Regulation (EC) No 1831/2003
Article 16 – paragraph 2 – point b
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the name or business name and the address or registered place of business of the person responsible for the labelling referred to in this Article, and, where the producer is not the person responsible for the labelling, the name or business name and address of the producer; | (b) the name or business name and the address or registered place of business of the person responsible for the labelling referred to in this Article; |
Or. en
Amendment 73
Proposal for a regulation
Article 7 – paragraph 1 a (new)
Regulation (EC) 852/2004
Article 5 – paragraph 5 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| In Article 5, the following paragraph 5 a is inserted: | |
| "5a. In accordance with the guidance document 2022/C 355/01, Member States shall ensure that small and medium-sized enterprises (SMEs) and retail establishments, where the hazard analysis does not identify specific critical control points (CCPs) or where the nature of the activity is simple may replace the formal documentation of HACCP procedures with the proportionate application of good hygiene practices (GHP/PRPs) and the simplified recording of critical non-compliances only. " |
Or. en
(32004R0852)
Amendment 74
Proposal for a regulation
Article 11 – paragraph 1 – point 1
Regulation (EU) 2017/625
Article 41 – paragraph 1 – introductory part
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the cases where, and the conditions under which, competent authorities may designate as official laboratories, in accordance with Article 37(1), laboratories which do not fulfil: | The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the cases where, and the conditions under which, competent authorities may designate as official laboratories, in accordance with Article 37(1), in duly justified and exceptional cases and for a limited period of time, laboratories which do not fulfil: |
Or. en
Amendment 75
Proposal for a regulation
Article 11 – paragraph 1 – point 1
Regulation (EU) 2017/625
Article 41 – paragraph 1 – point b – point ii
| Text proposed by the Commission | Amendment |
|---|---|
| ii. they make regular and significant use of the methods for which they have obtained the accreditation referred to in point (i) ; except, as regards the area governed by the rules referred to in point (g) of Article 1(2), where a validated method for the detection of the particular pests of plants referred to in Article 34(1) and (2) does not exist.; | ii. they make regular and significant use of the methods for which they have obtained the accreditation referred to in point (i) and use harmonised EU guidelines for the internal validation of analytical methods; except, as regards the area governed by the rules referred to in point (g) of Article 1(2), where a validated method for the detection of the particular pests of plants referred to in Article 34(1) and (2) does not exist.; |
Or. en
Explanatory statement 9 paragraphs
The proposal is part of the cross-cutting legislative simplification package announced in the European Commission’s Vision for Agriculture and Food, which aims to reduce unnecessary regulatory burdens while maintaining high standards for food and feed safety, and for the protection of human and animal health, and the environment. As an element of the 10th Simplification Omnibus, the proposal is also part of the “One Europe, One Market” Roadmap of the European Parliament, the Council of the European Union and the European Commission.
The co-rapporteurs generally welcome the Commission proposal, which simplifies several regulations in the area of food and feed safety. In particular, proposed changes to Regulation (EC) 1107/2009 (on placing of plant protection products on the market), aim at speeding up the approval of biocontrol agents and at addressing the current delays in approval and renewal of active substances used in plant protection products. In this regard, the co-rapporteurs consider that priority should be given to the processing of biocontrol and low-risk substances, without hampering the authorisation process of most needed active substances.
Currently, the average duration of the approval procedure for an active substance in the EU is more than seven years. The co-rapporteurs consider that swift action is necessary in view of the lack of active substances that are available for farmers. In that regard, they consider that the evaluation of the application for the approval of an active substance shall not exceed 18 months from the date of submission of a complete dossier. The authorisation of a plant protection product shall also be possible for an unlimited period, if the product concerned contains only active substances, safeners, and synergists with unlimited approval period. In addition, the co-rapporteurs propose to strengthen the principle of automatic mutual recognition for both the authorisation of plant protection products and emergency authorisations, ensuring a faster and more coordinated response to plant health emergencies across the Union.
Moreover, in order to ensure predictability and facilitate the transition to alternative solutions,
extended grace periods following non-renewal decisions should apply systematically, except where withdrawal is justified by serious risks to human health or the environment.
The co-rapporteurs welcome the approach of the Commission concerning Regulation (EC) 396/2005 (on Maximum Residue Levels), calling for a further development of the principle of reciprocity in production standards, in order to guarantee a level playing field between Union producers and those in third countries, while upholding the Union’s high environmental and health objectives.
Additional amendments are tabled to the Regulation 852/2004 (on food hygiene) and Regulation 1831/2003 (on feed additives) in order to simplify the rules applicable to farmers and food operators. The amendments aim at ensuring food safety, limiting record-keeping requirements to information that is strictly necessary for food safety purposes, and focusing official controls on the effective implementation of food safety measures rather than on documentary checks.
Finally, the co-rapporteurs consider that the establishment of harmonised EU guidelines for the internal validation of analytical methods would ensure the consistent recognition of results produced by official laboratories across the Union, enhancing legal certainty and the uniform application of EU rules.
In light of the above, the co-rapporteurs consider that the proposed simplification package represents a balanced and necessary step towards a more efficient and predictable food and feed safety framework, without compromising the Union's high standards of health and environmental protection. By accelerating the approval of active substances, reinforcing mutual recognition, and ensuring greater coherence with third countries, the proposal addresses long-standing concerns raised by farmers and food business operators regarding the practical implementation of current rules. The co-rapporteurs are confident that these amendments will help restore the competitiveness of Union agriculture while preserving consumer trust in food safety.
Annex: declarations of input 4 paragraphs
Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteurs declare that they included in their report input on matters pertaining to the subject of the file that they received, in the preparation of the draft report, from the following interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register, or from the following representatives of public authorities of third countries, including their diplomatic missions and embassies:
| 1. Interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register |
| COPA-COGEGA |
| ConfCooperative |
| CropLife |
| CIA – Agricoltori Italiani |
| European Union Cooper Task Force |
| Confagricoltura |
| Coldiretti |
| European Crop Care Association |
| Federchimica-Agrofarma |
| Bayer AG |
| BASF |
| Corteva Agriscence |
| IBMA – International Biocontrol Manufacturers Association |
| Euroseed |
| 2. Representatives of public authorities of third countries, including their diplomatic missions and embassies |
| None |
The list above is drawn up under the exclusive responsibility of the rapporteurs.
Where natural persons are identified in the list by their name, by their function or by both, the rapporteurs declare that they have submitted to the natural persons concerned the European Parliament's Data Protection Notice No 484 (https://www.europarl.europa.eu/data-protect/index.do), which sets out the conditions applicable to the processing of their personal data and the rights linked to that processing.