Sittings · Document
OPINION (COM(2025)0531 – C100143/2025 – 2025/0531(COD)) 2026-02-27
On the proposal for a regulation of the European Parliament and of the Council amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products
Committee on Agriculture and Rural Development · Rapporteur: Veronika Vrecionová
SHORT JUSTIFICATION
The Rapporteur welcomes the Commission’s proposal, which represents a balanced and timely step towards simplifying selected procedures and requirements for chemical products, including fertilising products. In her view, the approach appropriately maintains high safety standards while aiming to reduce unnecessary administrative burden, improve regulatory predictability and facilitate innovation.
From an agricultural perspective, simplification is not an end in itself. It should result in faster and more proportionate pathways for safe, effective and affordable fertilising and biostimulant products to reach the market. This is particularly important for small and medium-sized producers, who face disproportionate compliance costs under the current system. Improving access to innovative microbial and organic fertilisers can help farmers enhance nutrient-use efficiency, soil health and resilience, while reducing dependency on imported conventional fertilisers.
The Rapporteur’s amendments therefore focus on technical improvements that remain fully within the scope of the Commission’s proposal and respect its overall architecture. They aim to strengthen legal clarity, ensure science-based decision-making and support innovations with proven safety profiles. In particular, the creation of a Union list of low-risk microorganisms, based on existing scientific assessments and practical experience, would provide a predictable and regularly updated framework for the safe use of microbial products under CMC 7.
Overall, the Rapporteur considers that these targeted adjustments will contribute to a more efficient, proportionate and innovation-friendly regulatory environment, ultimately benefiting farmers, SMEs and the competitiveness of EU agriculture.
AMENDMENTS
The Committee on Agriculture and Rural Development submits the following to the Committee on the Environment, Climate and Food Safety and the Committee on the Internal Market and Consumer Protections, as the committees responsible:
Amendment 1
Proposal for a regulation
Recital 1
| Text proposed by the Commission | Amendment |
| (1) High quality and safety requirements for products on the Single Market ensure a high level of protection of human health and the environment and contribute to a fair and sustainable economy. In international competition, the reputation of high-grade products manufactured in the Union can create an advantage for Union companies. | (1) High quality and safety requirements for products on the Single Market ensure a high level of protection of human and animal health and the environment and contribute to a fair and sustainable economy. In international competition, the reputation of high-grade products manufactured in the Union can create an advantage for Union companies. |
Amendment 2
Proposal for a regulation
Recital 2
| Text proposed by the Commission | Amendment |
| (2) The findings of the 2024 Draghi report2 indicated that the increasing number and complexity of rules risks limiting room for manoeuvre for Union businesses and preventing them from remaining competitive. Against this background, certain procedures and requirements laid down in Regulations (EC) No 1272/20083, (EC) No 1223/20094 and (EU) 2019/10095 of the European Parliament and of the Council should be simplified and unnecessary regulatory burdens should be removed, while maintaining the same level of protection of human health and of the environment. | (2) The findings of the 2024 Draghi report2 indicated that the increasing number and complexity of rules risks limiting room for manoeuvre for Union businesses and preventing them from remaining competitive. Against this background, certain procedures and requirements laid down in Regulations (EC) No 1272/20083, (EC) No 1223/20094 and (EU) 2019/10095 of the European Parliament and of the Council should be simplified and unnecessary regulatory burdens should be removed, while maintaining the same level of protection of human and animal health and of the environment. |
| __________ | ________ |
| 2 2024 report by Mario Draghi on the future of European competitiveness: https://commission.europa.eu/topics/eu-competitiveness/draghi-report_en#paragraph_47059 | 2 2024 report by Mario Draghi on the future of European competitiveness: https://commission.europa.eu/topics/eu-competitiveness/draghi-report_en#paragraph_47059 |
| 3 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj). | 3 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj). |
| 4 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (OJ L 342, 22.12.2009, p. 59, ELI: http://data.europa.eu/eli/reg/2009/1223/oj). | 4 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (OJ L 342, 22.12.2009, p. 59, ELI: http://data.europa.eu/eli/reg/2009/1223/oj). |
| 5 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (OJ L 170, 25.6.2019, p. 1, ELI: http://data.europa.eu/eli/reg/2019/1009/oj). | 5 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (OJ L 170, 25.6.2019, p. 1, ELI: http://data.europa.eu/eli/reg/2019/1009/oj). |
Amendment 3
Proposal for a regulation
Recital 2 a (new)
| Text proposed by the Commission | Amendment |
| (2a) Fertilising products covered by Regulation (EU) 2019/1009 directly affect farmers’ production costs, incomes and competitiveness, while regulatory and administrative burdens on producers are transmitted along the supply chain. As competitiveness of the Union depends, inter alia, on its capacity to innovate, the regulatory framework should support innovation and technical progress by remaining proportionate and avoiding unnecessary burdens, while ensuring the objectives of that Regulation are achieved. |
Amendment 4
Proposal for a regulation
Recital 7
| Text proposed by the Commission | Amendment |
| (7) Regulation (EU) 2024/2865 laid down rules on mandatory requirements for label formatting. New information7 pointed to excessive administrative burden and costs, associated with these requirements. To balance the need for label information to be clearly understood by consumers with the need to reduce market barriers and burden for industry8, it is necessary to simplify the current formatting obligations without reducing the level of protection of human health and the environment. Economic operators and enforcement authorities must remain responsible for ensuring that the labels are legible in accordance with the legal requirements. | (7) Regulation (EU) 2024/2865 laid down rules on mandatory requirements for label formatting. New information7 pointed to excessive administrative burden and costs, associated with these requirements. To balance the need for label information to be clearly understood by consumers with the need to reduce market barriers and burden for industry8, it is necessary to simplify the current formatting obligations without reducing the level of protection of human and animal health and the environment. Economic operators and enforcement authorities must remain responsible for ensuring that the labels are legible in accordance with the legal requirements. |
| _________________ | ____________________ |
| 7 Detailed analysis of costs associated with new formatting requirements is provided in the Staff Working Document Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products, SWD(2025) 531, p. 14. | 7 Detailed analysis of costs associated with new formatting requirements is provided in the Staff Working Document Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products, SWD(2025) 531, p. 14. |
| 8 As outlined in the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions The Single Market: our European home market in an uncertain world, A Strategy for making the Single Market simple, seamless and strong, COM(2025) 500 final, p. 10, available at: https://single-market-economy.ec.europa.eu/document/download/d92c78d0-7d47-4a16-b53f-1cead54bcb49_en?filename=Communication%20-%20Single%20Market%20Strategy.pdf. | 8 As outlined in the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions The Single Market: our European home market in an uncertain world, A Strategy for making the Single Market simple, seamless and strong, COM(2025) 500 final, p. 10, available at: https://single-market-economy.ec.europa.eu/document/download/d92c78d0-7d47-4a16-b53f-1cead54bcb49_en?filename=Communication%20-%20Single%20Market%20Strategy.pdf. |
Amendment 5
Proposal for a regulation
Recital 26 a (new)
| Text proposed by the Commission | Amendment |
| (26a) Digitalisation of declarations of conformity and technical product information may offer certain advantages. Due regard should be given to cybersecurity, the availability and interoperability of digital infrastructure, as well as the costs of introducing and operating such systems. Moreover, the transition towards a digital-by-default approach should be supported by appropriate transitional arrangements and timelines, taking into account the diversity of economic operators and national systems. The overall cost-effectiveness of such an approach, including staff-training needs, should therefore be carefully assessed and monitored to ensure that digitalisation does not create disproportionate administrative burdens for economic operators or public authorities. |
Amendment 6
Proposal for a regulation
Recital 26 b (new)
| Text proposed by the Commission | Amendment |
| (26b) Regulation (EU) 2019/1009 should not apply to plant protection products, including biological control products, falling within the scope of Regulation (EC) No 1107/2009. |
Amendment 7
Proposal for a regulation
Recital 28
| Text proposed by the Commission | Amendment |
| (28) In order to accelerate the assessment of micro-organisms and to open the single market for more microbial plant biostimulants, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of Annex II, Part II, component material category (CMC) 7, to Regulation (EU) 2019/1009 to allow the Commission to introduce general criteria and a methodology for the assessment of micro-organisms. Those criteria and the methodology should allow manufacturers and notified bodies to demonstrate and verify that micro-organisms used in microbial plant biostimulants, other than those listed in CMC 7, do not present a risk to human, animal or plant health, to safety or to the environment and ensure agronomic efficiency. In order to refine and validate the criteria and methodology to be introduced, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making13. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. | (28) The wider use of microbial plant biostimulants can improve nutrient-use efficiency and soil health, thereby fostering the development of sustainable while highly productive agriculture. In order to accelerate the assessment of micro-organisms and to open the single market for more microbial plant biostimulants, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of Annex II, Part II, component material category (CMC) 7, to Regulation (EU) 2019/1009 to allow the Commission to introduce general criteria and a methodology for the assessment of micro-organisms, with a view to ensuring uniform criteria throughout the Union, taking into account technical studies contracted by the Commission in the context of this Regulation. Those criteria and the methodology should allow manufacturers and notified bodies to demonstrate and verify that micro-organisms used in microbial plant biostimulants, other than those listed in CMC 7, do not present a risk to human, animal or plant health, to safety or to the environment and ensure agronomic efficiency. The methodology could allow for a differentiated approach, taking into account relevant previous assessments and existing information concerning the safety of the micro-organism concerned. In order to refine and validate the criteria and methodology to be introduced, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, with relevant scientific bodies such as the European Food Safety Authority and the Joint Research Centre, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making13. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. |
| __________ | ___________ |
| 13 OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj. | 13 OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj. |
Amendment 8
Proposal for a regulation
Recital 30 a (new)
| Text proposed by the Commission | Amendment |
| (30a) The framework established by Regulation (EU) 2019/1009 aims to facilitate the making available on the market of EU fertilising products while ensuring a high level of protection of human and animal health and of the environment, and while promoting resource efficiency and the circular use of materials. In order to achieve those objectives, the regulatory treatment of component materials used in EU fertilising products should take into account their intended use and their specific risk profile, including where such materials are derived from animal sources. Union rules on animal by-products, laid down in Regulation (EC) No 1069/2009 of the European Parliament and of the Council1a, establish processing requirements that are primarily designed to address risks related to feed and other uses. Those requirements do not always correspond to the risk profile associated with the application of materials to soil for fertilising purposes. Where the risks related to the use of derived materials in EU fertilising products have been adequately addressed through the requirements and conformity assessment procedures applicable under Regulation (EU) 2019/1009, those requirements and procedures should be taken into account when determining whether such materials may be used as component materials in EU fertilising products. Regulation (EC) No 1069/2009 applies only to animal by-products and derived products within the meaning of that Regulation. Materials of animal origin which do not fall within its scope should therefore be assessed solely under the framework established by Regulation (EU) 2019/1009. The fact that a material of animal origin is not subject to Regulation (EC) No 1069/2009 should not, in itself, prevent its use in EU fertilising products, provided that all applicable safety, quality and conformity requirements laid down in Regulation (EU)2019/1009 are fulfilled. Where Union hygiene legislation establishes treatment standards for materials of animal origin in order to address risks to human or animal health, compliance with those standards should be taken into account as one element demonstrating that appropriate safeguards are in place. When determining, for the purposes of Regulation (EU) 2019/1009, the conditions under which derived materials from animal by-products may be used as component materials in EU fertilising products, compliance with such hygiene standards should be considered together with the relevant requirements and conformity assessment procedures applicable under Regulation (EU) 2019/1009. | |
| _______________________ | |
| 1a Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300 14.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1069/2019-12-14). |
Amendment 9
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Regulation (EU) 2019/1009
Article 2 – point 15 a (new)
| Text proposed by the Commission | Amendment |
| (15a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download an application; | (15a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached directly, without the need for any intermediate step or to register any data or download an application; |
Amendment 10
Proposal for a regulation
Article 3 – paragraph 1 – point 9 – point b
Regulation (EU) 2019/1009
Article 42 – paragraph 4a
| Text proposed by the Commission | Amendment |
| 4a. The Commission may also adopt delegated acts pursuant to paragraph 1 amending Annex II to set out criteria and a methodology for the assessment of micro-organisms other than those listed in Annex II, which, if compliance with those criteria is demonstrated in the conformity assessment of the EU fertilising product in accordance with that methodology, may be used as component material in EU fertilising products. The criteria and methodology shall allow for verification that the micro-organisms fulfil the criteria in paragraph 1, point (b), and provide, as a minimum, for the consideration of the following elements: | 4a. The Commission may also adopt delegated acts pursuant to paragraph 1 amending Annex II to set out criteria and a methodology for the assessment of micro-organisms other than those listed in Annex II, which, if compliance with those criteria is demonstrated in the conformity assessment of the EU fertilising product in accordance with that methodology, may be used as component material in EU fertilising products. The criteria and methodology shall allow a notified body to verify that the micro-organisms fulfil the criteria in paragraph 1, point (b), and provide, as a minimum, for the consideration of the following elements: |
| (a) scientific literature reporting about safe production, conservation and use of the micro-organism; | (a) scientific or technical information supporting safe sourcing, processing and use of the material; |
| (b) taxonomic relation of the micro-organism to micro-organisms species fulfilling the requirements for a Qualified Presumption of Safety as established by the European Food Safety Authority; | (b) information on the processing method applied to the material; |
| (c) information on the production process of the micro-organism, including, where relevant, the composition of the cultivation medium, processing methods such as spray drying, fluid-bed drying, static drying, centrifugation, deactivation by heat, filtration and grinding; | (c) information enabling an assessment of potential risks to human, animal or plant health, or to the environment under intended conditions of use; |
| (d) information on the identity and residue levels of residual intermediates, toxins or microbial metabolites in the component material; | (d) information supporting agronomic value or technical function relevant to the fertilising product in which the material is used; |
| (e) natural occurrence, survival and mobility in the environment; | (e) natural occurrence, survival and mobility in the environment; |
| (f) susceptibility to all relevant antimicrobial agents as defined in the Annex, Introduction to Part B, point (ii)(28), to Commission Regulation (EU) No 283/2013*, with the exception of intrinsic resistance. | (f) susceptibility to compounds of at least two classes of relevant antimicrobial agents as defined in the Annex, Introduction to Part B, point (ii)(28), to Commission Regulation (EU) No 283/2013*, with the exception of intrinsic resistance. |
| ______________ | _________________ |
| * Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 1, ELI: http://data.europa.eu/eli/reg/2013/283/oj).’ | * Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 1, ELI: http://data.europa.eu/eli/reg/2013/283/oj).’ |
Amendment 11
Proposal for a regulation
Article 3 – paragraph 1 – point 9 – point b a (new)
Regulation (EU) 2019/1009
Article 42 – paragraph 4 a a (new)
| Text proposed by the Commission | Amendment |
| (ba) the following paragraph is inserted: | |
| ‘4aa. The Commission may also adopt delegated acts pursuant to paragraph 1 amending Annex II to establish general criteria and a methodology for the assessment of materials and processing methods other than those already listed in Annex II, excluding micro-organisms, which may be used as component materials in EU fertilising products where compliance with those criteria is demonstrated in the conformity assessment. The criteria and methodology shall, as a minimum, provide for the consideration of scientific or technical information supporting safe sourcing, processing and use of the material.’ |
Amendment 12
Proposal for a regulation
Article 3 – paragraph 1 – point 9 – point b b (new)
Regulation (EU) 2019/1009
Article 42 – paragraph 5 a (new)
| Text proposed by the Commission | Amendment |
| (bb) the following paragraph is inserted: | |
| ‘5a. For the purposes of this Regulation, products derived from animal by-products that are used solely as component materials in EU fertilising products may be made available on the market only where they originate from animal by-products or derived products that have reached an end point in the manufacturing chain in accordance with Article 5(2) of Regulation (EC) No 1069/2009. | |
| When determining such end points for derived products intended for use in EU fertilising products, the Commission shall ensure that: | |
| a) the processing and safety criteria, as well as any necessary risk-mitigation measures, are proportionate and specifically relevant to fertilising uses; | |
| b) those criteria and measures are appropriate to the risks arising from the application of fertilising products to soil; and | |
| c) those criteria and measures are aligned with the requirements set out in Article 42(5) of this Regulation. | |
| Where existing delegated or implementing acts adopted under Regulation (EC) No 1069/2009 do not meet those conditions, the Commission shall, where appropriate and in accordance with the procedures laid down in that Regulation, review them and, where necessary, amend them to ensure such consistency. | |
| For that purpose, the Commission shall, where relevant, request scientific opinions from the European Food Safety Authority to assess risks specific to fertilising uses, taking into account exposure pathways that are distinct from those associated with feed or other uses.’ |
Amendment 13
Proposal for a regulation
Article 3 – paragraph 1 – point 9 – point b c (new)
Regulation (EU) 2019/1009
Article 42 – paragraph 8 a (new)
| Text proposed by the Commission | Amendment |
| (bc) the following paragraph is added: | |
| ‘8a. The Commission shall adopt the first delegated act pursuant to paragraph 4a by ... [18 months after the entry into force of this Regulation].’ |
Amendment 14
Proposal for a regulation
Article 3 – paragraph 1 – point 10 a (new)
Regulation (EU) 2019/1009
Article 49 a (new)
| Text proposed by the Commission | Amendment |
| (10a) The following article is inserted: | |
| ‘Article 49a | |
| Review | |
| The Commission shall periodically revise whether the requirements governing the treatment of materials intended for use in fertilising products remain appropriate and, where necessary, adapt them in light of scientific and technical advances, taking into account national practices, and the objectives of Regulation (EU) 2019/1009. This review shall be carried out for the first time no later than two years after the entry into force of this Regulation.’ |
ANNEX: DECLARATION OF INPUT
The rapporteur for opinion declares under her exclusive responsibility that she did not include in her opinion input from interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register, or from representatives of public authorities of third countries, including their diplomatic missions and embassies, to be listed in this Annex pursuant to Article 8 of Annex I to the Rules of Procedure.