CELEX:52025PC1030: 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

EUROPEAN COMMISSION Strasbourg, 16.12.2025 COM(2025) 1030 final 2025/0410(COD)

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

{SWD(2025) 1030 final}

EXPLANATORY MEMORANDUM

1. CONTEXT OF THE PROPOSAL

• Reasons for and objectives of the proposal

The proposal is part of the cross‑cutting legislative simplification package announced in the European Commission’s Vision for Agriculture and Food [1]. The aim of the package is 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. The proposal responds to repeated requests from stakeholders and EU Member States for faster and clearer regulatory procedures.

This initiative aims at simplifying and streamlining certain requirements and procedures for products used in the production of food and feed identified as particularly burdensome by industry and authorities. These provisions would benefit from regulatory streamlining and modernisation, which would make the respective legislation more efficient and cost‑effective for industry and Member States authorities, while at the same time ensuring a high level of protection of human and animal health and the environment. More specifically, this initiative is aiming at simplification of certain provisions and procedures and ensure a better implementation of the following acts:

• Regulation (EC) No 1107/2009 [2]: accelerate access to the market for new biocontrol substances and products containing them.
• Regulation (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, (EU) No 528/2012, (EU) 2017/625 – as set out in the detailed amendments below.

Biocontrol substances

Biocontrol substances (such as micro‑organisms, semiochemicals (pheromones), plant extracts) are more sustainable alternatives to chemical active substances. However, the range of pests that those already approved today can control and the number of crops on which they are allowed to be used is relatively limited. Prospective applicants for the approval of new biocontrol substances and for product authorisations on a wider range of crops complain that the capacity and expertise in Member States to conduct the necessary risk assessments is insufficient and that the time‑to‑market is too long. The Commission has already taken steps to facilitate placing on the market of biocontrol substances. For instance, updated data requirements [3,4] and uniform principles [5] for micro‑organisms were adopted in 2022 to make them more fit‑for‑purpose, and a Single Market Enforcement Taskforce (SMET) project [6] was developed to address delays in the authorisation of biocontrol products by Member States through sharing of good practices and solutions for more efficiency and less burden. However, the measures taken are not yet sufficient. Therefore, this legislative proposal contains several targeted amendments to Regulation (EC) No 1107/2009 to accelerate market access for biocontrol substances and products containing them.

Several stakeholders have submitted comments in the call for evidence of the Biotech Act 8 (14 May 2025 – 11 June 2025) asking, among other things, to streamline the regulatory process for biocontrol products and to have a clear definition for this group of substances to delineate the scope of substances benefitting from the simplification efforts proposed in the amended Regulation (EC) No 1107/2009. Their input is also included and considered in the proposed provisions.

Several Member States, in particular smaller ones, have also signalled that applicants for the authorisation of products containing biocontrol substances and low‑risk active substances do not submit applications in their territories considering the limited market potential versus costs and delays related to the need to obtain authorisations in the different zones to which Member States are assigned in accordance with Annex I to Regulation (EC) No 1107/2009 and due to difficulties and delays in mutual recognition procedures. Therefore, it is proposed to reinforce the mutual recognition procedure for plant protection products containing only biocontrol or low‑risk active substances by providing for tacit agreement in case the concerned Member State does not decide on the mutual recognition procedure in the 120‑day period.

Article 67(1) of Regulation (EC) No 1107/2009 requires that professional users of plant protection products keep, for at least three years, records of the plant protection products they use, containing the name of the product, the time and the dose of application, the area and the crop where the plant protection product was used in order to raise the protection of human and animal health and the environment by ensuring the traceability and potential exposure, to increase the efficiency of monitoring and control and to reduce the costs of monitoring water quality. Considering that such information is less relevant for plant protection products containing biocontrol substances, and in order to reduce the administrative burden for farmers, the obligation to keep records should not apply to plant protection products containing only biocontrol substances.

Furthermore, experience with the implementation of Regulation (EC) No 1107/2009 and the findings of the Report on the REFIT revaluation of the pesticides legislation [7] as well as suggestions by Member States and stakeholders have shown that amending certain other provisions in the Regulation can increase clarity, address concerns about continued ability of farmers to produce crops to ensure food security, and significantly reduce administrative burdens for authorities and stakeholders without lowering the level of protection of human or animal health or the environment.

The REFIT evaluation of Regulation (EC) No 1107/2009 showed that the most significant burdens for companies and Member States relate to the procedures for approval and renewal of active substances and for authorisation and renewal of plant protection products. In particular, due to lack of resources in the Member States’ competent authorities, in most cases, regulatory deadlines for completing administrative procedures cannot be respected [8], causing negative impacts for farmers and industry. The workshop Zonal Authorisation Procedure – Improvements and Developments (ZAPID) held in 2023 [9] intended to address these delays by considering different options for increasing efficiency in the assessment of applications for product authorisations. One of the findings of the workshop was that Member States dedicate significant resources to the systematic renewal of approvals of active substances followed by the renewals of authorisations of plant protection products, as these are time‑limited and would expire if no applications for renewal were submitted and assessed. As a consequence, approvals of new active substances and first‑time authorisations of plant protection products containing new active substances are often even more delayed or potential applicants find no Member State who is able to take on the role as rapporteur or reference Member State.

These delays prevent a transition towards more sustainable active substances and plant protection products. Therefore, resources in the Member States dedicated to renewal procedures should be made available for the assessment of applications for new active substances and products. Considering that most approved active substances have gone through at least one renewal process and that new active substances are expected to have better toxicological and ecotoxicological properties, it is proposed that approvals of active substances become unlimited in duration, except for active substances that are candidates for substitution and those approved under Article 4(7) of Regulation (EC) No 1107/2009 as these have properties that are of concern with regards to human or animal health or the environment. Nevertheless, in order to maintain a high level of protection of human and animal health and the environment, it will still be possible to set time limits for approvals if found appropriate in light of the outcome of the risk assessment. In addition, the Commission, taking into account requests from Member States, may identify active substances with unlimited approval for which a full renewal procedure will be carried out or identify active substances with unlimited or limited approval periods for targeted reassessment. The possibility for ad‑hoc reviews already foreseen in Article 21 of Regulation (EC) No 1107/2009 is maintained.

Article 22 of Regulation (EC) No 1107/2009 sets out criteria to identify low‑risk active substances, referring to hazard‑based criteria for the substance set out in point 5 of Annex II and risk‑based criteria for the plant protection products containing them set out in Article 47. Implementation of these provisions has proven difficult in practice as at the time of the approval or renewal of approval of active substances it is generally not known whether the criteria related to products in Article 47 can be fulfilled or not. The criteria are therefore simplified to only refer to intrinsic properties of the active substance.

There have been cases where an active substance could not be approved as low‑risk because certain elements related to the criteria could not be fully clarified during the approval or renewal of approval procedure, while further information showing that these are fulfilled was generated later. However, there is currently no possibility in Regulation (EC) No 1107/2009 to apply for a change of the status of an approved active substance to low‑risk. Such a possibility is, therefore, introduced.

Article 4(7) of Regulation (EC) No 1107/2009 provides for a derogation to allow for the approval of active substances not meeting the approval criteria in Article 4 and Annex II where it is necessary to do so because of a serious danger to plant health which cannot be contained by other available means including chemical and non‑chemical methods with comparable costs and efficacy, except for active substances having particularly hazardous properties. In such cases, all measures to reduce exposure to the active substance must be taken and consumer safety must be safeguarded. Member States authorising plant protection products containing such active substances must draw up a phasing‑out plan and submit it to the Commission. However, experience has shown that the drafting of this provision is not clear as regards its scope and should be improved to clarify for which substances such a derogation is possible. Furthermore, the obligation on Member States authorising plant protection products containing such active substances to draw up a phasing‑out plan is disproportionate when considering that approvals under this provision are in any case limited to five years. This obligation is, therefore, removed and the scope of Article 4(7) is further clarified.

Following the non‑renewal of the approval of an active substance, Member States must withdraw all authorisations of products containing the active substance and farmers must stop using these products. In such situations, Member States need time to enact withdrawals of product authorisations and in order to avoid creation of waste and give time to farmers to find alternatives, Article 20(2) foresees the possibility in certain cases to provide for grace periods not exceeding maximum deadlines for placing on the market and use of existing stocks of plant protection products for which authorisations must be withdrawn. Currently Article 20(2) does not cover situations where the reasons for the renewal are related to protection of health or the environment but there are no immediate concerns for human health or animal health or the environment. However, also in these situations it would be preferable that the Regulation not renewing the approval of an active substance provides for maximum grace periods that the Member States may set under Article 46 in order to enable farmers to find alternatives.

The maximum length of grace periods specified in the current Article 20(2), i.e. 6 months for sale and distribution and a further 1 year for disposal, storage and use of existing stocks, might not be sufficient for farmers to get access to suitable alternatives in cases where reasonable alternatives do not currently exist. Doubling the maximum overall length of grace periods to 3 years would allow for alternative plant protection products to be authorised in such cases, if necessary, thus preventing losses of revenue for farmers and ensuring food security for consumers.

A survey [10] conducted by the Authority has shown that the competent authorities of many Member States lack technical or scientific expertise to complete their tasks as rapporteur Member States within the periods foreseen in Regulation (EC) No 1107/2009. This causes significant delays in delivering and updating draft assessment reports for applications for approval or renewal of active substances, safeners or synergists. Therefore, the proposal provides for the possibility for rapporteur Member States to ask the European Food Safety Authority (‘the Authority’) for support during the preparation of a draft assessment report for an application for approval or renewal of an active substance, the assessment of additional information required during the peer‑review process and when updating the draft assessment report after its initial submission.

The requirement for Member States to consider ‘current scientific and technical knowledge’ in the context of product authorisations has led to some confusion and divergent interpretation of what constitutes such current knowledge – in particular, if applications for product authorisations (or mutual recognition thereof) are submitted several years after an approval or renewal of an active substance. This has led to divergent risk assessment outcomes among Member States and unequal access to plant protection products for farmers depending on the Member State of their establishment. Article 36(3) is, therefore, clarified to allow for harmonised assessment of the latest scientific and technical knowledge while ensuring any specific needs for further assessment of active substances are followed up.

It has been observed that applicants have obtained product authorisations in a reference Member State having set lower fees than others in order to afterwards apply for mutual recognition of these authorisations in other Member States, without, however, placing the plant protection products concerned on the market in the reference Member State having granted the first authorisation. As a consequence, farmers in that Member State have no access to the plant protection products concerned despite the existing authorisation. In order to prevent abuse of the mutual recognition system and circumvention of higher fees, application for mutual recognition of a product authorisation shall only be possible, if the product for which authorisation by mutual recognition is sought is actually placed on the market in the reference Member State.

Article 51 of Regulation (EC) No 1107/2009 has set out specific provisions to facilitate obtaining authorisations of plant protection products for minor uses. However, in practice, some of the conditions have proven too restrictive i.e. that extension of an authorisation must be in the public interest or that mutual recognition of an authorisation from another Member State is only possible if that authorisation is also for a minor use. Therefore, these restrictions should be removed. Furthermore, the application of Article 51 varies significantly depending on the Member States. A report of the European Minor Use Coordination Facility from 2022 [11] stressed the lack of harmonisation and difficulties to make available plant protection products for minor crops, which although occupying a lower production acreage in the Union compared with major crops, may be high value crops and are important for the environment, farmers, producers, and consumers. Therefore, transparency and sharing of best practices should be increased to achieve more equal access to plant protection products for minor users by all farmers independent of the Member State of establishment.

Regulation (EU) 2016/2031 [12] aims at preventing the establishment or spreading of pests that would have unacceptable economic, environmental or social impacts on Union territory including EU agricultural production. The availability of plant protection product authorised uses to apply the provisions of Regulation (EU) 2016/2031 is essential and Member States have repeatedly mentioned difficulties in this regard. Administrative simplifications like a one‑zone approach (instead of three zones), and a prioritisation of applications for this kind of purposes would increase the timely availability of plant protection product uses and ensure the possibility to apply the provisions of Regulation (EU) 2016/2031.

Regulation (EC) No 1107/2009 contains specific provisions for the use of basic substances, which are defined as active substances that have primary uses for other purposes than plant protection but are nevertheless useful for farmers for protecting plants against pests. Most approved basic substances are biocontrol but not all. Following their approval under Regulation (EC) No 1107/2009, they can be directly used by farmers without obtaining national authorisations by Member States. However, in practice, certain provisions related to basic substances have proven to be unclear and hinder their availability to farmers, in particular the prohibition that they cannot be substances of concern, cannot be placed on the market as plant protection products or that there must be a primary use for purposes other than plant protection. The ambiguity of some of the current legal provisions on basic substances led to disharmonised implementation across the EU, as became evident in a workshop with Member States organised in 2024. Therefore, the relevant provisions are amended and clarified so that in addition to use, the placing on the market of approved basic substances for plant protection purposes does not require an authorisation by Member States to allow for easier access to basic substances by farmers in a suitable form and with clear instructions for use.

Experience has shown that Member States have developed different interpretations of the provisions related to the placing on the market and use of seeds treated with plant protection products in Regulation (EC) No 1107/2009. In particular, divergent views on whether the sowing of treated seeds constitutes a use of plant protection products has created confusion amongst producers of treated seeds, farmers and competent authorities. Additionally, Member States have different interpretations as to whether the provision on treated seeds cover also other types of plant reproductive materials such as tubers, bulbs, or seed potatoes. The lack of clarity creates barriers for the free circulation of treated seeds and plant reproductive materials and has created disparity between the Member States as regards imports of seeds treated with active substances not approved for use in the EU and their sowing. Therefore, the relevant provisions should be clarified, in order to increase harmonisation among Member States.

The provisions in Regulation (EC) No 1107/2009 related to the protection of data in test and study reports used in regulatory procedures for the approval of active substances and authorisation of plant protection products had been significantly amended compared to the ones under the repealed Directive 91/414/EEC [13]. Experience has shown that the current patched territorial scope under Regulation (EC) No 1107/2009 (Member State per Member State) creates barriers to the entry to the market of new suppliers of plant protection products and unequal distribution and different costs of plant protection products depending on the size of the Member State’s market, thus creating unfair competition between plant protection product manufacturers and farmers. Furthermore, the current data protection regime is highly complex and lacks transparency in terms of when data protection for a given test or study report expires in the different Member States, in particular for studies or tests used for renewals of approvals or review of authorisations. The relevant provisions are therefore amended to install Union‑wide territorial scope of data protection and the same length of data protection periods for a given test or study report across the Union to increase transparency and facilitate market access for alternative suppliers and to increase the availability of plant protection products at comparable costs to farmers independent from the Member States where they are established.

Lastly, transitional provisions are established in order to provide legal certainty in procedures for applications for approval or renewal of active substances including basic substances, or for the authorisation of plant protection products that are ongoing at the time of entry into force of this Regulation and to ensure a smooth transition from the current provisions in Regulation (EC) No 1107/2009 to the amended provisions.

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

• Legal basis: Article 43(2), Article 114, Article 168(4)(b) and Article 192(1) of the Treaty on the Functioning of the European Union (TFEU).
• Subsidiarity: The proposed amendments are adopted at EU level as the Regulations concerned were adopted at EU level and the intended objectives could not be sufficiently achieved at Member State level.
• Proportionality: The initiative does not go beyond what is necessary to achieve the objectives of simplification and burden reduction without lowering the protection of human health and environment.
• Choice of instrument: Legislative proposal, as the relevant Regulations to be amended were adopted by co‑decision/ordinary legislative procedure.

3. RESULTS OF EX‑POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

(omitted for brevity – see original document for full details)

4. BUDGETARY IMPLICATIONS

The proposed initiative is expected to result in an increase of EUR 15 073 million in the subsidy paid by the Commission to the Authority for the period 2028–2034. Without prejudice to the negotiations on the next MFF, the additional appropriations allocated to the agency from 2028 onwards will be compensated via redeployments from programmes under the same heading as the agency under the 2028‑2034 MFF.

5. OTHER ELEMENTS

(omitted for brevity – see original document for full details)

HAVE ADOPTED THIS REGULATION:

Article 1

Amendments to Regulation (EC) No 1107/2009

1. Article 2 is amended as follows:
   • paragraph 1, point (b) is replaced by: “(b) ‘disrupting life processes of plants, such as substances regulating their growth, other than as a nutrient or a plant biostimulant’”.
   • paragraph 2 is replaced by: “2. This Regulation shall apply to substances, including biocontrol substances having general or specific action against harmful organisms or on plants, parts of plants or plant products, referred to as ‘active substances’.”
2. Article 3 is amended as follows:
   • point 17 is replaced by: “‘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.”
   • point 34 is replaced by: “‘plant biostimulant’ means a product having at least one of the following actions: (1) stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: (a) nutrient use efficiency; (b) quality traits; (c) availability of confined nutrients in soil or rhizosphere; (2) stimulating life processes of crops to improve their tolerance to abiotic stress. Substances disrupting life processes of crops which are not fulfilling the definition of plant biostimulants are active substances covered by this Regulation.”
   • point 35 added: “‘biocontrol substance’ means: (a) micro‑organisms, (b) inorganic substances as occurring in nature, with the exception of heavy metals and their salts or (c) substances of biological origin or produced synthetically that are functionally identical and structurally similar to them.”
   • point 36 added: “‘basic substances’ means active substances that are not predominantly used for plant protection purposes, including foodstuffs and substances evaluated in accordance with other Union legislation, but are nevertheless useful in plant protection.”
3. Article 4, paragraph 7 is replaced by: “7. 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 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. The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. 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.”
4. Article 5 is replaced by: “Article 5 – First approval The first approval shall be for an unlimited period except for: (a) active substances that are identified as candidates for substitution in accordance with Article 24; (b) active substances that are approved under Article 4(7); or (c) active substances for which a limited period of approval is set in accordance with Article 6 (j) in particular in the light of relevant uncertainties emerging from the risk assessment, including as a result of data gaps.”
5. Article 7, paragraph 1 is replaced by: “(1) An application for the approval of an active substance, for an amendment of the conditions of approval, or for a change of status for an active substance as identified in the regulation referred to in Article 13(4), shall be submitted by the producer of the active substance to a Member State (the ‘rapporteur Member State’) together with a summary and a complete dossier as provided for in Articles 8(1) and (2) this Regulation or a scientifically reasoned justification for not providing certain parts of those dossiers. The application shall demonstrate that the active substance fulfils the approval criteria provided for in Article 4 of this Regulation or, where applicable, that the change of status of the active substance is justified. The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002 of the European Parliament and of the Council, which shall apply mutatis mutandis. A joint application may be submitted by an association of producers designated by the producers for the purpose of compliance with this Regulation. The application shall be examined by the Member State proposed by the applicant, unless another Member State agrees to examine it. By way of derogation from the first subparagraph, applications for the approval of biocontrol substances may be submitted to the Authority which shall assume the duties of the rapporteur Member State.”
6. Article 11 is amended as follows:
   • paragraph 1a added: “1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.”
   • end of paragraph 2: “The rapporteur Member State may ask the Authority to provide technical and scientific support during the assessment required for the preparation and delivery of the draft assessment report, during the assessment of the additional information referred to in Article 12(3), and for the preparation of necessary updates of the draft assessment report after its initial submission.”
7. Article 13, paragraph 4 is replaced by: “4. Approved active substances shall be included in the Regulation referred to in Article 78(3) containing the list of active substances already approved. The Commission shall maintain a list of approved active substances electronically available to the public. This list shall indicate whether an active substance is a biocontrol substance.”
8. Subsection 3 heading replaced by: “Subsection 3 – Renewal, reassessment and review”
9. Article 14 is replaced by: “Article 14 – Renewal of approval
10. Upon application, the approval of an active substance with a limited approval period shall be renewed where it is established that the approval criteria provided for in Article 4 are satisfied…
11. The renewal of the approval of active substances shall be for an unlimited period, except for: (a) active substances that are approved as candidates for substitution in accordance with Article 24, (b) active substances whose approvals are renewed under Article 4(7); or (c) active substances for which a limited period of renewal is set in accordance with Article 6 (j) in particular in the light of relevant uncertainties emerging from the risk assessment including as a result of data gaps.”
12. Article 18 is replaced by: “Article 18 – Work programme for renewal of approval of active substances with unlimited approval periods
13. 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…
14. The implementing acts shall: (a) list the active substances concerned; (b) list the rapporteur and co‑rapporteur Member States; (c) set deadlines for the submission of applications for renewal of the approval of the active substances concerned that allow sufficient time for the generation of the necessary data and the submission of the said applications; and (d) set expiry dates for the approvals of the active substances concerned that allow sufficient time for the submission and evaluation of the applications and for the adoption of decisions on the renewal of the approval of the active substances concerned.
15. Articles 14, 15(2), 16, 17 and 20 shall apply.”
16. New Article 18a inserted – “Article 18a – Work programme for targeted reassessment of active substances” (full text omitted for brevity).
17. Article 19 replaced by: “Article 19 – Implementing measures An implementing act, adopted in accordance with the procedure referred to in Article 79(3), shall set out the provisions necessary for the implementation of the renewal procedure and of the targeted reassessment procedure, as provided for in this Subsection 3.”
18. Article 20, paragraph 2 replaced by: “2. 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. 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.”
19. Article 22, paragraphs 1‑2 replaced by: “1. An active substance complying with the criteria provided for in Article 4 and in point 5 of Annex II shall be approved as a low‑risk active substance.
20. Articles 4 to 21 shall apply. Low‑risk active substances shall be listed separately in the Regulation referred to in Article 13(4).”
21. Article 23 replaced by: “Article 23 – Approval criteria for basic substances
22. An approval granted pursuant to this Article and Article 23a shall cover: (a) the direct use of the basic substance for plant protection purposes as such or when produced by the user directly from plants or parts of plants after simple preparation; (b) the use of the basic substance in a product consisting of the basic substance and, as applicable, a simple diluent, other basic substances or substances necessary to stabilise the product. (c) Any product containing a basic substance with a composition not complying with point (b) shall be considered as a plant protection product and shall require an authorisation in accordance with Chapter III.
23. By way of derogation from Article 4, the basic substance shall be approved where all the following criteria are fulfilled: (a) the basic substance is not a substance of concern or the hazard classification of the substance in accordance with Regulation (EC) No 1272/2008 does not apply to the product in which it is approved for use; (b) the basic substance or the product in which it is used does not have an inherent capacity to cause endocrine‑disrupting, neurotoxic or immunotoxic effects; (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; (d) the basic substance or the product in which it is used has neither immediate or delayed harmful effects in human health, including that of vulnerable groups, or animal health, nor unacceptable effects on the environment, arising from its use(s) for plant protection purposes.”
24. New Article 23a inserted – “Article 23a – Approval procedure and labelling of basic substances” (full text omitted for brevity).
25. New Article 27a inserted – “Article 27a – Approval periods of already granted approvals” (full text omitted for brevity).
26. Article 28, paragraph 2 amended – “(a) ‘placing on the market and use of basic substances or products referred to in Article 23(1).’ (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.’”
27. Article 30 replaced by: “Article 30 – Provisional authorisations for plant protection products containing biocontrol active substances
28. 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 …
29. When a Member State grants a provisional authorisation … the Member State shall immediately inform the other Member States and the Commission …
30. Article 44 applies to provisional authorisations …
31. Following the approval of an active substance … the Member States may transform the provisional authorisation into an authorisation granted in accordance with Article 36, unless the conditions set in the approval require amendment of the provisional authorisation.”
32. Article 32 replaced by: “Article 32 – Duration
33. The period of authorisation shall be laid down in the authorisation. Without prejudice to Article 44, the duration of an authorisation shall be set for a period: (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. This period shall allow the examination as provided for in Article 43 to be carried out.
34. Authorisations may be granted for shorter periods to synchronise the re‑evaluation of similar products for the purposes of a comparative assessment of products containing candidates for substitution as provided for in Article 50.”
35. Article 33, paragraph 2, point (b) replaced by: “(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 … only one Member State shall be proposed, which evaluates the application taking account of all zones.”
36. Article 36, paragraph 1, first subparagraph replaced by: “1. The Member State examining the application shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge using guidance documents available at the time of the application. It shall give all Member States in the same zone the opportunity to submit comments to be considered in the assessment. 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 that case the Member State shall request the Commission to act under Articles 18, 18a or 21.”
37. New paragraphs 5‑7 added to Article 37 – “(5) Where the application concerns a plant protection product … the authorisation shall be deemed as having been granted … (6) The Member State examining the application shall give priority to the processing of applications for plant protection products containing only biocontrol substances. (7) The Member State examining an application for plant protection product uses … shall endeavour to decide as early as possible and in any case within 6 months.”
38. Article 40 replaced by: “Article 40 – Mutual recognition
39. The holder of an authorisation … may apply for an authorisation for the same plant protection product … provided that: (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) … (c) …
40. Where a plant protection product is not authorised in a Member State because no application … official or scientific bodies … may apply for an authorisation …”
41. Article 42 replaced by: “Article 42 – Procedure
42. The application shall be accompanied by: (a) a copy of the authorisation granted by the reference Member State … (b) a formal statement … (c) a complete or summary dossier … (d) an assessment report … (Points c and d shall not apply to applications submitted under Article 40(2) and Article 51(7)).
43. The Member State to which an application … shall decide on the application within 120 days.
44. Where the application concerns a plant protection product containing only biocontrol or low‑risk active substances … the authorisation shall be deemed as having been granted …
45. …
46. Detailed rules … may be established …

(The remainder of the amendment text continues in the same structure, covering Articles 43‑59, Article 67, and transitional provisions. For brevity, the full verbatim legal text is omitted here but is part of the official legislative proposal.)

End of Document

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