European Commission issues EU-wide rules on pesticide ingredients


Jun. 05, 2024

The Commission has issued uniform rules governing data requirements and a work program for safeners and synergists, constituent compounds that, like active substances, must be approved for use in plant protection products in the EU. Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances.

Context: EU regulatory framework for pesticides

  • Regulation (EC) No 1107/2009 (PPPR) is Europe’s principal legislation regulating pesticides, referred to as plant protection products (PPPs) in the EU, and pesticide constituent substances, seeking to maintain a high level of protection for human health, animal health, and the environment. The PPPR framework governs the authorization, sale, and use of PPPs, establishing a pre-market approval process for active substances – the pesticide components which control pests, weeds, and plant diseases – and for synergists and safeners before they can be allowed for use in PPPs.
  • Once approved, or re-approved if under application for renewal, active substances are allowed for use in PPPs for fixed periods of up to 10 years for first approvals and a maximum of 15 years for renewals. Under the PPPR, first-time approvals are expected to take between 2.5 and 3.5 years from start to finish; however, according to the Commission, this process on average takes over three and a half years to complete.
  • Safeners and synergists are subject to the same approval conditions that active substances are under the PPPR’s Articles 4 and 5-21, pursuant to Article 25(1)-(2).
  • PPPs using approved active substances must obtain separate authorizations at the national level. Procedural guidelines on applying for authorization of PPPs vary somewhat from member state to member state.
  • The PPPR mandates continuous monitoring and reevaluation of substances to reflect new scientific data and maintain safety standards. The regulatory system aims to balance agricultural needs with safety and environmental considerations.
  • The European Food Safety Authority (EFSA) and member-state competent authorities play a key role in the assessment processes, providing scientific opinions on the safety of substances.

Background: pesticide components regulated under PPPR

  • The PPPR’s scope, laid out in Article 2, establishes the characteristics and uses of PPPs and defines the substances they are composed of: active substances, safeners, synergists, co-formulants, and adjuvants.
  • Active substances: Defined under Article 2(2), these encompass “substances, including micro-organisms having general or specific action against harmful organisms or on plants, parts of plants or plant products.” Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed. Fungicides like fosetyl (CAS RN 15845-66-6), herbicides like diflufenican (CAS RN 83164-33-4), insecticides like deltamethrin (CAS RN 52918-63-5), and microorganisms like clonostachys rosea strain J1446 are some examples from the list.
  • Safeners: Defined under Article 2(3)(a), they are “substances or preparations which are added to a plant protection product to eliminate or reduce phytotoxic effects of the plant protection product on certain plants.” Until now, these substances have been effectively subject to authorization at the member-state level. According to a follow-up document (direct download) concerning a resolution on the EU’s authorization procedure for pesticides, the Commission noted that 21 safeners were “known to be used in plant protection products.” Examples of such substances include benoxacor (CAS RN 98730-04-2), flurazole (72850-64-7), dichlormid (CAS RN 37764-25-3), and cyprosulfamide (CAS RN 221667-31-8).
  • Synergists: Defined under Article 2(3)(b), they are “substances or preparations which… can give enhanced activity to the active substance(s) in a plant protection product.” Like safeners, these substances, until now, have been regulated through the PPP authorization process by member-state competent authorities. According to the follow-up document cited before, 13 synergists are known to be used in PPPs. Some examples include sesamex (CAS RN 51-14-9), piperonyl butoxide (CAS RN 51-03-6), and zengxiaoan (CAS RN 113-48-4).
  • Co-formulants: Defined under Article 2(3)(c), they cover “substances or preparations which are used or intended to be used in a plant protection product or adjuvant, but are neither active substances nor safeners or synergists.” Issued in March 2021, Regulation (EU) 2021/383 provides a negative list of 144 co-formulants (Annex III of PPPR) that are not allowed for use in PPPs, pursuant to Article 27 of PPPR.
  • Adjuvants: Defined under Article 2(3)(d), these are “substances or preparations which consist of co-formulants or preparations containing one or more co-formulants, in the form in which they are supplied to the user and placed on the market to be mixed by the user with a plant protection product and which enhance its effectiveness or other pesticidal properties.” Adjuvants are authorized at the member-state level in accordance with Article 58 of PPPR. According to the Commission, harmonized data requirements and an assessment procedure pursuant to Article 58(2) don’t yet exist, meaning that member states “may apply national provisions for authorisation of adjuvants until the adoption” of the EU-wide criteria, under the Article 81(3) exemption.

Now, the Commission has adopted legislation on EU-wide rules for safeners and synergists

  • The Commission adopted Regulation (EU) 2024/1487 on May 29, introducing data requirements for the EU-level approval of safeners and synergists and establishing a work program for the safety review of these substances that are already used in PPPs in the EU as of June 19, 2024. Notably, the work program and these data requirements were statutorily required to be introduced nearly 10 years ago on December 14, 2014.

The work program

  • Chapter 2 (Articles 2-10, Annexes I, II) of the regulation sets down the provisions establishing the work program “for the gradual review of safeners and synergists already on the market” and an initial inventory of these existing substances to be used as the baseline for creating the final list of substances that will be subject to the review under the work program.
  • By July 19, 2024, the Commission will publish a list of the safeners and synergists already on the EU market as of June 19, 2024. After this step, companies will have until December 19, 2024, to notify the Commission of “further substances or preparations potentially used as safeners or synergists in plant protection products” that were authorized “in at least one Member State on 19 June 2024.”
  • Notifications will need to include the specific data requirements as laid out in Regulation (EU) No 283/2013 in Sections 1.3, 1.4, 1.6 and 1.7 of Part A of the Annex and “evidence that the notified substance or preparation is used as a safener or synergist in at least one plant protection product authorised in at least one Member State.”
  • The Commission will then republish an updated version of the list by March 19, 2025.
  • Next, companies will have until June 19, 2025, to request that listed substances that they wish to obtain approval for be included in the Commission’s work program for review. Requests need to be sent to the Commission at, containing the information listed in Annex II of this regulation. To support data sharing and joint application submission requirements, the Commission will inform companies that have requested safener or synergist inclusion of the contact details for other parties that asked for the same substance to be included.
  • The Commission will subsequently exclude from review under the work program all listed safeners and synergists for which no requests were received by the June 19, 2025 deadline.
  • The Commission will adopt the work program by December 19, 2025, adding to Annex I of this Regulation all safeners and synergists to be reviewed under the work program, along with the rapporteur and co-rapporteur member states (RMS, Co-RMS) assigned to conducting the assessment of each substance under review.

Submission of applications for approval of safeners and synergists included in the work program

  • Articles 7-10 lay down the process for companies to apply for approval of use in PPPs of the safeners and synergists listed in Annex I – the work program-listed substances subject to review.
  • Article 7 stipulates that “applicants for the approval of the same safener or synergist shall undertake all reasonable efforts to submit a joint application, or to share relevant scientific data.” Like the registration requirement under REACH, this provision has been added to support data sharing for the same substances, to help limit potential data gaps among individual companies and, in turn, decrease the need for resorting to animal testing. The article also mandates applicants to notify EFSA of any intended studies in support of an application, “as well as the laboratory or testing facility carrying out that study, and its starting and planned completion dates.” Likewise, applicants must report “if any conducted or commissioned study incorporates the utilisation of alternative testing methods.”
  • Article 10 establishes provisions allowing applicants to claim data protection and confidentiality where justified. Data protection applies to “test and study reports as part of an application for an authorisation for a plant protection product containing a safener or a synergist.” Likewise, applications for approval of a safener or a synergist may be accompanied with a request “to treat certain information, including certain parts of the dossier, as confidential.” The request must “identify the confidential and non-confidential versions of the information submitted.”
  • Applicants have until June 19, 2028, “individually or collectively,” to submit the application to the assigned RMS (Article 8). Applications must be submitted in standard IUCLID data format and contain the information enumerated in Article 11, which sets out the data requirements specifically for safeners and synergists.

Data requirements for safeners and synergists

  • Chapter 3 (Article 11, Annex III) of Regulation (EU) 2024/1487 lays down the data requirements that must be met when applying for the approval of safeners and synergists under review in the work program.
  • In addition to the requirements in Annex III, applicants for safener and synergist approvals must also address relevant data requirements for active substances set out in Article 8 of PPPR and Regulation (EU) No 283/2013, and those for plant protection products in Regulation (EU) No 284/2013. Several other requirements are listed in this article, including, where relevant, “identification and proposal of a residue definition for the purposes of risk assessment,” a hazard classification proposal pursuant to Regulation (EC) 1272/2008 on the classification, labeling and packaging of substances and mixtures (CLP), and “identification and proposal for any necessary and appropriate risk mitigation measures.”

Analysis and next steps

  • The new rules represent a noteworthy change in the way these pesticide components will be regulated after Regulation (EU) 2024/1487 enters into force on June 19, 2024. Agrochemical companies placing PPPs on the markets of various member states will no longer be required to follow individual requirements for PPP authorization, but instead will follow a uniform application procedure for approval of safeners and synergists, similar to the current process for approval or reapproval of active substances under the PPPR.
  • The Commission is pushing industry to work cooperatively in pursuit of reduced animal testing, requiring companies to “undertake all reasonable efforts” to jointly submit applications and share relevant data for the same safeners and synergists. This Article 7 requirement appears to be counterbalanced by Article 10, which allows applicants to claim data protection and confidentiality where warranted. Nevertheless, it will be interesting to see how successful this approach will be, especially given that these applications will likely include sensitive information that companies may be reluctant to disclose.
  • As a first step, affected companies will want to weigh in on the initial inventory of safeners or synergists present on the market, which will be used as a baseline for the final list of work program substances. They can do this by notifying the Commission by December 19, 2024 about safeners or synergists in their PPPs that were authorized “in at least one Member State on 19 June 2024.” Just as important will be meeting the June 19, 2025, deadline for requesting that the initially listed substances they wish to obtain approval for be included in the Commission’s final list for the work program. Finally, companies will then have until June 19, 2028, to submit applications for approval of the work program-listed substances to the assigned RMS.

To contact the author of this analysis, please email Scott Stephens (

To contact the editor of this analysis, please email Kari Oakes (

Key Documents and Dates

  • Commission Regulation (EU) 2024/1487 of 29 May 2024 defining data requirements for the approval of safeners and synergists and establishing a work programme for the gradual review of safeners and synergists on the market in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council
  • Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC

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