The Assessment of Plant Protection Products (PPPs)

Plant protection products (PPP) are mixtures composed of one or more active substance(s) - intended to repel, control or kill pests - and co-formulants that facilitate handling/application, ensure even distribution on the plants and/or improve storage and product/user safety (such as solvents, carriers, wetting agents, dyes, etc.).

Safety must be demonstrated for each PPP. Information on the product – i.e. the mixture, which also includes co-formulants - is required as part of applications for authorisation in accordance with the data requirements on PPPs as set out in Commission Regulation 284/2013.

Certain co-formulants cannot be used in plant protection products because of the harmful effects of their use and/or residues on human health or the environment (listed in Annex III to Regulation (EC) No 1107/2009).

Rules and criteria for the identification of other unacceptable co-formulants are also available (Commission Implementing Regulation (EU) 2023/574).

In addition, co-formulants are subject to several other EU legal frameworks, particularly Regulation 1907/2006 on REACH. Co-formulants may also be used for other purposes, e.g., food additives, paints, food contact materials or industrial chemicals.

All information available from these other legal frameworks must be considered in evaluating PPPs to avoid unnecessary animal testing.

The Commission, in collaboration with EFSA and Member State competent authorities, is working towards improving transparency and efficiency of the assessment of plant protection products – particularly regarding co-formulants.- focusing on 3 initiatives identified by the Member States: establishment a common database of co-formulants, development of a guidance document on the assessment of PPP including co-formulants and communication.

The following actions have been organised:

1. EFSA published a technical report on data on co‐formulants in products submitted for representative uses in the dossiers for active substances, including information from other EU legislation.
2. Workshop on the assessment of plant protection products and co-formulants (scene setting and identification of possible ways forward) – 23 May 2023 - Report.
3. Technical workshop organised by EFSA - 21 and 22 June 2023. Further information.
4. Discussion at the Pesticide Steering Network meeting organised by EFSA - 24 October 2023 - Report.
5. Workshop on the Zonal Authorisation Procedure – Improvement and Development (ZAPID), 5 to 7 December 2023, Braunschweig (DE) - Agenda - Report
6. Workshop on guidance document and database for the assessment of PPP including co-formulants (with the participation of MS authorities, EFSA, ECHA and Commission) – 20 June 2024, on-line - Agenda - Report
7. Request from the European Parliament to EFSA for scientific review of the methodologies available to assess the long-term toxicity and carcinogenicity of plant protection products and mixtures