Data collection on co‐formulants used in representative plant protection product formulations in the context of the EFSA peer review process for approval/renewal of approval of active substances

EFSA collected data on co‐formulants contained in plant protection product (PPP) formulations for representative uses as part of applications for approval or renewal of active substances, to collate the information available during the peer review process. Information was extracted from pesticide active substances dossiers for which a peer review output was issued between January 2019 and March 2022, in which a total of 182 co‐formulants were found. Most of the data submitted on the identity and physicochemical properties of the co‐formulants are complete as required by Regulation (EU) 284/2013. The data related to (eco)toxicological properties mainly refers to the safety data sheet of the individual co‐formulants and, if available, to registration dossiers under Regulation (EC) 1907/2006 (REACH). Fifty‐three % of the identified co‐formulants have been registered under REACH and about 80% of the 53% are registered for more than 1000 tonnes a year for which registrants are required to submit the most complete data set under REACH. For the remaining percentage, a more limited range of toxicological information is available: ECHA investigated whether they are exempted from registration under REACH. Co‐formulants contained in plant protection products may also be subject to other European legislation such as the regulations on biocidal active substances, food/feed additives, food contact materials, or are included in lists of excipients or cosmetic ingredients. On 28 September 2023, the European Commission requested EFSA to inform the European Commission if and which of the co‐formulants listed in this EFSA technical report, fulfils any of the criteria 1 to 9 in the Annex to Commission Implementing Regulation (EU) No 574/2023 and is not already listed in Annex III to Regulation (EC) No 1107/2009. Out of the 182 co‐formulants, 8 meet at least one of the 9 criteria and are concluded as unacceptable. For twenty‐two co‐formulants no CAS/EC numbers were available in Volume 4 of the respective DAR/RAR. Observations highlighted in the present report can serve Member State risk assessors and risk managers to harmonise the assessment of co‐formulants in collaboration with the EU agencies (EFSA, ECHA).

This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2022.EN-7547/full