EUROPE: Update of the list of candidates for substitution
27 July 2022
FRANCE – ANSES : National provisions for the implementation of the european guidance document on MRLs in honey
31 August 2022
EFSA collected data on 182 co‐formulants contained in representative plant protection product (PPP) formulations as part of applications for approval or renewal of active substances assessed between January 2019 and March 2022. The aim was to provide an overview of the available data and the main considerations for the assessment of co-formulants during the peer review process.
Data submitted on the identity and physico-chemical properties of the co‐formulants are frequently reported 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). The main comments raised during the evaluation of co-formulants refer to substance identification (SID) and composition, harmonisation of classification and labelling and hazard assessment.
Noted that 53 % 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. Quantities for which registrants are required to submit the most complete data set under REACH. 23 % of the identified co‐formulants have been approved by EU legal frameworks other than REACH (biocide, food contact material, cosmetic, excipient or feed/food additive). For the remaining percentage, a more limited range of toxicological information was available: EFSA will investigate whether these are exempted from registration under REACH.
As a reminder, the Regulation (EU) 2021/383 lists into Annex III to the Regulation 1107/2009 the 144 co-formulants prohibited in PPP. The amendment or withdrawal of marketing authorisations for PPP containing these co-formulants will take effect by 24 March 2023 at the latest.
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See also our previous articles:
FRANCE – ANSES: Implementation of the regulatory provisions on banned co-formulants
EUROPE – COM: Publication of the list of co-formulants banned in PPP
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