Evaluation of other substances
Below, relevant points regarding the evaluation of co-formulants (as constituents of plant protection products), adjuvants, and safeners and synergists are highlighted. Note that, beside for co-formulants, a formalized Regulatory framework is not yet available.
Co-formulants
By definition, co-formulants are used in plant protection products and adjuvants to bestow a desired functionality to the product, though they are not categorized as active substances, safeners, or synergists. Evaluation of the (eco)toxicological potential of co-formulants is an intrinsic part of any PPP-assessment, but as of March 24th 2021, hazards associated with constituents of co-formulants are more restrictively governed through Regulation (EU) 2021/383. The Regulation effectively fills up the Annex III list of unacceptable co-formulants, referred to in Article 27 of Regulation (EC) No 1107/2009 and provides criteria for substance inclusion, information on restrictions, and timelines for compliance. See (EU) 2021/383 for more detailed information.
Notification of co-formulants for inclusion in Annex III of (EC) No 1107/2009 through Reg. (EU) 2023/574
According to Regulation (EU) 2023/574, a check must be carried out for potentially unacceptable co-formulants within all applications for authorisation, change or renewal of a product, submitted from 3 April 2023 onwards. During this check, the co-formulants in the respective product are screened for ten criteria, which are described in the Annex of (EU) 2023/574. If a co-formulant meets one or more criteria, it can be considered unacceptable on the basis of its (eco)toxicologically harmful properties.
In that case, a procedure is initiated to notify the substance for inclusion in Annex III, with the ultimate goal of strongly restricting/phasing out its use as a co-formulant in plant protection products within the EU.
Regulation (EU) 2023/574 is an addition to Regulation (EU) 2021/383.
Adjuvants for plant protection products
Adjuvants are defined as mixtures or preparations which are marketed separately and are mixed with a plant protection product before use. Examples of adjuvants are anti-foaming agents, wetting agents, uptake enhancers and sticking agents. Like co-formulants, adjuvants are subject to Regulation (EU) 2021/383 (entry into force: March 24th 2021) that puts a restriction on the presence of hazardous substances in these commodities (see ‘Co-formulants’ for more information).
Safeners and synergists
A programme for safeners and synergists should be completed by the Commission, but is not yet available.