ORP- Notice for authorization holders
Unacceptable co-formulants in plant protection products and adjuvants
Notice for authorization holders
The Central Control and Testing Institute in Agriculture in Bratislava (hereinafter referred to as the “Control Institute”) informs the holders of authorizations of plant protection products and of adjuvants that on 4 March 2021 Commission Regulation (EU) 2021/383 amending Annex III to Regulation (EC) No 1107/2009 of the European Parliament and of the Council listing co-formulants which are not accepted for inclusion in plant protection products, was published in the Official Journal of the European Union. The list currently contains 144 co-formulants and, apart from plant protection products, also applies to adjuvants. Since the Regulation obliges Member States to amend or withdraw authorizations of plant protection products and adjuvants containing one of the listed co-formulants by 24 March 2023 at the latest, the Control Institute recommends that authorization holders check the composition of their authorized plant protection products and / or adjuvants and for plant protection products and/or adjuvant containing an unacceptable co-formulant which they still want to place on the market submit an application for a change in the composition of the concerned plant protection products and/or adjuvants. Applications for a change in the composition, together with the necessary documentation, must be submitted to the Department of Pesticide Registration of the Control Institute no later than 30 November 2021. When assessing changes in the composition of plant protection products, the Control Institutes takes into account the European Commission's guidance document Guidance document on significant and non-significant changes of the chemical composition of authorized plant protection products under Regulation (EC) No 1107/2009 of the EU Parliament and Council on placing of plant protection products on the market and repealing Council Directives 79/117 / EEC and 91/414 / EEC, SANCO / 12638/2011. When submitting an application for a change in the composition, the information on co-formulants must be submitted in accordance with the information published on the website of the Control Institute (https://www.uksup.sk/aktualita/176/informacia-o-poziadavkach-na-udaje-o-pripravkoch-na-ochranu-rastlin-v-suvislosti-so-zlozenim-koformulantov).
In the coming months, the Control Institute will check the compositions of all authorized plant protection products and adjuvants with regard to the content of co-formulants. For those plant protection products and adjuvants which contain an unacceptable co-formulant and for which no application for a change in the composition has been submitted, a withdrawal procedure shall be initiated. In the case of plant protection products and / or adjuvants for which it will not be possible to unambiguously determine whether they contain unacceptable co-formulants, the Control Institute shall initiate proceedings for the review of the authorization pursuant to Art. 44 (1) of Regulation (EC) No 1107/2009 of the European Parliament and the Council concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC or according to § 12 par. 7 of Act No. 387/2013 on auxiliary plant products in plant protection and shall invite the authorization holder to clearly demonstrate that the product does not contain such substances. If the applicant does not comply with the above requirement, the Control Institute, due to precautionary principle, withdraws the authorization of such plant protection products, or adjuvants according to Art. 44 (3a) of Regulation (EC) No 1107/2009 or according to § 17 par. 1 letter c) of Act No. 387/2013.