Information on plant pesticide products autorization data requirements for co-formulants

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Central Control and Testing Institute in Agriculture (hereinafter referred to as the “Control Institute”) informs the applicants that from 1 June 2020 in the framework of data requirements according to Article 33 (3a) and 42 (1c) of Regulation (EC) No 1107/2009 of the European Parliament and the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC and according to Part A of Annex, Section 1, Point 1.4.3. of Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market all applications for new authorisation of plant protection products, mutual recognition of plant protection products, renewal of authorisation of plant protection products and composition change of plant protection products must be accompanied with the full composition details of all co-formulants (both, substances and mixtures) used in the relevant plant protection products.

According to the above-mentioned requirements co-formulants shall, where possible, be identified both by their chemical name as given in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council or, if not included in that Regulation, in accordance with both the International Union of Pure and Applied Chemistry (IUPAC) and Chemical Abstracts (CA) nomenclature. Their structural formula shall be established and provided. For each component of the co-formulants the relevant EC number and Chemical Abstracts Service (CAS) number, where they exist, shall be provided. Where the information provided does not fully identify the co-formulant, an appropriate specification shall be provided. The trade name, where available, shall also be provided. Current mass safety data sheets pursuant to Article 31 of Regulation (EC) No 1907/2006 and other Europan legislation shall be provided. They shall be up to date and in accordance with other Union legislation.

The applicant shall ensure the delivery of the required documentation even if he does not have access to it, the composition must be delivered directly from the manufacturer of the co-formulant to the Control Institute.