EUROPE – COM – Public Consultation : Draft regulation for the identification of unacceptable co-formulants

The European commission has launched a public consultation from 21 October 2022 to 18 November 2022 on a draft implementing regulation to detail the rules and criteria for the identification of unacceptable co-formulants for inclusion in plant protection products (PPP).

In addition to setting out the criteria for the identification of unacceptable co-formulants, detailed below, the draft regulation presents how Member State (MS) will assess co-formulants and notify those that appear unacceptable. The content of the notification report for a co-formulant identified as unacceptable and the procedure for its publication by the Commission is described. The procedure for inclusion of the co-formulant in Annex III to Regulation (EC) No 1107/2009 is also detailed.

The annex of the regulation lists the 10 criteria that may lead to the identification of a co-formulant as  unacceptable :

• The co-formulant is classified as mutagen category 1A or 1B (1), carcinogen category 1A or 1B (2) or  toxic for reproduction category 1A or 1B (3) in Part 3 of Annex VI to Regulation (EC) No 1272/2008.

• The co-formulant is listed in Annexes I to V to Regulation (EU) 2019/1021 (4).
• The co-formulant is included in the list referred to in Article 59(1) of Regulation (EC) No 1907/2006, identified as persistent, bioaccumulative and toxic (Article 57, point (d)), very persistent and very bioaccumulative (Article 57, point (e)) or of very high concern  due to endocrine disrupting properties (Article 57, point (f)) (5).
• The co-formulant is identified as having endocrine-disrupting properties in accordance with Regulation (EU) No 528/2012 (6).
• A decision was adopted not to approve the co-formulant as an active substance for product-type 6 (7) or to approve it as an active substance with restrictions that are relevant for PPP uses (8) under Regulation (EU) No 528/2012.
• The use of the substance as a co-formulant is included in Annex XVII to Regulation (EC) No 1907/2006 and restricted for the use in PPP (9).
• The co-formulant does not fall under any of the points (1) to (9), but, having regard to realistic conditions of use and good plant protection practice, it does not comply with one of the criteria for the approval of active substances as provided for in Annex II to Regulation (EC) No 1107/2009, when used as a co-formulant in a PPP (10).

Interested parties are invited to submit comments on the draft document via the dedicated consultation page. The adoption of the regulation by the Commission is planned for the fourth quarter 2022.

To download: 

Draft implementing regulation and its Annex for the establishment of harmonised criteria and procedures for identifying unacceptable co-formulants

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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