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20 March 2023
EUROPE – COM : Publication of the regulation amending CLP
4 April 2023
Following the public consultation on the draft regulation, the Commission published on 14 March 2023 in the Official Journal of the European Union Regulation (EU) 2023/574 setting out detailed rules for the identification of unacceptable co-formulants in PPP in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council.
The annex to Regulation (EU) 2023/574 lists the 10 criteria for identifying a co-formulant as unacceptable (see our previous article) and the regulation specifies the assessment procedure that may lead to inclusion in annex III of Regulation (EC) No 1107/2009 listing co-formulants which are not accepted for inclusion in PPP.
A first list of unacceptable co-formulants has been established by Commission Regulation (EU) 2021/383.
During the evaluation of PPP applications, when a Member State considers that a co-formulant could meet one or more of the criteria set out in the annex to Regulation 2023/574, it will have to notify the other Member States, the Commission and the European Food Safety Agency (EFSA) with an assessment report. When criterion 10 applies “[…], having regard to realistic conditions of use and good plant protection practice, [the co-formulant] 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 plant protection product”, EFSA will conduct an independent assessment and update the report on the co-formulant.
The Commission will then present a draft regulation. The adopted regulation will provide that :
- a co-formulant is listed in annex III to Regulation (EC) No 1107/2009, subject to conditions and restrictions, where appropriate;
- a co-formulant is not listed in annex III to Regulation (EC) No 1107/2009; or
- the entry of a co-formulant in the list in annex III to Regulation (EC) No 1107/2009 is amended; or
- the entry of a co-formulant is deleted from the list in annex III to Regulation (EC) No 1107/2009.
To be noted, in accordance with Regulation (EC) No 1107/2009, the Commission may review the case of a co-formulant at any time and Member States will still have the possibility to temporarily prohibit or restrict the use of a co-formulant within their territory.
Regulation 2023/574 will apply to applications for authorisation of PPP, including for their amendment or renewal, submitted from 3 April 2023.
To download:
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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