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Latest release! 10 judgment standards for prohibited additives in plant protection products

2023-03-14

Latest release! 10 judgment standards for prohibited additives in plant protection products

On March 14, 2023, the European Commission officially issued the Decision Criteria Act (EU) 2023/574 on Prohibiting the Use of Additives in Plant Protection Products (PPP) in the Official Gazette. The regulations of this Act will apply to applications for the authorization of PPP products submitted from April 3, 2023 (including product applications, updates, and modifications).
The Annex to Regulation (EU) 2023/574 lists a total of 10 criteria for the determination of additives that cannot be used in plant protection products, and specifies the evaluation procedures for listing these unacceptable additives in Annex III (List of Prohibited Additives) of Regulation (EC) 1107/2009. Those that meet the criteria may be formally listed in Annex III of the Prohibited Additives List. During the review of a PPP application by a Member State, if it is considered that an additive meets one or more of the standards set out in the Annex to Regulation (EU) 2023/574, the Member State must notify the other Member States, the European Commission, and the European Food Safety Agency EFSA. EFSA will also conduct an independent evaluation of the additive. The European Commission will then submit a draft regulation to provide for, for example, the additives listed in Annex III to Regulation (EC) 1107/2009, Will be constrained by usage restrictions, modified, or deleted/added as appropriate.

Table 1 10 Judgment Criteria for Additives Not Available for Plant Protection Products

Number	standard of criterion
1	The substance is classified as mutagenic 1A or 1B
2	The substance is classified as carcinogenic 1A or 1B
3	The substance is classified as reproductive toxicity 1A or 1B
4	The substance is classified as a persistent organic pollutant (POP substance)
5	The substance is identified as persistent, bioaccumulative, and toxic (PBT substance); The substance is considered to be very persistent and very bioaccumulative (vPvB substance); Or substances of high concern due to endocrine disrupting properties
6	The substance has been identified as having endocrine disrupting properties
7	Additives prohibited for use in biocide product type 6
8	Substances approved for use as biocides but limited in their use as adjuvants in plant protection products
9	Registration of pesticide auxiliaries under REACH regulations has been completed, but the use of substances in PPP is limited
10	Does not fall within the above points 1 to 9, but does not meet the approval criteria for active substances specified in Annex II to (EC) 1107/2009 considering the actual conditions under which the substance is used for the production of PPP

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