Recently, the European Union issued a draft regulation on the supervision of pesticide additives in the EU, which proposes detailed standards for the supervision of pesticide additives in the EU (co-formulant in plant protection products), as well as the rules and procedures for evaluation.
Perhaps many companies still have the impression that the last time the EU issued regulatory regulations on additives was in March 2021, when the EU issued a list of pesticide banned additives (Annex III to regulation 1107), ending the history of EU member States using their respective lists of additives.
Unacceptable draft amendments to auxiliaries
Obviously, only the list is not enough, this time the EU has carried out a detailed development in accordance with the provisions of Article 27 of Regulation 1107 on unacceptable additives, and issued a draft regulation of unacceptable co-formulants.
This draft puts forward a very complete rule framework for the supervision of auxiliaries. For example, the judgment criteria of unacceptable additives, the process of evaluation and notification, the participants involved (member States, EFSA, EC, etc.) and their respective divisions of labor, including the later public review, expert evaluation, decision issuance and so on.
At the same time, the draft also incorporates the requirements of some relevant regulations. Including the other provisions of regulation 1107, the European Union persistent Organic pollutants regulation, the European Union REACH regulation, the European Union Biocide regulation, the European Union Uniform Classification of substances Regulation and other parts of the content, involving EU member states, EFSA, ECHA, EC and other multi-party cooperation. In other words, the compliance of additives will not only be limited to the 1107 regulation, but also involve the cross-supervision of multiple regulations.
Unacceptable auxiliaries classification standard
The draft EU Regulation on additives elaborates on the criteria for determining unacceptable additives. So, what kind of additives will be classified as unacceptable by the EU?
The annex to the
draft clearly proposes 10 criteria, including,
1, the auxiliaries are classified as mutagenic 1A or 1B.
2, additives are classified as carcinogenic category 1A or 1B.
3, additives are classified as reproductive toxicity 1A or 1B.
4, additives are listed in the EU Persistent Organic Pollutants Regulation (EC) No 2019/1021 Annex I to V (POP substances).
(5) Additives are included in the list referred to in Article 59(1) of the EU REACH Regulation (EC) No 1907/2006 (Candidate List). Include:
Identified as persistent, bioaccumulative, and toxic (PBT substances).
Identified as very persistent and very bioaccumulative (vPvB substance)
is identified as having endocrine disrupting properties and is a substance of high concern.
In accordance with Regulation (EU) No 528/2012, additives are identified as having endocrine-disrupting properties.
7, the decision has been adopted not to approve the additive as an active substance in product type 6 under the EU Biocidal Regulation (BPR, Regulation (EU) No 528/2012).
8, an active substance approved under the EU Biocidal Regulation (BPR, Regulation (EU) No 528/2012), but with restrictions on its use as an additive in plant protection products.
9, as an additive in plant protection products is listed in Annex XVII of the EU REACH Regulation (EC) No 1907/2006, restricting its use in plant protection products.
10, additives do not belong to any of the points 1 to 9 above, but when used as additives in plant protection products, do not meet the criteria for approval of active substances as specified in Annex II of the EU Pesticide Regulation (EC) No 1107/2009.
Consultation
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