The European Union publishes draft regulations for pesticide additives

Recently, the European Union released the draft regulatory regulations on EU pesticide additives, which put forward detailed standards for the supervision of EU pesticide additives (co-formulant in plant protection products), as well as the rules and procedures
for review.

Perhaps many companies still have the impression that the last time the EU issued regulations on additives was in March 2021, when the EU released a list of additives banned for pesticides (Annex III of Regulation 1107), ending the history of
EU member states using self-help lists.

◆ This list of EU pesticide banned additives is ten years late, and 144 substances are listed as banned additives

Amendments to the draft auxiliaries are not acceptable

Obviously, a list is not enough, and this time the EU has developed in detail in accordance with Article 27 of Regulation 1107 on unacceptable additives, and issued a systematic draft
regulation of unacceptable co-formulants.

This draft proposes a very complete framework of rules for the regulation of auxiliaries
.
For example, the criteria for judging unacceptable additives, the process of evaluation and notification, the participants involved (Member States, EFSA, EC, etc.
) and their respective division of labor, including a complete set of processes
such as later public comment, expert evaluation, decision release, etc.

At the same time, the draft also incorporates the requirements
of some relevant regulations.
Including other provisions of the 1107 regulation, the EU Persistent Organic Pollutants Regulation, the EU REACH Regulation, the EU Biocides Regulation, the EU Harmonized Classification of Substances Regulation, etc.
, 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.

This shows the systematic nature of EU regulation development, and at the same time puts forward higher requirements
for corporate compliance.
If you have related questions, you can seek the help
of professional consulting agencies.

Additive classification criteria are not acceptable

The draft EU Auxiliaries Regulation elaborates
on the criteria for determining unacceptable additives.
So, what kind of additives will be classified as unacceptable in the EU?

The annex to the draft specifies 10 criteria, including,

1.
Auxiliaries are classified as mutagenic 1A or 1B categories
.

2.
Auxiliaries are classified as carcinogenic 1A or 1B categories
.

3
.
Auxiliaries are classified as reproductive toxicity category 1A or 1B.

4.
Auxiliaries are listed in Annexes I to V (POP substances) of Regulation (EC)
No 2019/1021.

5.
Auxiliaries are included
because they are recognized as being in the list referred to in Article 59(1) of the Regulation (EC) No 1907/2006 (Candidate List).
Include:

· Recognized as persistent, bioaccumulative and toxic (PBT substance).

· Identified as very persistent and very bioaccumulative (vPvB substance)

· It is recognized as having endocrine-disrupting properties and is a substance
of high concern.

6.
According to Regulation (EU) No.
528/2012, additives are determined to have endocrine-disrupting properties
.

A decision has been adopted not to approve the additive as an active substance
for product type 6 under the EU Biocicide Regulation (BPR, Regulation (EU) No 528/2012).

8.
Active substances approved according to the EU Biocides Regulation (BPR, Regulation (EU) No 528/2012), but restricting their use
as auxiliaries in plant protection products.

9.
As an additive in plant protection products, it is listed in Annex XVII of Regulation (EC) No 1907/2006) of the EU REACH regulation, restricting its use
in plant protection products.

10.
Auxiliaries do not fall under any of the above points 1 to 9, but when used as additives in plant protection products, they do not meet the criteria
for the approval of active substances specified in Annex II of Regulation (EC) No 1107/2009).

In accordance with the above criteria and the process in the draft, the EU will update the list of banned additives proposed in 2021 (Annex III of Regulation 1107), including by allowing additives already on the list to be removed from or amended from the list, or new substances to be added to
the list.