Draft EU regulation (Pesticides) – Identification of unacceptable co-formulants

The European Commission opened a 4-week feedback period to submit comments on a draft Regulation setting out detailed rules for the identification of unacceptable co-formulants in plant protection products.

Deadline is 18 November 2022.

The draft regulation has the following purposes:

- Set out detailed rules for identification of unacceptable co-formulants.

- Lay down rules on the procedure to follow for the inclusion of co-formulants in Annex III to Regulation (EC) No 1107/2009.

- Establish a procedure allowing Member States to notify the Commission about co-formulants already listed in Annex III to Regulation (EC) No 1107/2009 which may need to be deleted from that Annex or about any conditions established in that Annex for co-formulants which may need to be amended.

According to the draft regulation, a co-formulant should not be accepted for inclusion in plant protection products if:

- It is or has to be classified as carcinogenic, mutagenic or toxic to reproduction, Categories 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CLP Regulation).

- It is identified as substance of very high concern in accordance with Regulation (EC) No 1907/2006 for reasons other than its classification as carcinogenic, mutagenic or toxic to reproduction, Categories 1A or 1B.

- It has been identified as a persistent organic pollutant under Regulation (EU) 2019/1021.

- It has been identified as having endocrine-disrupting properties under Regulation (EU) No 528/2012 and has not been approved as active substance for use as preservative during storage, or any restrictions have been established in accordance with that Regulation which affect uses in plant protection products.

- The restrictions as provided for in Annex XVII to Regulation (EC) 1907/2006 should also apply for all those substances susceptible to be used, or which are currently used, as co-formulants in plant protection products.

- The criteria for the approval of active substances concerning human or animal health and the environment, as provided for in Annex II to Regulation (EC) No 1107/2009, insofar as not already covered by the other criteria for not accepting co-formulants, should also apply to co-formulants.

The legal basis to adopt this new regulation is Article 27.5 of Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market, which provides for the possibility of establishing detailed rules for the determination of unacceptable co-formulants and their inclusion in Annex III of Regulation (EC) No 1107/2009. The draft regulation incorporates criteria already discussed by the European Commission and the Member States in the recent years, in line with those established in parallel regulations with an impact on the authorisation of plant protection products and their active substances, such as REACH and CLP. These criteria was also summarised in the recitals of Commission Regulation (EU) 2021/383 of 3 March 2021, which established the first list of unacceptable co-formulants. However, strictly speaking, there is not yet any Regulation establishing these criteria with binding force in the EU.

The adoption of this draft Regulation might contribute to the establishment of a harmonised EU criteria to be followed by all Member States, thereby, ensuring uniformity in decisions taken at national level in authorisation of plant protection products in relation to their co-formulants. However, there are certain provisions in the draft regulation that could lead to contradictions and generate legal uncertainty in this respect. This should therefore be regulated in a clearer and more detailed way in the final version.

Link to the EU Initiative: Plant protection products (pesticides) – identification of unacceptable co-formulants (europa.eu)

For comments or assitance, please contact Claudio.Mereu@fieldfisher.com and Adrian.ParraGarcia@fieldfisher.com