NIPH would like to inform applicants as well as plant protection products (PPPs) authorisation holders that the EU has issued Regulation (EC) 2021/383 on the 10th of March 2021 amending thereby Annex III to Regulation (ES) No 1107/2009 by listing the co-formulants unacceptable for inclusion in PPPs.

The Regulation concerns co-formulants unacceptable as inclusion in PPPs or adjuvants.

The full text of respective Regulation is to be found at the official EU website HERE.

The list entails mainly substances classified as carcinogenic, mutagenic for human germ cells, reprotoxic cat. 1 (regardless of reprotoxic 1A or 1B subcategories), suspected to bear endocrine disrupting properties and a few other categories of substances. There are 144 entries in the list currently.

In cases where NIPH’s evaluators encountered such a substance as a constituent of a plant protection product during the assessment, the applicant was informed. This applies to assessments conducted approximately in the past 5 years.

A summary of Regulation (EC) 2021/383:

Article 1

Annex III to Regulation (EC) No 1107/2009 is amended in accordance with the Annex to this Regulation.

Article 2

Member States which have granted authorisations for plant protection products containing co-formulants listed in Annex III to Regulation (EC) No 1107/2009, as amended by this Regulation, shall amend or withdraw those authorisations as soon as possible but no later than 24 March 2023.

Article 3

Member States shall not authorise the placing on the market or use of adjuvants containing co-formulants listed in Annex III to Regulation (EC) No 1107/2009, as amended by this Regulation.

Member States which have authorised adjuvants containing co-formulants listed in Annex III to Regulation (EC) No 1107/2009, as amended by this Regulation, shall amend or withdraw those authorisations as soon as possible but no later than 24 March 2023.

Article 4

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 or national provisions for authorisation of adjuvants shall be as short as possible and shall expire for the sale and distribution at the latest 3 months and for the disposal, storage and use additional 9 months after the date of amendment or withdrawal of the authorisations referred to in Articles 2 and 3.