Prohibition of products with unacceptable co-formulants
On 3 March 2021 Annex III – the list of unacceptable co-formulants – was published to supplement Article 27 of the Plant Protection Products Regulation (EC) No. 1107/2009. The corresponding Regulation (EU) 2021/383 entered into force on 24 March 2021
As a result, from 24 March 2023, any plant protection products and adjuvants that are co-formulated with the substances on the list can no longer be on the market. For unacceptable substances that end up in the product as a co-formulant-borne impurity, a threshold value of 0.1% by weight of the whole product applies.
The Ctgb has the obligation to amend or withdraw authorisations for plant protection products; and adjuvants that contain an unacceptable co-formulant. The Ctgb will therefore request the companies concerned to modify the formulation of these products or allow the withdrawal of the authorisation.
In order to bring authorised products with unacceptable co-formulants into line with the new Regulation, a formulation change request is required. To meet the obligations before the deadline, applicants must take the following processing times into account (calculated from the time of payment):
- Major change in the formulation of the plant protection product: zonal application: 1.5 years.
- Minor change in the formulation of a plant protection product: administrative application (form WI): 12 weeks.
- Change in formulation of an adjuvant: 6 weeks.
- Withdrawal of plant protection product/adjuvant: 6 weeks.
Screening for Annex III substances
An important point of attention with co-formulants that are themselves a mixture of substances is that none of the deliberately added components may appear on the Annex III list. In practice, therefore, the CAS number of the total mixture is not determinant, but that of the individual components.
The evaluation manual will soon be updated with the criteria the Ctgb uses.
Authorisation holders of derived authorisations with prohibited substances are not required to take any action if their products contain unacceptable co-formulants. This is because derived authorisations follow the original authorisation.
Parallel trade permits
Authorisation holders with parallel trade permits do not need to take any action either; the competent authority of the relevant Member State from which the product is imported will ensure that the product does not contain unacceptable co-formulants from 24 March 2023.
The authorisation holder is responsible
Authorisation holders who hold an authorisation/permit for a plant protection product or an adjuvant with unacceptable co-formulants are themselves responsible for ensuring that their authorisation/permit is in line after 24 March 2023 with the new Regulation (EU) 2021/383. Therefore, if you have not been notified, but your product does contain unacceptable substances, you must still submit a change or withdrawal request before the deadline. If you hold no current authorisations for products with prohibited substances, no action is required.