Co-formulants

Date: 27 May 2020

According to Article 2(3)c of Regulation (EC) No 1107/2009, co-formulants are "substances or preparations which are used or intended to be used in a plant protection product or adjuvant, but are neither active substances nor safeners or synergists”. Apart from the active substances, plant protection products therefore contain co-formulants which give the product the necessary properties for application such as solvents, carriers, inert material, wetting agents, etc. and which are supposed to have a positive effect on production, storage or use of a product. Co-formulants in turn can consist of several components.

All co-formulants which are contained in the formulation of a plant protection product have to be characterized by the applicant or the manufacturer when an application is made for authorization. Co-formulants deemed to have an unacceptable harmful effect on human/animal health or on the environment, will not be permitted to be included in plant protection products as specified in Article 27 of Regulation (EC) No 1107/2009. A list of the co-formulants whose use is not permitted in plant protection shall be provided in Annex III of Regulation (EC) No 1107/2009 but up to now this annex has no entries. Nevertheless, the EU draft regulation implementing the list of co-formulants that shall not be used in plant protection products is under discussion. After entry into force of the list Member States must withdraw authorizations of products containing any of the listed unacceptable co-formulants at the latest by 2 years.

For a transitional period the Member States can continue to apply national provisions for co-formulants. For example in Germany, a series of toxicologically or ecotoxicologically relevant co-formulants have been replaced in plant protection products over the past few years on national level. This means that plant protection products containing a co-formulant mentioned in the accordant "List of unwanted co-formulant substances" have no prospect of being authorized in Germany.

In the other hand Germany provides also a list of 1654 co-formulants in alphabetical order of their commercial names which are contained in authorized plant protection products and the composition of which is sufficiently known to the Federal Office of Consumer Protection and Food Safety (BVL). For these co-formulants information on the composition is usually not needed. It is sufficient if a current safety data sheet is submitted with the application for authorization.

Joachim Kranz