Adjuvants

Date: 26 May 2020

Adjuvants are substances used to enhance the efficacy or other properties of plant protection products and thus, shall fall also under the scope of the EU plant protection Regulation 1107/2009.

Considering the current needs of agriculture in the EU e.g. with respect to reduction of dose rates for plant protection products, adjuvants used as mixing partners are a valuable tool for agricultural practice. Therefore, according to Article 58(2) of Regulation 1107/2009 defining the placing on the market and the use of adjuvants, an additional regulation should be adopted providing “detailed rules for the authorization of adjuvants, including data requirements, notification, evaluation, assessment and decision making procedures” but such a regulation on adjuvants is currently still not available.
Accordingly, registration of adjuvants is still the objective of national plant protection laws of the EU Member States. In consequence, registration procedures for adjuvants vary hugely between countries. The differences between registration procedures established in the Member States apply to the data requirements as well as the administrative procedures.

With respect to data requirements some member states like Germany have no or very low data requirements besides a detailed analysis of the composition of the product as well as of the composition of possible co-formulants used in the adjuvant. On the other hand the procedure established for adjuvant registration e.g. in France is quite similar to the authorization procedure for plant protection products according to Regulation 1107/2009 including the submission of a draft registration report and, if applicable, studies for all relevant sections such as e.g. physical chemical parameters and analytics, toxicology, ecotoxicology and efficacy.

Administrative procedures for adjuvants also vary between the Member States. This applies not only for a direct application for authorization but also for procedures such as mutual recognition or the authorization of generic products. In Germany for example, mutual recognition is not possible, whereas France accepts both procedures in addition to a direct application for authorization. Thus, in France adjuvants are already handled more or less in compliance to Regulation 1107/2009 considering data requirements as well as administrative procedures whereas in countries such as Germany the registration procedure is still a national issue.

Joachim Kranz