REGULATORY NEWS

Adjuvant registration

Date: 15 December 2020

Adjuvants are products such as wetting agents, stickers and anti-foaming agents which are added and mixed with a plant protection product (PPP) to improve the efficacy of a PPP, to allow better adherence of products for seed treatment or to prevent excessive foam formation.

Before an adjuvant can be placed on the market an authorisation is required. In general, adjuvants fall within the scope of the Regulation 1107/2009 (the Plant Protection Products Regulation. Detailed rules for the authorisation of adjuvants, including data requirements, notification, evaluation, assessment, and decision making procedures are foreseen in Art. 58(2) of the Regulation but still have not been finalised on EU level. For example, Annex III of Reg. (EC) No 1107/2009 includes a list of co-formulants which are not accepted for inclusion in plant protection products, including adjuvants, as referred to in Article 27. Currently this list does not include any entries. Due to the lack of harmonised rules at EU level, adjuvant registration is currently handled nationally on Member State level according to national plant protection laws.

Data requirements and procedures in the Member States differ significantly. In Austria for example no registration procedure for adjuvants exists. The placing on the market of an adjuvant and its correct classification and labelling is solely in the responsibility of the manufacturer. In other Member States such as Germany or the Netherlands a notification/registration procedure exists and information on function, composition, intended use and area of use of the adjuvant needs to be provided as well as a draft label and safety data sheets of the product and its co-formulants. In other countries as for example Belgium or Hungary data requirements are much stricter and already more or less mirror the data requirements for PPP registration according to Regulation 1107/2009 and require data from all sections in dRR-format. However, especially for biological products, data requirements often can be addressed by scientific justifications and literature in spite of studies.

SCC GmbH can provide scientific and regulatory support for national adjuvant registration, starting with a feasibility check or a data gap analysis for your product to develop a registration strategy following up with preparation of final application documents, submission to authority and defence of the application.