Definition and Registration Requirements
Adjuvants, such as wetting agents, stickers and anti-foaming agents, are products added and mixed with a plant protection product, fertiliser or biostimulant to improve its efficacy, to allow better adherence of products for seed treatment or to prevent excessive foam formation.
Before an adjuvant can be placed on the European market, an authorisation is required. In general, adjuvants for plant protection products 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 have not yet been finalised on EU level. Consequently, adjuvants are in practice still regulated under the national laws of each European Member state.
Adjuvant registration procedure in the EU Member States
Data requirements and procedures in the EU Member States differ significantly. In Austria, for example, no registration procedure exists for adjuvants. The placing on the market of an adjuvant and its correct classification and labelling is solely the responsibility of the manufacturer. Other Member States, such as Germany or the Netherlands, have a notification/registration procedure, according to which 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 adjuvant and its co-formulants. In other countries, such as Belgium or Hungary, data requirements are much stricter and already mirror more or less the data requirements for PPP registration according to Regulation 1107/2009. Data from all sections need to be provided in dRR-format. However, data requirements, especially for biological products, can often be addressed by scientific justifications and literature in spite of studies.
Our Services for Adjuvant Registration
Good knowledge of national requirements is essential for an adjuvant registration in European Member States. SCC can provide scientific and regulatory support for national adjuvant registration, including:
- Feasibility check or data gap analysis
- Developing a registration strategy
- Preparing and submitting final application documents
- Subsequent defence