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Active substances have to fulfil certain requirements to be eligible for classification as basic substance, i.e. the substance is not a substance of concern, does not have an inherent capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects, is not predominantly used for plant protection purposes but nevertheless is useful in plant protection either directly or in a product consisting of the substance and a simple diluent and is not placed on the market as a plant protection product. Furthermore, the substance shall have neither an immediate or a delayed harmful effect on human or animal health nor an unacceptable effect on the environment. Examples for basic substances are onion oil, vinegar, beer or sunflower oil.

The approval procedure for basic substances deviates from the procedures for low risk or conventional active substances. The application for the approval of a basic substance is submitted by a Member State or by any interested party directly to the Commission. The application has to include for example any evaluation of its possible effects on human or animal health or the environment carried out in accordance with other Community legislation regulating the use of the substance as well as any other relevant information on its possible effects on human or animal health or the environment. On its part, the Commission asks EFSA for an opinion, or for scientific or technical assistance.

Basic substances are approved for an unlimited period. However, the Commission can review the approval of a basic substance at any time. It may take into account the request of a Member State to review the approval. Where the Commission considers that there are indications that the substance no longer satisfies the criteria the approval may be withdrawn or amended.

According to Article 28(2a) of Regulation 1107/2009 on the authorisation for placing of plant protection products on the market, for basic substances no product authorisation is required for the “use of products containing exclusively one or more basic substances” whereat for basic substances product is defined as “consisting of the substance and a simple diluent” (Article 23 (1c)). Interestingly, the working document on the procedure for application of basic substances (SANCO/10363/2012 rev.9 of 21 March 2014) clearly states that “any other products deviating from the definition of Article 28(2)(a) containing for example an already approved “basic substance” and a co-formulant shall have to be considered as plant protection product. Therefore, in compliance with Article 2 [defining the scope of Regulation 1107/2009] in that case the substance will constitute the “active substance“. In such case, the substance needs to be approved as active substance. An application accompanied by a dossier in compliance with Article 8 [defining active substance dossiers] of the Regulation will have to be submitted”.

Basic substances automatically qualify for use in organic farming.

Lars Huber