Basic substances
Basic substances according to Article 23 of Regulation (EC) No 1107/2009 are substances that are useful for plant protection but are not primarily used for plant protection or marketed as plant protection products. Furthermore, the substances must be harmless and must not be capable of causing endocrine disruption or neurotoxic or immunotoxic effects.
Authorization
Applications for approval of basic substances may be submitted to the Commission by interested parties or by a Member State. The documents to be submitted are listed in general terms in Article 23(3) of Regulation (EC) No 1107/2009.
The approval of a basic substance is based on an assessment report by the Commission. This defines the identity and specification, describes the permitted uses and sets out the conditions under which the basic substance may be used. The Commission receives scientific support from the European Food Safety Authority (EFSA).
Approvals of basic substances are valid indefinitely. However, they can be reviewed at any time if there is reason to believe that the above criteria are no longer met.
The approval status of basic substances can be called up in the European Commission's database of active substances (EU Pesticides Database). Basic substances can be searched for by selecting the category "Active substances" and the type "Basic substance". All assessment reports are also available in the active substance database.
Differentiation from plant protection products
Basic substances are not plant protection products and may not be labeled or marketed as such. Nor may the main purpose of a basic substance product be plant protection. However, they do have a secondary use for plant protection and users, especially those who are not knowledgeable, should be informed about the stipulated application specifications.
Information on efficacy and instructions for use may therefore be given in advertising and on the packaging material, but must be consistent with the approval of the basic substance contained and its assessment report.
Statements and representations that go beyond this or are misleading in an overall view, as well as those that suggest the sale of a plant protection product, are not permitted. In this case, the placing on the market of an (unauthorized) plant protection product would have to be assumed.