Although the vast majority of food products do not require authorisation per se, there are a number of considerations to bear in mind before entering the market. Notifications at national level are required for food supplements and certain special-purpose foods.
The nature and scope of the documentation to be submitted depend on the legal and regulatory requirements. In particular, for foods for special medical purposes (FSMPs), in addition to the formal criteria, the nutritional suitability must also be justified from a scientific perspective.
Substance-specific authorisation must be obtained in advance for technological additives, enzymes and certain flavourings (so-called FIAP substances) as well as novel foods. This primarily affects suppliers of ingredients, who must deal with the wide range of implementing regulations and EFSA guidelines within the European framework.
My Services
Clarification of any potential regulatory requirements
Strategy consultation
Involvement of the relevant authorities where necessary
Consultation procedures
Gap analysis and data requirements
Literature review
Preparation of test plans
Risk assessment taking into account the intended use
Support with the preparation of dossiers (in accordance with EFSA guidelines)
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