Food for Special Medical Purposes form part of a larger framework of Food for Specific Groups (FSG). The unique regulatory requirements of Foods for Special Medical Purposes can bring about possible hurdles for Food Business Operators.

In this report, we take a closer look at the legal requirements, specific regulatory framework and we provide tips on how to prevent potential pitfalls from the start.

The appetite for alternative proteins as a substitute to animal proteins is increasing. This is evidently nourishing numerous developments with the innovative use and mixing of plant, algae, insect ingredients through innovative techniques, such as precision fermentation and cell differentiation. To make the research and development worthwhile it is essential to adequately grasp and manoeuvre the regulatory pathway for bringing innovative foods to the actual tables of consumers. This report outlines the legal framework applicable to alternative protein products in the European Union. It particularly focuses on the EU novel food Regulation, being the core Regulation for foods that have no established history consumption in the Europe Union. Explained are the process steps and timelines as well as the important elements to consider for the risk evaluation and the labelling of alternative protein products to guarantee a successful entry into the European Union Market.

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Rapid improvements in the field of cellular agriculture, especially within the area of cultured meat, has regulatory authorities awaiting companies to start submitting applications for the registration of these products. Risk management and risk assessment of foods in the European Union are the responsibility of the European Commission (EC) and the European Food Safety Authority (EFSA). It is currently believed that the first applications for cultured meat will be evaluated in the same way as novel foods for regulatory approval. The existing guidelines that are applicable to all novel foods should be followed by food business operators when submitting applications for cultured meats, as confirmed by EFSA.

In this comprehensive report, we cover the regulatory context for cultured meats in the European Union and demonstrates how they can be adequately assessed for safety in line with EFSA´s Novel Food Guidance.

An interesting addition to this report is the inclusion of the Singapore Food Agency’s updated Novel Food guidance on cultured meats, as Singapore is the first country to approve a cultured meat product.