What is the regulatory status of collagen peptides in the EU and US?

Beyond Biopharma | Collagen Peptide FAQ

Short answer: Collagen peptides have a long history of use as food protein in both the United States and the European Union. In the United States the central question is the basis on which the ingredient is considered safe for its intended use, usually a GRAS position, together with lawful labelling. In the European Union the first gate is whether the ingredient has a history of consumption as food before 15 May 1997, which decides whether it falls under the Novel Food rules. The precise position for a specific product is confirmed by the importer against current rules in each market.

A shared starting point

Collagen peptide is protein from animal tissue that has been hydrolysed into short chains. In both markets it is treated as a food ingredient rather than a drug, and it is used in supplements, beverages, bars, gummies and clinical nutrition. The ingredient itself is therefore rarely the difficult part of a regulatory review; the difficulty usually lies in the safety basis for a particular production process, the labelling of the finished product, and any claim a brand wants to make.

The United States: GRAS is the key concept

Under the Federal Food, Drug, and Cosmetic Act, a substance added to food must either be approved as a food additive or be generally recognised as safe (GRAS) for its intended use. GRAS status rests on scientific evidence widely accepted by qualified experts, or on a history of common use in food before 1958. Collagen peptides are widely understood to fall into that category, and a supplier supports the position in one of two ways: a self-affirmed GRAS conclusion held in an internal dossier, or a voluntary GRAS Notice filed with the Food and Drug Administration, published together with the agency response. Reading the published notice and response for the specific ingredient is far more informative than relying on the phrase generally recognised as safe on a data sheet, because the notice states the intended uses and use levels that were reviewed.

The European Union: the Novel Food question comes first

In the EU, food not used for human consumption to a significant degree before 15 May 1997 is a novel food and requires authorisation before it can be placed on the market, while ingredients with a documented history of consumption before that date fall outside the Novel Food Regulation. Many conventional collagen hydrolysates from bovine and fish sources are placed on the market on the basis of that history, while ingredients made by a genuinely new process, or from a source without that history, may need the authorisation route, which involves a safety assessment and a Union list entry. The practical check is the European Commission Novel Food Catalogue and, where the position is not obvious, the competent authority in the member state where the product will be sold.

What this means in practice

• Ask the supplier which regulatory basis applies to the exact grade and process, and what documentation exists for it.
• Read primary documents where they exist - a published GRAS Notice, a Union list entry or a catalogue entry - rather than a summary.
• Keep the intended use and use level consistent with the basis reviewed, because a GRAS position covers a stated use, not unlimited use.
• Confirm the labelling rules for the finished product, including allergen and nutrition declarations.

Rules, guidance and catalogue entries change, and a conclusion correct for one product may not transfer to another source, process or use level. For markets beyond the two discussed, and for any product whose position is not clearly documented, treat current local requirements as authoritative and consult a regulatory adviser before launch.

Related reading

For more detail, see structure-function claims for collagen peptides, which certificates buyers check and non-GMO status and allergen control.