New Peptides: a challenge in terms of regulatory compliance?

Although peptides have long been present in foods, interest in new peptide-based ingredients has grown significantly in recent years. While Asia and the United States have driven much of this development, these peptide ingredients are now gaining increasing attention worldwide.

Unlike the conventional peptides (short chains of amino acids) naturally present in foods through the digestion or breakdown of proteins, many of the new peptide ingredients are specifically isolated and concentrated using advanced technologies such as hydrolysis, fermentation or other manufacturing processes.

This technological evolution developed for their potential targeted physiological effects, creates new opportunities for the food sector, but also raises important regulatory questions.

Legal status of peptides

In Europe, peptides that cannot claim a significant history of food consumption prior to 1997, will be classified as “novel foods,” and considered dangerous. Therefore, they are not allowed to be placed on the market until they are authorized under the related Regulation EU 2015/2283 (1). In order to get this authorization, the Food Business Operator (who is responsible for the right qualification of its product) must proceed with different analyses regarding the substance itself, to demonstrate its safety for the contemplated use.

Only if the European Food Safety Authority (EFSA) gives a positive opinion, the European Commission can add this substance to the Union list of authorized novel foods (2).

While peptides are often used for their low allergenic potential (baby food) and their easy absorption (muscle recovery), they are increasingly intended for use in food supplements. To date, two peptide mixtures were authorized by the European Commission (2011, 2018) (3). Four protein hydrolysates were also authorized in 2002, 2018, and 2023 (4).

More recently, the European Food Safety Authority (EFSA) issued a positive assessment (May 21, 2026) for the nonapeptide-pentapeptide mixture as a novel food for use in food supplements (5).

Marketing issues and claims

Peptide-based ingredients are frequently marketed for benefits relating to skin appearance, healthy ageing, sports recovery, joint health or metabolic wellness. In the European Union, however, such benefits cannot be communicated freely.

Accordingly, any claims must comply with the provisions of Regulation (EC) No 1924/2006 (6) which distinguish between nutrition and health claims, the latter establishing a link between a food, or one of its constituents, and health. They are subject to a specific authorisation regime and may only be used where they have been authorised and fully comply with relevant conditions of use.

Therefore, operators may, either rely on general health claims that have already been authorised based on a scientific assessment conducted by EFSA, and then included in the EU Register, or submit a new application. The dossier is assessed by EFSA, which examines whether a cause-and-effect relationship between the ingredient and the claimed physiological effect has been scientifically established. Based on EFSA’s opinion, the European Commission decides whether the claim should be authorised.

For peptide-based ingredients, the regulatory picture remains challenging, as no health claim specifically relating to peptide has been authorised to date.

Several peptide-related claims have been assessed but ultimately rejected, for example:

• Lactotripeptides (IPP and VPP) for blood pressure management (multiple negative assessments between 2009 and 2012) (7), and;
• Collagen hydrolysates for the maintenance of joint health  (8);

This does not mean that peptide-containing products cannot bear health claims but illustrates the fact that usually it is easier to rely on authorised claims relating to other nutrients present in the formulation.

For example, claims such as “protein contributes to the growth of muscle mass” or “protein contributes to the maintenance of muscle mass”, or “vitamin C contributes to normal collagen formation for the normal function of skin”.

References and notes

1. Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods. https://eur-lex.europa.eu/eli/reg/2015/2283/oj/eng
2. Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R2470-20260316
3. Ibid.
4. EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), Turck, D.,Bohn, T., Cámara, M., Castenmiller, J., De Henauw, S., Jos, Á., Maciuk, A., Mangelsdorf, I., McNulty, B., Naska, A.,Pentieva, K., Siani, A., Thies, F., Aguilera- Gómez, M., Frenzel, T., Marcon, F., McArdle, H. J., Moldeus, P., … Hirsch-Ernst,K. I. (2026). Safety of nonapeptide–pentapeptide mixture as a novel food pursuant to regulation (EU) 2015/2283.EFSA Journal, 24(5), e10098.
   https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R2470-20260316
5. https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.10098
6. Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. https://eur-lex.europa.eu/eli/reg/2006/1924/oj/eng
7. https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2009.1259
8. https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2011.2247