Tier 3 — preclinical

Safety of Egg Membrane Collagen Peptides as a Novel Food Pursuant to Regulation (EU) 2015/2283

EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

EFSA Journal 2025 23(12):e9709

Bibliography

PubMed: PMID 41346947
PubMed Central: PMC12673277
DOI: 10.2903/j.efsa.2025.9709
Funding: This scientific opinion was prepared by the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) in response to a request from the European Commission, following a novel food application submitted by Eggnovo S.L. Panel members' declarations of interest are published at https://open.efsa.europa.eu/experts. Biohack Blueprint assessment: this is a regulatory safety opinion evaluating an industry-submitted dossier, not an independent primary research study; the applicant (Eggnovo S.L.) requested data protection for parts of the underlying dossier under Article 26 of Regulation (EU) 2015/2283.
Competing interests: Panel members' declarations of interest are published separately by EFSA; none are reported within the opinion text itself.

Study snapshot

Design	Regulatory scientific safety opinion (novel food dossier assessment); not an original research study
Model	Not applicable — the assessment concerns a novel food ingredient rather than a specific study population; the applicant proposed the general adult population, excluding pregnant and lactating women, as the target group
Sample	Not applicable (dossier-based safety assessment; the Panel concluded no toxicological studies were necessary given the nature, compositional data and production process of the novel food)
Intervention	Egg membrane collagen peptides (hydrolysed eggshell membrane), produced by papain enzymatic hydrolysis of eggshell membranes from farmed chicken eggs, proposed at a maximum daily dose of 500 mg in food supplements for adults, excluding pregnant and lactating women. This is a distinct raw material — eggshell membrane, not hydrolysed bovine, porcine, marine or fish collagen — at a milligram-scale dose roughly 10 to 30 times lower than typical gram-scale hydrolysed collagen peptide products.
Duration	Not applicable
Endpoints	Compositional and production-process safety review; History of use, including a related 2018 EFSA opinion on egg membrane hydrolysate at 450 mg/day; Allergenicity assessment; Overall safety conclusion under the proposed conditions of use

What the study showed, in plain terms

This is a regulatory document, not a clinical study — the European Food Safety Authority's expert panel reviewing whether a new collagen-derived ingredient, egg membrane collagen peptides, is safe to sell as a food supplement in the EU.

The ingredient is made by enzymatically hydrolysing the thin membrane inside eggshells from farmed chicken eggs — a completely different raw material from the bovine, porcine, marine or fish collagen typically used in hydrolysed collagen peptide products, and used at a far lower dose (up to 500 mg/day versus the 5–15 g/day doses tested in most collagen peptide trials on this site).

The Panel concluded the ingredient is safe under its proposed conditions of use and that no additional toxicological studies were required, based on the nature of the product, its composition and its production process. This paper is included here purely as a differentiation and safety reference — it says nothing about hydrolysed collagen peptides as reviewed elsewhere on this site.

Key findings

The Panel concluded that egg membrane collagen peptides, as a novel food, are safe under the applicant's proposed conditions of use (up to 500 mg/day in food supplements for adults, excluding pregnant and lactating women).
The production process (papain enzymatic hydrolysis of eggshell membrane from farmed chicken eggs) is sufficiently described and does not raise safety concerns.
No toxicological studies were deemed necessary by the Panel, given the nature of the novel food, its compositional data, and information on the production process.
A related, earlier EFSA opinion (2018) had already concluded that a related egg membrane hydrolysate is safe at up to 450 mg/day in the general adult population.

What this study can and cannot tell us

This is a regulatory dossier assessment, not a primary clinical or preclinical research study — it evaluates a manufacturer-submitted application rather than generating new independent data.
The assessment concerns egg membrane collagen peptides specifically, an entirely different raw material and dose scale from the hydrolysed bovine, porcine, marine and fish collagen peptides reviewed elsewhere in this Data Center; its safety conclusion cannot be extended to those products or vice versa.
Parts of the underlying application dossier are subject to a data-protection request by the applicant (Eggnovo S.L.) under Article 26 of Regulation (EU) 2015/2283, meaning some underlying data are not fully public.
The opinion explicitly states it concerns only safety, not any assessment of efficacy or claimed health benefit.

Tier 3

Hydrolyzed Collagen—Sources and Applications

Arely León-López et al. · Molecules · 2019

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