Commission Implementing Regulation (EU) 2026/1427 authorizes the placing on the market of “egg membrane hydrolysate (enzymatically produced)” as a novel food within the European Union. This regulation formally integrates the product into the existing Union list of authorized novel foods established by Regulation (EU) 2017/2470. The authorization is granted specifically to the applicant, Eggnovo SL, under strict conditions regarding its use, composition, and labeling.
### Structure and Main Provisions
The regulation is structured into four operative articles and an annex that amends the Union list of novel foods.
* **Article 1** provides the legal authorization and mandates the update of the Union list.
* **Article 2** establishes a five-year period of market exclusivity for the applicant, Eggnovo SL, starting from 23 July 2026.
* **Article 3** grants data protection for the proprietary scientific studies submitted by the applicant, preventing other entities from relying on this data for their own applications during the five-year protection window without the applicant’s consent.
* **The Annex** serves as the technical core, detailing the specific conditions of use, mandatory labeling requirements, and the precise chemical and microbiological specifications for the product.
Compared to previous versions of the Union list, this regulation introduces a new entry that distinguishes this specific enzymatically produced hydrolysate from other previously authorized egg membrane products, ensuring that the designation accurately reflects its composition (15-30% collagen content).
### Key Provisions for Practical Use
For stakeholders, the following provisions are critical:
* **Conditions of Use:** The product is strictly authorized for use in food supplements as defined by Directive 2002/46/EC, with a maximum intake level of 500 mg/day for the general adult population.
* **Target Population Restrictions:** Use is explicitly prohibited for pregnant and lactating women, and the labeling must reflect this, alongside a statement that it should not be consumed by persons under 18 years of age.
* **Labeling Requirements:** Because the product is derived from eggs, it must comply with the allergen labeling requirements set out in Regulation (EU) No 1169/2011. The label must clearly state the designation “egg membrane hydrolysate.”
* **Technical Specifications:** The product must meet rigorous quality standards, including a crude protein content of at least 70% and strict microbiological criteria (e.g., absence of *Salmonella* and *Listeria monocytogenes*).
* **Market Exclusivity:** Until 23 July 2031, only Eggnovo SL is permitted to place this specific novel food on the market, unless a subsequent applicant secures their own authorization based on independent data or obtains the rights to use the protected data.
**:** As this product is derived from eggs, which are recognized allergens under EU law, strict adherence to the labeling requirements is mandatory to ensure consumer safety and compliance with the Union’s food information regulations.
