Egg membrane hydrolysate: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Food Supplements as defined in Directive 2002/46/EC intended for the general adult population: 450 mg/day

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘egg membrane hydrolysate’.

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Description

The egg membrane hydrolysate is derived from the eggshell membranes of chicken eggs. The eggshells undergo hydro-mechanical separation in order to obtain the egg membranes, which are then further processed using a patented solubilisation method. Following the solubilisation process, the solution is filtered, concentrated, spray-dried and packaged.

Characteristics/Composition

Chemical parameters

Methods

Total nitrogen-containing compounds (% w/w): ≥ 88

Combustion according to AOAC 990.03 and AOAC 992.15

Collagen (% w/w): ≥ 15

SircolTM Soluble Collagen Assay

Elastin (% w/w): ≥ 20

FastinTM Elastin Assay

Total glycosaminoglycans (% w/w): ≥ 5

USP26 (chondroitin sulphate K0032 method)

Calcium: ≤ 1 %

Physical parameters

pH: 6,5 - 7,6

Ash (% w/w): ≤ 8

Moisture (% w/w): ≤ 9

Water activity: ≤ 0,3

Solubility (in water): soluble

Bulk density: ≥ 0,6 g/cc

Heavy metals

Arsenic ≤ 0,5 mg/kg

Microbiological criteria

Aerobic plate count: ≤ 2 500 CFU/g

Escherichia coli: ≤ 5 MPN/g

Salmonella: Negative (in 25 g)

Coliforms: ≤ 10 MPN/g

Staphylococcus aureus: ≤ 10 CFU/g

Mesophilic spore count: ≤ 25 CFU/g

Thermophilic spore count: ≤ 10 CFU/10 g

Yeast: ≤ 10 CFU/g

Mould: ≤ 200 CFU/g

CFU: Colony Forming Units; MPN = Most Probable Number; USP: United States Pharmacopeia.

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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