Hen egg white lysozyme 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 adult population: 1000 mg/day

Additional specific labelling requirements

The designation of the novel food on the labelling of food supplements containing it shall be ‘Hen egg white lysozyme hydrolysate’.

Specification (Table 2)

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

Description/Definition

Hen egg white lysozyme hydrolysate is obtained from hen egg white lysozyme by an enzymatic process, using subtilisin from Bacillus licheniformis.

The product is a white to light yellow powder.

Specification

Protein (TN(*) x 5,30): 80-90 %

Tryptophan: 5-7 %

Ratio Tryptophan/LNAA(**): 0,18-0.25

Degree of hydrolysis: 19-25 %

Moisture: < 5 %

Ash: < 10 %

Sodium: < 6 %

Heavy metals

Arsenic: < 1 ppm

Lead: < 1 ppm

Cadmium: < 0,5 ppm

Mercury: < 0,1 ppm

Microbiological criteria

Total aerobic count: < 103 CFU/g

Total combined yeasts/moulds count: < 102 CFU/g

Enterobacteria: < 10 CFU/g

Salmonella spp: Absence in 25 g

Escherichia coli: Absence in 10 g

Staphylococcus aureus: Absence in 10 g

Pseudomonas aeruginosa: Absence in 10 g

* TN: total nitrogen

** LNAA: large neutral amino acids

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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