Commission Implementing Regulation (EU) 2018/991 of 12 July 2018 authorising the placing on the market of hen egg white lysozyme hydrolysate as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance.)
Commission Implementing Regulation (EU) 2018/991 of 12 July 2018 authorising the placing on the market of hen egg white lysozyme hydrolysate as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance.)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
1. Hen egg white lysozyme hydrolysate as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283.
2. The entry in the Union list referred to in the first paragraph shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.
3. The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.
ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1)
The following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:
‘Authorised novel food
Conditions under which the novel food may be used
Additional specific labelling requirements
Other requirements
Hen egg white lysozyme hydrolysate
Specified food category
Maximum levels
The designation of the novel food on the labelling of food supplements containing it shall be “Hen egg white lysozyme hydrolysate”.’
Food supplements as defined in Directive 2002/46/EC ( 1 ) intended for adult population
1 000 mg/day
(2)
The following entry is inserted in Table 2 (Specifications) in alphabetical order:
‘Authorised Novel Food
Specification
Hen egg white lysozyme hydrolysate
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 (*) × 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: < 10 3 CFU/g
Total combined yeasts/moulds count: < 10 2 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’
( 1 ) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements ( OJ L 183, 12.7.2002, p. 51 ).
