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)
Article 1
Article 2
Article 3
ANNEX
‘Authorised novel food |
Conditions under which the novel food may be used |
Additional specific labelling requirements |
Other requirements |
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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”.’ |
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Food supplements as defined in Directive 2002/46/EC(1) intended for adult population |
1 000 mg/day |
‘Authorised Novel Food |
Specification |
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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: < 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
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