
Article 1 

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.
Article 2 
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 12 July 2018.
For the Commission
The President
Jean-Claude JUNCKER
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 intended for adult population 1 000 mg/day

((2)) The following entry is inserted in Table 2 (Specifications) in alphabetical order:
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Authorised Novel Food Specification
Hen egg white lysozyme hydrolysate 
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.

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 %

Arsenic: < 1 ppm

Lead: < 1 ppm

Cadmium: < 0,5 ppm

Mercury: < 0,1 ppm

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
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