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.)

• CELEX: Implementing Regulation (EU) 2018/991
• Articles: 4

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 .

Schedules & Appendices

ANNEX

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 ).