COMMI SSION IMPLEMENTING REGUL ATION (EU) 2018/991 
of 12 July 2018 
author ising 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) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on 
novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing 
Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof, 
Whereas: 
(1)  Regulation (EU) 2015/2283 provi des that only novel foods author ised and included in the Union list may be 
placed on the market within the Union. 
(2)  Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) 
was adopt ed, which establishes a Union list of author ised novel foods. 
(3)  Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the author isation and on 
the placing on the Union market of a novel food and updating the Union list. 
(4)  On 31 August 2016, the compan y DSM Nutr itional Products Ltd, United Kingdom, made a request to the 
compet ent author ity of Ireland to place hen egg whit e lysozyme hydrolysate on the Union mark et as a novel 
food within the meaning of point (e) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament 
and of the Council (3). The application requests for hen egg whit e lysozyme hydrolysat e to be used in food 
supplements and other food cate gories, in particular , in non-alcoholic beverages. 
(5)  Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the mark et 
within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 and 
for which the final decision has not been taken before 1 Januar y 2018, shall be treated as an application 
submitte d under Regulation (EU) 2015/2283. 
(6)  While the request for placing hen egg white lysozyme hydrolysate on the market as a novel food within the 
Union was submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, the 
application also meets the requirements laid down in Regulation (EU) 2015/2283. 
(7)  On 12 May 2017, the compet ent author ity of Ireland issued its initial assessment repor t. In that repor t it came to 
the conclusion that hen egg whit e lysozyme hydrolysate meets the criteria for novel food set out in Article 3(1) 
of Regulation (EC) No 258/97. 
(8)  On 31 May 2017, the Commission forwarded the initial assessment repor t to the other Member State s. Reasoned 
objections were raised by the other Member States within the 60-da y period laid down in the first subparagraph 
of Article 6(4) of Regulation (EC) No 258/97 with regard to insufficient information on intended uses and 
exposure assessment, toxicological data, product specifi cation and production process. 
(9)  In view of the objections raised by the other Member State s, in particular the insuffi cient exposure assessment on 
the poten tial combined intak e from all possible proposed uses the applicant modifi ed the request with regar d to 
the food categor ies by limiting the use of the novel food only to food supplements. The changes in the proposed 
uses of the novel food and additional explanations by the applicant alleviated the concer ns regarding compl iance 
with Article 7 of Regulation (EU) 2015/2283 to the satisf action of the Member States and the Commission. 13.7.2018 L 177/9 Official Jour nal of the European Union EN     
(1)OJ L 327, 11.12.2015, p. 1. 
(2)Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance 
with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72). 
(3)Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 Januar y 1997 concer ning novel foods and novel foods 
ingredients (OJ L 43, 14.2.1997, p. 1). (10)  Those explanations give sufficient grounds to establish that hen egg whit e lysozyme hydrolysate in the proposed 
uses and use levels when used as an ingredient in food supplements, compl ies with Article 12(1) of Regulation 
(EU) 2015/2283. 
(11)  Directive 2002/46/EC of the European Parliament and of the Council (1) lays down requirements on food 
supplements. The use of hen egg white lysozyme hydrolysat e should be author ised without prejudice to that 
Directive. 
(12)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
1. Hen egg white lysozyme hydrolysat e as specifi ed in the Annex to this Regulation shall be included in the Union 
list of author ised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283. 
2. The entr y 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 author isation 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 followi ng 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 State s. 
Done at Brussels, 12 July 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  13.7.2018 L 177/10 Official Jour nal of the European Union EN     
(1)Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the appro ximation of the laws of the Member 
States relating to food supplements (OJ L 183, 12.7.2002, p. 51). ANNEX 
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:  
(1) The followi ng entr y is inser ted in Table 1 (Auth orised 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 categor y 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/da y 
(1)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the appro ximation of the laws of 
the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).   
(2) The followi ng entr y is inser ted in Table 2 (Specifi cations) in alphabetical order: 
‘Authorised Novel Food Specification 
Hen egg white lysozyme 
hydrolysate Descr iption/Def inition: 
Hen egg whit e lysozyme hydrolysat e is obtained from hen egg whit e lysozyme 
by an enzymatic process, using subtilisin from Bacillus lichenifo rmis. 
The product is a whit e to light yello w powder . 
Specif ication: 
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 met als: 
Arsenic: < 1 ppm 
Lead: < 1 ppm 
Cadmium: < 0,5 ppm 
Mercur y: < 0,1 ppm 
Microbiological criter ia: 
Total aerobic count: < 103 CFU/g 
Total combined yeasts/moulds count: < 102 CFU/g 
Enterobact eria: < 10 CFU/g 
Salmonella spp: Absence in 25 g 
Escher ichia coli: Absence in 10 g 
Staphylococcus aureu s: Absence in 10 g 
Pseudomonas aeruginosa: Absence in 10 g 
(*)  TN: total nitroge n 
(**)  LNAA: large neutral amino acids ’   13.7.2018 L 177/11 Official Jour nal of the European Union EN