(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised 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 adopted, which establishes a Union list of authorised novel foods.

(3)

Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and updating the Union list.

(4)

On 31 August 2016, the company DSM Nutritional Products Ltd, United Kingdom, made a request to the competent authority of Ireland to place hen egg white lysozyme hydrolysate on the Union market 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 white lysozyme hydrolysate to be used in food supplements and other food categories, 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 market 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 January 2018, shall be treated as an application submitted 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 competent authority of Ireland issued its initial assessment report. In that report it came to the conclusion that hen egg white 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 report to the other Member States. Reasoned objections were raised by the other Member States within the 60-day 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 specification and production process.

(9)

In view of the objections raised by the other Member States, in particular the insufficient exposure assessment on the potential combined intake from all possible proposed uses the applicant modified the request with regard to the food categories 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 concerns regarding compliance with Article 7 of Regulation (EU) 2015/2283 to the satisfaction of the Member States and the Commission.

(10)

Those explanations give sufficient grounds to establish that hen egg white lysozyme hydrolysate in the proposed uses and use levels when used as an ingredient in food supplements, complies with Article 12(1) of Regulation (EU) 2015/2283.

(11)

Directive 2002/46/EC of the European Parliament and of the Council (4) lays down requirements on food supplements. The use of hen egg white lysozyme hydrolysate should be authorised without prejudice to that Directive.

(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,