EU permits market entry of egg lysozyme hydrolysate for supplement use

The EC agreed with the findings of Ireland’s Food Safety Authority (FSAI) and assigned the novel food status for use in labelling food supplements containing the ingredient at a maximum permitted dose of 1 000 milligrams per day (mg/day).

“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,” ​the ruling stated.

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

DSM submitted request ​

The decision follows a request by DSM Nutritional Products on the 31 August 2016 to the FSAI requesting the ingredient be placed on the Union market as a novel food. The FSAI reported no safety concerns associated with its consumption.

DSM’s egg white lysozyme hydrolysate product LumiVida, was given a positive reference by the Authority on 12 May 2017.

In its initial assessment report, the FSAI came to the conclusion that hen egg white lysozyme hydrolysate met the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.

On 31 May 2017, the Commission forwarded the initial assessment report to the other Member States.

“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 commission said in its latest decision.

“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.”​

Multiple uses of egg white hydrosylate​

Hen egg white lysozyme has a long history of safe consumption in the EU and around the world as a constituent in eggs, as well as an EU-authorised additive (E1105) with preservative anti-microbial effects, for example in the cheese and wine manufacturing industries.

The hysdolysate of hen egg white lysozyme is almost identical to the lysozyme itself in terms of composition, though some amino acid loss may occur due to the hydrolysis process.

The obvious difference is that lysozyme is a 129 amino acid protein molecule while the hydrolysate is composed of a mix or primarily di-and tri-peptides.

DSM added in its application that adults and adolescents were to be the primary target population groups, though consumption by other age groups could not be discounted.

Food supplements containing up to 500mg/serving of the novel ingredient would be in the form of tablets, capsules, soft gels, gel caps, liquids or powders, the firm stated with a recommended daily intake up to 1,000 mg/day.