http://www.legislation.gov.uk/id/eudn/2015/545

Commission Implementing Decision (EU) 2015/545

of 31 March 2015

authorising the placing on the market of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document C(2015) 2082)

(Only the English text is authentic)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients1, and in particular Article 7 thereof,

Whereas:

(1)

On 18 September 2013, the company DSM Nutritional Products made a request to the competent authorities of the United Kingdom to place on the market oil rich in DHA (docosahexaenoic acid) from the micro-algae Schizochytrium sp. as a novel food ingredient. The strain of the micro-algae is specified as the strain American Type Culture Collection (ATCC) PTA-9695.

(2)

On 2 April 2014, the competent food assessment body of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that the use of this algal oil meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.

(3)

On 10 April 2014, the Commission forwarded the initial assessment report to the other Member States.

(4)

Reasoned objections were raised within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97. In particular, objections concerning elevated intake levels of DHA were raised. In accordance with Article 7(1) of Regulation (EC) No 258/97 a Decision should be adopted taking into account the objections raised. The applicant consequently modified the request concerning the maximum amount of DHA in food supplements. This change and additional explanations provided by the applicant alleviated the concerns to the satisfaction of Member States and the Commission.

(5)

Directive 2002/46/EC of the European Parliament and of the Council2 lays down requirements on food supplements. Regulation (EC) No 1925/2006 of the European Parliament and of the Council3 lays down requirements on the addition of vitamins and minerals and of certain other substances to foods. Directive 2009/39/EC of the European Parliament and of the Council4 lays down requirements on foodstuffs intended for particular nutritional uses. Commission Directive 96/8/EC5 lays down requirements on foods intended for use in energy-restricted diets for weight reduction. Commission Directive 1999/21/EC6 lays down requirements for dietary foods for special medical purposes. Commission Directive 2006/125/EC7 lays down requirements on processed cereal-based foods and baby foods for infants and young children. Commission Directive 2006/141/EC8 lays down requirements on infant formulae and follow-on formulae. The use of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) should be authorised without prejudice to the requirements of those legislations.

(6)

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

HAS ADOPTED THIS DECISION: