Commission Implementing Decision (EU) 2017/450

of 13 March 2017

authorising the placing on the market of lactitol as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document C(2017) 1576)

(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 16 March 2015, the company DuPont Nutrition Biosciences ApS made a request to the competent authorities of Denmark to place lactitol on the Union market as a novel food ingredient within the meaning of point (c) of Article 1(2) of Regulation (EC) No 258/97. In its request, the company proposes lactitol to be used in the same food categories and in the same use levels that are currently being used, when lactitol is added as a food additive under Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council2.
(2)

On 1 July 2015, the competent food assessment body of Denmark issued its initial assessment report. In that report it came to the conclusion that lactitol under the conditions of use proposed by the applicant meets the criteria for novel food ingredients set out in Article 3(1) of Regulation (EC) No 258/97.

(3)

On 13 July 2015, the Commission forwarded the initial assessment report to the other Member States.

(4)

Some Member States made comments within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97. Concerns were raised regarding the excess of lactitol intake and the possibility of misleading the consumer as the same uses and use levels are already authorised for lactitol as a food additive.

(5)

In the light of the Member States' comments, the competent authorities of Denmark reviewed the initial assessment report and concluded that an additional assessment was required in accordance with Article 7 of Regulation (EC) No 258/97.

(6)

That report takes into account the concerns regarding the excess of lactitol intake and the possibility of misleading the consumer and therefore gives sufficient grounds to restrict the use of lactitol to food supplements only and to establish that lactitol used in food supplements intended for adults is safe under the proposed conditions of use.

(7)
Directive 2002/46/EC of the European Parliament and of the Council3 lays down requirements for food supplements. The use of lactitol should be authorised without prejudice to the provisions of that Directive.
(8)

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: