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 ingredients, and in particular Article 7 thereof,
Whereas:
(1)
On 1 November 2007 the company Kaneka Pharma Europe made a request to the competent authorities of Belgium to place flavonoids from Glycyrrhiza glabra L. (Glavonoid) on the market as novel food ingredient.
(2)
On 3 December 2008 the competent authority for food assessment of Belgium issued the initial assessment report. In that report it came to the conclusion that the company Kaneka provided sufficient information to authorise the placing on the market of flavonoids from Glycyrrhiza glabra L. as a novel food ingredient.
(3)
The Commission forwarded the initial assessment report to all Member States on 19 February 2009.
(4)
Within the 60-day period laid down in Article 6(4) of Regulation (EC) No 258/97 reasoned objections to the marketing of the product were raised in accordance with that provision.
(5)
Therefore the European Food Safety Authority (EFSA) was consulted on 22 July 2009.
(6)
On 30 June 2011, EFSA in the ‘Scientific opinion on the safety of “Glavonoid®”, an extract derived from the roots of or rootstock of Glycyrrhiza glabra L., as a novel food ingredient on request from the European Commission’ came to the conclusion that Glavonoid was safe for the general adult population at an intake of up to 120 mg per day.
(7)
In order not to exceed an intake of 120 mg per day of Glavonoid, Kaneka Pharma Europe NV agreed on 11 August 2011 to limit the use of Glavonoid as an ingredient to food supplements and beverages.
(8)
On the basis of the scientific assessment, it is established that Glavonoid complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.
(9)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DECISION: