Commission Decision
of 4 February 2011
authorising the placing on the market of a fish （Sardinops sagax） peptide product as a novel food ingredient under Regulation （EC） No 258/97 of the European Parliament and of the Council
（notified under document C（2011） 522）
（Only the English text is authentic）
（2011/80/EU）
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 [1], and in particular Article 7 thereof,
Whereas:
（1） On 28 April 2008 the company of Senmi Ekisu Co. Ltd made a request to the competent authorities of Finland to place a fish （Sardinops sagax） peptide product on the market as a novel food ingredient.
（2） On 12 January 2009 the competent food assessment body of Finland issued its initial assessment report. In that report it came to the conclusion that the fish peptide product may be placed on the market.
（3） The Commission forwarded the initial assessment report to all Member States on 10 March 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 14 August 2009.
（6） On 9 July 2010, EFSA （Panel on Dietetic Products, Nutrition and Allergies） in the "Scientific opinion on the safety of "Sardine Peptide Product" as a novel food ingredient" [2] came to the conclusion that the fish peptide product was safe under the proposed conditions of use and the proposed levels of intake.
（7） On the basis of the scientific assessment, it is established that the fish peptide product complies with the criteria laid down in Article 3（1） of Regulation （EC） No 258/97.
（8） 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:
Article 1
The fish （Sardinops sagax） peptide product as specified in Annex I may be placed on the market in the union as a novel food ingredient for the uses listed in Annex II.
Article 2
The designation of fish （Sardinops sagax） peptide product authorised by this Decision on the labelling of the foodstuff containing it shall be "fish （Sardinops sagax） peptides".
Article 3
This Decision is addressed to Senmi Ekisu Co. Ltd, Research & Development Department, 779-2 Noda, Hirano-Cho, Ohzu-City, Ehime 795-0021, Japan.
Done at Brussels, 4 February 2011.
For the Commission
John Dalli
Member of the Commission
[1] OJ L 43, 14.2.1997, p. 1.
[2] EFSA Journal 2010; 8（7）： 1684.
--------------------------------------------------
ANNEX I
SPECIFICATIONS OF FISH （SARDINOPS SAGAX） PEPTIDE PRODUCT
De
The novel food ingredient is a peptide mixture, which is obtained by an alkaline protease-catalysed hydrolysis of fish （Sardinops sagax） muscle, subsequent isolation of the peptide fraction by column chromatography, concentration under vacuum and spray drying. It is a yellowish white powder.
Specification of fish （Sardinops sagax） peptide product |
Peptides [1] （short chain peptides, dipeptides and tripeptides with a molecular weight of less than 2 kDa） | ≥ 85 g/100 g |
Val-Tyr （dipeptide） | 0,1 to 0,16 g/100 g |
Ash | ≤ 10 g/100 g |
Moisture | ≤ 8 g/100 g |
[*] Kjeldahl method.
--------------------------------------------------
ANNEX II
USES OF THE FISH PEPTIDE PRODUCT
Use group | Maximum level of fish peptide product |
Foods based on yoghurt, yoghurt drinks, fermented milk products, and powdered milk | 0,48 g/100 g （ready to eat/drink） |
Flavoured water, and vegetable-based drinks | 0,3 g/100 g （ready to drink） |
Breakfast cereals | 2 g/100 g |
Soups, stews and soup powders | 0,3 g/100 g （ready to eat） |