Commission Implementing Decision (EU) 2016/376 of 11 March 2016 authorising the placing on the market of 2′-O-fucosyllactose as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2016) 1423)
Date: 2016-03-11
Institutions: European Commission
Subjects: food inspection, food safety, food supplement, health risk, human nutrition, market approval




L_2016070EN.01002701.xml










16.3.2016   


EN


Official Journal of the European Union


L 70/27








            COMMISSION IMPLEMENTING DECISION (EU) 2016/376
of 11 March 2016
         
authorising the placing on the market of 2′-O-fucosyllactose as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council


(notified under document C(2016) 1423)


(Only the Danish 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 ingredients (1), and in particular Article 7 thereof,

Whereas:







(1)


On 23 June 2014, the company Glycom A/S made a request to the competent authorities of Ireland to place 2′-O-fucosyllactose on the market as a novel food ingredient.












(2)


On 3 October 2014, the competent food assessment body of Ireland issued its initial assessment report. In that report, it came to the conclusion that 2′-O-fucosyllactose meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.












(3)


On 9 October 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.












(5)


On 22 December 2014, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an assessment for 2′-O-fucosyllactose as a novel food ingredient in accordance with Regulation (EC) No 258/97.












(6)


On 29 June 2015, EFSA in its ‘Scientific Opinion on the safety of 2′-O-fucosyllactose as a novel food ingredient pursuant to Regulation (EC) No 258/97’ (2), concluded that 2′-O-fucosyllactose is safe for the proposed uses and use levels.












(7)


On 5 October 2015, the applicant sent a letter to the Commission and provided additional information to support the use and approval of 2′-O-fucosyllactose and lacto-N-neotetraose in food supplements for general population (excluding infants) under Regulation (EC) No 258/97.












(8)


On 14 October 2015, the Commission consulted EFSA asking it to carry out an assessment of the safety of these novel foods in food supplements also for children (excluding infants).












(9)


On 28 October 2015, EFSA in its ‘Statement on the safety of lacto-N-neotetraose and 2′-O-fucosyllactose as novel food ingredients in food supplements for children’ (3), concluded that 2′-O-fucosyllactose is safe for the proposed uses and use levels.












(10)


Commission Directive 96/8/EC (4) lays down requirements on foods intended for use in energy-restricted diets for weight reduction. Commission Directive 1999/21/EC (5) lays down requirements for dietary foods for special medical purposes. Directive 2002/46/EC of the European Parliament and of the Council (6) lays down requirements on food supplements. Commission Directive 2006/125/EC (7) lays down requirements for processed cereal-based foods and baby foods for infants and young children. Commission Directive 2006/141/EC (8) lays down requirements for infant formulae and follow-on formulae. Regulation (EC) No 1925/2006 of the European Parliament and of the Council (9) lays down requirements on the addition of vitamins and minerals and of certain other substances to foods. Commission Regulation (EC) No 41/2009 (10) lays down requirements for the composition and labelling of foodstuffs suitable for people intolerant to gluten. Commission Implementing Regulation (EU) No 828/2014 (11) lays down the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food. The use of 2′-O-fucosyllactose should be authorised without prejudice to the requirements of those legislations












(11)


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:



Article 1
2′-O-Fucosyllactose as specified in Annex I may be placed on the market in the Union as a novel food ingredient for the uses defined and at the maximum levels established in Annex II without prejudice to the specific provisions of Directives 96/8/EC, 1999/21/EC, 2002/46/EC, 2006/125/EC, 2006/141/EC and Regulations (EC) No 1925/2006, (EC) No 41/2009 and Implementing Regulation (EU) No 828/2014


Article 2

1.   The designation of 2′-O-fucosyllactose authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘2′-O-fucosyllactose’.


2.   Information shall be given to the consumer that food supplements containing 2′-O-fucosyllactose should not be used if other foods with added 2′-O-fucosyllactose are consumed the same day.


3.   Information shall be given to the consumer that food supplements containing 2′-O-fucosyllactose intended for young children should not be used if breast milk or other foods with added 2′-O-fucosyllactose are consumed the same day.



Article 3
This Decision is addressed to Glycom A/S, Diplomvej 373, 2800 Kgs. Lyngby, Denmark.




Done at Brussels, 11 March 2016.


For the Commission

Vytenis ANDRIUKAITIS
            

Member of the Commission






(1)  
            OJ L 43, 14.2.1997, p. 1.

(2)  EFSA Journal 2015; 13(7):4184.

(3)  EFSA Journal 2015;13(11):4299.

(4)  Commission Directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction (OJ L 55, 6.3.1996, p. 22).

(5)  Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (OJ L 91, 7.4.1999, p. 29).

(6)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

(7)  Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (OJ L 339, 6.12.2006, p. 16).

(8)  Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (OJ L 401, 30.12.2006, p. 1).

(9)  Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ L 404, 30.12.2006, p. 26).

(10)  Commission Regulation (EC) No 41/2009 of 20 January 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten (OJ L 16, 21.1.2009, p. 3).

(11)  Commission Implementing Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food (OJ L 228, 31.7.2014, p. 5).




ANNEX I

SPECIFICATION OF 2′-O-FUCOSYLLACTOSE


Definition:







Chemical name


α-l-Fucopyranosyl-(1→2)-β-d-galactopyranosyl-(1→4)-d-glucopyranose




Chemical formula


C18H32O15





Molecular weight


488,44 g/mol




CAS No


41263-94-9





Description: 2′-O-fucosyllactose is a white to off-white powder.

Purity:







Test


Specification




Assay


Not less than 95 %




D-Lactose


Not more than 1,0 w/w %




L-Fucose


Not more than 1,0 w/w %




Difucosyl-d-lactose isomers


Not more than 1,0 w/w %




2′-Fucosyl-d-lactulose


Not more than 0,6 w/w %




pH (20 °C, 5 % solution)


3,2-7,0




Water (%)


Not more than 9,0 %




Ash, sulphated


Not more than 0,2 %




Acetic acid


Not more than 0,3 %




Residual solvents (methanol, 2-propanol, methyl acetate, acetone)


Not more than 50 mg/kg singly
Not more than 200 mg/kg in combination




Residual proteins


Not more than 0,01 %




Palladium


Not more than 0,1 mg/kg




Nickel


Not more than 3,0 mg/kg





Microbiological criteria:







Aerobic mesophilic bacteria total count


Not more than 500 CFU/g




Yeasts


Not more than 10 CFU/g




Moulds


Not more than 10 CFU/g




Residual endotoxins


Not more than 10 EU/mg









ANNEX II

AUTHORISED USES OF 2′-O-FUCOSYLLACTOSE







Food category


Maximum levels




Unflavoured pasteurised and sterilised (including UHT) milk-based products


1,2 g/l




Unflavoured fermented milk-based products


1,2 g/l beverages
19,2 g/kg products other than beverages




Flavoured fermented milk-based products including heat-treated products


1,2 g/l beverages
19,2 g/kg products other than beverages




Dairy analogues, including beverage whiteners


1,2 g/l beverages
12 g/kg for products other than beverages
400 g/kg for whitener




Cereal bars


12 g/kg




Table-top sweeteners


200 g/kg




Infant formulae as defined in Directive 2006/141/EC


1,2 g/l in combination with 0,6 g/l of lacto-N-neotetraose at a ratio of 2:1 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer




Follow-on formulae as defined in Directive 2006/141/EC


1,2 g/l in combination with 0,6 g/l of lacto-N-neotetraose at a ratio of 2:1 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer




Processed cereal-based food and baby food for infants and young children as defined in Directive 2006/125/EC


12 g/kg for products other than beverages
1,2 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer




Milk-based drinks and similar products intended for young children


1,2 g/l for milk-based drinks and similar products added alone or in combination with lacto-N-neotetraose, at concentrations 0,6 g/l, at a ratio of 2:1 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer




Dietary foods for special medical purposes as defined in Directive 1999/21/EC


In accordance with the particular nutritional requirements of the persons for whom the products are intended




Foods intended for use in energy-restricted diets for weight reduction as defined in Directive 96/8/EC (only for products presented as a replacement for the whole of the daily diet)


4,8 g/l for drinks
40 g/kg for bars




Bread and pasta products for people intolerant to gluten as defined in Regulation (EC) No 41/2009 (1)



60 g/kg




Flavoured drinks


1,2 g/l




Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products


9,6 g/l (2)





Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants


3,0 g/day for general population
1,2 g/day for young children






(1)  From 20 July 2016 the category ‘Bread and pasta products for people intolerant to gluten as defined in Regulation (EC) No 41/2009’ shall be replaced by the following: ‘Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014’.

(2)  The maximum level refers to the products ready to use.