# L_2016070EN.01002701.xml

| 16.3.2016 | EN | Official Journal of the European Union | L 70/27 |
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16.3.2016

EN

Official Journal of the European Union

L 70/27

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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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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). |
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(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. |
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(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 |
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(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, |
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(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

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

1

(2)  EFSA Journal 2015; 13(7):4184.

2

(3)  EFSA Journal 2015;13(11):4299.

3

(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).

4

(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).

5

(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).

6

(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).

7

(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).

8

(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).

9

(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).

10

(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).

11

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ANNEX I

SPECIFICATION OF 2′-O-FUCOSYLLACTOSE

Definition:

| Chemical name | α-l-Fucopyranosyl-(1→2)-β-d-galactopyranosyl-(1→4)-d-glucopyranose |
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| Chemical formula | C18H32O15 |
| Molecular weight | 488,44 g/mol |
| CAS No | 41263-94-9 |

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 |

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 |

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

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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 |

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

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(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.

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