# L_2023128EN.01006801.xml

| 15.5.2023 | EN | Official Journal of the European Union | L 128/68 |
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15.5.2023

EN

Official Journal of the European Union

L 128/68

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COMMISSION IMPLEMENTING REGULATION (EU) 2023/950

of 12 May 2023

amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food 2’-Fucosyllactose

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,

Whereas:

| (1) | Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union. |
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(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.

| (2) | Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) has established a Union list of novel foods. |
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(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) has established a Union list of novel foods.

| (3) | The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes 2’-Fucosyllactose of synthetic and microbial source as an authorised novel food. |
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(3)

The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes 2’-Fucosyllactose of synthetic and microbial source as an authorised novel food.

| (4) | Commission Implementing Decision (EU) 2016/376 (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4), the placing on the market of synthetic 2’-Fucosyllactose as a novel food ingredient. |
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(4)

Commission Implementing Decision (EU) 2016/376 (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4), the placing on the market of synthetic 2’-Fucosyllactose as a novel food ingredient.

| (5) | On 23 June 2016, the company Glycom A/S (‘the applicant’), notified the Commission, pursuant to Article 5 of Regulation (EC) No 258/97, of its intention to place on the market 2’-Fucosyllactose produced by bacterial fermentation with Escherichia coli strain K-12. 2’-Fucosyllactose of microbial origin produced with Escherichia coli strain K-12 was included in the Union list of novel foods on the basis of that notification when the Union list was established. |
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(5)

On 23 June 2016, the company Glycom A/S (‘the applicant’), notified the Commission, pursuant to Article 5 of Regulation (EC) No 258/97, of its intention to place on the market 2’-Fucosyllactose produced by bacterial fermentation with Escherichia coli strain K-12. 2’-Fucosyllactose of microbial origin produced with Escherichia coli strain K-12 was included in the Union list of novel foods on the basis of that notification when the Union list was established.

| (6) | Commission Implementing Decision (EU) 2017/2201 (5) authorised, in accordance with Regulation (EC) No 258/97, the placing on the market of 2’-Fucosyllactose produced with Escherichia coli strain BL21 as a novel food ingredient. |
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(6)

Commission Implementing Decision (EU) 2017/2201 (5) authorised, in accordance with Regulation (EC) No 258/97, the placing on the market of 2’-Fucosyllactose produced with Escherichia coli strain BL21 as a novel food ingredient.

| (7) | On 13 October 2022, the applicant submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change in the conditions of use of 2’-Fucosyllactose. The applicant requested the removal of the obligatory condition that, when 2’-Fucosyllactose is used in combination with Lacto-N-neotetraose in infant formula and follow-on formula as defined in Article 2 of Regulation (EU) No 609/2013 of the European Parliament and of the Council (6), and in milk-based drinks and similar products intended for young children, at the currently authorised levels of up to 1,2 g/l, they should be used only at a 2:1 ratio (two parts 2’-Fucosyllactose to one part Lacto-N-neotetraose). |
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(7)

On 13 October 2022, the applicant submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change in the conditions of use of 2’-Fucosyllactose. The applicant requested the removal of the obligatory condition that, when 2’-Fucosyllactose is used in combination with Lacto-N-neotetraose in infant formula and follow-on formula as defined in Article 2 of Regulation (EU) No 609/2013 of the European Parliament and of the Council (6), and in milk-based drinks and similar products intended for young children, at the currently authorised levels of up to 1,2 g/l, they should be used only at a 2:1 ratio (two parts 2’-Fucosyllactose to one part Lacto-N-neotetraose).

| (8) | In the application for the proposed modification in the conditions of use of 2’-Fucosyllactose, the applicant considered that the 2:1 obligatory ratio of 2’-Fucosyllactose to Lacto-N-neotetraose when they are used together in infant formula and follow on formula as defined in Article 2 of Regulation (EU) No 609/2013, and in milk-based drinks and similar products intended for young children, unnecessarily limits the ability of food business operators to place on the market these foods with different ratios of those two oligosaccharides |
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(8)

In the application for the proposed modification in the conditions of use of 2’-Fucosyllactose, the applicant considered that the 2:1 obligatory ratio of 2’-Fucosyllactose to Lacto-N-neotetraose when they are used together in infant formula and follow on formula as defined in Article 2 of Regulation (EU) No 609/2013, and in milk-based drinks and similar products intended for young children, unnecessarily limits the ability of food business operators to place on the market these foods with different ratios of those two oligosaccharides

| (9) | The Commission considers that the requested update of the Union list of novel foods is not liable to have an effect on human health and that a safety evaluation by the European Food Safety Authority (‘the Authority’) in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. In this regard the Authority in the recent opinion (7), concluded that the use of 2’-Fucosyllactose alone or Lacto-N-neotetraose alone in food supplements as defined in Article 2 of Directive 2002/46/EC of the European Parliament and of the Council (8) at the currently maximum authorised levels of up to 1,2 g/day or up to 0,6 mg/day respectively, is safe and the resulting intakes of each of these oligosaccharides from these uses would be lower than the intakes of Lacto-N-neotetraose or 2’-Fucosyllactose from human milk which naturally contains them. |
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(9)

The Commission considers that the requested update of the Union list of novel foods is not liable to have an effect on human health and that a safety evaluation by the European Food Safety Authority (‘the Authority’) in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. In this regard the Authority in the recent opinion (7), concluded that the use of 2’-Fucosyllactose alone or Lacto-N-neotetraose alone in food supplements as defined in Article 2 of Directive 2002/46/EC of the European Parliament and of the Council (8) at the currently maximum authorised levels of up to 1,2 g/day or up to 0,6 mg/day respectively, is safe and the resulting intakes of each of these oligosaccharides from these uses would be lower than the intakes of Lacto-N-neotetraose or 2’-Fucosyllactose from human milk which naturally contains them.

| (10) | The information provided in the application and the Authority’s opinion give sufficient grounds to establish that the changes in the conditions of use of the novel food 2’-Fucosyllactose are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved. |
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(10)

The information provided in the application and the Authority’s opinion give sufficient grounds to establish that the changes in the conditions of use of the novel food 2’-Fucosyllactose are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved.

| (11) | The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly. |
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(11)

The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

| (12) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 12 May 2023.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 327, 11.12.2015, p. 1.

1

(2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

2

(3)  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 (OJ L 70, 16.3.2016, p. 27).

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(4)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel food and novel food ingredients (OJ L 43, 14.2.1997, p. 1).

4

(5)  Commission Implementing Decision (EU) 2017/2201 of 27 November 2017 authorising the placing on the market of 2′-fucosyllactose produced with Escherichia coli strain BL21 as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 313, 29.11.2017, p. 5).

5

(6)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).

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(7)  
  EFSA Journal 2022;20(5):7257.

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EFSA Journal

(8)  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).

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ANNEX

In Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for 2’-Fucosyllactose is replaced by the following:

| Authorised novel food | Conditions under which the novel food may be used | Additional specific labelling requirements | Other requirements |
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| ‘2’-Fucosyllactose | Specified food category | Maximum levels | 1. | The designation of the novel food on the labelling of the foodstuffs containing it shall be “2′-fucosyllactose”. |

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

‘2’-Fucosyllactose

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be “2′-fucosyllactose”.

| 2. | The labelling of food supplements containing 2′-fucosyllactose shall bear a statement that the supplements should not be used if other foods with added 2′-fucosyllactose are consumed the same day. |
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2.

The labelling of food supplements containing 2′-fucosyllactose shall bear a statement that the supplements should not be used if other foods with added 2′-fucosyllactose are consumed the same day.

| 3. | The labelling of food supplements containing 2′-fucosyllactose intended for young children shall bear a statement that the supplements should not be used if breast milk or other foods with added 2′-fucosyllactose are consumed the same day.’ |
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3.

The labelling of food supplements containing 2′-fucosyllactose intended for young children shall bear a statement that the supplements should not be used if breast milk or other foods with added 2′-fucosyllactose are consumed the same day.’

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

1,2 g/l

Unflavoured fermented milk-based products

1,2 g/l for beverages

19,2 g/kg for products other than beverages

Flavoured fermented milk-based products including heat-treated products

1,2 g/l for beverages

19,2 g/kg for products other than beverages

Dairy analogues, including beverage whiteners

1,2 g/l for 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 formula as defined under Regulation (EU) No 609/2013

1,2 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

Follow-on formula as defined under Regulation (EU) No 609/2013

1,2 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

Processed cereal-based foods and baby foods for infants and young children as defined under Regulation (EU) No 609/2013

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 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

Foods for special medical purposes as defined under Regulation (EU) No 609/2013

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

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013

4,8 g/l for drinks

40 g/kg for bars

Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Implementing Regulation (EU) No 828/2014

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 – the maximum level refers to the products ready to use

Food supplements as defined in Directive 2002/46/EC, for the general population, excluding infants

3,0 g/day for general population

1,2 g/day for young children

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