# L_2019023EN.01000701.xml

| 25.1.2019 | EN | Official Journal of the European Union | L 23/7 |
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25.1.2019

EN

Official Journal of the European Union

L 23/7

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/109

of 24 January 2019

authorising an extension of use of Schizochytrium sp. oil as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470

(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 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 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) establishing a Union list of authorised novel foods was adopted. |
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(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283 Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted.

| (3) | Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list. |
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(3)

Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.

| (4) | Commission Implementing Decision 2014/463/EU (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 oil from the microalgae Schizochytrium sp. as a novel food to be used in a number of foods. |
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(4)

Commission Implementing Decision 2014/463/EU (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 oil from the microalgae Schizochytrium sp. as a novel food to be used in a number of foods.

| (5) | Commission Implementing Regulation (EU) 2018/1032 (5) extended the authorisation of oil from the microalgae Schizochytrium sp. (T18) as a novel food under Regulation (EU) 2015/2283 to fruit/vegetable purees. |
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(5)

Commission Implementing Regulation (EU) 2018/1032 (5) extended the authorisation of oil from the microalgae Schizochytrium sp. (T18) as a novel food under Regulation (EU) 2015/2283 to fruit/vegetable purees.

| (6) | On 10 September 2018, the company DSM Nutritional Products Europe made a request to the Commission to change the conditions of use of the novel food Schizochytrium sp. oil within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to extend the use of Schizochytrium sp. oil to fruit and vegetable purees. |
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(6)

On 10 September 2018, the company DSM Nutritional Products Europe made a request to the Commission to change the conditions of use of the novel food Schizochytrium sp. oil within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to extend the use of Schizochytrium sp. oil to fruit and vegetable purees.

| (7) | The proposed extension of use of the novel food does not change the safety considerations that supported the authorisation of Schizochytrium sp. (T18) oil by Implementing Regulation (EU) 2018/1032 and it does not either pose any safety concern. Taking into account those considerations, the proposed extension of use complies with Article 12(1) of Regulation (EU) 2015/2283. |
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(7)

The proposed extension of use of the novel food does not change the safety considerations that supported the authorisation of Schizochytrium sp. (T18) oil by Implementing Regulation (EU) 2018/1032 and it does not either pose any safety concern. Taking into account those considerations, the proposed extension of use complies with Article 12(1) of Regulation (EU) 2015/2283.

| (8) | The Commission did not request an opinion from the European Food Safety Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283, as an extension of use of Schizochytrium sp. oil and the subsequent updating of the Union list are not liable to have an effect on human health. |
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(8)

The Commission did not request an opinion from the European Food Safety Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283, as an extension of use of Schizochytrium sp. oil and the subsequent updating of the Union list are not liable to have an effect on human health.

| (9) | 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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(9)

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

1.   The entry in the Union list of authorised novel foods, established under Implementing Regulation (EU) 2017/2470, referring to the substance Schizochytrium sp. oil shall be amended as specified in the Annex to this Regulation.

2.   The entry in the Union list referred to in the first paragraph shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.

Article 2

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

Article 3

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, 24 January 2019.

For the Commission

The President

Jean-Claude JUNCKER

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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 2014/463/EU of 14 July 2014 on authorising the placing on the market of oil from the micro-algae Schizochytrium sp. as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council and repealing Decisions 2003/427/EC and 2009/778/EC (OJ L 209, 16.7.2014, p. 55).

3

Schizochytrium

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

4

(5)  Commission Implementing Regulation (EU) 2018/1032 of 20 July 2018 authorising the extension of use of oil from the micro algae Schizochytrium sp. as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 (OJ L 185, 23.7.2018, p. 9).

5

Schizochytrium

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ANNEX

The entry for ‘
  Schizochytrium sp. oil’ in Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470 is replaced by the following:

| Authorised novel food | Conditions under which the novel food may be used | Additional specific labelling requirements | Other requirements |
| --- | --- | --- | --- |
| ‘
  Schizochytrium

  sp. oil | Specified food category | Maximum levels of DHA | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.”’ | |
| Dairy products except milk-based drinks | 200 mg/100 g or for cheese products 600 mg/100 g |
| Dairy analogues except drinks | 200 mg/100 g or for analogues to cheese products 600 mg/100 g |
| Spreadable fat and dressings | 600 mg/100 g |
| Breakfast cereals | 500 mg/100 g |
| Food Supplements as defined in Directive 2002/46/EC | 250 mg DHA/day for general population |
| 450 mg DHA/day for pregnant and lactating women |
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control | 250 mg/meal |
| Milk-based drinks and similar products intended for young children | 200 mg/100 g |
| Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013 |
| Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen |
| Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Implementing Regulation (EU) No 828/2014 |
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended |
| Bakery products (breads, rolls, and, sweet biscuits) | 200 mg/100 g |
| Cereal bars | 500 mg/100 g |
| Cooking fats | 360 mg/100 g |
| Non-alcoholic beverages (including dairy analogue and milk-based drinks) | 80 mg/100 ml |
| Fruit/vegetable puree | 100 mg/100 g |

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

‘
  Schizochytrium

  sp. oil

Specified food category

Maximum levels of DHA

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.”’

Dairy products except milk-based drinks

200 mg/100 g or for cheese products 600 mg/100 g

Dairy analogues except drinks

200 mg/100 g or for analogues to cheese products 600 mg/100 g

Spreadable fat and dressings

600 mg/100 g

Breakfast cereals

500 mg/100 g

Food Supplements as defined in Directive 2002/46/EC

250 mg DHA/day for general population

450 mg DHA/day for pregnant and lactating women

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

250 mg/meal

Milk-based drinks and similar products intended for young children

200 mg/100 g

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

Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

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

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

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

Bakery products (breads, rolls, and, sweet biscuits)

200 mg/100 g

Cereal bars

500 mg/100 g

Cooking fats

360 mg/100 g

Non-alcoholic beverages (including dairy analogue and milk-based drinks)

80 mg/100 ml

Fruit/vegetable puree

100 mg/100 g

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