# L_2022205EN.01023001.xml

| 5.8.2022 | EN | Official Journal of the European Union | L 205/230 |
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5.8.2022

EN

Official Journal of the European Union

L 205/230

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COMMISSION IMPLEMENTING REGULATION (EU) 2022/1365

of 4 August 2022

amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food Schizochytrium sp. oil rich in DHA and EPA

(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 of the European Parliament and of the Council 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 Schizochytrium sp. oil rich in DHA and EPA 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 Schizochytrium sp. oil rich in DHA and EPA as an authorised novel food.

| (4) | Pursuant to Article 4(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council (3), Schizochytrium sp. oil rich in DHA and EPA has been authorised to be placed on the market as a novel food to be used in a number of foods. |
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(4)

Pursuant to Article 4(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council (3), Schizochytrium sp. oil rich in DHA and EPA has been authorised to be placed on the market as a novel food to be used in a number of foods.

| (5) | Commission Implementing Decision (EU) 2015/546 (4) amended the conditions of use of Schizochytrium sp. oil rich in DHA and EPA. In particular, the use of Schizochytrium sp. oil rich in DHA and EPA has been extended to additional foods, namely, food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (5). |
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(5)

Commission Implementing Decision (EU) 2015/546 (4) amended the conditions of use of Schizochytrium sp. oil rich in DHA and EPA. In particular, the use of Schizochytrium sp. oil rich in DHA and EPA has been extended to additional foods, namely, food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (5).

| (6) | On 8 December 2021, the company DSM Nutritional Products (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for an amendment of the conditions of use of the novel food Schizochytrium sp. oil rich in DHA and EPA. The applicant requested to extend the use of Schizochytrium sp. oil rich in DHA and EPA to fish analogues and meat analogues at levels 300 mg/100 g and 300 mg/100 g respectively, intended for the general population. |
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(6)

On 8 December 2021, the company DSM Nutritional Products (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for an amendment of the conditions of use of the novel food Schizochytrium sp. oil rich in DHA and EPA. The applicant requested to extend the use of Schizochytrium sp. oil rich in DHA and EPA to fish analogues and meat analogues at levels 300 mg/100 g and 300 mg/100 g respectively, intended for the general population.

| (7) | The Commission considers that the requested update of the Union list 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. The requested extension of use will result in intakes of Schizochytrium sp. oil rich in DHA and EPA which, combined with the intakes from the currently authorised uses of the novel food, are comparable with the intakes assessed by the Authority (6) as safe and which supported the authorisation of an extension of use of Schizochytrium sp. oil rich in DHA and EPA by Implementing Decision (EU) 2015/546. Therefore, it is appropriate to amend the conditions of use of the novel food Schizochytrium sp. oil rich in DHA and EPA by extending its use to fish analogues and meat analogues. |
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(7)

The Commission considers that the requested update of the Union list 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. The requested extension of use will result in intakes of Schizochytrium sp. oil rich in DHA and EPA which, combined with the intakes from the currently authorised uses of the novel food, are comparable with the intakes assessed by the Authority (6) as safe and which supported the authorisation of an extension of use of Schizochytrium sp. oil rich in DHA and EPA by Implementing Decision (EU) 2015/546. Therefore, it is appropriate to amend the conditions of use of the novel food Schizochytrium sp. oil rich in DHA and EPA by extending its use to fish analogues and meat analogues.

| (8) | The information provided in the application gives sufficient grounds to establish that the changes to the conditions of use of the novel food are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved. |
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(8)

The information provided in the application gives sufficient grounds to establish that the changes to the conditions of use of the novel food are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved.

| (9) | The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly. |
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(9)

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

| (10) | 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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(10)

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, 4 August 2022.

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)  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).

3

(4)  Commission Implementing Decision (EU) 2015/546 of 31 March 2015 authorising an extension of use of DHA and EPA-rich 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 (OJ L 90, 2.4.2015, p. 11).

4

Schizochytrium

(5)  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).

5

(6)  Scientific Opinion on the extension of use for DHA and EPA-rich algal oil from Schizochytrium sp. as a Novel Food ingredient (EFSA Journal 2014;12(10):3843).

6

Schizochytrium

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ANNEX

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

| Authorised novel food | Conditions under which the novel food may be used | Additional specific labelling requirements | Other requirements | Data protection |
| --- | --- | --- | --- | --- |
| ‘Schizochytrium sp. oil rich in DHA and EPA | Specified food category | Maximum levels of DHA and EPA combined | The designation of the novel food on the labelling of the foodstuffs containing it shall be “DHA and EPA-rich oil from the microalgae Schizochytrium sp.”’ | | |
| Food supplements as defined in Directive 2002/46/EC for the adult population excluding pregnant and lactating women | 3 000 mg/day |
| Food supplements as defined in Directive 2002/46/EC for pregnant and lactating women | 450 mg/day |
| 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 |
| 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 food and baby food 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 Commission Implementing Regulation (EU) No 828/2014 |
| Bakery products (breads, rolls and sweet biscuits) |
| Breakfast cereals | 500 mg/100 g |
| Cooking fats | 360 mg/100 g |
| Dairy analogues, except drinks | 600 mg/100 g for cheese; 200 mg/100 g for soy and imitation milk products (excluding drinks) |
| Dairy products except milk-based drinks | 600 mg/100 g for cheese; 200 mg/100 g for milk products (including milk, fromage frais and yoghurt products; excluding drinks) |
| Non-alcoholic beverages (including dairy analogue and milk-based drinks) | 80 mg/100 g |
| Cereal/nutrition bars | 500 mg/100 g |
| Spreadable fats and dressings | 600 mg/100 g |
| Fish analogues | 300 mg/100 g |
| Meat analogues | 300 mg/100 g |

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

‘Schizochytrium sp. oil rich in DHA and EPA

Specified food category

Maximum levels of DHA and EPA combined

The designation of the novel food on the labelling of the foodstuffs containing it shall be “DHA and EPA-rich oil from the microalgae Schizochytrium sp.”’

Food supplements as defined in Directive 2002/46/EC for the adult population excluding pregnant and lactating women

3 000 mg/day

Food supplements as defined in Directive 2002/46/EC for pregnant and lactating women

450 mg/day

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

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 food and baby food 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 Commission Implementing Regulation (EU) No 828/2014

Bakery products (breads, rolls and sweet biscuits)

Breakfast cereals

500 mg/100 g

Cooking fats

360 mg/100 g

Dairy analogues, except drinks

600 mg/100 g for cheese; 200 mg/100 g for soy and imitation milk products (excluding drinks)

Dairy products except milk-based drinks

600 mg/100 g for cheese; 200 mg/100 g for milk products (including milk, fromage frais and yoghurt products; excluding drinks)

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

80 mg/100 g

Cereal/nutrition bars

500 mg/100 g

Spreadable fats and dressings

600 mg/100 g

Fish analogues

300 mg/100 g

Meat analogues

300 mg/100 g

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