# L_2015090EN.01001101.xml

| 2.4.2015 | EN | Official Journal of the European Union | L 90/11 |
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2.4.2015

EN

Official Journal of the European Union

L 90/11

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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

Schizochytrium

(notified under document C(2015) 2083)

(notified under document C(2015) 2083)

(Only the English 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,

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Whereas:

| (1) | On 6 July 2012, the competent authorities of the United Kingdom authorised, in accordance with Regulation (EC) No 258/97, the placing on the market of docosahexaenoic acid (DHA) and eicosapentaenoic (EPA)-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient to be used in certain foods. |
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(1)

On 6 July 2012, the competent authorities of the United Kingdom authorised, in accordance with Regulation (EC) No 258/97, the placing on the market of docosahexaenoic acid (DHA) and eicosapentaenoic (EPA)-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient to be used in certain foods.

Schizochytrium

| (2) | On 19 November 2012, the company DSM Nutritional Products made a request to the competent authorities of the United Kingdom for extension of use of DHA and EPA-rich oil from micro-algae Schizochytrium sp. as a novel food ingredient. |
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(2)

On 19 November 2012, the company DSM Nutritional Products made a request to the competent authorities of the United Kingdom for extension of use of DHA and EPA-rich oil from micro-algae Schizochytrium sp. as a novel food ingredient.

Schizochytrium

| (3) | On 29 April 2013, the competent food assessment body of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that the extension of use of this algal oil meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97. |
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(3)

On 29 April 2013, the competent food assessment body of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that the extension of use of this algal oil meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.

| (4) | On 9 July 2013, the Commission forwarded the initial assessment report to the other Member States. |
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(4)

On 9 July 2013, the Commission forwarded the initial assessment report to the other Member States.

| (5) | 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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(5)

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.

| (6) | On 25 March 2014, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment of the extension of use of DHA and EPA-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient in accordance with Regulation (EC) No 258/97. |
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(6)

On 25 March 2014, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment of the extension of use of DHA and EPA-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient in accordance with Regulation (EC) No 258/97.

Schizochytrium

| (7) | On 18 September 2014, EFSA adopted a scientific opinion on the extension of use for DHA and EPA-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient (2), concluding that it is safe under the proposed uses and use levels. |
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(7)

On 18 September 2014, EFSA adopted a scientific opinion on the extension of use for DHA and EPA-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient (2), concluding that it is safe under the proposed uses and use levels.

Schizochytrium

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| (8) | That opinion gives sufficient grounds to establish that DHA and EPA-rich oil from the micro-algae Schizochytrium sp. in the proposed uses and use levels complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97. |
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(8)

That opinion gives sufficient grounds to establish that DHA and EPA-rich oil from the micro-algae Schizochytrium sp. in the proposed uses and use levels complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

Schizochytrium

| (9) | Directive 2002/46/EC of the European Parliament and of the Council (3) lays down requirements on food supplements. The use of DHA and EPA-rich oil from the micro-algae Schizochytrium sp. should be authorised without prejudice to the requirements of that legislation. |
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(9)

Directive 2002/46/EC of the European Parliament and of the Council (3) lays down requirements on food supplements. The use of DHA and EPA-rich oil from the micro-algae Schizochytrium sp. should be authorised without prejudice to the requirements of that legislation.

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Schizochytrium

| (10) | 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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(10)

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

DHA and EPA-rich oil from the micro-algae Schizochytrium sp. as specified in Annex I may be placed on the market in the Union as a novel food ingredient for the use defined and at the maximum level established in Annex II without prejudice to the provisions of Directive 2002/46/EC.

Schizochytrium

Article 2

The designation of DHA- and EPA-rich oil from the micro-algae Schizochytrium sp. authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the micro-algae Schizochytrium sp.’.

Schizochytrium

Schizochytrium

Article 3

This Decision is addressed to DSM Nutritional Products, 6480 Dobbin Road, Columbia, MD 21045, USA.

Done at Brussels, 31 March 2015.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

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

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(2)  EFSA Journal 2014; 12(10):3843.

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EFSA Journal

(3)  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 I

Specification of DHA (docosahexaneoic acid) and EPA (eicosapentaenoic acid)-rich oil from the micro-algae Schizochytrium sp.

| Test | Specification |
| --- | --- |
| Acid value | Not more than 0,5 mg KOH/g |
| Peroxide value (PV) | Not more than 5,0 meq/kg oil |
| Moisture and volatiles | Not more than 0,05 % |
| Unsaponifiables | Not more than 4,5 % |
| Trans-fatty acids | Not more than 1,0 % |
| DHA content | Not less than 22,5 % |
| EPA content | Not less than 10 % |

Test

Specification

Acid value

Not more than 0,5 mg KOH/g

Peroxide value (PV)

Not more than 5,0 meq/kg oil

Moisture and volatiles

Not more than 0,05 %

Unsaponifiables

Not more than 4,5 %

Trans-fatty acids

Not more than 1,0 %

DHA content

Not less than 22,5 %

EPA content

Not less than 10 %

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ANNEX II

Authorised uses of DHA (docosahexaenoic acid) and EPA (eicosapentaenoic acid)-rich oil from the micro-algae Schizochytrium sp.

| Food category | Maximum use level of DHA and EPA (mg/day) |
| --- | --- |
| Food supplements | 3 000 mg as recommended by the manufacturer for adult population excluding pregnant and lactating women |

Food category

Maximum use level of DHA and EPA (mg/day)

Food supplements

3 000 mg as recommended by the manufacturer for adult population excluding pregnant and lactating women

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