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 (Text with EEA relevance.)

• Published date: 23 July 2018
• Subject Matter: Foodstuffs,Internal market - Principles
• Official Gazette Publication: Official Journal of the European Union, L 185, 23 July 2018

23.7.2018 EN Official Journal of the European Union L 185/9

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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

(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.

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

(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 updating the Union list.

(4) Commission Implementing Decision (EU) No 463/2014 (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4) concerning novel food and novel food ingredients, the placing on the market of oil containing docosahexaenoic acid (‘DHA’) from the micro algae Schizochytrium sp. as a novel food ingredient to be used in certain foods, foods intended for use in energy restricted diets for weight reduction, dietary foods for special medical purposes, other foods for particular nutritional uses as defined in Directive 2009/39/EC of the European Parliament and of the Council (5) (excluding infant and follow on formulae) and food supplements.

(5) Commission Implementing Decision (EU) 2015/545 (6) authorised, in accordance with Regulation (EC) No 258/97, the placing on the market of oil containing docosahexaenoic acid (‘DHA’) from another strain of the micro algae Schizochytrium sp. (ATCC PTA 9695), as a novel food ingredient to be used in certain foods, including infant and follow on formulae and processed cereal-based foods and baby foods for infants and young children.

(6) On 21 November 2016, the company Mara Renewables Corporation made a request to the competent authority of the United Kingdom for an extension of use of oil produced from a different strain of the micro algae Schizochytrium sp. (strain T18) within the meaning of point (d) of Article 1(2) of Regulation (EC) No 258/97. The application requested to use oil from this Schizochytrium sp. strain T18 for all foods authorised by Implementing Decisions (EU) No 463/2014 and (EU) 2015/545, and extend its use to fruit and vegetable purees.

(7) On 10 January 2017, the company Mara Renewables Corporation notified the Commission that it placed the novel food ingredient ‘oil from Schizochytrium sp.’ produced with strain T18 on the Union market pursuant to Article 5 of Regulation (EC) No 258/97. The company intended to use this novel food ingredient in all previously authorised foods under Implementing Decision (EU) No 463/2014.

(8) On 22 September 2017, the company Nutraveris notified the Commission that it placed the novel food ingredient ‘oil from Schizochytrium sp.’ produced with strain T18 on the Union market pursuant to Article 5 of Regulation (EC) No 258/97. The company intended to use this novel food ingredient in all previously authorised foods under Implementing Decisions (EU) No 463/2014 and (EU) 2015/545.

(9) On 23 October 2017, the company BASF notified the Commission that it placed the novel food ingredient ‘oil from Schizochytrium sp.’ produced with strain T18 on the Union market pursuant to Article 5 of Regulation (EC) No 258/97. The company intended to use this novel food ingredient in all previously authorised foods under Implementing Decisions (EU) No 463/2014 and (EU) 2015/545.

(10) Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 and for which the final decision has not been taken before 1 January 2018 shall be treated as an application submitted under Regulation (EU) 2015/2283.

(11) While the request for an extension of use of oil from the micro-algae species Schizochytrium sp. strain T18 was submitted to a Member State in accordance with Article 4 of

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