# Commission Implementing Decision (EU) 2015/1290Show full title

Commission Implementing Decision (EU) 2015/1290 of 23 July 2015 authorising the placing on the market of refined oil from            the seeds of Buglossoides arvensis as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and            of the Council (notified under document C(2015) 4961) (Only the English text is authentic)         

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U.K.

# Commission Implementing Decision (EU) 2015/1290                     

# of 23 July 2015

# authorising the placing on the market of refined oil from the seeds of *Buglossoides arvensis* as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council                     

# *(notified under document C(2015) 4961)*

# (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,                        

Whereas:

(1)On 25 June 2013, the company Technology Crops International made a request to the competent authorities of the United Kingdom                              to place refined oil from the seeds of *Buglossoides arvensis* on the market as a novel food ingredient.

(2)On 6 January 2014, the competent food assessment body of the United Kingdom issued its initial assessment report. In that                              report, it came to the conclusion that refined oil from the seeds of *Buglossoides arvensis* meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.

(3)On 21 January 2014, the Commission forwarded the initial assessment report to the other Member States.

(4)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.

(5)On 11 June 2014, the Commission consulted the European Food Safety Authority (EFSA), asking it to carry out an assessment                              for refined oil from the seeds of *Buglossoides arvensis* as a novel food ingredient in accordance with Regulation (EC) No 258/97.

(6)On 5 February 2015, EFSA in its ‘Scientific Opinion on the safety of refined *Buglossoides* oil as a novel food ingredient’(2), concluded that refined oil from the seeds of *Buglossoides arvensis* is safe for the proposed uses and use levels.

(7)Directive 2002/46/EC of the European Parliament and of the Council(3) lays down requirements on food supplements. Regulation (EC) No 1925/2006 of the European Parliament and of the Council(4) lays down requirements on the addition of vitamins and minerals and of certain other substances to foods. Commission Directive                              1999/21/EC(5) lays down requirements for dietary foods for special medical purposes. Commission Directive 96/8/EC(6) lays down requirements on foods intended for use in energy-restricted diets for weight reduction. The use of refined oil                              from the seeds of *Buglossoides arvensis* should be authorised without prejudice to the requirements of those legislations.

(8)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 1U.K.

Refined oil from the seeds of *Buglossoides arvensis* as specified in Annex I may be placed on the market in the Union as a novel food ingredient for the uses defined and at the                     maximum levels established in Annex II without prejudice to the specific provisions of Directive 2002/46/EC, Regulation (EC)                     No 1925/2006, Directive 1999/21/EC and Directive 96/8/EC.                  

# Article 2U.K.

The designation of refined oil from the seeds of *Buglossoides arvensis* authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘refined Buglossoides oil’.                  

# Article 3U.K.

This Decision is addressed to Technology Crops International, 7996 North Point Blvd Winston Salem, NC 27106, USA.

Done at Brussels, 23 July 2015.

*For the Commission*                            

Vytenis Andriukaitis                            

*Member of the Commission*                            

## ANNEX IU.K.**SPECIFICATION OF REFINED OIL FROM THE SEEDS OF *BUGLOSSOIDES ARVENSIS***

**Description**: Refined Buglossoides oil is extracted from the seeds of *Buglossoides arvensis* (L.) I.M.Johnst.                  

## ANNEX IIU.K.**AUTHORISED USES OF REFINED OIL FROM THE SEEDS OF *BUGLOSSOIDES ARVENSIS***

1

OJ L 43, 14.2.1997, p. 1.                           

2

*EFSA Journal* 2015; 13(2):4029.                           

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).                           

4

Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins                              and minerals and of certain other substances to foods (OJ L 404, 30.12.2006, p. 26).                           

5

Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (OJ L 91, 7.4.1999, p. 29).                           

6

Commission Directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction                              (OJ L 55, 6.3.1996, p. 22).