21.3.2018   

EN

Official Journal of the European Union

L 78/2

(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 shall submit a draft implementing act on the placing on the Union market of a novel food and on the updating of the Union list.

(4)

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 of the European Parliament and of the Council (3) 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.

(5)

On 14 May 2015, the company Botamedi Inc. made a request to the competent authority of Ireland to place phlorotannins extracted from the edible marine alga Ecklonia cava (‘Ecklonia cava phlorotannins’) on the Union market as a novel food ingredient within the meaning of point (c) of Article 1(2) of Regulation (EC) No 258/97. The application requests for Ecklonia cava phlorotannins to be used in food supplements for the general population, excluding children below 12 years of age.

(6)

While the request for placing Ecklonia cava phlorotannins as a novel food on the Union market was submitted in accordance with Article 4 of Regulation (EC) No 258/97, the application also meets the requirements laid down in Regulation (EU) 2015/2283.

(7)

On 29 March 2016, the competent authority of Ireland issued its initial assessment report. In that report it came to the conclusion that an additional assessment is required for Ecklonia cava phlorotannins in accordance with Article 6(3) of Regulation (EC) No 258/97.

(8)

On 10 May 2016, the Commission forwarded the initial assessment report to the other Member States. The Member States, within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97, agreed with the initial assessment report of Ireland.

(9)

In view of the initial assessment report issued by Ireland, to which the other Member States agreed, on 22 July 2016, the Commission consulted the European Food Safety Authority (EFSA), asking it to carry out an additional assessment for Ecklonia cava phlorotannins as a novel food ingredient in accordance with Regulation (EC) No 258/97.

(10)

On 20 September 2017, EFSA adopted ‘Scientific Opinion on the safety of Ecklonia cava phlorotannins as a novel food pursuant to Regulation (EC) No 258/97’ (4). This opinion, although elaborated and adopted by EFSA under Regulation (EC) No 258/97, is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

(11)

The EFSA opinion underlined that iodine intake from food supplements containing Ecklonia cava phlorotannins may be of concern for people at risk of thyroid disease, and that, if people who are not at risk of thyroid disease take food supplements containing Ecklonia cava phlorotannins in addition to other food supplements containing iodine, their overall iodine intake may exceed the upper limit established for iodine (5). Food supplements containing Ecklonia cava phlorotannins should therefore be appropriately labelled.

(12)

Moreover, taking into account the intended use and the fact that the request for authorisation excludes children under the age of 12 years, food supplements containing Ecklonia cava phlorotannins should also be appropriately labelled in this regard.

(13)

It follows, that the EFSA opinion gives sufficient grounds to establish that Ecklonia cava phlorotannins in the proposed uses and use levels when used as an ingredient in food supplements, complies with the criteria laid down in Article 12(1) of Regulation (EU) 2015/2283

(14)

Directive 2002/46/EC of the European Parliament and of the Council (6) lays down requirements on food supplements. The use of Ecklonia cava phlorotannins should be authorised without prejudice to that Directive.

(15)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,