(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) establishing a Union list of authorised novel foods was adopted.

(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 the updating of the Union list.

(4)

Commission Implementing Decision (EU) 2015/545 (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4), the placing on the market in the Union of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) as a novel food to be used in a number of foods.

(5)

Commission Implementing Regulation (EU) 2018/1032 (5) extended the authorisation of oil from the microalgae Schizochytrium sp. (T18) as a novel food under Regulation (EU) 2015/2283 to fruit/vegetable purees.

(6)

On 10 September 2018, the company DSM Nutritional Products Europe made a request to the Commission to change the conditions of use of the novel food Schizochytrium sp. (ATCC PTA-9695) oil within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to extend the use of Schizochytrium sp. (ATCC PTA-9695) oil to fruit and vegetable purees.

(7)

The proposed extension of use of the novel food does not change the safety considerations that supported the authorisation for extension of use of Schizochytrium sp. (T18) oil by Implementing Regulation (EU) 2018/1032 to fruit and vegetable purees and it does not either pose any safety concern. Taking into account those considerations, the proposed extension of use complies with Article 12(1) of Regulation (EU) 2015/2283.

(8)

On 10 September 2018, the company DSM Nutritional Products Europe also made a request to the Commission to authorise the change of the designation and of the specific labelling requirement for Schizochytrium sp. (ATCC PTA-9695) oil within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requests the deletion of the mention of the strain ‘(ATCC PTA 9695)’ from the designation of the novel food as listed in the Union list and from the labelling of foods containing it.

(9)

The Applicant considers that the change of the designation and the labelling requirements for Schizochytrium sp. (ATCC PTA-9695) oil is necessary because the indication of the strain ‘(ATCC PTA-9695)’ on the labelling of foods containing Schizochytrium sp. (ATCC PTA-9695) oil is not understandable nor relevant for consumers.

(10)

There are four oils from Schizochytrium sp. currently authorised and listed in the Union list of novel foods. However, Schizochytrium sp. (ATCC PTA-9695) oil is the only one for which the strain must be specified on the label. Therefore, the change of the designation and labelling of Schizochytrium sp. (ATCC PTA-9695) oil will ensure consistency in the designation and labelling of all oils from Schizochytrium sp. authorised as novel foods without having a negative impact on human health and consumer interests.

(11)

Considering the removal of the mention of the strain ‘(ATCC PTA 9695)’ from the designation of the novel food and of the specific labelling requirement for Schizochytrium sp. (ATCC PTA-9695) oil, the wording ‘(ATCC PTA 9695)’ should be included in the specifications as it is necessary for a proper identification of the novel food. Therefore, the specifications of the entry ‘Schizochytrium sp. (ATCC PTA-9695) oil’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 should be amended accordingly.

(12)

The Commission did not request an opinion from the European Food Safety Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283, as an extension of use of Schizochytrium sp. (ATCC PTA-9695) oil, the change of the designation and of the specific labelling requirement for Schizochytrium sp. (ATCC PTA-9695) oil and the subsequent updating of the Union list are not liable to have an effect on human health.

(13)

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