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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 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001note, and in particular Article 12(1) thereof,Whereas:
(1)Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.
(2)Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470note has established a Union list of novel foods.
(3)On 17 December 2020, the company ATK Biotech Co., Ltd.note (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place Schizochytrium sp. (TKD-1) oil on the Union market as a novel food. The applicant requested for the novel food to be authorised for use in infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Councilnote. The strain of Schizochytrium sp. used by the applicant and concerned by this application is specified as strain TKD-1.
(4)On 21 April 2021, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of Schizochytrium sp. (TKD-1) oil as a novel food.
(5)On 26 October 2023, the Authority adopted its scientific opinion on the ‘Safety of oil from Schizochytrium limacinum (strain TKD-1) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283’note in accordance with Article 11 of Regulation (EU) 2015/2283.
(6)In its scientific opinion, the Authority concluded that the novel food, oil produced from the strain TKD-1 belonging to species Schizochytrium limacinum, is safe under the proposed conditions of use. The Authority noted that the proposed use levels are in accordance with Regulation (EU) No 609/2013 and its supplementing Regulation (EU) 2016/127note. The Authority also noted that the available evidence indicates that the source organism (Schizochytrium sp., strain TKD-1) belongs to the species Schizochytrium limacinum. In its opinion, the Authority further noted that the source organism which is assessed in the application is Schizochytrium limacinum (strain TKD-1) and not the generic Schizochytrium sp. Therefore, that scientific opinion gives sufficient grounds to establish that Schizochytrium limacinum (TKD-1) oil, when used under the proposed conditions of use, fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.
(7)It is appropriate that the inclusion of Schizochytrium limacinum (TKD-1) oil as a novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283.
(8)Schizochytrium limacinum (TKD-1) oil should therefore be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.
(9)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1#
1.Schizochytrium limacinum (TKD-1) oil is authorised to be placed on the market within the Union.Schizochytrium limacinum (TKD-1) oil shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.
2.The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Article 2#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
(1)in Table 1 (Authorised novel foods), the following entry is inserted:Authorised novel food | Conditions under which the novel food may be used | Additional specific labelling requirements | Other requirements | Data protectionSchizochytrium limacinum (TKD-1) oil | Specified food category | Maximum levels of DHA | The designation of the novel food on the labelling of the foodstuffs containing it shall be Oil from the microalgae Schizochytrium limacinum. | |Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013
(2)in Table 2 (Specifications), the following entry is inserted:Authorised Novel Food | SpecificationSchizochytrium limacinum (TKD-1) oil | Description/Definition:The novel food is an oil produced from the strain TKD-1 of the microalgae species Schizochytrium limacinum.Composition:DHA content: ≥ 35,0 %Acid value: ≤ 0,5 mg KOH/gPeroxide value: ≤ 5,0 meq/kgMoisture and volatiles: ≤ 0,05 %Unsaponifiables: ≤ 3,5 %Trans-fatty acids: ≤ 2,0 %Free fatty acids: ≤ 0,4 %p-Anisidine value: ≤ 10
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
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