Commission Implementing Regulation (EU) 2022/961 of 20 June 2022 authorising the placing on the market of tetrahydrocurcuminoids as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

• Published date: 21 June 2022
• Subject Matter: Foodstuffs,Internal market - Principles
• Official Gazette Publication: Official Journal of the European Union, L 165, 21 June 2022

21.6.2022 EN Official Journal of the European Union L 165/41

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COMMISSION IMPLEMENTING REGULATION (EU) 2022/961

of 20 June 2022

authorising the placing on the market of tetrahydrocurcuminoids as a novel food and amending 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 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), 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) 2017/2470 (2) has established a Union list of novel foods.

(3) On 22 January 2020, the company ‘Sabinsa Europe GmbH’ (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place tetrahydrocurcuminoids on the Union market as a novel food. The tetrahydrocurcuminoids are produced by the hydrogenation of curcuminoids extracted from the rhizomes of the turmeric plant (Curcuma longa L.). The applicant requested for tetrahydrocurcuminoids to be used at levels not exceeding 300 mg/day, in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3), intended for the adult population, excluding pregnant and lactating women.

(4) On 22 January 2020, the applicant also made a request to the Commission for the protection of proprietary data for the analytical data (4), a bacterial reverse mutation test (5), an in vitro micronucleus assay (6), a 90-day oral sub-chronic toxicity study and a reproduction/developmental toxicity screening test in rodents (7), submitted in support of the application.

(5) On 29 July 2020, the Commission, requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of tetrahydrocurcuminoids as a novel food.

(6) On 27 October 2021, the Authority adopted its scientific opinion on the ‘Safety of tetrahydrocurcuminoids from turmeric (Curcuma longa L.) as a novel food pursuant to Regulation (EU) 2015/2283’ (8) in accordance with Article 11 of Regulation (EU) 2015/2283.

(7) In its scientific opinion, the Authority concluded that tetrahydrocurcuminoids are safe under the proposed conditions of use, for the proposed target populations, at levels not exceeding 140 mg/day. The Authority further stated that such intake, although lower than the 300 mg/day level proposed by the applicant, provides an adequate Margin of Exposure (‘MoE’) to the identified No Observed Adverse Effect Levels (‘NOAELs’) from the subchronic toxicity and the reproductive/developmental toxicity studies. Therefore, that scientific opinion gives sufficient grounds to establish that tetrahydrocurcuminoids when used at levels not exceeding 140 mg/day in food supplements intended for the adult population, excluding pregnant and lactating women, fulfil the conditions for their placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.

(8) In its scientific opinion, the Authority noted that its conclusion on the safety of the novel food was based on the analytical data, the bacterial reverse mutation test, the in vitro micronucleus assay, the 90-day oral sub-chronic toxicity study and the reproduction/developmental toxicity screening test in rodents, contained in the applicant’s file, without which it could not have assessed the novel food and reached its conclusion.

(9) The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over those studies and tests and to clarify their claim to an exclusive right of reference to them in accordance with Article 26(2)(b) of Regulation (EU) 2015/2283.

(10) The applicant declared that they held proprietary and exclusive rights of reference to the analytical data, the bacterial reverse mutation test, the in vitro micronucleus assay, the 90-day oral sub-chronic toxicity study and the reproduction/developmental toxicity screening test in rodents, at the time they submitted the application, and that third parties cannot lawfully access, use or refer to those data.

(11) The Commission assessed all the information provided by the applicant and considered that they have sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the analytical data, the bacterial reverse

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