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)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
1. Tetrahydrocurcuminoids is authorised to be placed on the market within the Union. Tetrahydrocurcuminoids 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.
Only the company ‘Sabinsa Europe GmbH’ ( 9 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of five years from 11 July 2022, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of Sabinsa Europe GmbH.
The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of five years from 11 July 2022 without the agreement of ‘Sabinsa Europe GmbH’.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEX The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows: (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 Protection ‘ Tetrahydrocurcuminoids Specified food category Maximum levels The designation of the novel food on the labelling of the foodstuffs containing it shall be “tetrahydrocurcuminoids”. The labelling of food supplements containing tetrahydrocurcuminoids shall bear a statement that a) they should be consumed by adults only, excluding pregnant and lactating women; b) they should not be consumed if other food supplements containing curcumin and/or curcuminoids are consumed on the same day. Authorised on 11 July 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: “Sabinsa Europe GmbH”, Monzastrasse 4, 63225 Langen, Germany. During the period of data protection, the novel food tetrahydrocurcuminoids is authorised for placing on the market within the Union only by “Sabinsa Europe GmbH” unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of “Sabinsa Europe GmbH”. End date of the data protection: 11 July 2027.’ Food Supplements as defined in Directive 2002/46/EC for the adult population, excluding pregnant and lactating women 140 mg/day (2) in Table 2 (Specifications), the following entry is inserted in alphabetical order: Authorised Novel Food Specification ‘ Tetrahydrocurcuminoids Description: The tetrahydrocurcuminoids are produced via a series of steps involving the extraction of curcuminoids from the dried, pulverised rhizomes of turmeric ( Curcuma longa L.), hydrogenation (using palladium on carbon (Pd/C) as a catalyst), concentration, crystallisation, drying, and milling into a powder. Characteristics/Composition: Total tetrahydrocurcuminoids (dry basis) (% w/w): > 95,0 Moisture (% w/w): ≤ 1,0 Ash (% w/w): ≤ 1,0 Palladium (mg/kg): < 5,0 Microbiological criteria: Total aerobic microbial count: ≤ 5 000 CFU/g Total yeast/moulds count: ≤ 100 CFU/g Escherichia coli : < 10 CFU/g Staphylococcus aureus : ≤ 10 CFU/g Enterobacteriaceae: ≤ 10 CFU/g Salmonella spp.: Absence in 25 g Coliforms: ≤ 10 CFU/g CFU: Colony Forming Units’
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.