Commission Regulation (EU) 2026/175 of 26 January 2026 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the inclusion of hesperetin dihydrochalcone in the Union list of flavourings (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/regulation/2026/175@2026-01-26/en
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC, and in particular Article 11(3) thereof,
Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings, and in particular Article 7(5) thereof,
Whereas:
(1) Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials approved for use in and on foods and their conditions of use.
(2) Commission Implementing Regulation (EU) No 872/2012 adopted the list of flavouring substances and introduced that list in Part A of Annex I to Regulation (EC) No 1334/2008.
(3) That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application submitted by a Member State or by an interested party.
(4) On 7 November 2022, an application was submitted to the Commission for the authorisation of hesperetin dihydrochalcone (FL No. 16.137) as a flavouring substance to be used in various foods falling under a number of food categories referred to in the Union list of flavourings and source materials. The application was notified to the European Food Safety Authority (the Authority) for its opinion. The Commission also made the application available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.
(5) In its opinion adopted on 23 October 2024, the Authority evaluated the safety of hesperetin dihydrochalcone (FL No. 16.137) when used as a flavouring substance and concluded that such use under the proposed conditions and levels of use does not raise a safety concern. The Authority also concluded that the cumulative exposure to hesperetin dihydrochalcone (FL No. 16.137) and four structurally related substances (FL No. 16.061, 16.109, 16.110, 16.112) does not raise a safety concern either.
(6) In the light of the opinion of the Authority, since the use of hesperetin dihydrochalcone (FL No. 16.137) as a flavouring substance does not give rise to safety concerns under the specified conditions of use and it is not expected to mislead the consumer, it is appropriate to authorise such use.
(7) Annex I to Regulation (EC) No 1334/2008 should therefore be amended accordingly to include hesperetin dihydrochalcone (FL No. 16.137) in the Union list of flavourings.
(8) 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
Annex I to Regulation (EC) No 1334/2008 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
This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 26 January 2026. For the Commission The President Ursula von der Leyen
ANNEX
ANNEX
In Part A, Section 2, Table 1, of Annex I to Regulation (EC) No 1334/2008, the following entry is inserted after the entry concerning FL No. 16.136: 16.137 Hesperetin dihydrochalcone 35400–60-3 2262 In category 1.4 – not more than 10 mg/Kg In category 3 – not more than 10 mg/Kg In category 4.2 – not more than 10 mg/Kg In category 5.2 – not more than 10 mg/Kg In category 5.3 – not more than 10 mg/Kg In category 6.3 – not more than 10 mg/Kg In category 7.1 – not more than 10 mg/Kg In category 7.2 (only savoury crackers) – not more than 10 mg/Kg In category 12.2 – not more than 10 mg/Kg In category 12.6 – not more than 10 mg/Kg In category 14.1 – not more than 10 mg/Kg In category 14.2.1 – not more than 10 mg/Kg In category 15.1 – not more than 10 mg/Kg In category 16 (only dairy, dairy analogues, fruit and vegetable based) – Not more than 10 mg/Kg EFSA