Home Europe European Commission Commission Regulation (EU) 2025/140 of 29 January 2025 amend...
Date: 30-Jan-2025 Category: Not Applicable State: Union Government Country: Europe

Commission Regulation (EU) 2025/140 of 29 January 2025 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the inclusion of (E)-3-benzo[1,3]dioxol-5-yl-N,N-diphenyl-2-propenamide in the Union list of flavourings

Issued by European Commission · Directorate-General for Health and Food Safety

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Executive Summary & Key Takeaways

What it means

  • Commission Regulation (EU) 2025/140 amends Annex I to Regulation (EC) No 1334/2008 to include (E)-3-benzo[1,3]dioxol-5-yl-N,N-diphenyl-2-propenamide (FL No 16.135) in the Union list of flavorings.

Key Changes

  • The regulation adds (E)-3-benzo[1,3]dioxol-5-yl-N,N-diphenyl-2-propenamide (FL No 16.135, CAS No 1309389-73-8) to the Union list of flavorings in Annex I, Part A, Section 2, Table 1 of Regulation (EC) No 1334/2008.
  • The permitted usage levels for FL No 16.135 are specified as follows:
  • - Not more than 250 mg/kg in category 5 (other than 5.1, 5.3 and 5.4)
  • - Not more than 500 mg/kg in category 5.3
  • - Not more than 150 mg/kg in category 5.4
  • The European Food Safety Authority (EFSA) evaluated the safety of FL No 16.135 and concluded that there is no safety concern at the estimated levels of dietary exposure based on the intended uses and use levels.

Impact Analysis

Food Manufacturers

  • Action Item: Update product formulations and labeling to reflect the inclusion of (E)-3-benzo[1,3]dioxol-5-yl-N,N-diphenyl-2-propenamide as a permitted flavoring substance, ensuring adherence to specified limits.

Consumers

  • No direct action is required from consumers.

Regulatory Bodies

  • Action Item: Incorporate the changes into national regulations and monitoring programs.

Key Entities Referenced

European Commission: The European Commission is responsible for proposing and adopting regulations related to food safety and flavorings. European Parliament and Council: The European Parliament and Council are the legislative bodies responsible for enacting regulations on flavorings and food ingredients. European Food Safety Authority (EFSA): EFSA provides scientific opinions and advice to the European Commission on food safety matters, including the safety assessment of flavoring substances. Regulation (EC) No 1334/2008: 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. Regulation (EC) No 1331/2008: 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. Commission Implementing Regulation (EU) No 872/2012: Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Decision 1999/217/EC. (E)-3-benzo[1,3]dioxol-5-yl-N,N-diphenyl-2-propenamide (FL No 16.135): A flavoring substance with CAS No 1309389-73-8, now included in the Union list of flavorings with specific usage conditions.
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Official Journal EN of the European Union L series 2025/140 30.1.2025 COMMISSION REGULATION (EU) 2025/140 of 29 January 2025 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the inclusion of (E)-3-benzo[1,3]dioxol-5-yl-N,N-diphenyl-2-propenamide in the Union list of flavourings (Text with EEA relevance) 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 2008on 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(1), 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(2), 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(3) adopted the list of flavouring substances and introduced that list in Annex I, Part A, 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 15 January 2019, an application was submitted to the Commission for the authorisation of (E)-3-benzo[1,3] dioxol-5-yl-N,N-diphenyl-2-propenamide, (FL No 16.135), 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 18 May 2022(4), the Authority evaluated the safety of the substance FL No 16.135 when used as a flavouring substance and concluded that there is no safety concern at the estimated level of dietary exposure calculated using the added portions exposure technique based on the intended uses and use levels. The Authority further concluded that the combined exposure to FL No 16.135 from its use as a food flavouring substance and from its presence in toothpaste is also not of safety concern. (6) In light of the opinion of the Authority, since the use of the substance FL No 16.135 as a flavouring substance does not give rise to safety concerns with the specified conditions of use and it is not expected to mislead the consumer, it is appropriate to authorise such use. (1) OJ L 354, 31.12.2008, p. 34, ELI: http://data.europa.eu/eli/reg/2008/1334/oj. (2) OJ L 354, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1331/oj. (3) Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Decision 1999/217/EC (OJ L 267, 2.10.2012, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2012/872/oj). (4) EFSA Journal 2022;20(7):7355. ELI: http://data.europa.eu/eli/reg/2025/140/oj 1/3EN OJ L, 30.1.2025 (7) Annex I, Part A, to Regulation (EC) No 1334/2008 should therefore be amended accordingly to include (E)- 3-benzo[1,3]dioxol-5-yl-N,N-diphenyl-2-propenamide 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, Part A, 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, 29 January 2025. For the Commission The President Ursula VON DER LEYEN 2/3 ELI: http://data.europa.eu/eli/reg/2025/140/ojANNEX In Annex I, Part A, Section 2, Table 1 to Regulation (EC) No 1334/2008, the following entry is inserted after the entry concerning FL No 16.133: ‘16.135 (E)-3-benzo[1,3]dioxol-5-yl-N,N-diphenyl- 1309389-73-8 In category 5 (other than 5.1, 5.3 EFSA’ 2-propenamide and 5.4) – not more than 250 mg/kg In category 5.3 – not more than 500 mg/kg In category 5.4 – not more than 150 mg/kg ELI: http://data.europa.eu/eli/reg/2025/140/oj 3/3 OJ L, 30.1.2025 EN

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