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Food Safety

EU Rules - flavourings

I. EU Legislation

Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in/on foods was adopted on 16 December 2008 and entered into force on 20 January 2009. This Regulation repealed Directive 88/388/EEC and Commission Directive 91/71/EEC from 20 January 2011 onwards.

Regulation (EC) No 1334/2008 lays down general requirements for safe use of flavourings and provides definitions for different types of flavourings. The Regulation sets out substances for which an evaluation and approval is required. The Union list of flavouring substances, approved for use in and on foods, was adopted on 1 October 2012 and was introduced in Annex I of this Regulation.

The Union list of flavourings has been amended as follows:

The Regulation prohibits the addition of certain natural undesirable substances as such to food and lays down maximum levels for certain substances, which are naturally present in flavourings and in food ingredients with flavourings properties, but which may raise concern for human health.

The union list of flavourings (Annex I of Regulation 1334/2008) is described here.

Other pieces of EU legislation relevant to flavourings are the following:

Both Regulation (EC) No 178/2002 and Regulation (EC) No 1331/2008 were amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain amended with effect from 27 March 2021. Please see further information on the implementation of that Regulation.

Regulation (EU) No 234/2011 implements the common authorisation procedure and applies from 11 September 2011. That Regulation has been amended by Commission Implementing Regulation (EU) No 562/2012 which lays down derogation from submitting toxicological data in some specific cases and the possibility of grouping food enzymes under one application under certain conditions. It has also been adjusted by Commission Implementing Regulation (EU) 2020/1823 to accommodate the changes linked to Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain. These new provisions are applicable to applications submitted from 27 March 2021.

II. Labelling of flavourings

The overall rules on the labelling of food are also relevant for flavourings. Please refer to the Labelling and Nutrition web section.

However there are some specific provisions regarding the labelling of flavourings in Chapter IV of Regulation 1334/2008.

Regulation (EC) No 1334/2008 also sets out the rules for labelling of flavourings from business to business and for sale to the final consumers.

It also describes the specific requirements for use of the term "natural". This Regulation also harmonises and clarifies the rules for the use of these substances in the EU.

III. Smoke flavourings

Smoke flavourings are a specific category of flavourings and are governed by a specific set of regulations:

  • Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods. The Regulation establishes a Community procedure for the safety assessment and the authorisation of smoke flavourings intended for use in or on foods in order to ensure a high level of protection of human health and protection of consumers' interests, as well as to ensure fair trade practices. Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain amended Regulation (EC) No 178/2002 and Regulation (EC) No 2065/2003 and is applicable as of 27 March 2021. Please see further information on the implementation of that Regulation.
  • Regulation (EC) No 627/2006 of 21 April 2006 implementing Regulation (EC) No 2065/2003 of the European Parliament and of the Council as regards quality criteria for validated analytical methods for sampling, identification and characterisation of primary smoke products.
  • Regulation (EU) No 1321/2013 establishing the Union list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings, was published in the Official Journal on 12 December 2013. This Regulation lists the authorised smoke flavouring primary products for use in or on foods and their conditions of use. This list was established on the basis of the applications submitted under article 20 of the Regulation 2065/2003 and after evaluation by EFSA.

IV. Rules for use of additives in food flavourings

The food additives that may be used in flavourings and their conditions of use can be consulted under additives.

V. Background on older legislations on flavourings still partially valid

Legislations on flavouring substances that are still partially valid

  • European Parliament and Council Regulation (EC) No 2232/96 of 28 October 1996 laying down a Community procedure for flavouring substances used or intended for use in or on foodstuffs. This Regulation will remain in force until a number of substances for which the EU risk assessment have not been completed at the time of entry into force of Regulation (EC) No 872/2012 have been fully evaluated and added to the Union list. At that time, the authorisation procedure for flavourings under Regulation (EC) No 1331/2008 will be fully applicable.

  • Regulation (EC) No 1565/2000 of 18 July 2000 laying down the measures necessary for the adoption of an evaluation programme in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council. This Regulation will remain in force until a number of substances for which the EU risk assessment have not been completed at the time of entry into force of Regulation (EC) No 872/2012 have been fully evaluated and added to the Union list. At that time, the authorisation procedure for flavourings under Regulation (EC) No 1331/2008 will be fully applicable.

Repealed legislations on flavouring substances