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Summaries of EU Legislation

    Smoke flavourings — safety assessment

     

    SUMMARY OF:

    Regulation (EC) No 2065/2003 — smoke flavourings for foods

    WHAT IS THE AIM OF THIS REGULATION?

    It sets EU-wide rules on authorising and using smoke flavourings in foods.

    KEY POINTS

    The regulation introduces a safety assessment and authorisation procedure for primary smoke condensates* and primary tar fractions* which can be used in and on foods and/or for the production of derived smoke flavourings*.

    The primary products* for which no health concern is expressed during evaluation are then included in a list of authorised products under specific conditions of use.

    Authorisations are granted for a period of 10 years after which they have to be renewed. This ensures that products are regularly re-assessed in the light of the latest scientific and technical knowledge and that authorised products, that are no longer used, are removed from the EU’s positive list.

    Applicants for the authorisation of a primary product must provide detailed information on:

    • the type of wood used for the production of the primary product;
    • detailed information on the production methods of the primary products and the further processing in the production of derived smoke flavourings;
    • the intended uses in or on specific foods or food categories;
    • chemical specifications;
    • toxicological studies; and
    • validated methods for sampling and detecting primary products and derived smoke flavourings.

    The safety evaluation of the applications is carried out by the European Food Safety Authority (EFSA) according to a specific time-frame and on the basis of transparent procedures.

    The application is made to EFSA, the Commission and the EU countries. If requested by the applicant, certain sensitive data may remain confidential.

    The EFSA assessments on smoke flavourings are available here: EU lists of flavourings – Scientific advice – 3 Smoke flavourings (primary products)

    Commission Regulation (EC) No 627/2006 establishes quality criteria for the validated analytical methods for sampling, identification and characterisation of primary smoke products, as referred to in Annex II of Regulation (EC) No 2065/2003.

    FROM WHEN DOES THE REGULATION APPLY?

    It has applied since 16 December 2003 apart from its Article 4(2) prohibiting the placing on the market of a smoke flavouring or food in or on which smoke flavouring is present if the flavouring has not been authorised, which has applied since 16 June 2005.

    BACKGROUND

    For more information, see:

    KEY TERMS

    Primary smoke condensates: the purified water-based part of condensed smoke which falls within the definition of smoke flavourings.
    Primary tar fractions: the purified fraction of the water-insoluble high-density tar phase of condensed smoke which falls within the definition of smoke flavourings.
    Derived smoke flavourings: flavourings produced as a result of the further processing of primary products used in or on foods in order to impart smoke flavour to those foods.
    Primary products: primary smoke condensates and primary tar fractions.

    MAIN DOCUMENT

    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 (OJ L 309, 26.11.2003, pp. 1-8)

    Successive amendments to Regulation (EC) No 2065/2003 have been incorporated into the original document. This consolidated version is of documentary value only.

    RELATED DOCUMENTS

    Commission Implementing Regulation (EU) No 1321/2013 of 10 December 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 (OJ L 333, 12.12.2013, p. 54-67)

    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 (OJ L 354, 31.12.2008, pp. 34-50)

    See consolidated version.

    Commission 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 (OJ L 109, 22.4.2006, pp. 3-6)

    last update 11.04.2018

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