FSA Consultation Letter, 28 September 2004

FLAVOURINGS - Consultation on Draft Smoke Flavourings (England) Regulations 2004

Consultation on draft regulations enforcing provisions of Regulation (EC) 2065/2003 of the European Parliament and of the Council on smoke flavourings used or intended for use in or on foods. Responses are requested by: 21 December 2004

Consultation details

Regulation (EC) No. 2065/2003 of 10 November 2003 was published in the Official Journal of the European Communities (L309) on 26 November 2003. This regulation establishes Community procedures within the European Union for the safety assessment and authorisation of primary products and/or derived smoke flavourings intended for use in or on foods

What are smoke flavourings?

Article 5(1) of Council Directive 88/388/EEC (the Flavourings Framework Directive) provides for the adoption of appropriate provisions concerning source materials (e.g. untreated woods) used in the production of smoke flavourings and the reaction conditions under which they are prepared. The directive defines a smoke flavouring as 'a smoke extract used in traditional foodstuffs smoking processes'.

Regulation (EC) No. 2065/2003 provides definitions for 'primary smoke condensate', 'primary tar fraction', 'primary products' and 'derived smoke flavourings:'

• primary smoke condensate is the purified part of the condensed smoke that can be dissolved in water.
• primary tar fraction this part of the purification stage produces condensed smoke that is not soluble in water and high in tar residues (only the purified part of this fraction can be used in the production of smoke flavourings).
• primary products refers to primary smoke condensates and primary tar fractions.
• derived smoke flavourings flavourings produced as a result of further processing of primary products and which are used or intended to be used in or on foods in order to impart smoke flavour to those food.
  

What will the proposed regulations implement?

Regulation (EC) No. 2065/2003 harmonises the scientific evaluation, authorisation and use of smoke flavourings within the European Community. The Smoke Flavourings (England) Regulations 2004 will enforce the following provisions detailed in Regulation (EC) No. 2065/2003:

• Prohibition on marketing a smoke flavouring not on the list of authorised smoke flavourings, or any food in or on which such a smoke flavouring is present. Prohibition on marketing an authorised smoke flavouring, or any food in or on which such a smoke flavouring is present, otherwise than in accordance with any conditions of use laid down in the authorisation (Article 4.2).
• Prohibition on using treated wood, unless it can be demonstrated by appropriate certification or documentation that the substance used in treatment does not give rise to potentially toxic substances during combustion. Requirement to be able to demonstrate by documentation or certification that the prohibition described above has been observed (Article 5.1).
• Requirement to observe conditions during production of primary products. Prohibition on the use of water-insoluble oily phase during the production of smoke flavourings (Article 5.2).
• Requirement that an authorisation holder or any other food business operator using an authorised product, or a derived smoke flavouring produced from an authorised product, shall comply with any conditions or restrictions attached to the authorisation (Article 9.4).
• Requirement that an authorisation holder inform the Commission of any new scientific or technical information relating to an authorised product, which might influence the assessment of the safety of that authorised product (Article 9.5).
• Requirement that food business operators ensure that the information specified is transmitted to the receiving food business operator when the product is first placed on the market (Article 13.1).
• Requirement that following first placing on the market, on each occasion that the product is placed on the market, food business operators placing the products on the market transmit the information specified in Article 13.1 to the receiving food business operators (Article 13.2).
• Requirement that food business operators have systems and procedures in place to identify from whom they received and to whom they passed on the product (Article 13.3).

These provisions are scheduled to come into force on 16 June 2005 as they apply to the establishment of an initial Community list of authorised primary products. Until the list is established, national provisions may continue in force. Although the UK does not have specific national provisions in place governing the authorisation and use of smoke flavourings, the use of smoke flavourings is subject to the general requirements of Food law.

Devolved administrations

Colleagues in Scotland, Wales and Northern Ireland are drawing up their own Regulations to implement the new EC Regulation and are carrying out similar consultation exercises.