EU Regulation on smoke flavourings

First Reading

A proposal for a EU Regulation on smoke flavourings used or intended for use in or on foods has had its first reading in the European Parliament and the report on this is dated 6 March 2003.

Smoke flavourings are produced from condensed smoke. The chemical composition of smoke is complex depending among other things on the species of wood used, the method used for developing smoke, the water content of the wood and the temperature and oxygen concentrate during smoke generation. There is concern for health risks of using this procedure, in particular whether the product gives rise to cancer causing effects. However, the proposal accepts that the condensed smoke is fractionated and purified during the product of smoke flavourings and because of this purification process, the use of smoke flavourings is generally considered to be of less health concern than the traditional smoking process.

Nevertheless, the proposed Regulations are directed at smoke flavourings and not the traditional smoking procedure itself.

The present draft proposes to establish a safety assessment and authorisation procedure for primary smoke condensates and primary tar fractions which can be used as such in and on foods and/or for the production of derived smoke flavourings.

Safety Assessment and Authorisation Procedure

A list of the primary smoke condensates and primary tar fractions authorised to the exclusion of all others in the Community for use as such in or on foods and/or for the production of derived smoke flavourings is to be established and each authorised product will be given a unique code. This will include:

• the name and address of the authorisation holder
• a clear description and characterisation of the primary product
• the conditions of its use in or on specific foods or food categories and
• a date from which the product is authorised.

Following the establishment of this list, primary smoke condensates or primary tar fractions may be added to that list. No smoke flavouring or food containing a smoke flavouring may be marketed if this authorisation procedure and any associated conditions of use have not been adhered to.

The use of smoke flavourings in or on food shall only be authorised if it is sufficiently demonstrated that:

• it does not present any risks to human health
• it does not mislead consumers.

During the 18 months following the entry into force of the proposed Regulation, business operators shall submit an application to be sent first to the National Competent Authority of the Member State which will then acknowledge receipt and in a form and make the application to the European Food Safety Authority ("EFSA").

The application must be accompanied by:

• the name and address of the applicant
• detailed information and the product methods
• the qualitative and quantitative chemical composition of the primary product
• validated analytical method(s) for identification and characterisation of the primary product and of derived smoke flavourings
• information on the intended use levels in or on specific food or food categories
• toxicological data following the advice of the scientific committee on food given in its report on smoke flavourings of 25 June 1993 or its latest update
• a recent statement affirming that the use of smoke flavourings in or on food does not present any risk to human health and does not mislead consumers
• a summary of the dossier.

The EFSA will publish detailed guidance concerning the preparation and the submission of the application. The authority shall give an opinion within 6 months of the receipt of a valid application. The Commission shall prepare a draft of the measure to be taken in respect of the application for inclusion of the substance in the authorised list within 3 months of receiving the opinion of the EFSA.

Renewal of authorisations will be possible after 10 year periods on application to the EFSA by the authorisation holder. Due to the requirement of transparency, the application for authorisation, supplementary information from the applicant and opinions from the authority, excluding confidential information, shall be made accessible to the public. Information may be kept confidential if verifiable justification can be given that disclosure may significantly harm competitive position. The EFSA shall make the final decision on this.

Transitional Measures

Primary products and derived smoke flavourings, as well as foods containing any of these products, already on the market on the date of entry into force of the proposed Regulation, have a variety of extensions afforded to them ranging from 30 months after the date of entry into force of the proposed Regulation until the establishment of the Community List of authorised smoke flavourings depending on when they were first lawfully put on the market and when a valid application was submitted.

Traceability

When an authorised primary smoke condensate or primary tar fraction or smoke flavouring derived from the authorised products specified in the authorised list is placed on the market, food business operators must ensure that the following information is transmitted to the food business operator receiving the product:

• the code of the authorised product as given in the authorised list referred to above
• the conditions of use of the authorised product as set out in the list
• in the case of a derived smoke flavouring, the quantitative relation to the primary product>p>
• this shall be expressed in clear and easily understandable terms. At all subsequent stages of the placing on the market of the products referred to above, food business operators shall ensure that the information received in accordance with this requirement are transmitted to the food business operators receiving the product. Food business operators shall have in place systems and procedures in accordance to which it is possible to identify the person from whom and to whom the products mentioned above have been made available. Labelling An amendment to the labelling requirements has been inserted in that food business operations using a primary product or a smoke flavouring derived from the authorised product specified in the authorised list should be required to indicate its use in food stuffs in the list of ingredients by the name "smoke flavouring" and the code given for that product. The justification for this requirement is that Directive 2000/13/EEC which covers the labelling of smoke flavourings is not meticulous enough. Summary These proposed Regulations have been reported as potentially spelling the end of such popular choices as smoky bacon crisps, char-grilled burgers and barbeque sauces. It is the requirement that products do not provide any risk to human health which may cause an obstacle to authorisation, as some epidemiological studies have shown an increased risk of certain types of cancer in places such as Hong Kong, where there is a high consumption of smoked foods, the but link is by association only. However, this is a first reading only and the fact that naturally smoked products contain much higher levels of potentially cancer causing chemicals underlines that this is likely to simply be a further layer of regulation for food flavourings. If you have any questions on these matters, please contact Charles Spragge by email at [email protected] or on + 44 (0)20 7367 2525 or Jessica Burt by email at [email protected] or on + 44 (0)20 7367 3589.