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 EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in
particular Article 95 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the European Economic and Social
Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the
Treaty(3),
Whereas:
(1) Council Directive 88/388/EEC of 22 June 1988 on the approximation of
the laws of the Member States relating to flavourings for use in foodstuffs and
to source materials for their production(4), and in particular Article 5(1),
seventh indent thereof, provides for the adoption of appropriate provisions
concerning source materials used for the production of smoke flavourings and
reaction conditions under which they are prepared.
(2) The free movement of safe and wholesome food is an essential aspect
of the internal market and contributes significantly to the health and
well-being of citizens, and to their social and economic interests.
(3) A high level of protection of human life and health should be assured
in the pursuit of Community policies.
(4) In order to protect human health, smoke flavourings should undergo a
safety assessment through a Community procedure before being placed on the
market or used in or on foods within the Community.
(5) Differences between national laws, regulations and administrative
provisions concerning the assessment and authorisation of smoke flavourings may
hinder their free movement, creating conditions of unequal and unfair
competition. An authorisation procedure should therefore be established at
Community level.
(6) The chemical composition of smoke is complex and depends among other
things on the types of wood used, the method used for developing smoke, the
water content of the wood and the temperature and oxygen concentration during
smoke generation. Smoked foods in general give rise to health concerns,
especially with respect to the possible presence of polycyclic aromatic
hydrocarbons. Because smoke flavourings are produced from smoke which is
subjected to fractionation and purification processes, the use of smoke
flavourings is generally considered to be of less health concern than the
traditional smoking process. However, the possibility of wider applications of
smoke flavourings in comparison to conventional smoking has to be taken into
account in safety assessments.
(7) This Regulation covers smoke flavourings as defined in Directive
88/388/EEC. The production of these smoke flavourings starts with the
condensation of smoke. The condensed smoke is normally separated by physical
processes into a water-based primary smoke condensate, a water-insoluble
high-density tar phase and a water-insoluble oily phase. The water-insoluble
oily phase is a by-product and unsuitable for the production of smoke
flavourings. The primary smoke condensates and fractions of the water-insoluble
high-density tar phase, the "primary tar fractions", are purified to remove
components of smoke which are most harmful to human health. They may then be
suitable for use as such in or on foods or for the production of derived smoke
flavourings made by further appropriate physical processing such as extraction
procedures, distillation, concentration by evaporation, absorption or membrane
separation and the addition of food ingredients, other flavourings, food
additives or solvents, without prejudice to more specific Community
legislation.
(8) The Scientific Committee on Food concluded that because of the wide
physical and chemical differences in smoke flavourings used for flavouring food,
it is not possible to design a common approach to their safety assessment and,
accordingly, toxicological evaluation should focus on the safety of individual
smoke condensates. Following this advice, this Regulation should provide for the
scientific evaluation of primary smoke condensates and primary tar fractions,
hereinafter referred to as "primary products", in terms of the safety of their
use as such and/or for the production of derived smoke flavourings intended for
use in or on foods.
(9) As regards conditions of production, this Regulation reflects the
findings set out by the Scientific Committee on Food in its report on smoke
flavourings of 25 June 1993(5), in which it specified various production
conditions and the information necessary to evaluate smoke flavourings used or
intended for use in or on foods. That report was based, in turn, on the report
of the Council of Europe on health aspects of using smoke flavours as food
ingredients(6). It also contains a non-exhaustive list of types of wood which
may be regarded as an indicative list of woods suitable for the production of
smoke flavourings.
(10) Provision should be made for the establishment, on the basis of the
safety assessment, of a list of primary products authorised for use as such in
or on foods and/or for the production of smoke flavourings for use in or on
foods within the Community. That list should clearly describe the primary
products, specifying conditions of their uses and the dates from which the
authorisations are valid.
(11) In order to ensure harmonisation, safety assessments should be
carried out by the European Food Safety Authority ("the Authority"), established
by Regulation (EC) No 178/2002 of the European Parliament and of the Council of
28 January 2002 laying down the general principles and requirements of food law,
establishing the European Food Safety Authority and laying down procedures in
matters of food safety(7).
(12) The safety assessment of a specific primary product should be
followed by a risk-management decision as to whether the product should be
entered on the Community list of authorised primary products. That decision
should be adopted in accordance with the regulatory procedure so as to ensure
close cooperation between the Commission and the Member States.
(13) It is appropriate that the person ("the applicant") who intends to
place on the market primary products or derived smoke flavourings should submit
all the information necessary for the safety assessment. The applicant should
also propose a validated method of sampling and detection for the primary
products to be used for control of compliance with the provisions of this
Regulation. If necessary, the Commission should adopt quality criteria for those
analytical methods after having
