26.11.2003 Official Journal of the European Union L 309/1 (Acts whose publication is obligatory) 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 Com- munity, and in particular Article 95 thereof, Having regard to the proposal from the Commission ('), Having regard to the opinion of the European Economic and Social Committee (), Acting in accordance with the procedure laid down in Article 251 of the Treaty (), 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 mate- rials for their production (), 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 reac- tion 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. () A high level of protection of human life and health should be assured in the pursuit of Community policies. () O] C 262 E, 29.10.2002, p. 523. () O] C 85, 8.4.2003, p. 32. (*) Opinion of the European Parliament of 5 June 2003 (not yet published in the Official Journal) and the Council Decision of 9 October 2003. (*) OJ L 184, 15.7.1988, p. 61; Directive as amended by Commission Directive 91/71/EEC (O] L 42, 15.2.1991, p. 25). (4) In order to protect human health, smoke flavourings should undergo a safety assessment through a Commu- nity procedure before being placed on the market or used in or on foods within the Community. 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 there- fore be established at Community level. 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 puri- fication processes, the use of smoke flavourings is gener- ally 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. 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 frac- tions of the water-insoluble high-density tar phase, the ‘primary tar fractions’, are purified to remove compo- nents 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 flavour- ings 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.