The regulation of preservatives in the European Community.
Community regulation of preservatives is based on Council Directive 64/54/EEC of 5 November 1963, which defined 'preservatives' and established an exclusive approved list which Member States could permit. In some instances the Directive set limits on conditions of use and general purity criteria; specific purity criteria were established in a second Directive 65/66/EEC. The base Directive has been amended twenty-four times and that relating to purity criteria three times. The approved list has two parts, listing separately substances whose primary function is preservative and those whose primary function is other than preservative but which have a secondary preservative effect. Separate labelling laws require that the presence of additives, including preservatives, be declared. Permitted preservatives must be safe and technologically effective. Safety evaluation is carried out by the Scientific Committee for Food; technological effectiveness is assessed by experts from governments of Member States, food and chemical industry and the Commission. In future, preservatives will be encompassed by the general additives 'Framework Directive' which addresses areas including: exclusive permitted lists; lists of foodstuffs to which and conditions under which additives may be used; purity criteria; methods of analysis and sampling procedures. The Framework Directive also specifies criteria to be satisfied before an additive may be approved including guidance on what constitutes 'need', appropriate safety evaluation (and re-evaluation as necessary). Agreed conditions of use will need to ensure that ADIs are not compromised; where these are sufficiently high, the concept of 'quantum satis' might be applied whereas low ADIs may necessitate limitations on number of uses and levels of addition.