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.