Legislative requirements for food analytical laboratories in Europe

摘要

The European Union legislative laboratory quality requirements for food control laboratories are described. These are laid down in the Additional Measures Food Control Directive and require laboratories to comply with the general criteria for the operation of testing laboratories laid down in European standard EN 45001 supplemented by Standard Operating Procedures and the random audit of their compliance by quality assurance personnel, in accordance with the OECD principles Nos 2 and 7 of good laboratory practice as set out in Section II of Annex 2 of the Decision of the Council of the OECD of 12 March 1981 concerning the mutual acceptance of data in the assessment of chemicals. In addition, the laboratories shall participate in proficiency testing schemes as far as appropriate and use validated methods as far as possible (that is, methods which comply with Directive 85/591 on Methods of Sampling and Analysis for Foodstuffs). The proficiency testing schemes shall comply with the International Harmonised Protocol. The recent moves towards the replacement of specified methods by method criteria are explained. The elements of these requirements are explained together with the difficulty of achieving them. It is also commented that: (1) The accreditation and assessment of testing laboratories referred to in this article may relate to individual tests or groups of tests. (2) The accreditation agency itself is to be assessed by its peer agencies (hence the mutual recognition agreements and EN 45003/ISO Guide 58). (3) Although the requirements described are European, the requirements of the Codex Alimentarius Commission "Guidelines for the Assessment of the Competence of Testing Laboratories Involved in the Import and Export Control of Food" are very similar in format and intent and so they are of wider interest than simply in Europe.