22.12.2005 Official Journal of the European Union L 338/1 (Acts whose publication is obligatory) COMMISSION REGULATION (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (1), and in particular Articles 4(4) and 12 thereof, Whereas: 1 A high level of protection of public health is one of the fundamental objectives of food law, as laid down in Regulation (EC) No 178/2002 of the European Parlia- ment 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 (%). Microbiological hazards in foodstuffs form a major source of food-borne diseases in humans. Foodstuffs should not contain micro-organisms or their toxins or metabolites in quantities that present an unacceptable risk for human health. Regulation (EC) No 178/2002 lays down general food safety requirements, according to which food must not be placed on the market if it is unsafe. Food business operators have an obligation to withdraw unsafe food from the market. In order to contribute to the protection of public health and to prevent differing interpretations, it is appropriate to establish harmonised safety criteria on the acceptability of food, in particular as regards the presence of certain pathogenic micro-organisms. OJ L 139, 30.4.2004, p. 1, corrected by O] L 226, 25.6.2004, p. 3. OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC) No 1642/2003 (O] L 245, 29.9.2003, p. 4). ) Microbiological criteria also give guidance on the acceptability of foodstuffs and their manufacturing, handling and distribution processes. The use of micro- biological criteria should form an integral part of the implementation of HACCP-based procedures and other hygiene control measures. The safety of foodstuffs is mainly ensured by a preventive approach, such as implementation of good hygiene practice and application of procedures based on hazard analysis and critical control point (HACCP) principles. Microbiological criteria can be used in validation and verification of HACCP procedures and other hygiene control measures. It is therefore appropriate to set microbiological criteria defining the acceptability of the processes, and also food safety microbiological criteria setting a limit above which a foodstuff should be considered unacceptably contaminated with the micro- organisms for which the criteria are set. According to Article 4 of Regulation (EC) No 852/2004, food business operators are to comply with microbiolo- gical criteria. This should include testing against the values set for the criteria through the taking of samples, the conduct of analyses and the implementation of corrective actions, in accordance with food law and the instructions given by the competent authority. It is therefore appropriate to lay down implementing mea- sures concerning the analytical methods, including, where necessary, the measurement uncertainty, the sampling plan, the microbiological limits, the number of analytical units that should comply with these limits. Furthermore, it is appropriate to lay down implementing measures concerning the foodstuft to which the criterion applies, the points of the food chain where the criterion applies, as well as the actions to be taken when the criterion is not met. The measures to be taken by the food business operators in order to ensure compliance with criteria defining the acceptability of a process may include, among other things, controls of raw materials, hygiene, temperature and shelf-life of the product.