Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (1)

Section:Serie L

I (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,


(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 Parliament 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 (2).

Microbiological hazards in foodstuffs form a major source of food-borne diseases in humans.

(2) Foodstuffs should not contain micro-organisms or their toxins or metabolites in quantities that present an unacceptable risk for human health.

(3) 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.

(4) Microbiological criteria also give guidance on the acceptability of foodstuffs and their manufacturing, handling and distribution processes. The use of microbiological criteria should form an integral part of the implementation of HACCP-based procedures and other hygiene control measures.

(5) 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 microorganisms for which the criteria are set.

(6) According to Article 4 of Regulation (EC) No 852/2004, food business operators are to comply with microbiological 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 measures 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 foodstuff 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.

22.12.2005 EN Official Journal of the European Union L 338/1 (1) OJ L 139, 30.4.2004, p. 1, corrected by OJ L 226, 25.6.2004, p. 3.

(2 ) OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

(7) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (1) requires the Member States to ensure that official controls are carried out regularly, on a risk basis and with appropriate frequency. Those controls should take place at appropriate stages of the production, processing and distribution of food to ensure that the criteria laid down in this Regulation are complied with by food business operators.

(8) The Communication from the Commission on the Community Strategy for setting microbiological criteria for foodstuffs (2) describes the strategy to lay down and revise the criteria in Community legislation, as well as the principles for the development and application of the criteria. This strategy should be applied when microbiological criteria are laid down.

(9) The Scientific Committee on Veterinary Measures relating to Public Health (SCVPH) issued an opinion on 23 September 1999 on the evaluation of microbiological criteria for food products of animal origin for human consumption. It highlighted the relevance of basing microbiological criteria on formal risk assessment and internationally approved principles. The opinion recommends that microbiological criteria should be relevant and effective in relation to consumer health protection.

The SCVPH proposed, while awaiting formal risk assessments, certain revised criteria as interim measures.

(10) The SCVPH issued at the same time a separate opinion on Listeria monocytogenes. That opinion recommended that it be an objective to keep the concentration of Listeria monocytogenes in food below 100 cfu/g. The Scientific Committee on Food (SCF) agreed with these recommendations in its opinion of 22 June 2000.

(11) The SCVPH adopted an opinion on Vibrio vulnificus and Vibrio parahaemolyticus on 19 and 20 September 2001. It concluded that currently available scientific data do not support setting specific criteria for pathogenic V.

vulnificus and parahaemolyticus in seafood. However, it recommended that codes of practice should be established to ensure that good hygiene practice has been applied.

(12) The SCVPH issued an opinion on Norwalk-like viruses (NLVs, noroviruses) on 30-31 January 2002. In that opinion it concluded that the conventional faecal indicators are unreliable for demonstrating the presence or absence of NLVs and that the reliance on faecal bacterial indicator removal for determining shellfish purification times is unsafe practice. It also recommended using E. coli rather than faecal coliforms to indicate faecal contamination in shellfish harvesting areas, when applying bacterial indicators.

(13) On 27 February 2002 the SCF adopted an opinion on specifications for gelatine in terms of consumer health. It concluded that the microbiological criteria set in Chapter 4 of Annex II to Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A(I) to Directive 89/662/ EEC and, as regards pathogens, to Directive 90/425/ EEC (3) in terms of consumer health were excessive, and considered it sufficient to apply a mandatory microbiological criterion for salmonella only.

(14) The SCVPH issued an opinion on verotoxigenic E. coli (VTEC) in foodstuffs on 21 and 22 January 2003. In its opinion it concluded that applying an end-product microbiological standard for VTEC O157 is unlikely to deliver meaningful reductions in the associated risk for the consumers. However, microbiological guidelines aimed at reducing the faecal contamination along the food chain can contribute to a reduction in public health risks, including VTEC. The SCVPH identified the following food categories where VTEC represents a hazard to public health: raw or undercooked beef and possibly meat from other ruminants, minced meat and fermented beef and products thereof, raw milk and raw milk products, fresh produce, in particular sprouted seeds, and unpasteurised fruit and vegetable juices.

(15) On 26 and 27 March 2003 the SCVPH adopted an opinion on staphylococcal enterotoxins in milk products, particularly in cheeses. It recommended revising the criteria for coagulase-positive staphylococci in cheeses, in raw milk intended for processing and in powdered milk.

In addition, criteria for staphylococcal enterotoxins should be laid down for cheeses and powdered milk.

L 338/2 EN Official Journal of the European Union 22.12.2005 (1 ) OJ L 165, 30.4.2004, p. 1, corrected by OJ L 191, 28.5.2004, p. 1.

(2 ) SANCO/1252/2001 Discussion paper on strategy for setting microbiological criteria for foodstuffs in Community legislation, p. 34.

(3 ) OJ L 62, 15.3.1993, p. 49. Directive as last amended by Commission Regulation (EC) No 445/2004 (OJ L 72, 11.3.2004, p. 60).

(16) The SCVPH adopted an opinion on salmonellae in foodstuffs on 14 and 15 April 2003. According to the opinion, food categories possibly posing a high risk to public health include raw meat and some products intended to be eaten raw, raw and undercooked products of poultry meat, eggs and products containing raw eggs, unpasteurised milk and some products thereof. Sprouted seeds and unpasteurised fruit juices are also of concern. It recommended that the decision on the need for microbiological criteria should be taken on the basis of its ability to protect the consumers and its feasibility.

(17) The Scientific Panel on Biological Hazards (BIOHAZ Panel) of the European Food Safety Authority (EFSA) issued an opinion on the microbiological risks in infant formulae and follow-on formulae on 9 September 2004.

It concluded that Salmonella and Enterobacter sakazakii are the micro-organisms of greatest concern in infant formulae, formulae for special medical purposes and follow-on formulae. The presence of these pathogens...

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