12.3.2013 Official Journal of the European Union L 68/19 COMMISSION REGULATION (EU) No 209/2013 of 11 March 2013 amending Regulation (EC) No 2073/2005 as regards microbiological criteria for sprouts and the sampling rules for poultry carcases and fresh poultry meat (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, 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 ('), and in particular Article 4(4) thereof, Whereas: ) 0] 0] Regulation (EC) No 852/2004 lays down general rules for food business operators on the hygiene of foodstuffs, taking particular account of procedures based on the application of hazard analysis and critical control point (HACCP) principles. Article 4 of that Regulation provides that food business operators are to adopt specific hygiene measures concerning, inter alia, compliance with microbiological criteria for foodstuffs and sampling and analysis requirements. Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for food- stuffs (3 lays down microbiological criteria for certain micro-organisms and the implementing rules to be complied with by food business operators when imple- menting the general and specific hygiene measures referred to in Article 4 of Regulation (EC) No 852/2004. Chapter 1 of Annex I to Regulation (EC) No 2073/2005 sets out the food safety criteria to be complied with by certain food categories, including sampling plans, analytical reference methods and limits for micro- organisms or their toxins and metabolites. That Chapter lists the food safety criteria for sprouted seeds, as regards Salmonella. Following the outbreak of Shiga toxin-producing E. coli (STEC) in May 2011 in the Union, consumption of sprouts was identified as the most likely origin of the outbreaks. L 139, 30.4.2004, p. 1. L 338, 22.12.2005, p. 1. () On 20 October 2011 the European Food Safety Authority (EFSA’) adopted a Scientific Opinion on the risk posed by Shiga toxin-producing Escherichia coli and other pathogenic bacteria in seeds and sprouted seeds (3). In its Opinion, EFSA concludes that the contamination of dry seeds with bacterial pathogens is the most likely initial source of the sprout-associated outbreaks. In addition, the Opinion states that, due to the high humidity and the favourable temperature during sprouting, bacterial pathogens present on dry seeds can multiply during sprouting and result in a public health risk. In its Opinion, EFSA recommends, inter alia, that microbiological criteria should be strengthened as one of the components of a food safety management system for the sprouted seeds production chain. That recommendation concerns the existing microbiological criteria on Salmonella for sprouted seeds and the consideration of microbiological criteria on other pathogens. EFSA also states that available data indicates a higher risk for sprouts in comparison with other sprouted seeds. In its Opinion, EFSA considers different options for microbiological criteria for pathogenic E. coli for seeds: before the start of the production process, during sprouting and in the final product. In that context, EFSA states that the detection and mitigation of a contamination problem earlier in the sprouted seed production chain may have advantages as it avoids contamination being amplified during the full sprouting process. It also acknowledges that testing seeds alone does not allow for the detection of contamination which may come at a later stage in the production process. EFSA therefore concludes that microbiological criteria could be useful during the sprouting process andfor for the final product. When considering a microbiological criterion for the final sprouted seeds, EFSA notes that the time required for the detection methods for pathogenic bacteria combined with the short shelf-life may not allow withdrawing the product in the event of non-compliance. In its opinion EFSA considers that it is currently not possible to evaluate the extent of public health protection provided by specific microbiological criteria for seeds and sprouted seeds. This highlights the need for data collection to conduct quantitative risk assessment. Therefore this criterion should be reviewed taking into account progress in science, technology and methodology, emerging pathogenic micro-organisms in foodstuffs and information from risk assessment. (%) EFSA Journal 2011; 9(11):2424.