L 32212 Official Journal of the European Union 7.12.2007 COMMISSION REGULATION (EC) No 1441/2007 of 5 December 2007 amending Regulation (EC) No 20732005 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 Article 4(4) thereof, Whereas: 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 im- plementing the general and specific hygiene measures referred to in Article 4 of Regulation (EC) No 852/2004. Regulation (EC) No 2073/2005 also provides that food business operators are to ensure that foodstuffs comply with the relevant microbiological criteria set out in Annex I to that Regulation. Chapters 1 and 2 of Annex I to Regulation (EC) No 2073/2005 set out food safety criteria and process hygiene criteria regarding dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age (dried infant formulae and dried dietary foods). Part 2.2 of Chapter 2 of that Annex provides that where dried infant formulae and dried dietary foods are tested and Enterobacteriaceae are detected in any of the sample units, the batch is to be tested for Enterobacter sakazakii and Salmonella. On 24 January 2007, the Scientific Panel on Biological Hazards (BIOHAZ Panel) of the European Food Safety Authority (EFSA) issued an opinion with regard to Enterobacteriaceae as indicators of Salmonella and Enterobacter sakazakii. It concluded that it is not possible (") O] L 139, 30.4.2004, p. 1, as corrected by O] L 226, 25.6.2004, 3 p. . () O] L 338, 22.12.2005, p. 1. to establish a correlation between Enterobacteriaceae and Salmonella, and no universal correlation between Entero- bacteriaceae and Enterobacter sakazakii exists. At individual plant level, a correlation between Enterobacteriaceae and Enterobacter sakazakii may however be established. Therefore the requirement laid down in Regulation (EC) No 2073/2005 as regards the testing of dried infant formulae and dried dietary foods for Salmonella and Enterobacter sakazakii where Enterobacteriaceae are detected in any of the sample units should no longer apply. Part 2.2 of Chapter 2 of Annex I to that Regu- lation should therefore be amended accordingly. In line with the opinion on the microbiological risks in infant formulae and follow-on formulae issued by the BIOHAZ Panel of EFSA on 9 September 2004, micro- biological criteria on Salmonella and Enterobacteriaceae should be laid down for dried follow-on formulae. The BIOHAZ Panel of EFSA issued an opinion on Bacillus cereus and other Bacillus spp. in foodstuffs on 26 and 27 January 2005. It concluded that one of the major control measures is to control temperature and to establish a system based on hazard analysis and critical control point principles. Dehydrated foods, in which the presence of spores of pathogenic Bacillus spp. is frequent, might permit the growth of Bacillus cereus once rehydrated in warm water. Some dehydrated foods, including dried infant formulae and dried dietary foods, are consumed by potentially fragile consumers. In line with the EFSA opinion, the numbers of Bacillus cereus spores in dried infant formulae and dried dietary foods should be as low as possible during processing and a process hygiene criterion should be laid down in addition to good practices designed to reduce delay between preparation and consumption. Chapter 1 of Annex I to Regulation (EC) No 2073/2005 provides for the analytical reference method for staphy- lococcal enterotoxins in certain cheeses, milk powder and whey powder. That method has been revised by the Community reference laboratory for coagulase positive staphylococci. The reference to that analytical reference method should therefore be amended. Chapter 1 of Annex 1 to that Regulation should therefore be amended accordingly.