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1、L 322/12ENOfficial Journal of the European UnionCOMMISSION REGULATION (EC) No 1441/2007of 5 December 20077.12.2007amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishi
2、ng the EuropeanCommunity,Having regard to Regulation (EC) No 852/2004 of the EuropeanParliament and of the Council of 29 April 2004 on the hygieneof foodstuffs (1), and in particular Article 4(4) thereof,Whereas:(1)Commission Regulation (EC) No 2073/2005 of 15November 2005 on microbiological criteri
3、a for food-stuffs (2) lays down microbiological criteria for certainmicro-organisms and the implementing rules to becomplied with by food business operators when im-plementing the general and specific hygiene measuresreferred to in Article 4 of Regulation (EC) No852/2004.Regulation(EC)No2073/2005als
4、oprovides that food business operators are to ensurethat foodstuffs comply with the relevant microbiologicalcriteria set out in Annex I to that Regulation.(2)Chapters 1 and 2 of Annex I to Regulation (EC) No2073/2005 set out food safety criteria and processhygiene criteria regarding dried infant for
5、mulae anddried dietary foods for special medical purposesintended for infants below six months of age (driedinfant formulae and dried dietary foods). Part 2.2 ofChapter 2 of that Annex provides that where driedinfant formulae and dried dietary foods are tested andEnterobacteriaceae are detected in a
6、ny of the sampleunits, the batch is to be tested forEnterobacter sakazakiiand Salmonella.(3)On 24 January 2007, the Scientific Panel on BiologicalHazards (BIOHAZ Panel) of the European Food SafetyAuthority (EFSA) issued an opinion with regard toEnterobacteriaceae as indicators ofSalmonellaandEnterob
7、acter sakazakii. It concluded that it is not possible(1) OJ L 139, 30.4.2004, p. 1, as corrected by OJ L 226, 25.6.2004,p. 3.(2) OJ L 338, 22.12.2005, p. 1.to establish a correlation between Enterobacteriaceae andSalmonella, and no universal correlation between Entero-bacteriaceae and Enterobacter s
8、akazakii exists. At individualplant level, a correlation between Enterobacteriaceae andEnterobacter sakazakiimay however be established.(4)Therefore the requirement laid down in Regulation(EC) No 2073/2005 as regards the testing of driedinfant formulae and dried dietary foods forSalmonellaandEnterob
9、acter sakazakiiwhere Enterobacteriaceae aredetected in any of the sample units should no longerapply. Part 2.2 of Chapter 2 of Annex I to that Regu-lation should therefore be amended accordingly.(5)In line with the opinion on the microbiological risks ininfant formulae and follow-on formulae issued
10、by theBIOHAZ Panel of EFSA on 9 September 2004, micro-biological criteria onSalmonellaand Enterobacteriaceaeshould be laid down for dried follow-on formulae.(6)The BIOHAZ Panel of EFSA issued an opinion on Bacilluscereusand other Bacillusspp. in foodstuffs on 26 and 27January 2005. It concluded that
11、 one of the major controlmeasures is to control temperature and to establish asystem based on hazard analysis and critical controlpoint principles. Dehydrated foods, in which thepresence of spores of pathogenicBacillusspp. isfrequent, might permit the growth ofBacillus cereusonce rehydrated in warm
12、water. Some dehydratedfoods, including dried infant formulae and dried dietaryfoods, are consumed by potentially fragile consumers. Inline with the EFSA opinion, the numbers of Bacillus cereusspores in dried infant formulae and dried dietary foodsshould be as low as possible during processing and ap
13、rocess hygiene criterion should be laid down inaddition to good practices designed to reduce delaybetween preparation and consumption.(7)Chapter 1 of Annex I to Regulation (EC) No 2073/2005provides for the analytical reference method for staphy-lococcal enterotoxins in certain cheeses, milk powder a
14、ndwhey powder. That method has been revised by theCommunity reference laboratory for coagulase positivestaphylococci. The reference to that analytical referencemethod should therefore be amended. Chapter 1 ofAnnex I to that Regulation should therefore beamended accordingly.7.12.2007ENOfficial Journa
15、l of the European UnionL 322/13(8)Chapter 3 of Annex I to Regulation (EC) No 2073/2005sets out sampling rules for carcasses of cattle, pig, sheep,goats and horses forSalmonellaanalyses. Pursuant tothose rules the sampling area is to cover a minimumof 100 cm2per site selected. However, neither thenumber of sampling sites nor the minimum total areaof sampling is specified. In order to improve theimplementation of these rules in the Community, it isappropriate to furth