欧盟食品中微生物限量标准

L 322/12 EN Official 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 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 hygieneof foodstuffs (1), and in particular Article 4(4) thereof,Whereas:(1) Commission Regulation (EC) No 2073/2005 of 15November 2005 on microbiological criteria 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) No 2073/2005 alsoprovides that food business operators are to ensurethat foodstuffs comply with the relevant microbiological criteria 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 formulae 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 any of the sampleunits, the batch is to be tested for Enterobacter 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 of Salmonella andEnterobacter 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 sakazakii exists. At individualplant level, a correlation between Enterobacteriaceae andEnterobacter sakazakii may 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 for Salmonellaand Enterobacter sakazakii where 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 by theBIOHAZ Panel of EFSA on 9 September 2004, micro-biological criteria on Salmonella and Enterobacteriaceaeshould be laid down for dried follow-on formulae.(6) The BIOHAZ Panel of EFSA issued an opinion on Bacilluscereus and other Bacillus spp. in foodstuffs on 26 and 27January 2005. It concluded that 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 pathogenic Bacillus spp. isfrequent, might permit the growth of Bacillus cereusonce rehydrated in warm water. Some dehydratedfoods, including dried infant formulae and dried dietaryfoods, are consumed by potentially fragile consumers. In line 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 aprocess 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 andwhey 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.7.12.2007 EN Official Journal of the European Union L 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 for Salmonella analyses. 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 further specify in Regulation (EC) No2073/2005 that the areas most likely to be contaminatedshould be selected for sampling and that the totalsampling area should be increased. Chapter 3 ofAnnex I to that Regulation should therefore beamended accordingly.(9) In the interests of clarity of Community legislation, it isappropriate to replace Annex I to Regulation (EC) No2073/2005 by the text set out in the Annex to thisRegulation. (10) The measures provided for in this Regulation are inaccordance with the opinion of the StandingCommittee on the Food Chain and Animal Health,HAS ADOPTED THIS REGULATION:Article 1Annex I to Regulation (EC) No 2073/2005 is replaced by the text in the Annex to this Regulation.Article 2This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 5 December 2007.For the CommissionMarkos KYPRIANOUMember of the CommissionL 322/14 ENChapter 1.Chapter 2.Official Journal of the European UnionANNEX‘ANNEX IMicrobiological criteria for foodstuffsFood safety criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Process hygiene criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207.12.20072.1 Meat and products thereof . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202.2 Milk and dairy products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232.3 Egg products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262.4 Fishery products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272.5 Vegetables, fruits and products thereof . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Chapter3. Rules for sampling and preparation of test samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293.1 General rules for sampling and preparation of test samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293.2 Bacteriological sampling in slaughterhouses and at premises producing minced meat and meatpreparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297.12.2007ENOfficial Journal of the European UnionL 322/15C h a p t e r 1. F o o d s a f e t y c r i t e r i aeeeeeeeeL 322/16 EN Official Journal of the European Union 7.12.2007e e e e e e e e e e7.12.2007 EN Official Journal of the European Union L 322/17e e e e e e e eL 322/18ENOfficial Journal of the European Union7.12.2007e1 (2 ) F o r p o i n t s 1.1-1.25 m = M . (3 ) T h e m o s t r e c e n t e d i t i o n o f t h e s t a n d a r d s h a l l b e u s e d . (4 ) R e g u l a r t e s t i n g a g a i n s t t h e c r i t e r i o n i s n o t r e q u i r e d i n n o r m a l c i r c u m s t a n c e s f o r t h e f o l l o w i n g r e a d y -t o -e a t f o o d s : — t h o s e w h i c h h a v e r e c e i v e d h e a t t r e a t m e n t o r o t h e r p r o c e s s i n g e f f e c t i v e t o e l i m i n a t e L . m o n o c y t o g e n e s , w h e n r e c o n t a m i n a t i o n i s n o t p o s s i b l e a f t e r t h i s t r e a t m e n t (f o r e x a m p l e , p r o d u c t s h e a t t r e a t e d i n t h e i r f i n a l p a c k a g e ), — f r e s h , u n c u t a n d u n p r o c e s s e d v e g e t a b l e s a n d f r u i t s , e x c l u d i n g s p r o u t e d s e e d s , — b r e a d , b i s c u i t s a n d s i m i l a r p r o d u c t s , — b o t t l e d o r p a c k e d w a t e r s , s o f t d r i n k s , b e e r , c i d e r , w i n e , s p i r i t s a n d s i m i l a r p r o d u c t s , — s u g a r , h o n e y a n d c o n f e c t i o n e r y , i n c l u d i n g c o c o a a n d c h o c o l a t e p r o d u c t s , — l i v e b i v a l v e m o l l u s c s . (5 ) T h i s c r i t e r i o n s h a l l a p p l y i f t h e m a n u f a c t u r e r i s a b l e t o d e m o n s t r a t e , t o t h e s a t i s f a c t i o n o f t h e c o m p e t e n t a u t h o r i t y , t h a t t h e p r o d u c t w i l l n o t e x c e e d t h e l i m i t 100 c f u /g t h r o u g h o u t t h e s h e l f -l i f e . T h e o p e r a t o r m a y f i x i n t e r m e d i a t e l i m i t s d u r i n g t h e p r o c e s s t h a t m u s t b e l o w e n o u g h t o g u a r a n t e e t h a t t h e l i m i t o f 100 c f u /g i s n o t e x c e e d e d a t t h e e n d o f s h e l f -l i f e . (6 ) 1 m l o f i n o c u l u m i s p l a t e d o n a P e t r i d i s h o f 140 m m d i a m e t e r o r o n t h r e e P e t r i d i s h e s o f 90 m m d i a m e t e r . (7 ) T h i s c r i t e r i o n s h a l l a p p l y t o p r o d u c t s b e f o r e t h e y h a v e l e f t t h e i m m e d i a t e c o n t r o l o f t h e p r o d u c i n g f o o d b u s i n e s s o p e r a t o r , w h e n h e i s n o t a b l e t o d e m o n s t r a t e , t o t h e s a t i s f a c t i o n o f t h e c o m p e t e n t a u t h o r i t y , t h a t t h e p r o d u c t w i l l n o t e x c e e d t h e l i m i t o f 100 c f u /g t h r o u g h o u t t h e s h e l f -l i f e . (8 ) P r o d u c t s w i t h p H ≤ 4,4 o r a w ≤ 0,92, p r o d u c t s w i t h p H ≤ 5,0 a n d a w≤ 0,94, p r o d u c t s w i t h a s h e l f -l i f e o f l e s s t h a n f i v e d a y s s h a l l b e a u t o m a t i c a l l y c o n s i d e r e d t o b e l o n g t o t h i s c a t e g o r y . O t h e r c a t e g o r i e s o f p r o d u c t s c a n a l s o b e l o n g t o t h i s c a t e g o r y , s u b j e c t t o s c i e n t i f i c j u s t i f i c a t i o n . ( 9 ) T h i s c r i t e r i o n s h a l l a p p l y t o m e c h a n i c a l l y s e p a r a t e d m e a t (M S M ) p r o d u c e d w i t h t h e t e c h n i q u e s r e f e r r e d t o i n p a r a g r a p h 3 o f C h a p t e r I I I o f S e c t i o n V o f A n n e x I I I t o R e g u l a t i o n (E C ) N o 853/2004 o f t h e E u r o p e a n P a r l i a m e n t a n d o f t h e C o u n c i l . ( 10 ) E x c l u d i n g p r o d u c t s w h e n t h e m a n u f a c t u r e r c a n d e m o n s t r a t e t o t h e s a t i s f a c t i o n o f t h e c o m p e t e n t a u t h o r i t i e s t h a t , d u e t o t h e r i p e n i n g t i m e a n d a wo f t h e p r o d u c t w h e r e a p p r o p r i a t e , t h e r e i s n o s a l m o n e l l a r i s k . ( 11 ) O n l y i c e c r e a m s c o n t a i n i n g m i l k i n g r e d i e n t s . ( 12 ) P r e l i m i n a r y t e s t i n g o f t h e b a t c h o f s e e d s b e f o r e s t a r t i n g t h e s p r o u t i n g p r o c e s s o r t h e s a m p l i n g m u s t b e c a r r i e d o u t a t t h e s t a g e w h e r e t h e h i g h e s t p r o b a b i l i t y o f f i n d i n g S a l m o n e l l a i s e x p e c t e d . ( 13 ) R e f e r e n c e : C o m m u n i t y r e f e r e n c e l a b o r a t o r y f o r c o a g u l a s e p o s i t i v e s t a p h y l o c o c c i . E u r o p e a n s c r e e n i n g m e t h o d f o r t h e d e t e c t i o n o f s t a p h y l o c o c c a l e n t e r o t o x i n s i n m i l k a n d m i l k p r o d u c t s . ( 14 ) P a r a l l e l t e s t i n g f o r E n t e r o b a c t e r i a c e a e a n d E . s a k a z a k i i s h a l l b e c o n d u c t e d , u n l e s s a c o r r e l a t i o n b e t w e e n t h e s e m i c r o -o r g a n i s m s h a s b e e n e s t a b l i s h e d a t a n i n d i v i d u a l p l a n t l e v e l . I f E n t e r o b a c t e r i a c e a e a r e d e t e c t e d i n a n y o f t h e p r o d u c t s a m p l e s t e s t e d i n s u c h a p l a n t , t h e b a t c h m u s t b e t e s t e d f o r E . s a k a z a k i i . I t s h a l l b e t h e r e s p o n s i b i l i t y o f t h e m a n u f a c t u r e r t o d e m o n s t r a t e t o t h e s a t i s f a c t i o n o f t h e c o m p e t e n t a u t h o r i t y w h e t h e r s u c h a c o r r e l a t i o n e x i s t s b e t w e e n E n t e r o b a c t e r i a c e a e a n d E . s a k a z a k i i . ( 15 ) E . c o l i i s u s e d h e r e a s a n i n d i c a t o r o f f a e c a l c o n t a m i n a t i o n . ( 16 ) A p o o l e d s a m p l e c o m p r i s i n g a m i n i m u m o f 10 i n d i v i d u a l a n i m a l s . ( 17 ) P a r t i c u l a r l y f i s h s p e c i e s o f t h e f a m i l i e s : S c o m b r i d a e , C l u p e i d a e , E n g r a u l i d a e , C o r y f e n i d a e , P o m a t o m i d a e , S c o m b r e s o s i d a e . ( 18 ) S i n g l e s a m p l e s m a y b e t a k e n a t r e t a i l l e v e l . I n s u c h a c a s e t h e p r e s u m p t i o n l a i d d o w n i n A r t i c l e 14(6) o f R e g u l a t i o n (E C ) N o 178/2002, a c c o r d i n g t o w h i c h t h e w h o l e b a t c h i s t o b e d e e m e d u n s a f e , s h a l l n o t a p p l y . ( 19 ) R e f e r e n c e s : 1 . M a l l e P ., V a l l e M ., B o u q u e l e t S . A s s a y o f b i o g e n i c a m i n e s i n v o l v e d i n f i s h d e c o m p o s i t i o n . J . A O A C I n t e r n a t . 1996, 79, 43-49. 2. D u f l o s G ., D e r v i n C . , M a l l e P ., B o u q u e l e t S . R e l e v a n c e o f m a t r i x e f f e c t i n d e t e r m i n a t i o n o f b i o g e n i c a m i n e s i n p l a i c e ( P l e u r o n e c t e s p l a t e s s a ) a n d w h i t i n g ( M e r l a n g u s m e r l a n g u s . J . A O A C I n t e r n a t . 1999, 82, 1097-1101.7.12.2007ENOfficial Journal of the European UnionL 322/19I n t e r p r e t a t i o n o f t h e t e s t r e s u l t sT h e l i m i t s g i v e n r e f e r t o e a c h s a m p l e u n i t t e s t e d , e x c l u d i n g l i v e b i v a l v e m o l l u s c s a n d l i v e e c h i n o d e r m s , t u n i c a t e s a n d g a s t r o p o d s i n r e l a t i o n t o t e s t i n g E . c o l i , w h e r e t h e l i m i t r e f e r s t o a p o o l e d s a m p l e .T h e t e s t r e s u l t s d e m o n s t r a t e t h e m i c r o b i o l o g i c a l q u a l i t y o f t h e b a t c h t e s t e d ( 1 ).L . m o n o c y t o g e n e s i n r e a d y -t o -e a t f o o d s i n t e n d e d f o r i n f a n t s a n d f o r s p e c i a l m e d i c a l p u r p o s e s :— s a t i s f a c t o r y , i f a l l t h e v a l u e s o b s e r v e d i n d i c a t e t h e a b s e n c e o f t h e b a c t e r i u m ,— u n s a t i s f a c t o r y , i f t h e p r e s e n c e o f t h e b a c t e r i u m i s d e t e c t e d i n a n y o f t h e s a m p l e u n i t s .L . m o n o c y t o g e n e s i n r e a d y -t o -e a t f o o d s a b l e t o s u p p o r t t h e g r o w t h o f L . m o n o c y t o g e n e s b e f o r e t h e f o o d h a s l e f t t h e i m m e d i a t e c o n t r o l o f t h e p r o d u c i n g f o o d b u s i n e s s o p e r a t o r w h e n h e i s n o t a b l e t o d e m o n s t r a t et h a t t h e p r o d u c t w i l l n o t e x c e e d t h e l i m i t o f 100 c f u /g t h r o u g h o u t t h e s h e l f -l i f e :— s a t i s f a c t o r y , i f a l l t h e v a l u e s o b s e r v e d i n d i c a t e t h e a b s e n c e o f t h e b a c t e r i u m ,— u n s a t i s f a c t o r y , i f t h e p r e s e n c e o f t h e b a c t e r i u m i s d e t e c t e d i n a n y o f t h e s a m p l e u n i t s .L . m o n o c y t o g e n e s i n o t h e r r e a d y -t o -e a t f o o d s a n d E . c o l i i n l i v e b i v a l v e m o l l u s c s :— s a t i s f a c t o r y , i f a l l t h e v a l u e s o b s e r v e d a r e ≤ t h e l i m i t ,— u n s a t i s f a c t o r y , i f a n y o f t h e v a l u e s a r e > t h e l i m i t .S a l m o n e l l a i n d i f f e r e n t f o o d c a t e g o r i e s :— s a t i s f a c t o r y , i f a l l t h e v a l u e s o b s e r v e d i n d i c a t e t h e a b s e n c e o f t h e b a c t e r i u m ,— u n s a t i s f a c t o r y , i f t h e p r e s e n c e o f t h e b a c t e r i u m i s d e t e c t e d i n a n y o f t h e s a m p l e u n i t s .S t a p h y l o c o c c a l e n t e r o t o x i n s i n d a i r y p r o d u c t s :— s a t i s f a c t o r y , i f i n a l l t h e s a m p l e u n i t s t h e e n t e r o t o x i n s a r e n o t d e t e c t e d ,— u n s a t i s f a c t o r y , i f t h e e n t e r o t o x i n s a r e d e t e c t e d i n a n y o f t h e s a m p l e u n i t s .E n t e r o b a c t e r s a k a z a k i i i n d r i e d i n f a n t f o r m u l a e a n d d r i e d d i e t a r y f o o d s f o r s p e c i a l m e d i c a l p u r p o s e s i n t e n d e d f o r i n f a n t s b e l o w 6 m o n t h s o f a g e :— s a t i s f a c t o r y , i f a l l t h e v a l u e s o b s e r v e d i n d i c a t e t h e a b s e n c e o f t h e b a c t e r i u m ,— u n s a t i s f a c t o r y , i f t h e p r e s e n c e o f t h e b a c t e r i u m i s d e t e c t e d i n a n y o f t h e s a m p l e u n i t s .H i s t a m i n e i n f i s h e r y p r o d u c t s f r o m f i s h s p e c i e s a s s o c i a t e d w i t h a h i g h a m o u n t o f h i s t i d i n e :— s a t i s f a c t o r y , i f t h e f o l l o w i n g r e q u i r e m e n t s a r e f u l f i l l e d :1. t h e m e a n v a l u e o b s e r v e d i s ≤ m2. a m a x i m u m o f c /n v a l u e s o b s e r v e d a r e b e t w e e n m a n d M3. n o v a l u e s o b s e r v e d e x c e e d t h e l i m i t o f M ,— u n s a t i s f a c t o r y , i f t h e m e a n v a l u e o b s e r v e d e x c e e d s m o r m o r e t h a n c /n v a l u e s a r e b e t w e e n m a n d M o r o n e o r m o r e o f t h e v a l u e s o b s e r v e d a r e > M .___________( 1 ) T h e t e s t r e s u l t s m a y b e u s e d a l s o f o r d e m o n s t r a t i n g t h e e f f e c t i v e n e s s o f t h e h a z a r d a n a l y s i s a n d c r i t i c a l c o n t r o l p o i n t p r i n c i p l e s o r g o o d h y g i e n e p r o c e d u r e o f t h e p r o c e s s .L 322/20ENOfficial Journal of the European Union7.12.2007C h a p t e r 2. P r o c e s s h y g i e n e c r i t e r i a2.1 M e a t a n d p r o d u c t s t h e r e o fr f r f r f r f r s f r f f f r f f f7.12.2007ENOfficial Journal of the European UnionL 322/21f f f f f ( 2 ) F o r p o i n t s 2.1.3-2.1.5 m = M . ( 3 ) T h e m o s t r e c e n t e d i t i o n o f t h e s t a n d a r d s h a l l b e u s e d . ( 4 ) T h e l i m i t s (m a n d M ) s h a l l a p p l y o n l y t o s a m p l e s t a k e n b y t h e d e s t r u c t i v e m e t h o d . T h e d a i l y m e a n l og sh a l l b e c a l c u l a t e d b y fi r s t t a k i n g a l o g v a l u e o f e a c h i n d i v i d u a l t e s t r e s u l t a n d t h e n c a l c u l a t i n g t h e m e a n o f t h e s e l o g v a l u e s . ( 5 ) T h e 50 s a m p l e s s h a l l b e d e r i v e d f r o m 10 c o n s e c u t i v e s a m p l i n g s e s s i o n s i n a c c o r d a n c e w i t h t h e s a m p l i n g r u l e s a n d f r e q u e n c i e s l a i d d o w n i n t h i s R e g u l a t i o n . ( 6 ) T h e n u m b e r o f s a m p l e s w h e r e t h e p r e s e n c e o f s a l m o n e l l a i s d e t e c t e d . T h e c v a l u e i s s u bj e c t t o r e v i e w i n o r d e r t o t ak e i n t o a c c o u n t t h e p r o g r e s s m a d e i n r e d u c i n g t h e s alm on e l l a p r e v a l e n c e . M e m b e r S t a t e so r r e g i o n s h a v i n g l o w s a l m o n e l l ap r e v a l e n c e m a y u s e l o w e r c v a l u e s e v e n b e f o r e t h e r e v i e w . ( 7 ) T h i s c r i t e r i o n s h a l l n o t a p p l y t o m i n c e d m e a t p r o d u c e d a t r e t a i l l e v e l w h e n t h e s h e l f -l i f e o f t h e p r o d u c t i s l e s s t h e n 24 h o u r s . ( 8 ) E . c o l i i s u s e d h e r e a s a n i n d i c a t o r o f f a e c a l c o n t a m i n a t i o n . ( 9 ) T h e s e c r i t e r i a a p p l y t o m e c h a n i c a l l y s e p a r a t e d m e a t (M S M ) p r o d u c e d w i t h t h e t e c h n iq u e sr e f e r r e d t o i n p a r a g r a p h 3 o f C h a p t e r I I I o f S e c t i o n V o f A n n e x I I I t o R e g u l a t i o n (E C ) N o 853/2004 o f t h e E u r o p e a n P a r l i a m e n t a n d o f t h e C o u n c i l .L 322/22ENOfficial Journal of the European Union7.12.2007I n t e r p r e t a t i o n o f t h e t e s t r e s u l t sT h e l i m i t s g i v e n r e f e r t o e a c h s a m p l e u n i t t e s t e d , e x c l u d i n g t e s t i n g o f c a r c a s e s w h e r e t h e l i m i t s r e f e r t o p o o l e d s a m p l e s .T h e t e s t r e s u l t s d e m o n s t r a t e t h e m i c r o b i o l o g i c a l q u a l i t y o f t h e p r o c e s s t e s t e d .E n t e r o b a c t e r i a c e a e a n d a e r o b i c c o l o n y c o u n t i n c a r c a s e s o f c a t t l e , s h e e p , g o a t s , h o r s e s a n d p i g s :— s a t i s f a c t o r y , i f t h e d a i l y m e a n l o g i s ≤ m ,— a c c e p t a b l e , i f t h e d a i l y m e a n l o g i s b e t w e e n m a n d M ,— u n s a t i s f a c t o r y , i f t h e d a i l y m e a n l o g i s > M. S a l m o n e l l a i n c a r c a s e s :— s a t i s f a c t o r y , i f t h e p r e s e n c e o f S a l m o n e l l a i s d e t e c t e d i n a m a x i m u m o f c /n s a m p l e s ,— u n s a t i s f a c t o r y , i f t h e p r e s e n c e o f S a l m o n e l l a i s d e t e c t e d i n m o r e t h a n c /n s a m p l e s .A f t e r e a c h s a m p l i n g s e s s i o n , t h e r e s u l t s o f t h e l a s t t e n s a m p l i n g s e s s i o n s s h a l l b e a s s e s s e d i n o r d e r t o o b t a i n t h e n n u m b e r o f s a m p l e s .E . c o l i a n d a e r o b i c c o l o n y c o u n t i n m i n c e d m e a t , m e a t p r e p a r a t i o n s a n d m e c h a n i c a l l y s e p a r a t e d m e a t (M S M ):— s a t i s f a c t o r y , i f a l l t h e v a l u e s o b s e r v e d a r e ≤ m ,— a c c e p t a b l e , i f a m a x i m u m o f c /n v a l u e s a r e b e t w e e n m a n d M , a n d t h e r e s t o f t h e v a l u e s o b s e r v e d a r e ≤ m ,— u n s a t i s f a c t o r y , i f o n e o r m o r e o f t h e v a l u e s o b s e r v e d a r e > M o r m o r e t h a n c /n v a l u e s a r e b e t w e e n m a n d M .7.12.2007ENOfficial Journal of the European UnionL 322/232.2 M i l k a n d d a i r y p r o d u c t sf s f s d --L 322/24ENOfficial Journal of the European Union7.12.2007f l- 1 ( 2 ) F o r p o i n t s 2.2.7, 2.2.9 a n d 2.2.10 m = M . ( 3 ) T h e m o s t r e c e n t e d i t i o n o f t h e s t a n d a r d s h a l l b e u s e d . ( 4 ) T h e c r i t e r i o n s h a l l n o t a p p l y t o p r o d u c t s i n t e n d e d f o r f u r t h e r p r o c e s s i n g i n t h e f o o d i n d u s t r y . ( 5 ) E . c o l i i s u s e d h e r e a s a n i n d i c a t o r f o r t h e l e v e l o f h y g i e n e . ( 6 ) F o r c h e e s e s w h i c h a r e n o t a b l e t o s u p p o r t t h e g r o w t h o f E . c o l i , t h e E . c o l i c o u n t i s u s u a l l y t h e h i g h e s t a t t h e b e g i n n i n g o f t h e r i p e n i n g p e r i o d , a n d f o r c h e e s e s w h i c h a r e a b l e t o s u p p o r t t h e g r o w t h o f E . c o l i , i t i s n o r m a l l y a t t h e e n d o f t h e r i p e n i n g p e r i o d . ( 7 ) E x c l u d i n g c h e e s e s w h e r e t h e m a n u f a c t u r e r c a n d e m o n s t r a t e , t o t h e s a t i s f a c t i o n o f t h e c o m p e t e n t a u t h o r i t i e s , t h a t t h e p r o d u c t d o e s n o t p o s e a r i s k o f s t a p h y l o c o c c a l e n t e r o t o x i n s . ( 8 ) O n l y i c e c r e a m s c o n t a i n i n g m i l k i n g r e d i e n t s . ( 9 ) P a r a l l e l t e s t i n g f o r E n t e r o b a c t e r i a c e a e a n d E . s a k a z a k i i s h a l l b e c o n d u c t e d , u n l e s s a c o r r e l a t i o n b e t w e e n t h e s e m i c r o -o r g a n i s m s h a s b e e n e s t a b l i s h e d a t a n i n d i v i d u a l p l a n t l e v e l . I f E n t e r o b a c t e r i a c e a e a r e d e t e c t e d i n a n y o f t h e p r o d u c t s a m p l e s t e s t e d i n s u c h a p l a n t , t h e b a t c h h a s t o b e t e s t e d f o r E . s a k a z a k i i . I t s h a l l b e t h e r e s p o n s i b i l i t y o f t h e m a n u f a c t u r e r t o d e m o n s t r a t e t o t h e s a t i s f a c t i o n o f t h e c o m p e t e n t a u t h o r i t y w h e t h e r s u c h a c o r r e l a t i o n e x i s t s b e t w e e n E n t e r o b a c t e r i a c e a e a n d E . s a k a z a k i i . ( 10 ) 1 m l o f i n o c u l u m i s p l a t e d o n a P e t r i d i s h o f 140 m m d i a m e t e r o r o n t h r e e P e t r i d i s h e s o f 90 m m d i a m e t e r .7.12.2007ENOfficial Journal of the European UnionL 322/25I n t e r p r e t a t i o n o f t h e t e s t r e s u l t sT h e l i m i t s g i v e n r e f e r t o e a c h s a m p l e u n i t t e s t e d .T h e t e s t r e s u l t s d e m o n s t r a t e t h e m i c r o b i o l o g i c a l q u a l i t y o f t h e p r o c e s s t e s t e d .E n t e r o b a c t e r i a c e a e i n d r i e d i n f a n t f o r m u l a e , d r i e d d i e t a r y f o o d s f o r s p e c i a l m e d i c a l p u r p o s e s i n t e n d e d f o r i n f a n t s b e l o w s i x m o n t h s o f a g e a n d d r i e d f o l l o w -o n f o r m u l a e :— s a t i s f a c t o r y , i f a l l t h e v a l u e s o b s e r v e d i n d i c a t e t h e a b s e n c e o f t h e b a c t e r i u m ,— u n s a t i s f a c t o r y , i f t h e p r e s e n c e o f t h e b a c t e r i u m i s d e t e c t e d i n a n y o f t h e s a m p l e u n i t s .E . c o l i , E n t e r o b a c t e r i a c e a e (o t h e r f o o d c a t e g o r i e s ) a n d c o a g u l a s e -p o s i t i v e s t a p h y l o c o c c i :— s a t i s f a c t o r y , i f a l l t h e v a l u e s o b s e r v e d a r e ≤ m ,— a c c e p t a b l e , i f a m a x i m u m o f c /n v a l u e s a r e b e t w e e n m a n d M , a n d t h e r e s t o f t h e v a l u e s o b s e r v e d a r e ≤ m ,— u n s a t i s f a c t o r y , i f o n e o r m o r e o f t h e v a l u e s o b s e r v e d a r e > M o r m o r e t h a n c /n v a l u e s a r e b e t w e e n m a n d M .P r e s u m p t i v e B a c i l l u s c e r e u s i n d r i e d i n f a n t f o r m u l a e a n d d r i e d d i e t a r y f o o d s f o r s p e c i a l m e d i c a l p u r p o s e s i n t e n d e d f o r i n f a n t s b e l o w s i x m o n t h s o f a g e :— s a t i s f a c t o r y , i f a l l t h e v a l u e s o b s e r v e d a r e ≤ m ,— a c c e p t a b l e , i f a m a x i m u m o f c /n v a l u e s a r e b e t w e e n m a n d M , a n d t h e r e s t o f t h e v a l u e s o b s e r v e d a r e ≤ m ,— u n s a t i s f a c t o r y , i f o n e o r m o r e o f t h e v a l u e s o b s e r v e d a r e > M o r m o r e t h a n c /n v a l u e s a r e b e t w e e n m a n d M .。