Commission Regulation (EC) No 2073/2005Show full title

Chapter 1. Food safety criteria

a n = number of units comprising the sample; c = number of sample units giving values over m or between m and M.
b For points 1.1-1.24 m=M.
c The most recent edition of the standard shall be used.
d Regular testing against the criterion is not useful in normal circumstances for the following ready-to-eat foods: those which have received heat treatment or other processing effective to eliminate L. monocytogenes, when recontamination is not possible after this treatment (e.g. products heat treated in their final package), fresh, uncut and unprocessed vegetables and fruits, excluding sprouted seeds, bread, biscuits and similar products, bottled or packed waters, soft drinks, beer, cider, wine, spirits and similar products, sugar, honey and confectionery, including cocoa and chocolate products, live bivalve molluscs.
e This criterion applies if the manufacturer is able to demonstrate, to the satisfaction of the competent authority, that the product will not exceed the limit 100 cfu/g throughout the shelf-life. The operator may fix intermediate limits during the process that should be low enough to guarantee that the limit of 100 cfu/g is not exceeded at the end of the shelf-life.
f 1 ml of inoculum is plated on a Petri dish of 140 mm diameter or on three Petri dishes of 90 mm diameter.
g This criterion applies to products before they have left the immediate control of the producing food business operator, when he is not able to demonstrate, to the satisfaction of the competent authority, that the product will not exceed the limit of 100 cfu/g throughout the shelf-life.
h Products with pH ≤ 4,4 or aw ≤ 0,92, products with pH ≤ 5,0 and aw ≤ 0,94, products with a shelf-life of less than five days are automatically considered to belong to this category. Other categories of products can also belong to this category, subject to scientific justification.
i This criterion applies to mechanically separated meat (MSM) produced with the techniques referred to in Chapter III, paragraph 3, in section V of Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin.
j Excluding products when the manufacturer can demonstrate to the satisfaction of the competent authorities that, due to the ripening time and aw of the product where appropriate, there is no salmonella risk.
l Only ice creams containing milk ingredients.
k Preliminary testing of the batch of seeds before starting the sprouting process or the sampling to be carried out at the stage where the highest probability of finding Salmonella is expected.
m Reference: Hennekinne et al., J. AOAC Internat. Vol. 86, No 2, 2003.
n E. coli is used here as an indicator of faecal contamination.
o A pooled sample comprising a minimum of 10 individual animals.
p Particularly fish species of the families: Scombridae, Clupeidae, Engraulidae, Coryfenidae, Pomatomidae, Scombresosidae.
q Single samples may be taken at retail level. In such a case the presumption laid down in Article 14(6) of Regulation (EC) No 178/2002, according to which the whole batch should be deemed unsafe, shall not apply.
r References: 1. Malle P., Valle M., Bouquelet S. Assay of biogenic amines involved in fish decomposition. J. AOAC Internat. 1996, 79, 43-49. 2. Duflos G., Dervin C., Malle P., Bouquelet S. Relevance of matrix effect in determination of biogenic amines in plaice (Pleuronectes platessa) and whiting (Merlangus merlangus). J. AOAC Internat. 1999, 82, 1097-1101.
Food category	Micro-organisms/their toxins, metabolites	Sampling-plana		Limitsb		Analytical reference methodc	Stage where the criterion applies
		n	c	m	M
1.1. Ready-to-eat foods intended for infants and ready-to-eat foods for special medical purposesd	Listeria monocytogenes	10	0	Absence in 25 g		EN/ISO 11290-1	Products placed on the market during their shelf-life
1.2. Ready-to-eat foods able to support the growth of L. monocytogenes, other than those intended for infants and for special medical purposes	Listeria monocytogenes	5	0	100 cfu/ge		EN/ISO 11290-2f	Products placed on the market during their shelf-life
		5	0	Absence in 25 gg		EN/ISO 11290-1	Before the food has left the immediate control of the food business operator, who has produced it
1.3. Ready-to-eat foods unable to support the growth of L. monocytogenes, other than those intended for infants and for special medical purposesd h	Listeria monocytogenes	5	0	100 cfu/g		EN/ISO 11290-2f	Products placed on the market during their shelf-life
1.4. Minced meat and meat preparations intended to be eaten raw	Salmonella	5	0	Absence in 25 g		EN/ISO 6579	Products placed on the market during their shelf-life
1.5. Minced meat and meat preparations made from poultry meat intended to be eaten cooked	Salmonella	5	0	From 1.1.2006 Absence in 10 g From 1.1.2010 Absence in 25 g		EN/ISO 6579	Products placed on the market during their shelf-life
1.6. Minced meat and meat preparations made from other species than poultry intended to be eaten cooked	Salmonella	5	0	Absence in 10 g		EN/ISO 6579	Products placed on the market during their shelf-life
1.7. Mechanically separated meat (MSM)i	Salmonella	5	0	Absence in 10 g		EN/ISO 6579	Products placed on the market during their shelf-life
1.8. Meat products intended to be eaten raw, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk	Salmonella	5	0	Absence in 25 g		EN/ISO 6579	Products placed on the market during their shelf-life
1.9. Meat products made from poultry meat intended to be eaten cooked	Salmonella	5	0	From 1.1.2006 Absence in 10 g From 1.1.2010 Absence in 25 g		EN/ISO 6579	Products placed on the market during their shelf-life
1.10. Gelatine and collagen	Salmonella	5	0	Absence in 25 g		EN/ISO 6579	Products placed on the market during their shelf-life
1.11. Cheeses, butter and cream made from raw milk or milk that has undergone a lower heat treatment than pasteurisationj	Salmonella	5	0	Absence in 25 g		EN/ISO 6579	Products placed on the market during their shelf-life
1.12. Milk powder and whey powderj	Salmonella	5	0	Absence in 25 g		EN/ISO 6579	Products placed on the market during their shelf-life
1.13. Ice creaml, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk	Salmonella	5	0	Absence in 25 g		EN/ISO 6579	Products placed on the market during their shelf-life
1.14. Egg products, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk	Salmonella	5	0	Absence in 25g		EN/ISO 6579	Products placed on the market during their shelf-life
1.15. Ready-to-eat foods containing raw egg, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk	Salmonella	5	0	Absence in 25 g or ml		EN/ISO 6579	Products placed on the market during their shelf-life
1.16. Cooked crustaceans and molluscan shellfish	Salmonella	5	0	Absence in 25 g		EN/ISO 6579	Products placed on the market during their shelf-life
1.17. Live bivalve molluscs and live echinoderms, tunicates and gastropods	Salmonella	5	0	Absence in 25g		EN/ISO 6579	Products placed on the market during their shelf-life
1.18. Sprouted seeds (ready-to-eat)k	Salmonella	5	0	Absence in 25 g		EN/ISO 6579	Products placed on the market during their shelf-life
1.19. Pre-cut fruit and vegetables (ready-to-eat)	Salmonella	5	0	Absence in 25 g		EN/ISO 6579	Products placed on the market during their shelf-life
1.20. Unpasteurised fruit and vegetable juices (ready-to-eat)	Salmonella	5	0	Absence in 25 g		EN/ISO 6579	Products placed on the market during their shelf-life
1.21. Cheeses, milk powder and whey powder, as referred to in the coagulase-positive staphylococci criteria in Chapter 2.2 of this Annex	Staphylococcal enterotoxins	5	0	Not detected in 25g		European screening method of the CRL for Milkm	Products placed on the market during their shelf-life
1.22. Dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age, as referred to in the Enterobacteriaceae criterion in Chapter 2.2 of this Annex	Salmonella	30	0	Absence in 25 g		EN/ISO 6579	Products placed on the market during their shelf-life
1.23. Dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age, as referred to in the Enterobacteriaceae criterion in Chapter 2.2 of this Annex	Enterobacter sakazakii	30	0	Absence in 10 g		ISO/DTS 22964	Products placed on the market during their shelf-life
1.24. Live bivalve molluscs and live echinoderms, tunicates and gastropods	E.coli n	1 o	0	230 MPN/100g of flesh and intra-valvular liquid		ISO TS 16649-3	Products placed on the market during their shelf-life
1.25. Fishery products from fish species associated with a high amount of histidinep	Histamine	9 q	2	100 mg/kg	200 mg/kg	HPLCr	Products placed on the market during their shelf-life
1.26. Fishery products which have undergone enzyme maturation treatment in brine, manufactured from fish species associated with a high amount of histidinep	Histamine	9	2	200 mg/kg	400 mg/kg	HPLCr	Products placed on the market during their shelf-life

Interpretation of the test results

The limits given refer to each sample unit tested, excluding live bivalve molluscs and live echinoderms, tunicates and gastropods in relation to testing E. coli, where the limit refers to a pooled sample.

The test results demonstrate the microbiological quality of the batch tested(1).

L. monocytogenes in ready-to-eat foods intended for infants and for special medical purposes:

• satisfactory, if all the values observed indicate the absence of the bacterium,

• unsatisfactory, if the presence of the bacterium is detected in any of the sample units.

L. monocytogenes in ready-to-eat foods able to support the growth of L. monocytogenes before the food has left the immediate control of the producing food business operator when he is not able to demonstrate that the product will not exceed the limit of 100 cfu/g throughout the shelf-life:

• satisfactory, if all the values observed indicate the absence of the bacterium,

• unsatisfactory, if the presence of the bacterium is detected in any of the sample units.

L. monocytogenes in other ready-to-eat foods and E. coli in live bivalve molluscs:

• satisfactory, if all the values observed are ≤ the limit,

• unsatisfactory, if any of the values are > the limit.

Salmonella in different food categories:

• satisfactory, if all the values observed indicate the absence of the bacterium,

• unsatisfactory, if the presence of the bacterium is detected in any of the sample units.

Staphylococcal enterotoxins in dairy products:

• satisfactory, if in all the sample units the enterotoxins are not detected,

• unsatisfactory, if the enterotoxins are detected in any of the sample units.

Enterobacter sakazakii in dried infant formulae and dried dietary foods for special medical purposes intended for infants below 6 months of age:

• satisfactory, if all the values observed indicate the absence of the bacterium,

• unsatisfactory, if the presence of the bacterium is detected in any of the sample units.

Histamine in fishery products from fish species associated with a high amount of histidine:

• satisfactory, if the following requirements are fulfilled:

  1.

  the mean value observed is ≤ m

  2.

  a maximum of c/n values observed are between m and M

  3.

  no values observed exceed the limit of M,

• unsatisfactory, if the mean value observed exceeds m or more than c/n values are between m and M or one or more of the values observed are >M.

(1)

The test results can be used also for demonstrating the effectiveness of the HACCP or good hygiene procedure of the process.