Chapter 1. Food safety criteriaF1

United Kingdom

Food category	Micro-organisms/their toxins, metabolites	Sampling plan ^f1		Limits ^f2		Analytical reference method ^f3	Stage where the criterion applies
n = number of units comprising the sample; c = number of sample units giving values between m and M.
F2For points 1.1-1.24, 1.27a, 1.28-1.30 m = M.
The most recent edition of the standard shall be used.
Regular testing against the criterion is not required 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 (for example, products heat treated in their final package), fresh, uncut and unprocessed vegetables and fruits F3 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 F4, F5food grade salt.
This criterion shall apply 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 must be low enough to guarantee that the limit of 100 cfu/g is not exceeded at the end of shelf-life.
1 ml of inoculum is plated on a Petri dish of 140 mm diameter or on three Petri dishes of 90 mm diameter.
This criterion shall apply 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.
Products with pH ≤ 4,4 or a _w ≤ 0,92, products with pH ≤ 5,0 and a _w ≤ 0,94, products with a shelf-life of less than five days shall be automatically considered to belong to this category. Other categories of products can also belong to this category, subject to scientific justification.
This criterion shall apply to mechanically separated meat (MSM) produced with the techniques referred to in paragraph 3 of Chapter III of Section V of Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council.
Excluding products when the manufacturer can demonstrate to the satisfaction of the competent authorities that, due to the ripening time and a _w of the product where appropriate, there is no salmonella risk.
Only ice creams containing milk ingredients.
F6

Parallel testing for Enterobacteriaceae and F7Cronobacter spp. shall be conducted, unless a correlation between these micro-organisms has been established at an individual plant level. If Enterobacteriaceae are detected in any of the product samples tested in such a plant, the batch must be tested for Cronobacter spp. It shall be the responsibility of the manufacturer to demonstrate to the satisfaction of the competent authority whether such a correlation exists between Enterobacteriaceae and Cronobacter spp.
E. coli is used here as an indicator of faecal contamination.
F8Each sample unit comprises a minimum number of individual animals according to EN/ISO 6887-3.
Particularly fish species of the families: Scombridae, Clupeidae, Engraulidae, Coryfenidae, Pomatomidae, Scombresosidae .
F9Single 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, unless the result is above M.

F10This criterion shall apply to fresh meat from breeding flocks of Gallus gallus , laying hens, broilers and breeding and fattening flocks of turkeys.
As regards monophasic Salmonella typhimurium only X11 ,4,[5],12:i:- is included.
F11Taking into account the most recent adaptation by the European Union reference laboratory for Escherichia coli , including Verotoxigenic E. coli (VTEC), for the detection of STEC O104:H4.
Excluding sprouts that have received a treatment effective to eliminate Salmonella spp. and STEC.
F12The term unpasteurised means that the juice has not been subjected to pasteurisation obtained by time-temperature combinations or to other processes validated to achieve an equivalent bactericidal effect to pasteurisation as regards its effect on Salmonella .
Food category	Micro-organisms/their toxins, metabolites	n	c	m	M	Analytical reference method ^f3	Stage where the criterion applies
1.1 Ready-to-eat foods intended for infants and ready-to-eat foods for special medical purposes ^f4	Listeria monocytogenes	10	0	Not detected 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/g ^f5		EN/ISO 11290-2 ^f6	Products placed on the market during their shelf-life
	Listeria monocytogenes	5	0	Not detected in 25 g ^f7		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 purposes ^f8	Listeria monocytogenes	5	0	100 cfu/g		EN/ISO 11290-2	Products placed on the market during their shelf-life
1.4 Minced meat and meat preparations intended to be eaten raw	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	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	Not detected in 25 g		EN ISO 6579-1	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	Not detected in 10 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.7 Mechanically separated meat (MSM) ^f9	Salmonella	5	0	Not detected in 10 g		EN ISO 6579-1	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	Not detected in 25 g		EN ISO 6579-1	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	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.10 Gelatine and collagen	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	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 pasteurisation ^f10	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.12 Milk powder and whey powder	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.13 Ice cream ^f11 , excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	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	Not detected in 25 g		EN ISO 6579-1	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	Not detected in 25 g or ml		EN ISO 6579-1	Products placed on the market during their shelf-life
1.16 Cooked crustaceans and molluscan shellfish	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.17 Live bivalve molluscs and live echinoderms, tunicates and gastropods	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.18 Sprouted seeds (ready-to-eat) ^f12	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.19 Precut fruit and vegetables (ready-to-eat)	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.20 Unpasteurised ^f13 fruit and vegetable juices (ready- to-eat)	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	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 25 g		EN ISO 19020	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	Salmonella	30	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.23 Dried follow-on formulae	Salmonella	30	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.24 Dried infant formulae and dried dietary foods for special medical purposes intended for infants below 6 months of age ^f14	Cronobacter spp. (Enterobacter sakazakii)	30	0	Not detected in 10 g		EN ISO 22964	Products placed on the market during their shelf-life
1.25 Live bivalve molluscs and live echinoderms, tunicates and marine gastropods	E. coli ^f15	5 ^f16	1	230 MPN/100 g of flesh and intravalvular liquid	700 MPN/100 g of flesh and intravalvular liquid	EN/ISO 16649-3	Products placed on the market during their shelf-life
1.26 Fishery products from fish species associated with a high amount of histidine ^f17	Histamine	9 ^f18	2	100 mg/kg	200 mg/kg	EN ISO 19343	Products placed on the market during their shelf-life
1.27 Fishery products, except those in food category 1.27a, which have undergone enzyme maturation treatment in brine, manufactured from fish species associated with a high amount of histidine	Histamine	9	2	200 mg/kg	400 mg/kg	EN ISO 19343	Products placed on the market during their shelf-life
X21.27a Fish sauce produced by fermentation of fishery products	Histamine	1	0	400 mg/kg		EN ISO 19343	Products placed on the market during their shelf-life
1.28 Fresh poultry meat ^f19	Salmonella Typhimurium ^f20 Salmonella Enteritidis	5	0	Not detected in 25 g		EN ISO 6579-1 (for detection) White- Kauffmann-Le Minor scheme (for serotyping)	Products placed on the market during their shelf-life
1.29 Sprouts	Shiga toxin producing E. coli (STEC) O157, O26, O111, O103, O145 and O104:H4	5	0	Not detected in 25 grams		CEN/ISO TS 13136 ^f21	Products placed on the market during their shelf-life
F131.30 Reptile meat	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life

Interpretation of the test results

Annotations

Textual amendments

F1: Substituted by Commission Regulation (EC) No 1441/2007 of 5 December 2007 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs (Text with EEA relevance).
F2: Substituted by Commission Regulation (EU) 2020/205 of 14 February 2020 amending Regulation (EC) No 2073/2005 as regards Salmonella in reptile meat (Text with EEA relevance).
F3: Deleted by Commission Regulation (EU) 2019/229 of 7 February 2019 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs as regards certain methods, the food safety criterion for Listeria monocytogenes in sprouted seeds, and the process hygiene criterion and food safety criterion for unpasteurised fruit and vegetable juices (ready-to-eat) (Text with EEA relevance).
F4: Substituted by Commission Regulation (EU) No 365/2010 of 28 April 2010 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs as regards Enterobacteriaceae in pasteurised milk and other pasteurised liquid dairy products and Listeria monocytogenes in food grade salt (Text with EEA relevance).
F5: Inserted by Commission Regulation (EU) No 365/2010 of 28 April 2010 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs as regards Enterobacteriaceae in pasteurised milk and other pasteurised liquid dairy products and Listeria monocytogenes in food grade salt (Text with EEA relevance).
F6: Deleted by 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).
F7: Substituted by Commission Regulation (EU) 2019/229 of 7 February 2019 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs as regards certain methods, the food safety criterion for Listeria monocytogenes in sprouted seeds, and the process hygiene criterion and food safety criterion for unpasteurised fruit and vegetable juices (ready-to-eat) (Text with EEA relevance).
F8: Substituted by Commission Regulation (EU) 2015/2285 of 8 December 2015 amending Annex II to Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption as regards certain requirements for live bivalve molluscs, echinoderms, tunicates and marine gastropods and Annex I to Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs (Text with EEA relevance).
F9: Substituted by Commission Regulation (EU) No 1019/2013 of 23 October 2013 amending Annex I to Regulation (EC) No 2073/2005 as regards histamine in fishery products (Text with EEA relevance).
F10: Inserted by Commission Regulation (EU) No 1086/2011 of 27 October 2011 amending Annex II to Regulation (EC) No 2160/2003 of the European Parliament and of the Council and Annex I to Commission Regulation (EC) No 2073/2005 as regards salmonella in fresh poultry meat (Text with EEA relevance).
F11: Inserted by 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).
F12: Inserted by Commission Regulation (EU) 2019/229 of 7 February 2019 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs as regards certain methods, the food safety criterion for Listeria monocytogenes in sprouted seeds, and the process hygiene criterion and food safety criterion for unpasteurised fruit and vegetable juices (ready-to-eat) (Text with EEA relevance).
F13: Inserted by Commission Regulation (EU) 2020/205 of 14 February 2020 amending Regulation (EC) No 2073/2005 as regards Salmonella in reptile meat (Text with EEA relevance).

Editorial notes

X1: Substituted by Corrigendum to Commission Regulation (EU) No 1086/2011 of 27 October 2011 amending Annex II to Regulation (EC) No 2160/2003 of the European Parliament and of the Council and Annex I to Commission Regulation (EC) No 2073/2005 as regards salmonella in fresh poultry meat (Official Journal of the European Union L 281 of 28 October 2011).
X2: Substituted by Corrigendum to Commission Regulation (EU) No 1019/2013 of 23 October 2013 amending Annex I to Regulation (EC) No 2073/2005 as regards histamines in fishery products (Official Journal of the European Union L 282 of 24 October 2013).

Footnotes

f1

n = number of units comprising the sample; c = number of sample units giving values between m and M.

f2

For points 1.1-1.24, 1.27a, 1.28-1.30 m = M.

f3

The most recent edition of the standard shall be used.

f4

Regular testing against the criterion is not required 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 (for example, 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 ,
food grade salt.

f5

This criterion shall apply 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 must be low enough to guarantee that the limit of 100 cfu/g is not exceeded at the end of shelf-life.

f6

1 ml of inoculum is plated on a Petri dish of 140 mm diameter or on three Petri dishes of 90 mm diameter.

f7

This criterion shall apply 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.

f8

Products with pH ≤ 4,4 or a _w ≤ 0,92, products with pH ≤ 5,0 and a _w ≤ 0,94, products with a shelf-life of less than five days shall be automatically considered to belong to this category. Other categories of products can also belong to this category, subject to scientific justification.

f9

This criterion shall apply to mechanically separated meat (MSM) produced with the techniques referred to in paragraph 3 of Chapter III of Section V of Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council.

f10

Excluding products when the manufacturer can demonstrate to the satisfaction of the competent authorities that, due to the ripening time and a _w of the product where appropriate, there is no salmonella risk.

f11

Only ice creams containing milk ingredients.

f12

Excluding sprouts that have received a treatment effective to eliminate Salmonella spp. and STEC.

f13

The term unpasteurised means that the juice has not been subjected to pasteurisation obtained by time-temperature combinations or to other processes validated to achieve an equivalent bactericidal effect to pasteurisation as regards its effect on Salmonella .

f14

Parallel testing for Enterobacteriaceae and Cronobacter spp. shall be conducted, unless a correlation between these micro-organisms has been established at an individual plant level. If Enterobacteriaceae are detected in any of the product samples tested in such a plant, the batch must be tested for Cronobacter spp. It shall be the responsibility of the manufacturer to demonstrate to the satisfaction of the competent authority whether such a correlation exists between Enterobacteriaceae and Cronobacter spp.

f15

E. coli is used here as an indicator of faecal contamination.

f16

Each sample unit comprises a minimum number of individual animals according to EN/ISO 6887-3.

f17

Particularly fish species of the families: Scombridae, Clupeidae, Engraulidae, Coryfenidae, Pomatomidae, Scombresosidae .

f18

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, unless the result is above M.

f19

This criterion shall apply to fresh meat from breeding flocks of Gallus gallus , laying hens, broilers and breeding and fattening flocks of turkeys.

f20

As regards monophasic Salmonella typhimurium only 1 ,4,[5],12:i:- is included.

f21

Taking into account the most recent adaptation by the European Union reference laboratory for Escherichia coli , including Verotoxigenic E. coli (VTEC), for the detection of STEC O104:H4.