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 )
Date: 2007-12-05
Institutions: European Commission
Subjects: food hygiene, food inspection, food safety, food standard, foodstuff, microorganism

L 322/12

EN

Official Journal of the European Union

7.12.2007

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)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

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:

(1)

(2)

Commission Regulation (EC) No 2073/2005 of 15
November 2005 on microbiological criteria for food-
stuffs (2)
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
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.

2073/2005

(EC) No

for

foods

Chapters 1 and 2 of Annex I to Regulation (EC) No
food safety criteria and process
2073/2005 set out
hygiene criteria regarding dried infant
formulae and
dried dietary
special medical purposes
intended for infants below six months of age (dried
formulae and dried dietary foods). Part 2.2 of
infant
Chapter 2 of
that Annex provides that where dried
infant formulae and dried dietary foods are tested and
the sample
Enterobacteriaceae are detected in any of
units, the batch is to be tested for Enterobacter sakazakii
and Salmonella.

(4)

(5)

(6)

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.

spores of pathogenic Bacillus

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
in which the
point principles. Dehydrated foods,
presence of
is
frequent, might permit
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.

the growth of Bacillus

spp.

(3)

On 24 January 2007, the Scientific Panel on Biological
Hazards (BIOHAZ Panel) of the European Food Safety
issued an opinion with regard to
Authority (EFSA)
and
indicators of Salmonella
as
Enterobacteriaceae
Enterobacter sakazakii. It concluded that it is not possible

(7)

(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.

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 I
to that Regulation should therefore be
amended accordingly.

7.12.2007

EN

Official Journal of the European Union

L 322/13

(8)

sampling is

site selected. However, neither

Chapter 3 of Annex I to Regulation (EC) No 2073/2005
sets out sampling rules for carcasses of cattle, pig, sheep,
goats and horses for Salmonella analyses. Pursuant
to
those rules the sampling area is to cover a minimum
of 100 cm2 per
the
number of sampling sites nor the minimum total area
to improve the
of
implementation of these rules in the Community,
it is
appropriate to further specify in Regulation (EC) No
2073/2005 that the areas most likely to be contaminated
should be selected for sampling and that
the total
sampling area
increased. Chapter 3 of
should be
Annex I
to that Regulation should therefore be
amended accordingly.

In order

specified.

(10)

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EC) No 2073/2005 is replaced by the
text in the Annex to this Regulation.

(9)

In the interests of clarity of Community legislation, it is
appropriate to replace Annex I to Regulation (EC) No
2073/2005 by the text set out in the Annex to this
Regulation.

Article 2

This 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 Commission

Markos KYPRIANOU
Member of the Commission

L 322/14

EN

Official Journal of the European Union

7.12.2007

ANNEX

‘ANNEX I

Microbiological criteria for foodstuffs

Chapter 1.

Food safety criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15

Chapter 2.

Process hygiene criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

20

2.1

2.2

2.3

2.4

2.5

Meat and products thereof

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

20

Milk and dairy products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

23

Egg products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

26

Fishery products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

27

Vegetables, fruits and products thereof . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

28

Chapter 3.

Rules for sampling and preparation of test samples

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

29

3.1

3.2

General rules for sampling and preparation of test samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

29

Bacteriological sampling in slaughterhouses and at premises producing minced meat and meat
preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

29

7.12.2007

EN

Official Journal of the European Union

L 322/15

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L 322/16

EN

Official Journal of the European Union

7.12.2007

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EN

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EN

Official Journal of the European Union

L 322/21

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EN

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7.12.2007

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EN

Official Journal of the European Union

7.12.2007

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EN

Official Journal of the European Union

7.12.2007

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7.12.2007

EN

Official Journal of the European Union

L 322/29

Chapter 3. Rules for sampling and preparation of test samples

3.1 General rules for sampling and preparation of test samples

In the absence of more specific rules on sampling and preparation of test samples, the relevant standards of the ISO
(International Organisation for Standardisation) and the guidelines of the Codex Alimentarius shall be used as reference
methods.

3.2 Bacteriological sampling in slaughterhouses and at premises producing minced meat and meat preparations

S a m p l i n g r u l e s f o r c a r c a s e s o f c a t t l e , p i g s , s h e e p , g o a t s a n d h o r s e s

The destructive and non-destructive sampling methods, the selection of the sampling sites and the rules for storage and
transport of samples are described in standard ISO 17604.

Five carcases shall be sampled at random during each sampling session. Sample sites must be selected taking into account
the slaughter technology used in each plant.

When sampling for analyses of Enterobacteriaceae and aerobic colony counts, four sites of each carcase shall be sampled.
Four tissue samples representing a total of 20 cm2 shall be obtained by the destructive method. When using the non-
destructive method for this purpose, the sampling area shall cover a minimum of 100 cm2 (50 cm2 for small ruminant
carcases) per sampling site.

When sampling for Salmonella analyses, an abrasive sponge sampling method shall be used. Areas most likely to be
contaminated shall be selected. The total sampling area shall cover a minimum of 400 cm2.

When samples are taken from the different sampling sites on the carcase, they shall be pooled before examination.

S a m p l i n g r u l e s f o r p o u l t r y c a r c a s e s

For the Salmonella analyses, a minimum of 15 carcases shall be sampled at random during each sampling session and
after chilling. A piece of approximately 10 g from neck skin shall be obtained from each carcase. On each occasion the
neck skin samples from three carcases shall be pooled before examination in order to form 5 × 25 g final samples.

More detailed guidelines on the sampling of carcases, in particular concerning the sampling sites, may be included in the
guides to good practice referred to in Article 7 of Regulation (EC) No 852/2004.

G u i d e l i n e s f o r s a m p l i n g

S a m p l i n g f r e q u e n c i e s f o r c a r c a s e s , 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

The food business operators of slaughterhouses or establishments producing minced meat, meat preparations or
mechanically separated meat shall take samples for microbiological analysis at least once a week. The day of sampling
shall be changed each week to ensure that each day of the week is covered.

As regards the sampling of minced meat and meat preparations for E. coli and aerobic colony count analyses and the
sampling of carcases for Enterobacteriaceae and aerobic colony count analyses, the frequency may be reduced to fort-
nightly testing if satisfactory results are obtained for six consecutive weeks.

In the case of sampling for Salmonella analyses of minced meat, meat preparations and carcases, the frequency may be
reduced to fortnightly if satisfactory results have been obtained for 30 consecutive weeks. The salmonella sampling
frequency may also be reduced if there is a national or regional salmonella control programme in place and if this
programme includes testing that replaces the sampling described in this paragraph. The sampling frequency may be
further reduced if the national or regional salmonella control programme demonstrates that the salmonella prevalence is
low in animals purchased by the slaughterhouse.

However, when justified on the basis of a risk analysis and consequently authorised by the competent authority, small
slaughterhouses and establishments producing minced meat and meat preparations in small quantities may be exempted
from these sampling frequencies.’