欧盟食品中微生物限量标准.doc

L 322/12
EN
Official Journal of the European Union

COMMISSION REGULATION (EC) No 1441/2007
of 5 December 2007
7.12.2007

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 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 hygiene
of foodstuffs (1), and in particular Article 4(4) thereof,

Whereas:

(1) 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 (EC) No 2073/2005 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.

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

(3) On 24 January 2007, the Scientific Panel on Biological
Hazards (BIOHAZ Panel) of the European Food Safety
Authority (EFSA) issued an opinion with regard to
Enterobacteriaceae as indicators of Salmonella and
Enterobacter 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 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.

(4) 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.

(5) 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.

(6) 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
point principles. Dehydrated foods, in which the
presence of spores of pathogenic Bacillus spp. is
frequent, might permit the growth of Bacillus 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.

(7) 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) 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 cm2per site selected. However, neither the
number of sampling sites nor the minimum total area
of sampling is specified. In order to improve the
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 should be increased. Chapter 3 of
Annex I to that Regulation should therefore be
amended accordingly.

(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.


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

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.

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

Chapter 1.

Chapter 2.
Official Journal of the European Union

ANNEX

‘ANNEX I

Microbiological criteria for foodstuffs

Food safety criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Process hygiene criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
7.12.2007

2.1 Meat and products thereof . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.2 Milk and dairy products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
2.3 Egg products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
2.4 Fishery products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
2.5 Vegetables, fruits and products thereof . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Chapter 3.

Rules for sampling and preparation of test samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

3.1 General rules for sampling and preparation of test samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
3.2 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
Chapter
1.
Food
safety
criteria
Food
category
Micro-organisms/th
eir
toxins,
metabolite
s
Sampling
plan
(
1
)
Limits
(
2
)
Analytical
reference
method
(
3
)
Stage
where
the
criterion
applies
nc
m
M
1.1
Ready-to-eat
foods
intended
for
infants
and
ready-to-eat
foods
for
special
medical
purposes
(
4
)
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/g
(
5
)
EN/ISO
11290-2
(
6
)
Products
placed
on
the
market
during
their
shelf-life
5
0
Absence
in
25
g
(
7
)
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
(
4
)(
8
)
Listeria
monocytogenes
5
0
100
cfu/g
EN/ISO
11290-2
(
6
)
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)
(
9
)
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

L 322/16
EN
Official Journal of the European Union
7.12.2007
Food
category
Micro-organisms/th
eir
toxins,
metabolite
s
Sampling
plan
(
1
)
Limits
(
2
)
Analytical
reference
method
(
3
)
Stage
where
the
criterion
applies
nc
m
M
1.9
Meat
products
made
from
poultrymeat
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
pasteurisation
(
10
)
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
powder
Salmonella
5
0
Absence
in
25
g
EN/ISO
6579
Products
placed
on
the
market
during
their
shelf-life
1.13
Ice
cream
(
11
),
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
25
g
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
o
r
m
l
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
25
g
EN/ISO
6579
Products
placed
on
the
market
during
their
shelf-life
1.18
Sprouted
seeds
(ready-to-eat)
(
12
)
Salmonella
5
0
Absence
in
25
g
EN/ISO
6579
Products
placed
on
the
market
during
their
shelf-life

7.12.2007
EN
Official Journal of the European Union
L 322/17
Food
category
Micro-organisms/th
eir
toxins,
metabolite
s
Sampling
plan
(
1
)
Limits
(
2
)
Analytical
reference
method
(
3
)
Stage
where
the
criterion
applies
nc
m
M
1.19
Precut
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
entero-
toxins
5
0
Not
detected
in
25
g
European
screening
method
of
the
CRL
for
coagulase
positive
staphylococci
(
13
)
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
Absence
in
25
g
EN/ISO
6579
Products
placed
on
the
market
during
their
shelf-life
1.23
Dried
follow-on
formulae
Salmonella
30
0
Absence
in
25
g
EN/ISO
6579
Products
plac