Commission Regulation (EC) No 2073/2005 of  15 November 2005  on microbiological criteria for foodstuffs   (Text with EEA relevance)
Date: 2005-11-15
Institutions: European Commission
Subjects: agri-foodstuffs, agricultural product, food inspection, food safety, foodstuff, health control, human nutrition, labelling, microorganism

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Official Journal of the European Union

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I

(Acts whose publication is obligatory)

COMMISSION REGULATION (EC) No 2073/2005

of 15 November 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 Articles 4(4)
and 12 thereof,

Whereas:

(1) A high level of protection of public health is one of the
fundamental objectives of food law, as laid down in
Regulation (EC) No 178/2002 of the European Parlia-
ment and of the Council of 28 January 2002 laying
down the general principles and requirements of food
law, establishing the European Food Safety Authority and
laying down procedures in matters of food safety (2).
Microbiological hazards in foodstuffs form a major
source of food-borne diseases in humans.

(2)

Foodstuffs should not contain micro-organisms or their
toxins or metabolites in quantities that present an
unacceptable risk for human health.

(3) Regulation (EC) No 178/2002 lays down general food
safety requirements, according to which food must not
be placed on the market if it is unsafe. Food business
operators have an obligation to withdraw unsafe food
from the market. In order to contribute to the protection
of public health and to prevent differing interpretations,
it is appropriate to establish harmonised safety criteria on
the acceptability of food,
in particular as regards the
presence of certain pathogenic micro-organisms.

(1) OJ L 139, 30.4.2004, p. 1, corrected by OJ L 226, 25.6.2004,

p. 3.

(2) OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation

(EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

(4) Microbiological criteria also give guidance on the
foodstuffs and their manufacturing,
acceptability of
handling and distribution processes. The use of micro-
biological criteria should form an integral part of the
implementation of HACCP-based procedures and other
hygiene control measures.

(5) The safety of foodstuffs is mainly ensured by a preventive
approach, such as implementation of good hygiene
practice and application of procedures based on hazard
analysis and critical control point (HACCP) principles.
Microbiological criteria can be used in validation and
verification of HACCP procedures and other hygiene
control measures.
is therefore appropriate to set
microbiological criteria defining the acceptability of the
processes, and also food safety microbiological criteria
setting a limit above which a foodstuff should be
considered unacceptably contaminated with the micro-
organisms for which the criteria are set.

It

It

(6) According to Article 4 of Regulation (EC) No 852/2004,
food business operators are to comply with microbiolo-
gical criteria. This should include testing against the
values set for the criteria through the taking of samples,
the conduct of analyses and the implementation of
corrective actions, in accordance with food law and the
instructions given by the competent authority.
is
therefore appropriate to lay down implementing mea-
including,
sures concerning the analytical methods,
the
where necessary,
sampling plan, the microbiological
limits, the number
of analytical units that should comply with these limits.
Furthermore, it is appropriate to lay down implementing
measures concerning the foodstuff to which the criterion
applies, the points of the food chain where the criterion
applies, as well as the actions to be taken when the
criterion is not met. The measures to be taken by the
food business operators in order to ensure compliance
with criteria defining the acceptability of a process may
include, among other things, controls of raw materials,
hygiene, temperature and shelf-life of the product.

the measurement uncertainty,

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(7) Regulation (EC) No 882/2004 of the European Parlia-
ment and of the Council of 29 April 2004 on official
controls performed to ensure
the verification of
compliance with feed and food law, animal health and
animal welfare rules (1) requires the Member States to
ensure that official controls are carried out regularly, on a
risk basis and with appropriate frequency. Those controls
should take place at appropriate stages of the production,
processing and distribution of food to ensure that the
criteria laid down in this Regulation are complied with by
food business operators.

(8) The Communication from the Commission on the
Community Strategy for setting microbiological criteria
for foodstuffs (2) describes the strategy to lay down and
revise the criteria in Community legislation, as well as the
principles for the development and application of the
criteria. This strategy should be applied when micro-
biological criteria are laid down.

(9) The Scientific Committee on Veterinary Measures relating
to Public Health (SCVPH)
issued an opinion on
23 September 1999 on the evaluation of microbiological
criteria for food products of animal origin for human
consumption.
It highlighted the relevance of basing
microbiological criteria on formal risk assessment and
internationally approved principles. The opinion recom-
mends that microbiological criteria should be relevant
and effective in relation to consumer health protection.
The SCVPH proposed, while awaiting formal
risk
assessments, certain revised criteria as interim measures.

(10) The SCVPH issued at the same time a separate opinion
on Listeria monocytogenes. That opinion recommended
that it be an objective to keep the concentration of
Listeria monocytogenes in food below 100 cfu/g. The
Scientific Committee on Food (SCF) agreed with these
recommendations in its opinion of 22 June 2000.

(11) The SCVPH adopted an opinion on Vibrio vulnificus and
Vibrio parahaemolyticus on 19 and 20 September 2001. It
concluded that currently available scientific data do not
setting specific criteria for pathogenic V.
support
vulnificus and parahaemolyticus in seafood. However,
it
recommended that codes of practice should be estab-
lished to ensure that good hygiene practice has been
applied.

(12) The SCVPH issued an opinion on Norwalk-like viruses
In that
(NLVs, noroviruses) on 30-31 January 2002.
opinion it concluded that
faecal
the conventional
indicators are unreliable for demonstrating the presence
or absence of NLVs and that the reliance on faecal
for determining shellfish
bacterial
purification times is unsafe practice.
It also recom-
mended using E. coli rather than faecal coliforms to
indicate faecal contamination in shellfish harvesting
areas, when applying bacterial indicators.

indicator

removal

criteria set

(13) On 27 February 2002 the SCF adopted an opinion on
specifications for gelatine in terms of consumer health. It
concluded that
in
the microbiological
Chapter 4 of Annex II to Council Directive 92/118/EEC
of 17 December 1992 laying down animal health and
public health requirements governing trade in and
imports into the Community of products not subject
to the said requirements laid down in specific Commu-
nity rules referred to in Annex A(I) to Directive 89/662/
EEC and, as regards pathogens, to Directive 90/425/
EEC (3) in terms of consumer health were excessive, and
considered it sufficient to apply a mandatory micro-
biological criterion for salmonella only.

(14) The SCVPH issued an opinion on verotoxigenic E. coli
(VTEC) in foodstuffs on 21 and 22 January 2003. In its
opinion it concluded that applying an end-product
microbiological standard for VTEC O157 is unlikely to
deliver meaningful reductions in the associated risk for
the consumers. However, microbiological guidelines
aimed at reducing the faecal contamination along the
food chain can contribute to a reduction in public health
risks,
including VTEC. The SCVPH identified the
following food categories where VTEC represents a
hazard to public health: raw or undercooked beef and
possibly meat from other ruminants, minced meat and
fermented beef and products thereof, raw milk and raw
milk products,
in particular sprouted
fresh produce,
seeds, and unpasteurised fruit and vegetable juices.

(15) On 26 and 27 March 2003 the SCVPH adopted an
opinion on staphylococcal enterotoxins in milk products,
It recommended revising the
particularly in cheeses.
criteria for coagulase-positive staphylococci in cheeses, in
raw milk intended for processing and in powdered milk.
In addition, criteria for
staphylococcal enterotoxins
should be laid down for cheeses and powdered milk.

(1) OJ L 165, 30.4.2004, p. 1, corrected by OJ L 191, 28.5.2004,

(2)

p. 1.
SANCO/1252/2001 Discussion paper on strategy for setting
microbiological criteria for foodstuffs in Community legisla-
tion, p. 34.

(3) OJ L 62, 15.3.1993, p. 49. Directive as last amended by
Commission Regulation (EC) No 445/2004 (OJ L 72,
11.3.2004, p. 60).

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(16) The SCVPH adopted an opinion on salmonellae in
foodstuffs on 14 and 15 April 2003. According to the
opinion, food categories possibly posing a high risk to
public health include raw meat and some products
intended to be eaten raw, raw and undercooked products
of poultry meat, eggs and products containing raw eggs,
unpasteurised milk and some products thereof. Sprouted
seeds and unpasteurised fruit juices are also of concern. It
recommended that
the decision on the need for
microbiological criteria should be taken on the basis of
its ability to protect the consumers and its feasibility.

(17) The Scientific Panel on Biological Hazards (BIOHAZ
Panel) of the European Food Safety Authority (EFSA)
issued an opinion on the microbiological risks in infant
formulae and follow-on formulae on 9 September 2004.
It concluded that Salmonella and Enterobacter sakazakii are
the micro-organisms of greatest concern in infant
formulae,
formulae for special medical purposes and
follow-on formulae. The presence of these pathogens
constitutes a considerable
conditions after
reconstitution permit multiplication. Enterobacteriaceae,
which are more often present, could be used as an
indicator for risk. Monitoring and testing of Enterobac-
teriaceae was recommended in both the manufacturing
environment and the finished product by the EFSA.
However, besides pathogenic species the family Enter-
obacteriaceae includes also environmental species, which
often appear in the food manufacturing environment
without posing any health hazard. Therefore, the family
Enterobacteriaceae can be used for routine monitoring,
and if they are present testing of specific pathogens can
be started.

risk if

(18)

International guidelines for microbiological criteria in
respect of many foodstuffs have not yet been established.
However,
the Commission has followed the Codex
Alimentarius guideline ‘Principles for the establishment
and application of microbiological criteria for foods
CAC/GL 21 — 1997’ and in addition, the advice of the
SCVPH and the SCF in laying down microbiological
criteria. Existing Codex specifications in respect of dried
milk products, foods for infants and children and the
histamine criterion for certain fish and fishery products
have been taken account. The adoption of Community
criteria should benefit trade by providing harmonised
microbiological requirements for foodstuffs and repla-
cing national criteria.

products of animal origin intended for human consump-
tion and amending Council Directives 89/662/EEC and
92/118/EEC and Council Decision 95/408/EC (1) should
be revised and certain new criteria set in the light of the
scientific advice.

(20) The microbiological criteria laid down in Commission
Decision 93/51 EEC of 15 December 1992 on the
microbiological criteria applicable to the production of
cooked crustaceans and molluscan shellfish (2) are
incorporated in this Regulation. It is therefore appro-
priate to repeal
that Decision. Since Commission
Decision 2001/471/EC of 8 June 2001 laying down
rules for the regular checks on the general hygiene
carried out by the operators in establishments according
to Directive 64/433/EEC on health conditions for the
production and marketing of fresh meat and Directive
71/118/EEC on health problems affecting the production
and placing on the market of fresh poultrymeat (3) is
repealed with effect from the 1 January 2006,
it is
appropriate to incorporate microbiological criteria set for
carcases in this Regulation.

(21) The producer or manufacturer of a food product has to
decide whether the product is ready to be consumed as
such, without the need to cook or otherwise process it in
order to ensure its safety and compliance with the
microbiological criteria. According to Article 3 of
Directive 2000/13/EC of the European Parliament and
of the Council of 20 March 2000 on the approximation
of the laws of the Member States relating to the labelling,
the
presentation and advertising of
instructions for use of a foodstuff are compulsory on
the labelling when it would be impossible to make
appropriate use of the foodstuff in the absence of such
instructions. Such instructions should be taken into
account by food business operators when deciding
appropriate sampling frequencies for the testing against
microbiological criteria.

foodstuffs (4),

(22) Sampling of the production and processing environment
can be a useful tool to identify and prevent the presence
of pathogenic micro-organisms in foodstuffs.

(23) Food business operators should decide themselves the
necessary sampling and testing frequencies as part of
their procedures based on HACCP principles and other
it may be
hygiene
necessary in certain cases to set harmonised sampling
frequencies at Community level, particularly in order to
ensure the same level of controls to be performed
throughout the Community.

control procedures. However,

(19) The microbiological criteria set for certain categories of
food of animal origin in Directives that were repealed by
Directive 2004/41/EC of the European Parliament and of
the Council of 21 April 2004 repealing certain Directives
concerning food hygiene and health conditions for the
production and placing on the market of certain

(1) OJ L 157, 30.4.2004, p. 33, corrected by OJ L 195, 2.6.2004,

p. 12.

(2) OJ L 13, 21.1.1993, p. 11.
(3) OJ L 165, 21.6.2001, p. 48. Decision as amended by Decision

2004/379/EC (OJ L 144, 30.4.2004, p. 1).

(4) OJ L 109, 6.5.2000, p. 29. Directive as last amended by

Directive 2003/89/EC (OJ L 308, 25.11.2003, p. 15).

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(24) Test results are dependent on the analytical method used,
and therefore a given reference method should be
associated with each microbiological criterion. However,
food business operators should have the possibility to use
analytical methods other than the reference methods, in
particular more rapid methods, as long as the use of
these alternative methods provides equivalent results.
Moreover, a sampling plan needs to be defined for each
criterion in order to ensure harmonised implementation.
It is nevertheless necessary to allow the use of other
including the use of
sampling and testing schemes,
alternative indicator organisms, on condition that these
schemes provide equivalent guarantees of food safety.

(25) Trends in test results should be analysed, as they are able
to reveal unwanted developments in the manufacturing
process enabling the food business operator to take
corrective actions before the process is out of control.

(26) The microbiological criteria set in this Regulation should
be open to review and revised or supplemented,
if
appropriate, in order to take into account developments
in the field of food safety and food microbiology. This
includes progress in science, technology and methodol-
ogy, changes in prevalence and contamination levels,
changes in the population of vulnerable consumers, as
well as the possible outputs from risk assessments.

(27)

In particular, criteria for pathogenic viruses in live bivalve
molluscs should be established when the analytical
methods are developed sufficiently. There is a need for
development of reliable methods for other microbial
hazards too, e.g. Vibrio parahaemolyticus.

(28)

It has been demonstrated that the implementation of
control programmes can markedly contribute to a
reduction of the prevalence of salmonella in production
animals and products thereof. The purpose of Regulation
(EC) No 2160/2003 of the European Parliament and of
the Council of 17 November 2003 on the control of
salmonella and other specified food-borne zoonotic
agents (1) is to ensure that proper and effective measures
are taken to control salmonella at relevant stages of the
food chain. Criteria for meat and products thereof should
take into account
in the
salmonella situation at the level of primary production.

the expected improvement

(29) For certain food safety criteria, it is appropriate to grant
the Member States a transitional derogation, enabling
them to comply with less stringent criteria but provided
the foodstuffs would only be marketed on the
that

(1) OJ L 325, 12.12.2003, p. 1.

national market. The Member States should notify the
Commission and other Member States where this
transitional derogation is used.

(30) 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

Subject-matter and scope

This Regulation lays down the microbiological criteria for
certain micro-organisms and the implementing rules to be
complied with by food business operators when implementing
the general and specific hygiene measures referred to in
Article 4 of Regulation (EC) No 852/2004. The competent
authority shall verify compliance with the rules and criteria
laid down in this Regulation in accordance with Regulation
(EC) No 882/2004, without prejudice to its right to undertake
further sampling and analyses for the purpose of detecting and
measuring other micro-organisms, their toxins or metabolites,
either as a verification of processes, for food suspected of
being unsafe, or in the context of a risk analysis.

This Regulation shall apply without prejudice to other specific
rules for
the control of micro-organisms laid down in
Community legislation and in particular the health standards
for foodstuffs laid down in Regulation (EC) No 853/2004 of
the European Parliament and of the Council (2), the rules on
parasites laid down under Regulation (EC) No 854/2004 of
the Council (3) and the
the European Parliament and of
microbiological criteria laid down under Council Directive 80/
777/EEC (4).

Article 2

Definitions

The following definitions shall apply:

(a)

(b)

‘micro-organisms’ means
yeasts,
moulds, algae, parasitic protozoa, microscopic parasitic
helminths, and their toxins and metabolites;

bacteria,

viruses,

‘microbiological criterion’ means a criterion defining the
acceptability of a product, a batch of foodstuffs or a
process, based on the absence, presence or number of
micro-organisms, and/or on the quantity of their toxins/
metabolites, per unit(s) of mass, volume, area or batch;

(2) OJ L 139, 30.4.2004, p. 55, corrected by OJ L 226, 25.6.2004,

p. 22.

(3) OJ L 139, 30.4.2004, p. 206, corrected by OJ L 226,

25.6.2004, p. 83.

(4) OJ L 229, 30.8.1980, p. 1.

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(c)

(d)

(e)

(f)

(g)

‘food safety criterion’ means a criterion defining the
acceptability of a product or a batch of
foodstuff
applicable to products placed on the market;

‘process hygiene criterion’ a criterion indicating the
acceptable functioning of the production process. Such a
criterion is not applicable to products placed on the
market. It sets an indicative contamination value above
which corrective actions are required in order
to
maintain the hygiene of the process in compliance with
food law;

‘batch’ means a group or set of identifiable products
obtained from a given process under practically identical
circumstances and produced in a given place within one
defined production period;

‘shelf-life’ means either the period corresponding to the
period preceding the ‘use by’ or the minimum durability
date, as defined respectively in Articles 9 and 10 of
Directive 2000/13/EC;

‘ready-to-eat food’ means food intended by the producer
or the manufacturer for direct human consumption
without
the need for cooking or other processing
effective to eliminate or reduce to an acceptable level
micro-organisms of concern;

(h)

‘food intended for
infants’ means
food specifically
intended for infants, as defined in Commission Directive
91/321/EEC (1);

(i)

(j)

(k)

‘food intended for special medical purposes’ means
dietary food for special medical purposes, as defined in
Commission Directive 1999/21/EC (2);

‘sample’ means a set composed of one or several units or
a portion of matter selected by different means in a
population or in an important quantity of matter, which
is intended to provide information on a given character-
istic of the studied population or matter and to provide a
basis for a decision concerning the population or matter
in question or concerning the process which has
produced it;

‘representative sample’ means a sample in which the
characteristics of the batch from which it is drawn are
maintained. This is in particular the case of a simple
random sample where each of the items or increments of
the batch has been given the same probability of entering
the sample;

(l)

‘compliance with microbiological criteria’ means obtain-
ing satisfactory or acceptable results set in Annex I when
testing against the values set for the criteria through the

(1) OJ L 175, 4.7.1991, p. 35.
(2) OJ L 91, 7.4.1999, p. 29.

the conduct of analyses and the
taking of samples,
implementation of corrective action, in accordance with
food law and the instructions given by the competent
authority.

Article 3

General requirements

Food business operators shall ensure that

1.
foodstuffs
comply with the relevant microbiological criteria set out in
Annex I. To this end the food business operators at each stage
of food production, processing and distribution,
including
retail, shall take measures, as part of their procedures based on
HACCP principles together with the implementation of good
hygiene practice, to ensure the following:

(a)

(b)

that the supply, handling and processing of raw materials
and foodstuffs under their control are carried out in such
a way that the process hygiene criteria are met,

that the food safety criteria applicable throughout the
shelf-life of the products can be met under reasonably
foreseeable conditions of distribution, storage and use.

2. As necessary, the food business operators responsible for
the manufacture of
the product shall conduct studies in
accordance with Annex II in order to investigate compliance
with the criteria throughout the shelf-life. In particular, this
applies to ready-to-eat foods that are able to support the
growth of Listeria monocytogenes and that may pose a Listeria
monocytogenes risk for public health.

Food businesses may collaborate in conducting those studies.

Guidelines for conducting those studies may be included in
the guides to good practice referred to in Article 7 of
Regulation (EC) No 852/2004.

Article 4

Testing against criteria

1.
Food business operators shall perform testing as appro-
priate against the microbiological criteria set out in Annex I,
when they are validating or verifying the correct functioning
of their procedures based on HACCP principles and good
hygiene practice.

2.
Food business operators shall decide the appropriate
sampling frequencies, except where Annex I provides for
specific sampling frequencies,
in which case the sampling
frequency shall be at least that provided for in Annex I. Food
business operators shall make this decision in the context of
their procedures based on HACCP principles and good

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hygiene practice, taking into account the instructions for use
of the foodstuff.

The frequency of sampling may be adapted to the nature and
the safety of
size of
foodstuffs will not be endangered.

the food businesses, provided that

Article 5

Specific rules for testing and sampling

1. The analytical methods and the sampling plans and
methods in Annex I shall be applied as reference methods.

Samples

2.
shall be taken from processing areas and
equipment used in food production, when such sampling is
necessary for ensuring that
In that
sampling the ISO standard 18593 shall be used as a reference
method.

the criteria are met.

Food business operators manufacturing ready-to-eat foods,
which may pose a Listeria monocytogenes risk for public health,
shall sample the processing areas and equipment for Listeria
monocytogenes as part of their sampling scheme.

Food business operators manufacturing dried infant formulae
or dried foods for special medical purposes intended for
infants below six months which pose an Enterobacter sakazakii
risk shall monitor the processing areas and equipment for
Enterobacteriaceae as part of their sampling scheme.

3. The number of sample units of the sampling plans set out
in Annex I may be reduced if the food business operator can
demonstrate by historical documentation that he has effective
HACCP-based procedures.

4.
If the aim of the testing is to specifically assess the
acceptability of a certain batch of foodstuffs or a process, the
sampling plans set out in Annex I shall be respected as a
minimum.

5.
Food business operators may use other sampling and
testing procedures, if they can demonstrate to the satisfaction
of the competent authority that these procedures provide at
least equivalent guarantees. Those procedures may include use
of alternative sampling sites and use of trend analyses.

Testing against alternative micro-organisms and related
limits as well as testing of analytes other
microbiological
than microbiological ones shall be allowed only for process
hygiene criteria.

The use of alternative analytical methods is acceptable when
the methods are validated against the reference method in

Annex I and if a proprietary method, certified by a third party
in accordance with
in EN/
ISO standard 16140 or other internationally accepted similar
protocols, is used.

protocol

out

the

set

If the food business operator wishes to use analytical methods
other than those validated and certified as described in
paragraph 3 the methods shall be validated according to
internationally accepted protocols and their use authorised by
the competent authority.

Article 6

Labelling requirements

1. When the requirements for Salmonella in minced meat,
meat preparations and meat products intended to be eaten
cooked of all species set down in Annex I are fulfilled, the
batches of those products placed on the market must be
clearly labelled by the manufacturer in order to inform the
consumer of
to
consumption.

thorough cooking prior

the need for

2. As from 1 January 2010 labelling as referred to in
paragraph 1 in respect of minced meat, meat preparations and
meat products made from poultrymeat will no longer be
required.

Article 7

Unsatisfactory results

1. When the results of testing against the criteria set out in
Annex I are unsatisfactory, the food business operators shall
take the measures laid down in paragraphs 2 to 4 of this
Article together with other corrective actions defined in their
HACCP-based procedures and other actions necessary to
protect the health of consumers.

In addition, they shall take measures to find the cause of the
unsatisfactory results in order to prevent the recurrence of the
unacceptable microbiological contamination. Those measures
may include modifications to the HACCP-based procedures or
other food hygiene control measures in place.

food safety criteria set out

2. When testing against
in
Chapter 1 of Annex I provides unsatisfactory results, the
product or batch of foodstuffs shall be withdrawn or recalled
in accordance with Article 19 of Regulation (EC) No 178/
2002. However, products placed on the market, which are not
yet at retail
level and which do not fulfil the food safety
criteria, may be submitted to further processing by a
treatment eliminating the hazard in question. This treatment
may only be carried out by food business operators other than
those at retail level.

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The food business operator may use the batch for purposes
other
than those for which it was originally intended,
provided that this use does not pose a risk for public or
animal health and provided that this use has been decided
within the procedures based on HACCP principles and good
hygiene practice and authorised by the competent authority.

3. A batch of 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, with
unsatisfactory results in respect of the Salmonella criterion,
may be used in the food chain only to manufacture heat-
treated meat products in establishments approved in accor-
dance with Regulation (EC) No 853/2004.

4.
In the event of unsatisfactory results as regards process
hygiene criteria the actions laid down in Annex I, Chapter 2
shall be taken.

(b) provide that the products to which such transitional
derogation applies shall be clearly labelled that they must
be thoroughly cooked prior to consumption;

(c)

undertake that when testing against
the Salmonella
criterion pursuant to Article 4, and for the result to be
acceptable as regards such transitional derogation, no
more than one out of five sample units shall be found to
be positive.

Article 9

Analyses of trends

Food business operators shall analyse trends in the test results.
When they observe a trend towards unsatisfactory results, they
shall take appropriate actions without undue delay to remedy
the
the occurrence of
microbiological risks.

situation in order

to prevent

Article 8

Transitional derogation

Article 10

Review

1. A transitional derogation is granted until 31 December
2009 at the latest pursuant to Article 12 of Regulation (EC)
No 852/2004 as regards compliance with the value set in
Annex I to this Regulation for Salmonella in minced meat,
meat preparations and meat products intended to be eaten
cooked placed on the national market of a Member State.

2. The Member States using this possibility shall notify the
Commission and other Member States thereof. The Member
State shall:

(a)

guarantee that the appropriate means, including labelling
and a special mark, which cannot be confused with the
identification mark provided for in Annex II, Section I to
Regulation (EC) No 853/2004, are in place to ensure that
the derogation applies only to the products concerned
when placed on the domestic market, and that products
dispatched for intra-Community trade comply with the
criteria laid down in Annex I;

This Regulation shall be reviewed taking into account progress
in science, technology and methodology, emerging pathogenic
micro-organisms in foodstuffs, and information from risk
assessments.
and conditions
concerning the presence of salmonella in carcases of cattle,
sheep, goats, horses, pigs and poultry shall be revised in the
light of the changes observed in salmonella prevalence.

In particular,

criteria

the

Article 11

Repeal

Decision 93/51/EEC is repealed.

Article 12

This Regulation shall enter into force on the 20th day
following its publication in the Official Journal of the European
Union.

It shall apply from 1 January 2006.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 November 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission

L 338/8

EN

Official Journal of the European Union

22.12.2005

ANNEX I

Microbiological criteria for foodstuffs

Chapter 1.

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

9

Chapter 2.

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

15

2.1. Meat and products thereof . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15

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

18

2.3. Egg products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

21

2.4. Fishery products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22

2.5. Vegetables, fruits and products thereof

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

23

Chapter 3.

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

24

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

24

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

24

22.12.2005

EN

Official Journal of the European Union

L 338/9

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EN

Official Journal of the European Union

22.12.2005

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EN

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L 338/11

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EN

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22.12.2005

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EN

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22.12.2005

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EN

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L 338/15

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L 338/16

EN

Official Journal of the European Union

22.12.2005

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EN

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EN

Official Journal of the European Union

22.12.2005

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EN

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Official Journal of the European Union

22.12.2005

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EN

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L 338/23

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EN

Official Journal of the European Union

22.12.2005

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

Sampling rules for carcases of cattle, pigs, sheep, goats and horses

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 should 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. The sampling area shall
cover a minimum of 100 cm2 per site selected.

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

Sampling rules for poultry carcases

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 x 25 g final samples.

Guidelines for sampling

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.

Sampling frequencies for carcases, minced meat, meat preparations and mechanically separated meat

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.

In the case of sampling for Salmonella analyses of minced meat, meat preparations and carcases, the frequency can 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 described sampling. 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.

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
fortnightly testing if satisfactory results are obtained for six consecutive weeks.

22.12.2005

EN

Official Journal of the European Union

L 338/25

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.

L 338/26

EN

Official Journal of the European Union

22.12.2005

ANNEX II

The studies referred to in Article 3(2) shall include:

— specifications for physico-chemical characteristics of the product, such as pH, aw, salt content, concentration of
preservatives and the type of packaging system, taking into account the storage and processing conditions, the
possibilities for contamination and the foreseen shelf-life, and

— consultation of available scientific literature and research data regarding the growth and survival characteristics

of the micro-organisms of concern.

When necessary on the basis of the abovementioned studies, the food business operator shall conduct additional
studies, which may include:

— predictive mathematical modelling established for the food in question, using critical growth or survival factors

for the micro-organisms of concern in the product,

— tests to investigate the ability of the appropriately inoculated micro-organism of concern to grow or survive in

the product under different reasonably foreseeable storage conditions,

— studies to evaluate the growth or survival of the micro-organisms of concern that may be present in the product

during the shelf-life under reasonably foreseeable conditions of distribution, storage and use.

The above mentioned studies shall take into account the inherent variability linked to the product, the micro-
organisms in question and the processing and storage conditions.