2. 10.81 Official Journal of the European Communities No C 252/7 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Decision on general conditions to be followed for establishing 
microbiological criteria for foodstuffs and feedingstuffs, including the conditions for their 
preparation, in the veterinary, foodstuffs and animal nutrition sectors 
(Submitted by the Commission to the Council on 22 September 1981) 
THE COUNCIL OF THE EUROPEAN 
COMMUNITIES, 
Having regard to the Treaty establishing the 
European Economic Community, and in particular 
Article 43 thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European 
Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas the creation of a single market for 
foodstuffs and feedingstuffs calls for the elimination 
of technical barriers tor trade, and in particular the 
coordination of measures concerning the micro­
biological criteria applicable to foodstuffs and 
feedingstuffs in the veterinary, foodstuffs and animal 
nutrition section; 
Whereas the object of microbiological control and 
microbiological criteria for foodstuffs and 
feedingstuffs is to protect the consumer, and in 
particular his health; 
Whereas the Council resolution of 12 March 1968 on 
Community measures to be taken in the veterinary 
sector (') laid down the principles underlying Community measures to be taken in the veterinary 
sector; whereas that resolution was expanded by the 
Council resolution of 22 July 1974 (2); 
Whereas the resolution of 28 May 1969 (3), as 
amended (4), laid down the principles underlying 
Community measures to be taken in the foodstuffs 
sector; 
Whereas, to ensure the uniform implementation of 
the Community rules, the microbiological criteria for 
foodstuffs and feedingstuffs must be based on 
Community principles; 
Whereas the basis of the control of microbiologically 
sensitive foodstuffs and feedingstuffs must also be the 
application of Community rules; 
Whereas, for the revision and adoption of 
Community provisions and measures, the exchange of 
scientific information between the Commission and 
Member States must be maintained and intensified by 
all appropriate means (including contacts with the 
international organizations concerned), with the 
specific purpose of regularly reviewing questions 
relating to microbiology in the fields in question, 
(') OJNo C 22, 18. 3. 1968, p.18. (2) OJ No C 92, 6. 8. 1974, p. 2. 
(J) OJNoC76, 17.6. 1969. 
(4) OJNoC 117, 31. 12. 1973. 
No C 252/8 Official Journal of the European Communities 2. 10.81 
2. Paragraph 1 shall apply in particular for the 
establishment of Community microbiological criteria 
for, first of all, the products listed in Annex B hereto. 
Article 2 
This Decision is addressed to the Member States. 
ANNEX A 
GENERAL PRINCIPLES TO BE FOLLOWED FOR ESTABLISHING MICROBIOLOGICAL 
CRITERIA 
1. For the purposes of Community legislation, a microbiological criterion consists of: 
— a statement of the micro-organisms to be sought and/or their toxins or metabolic products, 
including relevant microscopic parasites, 
— the microbiological limits where appropriate, 
— a sampling plan, 
— the methods for their detection and quantification. 
2. For the purpose of this Decision: 
(a) a 'microbiological guideline' defines a microbiological criterion used at a specified point 
during or after processing or in distribution and storage to monitor hygiene. It must be 
based on data obtained from microbiological monitoring during production and must be 
compatible with good manufacturing practice; 
(b) a 'microbiological end-product specification' defines a microbiological criterion that is 
applied by the competent control authorities and is intended to increase assurance that the 
provisions of Community legislation relating to hygiene have been adhered to. It must be 
derived from criteria which have been applied to the products or from data obtained in 
monitoring programmes during production; 
(c) a 'microbiological standard' defines a microbiological criterion used in Community 
legislation for an end-product and fixes the acceptable limits for micro-organisms, their 
toxins or metabolic products of significance for public health in a foodstuff or feedingstuff 
produced, packed or stored in, or imported into, the Community. The 'microbiological 
standard' must be derived from criteria which are based on the results of collaborative 
studies or which have been tested in practice or are the result of experience in the practical 
application of guidelines and end-product specifications; 
(d) a 'microbiological sampling plan' is the particular choice of sampling procedure including 
the number of samples to be taken, the way they are to be taken, the size of the sample 
unit, and the place and, if appropriate, the time at which the samples are to be taken and 
the number of samples which must not exceed the limits laid down. 
3. The need for the establishment of microbiological criteria shall be based on evidence of hazards 
to health and the practical feasibility of effective health protection through their application. For 
that purpose the following shall be taken into consideration: 
— information from Member States on the microbiology of the particular foodstuff or 
feedingstuff, including the raw material and the results of comparative studies using uniform 
microbiological techniques, HAS DECIDED AS FOLLOWS: 
Article 1 
1. In the veterinary, foodstuffs and animal 
nutrition sectors the microbiological criteria for 
foodstuffs and feedingstuffs, including the conditions 
for their preparation, shall be laid down in 
accordance with the general principles listed in 
Annex A hereto. 
2. 10.81 Official Journal of the European Communities No C 252/9 
— the effect of processing on the microbiology of the foodstuff or feedingstuff, 
— the likelihood and consequences of microbial contamination and/or changes in the number 
and types of micro-organisms during subsequent handling, storage and distribution, 
— the categories of consumers at risk, with special reference to vulnerable categories, 
— the relative advantage of other forms of inspection during the production, storage and 
distribution of products. 
4. The micro-organisms taken into consideration shall be accepted as relevant to the particular 
type of foodstuff or feedingstuff and its technology. The aim must be to provide the consumer 
with a sound, genuine and merchantable product. Micro-organisms whose significance with 
regard to the foodstuff or feedingstuff is in doubt should not be used in a criterion. 
5. In the choice of a test for detecting an indicator organism, there must be a clear understanding 
as to whether the test for this organism is used to indicate an unsatisfactory manufacturing 
practice or whether it is used to indicate the possible presence of pathogen. When pathogens 
can be detected directly, a method specific to those pathogens must be used. 
6. For use in a standard or end-product specification: (a) official methods elaborated by inter­
national organizations are to be preferred; (b) methods of which the reliability (accuracy, 
reproducibility, inter- and intra-laboratory variation) has been statistically established in 
comparative or collaborative studies in several laboratories within the Community should be 
preferred. 
Reference methods to be used in standards and end-product specifications must also be as 
sensitive and reproducible as possible. Methods to be used in guidelines may, to some degree, 
sacrifice sensitivity and reproducibility in the interest of speed and simplicity. They must, 
however, have been shown to give the requisite information in a reliable form. Reference 
methods must serve as a basis of comparison where other methods are being selected. A 
criterion should ideally contain a reference method and simplified methods for routine exam­
inations. 
7. Methods of broad application shall be given preference over methods which apply only to 
individual foodstuffs. Methods for testing rapidly perishable foodstuffs or feedingstuffs should 
be so designed that the results can be available before the foodstuffs are marketed. 
8. The microbiological limits must take into consideration the risk associated with the organisms 
likely to affect the acceptability of the foodstuff or feedingstuff and the way in which the 
foodstuff or feedingstuff has to be handled and consumed. 
The limits must also take account of the distribution of micro-organisms in the foodstuff or 
feedingstuff and the inherent variability of analysis methods. 
9. If a criterion requires the absence of a particular micro-orgnism, the size of the sample must be 
indicated. No feasible sampling plan can ensure complete absence of a particular organism. 
Nevertheless for acceptance of a lot, absence is assumed when the criterion is met. 
10. Microbiological limits for a foodstuff or feedingstuff can be related only to the time and place 
of sampling and not to the presumed number of micro-organisms at an earlier or a later stage. 
Good manufacturing practice aims at producing a foodstuff or feedingstuff with better micro­
biological characteristics than those required by public health considerations. A microbiological 
limit in a guideline may therefore be more stringent than in a standard or an end-product 
specification. 
11. Sampling plans must be administratively and economically feasible and indicate the decision 
criteria to determine lot acceptability. They must, in particular, take into account the 
heterogeneity of distribution of micro-organisms. 
No C 252/10 Official Journal of the European Communities 2.10.81 
12. The extent of testing shall be as defined in the criterion and shall not be exceeded. 
13. When a product fails to meet the microbiological criteria, the measures to be taken may vary 
according to the type of criterion and circumstances. They must preferably be indicated at the 
time the criteria are established. 
In particular: 
(a) if the limit exceeded is part of a standard, the product concerned must be rejected as unfit 
for its intended use; 
(b) if the limit exceeded is part of an end-product specification, action taken may vary in 
accordance with Community legislation applicable to the product in question; 
(c) if a limit exceeded is part of a guideline, this should not necessarily result in rejection of the 
product. However, if such a limit is exceeded, the causative factors must be identified and 
corrected in current and future production, storage or distribution. 
When a product is rejected as unfit for its intended use, several possible options are open, 
depending on findings and circumstances. The options include re-processing (e.g. heat 
treatment). In deciding on the option the major consideration must be to keep to a 
minimum the risk that an unacceptable foodstuff or feedingstuff reaches the consumer. 
However, foodstuffs or feedingstuffs must not be needlessly destroyed or declared unfit for 
consumption. 
ANNEX B 
Fresh meat of chickens, turkeys, ducks, geese and guinea-fowl, 
fresh meat of domestic bovine animals, swine, sheep, goats and solipeds, 
minced, ground or similarly chopped meat, 
meat products, 
raw milk and milk for heat treatment, 
egg products, 
raw milk destined for processing into milk products, 
fish and shellfish, 
mineral water, 
fruit juices and similar products, 
casein and caseinates, 
preserved milk, 
precooked frozen seafoods, 
ice-cream, 
food additives, 
foods for infants and young children, 
feedingstuffs.