CELEX: 51981PC0495
Language: en
Date: 1981-09-14
Title: 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, FOODSTUFF AND ANIMAL NUTRITION SECTORS

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                                     Community measures to be taken in the veterinary
COMMUNITIES,                                                    sector; whereas that resolution was expanded by the
                                                                Council resolution of 22 July 1974 ( 2 );
Having regard to the Treaty establishing the
European Economic Community, and in particular                  Whereas the resolution of 28 May 1969 (3), as
Article 43 thereof,                                             amended (4), laid down the principles underlying
                                                                Community measures to be taken in the foodstuffs
Having regard to the proposal from the Commission,              sector;
Having regard to the opinion of the European
Parliament,                                                     Whereas, to ensure the uniform implementation of
                                                                the Community rules, the microbiological criteria for
                                                                foodstuffs and feedingstuffs must be based on
Having regard to the opinion of the Economic and                Community principles;
Social Committee,
Whereas the creation of a single market for                     Whereas the basis of the control of microbiologically
foodstuffs and feedingstuffs calls for the elimination          sensitive foodstuffs and feedingstuffs must also be the
of technical barriers tor trade, and in particular the          application of Community rules;
coordination of measures concerning the micro-
biological criteria applicable to foodstuffs and                Whereas, for the revision and adoption of
feedingstuffs in the veterinary, foodstuffs and animal          Community provisions and measures, the exchange of
nutrition section;                                              scientific information between the Commission and
                                                                Member States must be maintained and intensified by
Whereas the object of microbiological control and               all appropriate means (including contacts with the
microbiological     criteria    for      foodstuffs   and       international organizations concerned), with the
feedingstuffs is to protect the consumer, and in                specific purpose of regularly reviewing questions
particular his health;                                          relating to microbiology in the fields in question,
Whereas the Council resolution of 12 March 1968 on
Community measures to be taken in the veterinary
sector (') laid down the principles underlying
                                                                (2) OJ No C 92, 6. 8. 1974, p. 2.
                                                                (J) O J N o C 7 6 , 17.6. 1969.
(') OJNo C 22, 18. 3. 1968, p.18.                               (4) O J N o C 117, 31. 12. 1973.
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HAS DECIDED AS FOLLOWS:                                               2.       P a r a g r a p h 1 shall apply in particular for the
                                                                      establishment of C o m m u n i t y microbiological criteria
                                                                      for, first of all, the products listed in A n n e x B hereto.
                         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 d o w n in                                                       Article 2
accordance with the general principles listed in
Annex A hereto.                                                        This Decision is addressed to the M e m b e r States.
                                                              ANNEX    A
             GENERAL PRINCIPLES T O 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,
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                — 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.
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            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.