CELEX: 51989PC0667
Language: en
Date: 1990-02-05
Title: PROPOSAL FOR A COUNCIL REGULATION ( EEC ) LAYING DOWN THE HEALTH RULES FOR THE PRODUCTION AND PLACING ON THE MARKET OF RAW MILK, OF MILK FOR THE MANUFACTURE OF MILK-BASED PRODUCTS AND OF MILK-BASED PRODUCTS

No C 84/112                              Official Journal of the European Communities                                           2. 4. 90
                                                              ANNEX G
            Semen, ova and embryos
            Semen, ova and embryos of equidae, sheep and goats, ova and embryos of swine and bovine ova must:
            (a) have been removed, treated, stored and transported subject to conditions adopted in accordance with the
                 procedure laid down for in Article 10;
            (b) come from animals which satisfy the health requirements adopted in accordance with the procedure laid down
                 in Article 10.
                                                              ANNEXH
            Apiculture products
            Apiculture products must not have originated in an area which is the subject of a prohibition order associated with
            an occurrence of American foulbrood or acariosis disease. The period of prohibition after the last recorded case
            must be at least 30 days, within a radius of 5 kilometres. Any derogations from these requirements must be
            determined in accordance with the procedure laid down in Article 10.
                                                               ANNEX I
            Milk and milk-based products
            Milk and milk-based products must not have originated in a surveillance area as provided for in Directive
            85/511/EEC. However, they may be placed on the market if the milk has been pasteurized (72 °C, 15 seconds)
            under the supervision of the competent authority.
            Proposal for a Council Regulation (EEC) laying down the health rules for the production and placing
            on the market of raw milk, of milk for the manufacture of milk-based products and of milk-based
                                                               products
                                                        COM(89) 667 final
                                     (Submitted by the Commission on 13 February 1990)
                                                            (90/C 84/10)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                                Having regard to the opinion of the Economic and Social
                                                                        Committee,
Having regard to the Treaty establishing the European
Economic Community, and in particular Article 43
thereof,                                                                Whereas raw milk, milk for the manufacture of milk-based
                                                                        products and milk-based products are included in the list of
Having regard to the proposal from the Commission,                      products in Annex II to the Treaty; whereas the production
                                                                        of and trade in raw milk, milk for the manufacture of
Having regard to the opinion of the European Parliament,
                                                                        milk-based products and milk-based products constitute a
 ---pagebreak--- 2. 4. 90                                  Official Journal of the European Communities                               N o C 84/113
source of income for a large part of the agricultural                Whereas health rules should be laid down for the placing on
population;                                                          the market of raw milk, of milk for the manufacture of
                                                                     milk-based products and of milk-based products; whereas
Whereas, in order to ensure the rational development of this         these rules should cover, in particular, production, storage,
sector and to increase productivity, health rules govering the       packaging and transport;
production and placing on the market of raw milk, of milk
for the manufacture of milk-based products and of                    Whereas certain milk-based products may be manufactured
milk-based products should be laid down at Community                 from raw milk; whereas given the nature of these products, it
level;                                                               may be necessary to draw up a list of such products as might
                                                                     be marketed;
Whereas the Community must adopt measures to bring
about the progressive establishment of the internal market in        Whereas account should be taken of certain special
the period ending on 31 December 1992;                               cheesemaking techniques;
Whereas the introduction of such rules will help to protect          Whereas the Commission should be entrusted with the
public health and to complete the internal market;                   adoption of measures for implementing this Regulation;
                                                                     whereas, for this purpose, a procedure should be provided
Whereas for certain requirements reference should be made            for establishing close and efficient cooperation between the
to Council Regulation (EEC) No . . . of . . . laying down            Commission and the Member States within the Standing
health rules for the production and placing on the market of         Veterinary Committee,
heat-treated drinking milk ( J );
Whereas it seems necessary to exclude from the scope of this         HAS ADOPTED THIS REGULATION:
Regulation certain products sold directly by the producer to
the consumer;
                                                                                                 Article 1
Whereas it is possible that, owing to certain special
circumstances, certain establishments that were in operation
                                                                     1.     This Regulation lays down health rules for the
before 1 January 1992 will be unable to comply with all the
                                                                     production and placing on the market of the following
rules laid down by this Regulation; whereas the question of
                                                                     products intended for human consumption: raw milk, milk
whether limited and temporary derogations may be granted
                                                                     for the manufacture of milk-based products, and milk-based
to such establishments within the general framework of
                                                                     products.
Council Decision . . ./EEC of . . . on the conditions for
granting limited and temporary derogations from specific
Community health rules on the production and marketing of            2.     This Regulation shall not apply to the direct sale to the
                                                                     consumer:
products of animal origin should be resolved (2);
                                                                     — by the producer, of raw milk produced on his farm,
Whereas it should be stressed that the exclusion of certain
operations from the scope of application of this Regulation          — by the producer, of milk-based products-processed on the
and the granting of any possible derogations from the health             producer's farm from milk produced on his farm,
rules laid down by this Regulation are without prejudice to
                                                                     — by the manufacturer, of milk-based products at his
the bringing of all operations relating to the production and
                                                                         processing plant, provided his entire production is sold
placing on the market of raw milk, of milk for the
                                                                         directly to the consumer on the spot.
manufacture of milk-based products and of milk-based
products under the general health rules laid down by Council
Regulation (EEC) No . . . of. . . laying down general health         3.     The Commission shall, where necessary, adopt
rules for the production and placing on the market of                suitable rules for the uniform application of paragraph 2 in
products of animal origins and specific health rules for             accordance with the procedure laid down in Article 15.
certain products of animal origin (3);
                                                                     4.     This Regulation shall apply without prejudice to:
Whereas Council Directive 79/112/EEC of 18 December                  — Council Directive 76 /118 / EEC of 18 December 1975 on
1978 on the approximation of the laws of the Member States               the approximation of the laws of the Member States
relating to the labelling, presentation and advertising of               relating to certain partly or wholly dehydrated preserved
foodstuffs for sale to the ultimate consumer (4) as last                 milk for human consumption (7),
amended by Directive 89/395/EEC (5) and Council
Directive 89/396/EEC of 14 June 1989 on indications or               — Council Directive 83/417/EEC of 25 July 1983 on the
marks identifying the lot to which a foodstuff belongs (6) are           approximation of the laws of the Member States relating
applicable;                                                              to certain lactoproteins (caseins and caseinates) intended
                                                                         for human consumption ( 8 ),
(») OJ No L . . .
(2) OJ  No L . . .                                                   — Council Regulation (EEC) No . . . of . . . (heat-treated
(3) OJ  No L . . .                                                       milk).
(4) OJ  N o L 3 3 , 8. 2. 1979, p. 1.
(s) OJ  No L 186, 30. 6. 1989, p. 17.                                (7) OJ No L 24, 30. 1. 1976, p. 49.
(6) OJ No L 186, 30. 6. 1989, p. 21.                                 (8) OJ No L 237, 26. 8. 1983, p. 25.
 ---pagebreak--- N o C 84/114                               Official Journal of the European Communities                                    2. 4. 90
                             Article 2                                2. meet the standards laid down in Chapter II of the Annex
                                                                         hereto;
For the purposes of this Regulation:
                                                                      3. where appropriate, satisfy the requirements laid down in
   1. raw milk means milk as produced by secretion of the                Article 3 (l)(g) of Regulation (EEC) N o . . .
       mammary glands of one or more cows, ewes, goats or                (heat-treated drinking milk);
       buffaloes, which has not been heated beyond 40° C or
       undergone a treatment that has an equivalent effect;           4. in the case of cow's milk, satisfy the requirements laid
                                                                         down in Article 3(1) (b), (c) and (d) of Regulation (EEC)
  2. milk for the manufacture of milk-based products means               No . . . (heat-treated drinking milk);
       either raw milk for processing or liquid or frozen milk
       obtained from raw milk, whether or not it has                  5. in the case of milk of other animals, satisfy the
       undergone an authorized physical treatment, such as               requirements set out in Chapter I of the Annex hereto.
       heat treatment or thermization, or modified in its
       composition, provided that these modifications are
       restricted to an addition and/or withdrawal of natural                                   Article 4
       milk constituents;
                                                                      Raw milk intended for direct human consumption must:
  3. milk-based products means milk products, namely
       products exclusively derived from milk, it being               1. satisfy the requirements laid down in Article 3 and in
       accepted that substances necessary for their                      point 2 of Chapter II of the Annex hereto;
       manufacture may be added, provided that these
                                                                      2. where it is not sold to the consumer within 2 hours after
       substances are not used to replace in part or in whole
                                                                         the end of milking, be cooled in accordance with
       any milk constituent, and composite milk products,
                                                                         Chapter III of Annex A to Regulation (EEC) No . . .
       namely products of which no part takes or is intended to
                                                                         (heat-treated drinking milk);
       take the place of any milk constituent and of which milk
       or a milk product is an essential part either by quantity      3. where appropriate, satisfy the requirements set out in
       or for characterization;                                          point 1 of Chapter V of the Annex hereto;
  4. heat treatment means any treatment involving heating             4. where appropriate, satisfy the additional requirements
       that causes, immediately after it has been applied, a             set out in accordance with the procedure laid down in
       negative reaction to the phosphatase test;                        Article 15 of this Regulation.
  5. thermization means the heating of milk under such
       combined conditions of time and temperature that the
                                                                                                Article 5
       reaction to the phosphatase test remains positive;
  6. production holding means an establishment at which               Milk for the manufacture of milk-based products must:
       one or more milk-producing cows, ewes, goats or
                                                                      1. be obtained from raw milk that meets the requirements
       buffaloes are kept;
                                                                         set out in Article 3;
  7. collection centre means an establishment where raw
                                                                      2. meet the standards and specifications laid down in
       milk may be collected and possibly cooled and
                                                                         Chapter III of the Annex hereto;
       filtered;
                                                                      3. where appropriate, be obtained in a processing
  8. processing establishment means an establishment
                                                                         establishment that meets the requirements set out in
       where milk for the manufacture of milk-based products
                                                                         Article 3 (2) of Regulation (EEC) No . . . (heat-created
      -and milk-based products are treated, processed and
                                                                         drinking milk);
       packaged.
                                                                      4. where appropriate, be stored, irrespective of the
  9. competent authority means the competent public health
                                                                         treatment it undergoes, in accordance with Article 3 {5)
       authority designated by the Member State;
                                                                         of Regulation (EEC) No . . . (heat-treated drinking
10. the definitions set out in Article 2 of Council Directive            milk);
       64/432/EEC of 26 June 1964 on animal health
       problems affecting intra-Community trade in bovine             5. where appropriate, be transported in accordance with
       animals and swine (x) and of Council Regulation (EEC)             Article 3 (6) of Regulation (EEC) No . . . (heat-treated
       No . . . of . . . on animal health conditions governing           drinking milk).
       intra-Community trade on ovine and caprine
       animals (2) shall apply where necessary.
                                                                                                Article 6
                             Article 3                                Milk-based products must:
                                                                      1. be obtained from milk that meets the requirements of
Raw milk for the manufacture of milk-based products
                                                                         Articles 3 or 5 or from milk-based products that satisfy
must:                                                                    the requirements of this Article or of Article 7;
1. be checked in accordance with Article 9 (1);
                                                                      2. be prepared in a processing establishment that meets the
(') OJ No 121, 29. 7. 1964, p. 1977/64.                                  requirements of Article 3 (2) of Regulation (EEC)
(2) OJ No 1                                                              No . . . (heat-treated drinking milk);
 ---pagebreak--- 2. 4 . 90                                    Official Journal of the European Communities                                   No C 84/115
3.    meet the standards laid d o w n in Chapter IV of the Annex                                        Article 8
      hereto;
                                                                         1.    Derogations from Article 6 (2) m a y be granted in
4.    be packaged and w r a p p e d in accordance with Chapter          accordance with the procedure laid d o w n in Article 15 for
      IV of the Annex to Regulation (EEC) N o . . . (general            establishments with limited production.
      health rules) and, if they are in liquid form and intended
      for sale to the end user, with points 1, 2 and 3 of               2.     When examining the derogations referred to in
      Chapter VIII of Annex B to Regulation (EEC) N o . . .             paragraph 1, the Commission shall take account of the
      (heat-treated drinking milk);                                     information and criteria set out in Articles 2 and 3 of
                                                                        Decision . . . / . . . / E E C of . . . on the conditions for
5.    be labelled in accordance with Chapter V of the Annex to
                                                                        granting temporary and limited derogations from specific
      Regulation (EEC) N o . . . (general health rules) and with
                                                                        C o m m u n i t y health rules on the production and marketing of
      Chapter V of the Annex hereto;
                                                                        products of animal origin.
6.    be stored and transported in accordance with Chapter VI
      of the Annex to Regulation (EEC) N o . . . (general               3.     When granting derogations within the meaning of
      health rules) and with Article 9 of and Chapter IX of the         paragraph 1, the Commission shall determine in accordance
      Annex to Regulation (EEC) N o . . . (heat-treated                 with the procedure laid d o w n in Article 15 the general and
      drinking milk);                                                   particular conditions applicable to the implementation of
                                                                        each derogation.
7.    be checked in accordance with Article 9 (4) of and
      Chapter III of the Annex to Regulation (EEC) N o . . .
      (general health rules);                                                                           Article  9
8.    where appropriate, contain only substances, other than
                                                                        1.     Article 5 of Regulation (EEC) N o . . . (heat-treated
      milk, that are fit for h u m a n consumption;
                                                                        drinking milk) shall apply.
9.    involve heat treatment during the manufacturing process
      or be m a d e from products that have undergone a heat            2.     Article 6 of Regulation (EEC) N o . . . (heat-treated
     treatment.                                                         drinking milk) shall apply mutatis mutandis in respect of
                                                                        collection centres and processing establishments.
                                                                        3.     Article 7 of Regulation (EEC) N o . . . (heat-treated
                              Article 7
                                                                        drinking milk) shall apply mutatis mutandis in respect of r a w
1.      Article 6 (9) shall not apply to products 'made with            milk, of milk for the manufacture of milk-based products and
raw milk'. Where appropriate, a list of products 'made with             of milk-based products, and in respect of processing
raw milk' that may be placed on the market shall be d r a w n up        establishments.
in accordance with the procedure laid d o w n in Article 15.
                                                                        4.     Articles 8, 9 and 10 of Regulation (EEC) N o . . .
2.      Milk from animals that are not infected or suspected of         (heat-treated drinking milk) shall apply mutatis mutandis in
being infected with tuberculosis or brucellosis and do not              respect of r a w milk, of milk for the manufacture of
comply with the provisions of point 1 (a) of Chapter I of the           milk-based products and of milk-based p r o d u c t s .
Annex to Regulation (EEC) N o . . . (heat-treated drinking
milk) or with points A (1) and (2) of Chapter I (A) of the
Annex hereto may, by way of derogation from Article 3 (4)                                              Article  10
and (5), be used under the supervision of the competent
                                                                        Council Regulation (EEC) N o . . . concerning veterinary
authority to manufacture milk-based products during the
                                                                        checks in intra-Community trade with a view to the
period in which the holding is disinfected. In this event, heat
                                                                        completion of the internal market (l) shall apply, in
treatment of the milk shall be compulsory.
                                                                        particular in respect oi the organization and monitoring of
                                                                        checks carried out by the M e m b e r State of destination and
3.      The manufacture of milk-based products with
                                                                        the protective measures to be applied.
traditional     characteristics     may be exempted          from
Article 6 ( 1 ) to (4) in accordance with the procedure laid
d o w n in Article 15. In this event, the general and particular
                                                                                                       Article  11
conditions applicable to the manufacture of each specific
product shall be determined in accordance with the same                 The Commission in accordance with the procedure laid
procedure.                                                              d o w n in Article 16 may d r a w up recommendations
                                                                        accompanied by guidelines on good manufacturing practices
4.      Manufacture of cheese with a long period of ageing or
                                                                        to be applied at the various stages of production and placing
ripening shall not be subject to the provisions of Article 6 ( 1 )
                                                                        on the market.
to (4). T h e procedure laid down in Article 15 shall be used to
fix general and special requirements applicable to the
manufacture of individual products, and if necessary                                                   Article  12
standards for this type of product.
                                                                        The Annex to this Regulation shall be a m e n d e d , in particular
5.      The Commission shall, where necessary, adopt                    so as to adapt it to technological and scientific developments,
suitable rules for the uniform application of paragraphs 1 to           in accordance with the procedure laid d o w n in Article 15.
4 in accordance with the procedure laid down in
Article 15.
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                         Article 13                                  The Commission shall adopt the measures envisaged if they
                                                                     are in accordance with the opinion of the Committee.
The reference methods and, where appropriate, the analysis
and test methods to be used to check that the standards laid         Where the measures envisaged are not in accordance with the
down in Articles 3 (2), 5 (2) and 6 (3) are being complied           opinion of the Committee, or if no opinion is delivered, the
with shall be adopted in accordance with the procedure laid          Commission shall, without delay, submit to the Council a
down in Article 15. Where necessary, rules for the taking of         proposal relating to the measures to be taken. The Council
samples shall be laid down in accordance with the same               shall act by a qualified majority.
procedure.
                                                                     If, on the expiry of a period of three months from the date of
However, pending these decisions, the internationally                referral to the Council, the Council has not acted, the
accepted analysis and test methods shall be recognized as            proposed measures shall be adopted by the Commission.
reference methods.
                         Article 14                                                             Article 16
Until Community arrangements on imports of raw milk, of              Where the procedure laid down in this Article is to be
milk for the manufacture of milk-based products and of               followed, the following rules shall apply.
milk-based products from third countries have been adopted,
Member States shall apply rules in respect of such imports           The representative of the Commission shall submit to the
that must be at least equivalent to those laid down by this          Committee a draft of the measures to be taken. The
Regulation.                                                          Committee shall deliver its opinion on the draft within a
                                                                     time-limit which the Chairman may lay down according to
                                                                     the urgency of the matter, if necessary by taking a vote.
                         Article 15
                                                                     The opinion shall be recorded in the minutes; in addition,
1.    The Commission shall be assisted by the Standing               each Member State shall have the right to ask to have its
Veterinary Committee set up by Council Decision                      position recorded in the minutes.
68/361/EEC (*), hereinafter          referred to as 'the
Committee'.                                                          The Commission shall take the utmost account of the
                                                                     opinion delivered by the Committee. It shall inform the
2.    Where the procedure laid down in this Article is to be         Committee of the manner in which its opinion has been taken
followed, the provisions set out below shall apply.                  into account.
The representative of the Commission, after consulting the
Management Committee for Milk and Milk Products
established by Council Regulation (EEC) No 804/68 (2)                                           Article 17
where matters of chemistry or technology are involved, shall
submit to the Committee a draft of the measures to be taken.         This Regulation shall enter into force on the thirtieth day
The Committee shall deliver its opinion on the draft within a        following that of its publication in the Official Journal of the
time-limit which the Chairman may lay down according to              European Communities.
the urgency of the matter. The opinion shall be delivered by
the majority laid down in Article 148 (2) of the Treaty in the       It shall apply from 1 January 1993.
case of decisions which the Council is required to adopt on a
proposal from the Commission. The votes of the
representatives of the Member States within the Committee
shall be weighted in the manner set out in that Article. The         This Regulation shall be binding in its entirety and directly
Chairman shall not vote.                                             applicable in all Member States.
(!) OJ No L 244, 19. 10. 1968, p. 23.
(2) OJ No L 148, 28. 9. 1968, p. 13.
 ---pagebreak--- 2. 4. 90                                 Official Journal of the European Communities                                       No C 84/117
                                                               ANNEX
                                                             CHAPTER
         ANIMAL HEALTH REQUIREMENTS FOR THE PRODUCTION OF RAW MILK OTHER THAN
                                                            COW'S MILK
         A. Conditions governing raw milk
              1. Raw milk must come from:
                 (a) sheep and goats
                       (i) belonging to a herd officially free or free of brucellosis (Brucella melitensis);
                      (ii) satisfying the requirements laid down in points 1 (b), (c), (d) and (f) of Chapter I of Annex A to
                           Council Regulation (EEC) No . . . / . . . (heat-treated drinking milk);
                 (b)   buffaloes
                       (i) belonging to a herd officially free of tuberculosis and officially free or free of brucellosis, as
                           defined in Chapters I and II of Annex A to Directive 64/432/EEC (*);
                      (ii) satisfying the requirements laid down in (a) (ii).
             2. Where different animal species are kept together on the holding, each species must satisfy the health
                 conditions which would be required if it were alone.
                 In addition, if goats are kept together with cows, they must undergo a tuberculosis check.
             3. Raw milk must be excluded from treatment and processing if it:
                 (a) is obtained from animals to which substances within the meaning of Directives 81/602/EEC (2) and
                      88/146/EEC (3) have been administered illegally;
                 (b) contains residues of substances within the meaning of Article 9 (4) which exceed the permitted
                      level.
         B.  Hygiene of the holding
             The raw milk must come from production holdings which are registered and checked in accordance with
             Article 9(1).
             The animals must be kept in good conditions of housing, hygiene, cleanliness and health.
             There must be good hygienic conditions for milking, handling and storage of milk.
         C. Hygiene in milking, the collection of raw milk and its treatment from the production holding to the collection
             centre or to the processing establishment — staff hygiene
             The provisions of Chapter III of Annex A to Regulation (EEC) No . . . / . . . (heat-treated drinking milk) shall
             apply.
         (') OJ No 121, 29. 7. 1964, p. 1977/64.
         (2) OJ No L 222, 1. 8. 1981, p. 32.
         (3) OJ No L 70, 16. 3. 1988, p. 16.
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                                                                 CHAPTER II
                                                      STANDARDS FOR RAW MILK
            1. Raw cow's milk for the manufacture of fermented, renneted, gelified or flavoured milk, milk desserts, creams
               and uncured or unripened cheeses must:
               (a) satisfy the following standards:
                    Plate count 30° (per ml)                                                      ^    100 000 (')
                    Somatic cell count (per ml)                                                   <   400 000 (2)
                    Antibiotics (per ml)
                    — penicillin                                                                    < 0,004 ug
                    — other                                                                         undetectable
                    (M Geometric average over a period of two months, with at least two samples a month.
                    (2) Geometric average over a period of three months, with at least one sample a month.
                    Compliance with the standards must be checked by random sampling, either on collection at the
                    production holding or on acceptance of the raw milk at the processing establishment or collection
                    centre;
               (b) unless it is treated within four hours of its arrival at the processing establishment, be cooled to a
                    temperature of not more than 6 °C and kept at that temperature until used.
            2. Raw cow's milk intended for direct human consumption and raw cow's milk for the manufacture of products
               'made with raw milk' whose manufacturing process does not involve any heat treatment must:
               (a) satisfy the requirements of paragraph 1;
               (b) in addition satisfy the following standard:
                    Staphylococcus aureus:
                    n = 5, m = 100, M = 300, c = 2
                    where:
                    n — is the number of samples collected
                    m — is the microorganism threshold value; the result being considered satisfactory if all the samples have
                            a level of microorganisms less than or equal to "m";
                    M — is the maximum permitted microorganism level; the result being considered unsatisfactory if one or
                            more samples have a level of microorganisms greater than or equal to "M";
                    c — is the number of samples where the microorganism level may be between "m" and "M", the result
                            still being considered acceptable if the other samples have a microorganism level less than or equal
                            to "m".
            3. Raw cow's milk for the manufacture of milk-based products other than those referred to in points 1
               and 2:
                                                                          From 1 January 1993               From 1 January 1995
               Plate count 30 °C (per ml)                                     < 300 000 0)                     < lOOOOO(')
               Somatic cell count (per ml)                                    < 500 000 (2)                    < 400 000 (2)
               Antibiotics (per ml)
               — penicillin                                                    < 0,004 ug                       < 0,004 ug
               — others                                                       undetectable                     undetectable
                (') Geometric average over a period of two months, with at least two samples a month.
               (2) Geometric average over a period of three months, with at least one sample a month.
               Compliance with the standards must be checked by random sampling, either on collection at the production
               holding or on acceptance of the raw milk at the processing establishment or collection centre.
            4. Non-bovine raw milk must, on acceptance, satisfy standards to be laid down under the Article 15
               procedure.
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                                                                CHAPTER HI
                   STANDARDS FOR MILK FOR THE MANUFACTURE OF MILK-BASED PRODUCTS
         1. The person in charge of the processing establishment must take all necessary steps to ensure that, in the case of
            products 'made with raw milk', the milk is treated or processed within 36 hours of acceptance.
         2. Where necessary, standards may be set in respect of milk for the manufacture of milk-based products in
            accordance with the procedure laid down in Article 15.
                                                                CHAPTER IV
                                            STANDARDS FOR MILK-BASED PRODUCTS
         1. Microbiological standards for certain milk-based products on removal from the processing establishment
               Type of microorganism                           Products                                  Standard (ml, g)
            A. Pathogenic
                microorganisms
                — Listeria monocyto-
                     genes                      — all                                     ab,< ent in 25 (mi, g) n = 5 , c = 0
                — Salmonella                    — all                                     abs>ent in 25 (ml, g) n = 5 , c = 0
                — Staphylococcus
                     aureus                     —  soft cheese                            m = 1 0 2 , M = 10-\ n = 5 , c = 2
                                                —  fresh cheese                           m = 10, M = 102, n = 5, c = 2
                                                —  frozen milk prod JCtS                  m = 0, M = 10, n = 5, c = 2
                — Other pathogens               —   all                                   absent in 25 (ml, g) n = 5 , c = 0
            B. Index organisms
                — Coliforms (44 °C)             — soft cheese                             m = 102, M = 10J, n = 5, c = 2
            C. Indicator organisms
                — Coliforms (30 °C)             — liquid milk and liquid milk
                                                    products                              m =     0, M =    5, n = 5, c = 2
                                                — butter                                  m =     0, M =     10, n = 5, c = 2
                                                — soft cheese                             m =     104, M    = 105, n = 5, c = 2
                                                — fresh cheese                            m =     102, M    = 103, n = 5, c = 2
                                                — powdered milk products                  m = 0, M = 10, n = 5 , c = 2
                                                — frozen milk prod ucts                   m = 0, M = 5, n = 5, c = 2
            D Other organisms
                — Total plate count             — heat treated unfermented
                                                    liquid     milk     and     milk
                                                    products (')                          m = 5 x 10 4 , M = 10 3 ,n = 5,c = 1
                                                — frozen milk products (2)                m = 10 5 , M = 3 x 10 5 , n = 5, c = 2
            (') After incubation at 6 °C for five days (plate count at 21 °C).
            (2) Plate count at 30 °C.
            where:
            n — is the number of samples collected;
            m — is the microorganism threshold value; the result being considered satisfactory if all the samples have a level of
                   microorganisms less than or equal to 'm';
            M — is the maximum permitted microorganism level; the result being considered unsatisfactory if one or more samples have a
                   level of microorganisms greater than or equal to 'M';
            c — is the number of samples where the microorganism level may be between 'm' and 'M', the result still being considered
                   acceptable if the other samples have a microorganism level less than or equal to 'm'.
         2. Standards for sterilized or UHT-treated milk-based products
            Sterilized or UHT-treated milk-based products that have been heat-treated in accordance with the
            requirements laid down in points 6 and 7 of Chapter VI of Annex B to Regulation (EEC) No . . . / . . .
            (heat-treated drinking milk) must satisfy the following standards after incubation for 15 days at 30 °C.
            (a) plate count at 30 °C (per 0,1 ml): < 10,
            (b) organoleptic test: normal.
 ---pagebreak--- No C 84/120                                Official Journal of the European Communities                                          2. 4. 90
              3. Where necessary, standards other than those set out in points 1 and 2 may be set in respect of milk-based
                 products in accordance with the procedure laid down in Article 15.
                 Microbiological standards applicable, under conditions managed and controlled by the manufacturer, to the
                 use-by date and, where appropriate, detailed rules of application may be laid down in accordnce with the same
                 procedure.
                                                                CHAPTER V
                                               CONDITIONS GOVERNING LABELLING
              1. For inspection purposes, the words 'raw milk' must appear clearly in the labelling of raw milk intended for
                 direct human consumption.
              2. For inspection purposes, the words 'made with raw milk' must appear clearly in the labelling of milk-based
                 products manufactured from raw milk whose manufacturing process does not include heat treatment.
              3. For inspection purposes, the labelling of milk-based products must, where appropriate, specify the type of heat
                 treatment applied at the end of the manufacturing process.
                 The type of heat treatment concerned may be pasteurization, UHT treatment or sterilization within the
                 meaning of Regulation (EEC) No . . . / . . . (heat-treated drinking milk).
              Proposal for a Council Regulation (EEC) laying down the health rules for the production and placing
                 on the market of minced meat, meat preparations and comminuted meat for industrial use
                                                            COM(89) 671 final
                                      (Submitted by the Commission on 16 February 1990)
                                                               (90/C 84/11)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                                  Whereas the Community must adopt the measures intended
                                                                          to progressively establish the internal market over a period
Having regard to the Treaty establishing the European                     expiring on 31 December 1992;
Economic Community, and in particular Article 43
thereof,                                                                  Whereas the laying down of such rules improves the
                                                                          protection of public health and consequently facilitates the
Having regard to the proposal from the Commission,
                                                                          completion of the internal market;
Having regard to the opinion of the European Parliament,
                                                                          Whereas, to achieve this purpose, it is necessary to extend the
Having regard to the opinion of the Economic and Social                   principal health rules laid down in Council Directive
Committee,                                                                88/657/EEC of 16 December 1988 laying down the
                                                                          requirements for the production of, and trade in, minced
Whereas minced meat, meat preparations and cominuted                      meat, meat in pieces of less than 100 grams and meat
meat for industrial use are included in the list of products in           preparations and amending Directives 64/433/EEC,
Annex II to the Treaty; whereas the production of and trade               71/118/EEC and 72/462/EEC (») to all production and
in minced meat, meat preparations and comminuted meat for                 placing on the market of minced meat and meat preparations
industrial use constitute an important source of income for               in the Community;
part of the farming population;
                                                                          Whereas it is possible that, due to certain particular
Whereas in order to ensure the rational development of the                circumstances, some establishments operating prior to 1
industry producing such meat and to increase productivity,                January 1992 will not be able to comply with all the rules laid
public health rules for the production and placing an the                 down in this regulation; whereas the question of whether
market of such meat must be laid down at Community
level;                                                                    (') O J N o L 3 8 2 , 3 1 . 12. 1988, p. 3.