CELEX: 51991PC0420
Language: en
Date: 1991-10-29
Title: Amendment to the 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

m&
              COMMISSION OF THE EUROPEAN COMMUNITIES
                                                     C0M(91) 420 final
                                                     Brussels, 29 October 1991
                                   Amendment to the 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
   t**^1
         i*#=
                        (presented by the Commission pursuant to Article 149(3)
                                           of the EEC Treaty)
  S5piS^ic^£
 ---pagebreak---                              EXPLANATORY MEMORANDUM
On 13 February 1990, the Commission submitted to the Council a proposal for a
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.1
In the wake of the opinion delivered by Parliament at its sitting of
11 June 1991,2 the Commission decided to amend its original proposal in       ,
accordance with Article 149(3) of the Treaty.
1    OJ C 84, 2.4.1990, p. 112
2    OJ C ...
 ---pagebreak---                               AMENDMENTS TO THE PROPOSAL FOR A
                             COUNCIL REGULATION (EEC) No
                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
                      (Submitted by the Commission pursuant to
                          Article 149(3) of the EEC Treaty)
On 13 February 1990, the Commission submitted the abovementloned proposal to the
Council. Following the opinion of the European Par I iament .de I ivered at its
sitting of 11 June 1991, the original proposal is hereby amended as foi lows:
1. The second recital is replaced by the following:
   "Whereas, in order to ensure the rational development of this sector and to
   increase productivity and competitiveness, health rules governing the
   production and placing on the market of raw milk, of milk for the manufacture
   of milk-based products and of milk-based products should be laid down at
   Communi ty level ; " ;
2. The fourth recital is replaced by the following:
   "Whereas the introduction of such rules will help to ensure a high levé! of
   protection for the public health of citizens;";
3. The sixth recital is replaced by the following:
   "Whereas it seems necessary to exclude from the scope of this Regulation
   certain products sold directly by the producer to the consumer, on condition
   that a minimum number of essential conditions of hygiene are guaranteed;";
 ---pagebreak---                                          2 -
4. The following recitals are inserted after the sixth recital:
   "Whereas it is vital for Community rules to be clear and comprehensible to
   the people concerned;
   Whereas the starting points in terms of the health conditions of  livestock
   and production and processing structures differ from one Member State to
   another ;
   Whereas the Commission must be provided with sufficient organizational,
   staffing and financial means fully to carry out  its monitoring tasks;";
5. The following recital  is added:
   "Whereas the Commission has agreed to submit to the Council a proposal for a
   Directive laying down a general framework for standards of health and safety
   for foodstuffs as soon as possible and preferably before the end of 1991;";
6. The first  indent of Article 1(2) is replaced by the following:
        by the producer, of raw milk produced on his farm, from a herd which is
        free of brucellosis and tuberculosis provided that the hygiene
        conditions of the holding comply with the minimum health guarantees laid
        down by the competent authority;";
 ---pagebreak---                                            -' 3 -
7. In Artide 2:
   - point 2 is replaced by the following:
      " 2)       'milk for the manufacture of milk-based products' means either raw
                milk for processing or liquid or frozen milk obtained from raw
                milk, whether or not it has undergone an authorized physical
                treatment, such as heat treatment or thermization, or modified in
                 its composition, provided that these modifications are restricted
                to an addition and/or withdrawal of any of the natural milk
                constituents in accordance with Regulation (EEC) No 1411/71 of
                29 June 1971 ( D . "
   - point 9 is replaced by the following:
     "9)        'competent authority' means the competent authority or the body
                designated by the Member State."
   - point 10 is replaced by the following:
     "10)       the definitions set out in Article 2 of Council
                Directive 64/432/EEC of 26 June 1964 on animal health problems
                affecting intra-Community trade in bovine animals and swine and of
                Council Regulation (EEC) No 91/68/EEC of 28 January 1991 on animal
                health conditions governing intra-Community trade in ovine and
                caprine animals^ 2 ), whiich define operating conditions, animals
                for slaughter, production and reproduction, as well as animals,
                holdings or zones free of tuberculosis, brucellosis and epizootic
                diseases, notifiable diseases, exporting country and country of
                destination, shall apply where necessary.
8. In Ar t i d e 3:
   - point 1 is replaced by the following:
     "1)        be checked in accordance Article 9(1), which refers to the need to
                introduce periodic checks in order to ensure that hygiene
                requirements are met;"
(1) OJ No. L 148 of 03.07.1971, p.4.
(2) OJ No. L      46 of 19.02.1991, p.19
 ---pagebreak---                                     - 4-
- point 2 is replaced by the following:
  "2)      meet the standards laid down in Chapter II of the Annex hereto,
           which lays down standards for raw milk;"
- point 3 is replaced by the following:
  "3)      where appropriate, satisfy the requirements laid down in
           Article 3(1)(g) of Regulation (EEC) No ... (heat-treated drinking
           milk) relating to the general conditions governing approval,
           registration and hygiene in respect of the premises, equipment and
           staff of collection centres;"
- point 4 is replaced by the following:
  "4)      in the case of cow's milk, satisfy the requirements laid down in
           Article 3(1)(b), (c) and (d) of Regulation (EEC) No ...
           (heat-treated drinking milk), which stipulate the conditions for
           the admission of raw milk to treatment establishments, the hygiene
           of holdings and the milking, collection and transport of raw milk;"
In Art icle 4:
- point 2 is replaced by the following:
  "2)      where it is not sold to the consumer within two hours after the end
           of milking, be cooled in accordance with Chapter I M of Annex A to
           Regulation (EEC) No ...(heat-treated drinking milk), which ensures
           hygiene in milking, in collecting raw milk and in its transport,
           and the hygiene of staff involved in handling and collecting milk;"
- point 3 is replaced by the following:
  "3)      satisfy the requirements set out in point 1 of Chapter V of the
           Annex hereto-,"
- point 4 is replaced by the following:
  "4)      satisfy the additional requirements set out in accordance with the
           procedure laid down in Article 15 of this Regulation."
 ---pagebreak---                                        - 5 -
10. In Article 5:
    - point 3 is replaced by the following:
      "3)    where appropriate, be obtained in a processing establishment that
             meets the requirements set out in Article 3(2) of Regulation (EEC)
             No ... (heat-treated drinking milk), which lays down the general
             and special conditions for the approval of treatment establishments
             and the hygiene requirements relating to premises, equipment and
             staff;"
    - point 4 is replaced by the following:
      "4)    where appropriate, be stored, irrespective of the treatment it
             undergoes, in accordance with Article 3(5) of Regulation (EEC)
             No ... (heat-treated drinking milk), which stipulates the way in
             which pasteurized milk must be stored in the treatment
             establishment;"
    - point 5 is replaced by the following:
      "5)    be transported in accordance with Article 3(6) of Regulation (EEC)
             No     (heat-treated drinking milk), which lays down the
             satisfactory conditions of hygiene relating to such transport."
11. In Article 6:
    - point 2 is replaced by the following:
      "2)    be prepared in a processing establishment that meets the
             requirements of Article 3(2) of Regulation (EEC) No . . .
             (heat-treated drinking milk), which lays down the features and
             equipment necessary to ensure the best possible conditions relating
             to the treatment of milk and the hygiene of the premises, equipment
             and staff of such processing establishments;"
 ---pagebreak---                                    - 6 -
- point 4 is replaced by the following:
  "4)    be packaged and wrapped   in accordance with Chapter     IV of the Annex
         to Regulation (EEC) No       (general health rules) and, if they are
         in liquid form and intended for sale to the end user, with
         points 1, 2 and 3 of Chapter VII of Annex B to Regulation       (EEC)
         No . . . (heat-treated drinking m i l k ) , which lay down rules relating
         to packaging  in containers  intended for sale to the final
         consumer ;"
- point 5 is replaced by the following:
  "5)    be labelled  in accordance with Chapter V of the Annex to Regulation
         (EEC) No ... (general health rules), as regards the labelling of
         products of animal origin, and with Chapter V of the Annex hereto;"
- point 7 is replaced by the following:
  "7)    be checked  in accordance with Article 9(4) of and Chapter      I I I of
         the Annex to Regulation (EEC) No         (general health rules), which
         establish systems of health checks and inspection and the
         supervision of production;"
- point 9 is replaced by the following:
  "9)    involve heat treatment during the manufacturing process or be made
         from products that have undergone a heat treatment, or be subject
         to sufficient hygiene provisions to meet the hygiene criteria        laid
         down for finished products."
 ---pagebreak---                                       - 7 -
12. In Article 7:
    - paragraph 2 is replaced by the following:
      "2)    Milk from animals that are not infected or suspected of being
             infected with tuberculosis or brucellosis and do not comply with
             the provisions of point 1(a) of Chapter      I of Annex A to Regulation
             (EEC) No ... (heat-treated drinking m i l k ) , which lays down the
             conditions under which a herd is officially considered safe, or
             with points A(1) and (2) of Chapter  l(A) of the Annex hereto may,
             by way of derogation from Article 3(4) and ( 5 ) , be used under the
             supervision of the competent authority to manufacture milk-based
             products during the period in which the holding is disinfected.
             In this event, heat treatment of the milk shall be compulsory."
    - paragraph 3 is replaced by the following:
      "3)    The manufacture of milk-based products with traditional
             characteristics may be exempted from Article 6(1) to ( 4 ) , subject
             to the provisions of Chapter  II of the Annex, in accordance with
             the procedure laid down in Article 15. In this event, the general
             and particular conditions applicable to the manufacture of each
             specific product shall be determined  in accordance with the same
             procedure."
    - paragraph 4 is replaced by the following:
      "4.    Manufacture of cheese with a long period of ageing or ripening
             shall not be subject to the provisions of Articie 6 ( 1 ) , (2) and
             (4). The 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 standards for this type of
             product."
 ---pagebreak---                                             8 -
13. In Ar t i d e 8:
    - paragraph 1 is replaced by the following:
      "1.       Derogations from Article 6(2) and Chapter   II of the Annex may be
                granted in accordance with the procedure laid down in Article 15
                for establishments with limited production."
    - the following paragraph 1a is inserted:
      "1a.       'Limited production' means a quantity of litres per day fixed by
                the Committee in accordance with Article 15."
    - paragraph 2 is replaced by the following:
      "2)       When examining the derogations referred to in paragraph 1, the
                Commission shall take account of the information and criteria set
                out in Articles 2 and 3 of Decision .../.../EEC of ... on the
                conditions for granting temporary and limited derogations from
                specific Community health rules on the production and marketing of
                products of animal origin, which lay down the procedure for
                requesting, considering and granting such derogations."
14. In Article 9:
    - paragraph 1 is replaced by the following:
      "1)       Article 5 of Regulation (EEC) No ... (heat-treated drinking m i l k ) ,
                which lays down the periodic checks on production holdings to be
                carried out by the competent authority   in order to ensure adequate
                conditions of hygiene, shall apply."
    - paragraph 2 is replaced by the following:
      "2.       Article 6 of Regulation (EEC) No ... (heat-treated drinking m i l k ) ,
                which requires each Member State to draw up a list of
                milk-treatment establishments approved by it, shall apply
                mutatis mutandis in respect of collection centres and processing
                estabI ishments."
 ---pagebreak---                                       - 9-
    - paragraph 3 is replaced by the following:
      "3)    Article 7 of Regulation (EEC) No ... (heat-treated drinking milk)
             relating to checks carried out in treatment establishments shall
             apply mutatis mutandis in respect of raw milk, of milk for the
             manufacture of milk-based products and of milk-based products, and
             in respect of processing establishments."
    - paragraph 4 is replaced by the following:
      "4)    Articles 8, 9 and 10 of Regulation (EEC) No ... (heat-treated
             drinking milk), which lay down the checks to be carried out on
             residues of substances, the conditions governing combined use of
             equipment for the transport of other foodstuffs and the checks
             which may be carried out by veterinary experts from the Commission,
             shall apply mutatis mutandis in respect of raw milk, of milk for
             the manufacture of milk-based products and of milk-based products."
15. The following paragraph is added to Article 10:
    "All Community checks shall be carried out in close cooperation with the
    competent authority of each Member State."
16. The title of Chapter I of the Annex is replaced by the following:
    "ANIMAL HEALTH REQUIREMENTS FOR RAW MILK"
17. Point A of Chapter I of the Annex is replaced by the following:
    "A. CONDITIONS GOVERNING RAW MILK
        1.   Raw milk must originate as follows:
             a)   from cows:
                  i)    belonging to a herd which is officially free of
                        tuberculosis and brucellosis and which does not show any
                        symptoms of infectious diseases communicable to human
                        beings through milk or likely to give the milk abnormal
                        organoleptic characteristics;
 ---pagebreak---                                      - 10 -
             ii) whose general state of health is not impaired by any visible
                 disorder and which must not be suffering from any infection of
                 the genital tract with discharge, enteritis with diarrhoea and
                 fever, or a recognizable inflammation affecting the skin of
                 the udder ;
            iii) which do not show any udder wound likely to affect the milk,
                 and which yield at least two litres of milk a day;
             iv) which have not been treated with substances that are
                 transmissible to milk or that are dangerous or likely to be
                 dangerous to human health, unless the milk has complied with
                 an official waiting period laid down in Community provisions
                 or, if absent, in national provisions;
      b)  from 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 point ( a ) ;
      c)  sheep and goats:
              i) belonging to a herd officially free or free of brucellosis
                 (Brucella melitensis),
             ii) satisfying the requirements laid down in point ( a ) .
2. When the 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, processing, sale and consumption
   if it:
   a) is obtained from animals to which substances within the meaning of
      Directives 81/602/EEC and 88/146/EEC have been administered     illegally;
 ---pagebreak---                                        11 -
    b) contains residues of substances within the meaning of Article 9(4) which
       exceed the permitted level."
18. Point B of Chapter I of the Annex is replaced by the following:
    "B. HYGIENE OF THE HOLDING
        1.  The raw milk must come from production holdings which are
            registered and checked in accordance with Article 9(1). The
            premises so used must be designed, constructed, maintained and
            managed in such a way as to ensure:
            a) good conditions of housing, hygiene, cleanliness and health of
               the animals, and
            b) satisfactory hygienic conditions for milking, handling and
               stor ing milk.
               Premises used for specific purposes must comply with the
               conditions described below.
        2.  Premises where cows are milked or milk is stored, handled or cooled
            must be so sitd and constructed as to avoid all risk of
            contamination of the milk. They must be easy to wash and disinfect
            and have at least :
            a) walls and flooring capable of being readily cleansed in those
               areas liable to soiling or infection;
            b) flooring laid in such a way as to facilitate the draining of
                liquids and satisfactory means of disposing of waste;
            c) adequate ventilation and lighting-,
            d) an adequate and sufficient supply of drinking water in
               accordance with Directive 80/778/EEC for use in milking,
               cleansing and cooling operations;
            e) adequate separation from all sources of contamination such as
               lavoratories and dung heaps;
 ---pagebreak---                                      - 12 -
            f) fittings and equipment which are easy to wash, cleanse and
                dis infect.
             In addition, premises for the storage of milk must have suitable
            milk refrigeration equipment, must be protected against vermin and
            must have adequate separation from any premises where animals are
            housed.
        3.  If a movable milking bail is used, the requirements in point 2(d)
            and (f) must be satisfied and in addition the bail must:
            a) be sited on fresh ground which is free from any accumulation of
                excreta or other waste matter;
            b) provide protection for the milk during the whole period in which
                it is in use;
            c) be so constructed and finished as to permit the interior
                surfaces to be kept clean.
        4.  A milking parlour or milking area, adequately separated from the
            housiing area, is obligatory when the cows are loose-housed.
        5.  The isolation of animals which are infected, or suspected of being
            infected, with any of the diseases referred to in Section A(l)(b)
            or the separation of the animals referred to in Section A(1)(c)
            from the rest of the herd must be possible and effective.
        6.  Animals of all species must be kept away from premises and sites
            where milk is stored, handled or cooled."
19. Point C of Chapter I of the Annex is replaced by the following:
    "C. HYGIENE IN MILKING, THE COLLECTION OF TAW MILK AND ITS TRANSPORT FROM
        THE PRODUCTION HOLDING TO THE COLLECTION OR STANDARDIZATION CENTRE OR
        TO THE MILK TREATMENT ESTABLISHMENT - HYGIENE OF STAFF
 ---pagebreak---                                    13
1. Milking must be carried out hygienically and under the general
   conditions of hygiene referred to in Article 5(2) of Regulation (EEC)
   No .../... (general health rules).
2. Immediately after milking, the milk must be placed in a clean place
   which is so equipped as to avoid adverse effects on the milk.
   If it is not collected within two hours of milking, the milk must be
   cooled to a temperature of 8*C at least in the case of daily collection
   or 6'C  if collection is not daily; while the refrigerated milk is being
   transported to the treatment establishments its temperature must not
   exceed 10*C.
3. Equipment and instruments or their surfaces which are intended to come
   into contact with milk (utensils, containers, tanks, etc., intended for
   milking, the collection or the transport of milk) must be made of smooth
   material which is easy to wash, clean and disinfect, resists corrosion
   and does not transfer substances to the milk in such quantities as to
   endanger human health, cause deterioration in the composition of the
   milk or adversely affect its organoleptic characteristics.
4. After use, the utensils used for milking, the mechanical milking
   equipment and the containers which come into contact with the milk in
   any way must be washed, cleaned and disinfected. After each journey, or
   after each series of journeys where there is only a very short space of
   time between unloading and the following loading, but in any event at
   least once a day, containers and tanks used for transporting raw milk to
   the milk collection or standardization centre or to the milk treatment
   establishment must be washed, cleaned and disinfected before re-use.
5. A control system shall be established under the supervision of the
   competent authority to prevent the presence of extraneous water  in milk.
   This sytem shall in particular  include regular checks on the freezing
   point of milk from each production holding. When extraneous water is
   detected the competent authority shall take appropriate measures.
 ---pagebreak---                                    - 14
   6. The treatment establishment shall inform the official veterinarian as
      soon as the maximum standards fixed for the cell count have been
      reached. The official veterinarian shall take the appropriate measures
   7. If, within three months after notification of the measures referred to
      in points 1, 2 and 3, milk from the holding in question does not meet
      the standards laid down, the holding must temporarily be excluded from
      supplying raw milk for the production of heat-treated drinking milk,
      until such time as it meets such standards again. However, milk
      containing residues of antibiotics which exceed the permitted levels
      must be excluded from human consumption."
20 In Chapter II of the Annex:
      paragraph 1 is replaced by the following:
      "1.  Raw cow's milk for the manufacture of fermented, renneted, gelified
           or flavoured milk, milk desserts, creams, uncured or unripened
           cheeses and other milk-based products must satisfy the following
           standards:
                                      from             from          from
                                    1.1. 1993      1 .1 .1995      1.1.1997
        Place count 30'C          < 400.000(1)   < 300.000(1)    < 100.000(1)
               (per ml)
        Somat ic ce I I count     < 600.000(2)   < 500.000(2)    < 400.000(2)
               (per ml)
        Ant ibiot ics (per ml)
        - pen ic i I I in         < 0,004 )ug    < 0 , 0 0 4 /zg < 0,004 fig
        - other                       non              non           non
                                   detectable     detectable      detectable
      (1)  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.
 ---pagebreak---                                      - 15 -
             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;
             With regard to the minimum permitted values for antibiotics other
             than penicillin, the Veterinary Committee shall lay down the
             detectable limits to be required using recognized biological
             methods."
    -   Paragraph 3 is deleted.
    -   Paragraph 4 is replaced by the following:
        "3.  Raw milk other than cow's milk must, on accpetance, satisfy
             standards to be laid down under the Article 15 procedure."
21. Point 1 of Chapter I I I of the Annex is replaced by the following:
    "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, if the milk is kept at a temperature above 4"C, or
             within 48 hours of acceptance if the milk is kept at a temperature
             of or lower than 4'C."
22. The third indent of point 1(A) of Chapter IV of the Annex is replaced by
    the foI lowing:
    "- Staphylococcus aureus         - cheese made from raw milk
                                       m =l03, M=104, n = 5 ,        c=2
                                     - soft cheese
                                       m = 10 2 , M = 10 3 , n = 5, c - 2
 ---pagebreak---                                       - 16 -
                            - fresh cheese
                              m - 10, M - 10 2 , n - 5, c = 2
                            - frozen mi Ik products
                              m«0, M=10,n=5, c=2."
23. Point 1(B) of Chapter IV of the Annex is replaced by the following:
    "B . Index organ i sms
       - Conforms (44"C)    - soft cheese m = 10 2 , M = 10 3 , n = 5, c - 2
                            - cheese made from raw milk
                              m = 1 0 4 , M = 1 0 5 , n - 5. c = 2."
 ---pagebreak---                                                                     ISSN 0254-1475
                                                              COM(91) 420 final
                                                     DOCUMENTS
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                                Catalogue number : CB-CO-91-477-EN-C
                                                            ISBN 92-77-76878-9
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