CELEX: 51993PC0715
Language: en
Date: 1994-01-10
Title: Proposal for a COUNCIL DIRECTIVE amending Directive 92/46/EEC laying down the health rules for the production and placing on the market of raw milk, heat-trated milk and milk-based products

COMMISSION OF THE EUROPEAN COMMUNITIES
                                          C0M(93) 715 final
                                          Brussels, 10 January 1994
                           Proposal for a
                         COUNCIL PI RECTI YE
       amending Directive 92/46/EEC laying down the health rules
       for the production and placing on the market of raw milk,
               heat-treated milk and milk-based products
                   (presented by the Commission)
 ---pagebreak---                                                                           I
                                 EXPLANATORY MEMORANDUM
In June 1992 the Community adopted measures on the production and placing of the
market of raw milk, heat-treated drinking milk, milk           for the manufacture of
milk-based products and milk-based products.
In the    light of  the experience gained,      it has been found necessary     to make
certain technical adjustments and additional specifications          in the annexes to
Directive 92/46/EEC.
The amendments, which are presented in the form of a proposal for a Directive, do
not concern the body of the Directive but only its annexes.
They concern, in particular:
- the temperatures for collection and transport of raw milk from the production
   holding to the treatment or processing establishment.
   These   amendments  must   take  account   of  the  fact  that  several   species  of
   milk-producing animals are covered by the Directive and uniform treatment would
   compromise certain traditional industrial practices;
- the    rules  concerning  equipment    in treatment   or  processing   establishments.
   Amendments   are needed   because of    the very wide diversity      in the size of
   industrial establishments.     The need to adapt the rules to take account of this
 . diversity has lead to greater       flexibility for small establishments, without
   Jeopardizing the hygiene of products or compromising consumer protection;
 ---pagebreak---                                                                              3
- lastly,  hygiene   and   standardization   requirements  for   the   production   of
  heat-treated drinking milk and milk-based products in order to improve checks
  by the competent authorities and to facilitate greater harmonization of the
  rules when these are transposed into national law.
These amendments are simply technical adjustments to the annexes with a view to
improving the application of Community      legislation, particularly    the measures
establishing the single market and free movement of foodstuffs of animal origin;
the amendments   in no way call    into question the high    level of public health
protection; they adjust the requirements so as to take better account of the
different  species  of   animal  concerned   and  the  differences   in   the  initial
situations  in the Member States. It, too is in the form of a Directive, which
Member States are required to implement under Commission supervision.
The proposal has no implications for the Community budget.
 ---pagebreak---                                    Proposal for a
                                 COUNCIL DIRECTIVE
             amending Directive 92/46/EEC laying down the health rules
             for the production and placing on the market of raw milk,
                     heat-treated milk and milk-based products
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 92/46/EEC laying down the health rules for the
production   and  placing  on  the   market   of  raw  milk,   heat-treated  milk  and
                     1
milk-based products* *, and in particular Article 21 thereof,
Having regard to the proposal from the Commission^ 2 ),
Whereas, following a detailed study of certain provisions          In the Annexes to
Directive 92/46/EEC,   it has been     found  necessary  to make    certain  technical
adjustments   in order   to ensure   better   application;   whereas  such  amendments
concern, in particular, the collection temperatures for raw milk, the rules on
equipment   in treatment   or processing    establishments   and  the manufacture   of
heat-treated milk and milk-based products,
(1) OJ No L 268, 14.09.1992, p. 1
(2) OJ No L
 ---pagebreak---                                                                             J"
HAS ADOPTED THIS DIRECTIVE:
                                      Article 1
Directive 92/46/EEC is hereby amended as follows:
1. In Annex A, the second subparagraph of Chapter II1(A)(2) is replaced by the
    fo11owIng:
    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 the milk is not
        collected within two hours of milking, it must be cooled to a temperature
        of 8"C or lower in the case of daily collection or 6"C     if collection is
        not daily. While the milk    is being transported to the treatment and/or
        processing establishment  its temperature must not exceed 10'C unless the
        milk has been collected within two hours of milking."
        For technological reasons concerning the manufacture of certain products
        based on goat's or ewe's milk, the competent     authorities may authorize
        derogations to the temperatures    laid down in the preceding subparagraph
        provided  the end product meets the standards set out     in Chapter II of
        Annex C."
 2. In Annex B, Chapter I, the first sentence of (3) is replaced by the following:
    "in rooms where the raw materials and the products covered by this Directive
    are stored, the same conditions as those at 2(a) to (f), except:"
 ---pagebreak---                                                                                G
3. in Annex B, Chapter 11(A)(3) is replaced by the following:
   "3. Working areas, instruments and working equipment must be used only for
       work on products for which approval has been granted.
       However, following authorization by the competent authority, they may be
       used at the same time or other times for work on other foodstuffs fit for
       human consumption or other milk-based products intended for use other than
       human   consumption,  provided   they   do not   create  contamination   of  the
       products for which agreement has been given."
4. In Annex B, the title of Chapter III is replaced by:
   "Special requirements for approval of collection centres".
5. In Annex B, the title of Chapter IV is replaced by:
   "Special requirements for approval of standardization centres".
6. In Annex B, Chapter V(a) is replaced by the following:
   "(a)  equipment   for the mechanical    filling and proper automatic sealing of
         containers which are to be used for packaging heat-treated drinking milk
         and milk-based products in liquid form, after filling, excluding churns,
          tanks  and  bulk  packaging   of   more  than   5 litres,   insofar  as  such
         operations are carried out there;
         However, in the case of limited production, the competent          authorities
         may authorize alternative non-automatic sealing methods provided that
         such methods carry equal assurances with regard to hygiene".
7. In Annex B, Chapter V(f) is replaced by the following:
   "(f)   In  the  case  of   treatment   establishments,    heat-treatment   equipment
          approved or authorized by the competent authority, fitted with:
          - an automatic temperature control,
          - a recording thermometer,
          - an automatic safety device preventing insufficient heating,
 ---pagebreak---                                                                                    9
          - an adequate safety system preventing the mixture of heat-treated milk
             with incompletely heated milk;
          - an automatic recording device for the safety system referred to in the
             preceding indent.
             However, the competent     authorities may authorize different equipment
             with  equivalent   performance     guarantees   and  equal    assurances   with
             regard to hygiene.
           In the case of processing establishments, insofar as such operations are
          carried out there, equipment       and methods for heating, thermization or
          heat-treatment, meeting the hygiene requirements".
8.   In Annex B, Chapter VI(3) is replaced by the following:
    "3. Equipment, containers and installations which come into contact with milk
         or   milk-based   products    or    other   perishable    raw   materials    during
         production must be cleaned and        if necessary disinfected according to a
         frequency and procedures consistent with the principles referred to in
         Article 14(1)".
9.  In Annex V, Chapter VI(4) is replaced by the following:
    "4. The    treatment  premises   must    in principle    be  cleaned   according   to a
         frequency   and procedures    consistent    in accordance with      the principles
         referred to in Article 14(1)."
10. In   Annex C,     in  the   first    sentence    of   the   second    subparagraph    of
    Chapter 1(A)(2), the word "cow's" is inserted between "raw" and "milk".
11. In Annex C,     the  first   indent   of   Chapter 1(A)(3)(a)    is   replaced  by   the
    fol Iow i ng:
    "-   raw milk, if it is not treated within 36 hours of acceptance, does not
         exceed immediately before heat treatment a plate count at 30*C of 300 000
         per ml   in the case of cow's milk or         1 000 000 per ml     in the case of
         sheep's, ewe's or    buffalo's milk".
 ---pagebreak---                                                                              ?
12. In Annex C, the following is added to Chapter 1(A)(4)(d):
    "Pasteurized milk may be produced in the same conditions from raw milk which
    has undergone only initial thermization".
13. In Annex C, Chapter 1(B)(1) is replaced by the following:
    "1. The operator or manager of the processing establishment must take all
         necessary steps to ensure that the raw milk is heat-treated, or used, in
         the case of products "made with raw milk",
         - as   soon  as  possible  after  acceptance   if  the  milk  has not   been
           refrigerated,
         - within 36 hours of acceptance if the milk is kept at a temperature not
           exceeding 6*C,
         - within 48 hours of acceptance if the miik is kept at a temperature not
           exceeding 4'C.
         However, for technological reasons concerning the manufacture of certain
         milk-based products, the competent authorities may authorize the times
         and temperatures referred to in the above three indents to be exceeded.
         They shall inform the Commission of such derogations, and their technical
         Just ification.
14. In Annex C, Chapter I(B)(3)(a)(i) is replaced by the following:
    "(i)    have been obtained from raw milk which, if it is not treated within
            36 hours of acceptance by the establishment, has a plate count at 30'C
           which does not exceed 300 000 per ml      in the case of cow's milk and
            1 000 000 per ml in the case of buffalo's, goat's or ewe's milk".
15. In Annex C, Chapter I (B)(3)(a)(iii) is replaced by the following:
    "If   it is used for the production of pasteurized, UHT or sterilized milk
     intended   for  the manufacture of milk-based    products, meet   the  following
    standards    before  treatment:  plate count  at   30'C  equal  to or  less  than
    100 000 per ml".
 ---pagebreak---                                                                                3
16. In Annex C, the last two subparagraphs of Chapter 11(A)(2) are replaced by
    the fol lowing:
    "In addition, whenever the standard M is exceeded in the case of cheese made
    from raw milk and from thermized milk and soft cheese, either testing must be
    carried out for the possible presence of toxins in such products, or strains
    of enterotoxinogenic Staphylococcus aureus or strains of Escherichia coli
    that are presumed to be pathogenic must be identified by means of methods to
    be determined     in accordance with the procedure    laid down   in Article 31 of
    this Directive.      If toxins are    found or   the above-mentioned   strains  are
    identified, all the batches involved shall be withdrawn from the market.         In
    this case the competent authority shall be informed of the findings, pursuant
    to the fifth indent of Article 14(1) of this Directive, and of the action
    taken    to   withdraw   the  suspect   batches   and the   corrective   procedures
     introduced into the production monitoring system."
17. "In Annex C,     the   first sentence of Chapter 11(A)(4)     is replaced   by  the
    fol lowing:
    "In addition, milk-based       products which   have undergone   UHT  treatment  or
    sterilization which are intended for conservation at room temperature must
    meet the following standards after incubation for 15 days at 30'C:"
18. In Annex C, the following is added to Chapter lll(3):
    "However, in the case of limited production, the competent authorities may
    authorize non-automatic sealing methods provided        that  these provide equal
    assurances with regard to hygiene".
19. In Annex C, the second subparagraph of Chapter lll(4) is replaced by the
    foI Iow i ng:
    "Sealing must be carried out       in the establishment   in which the last heat
    treatment of drinking milk and/or milk-based products in liquid form has been
    carried out,     immediately after filling, by means of sealing devices which
    ensure that the milk is protected from any adverse effects of external origin
    on its characteristics. The sealing system must be so designed that once the
    container has been opened, the evidence that it has been opened remains clear
    and easy to check."
 ---pagebreak---                                                                             1o
20. In Annex C, Chapter lll(5) is replaced by the following:
    "5. The operator or manager of the establishment must ensure for control
         purposes that in addition to the information required by Chapter IV the
         following information is visibly and legibly displayed on the packaging
         of the heat-treated milk and milk-based products in liquid form:
         - the nature*of the heat treatment which the milk has undergone,
         - an  indication,    in code or not, whereby    the date of    the  last heat
           treatment may be established and, in the case of pasteurized milk, the
           temperature at which the product must be stored".
21. In Annex C,     the  last    sentence of  Chapter IV(A)(1)   is  replaced   by  the
    following:
    "However, where a product is individually wrapped and packaged or split into
    small packaged units to be supplied to the final consumer by an institution,
     it will suffice for the health mark to be applied to the packaging."
22. In Annex C, the following is added to Chapter IV(A)(3)(a):
    "In   the  case   of  the bottles,    packaging  and  recipients  referred   to  in
    Article 11(4) and (6) of Directive 79/112/EEC, the health mark may indicate
    only the initials of the consigning country and the approval number of the
    establishment".
23. In Annex C, the last sentence of Chapter IV(A)(3)(b) is deleted.
24. In Annex C, the following is added to Chapter IV(A):
    "4. To take account of the disposal of existing packaging, application of the
         health mark on packaging shall be compulsory only from 1 January 1995.
         However, the health mark must be shown on the accompanying         commercial
         document   provided    for  in Article 5(8) and   the  last  subparagraph   of
         Article 7(A)(9) of this Directive".
 ---pagebreak---                                                                         41
25. In Annex C, the following is added to Chapter V(7):
    "and   authorize  a   tolerance   of  +2'C   during   deliveries  to   retail
    establishments".
                                    Article Z
Member States shall bring   into force the laws, regulations and administrative
provisions necessary to comply with this Directive before 1 July 1994. They shall
forthwith inform the Commission thereof.
When these measures are adopted by the Member      States, they shall   contain a
reference to this Directive or shall be accompanied by such reference on the
occasion of their official publication. The methods of making such a reference
shall be laid down by the Member States.
                                    Article 3
This Directive is addressed to the Member States.
 ---pagebreak---                                                                      ISsK 0254-1475
                                                              COM(93) 715 final
                                                      DOCUMENTS
EN                                                                              03
                                Catalogue number : CB-CO-93-766-EN-C
                                                             ISBN 92-77-63789-7
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