CELEX: 51989PC0672
Language: en
Date: 1990-03-23
Title: PROPOSAL FOR A COUNCIL REGULATION ( EEC ) ADOPTING HEALTH RULES FOR THE PRODUCTION AND PLACING ON THE MARKET OF HEAT­TREATED DRINKING MILL

N o C 84/130                                   Official Journal of the European Communities                                            2. 4. 90
                            In any event, the product must be considered toxic or tainted when contamination reaches the microbic
                            limit value S, which for general purposes is set at 103 m.
                            In the case of Staphylococcus aureus, the value of S must be allowed to exceed 5 x 10 4 .
                            Tolerances related to analytical techniques shall not apply to the values M and S.
                 B. Two categories for salmonella, with no category tolerance permitted:
                     — 'Absence in': the result is considered satisfactory,
                     — 'Presence in': the result is considered unsatifactory.
              2. The microbiological methods for examination will be established according to the procedure referred to in
                 Article 9.
              Proposal for a Council Regulation (EEC) adopting health rules for the production and placing on the
                                                     market of heat-treated drinking milk
                                                              COM(89)      672   final
                                            (Submitted   by the Commission       on 23 March           1990)
                                                                 (90/C 84/12)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                                     and animal health problems affecting i n t r a - C o m m u n i t y
                                                                             trade in heat-treated milk (l), as last amended by Directive
Having regard to the Treaty establishing the European                        8 9 / 1 6 5 / E E C ( 2 ); whereas this extension requires certain
Economic C o m m u n i t y , and in particular Article 43                    technical amendments to the said Directive;
thereof,
Having regard to the proposal of the Commission,                             Whereas it is possible that, due to certain circumstances,
                                                                             some establishments operating prior to 1 J a n u a r y 1992 will
                                                                             not be able to comply with all the rules laid d o w n in
Having regard to the opinion of the European Parliament,
                                                                             this Regulation; whereas the question of whether limited
                                                                             or temporary derogations may be granted to such
Having regard to the opinion of the Economic and Social                      establishments within the general framework laid d o w n in
Committee,                                                                   Council Decision . . . / . . . / E E C of . . . on the conditions
                                                                             for granting temporary and limited derogations from specific
Whereas heat-treated drinking milk is included in the list of                C o m m u n i t y health rules for certain products of animal
products in Annex II to the Treaty; whereas the production                   origin (3) should be resolved;
of and trade in r a w milk used for the preparation of
heat-treated drinking milk constitute an important source of
income for the farming population;                                           Whereas it should be stressed that the granting of derogations
                                                                             from the health rules laid d o w n in this Regulation is without
Whereas in order to ensure rational development of this                      prejudice to the submission of all operations of production
sector and to increase productivity, public health rules                     and placing on the market of heat-treated milk to the general
governing the production and placing on the market of this                   health rules laid d o w n in Council Regulation (EEC) N o . . .
product should be adopted at C o m m u n i t y level;                        of . . . laying d o w n general health rules for the production
                                                                             and placing on the market of products of animal origin and
                                                                             specific health rules for certain p r o d u c t s of animal
Whereas the C o m m u n i t y must adopt the measures intended               origin ( 4 );
to progressively establish the internal market over a period
expiring on 31 December 1 9 9 2 ;
                                                                             Whereas Council Directive 7 9 / 1 1 2 / E E C of 18 December
Whereas the laying d o w n of health rules promotes the                      1978 on the approximation of the laws of the M e m b e r States
protection of public health and completion of the internal
market;
                                                                             H    OJ   No L 226, 24. 8. 1985, p. 13.
                                                                             (2)  OJ   N o L 6 1 , 4. 3. 1989, p. 57.
Whereas it is necessary to extend the principles laid d o w n in             (3)  OJ   No L . . .
Council Directive 8 5 / 3 9 7 / E E C of 5 August 1985 on health             («)  OJ   No L . . .
 ---pagebreak--- 2. 4. 90                                   Official Journal of the European Communities                                 No C 84/131
relating to the labelling, presentation and advertising of                                       Article 3
foodstuffs ( 1 ), as last amended by Council Directive
 89/395/EEC( 2 ), and Council Directive 89/396/EEC of                 Heat-treated milk must meet the following conditions:
 14 June 1989 on indications or markings identifying the lot
to which a foodstuff belongs (3) are applicable;                      1. It must have been obtained from raw milk:
                                                                          (a) from which nothing has been removed and to which
Whereas the Commission should be entrusted with the task                       nothing has been added, except as an inherent
of adopting measures for implementing this Regulation;                         consequence of standardization and purification
whereas, to that end, procedures should be laid down                           operations;
establishing close and effective cooperation between the
Commission and the Member States within the Standing                      (b) which meets the conditions laid down in Annex A,
Veterinary Committee,                                                          Chapter I;
                                                                          (c) which comes from production holdings which meet
                                                                               the general hygiene conditions laid down in Annex
                                                                               A, Chapter II;
HAS ADOPTED THIS REGULATION:                                              (d) in respect of which the standards of hygiene
                                                                               observed during milking, collection, handling and
                                                                               transport, and those of the staff carrying out those
                                                                               operations, satisfy the requirements of Annex A,
                              Article 1                                        Chapter III;
                                                                         (e) which comes from cows and production holdings
This Regulation lays down health rules for the production                      which are checked at regular intervals by the
and placing on the market of heat-treated drinking milk.                       competent authorities, in particular pursuant to
                                                                               Article 5 (1);
                                                                         (f)   which has been checked in accordance with Article 7
                              Article 2                                        (1) and which meets the standards set out in Annex
                                                                               A, Chapter IV;
For the purposes of this Regulation:                                     (g) which, if appropriate, has been channelled through
                                                                               a milk-collection centre fulfilling the conditions laid
1. 'raw milk' means milk as produced by secretion from the                     down in Annex B, Chapters I, III and V;
      mammary glands of one or more dairy cows which has
      not been heated beyond 40 °C or subjected to similar               (h) which, if appropriate, has been channelled through
      treatment;                                                               a milk-standardization centre fulfilling the
                                                                               conditions laid down in Annex B, Chapters I, IV and
2.    'production holding' means an establishment at which                     V;
      one or more milk-producing cows are kept;
                                                                         (i)   which, if appropriate, has undergone an initial heat
3.    'beat-treated drinking milk' means prepacked drinking                    treatment in another establishment which fulfils the
      milk intended for sale to the final consumer and to                      conditions laid down in paragraph 2.
      institutions, obtained by heat treatment and presented in
      the form of pasteurized, UHT or sterilized milk ad              2. It must come from a milk-treatment establishment which
      defined in Annex B, Chapter VI (4), (6) and (7);                   meets the conditions laid down in Annex B, Chapters I, II
                                                                         and V.
4.    'competent authority' means the health authority
      designated by the Member State concerned;                       3. It must have been treated there in accordance with the
                                                                         requirements laid down in Annex B, Chapter VI;
5.    'milk treatment establishment' means an establishment at
      which milk is heat-treated;                                     4. It must have been packaged in accordance with Annex B,
                                                                         Chapter VII, at a milk-treatment establishment where
6. the definitions in Article 2 of Council Directive                     the milk has been subjected to final treatment.
      64/432/EEC of 26 June 1964 on animal health
      problems affecting intra-Community trade in bovine              5. It must have been stored in accordance with Annex B,
      animals and swine (4) and Article 3 of Regulation (EEC)            Chapter VIII.
      No 1411/71 of 29 June 1971 laying down additional
      rules on the common organization of the market in milk          6. It must be transported under satisfactory conditions of
      and milk products falling within tariff heading 04-01 (5)          hygiene in accordance with Annex B, Chapter IX.
      shall apply as necessary.
                                                                      7. It must have a weight of not less than 1 030 grams per
 1
i)   O J N o L 33, 8. 2. 1979, p. 1.                                     litre, as recorded in whole milk at 20 °C, or the
;2)  OJ No L 186, 30. 6. 1989, p. 17.                                    equivalent as recorded in totally fat-free milk at 20 °C,
[3)  OJ No L 186, 30. 6. 1989, p. 2 1 .                                  and contain a minimum of 28 grams of protein (total
;4)  OJ No 121, 29. 7. 1964, p. 1977/64.                                 nitrogen minus non-protein nitrogen) per litre and a
 s
   ) O J N o L 148, 3.7. 1971, p. 4.                                     fat-free dry matter content of not less than 8,5%.
 ---pagebreak--- No C 84/132                                  Official Journal of the European Communities                                     2. 4. 90
                             Article 4                                  collection and standardization centres shall be carried out
                                                                        under the responsibility of the competent authority.
1.     The reference methods and, where necessary, routine
methods of analysis and testing to be used to monitor                   The competent authority must at all times have free access to
compliance with the conditions laid down in Article 3 (1) (f),          all parts of establishments or centres involved in the
and (3), shall be adopted in accordance with the procedure
                                                                        production of heat-treated drinking milk in order to ensure
laid down in Article 16. If necessary, the sampling methods
                                                                        that this Regulation is being complied with.
shall be defined in accordance with the same procedure.
2.     The reference methods and, where necessary routine               3. The detailed rules for the application of this Article shall
methods to be used to monitor compliance with the                       be determined in accordance with the procedure laid down in
conditions laid down in Article 3 (7) shall be adopted in               Article 17.
accordance with the procedure laid down in Article 16.
In accordance with the same procedure, limits and methods
shall be established to enable a distinction to be made                                            Article 7
between different types of heat-treated milk as defined in
Annex B, Chapter VI.                                                    1.     Raw milk and heat-treated drinking milk shall undergo
                                                                        checks carried out by milk-treatment establishments, under
3.     However, pending the decisions referred to in                    the supervision and responsibility of the competent
paragraphs 1 and 2, any internationally accepted analysis               authority, with periodic inspection by the latter, in order to
and test methods shall be recognized as reference                       ensure that the milk complies with the requirements of this
methods.                                                                Regulation.
                                                                        2.     Where there are reasonable grounds for suspecting that
                             Article 5
                                                                        the requirements of this Regulation are not being satisfied,
1.     Production holdings shall undergo periodic inspection            the competent authority shall carry out the necessary checks
by the competent authority in order to ensure that hygiene              and, if that suspicion is confirmed, take appropriate
requirements are fulfilled.                                             measures, in particular the suspension of approval.
In addition, if there are reasonable grounds for suspecting             3.     The detailed rules for the application of this Article
that the animal health requirements laid down in Annex A                shall, if necessary, be determined in accordance with the
are not being fulfilled, the official veterinarian shall check the      procedure laid down in Article 17.
general state of health of the dairy animals and, should it
prove necessary, shall have a clinical examination of the
udders of those animals carried out.
                                                                                                  Article 8
If the inspection or inspections referred to in the first and
second subparagraphs show that not all hygiene                          1.     The competent authority shall carry out checks to
requirements are being fulfilled, the competent authority               detect any residues of substances having a pharmacological
shall take appropriate steps.                                           or hormonal action, and of antibiotics, pesticides, detergents
                                                                        and other substances which are harmful or which might alter
2.     The detailed arrangements for the inspection referred
                                                                        the organoleptic characteristics of milk or make its
to in paragraph 1 and the general hygiene conditions to be
                                                                        consumption dangerous or harmful to human health, in so
complied with by milk production holdings, in particular the            far as those residues exceed the permitted tolerance limits.
conditions for the upkeep of premises and those relating to
milking, shall be adopted in accordance with the procedure
laid down in Article 16.                                                2.     If the milk examined shows traces of residues which
                                                                        exceed the permitted tolerances, the heat-treated milk must
                                                                        be excluded from human consumption.
                             Article 6
                                                                        3.     Examinations for residues must be carried out in
1.     Each Member State shall draw up a list of                        accordance with proven methods which are scientifically
milk-treatment establishments approved by it and a list of              recognized, in particular those laid down in Community
approved collecition centres and standardization centres.               provisions or other international standards.
Each such establishment or centre shall have an approval
number.                                                                 4.     In accordance with the procedure laid down in Article
                                                                        16, the Commission shall adopt the detailed arrangements
A Member State shall not approve an establishment or centre
                                                                        for and the frequency of the checks, and, if necessary, the
unless compliance with this Regulation is assured. A Member
                                                                        tolerances provided for in paragraph 1 and the reference
State shall withdraw approval if the conditions for approval
                                                                        methods provided for in paragraph 3.
cease to be met.
2.     Regular inspection of approved establishments and                In accordance with the same procedure, a decision may be
centres shell be carried out by the competent authority. The            taken to extend the examinations to substances oth«r than
inspection and supervision of establishments and of                     those referred to in paragraph 1.
 ---pagebreak--- 2,^0                                             Official journal of the European Communities                                                ^oC^gP33
^.         Ontiltheentrymtoforceoftheimplementmgmeasures                      2.       In examining the derogations referred to in paragraph
forthisAi^ticle^ national rules shall remain applicable suh^ect               P the Commission shall take into consideration the
to compliance with the general provisions of theLreaty.                       information and criteria laiddown in A r t i c l e s 2 a n d 3 o f
                                                                              Uecison . . . B . g ^ ^ C of . . . ^on the conditions for
                                                                              granting temporary andhmitedderogationsfrom specific
                                                                              health rules for the production and placing on the market of
                                                                              certain products of animal origins
P        ^iilk tankers^ premises^ installations and working                   3.       ^ h e n granting the derogations referred to in
equipmentmay he usedforotherfoodstuffs provided that all                      paragraph P the Commission shall set the general and
appropriate measures are taken to present contamination or                    particular terms apphcahle to the implementationofeach
deterioration of heattreated drinking milk,                                   derogation in accordance with the procedure laid down in
                                                                              Article ID.
2.        ^dilktankersmusthearacleanndicationthattheymay
he used only for the transport of foodstuffs.
                                                                                                            Ar^^^2
3.       ^ h e r e an estahhshment makes products ohtamed in
part from milk and milk productsm^ Products used in the                       Lhe rules laid down in Council regulation ^ E E C ^ o . . . o f
manufacture of these foodstuffs must^ if they ha^e not                        ...concerning ^etermarychecks in mtra^Commumtytrade
previously undergone heat treatment or another kind of                        witha^iewto the completion ofthe internal marketP^shall
treatment which does not adversely affect milk or milk                        applymn particular with respect to the organisation and the
products^ he stored and treated in premises specially                         action to he taken following the checks carried out hy the
provided for this purpose.                                                    ^iemher^tate of destination and the safeguard measures to
                                                                              he applied.
^        In accordance with the procedure laid down in Article
l ^ t h e Commission shall adopt the detailed rules for the
application of this Articled and in particular the conditions                                               Ar^^^
relating to washings cleaning and disinfecting hefore reused
and the conditions of transport.                                              d^he Commission may^in accordance with the procedure laid
                                                                              down in A r t i c l e l ^ draw up recommendations containing
^uch rules may include an exclusion of certain types of                       guidelines on good manufacturmgp^actices apphcahle at the
foodstuffs^ if the conditions are not adequate for these                      different stages of production and placing on the market.
products.
                                A r ^ ^                                       I^he Annexes shall he amended^mp^rticularwitha^iew to
                                                                              adaptmgthem to take account of scientific and technological
1.       Vetermarye^pertsfromthe Commission may make                          progress^ hy the Commission in accordance with the
onthe^spot checks i n s o f a r as it is necessary for ensuring               procedure laid down in A r t i c l e d .
uniform application of this regulations they may^ in
particulars verify whether estahhshments are actually
complying with this regulation, r h e Commission shall                                                      Ar^^^
inform the ^iemher states of the results of the
inspections.                                                                  dihe Commission shall he assisted hythe^tandingVetennary
                                                                              Committeesetup hy Council tOecision ^ ^ ^ 3 ^ 1 B P ^ C 0 ^
A^viemher^tate in whose terntoryan inspection isheing                         hereinafter referred to as ^the Committee.
carried out shall gi^e all the necessary assistance to the
experts carrying out their dutis.
                                                                                                            Ar^^^
2.       If necessary m ^ ^ t i e r a l provisions in p a r a g r a p h l o f ^ h e r e the procedure laid down in this Article is to he
this Article shall he determined in accordance with the                       followed^ the following provisions shall apppA
procedure laid down in Article PB.
                                                                              d^he representative of the Commissions after consulting the
In accordance withthe same procedure^acode containing                         management Committee for ^iilk and ^lilk products set up
the rules to he followed forthe purpose ofthe checks referred                 hy Council regulation ^ C ^ o ^ O ^ B ^ ^ ^ m cases where
toinparagraphlmayheestahhshed.                                                aspects ofchemist^y or technology are m^ol^ed^ shall suhmit
                                                                              to the Committeeadraft of the measures to he adopted.d^he
                                                                              Committee shall deliver its opinion on thedraftwithmatime
                                                                              limit whichthe chairman m a y l a y d o w n according t o t h e
                                                                              urgency of the matter, r h e opinion shall he delivered hy the
                                                                              majority laid d o w n m A r t i c l e t ^ ^ o f t h e ^ P r e a t y in thecase
t.       In accordance with the procedure laid down in Article
^ d e r o g a t i o n s from the piDo^isions of Anne^l^ Chapters!^
tptU and IV may he granted for estahhshments with limited
production.                                                                   e ^ o ^ ^ L t ^ ^ ^         r^^,D        t^
 ---pagebreak--- No C 84/134                                 Official Journal of the European Communities                                         2. 4. 90
of decisions which the Council is required to adopt on                     The Commission shall take the utmost account of the
a proposal from the Commission. The votes of the                           opinion delivered by the Committee. It shall inform the
representatives of the Member States within the Committee                  Committee of the manner in which its opinion has been taken
shall be weighted in the manner set out in that Article. The               into account.
Chairman shall not vote.
The Commission shall adopt the proposed measures if they                                               Article 18
are in accordance with the opinion of the Committee.
                                                                           Until Community rules concerning the importation of
                                                                           heat-treated drinking milk from third countries are
If the proposed measures are not in accordance with the
                                                                           implemented, Member States shall apply to such imports
opinion of the Committee, or if no opinion is delivered, the
                                                                           conditions at least equivalent to those laid down in this
Commission shall, without delay, submit to the Council a
                                                                           Regulation.
proposal relating to the measures to be taken. The Council
shall act by a qualified majority.
If, on the expiry of a period of three months from the date of                                         Article 19
referral to the Council, the Council has not acted, the
proposed measures shall be adopted by the Commission.                      1.      Directive 85/397/EEC is hereby repealed with effect
                                                                           from 1 January 1993.
                                                                           2.      However, the implementing provisions adopted under
                                                                           Directive 85/397/EEC shall remain valid for the purposes of
                            Article 17                                     this Regulation.
Where the procedure laid down in the Article is to be
followed, the following provisions shall apply:                                                        Article 20
The representative of the Commission shall submit to the                   This Regulation shall enter into force on the 30th day
Committee a draft of the measures to be taken. The                         following its publication in the Official Journal of the
Committee shall deliver its opinion on the draft within a time             European Communities.
limit which the Chairman may lay down according to the
urgency of the matter, if necessary, by taking a vote.                     It shall apply from 1 January 1993.
The opinion shall be recorded in the minutes; in addition,
each Member State shall have the right to have its position                This Regulation shall be binding in its entirety and directly
recorded in the minutes.                                                   applicable in all Member States.
                                                                  ANNEX A
                      REQUIREMENTS RELATING TO THE ADMISSION OF RAW MILK TO TREATMENT
                                                             ESTABLISHMENTS
                                                                 CHAPTER I
                                                           Conditions for raw milk
               1. The raw milk must come from cows:
                  (a) belonging to a bovine herd which is officially tuberculosis-free and free or officially free from
                       brucellosis;
                  (b) not showing any symptoms of infectious diseases communicable to human beings through milk or likely to
                       give the milk abnormal organoleptic characteristics;
                  (c) 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 udder or the skin of the udder;
                  (d) not showing any udder wound likely to affect the milk;
                  (e) yielding at least two litres of milk a day;
 ---pagebreak--- 2. 4. 90                                  Official Journal of the European Communities                                           No C 84/135
             (f)   which have not been treated with substances that are transmissible to milk and 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.
         2. Raw milk must be excluded from treatment if it:
             (a) comes from animals which are treated with unauthorized substances referred to in Directives
                   81/602/EEC (») and 88/146/EEC (2);
             (b) contains residues of the substances referred to in Article 8 (1), in so far as those residues exceed the
                   permitted tolerance levels
                                                               CHAPTER II
                                                          Hygiene of the holding
         1. Raw milk must come from production holdings which are registered and checked in accordance with
             Article 5. The premises so used must be designed, constructed, maintained and managed in such a way as to
             ensure:
               (i) good conditions of housing, hygiene, cleanliness and health of the cows; and
             (ii) good hygienic conditions for milking, the handling and the storage of milk.
         2. Premises where cows are milked or milk is stored, handled and cooled must be so sited and constructed as to
              avoid 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 potable water within the meaning of Directive 80/778/EEC (3) for
                   use in milking, cleansing and cooling operations;
             (e) adequate separation from all sources of contamination such as lavatories and dung heaps;
             (f)   fittings and equipment which are capable of being readily and properly washed, cleansed and
                   disinfected.
             In addition, premises for the storage of milk must have suitable milk refrigeration equipment, must be suitably
             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 housing 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 Chapter I (1) (b) or the separation of the animals referred to in Chapter I (1) (c) from the rest of the herd must
              be possible and effective.
         6. Animals of all species must be kept from premises and sites where milk is stored, handled or cooled.
         (') OJ No L 222, 1. 8. 1981, p. 32.
         (2) OJ No L 70, 16. 3. 1988, p. 16.
         (3) OJ No L 229, 30. 8. 1980, p. 11.
 ---pagebreak--- No C 84/136                                  Official Journal of the European Communities                                            2. 4. 90
                                                                  CHAPTER III
          Hygiene in milking, in collecting raw milk and in its transport from the production holding to the collection or
                           standardization centre or to the milk-treatment establishment - hygiene of staff
           1. Milking must be carried out hygienically and under the general conditions of hygiene referred to in Article 5(2)
              of this Regulation.
           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 in 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. Where chemicals are used for the disinfection operations laid down in point 4, such chemicals must have been
              approved for that purpose by the competent authority.
          6. The tanks used in the collection of milk must be used in accordance with Article 9 and Annex B,
              Chapter IX.
          7. Persons who might transmit infectious diseases or any other kind of disease through the milk shall be
              prohibited from milking and from handling and collecting milk.
                                                                 CHAPTER IV
                                                       Standards to be met on admission
          1.  In order to be able to receive heat treatment and to meet the requirements of this Regulation, raw milk from
              each holding must satisfy the following minimum standards.
              Compliance with the standards must be checked either by means of random samples taken during collection at
              the farm, or when the raw milk is admitted to the treatment establishment, or at the milk collection or
              standardization centre.
                             Plate count 30 °C (per ml)                                       < 100 000 0)
                             Somatic cell count (per ml)                                      < 400 000 (2)
                             Antibiotics (per ml)
                             — penicillin                                                       < 0,004 ng
                             — other                                                           undetectable
                             (1) Geometric average recorded over a period of two months, with at least two samples a
                                 month.
                             (2) Geometric average recorded over a period of three months, with at least one sample a
                                 month.
              When the maximum standards are exceeded the competent authority shall take appropriate measures.
 ---pagebreak--- 2. 4. 90                                Official Journal of the European Communities                                           No C 84/137
          2.  A control system shall be established under the supervision of the competent authority to prevent the presence
              of extraneous water in milk. This system 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.
          3.  The treatment establishment shall inform the official veterinarian as soon as the maximum standards fixed for
              the cell count have been exceeded. The official veterinarian shall take the appropriate measures.
          4.  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 the standards
              again.
              However, milk containing residues of antibiotics which exceed the permitted levels must be excluded from
              human consumption.
                                                                ANNEXB
                                                              CHAPTER I
                                                    General approval requirements
         The general requirements for establishments and cold stores laid down in Chapter I of the Annex to Council
         Regulation (EEC) No . . . (general hygiene rules) shall apply to collection centres, standardization centres and
         treatment establishments.
                                                              CHAPTER II
                                 Special requirements for the approval of treatment establishments
         In addition to the general requirements laid down in Chapter I, treatment establishments must have at least:
         (a) equipment for the mechanical filling and proper automatic sealing of containers which are to be used for
              packaging heat-treated drinking milk, after filling, excluding churns and tanks in so far as such an operation is
              carried out there;
         (b) equipment for the cooling and cold storage of heat-treated milk and, in the cases provided for in Chapters III,
              IV and VII (1), raw milk. Cold stores must be equipped with temperature-measuring apparatus;
         (c) — in the case of packaging in disposable containers, an area for the storage of such containers and for storage
                  of the raw materials intended for their manufacture,
              — in the case of packaging in re-usable containers, a special area for their storage and equipment designed to
                  clean and disinfect them mechanically;
         (d) containers for storing raw milk, standardization equipment and containers for storing standardized milk;
         (e) centrifuges or any other suitable means for purifying milk;
         (f)  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,
              — an adequate safety system preventing the mixture of pasteurized or sterilized milk with incompletely
                  heated milk,
              — an automatic safety recording device preventing the aforementioned mixture.
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                                                                 CHAPTER HI
                                          Special requirements for registration of collection centres
           In addition to the general requirements laid down in Chapter I, milk collection centres must have at least:
           (a) cooling equipment or appropriate means for cooling and milk and, if milk is stored at the collection centre, an
                installation for cold-storing milk;
           (b) if milk is purified at the milk collection centre, purification must be carried out by means of centrifuges or by
                 any other suitable mechanical means.
                                                                 CHAPTER IV
                                       Special requirements for registration of standardization centres
           In addition to the general requirements laid down in Chapter I, milk standardization centres must have at
           least:
           (a) containers for the cold storage of raw milk, standardization equipment and containers for the storage of
                 standardized milk;
           (b) centrifuges or any other suitable mechanical means for purifying milk.
                                                                 CHAPTER V
                          Hygiene requirements relating to the premises, equipment and staff of establishments
           The general requirements laid down in Chapter II of the Annex to Council Regulation (EEC) No . . . (general
           hygiene rules) shall apply. In addition:
            1. the treatment premises must be cleaned at least once each working day;
           2. equipment, containers and installations which come into contact with milk, milk products or other foodstuffs
               must be washed, cleaned and disinfected at the end of each work phase and at least once each working
               day;
           3. as soon as possible 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.
                                                                 CHAPTER VI
                                                    Requirements relating to heat treatment
             1. Upon admission to a treatment establishment, milk must, unless treated within four hours of its arrival, be
                  cooled to a temperature not exceeding + 6 °C and maintained at that temperature until heat-treated.
             2. The manufacture of heat-treated milk shall include all necessary measures, in particular by means of random
                  sampling checks, to ensure that:
                  (a) raw milk, if it is not treated within 36 hours of its arrival, has, immediately before heat-treatment, a plate
                      count of 30 °C not exceeding 200 000 per ml;
                  (b) milk which has been subjected to a previous pasteurization has, immediately before the second heat
                       treatment, a plate count at 30 °C not exceeding 100 000 per ml.
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         3. Pasteurized milk which has been subjected to high-temperature pasteurization, UHT milk and sterilized milk
             may be produced from milk which has undergone, in another establishment, an initial heat treatment. In this
             case the 'time-temperature' set must be lower than or equivalent to pasteurization and the milk must show a
             positive reaction to the peroxidase test.
         4. Pasteurized milk must have been obtained by means of a treatment involving a high temperature for a short
             time (at least 71,7 °C for 15 seconds or any equivalent combination).
         5. In the random sampling checks carried out in a treatment establishment, pasteurized milk must also satisfy
             the following standards:
             A. Microbiological standards
                  Pathogens: absent in 25 grams: n = 5 , c = 0, m = 0, M = 0
                  Coliform (per ml): n = 5, c = 1, m = 0, m = 5
                  After incubation at 6 °C in five days:
                  Plate count 21 °C (per ml): n = 5, c = l , m = 5 x 10 4 , M = 10 5
                  where:
                  n    = number of sample units comprising the sample;
                  m = threshold value for the number of bacteria; the result is considered satisfactory if the number of
                           bacteria in all sample units does not exceed m;
                  M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of
                           bacteria in one or more sample units is M or more;
                  c    = number of sample units the bacterial count of which may be between m and M, the sample still
                           being considered acceptable if the bacterial count of the other sample units is m or less.
                  In accordance with the procedure laid down in Article 16 the Commission may establish microbiological
                  standards applicable to the labelled 'use by' date and the necessary implementing measures.
            B. Other standards
                  (a) Pasteurized milk must show a negative reaction to the phosphatase test and a positive reaction to
                        the peroxidase test, however, the production of pasteurized milk which shows a negative reaction
                        to the peroxidase test is authorized, provided that the milk is labelled as 'high-temperature
                        pasteurized'.
                  (b) Antibiotics (per ml): may not exceed permitted levels.
         6. UHT milk must satisfy the following conditions:
            — it must have been obtained by applying a continuous flow of heat entailing the application of a high
                 temperature for a short time (not less than 135 °C for not less than a second) with the aim of destroying all
                 residual spoilage microorganisms and their spores, and the use of aseptic opaque containers for
                 packaging, but so that the chemical, physical and organoleptic changes are minimal,
            — its preservability must be such that no deterioration can be observed by means of random sampling checks
                 after it has spent 15 days in a closed container at a temperature of + 30 °C; where necessary, provision
                can also be made for a period of seven days in a closed container at a temperature of + 55 °C;
            Where the 'ultra-high temperature' milk treatment process is employed by direct contact of milk and steam,
            the steam must be obtained from potable water and must not leave deposits of foreign matter in the milk or
            affect it adversely. Moreover, the use of this process must not cause any change in the water content of the
            treated milk.
         7. Sterilized milk must:
            — have been heated and sterilized in hermetically sealed packagings or containers, the seal of which must
                remain intact,
            — in the event of random sampling, have a preservability such that no deterioration can be observed after it
                has spent 15 days in a closed container at a temperature of + 30 °C; where necessary, provision can also
                be made for a period of seven days in a closed container at a temperature of + 55 °C;
         8. In the random sampling checks carried out in the treatment establishment, sterilized milk and UHT milk must
            meet the following standards after incubation at 30 °C for 15 days:
            — plate count (30 °C): < 10 (per 0,1 ml),
            — organoleptic check: normal,
            — antibiotics: not exceeding permitted levels.
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            9. For checks on the presence of extraneous water in milk the following provisions apply:
                (a) heat-treated drinking milk shall be subjected to regular checks on the presence of extraneous water, in
                      particular by verification of the freezing point. For this purpose a control system shall be established
                      under the supervision of the competent authority. When extraneous water is detected the competent
                       authority shall take adequate measures;
                (b) in establishing a control system the competent authority shall take account of:
                       — the results of the checks on raw milk referred to in Annex A, Chapter IV (2), and in particular their
                           variation and average;
                       — the effect of storage and processing of milk under Good Manufacturing Practices (GMP) conditions
                           on the freezing point.
                 (c) the Member States shall communicate to the Commission all details of the control system which they
                       apply and its justification before 1 June 1993.
           10. Heat-treated drinking milk may be subjected to any test which gives an indication of the microbiological
                condition of the milk before heat-treatment. The rules for the application of such tests and the criteria to be
                respected shall be established in accordance with the procedure laid down in Article 16.
           11. Heating processes, the temperatures and duration of heating in respect of pasteurized, sterilized and UHT
                milk, the types of heating equipment, the flow-diversion valve and the types of temperature controlling and
                recording devices shall be approved or authorized by the competent central authorities of the Member
                States.
           12. After pasteurization, milk must be cooled immediately, in order to comply with the temperatures laid down in
                Chapters VIII and IX as soon as possible.
           13. The graphs produced by recording thermometers must be dated and kept for two years so that they
                can be shown upon request to the officials appointed by the competent authorities to inspect the
                establishment.
                                                                CHAPTER VII
          Packaging at the treatment establishment of heat-treated drinking milk in containers intended for sale to the final
                                                                   consumer
          1. Without prejudice to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws
              of the Member States relating to materials and articles intended to come into contact with foodstuffs (*),
              wrapping and packaging shall comply with all the rules of hygiene and be strong enough to protect the
              heat-treated milk effectively.
          2. Bottling, filling, sealing of containers and packaging must be carried out automatically.
          3. Sealing must be carried out in the treatment establishment in which the heat treatment has been carried out
              immediately after filling, by means of a sealing device which ensures that the milk is protected from any adverse
              effects of external origin on its characteristics and that the seal cannot be re-used after opening.
          4. The producer must ensure for control purposes that in addition to the information required by Directive
              79/112/EEC (2) the following information is visibly and legibly displayed on the packaging of the
              product:
              (a) the nature of the heat treatment which the milk has undergone;
              (b) a batch identification and, in the case of pasteurized milk, the temperature at which the product must be
                     stored;
              (c) the initials (in latin script) of the country of production, i.e. B, DK, D, EL, ESP, F, IRL, I, L, NL, P or UK,
                    followed by the approval number of the treatment establishment and one of the following sets of initials:
                    CEE — EEG — EWG — E 0 F — EEC — EOK.
          (') OJ No L 40, 11. 2. 1989, p. 38.
          (2) O J N o L 33, 8.2. 1979, p. 1.
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                                                            CHAPTER VIII
                                   The storage of pasteurized milk in the treatment establishment
         After cooling, the maximum temperature of pasteurized milk must be + 6 °C until it leaves the treatment
         establishment.
         The storage temperature of the storage rooms must be recorded.
                                                            CHAPTER IX
                                                    Transport of heat-treated milk
         1. Tanks, churns and other containers which are used for the transport of pasteurized milk must comply with all
              the rules of hygiene and in particular the following:
              — their inside surfaces and any other part which may come into contact with the 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,
             — they must be designed so that the milk can drain away completely; if they are fitted with taps, these must be
                  easy to remove, dismantle, wash, clean and disinfect,
             — they must be washed, cleaned and disinfected immediately after each use and as necessary before further
                  use; cleaning and disinfection must be carried out in accordance with Chapter V (2) and (3),
             — they must be hermetically sealed shut before and during transportation by means of a watertight
                  closure.
         2. Vehicles and containers used for transporting pasteurized milk must be designed and equipped in such a way
             that the temperatures laid down in paragraph 5 can be maintained throughout the period of transport.
         3. Vehicles used for transporting heat-treated drinking milk and milk in small containers or in churns must be in
             good condition. They may not be used to transport any other product or object likely to cause the milk to
             deteriorate. Their internal surfaces must be smooth and easy to wash, clean and disinfect. The interiors of
             vehicles intended for transporting milk must comply with all the rules of hygiene. Vehicles intended for the
             transport of heat-treated milk in small containers or churns must be so designed as to give the containers or
             churns adequate protection against all contamination and atmospheric indluences and may not be used to
             transport animals.
         4. To that end, the competent authority must regularly check that the means of transport and loading conditions
             meet the hygiene requirements of this Chapter.
         5. During transport, the temperature of pasteurized milk transported in tanks or packed in small containers and
             in churns must not exceed 6 °C. However, the competent authorities may grant a derogation from this
             requirement for door-step deliveries.
         6. When heat-treated drinking milk is transported in tanks the information referred to in point 4 (a), (b) and (c) of
             Chapter VII shall be given in accompanying documents.