1992L0046 — EN — 26.05.1994 — 002.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE92/46/EEC
of16June1992
laying down the health rules for the production and placing on the market of raw milk, heat-
treatedmilkandmilk-basedproducts
(OJ L 268, 14.9.1992, p. 1)
Amended by:
Official Journal
No page date
►M1Council Directive 92/118/EEC of 17 December 1992 L 62 49 15.3.1993
►M2Commission Decision 94/330/EC of 25 May 1994 L 146 23 11.6.1994
▼B
COUNCILDIRECTIVE92/46/EEC
of16June1992
layingdownthehealthrulesfortheproductionandplacingonthe
marketofrawmilk,heat-treated milkandmilk-basedproducts
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 43 thereof,
Having regard to the proposals from the Commission(1),
Having regard to the opinions of the European Parliament(2),
Having regard to the opinions of the Economic and Social
Committee(3),
Whereas raw milk, heat-treated drinking milk, milk for the manufacture
of milk-based products and milk-based products are included in the listof products in Annex II to the Treaty; whereas the production of andtrade in suchmilk and products constitute an important source ofincome for the agricultural population;
Whereas, in order to ensure the rational development of this sector
health rules governing the production and placing on the market ofmilk and milk-based products should be laid down at Community level;
Whereas this principle has already been followed in Council Directive
85/397/EEC of 5 August 1985 on health and animal health problems
affecting intra-Community trade in heat-treated milk(
4);
Whereas the introduction of such rules will help to ensure a high level
of protection of public health;
Whereas the Community has to adopt measures for the gradual estab-
lishment of the internal market over a period expiring on 31 December
1992;
Whereas it seems necessary to exclude from the scope of this Directive
certain products sold directly by the producer to the consumer;
Whereas, in order to create the conditions for the internal market, the
principles and the rules on checks contained in Directive 89/662/
EEC(5) should be extended to all production of milk-based products;
Whereas products placed on the Community market which come from
third countries must afford the same degree of protection as regardshuman health; whereas guarantees equivalent to those offered by
products of Community origin should therefore be required in respect
of such products and they should be subject to the principles and ruleson checks contained in Directive 90/675/EEC(
6);
Whereas the hygiene rules must apply to the production, wrapping,
storage and transport of the products covered by this Directive;
Whereas in order to ensure uniformity of checks at origin, it is neces-
sary to provide for a procedure for the approval of establishmentsmeeting the health conditions laid down in this Directive, to determine1992L0046 — EN — 26.05.1994 — 002.001 — 2
(1) OJ No C 84, 2. 4. 1990, pp. 112 and 130. OJ No C 306, 26. 11. 1991, p. 7.
OJ No C 308, 28. 11. 1991, p. 14.
(2) OJ No C 183, 15. 7. 1991, pp. 60 and 61.
(3) OJ No C 332, 31. 12. 1990, pp. 91 and 102.
(4) OJ No L 226, 24. 8. 1985, p. 13. Last amended by Commission Decision 89/
165/EEC (OJ No L 61, 4. 3. 1989, p. 57).
(5) Council Directive 89/662/EEC of 11 December 1989 concerning veterinary
checks in intra-Community trade with a view to the completion of the
internal market (OJ No L 395, 30. 12. 1989, p. 13). Last amended by Direc-tive 91/496/EEC (OJ No L 268, 24. 9. 1991, p. 56).
(
6) Council Directive 90/675/EEC of 10 December 1990 laying down the prin-
ciples governing the organization of veterinary checks on products entering
the Community from third countries (OJ No L 373, 31. 12. 1990, p. 1).
Amended by Directive 91/496/EEC (OJ No L 268, 24. 9. 1991, p. 56).
▼B
the requirements regarding conditions of hygienic production to be
complied with by such establishments and to define the criteria to bemet by the products covered by this Directive;
Whereas low-capacity establishments should be approved by means of
simplified structure and infrastructure criteria, while complying withthe rules of hygiene laid down in this Directive;
Whereas health marking of milk-based products is the best way of
satisfying the competent authority of the place of destination that aconsignment complies with the provisions of this Directive;
Whereas prime responsibility for compliance with the requirements of
this Directive should lie with producers and the competent authorityshould be obliged to monitor application of this principle of own-checks;
Whereas, to ensure uniform application of this Directive, a Community
inspection procedure should be established;
Whereas, in order to allow the time necessary to set up a Community
inspection system to ensure that third countries comply with the guar-antees provided for in this Directive, national rules on checks should bemaintained for a transitional period as regards third countries;
Whereas the extension to all production of milk-based products of the
hygiene rules laid down in Directive 85/397/EEC, adapted as necessaryin the light of experience, make that Directive redundant;
Whereas the existing situation regarding health conditions for stock
farms and production and processing structures differs from oneMember State to another;
Whereas provision should therefore be made for gradual compliance
with the standards laid down in this Directive and whereas a distinction
should thus be maintained for the time being between trade and thenational market;
Whereas certain milk-based products may be manufactured from raw
milk; whereas, given the nature of these products, it may be necessaryto draw up specific conditions applicable thereto and a list of suchproducts as might be marketed;
Whereas account should be taken of certain special cheesemaking tech-
niques;
Whereas Council Directive 79/112/EEC of 18 December 1978 on the
approximation of the laws of the Member States relating to the label-
ling, presentation and advertising of foodstuffs for sale to the ultimateconsumer(
1) and Council Directive 89/396/EEC of 14 June 1989 on
indications or marks identifying the lot to which a foodstuff belongs(2),
are applicable;
Whereas Council Regulation (EEC) No 2377/90 of 26 June 1990
laying down a Community procedure for the establishment ofmaximum residue limits of veterinary medicinal products in foodstuffsof animal origin(
3), and in particular Annexes I and III thereto, is
applicable as regards the maximum residue levels for pharmacologi-
cally active substances in milk;
Whereas the Commission should be entrusted with the task of adopting
certain measures for implementing this Directive; whereas, to that end,
a procedure should be laid down establishing close and effective coop-
eration between the Commission and the Member States within theStanding Veterinary Committee;1992L0046 — EN — 26.05.1994 — 002.001 — 3
(1) OJ No L 33, 8. 9. 1979, p. 1. Last amended by Commission Directive 91/72/
EEC (OJ No L 42, 16. 2. 1991, p. 27).
(2) OJ No L 186, 30. 6. 1989, p. 21. Amended by Directive 91/238/EEC (OJ No
L 107, 27. 4. 1991, p. 50).
(3) OJ No L 224, 18. 8. 1990, p. 1. Last amended by Commission Regulation
(EEC) No 675/92 (OJ No L 73, 19. 3. 1992, p. 8).
▼B
Whereas the adoption of specific rules for the products covered by this
Directive is without prejudice to the adoption of rules on food hygieneand safety in general, on which the Commission has submitted a
proposal for a framework Directive;
Whereas the deadline for transposition into national law, set at 1
January 1992 in Article 32, should not effect the abolition of veterinarychecks at frontiers on 1 January 1993,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER ONE
General Rules
Article 1
1. This Directive lays down health rules for the production and
placing on the market of raw milk, heat-treated drinking milk, milk
for the manufacture of milk-based products and milk-based products
intended for human consumption.
2. This Directive shall not affect national rules applicable to the
direct sale to the consumer by a producer of raw milk obtained froma herd officially free of tuberculosis and officially free or free ofbrucellosis, or of milk-based products made on his holding with suchraw milk, provided that the hygiene conditions of the holding comply
with the minimum health rules laid down by the competent authority.
3. This Directive shall apply, as regards the health rules, without
prejudice to:
— Council Regulation (EEC) No 804/68 of 28 June 1968 on the
common organization of the market in milk and milk products(
1),
— Council Directive 76/118/EEC of 18 December 1975 on the approx-
imation of the laws of the Member States relating to certain partly
or wholly dehydrated preserved milk for human consumption(2),
— Council Directive 83/417/EEC of 25 July 1983 on the approxima-
tion of the laws of the Member States relating to certain
lactoproteins (caseins and caseinates) intended for human consump-tion(
3),
— Council Regulation (EEC) No 1898/87 of 2 July 1987 on the
protection of designations used in marketing of milk and milkproducts(
4).
Article 2
For the purposes of this Directive the following definitions shall apply:1. ‘raw milk’: milk produced by secretion of the mammary glands of
one or more cows, ewes, goats or buffaloes, which has not beenheated beyond 40 ºC or undergone any treatment that has an
equivalent effect;
2. ‘milk for the manufacture of milk-based products’: either raw
milk for processing or liquid or frozen milk obtained from rawmilk, whether or not it has undergone an authorized physicaltreatment, such as heat treatment or thermization, or is modified
in its composition, provided that these modifications are restricted
to the addition and/or removal of natural milk constituents;
3. ‘heat-treated drinking milk’: either drinking milk intended for sale
to the final consumer and to institutions, obtained by heat treat-1992L0046 — EN — 26.05.1994 — 002.001 — 4
(1) OJ No L 148, 28. 6. 1968, p. 13. Last amended by Regulation (EEC) No
1630/91 (OJ No L 150, 15. 6. 1991, p. 19).
(2) OJ No L 24, 30. 1. 1976, p. 49. Last amended by Directive 83/635/EEC (OJ
No L 357, 21. 12. 1983, p. 37).
(3) OJ No L 237, 26. 8. 1983, p. 25. Amended by the 1985 Act of Accession.
(4) OJ No L 182, 3. 7. 1987, p. 36. Amended by Regulation (EEC) No 222/88
(OJ No L 28, 1. 2. 1988, p. 1).
▼B
ment and presented in the forms defined in Annex C, Chapter I.A.
4 (a), (b), (c) and (d) or milk treated by pasteurization for sale inbulk at the request of the individual consumer;
4. ‘milk-based products’: milk products, namely products exclusively
derived from milk, it being accepted that substances necessary fortheir manufacture may be added, provided that these substances
are not used to replace in part or in whole any milk constituent,
and composite milk products, namely products of which no partreplaces or is intended to replace any milk constituent and ofwhich milk or a milk product is an essential part either in termsof quantity or for characterization of the product;
5. ‘heat treatment’: any treatment involving heating that causes,
immediately after it has been applied, a negative reaction to thephosphatase test;
6. ‘thermization’: the heating of raw milk for at least 15 seconds at a
temperature between 57 ºC and 68 ºC such that after treatment themilk shows a positive reaction to the phosphatase test;
7. ‘production holding’: an establishment at which one or more
milk-producing cows, ewes, goats or buffaloes are kept;
8. ‘collection centre’: an establishment where raw milk may be
collected and possibly cooled and filtered;
9. ‘standardization centre’: an establishment, which is not attached
to a collection centre or a treatment or processing establishment,in which raw milk may be skimmed or the natural constituents
modified;
10. ‘treatment establishment’: an establishment where milk is heat
treated;
11. ‘processing establishment’: an establishment or production
holding where milk and/or milk-based products are treated,processed and wrapped;
12. ‘competent authority’: the central authority of a Member State
responsible for carrying out health or public health checks or anyauthority to which it has delegated that responsibility;
13. ‘wrapping’: the protection of the products referred to in Article 1
(1) by the use of an initial wrapping or initial container in directcontact with the products concerned as well as the initial wrapperor initial container itself;
14. ‘packaging’: the placing of one or more wrapped or unwrapped
products as referred to in Article 1 (1) in a container, as well asthe container itself;
15. ‘hermetically sealed container’: container which, when sealed, is
intended to protect the contents against the entry of micro-organ-isms during and after heat treatment and which is impervious;
16. ‘placing on the market’: the stocking or display with a view to
sale, offering for sale, sale, delivery or any other manner of
disposal in the Community with the exception of retail sale, whichmust be subject to the checks laid down by national rules forretail business;
17. ‘trade’: trade between Member States in goods within the
meaning of Article 9 (2) of the Treaty.
In addition, the definitions in the provisions listed below shall
apply as necessary:
— Article 2 of Council Directive 64/432/EEC of 26 June 1964 on
animal health problems affecting intra-Community trade inbovine animals and swine(
1),1992L0046 — EN — 26.05.1994 — 002.001 — 5
(1) OJ No L 121, 29. 7. 1964, p. 1977/64. Last amended by Directive 91/499/
EEC (OJ No L 268, 24. 9. 1991, p. 107).
▼B
— Article 2 of Council Directive 91/68/EEC of 28 January 1991
on animal health conditions governing intra-Community tradein ovine and caprine animals(
1),
— Article 3 of Regulation (EEC) No 1411/71 of 29 June 1971
laying down additional rules on the common organization ofthe market in milk and milk products falling within Common
Customs Tariff heading 04-01(
2), and
— Article 2 of Regulation (EEC) No 1898/87.
CHAPTER II
RulesgoverningCommunityproduction
Article 3
1. Member States shall ensure that raw milk is not used for the
manufacture of milk-based products or heat-treated drinking milkunless it meets the following requirements:
(a) it comes from animals and holdings which are checked at regular
intervals by the competent authorities, pursuant to Article 13 (1);
(b) it is checked in accordance with Article 10 (2) and Articles 14 and
15 and meets the standards laid down in Annex A, Chapter IV;
(c) it meets the conditions laid down in Annex A, Chapter I;
(d) it comes from holdings which meet the conditions laid down in
Annex A, Chapter II;
(e) it meets the hygiene requirements defined in Annex A, Chapter III.
2. Member States shall ensure that milk from healthy animals
belonging to herds that do not meet the requirements of Annex A,
Chapter I (1) (a) (i) and (b) (i) can be used only for the manufactureof heat-treated milk or for the manufacture of milk-based products afterheat treatment under the supervision of the competent authority.
In the case of goat's milk and sheep's milk intended for trade, this heat
treatment must take place on the spot.
Article 4
Member States shall ensure that the placing on the market of raw milk
for human consumption in that state is authorized only if such milkmeets the following requirements:
1. it complies with the provisions of Article 3, Annex A, Chapter
IV.A.3 and Annex C, Chapter II.B.1;
2. where it is not sold to the consumer within two hours after the end
of milking, it is cooled in accordance withAnnex A, Ch apter III;
3. it satisfies the requirements of Annex C, Chapter IV;
4. it satisfies any additional requirements which may be set in accor-
dance with the procedure laid down in Article 31. In the meantimenational provisions concerning suchrequirements sh all continue to
apply subject to the general provisions of the Treaty.
Article 5
Member States shall ensure that heat-treated drinking milk is not
placed on the market unless it meets the following conditions:
1. it must have been obtained from raw milk, purified or filtered by the
equipment provided for in Annex B, Chapter V (e), which must:
(i) comply withArticle 3;
(ii) in the case of cow's milk, comply with the provisions of Article
3 (1) (b) and Article 6 (3) of Regulation (EEC) No 1411/71;1992L0046 — EN — 26.05.1994 — 002.001 — 6
(1) OJ No L 46, 19. 2. 1991, p. 19.
(2) OJ No L 148, 3. 7. 1971, p. 4. Last amended by Regulation (EEC) No 222/
88 (OJ No L 28, 1. 2. 1988, p. 1).
▼B
(iii) if appropriate, have passed through a milk-collection centre
fulfilling the conditions laid down in Annex B, Chapters I, II,III and VI or have been transferred from one tank to another
in good hygiene and distribution conditions;
(iv) if appropriate, have passed through a milk-standardization
centre fulfilling the conditions laid down in Annex B, Chapters
I, II, IV and VI.
If appropriate, milk intended for the production of sterilized milk
and UHT milk may have undergone an initial heat treatment in anestablishment fulfilling the conditions laid down in point 2. TheHellenic Republic shall be authorized to submit pasteurized milkfrom another Member State to a second pasteurization before
placing it on the market;
2. it must come from a treatment establishment which meets the condi-
tions laid down in Annex B, Chapters I, II, V and VI and has beenchecked in accordance with Article 10 (2) and Article 14;
3. it must have been treated in accordance with Annex C, Chapter I.A;4. it must meet the standards laid down in Annex C, Chapter II.B;5. it must be labelled in accordance withAnnex C, Ch apter IV, and be
wrapped in accordance withAnnex C, Ch apter III, at a treatment
establishment where the milk has been subjected to final treatment;
6. it must have been stored in accordance with Annex C, Chapter V;7. it must be transported under satisfactory conditions of hygiene in
accordance withAnnex C, Ch apter V;
8. it must be accompanied during transport by an accompanying
commercial document which must:
— in addition to the particulars provided for in Annex C, Chapter
IV, bear some indication by which the nature of the heat treat-
ment and the competent authority responsible for supervisingthe establishment of origin can be identified, if this is not clearfrom the approval number,
— be kept by the consignee for at least one year so that it can be
produced at the request of the competent authority,
— until 31 December 1997, in the case of heat-treated milk
intended for Greece after transit through the territory of a third
country, be approved by the competent authority of the borderinspection post at which the transit formalities are carried out tocertify that the heat-treated milk concerned meets the require-ments of this Directive.
However, an accompanying document shall not be required in the
case of milk transported by the producer for direct delivery to the
final consumer;
9. in the case of cow's milk, it must have a freezing point not higher
than − 0,520 ºC and a weight of not less than 1 028 grammes perlitre, as determined in whole milk at 20 ºC, or the equivalent asdetermined in totally fat-free milk at 20 ºC, and contain a minimum
of 28 grammes of protein per litre, obtained by multiplying the
percentage total nitrogen content of the milk by 6,38, and a fat-freedry matter content of not less than 8,50 %. ►
M2However, a
freezing point higher than − 0,52 ºC shall be acceptable subject tothe checks provided for in Annex C, Chapter 1.A.3 (b) showingthat there is no extraneous water present. ◄
No later than 1 January 1994, these requirements will, upon a
request from a Member State supported by scientific and statisticalstudies, be re-examined witha view to th eir amendment, in accor-dance with the procedure laid down in Article 31 of this Directive,in the light of seasonal considerations, on the understanding that therelationship between the above parameters must be maintained.1992L0046 — EN — 26.05.1994 — 002.001 — 7
▼B
Article 6
Member States shall ensure that milk-based products are manufactured
only from:
1. either raw milk that complies with the requirements set out in
Article 3 and the standards and specifications laid down in Annex
C, Chapter I, and if appropriate has passed through a milk-collection
or a milk-standardization centre fulfilling the conditions laid downin Annex B, Chapters I, II, III, IV and VI;
2. or milk intended for the manufacture of milk-based products
obtained from raw milk which meets the requirements of paragraph
1 and
(a) comes from a treatment establishment which meets the require-
ments of Annex B, Chapters I, II, V and VI;
(b) has been stored and transported in accordance with the require-
ments of Annex C, Chapter V.
Article 7
A. Milk-based products must:
1. have been obtained from milk that meets the requirements of
Article 6 or from milk-based products that satisfy the require-
ments of the present Article;
2. be prepared in a processing establishment that meets the stan-
dards and specifications of Annex B, Chapters I, II, V and VIand has been checked in accordance with Article 10 (2) and
Article 14;
3. meet the standards laid down in Annex C, Chapter II;4. be wrapped and packaged in accordance withAnnex C, Ch apter
III, and, if they are in liquid form and intended for sale to the
final consumer, with point 3 of that Chapter;
5. be labelled in accordance withAnnex C, Ch apter IV;6. be stored and transported in accordance withAnnex C, Ch apter
V;
7. be ch ecked in accordance withArticle 14 and withAnnex C,
Chapter VI;
8. where appropriate, contain only substances, other than milk, that
are fit for human consumption;
9. have undergone heat treatment during the manufacturing process
or be made from products that have undergone heat treatment orinvolve hygiene specifications that are sufficient to meet the
guaranteed hygiene criteria for all finished products.
In addition, milk-based products must meet the requirement in
Article 5 (8) regarding the accompanying commercial document.
B. Pending possible Community rules on ionization, milk and milk-
based products intended for trade must not have been subjected toionizing radiation.
Article 8
1. For the manufacture of cheese with a period of ageing or ripening
of at least 60 days Member States may grant individual or generalderogations as follows:
(a) as regards the characteristics of raw milk, from the requirements of
Annex A, Chapter IV;
(b) provided that the finished product has the characteristics provided
for in Annex C, Chapter II.A, from Article 7 A., points 2 and 4;
(c) from Annex C, Chapter IV.B.2.
General and particular requirements applicable to the manufacture of
individual products and standards specific to this type of product shall1992L0046 — EN — 26.05.1994 — 002.001 — 8
▼B
be adopted, as necessary in accordancy withth e procedure laid down in
Article 31.
2. In accordance withth e procedure laid down in Article 31,
Member States may, in so far as certain requirements of this Directive
are likely to affect the manufacture of milk-based products with tradi-
tional characteristics, be authorized to grant individual or generalderogations from Article 7 A.(1) to (4), provided that the milk used inthe manufacture of such products meets the requirements of Annex A,Chapter I.
Not later than three months before the date specified in Article 32
Member States shall inform the Commission of the list of products in
respect of which they are requesting application of the first subpara-
graph and of the nature of the derogations requested.
When the decision provided for in the first subparagraph is taken, the
general and particular conditions applicable to the manufacture of eachspecific product shall, if necessary, be determined.
3. A list of products ‘made withraw milk’ may be drawn up in
accordance withth e procedure laid down in Article 31.
Article 9
Member States shall ensure that, subject to the provisions of Council
Directive 92/47/EEC of 16 June 1992 on the conditions for grantingtemporary and limited derogations from specific community healthrules on the production and marketing of raw milk and milk-basedproducts(
1):
— treatment or processing establishments receiving raw milk which
does not meet the standards laid down in Annex A, Chapter IV,cannot be approved in accordance withArticles 10 or 11 and th atproducts from such establishments do not bear the health markprovided for in Annex C, Chapter IV, A.3, and cannot be the
subject of trade,
— products which do not meet the standards laid down in Annex C,
Chapters I and II, or standards to be fixed pursuant to Article 8
cannot be the subject of trade or be imported from third countries.
Article 10
1. Each Member State shall draw up a list of processing establish-
ments and treatment establishments approved by it — other than those
referred to in Article 11 — and a list of approved collection centres
and standardization centres. Each such establishment or centre shallhave an approval number.
The competent authority shall not approve the establishments or centres
in question unless it is satisfied that they comply with the requirementsof this Directive.
Where the competent authority finds an obvious failure to comply with
the hygiene rules laid down by this Directive or obstacles to anadequate inspection it shall be empowered:
(i) to act in respect of the use of equipment or premises and to take
any requisite measures which may go as far as limiting or tempora-rily suspending production;
(ii) if the measures provided for in (i) or the measures provided for in
the last indent of the second subparagraph of Article 14 (1) haveproved insufficient, to temporarily suspend approval, if appropriate,for the type of production in question.
If the operator or manager of the establishment or the centre does not
make good the shortcoming noted within the period fixed by thecompetent authority, the latter shall withdraw approval.1992L0046 — EN — 26.05.1994 — 002.001 — 9
(1) See page 33 of this Official Journal.
▼B
The competent authority shall in particular be obliged to comply with
the conclusions of any check carried out in accordance with Article 14.
The other Member States and the Commission shall be informed of the
suspension or withdrawal of approval.
2. Inspection and supervision of establishments or centres shall be
carried out by the competent authority in accordance with Annex C,
Chapter VI.
The establishment or centre shall remain under the permanent supervi-
sion of the competent authority on the understanding that the need forpermanent or periodic presence of the competent authority in a givenestablishment or centre will depend on the size of the establishment or
centre, the type of product manufactured, risk assessment and the guar-
antees offered in accordance with the fifth and sixth indents of thesecond subparagraphof Article 14 (1).
The competent authority must at all times have free access to all parts
of establishments or centres in order to ensure that this Directive isbeing complied with and, where there is doubt as to the origin of milkor milk-based products, to accounting documents which enable the
holding or establishment of origin of the raw material to be traced.
The competent authority must regularly analyse the results of the
checks provided for in Article 14 (1). It may, on the basis of theseanalyses, conduct further examinations at all stages of production oron the products.
The nature of the checks, their frequency and the methods of sampling
and of carrying out microbiological examinations shall be established
in accordance withth e procedure laid down in Article 31.
The results of the analyses shall be written up in a report, the conclu-
sions or recommendations of which shall be notified to the operator ormanager of the establishment or centre, who shall rectify the shortcom-ings noted witha view to improving h ygiene.
3. In the event of repeated shortcomings, checks shall be increased
and, where appropriate, labels or seals bearing the health mark shall beremoved.
4. The detailed rules for the application of this Article shall be
adopted in accordance withth e procedure laid down in Article 31.
Article 11
1. Member States may, when granting approval, grant derogations
from the provisions of Article 7 A.(2), Article 14 (2) and Annex B,
Chapters I and V, to establishments manufacturing milk-based productswhose production is limited.
Member States shall communicate to the Commission not later than
three months before the date specified in Article 32 the criteria whichthey have adopted to assess whether an establishment or a category ofestablishments may benefit from derogations as referred to in the first
subparagraph.
If, after examination of the criteria adopted or following the checks
carried out in accordance withArticle 17, th e Commission considersthat these criteria might jeopardize the uniform application of thisDirective, suchcriteria may be amended or supplemented in accor-dance with the procedure laid down in Article 31. The conditions
under which the competent authority of the Member State shall reclas-
sify the establishments in question shall be laid down by the sameprocedure.
2. On the basis of the information collected by the Commission in
accordance withth e second subparagraphof paragraph1, uniformcriteria for the application of this Article shall be established before 1January 1997 in accordance withth e procedure laid down in Article 31.1992L0046 — EN — 26.05.1994 — 002.001 — 10
▼B
Article 12
Establishments in operation must apply to the competent authority not
later than three months before the date specified in Article 32 for clas-sification on the basis of Article 10 or on the basis of Article 11.
Until such time as a decision has been taken by the competent
authority of the Member State, or until 31 December 1997 at the latest,
all products coming from an establishment which has not been classi-fied must not bear the health mark provided for in Annex C, ChapterIV, A.3 and must be marketed at national level.
Article 13
1. Member States shall ensure that:
— animals on production holdings undergo regular veterinary inspec-
tions to ensure that the requirements of Annex A, Chapter I, arebeing complied with.
These inspections may take place on the occasion of veterinary
checks carried out pursuant to other Community provisions.
If there are grounds for suspecting that the animal health require-
ments laid down in Annex A are not being complied with, thecompetent authority shall check the general state of health of thedairy animals and, should it prove necessary, shall have an addi-tional examination of those animals carried out,
— production holdings shall undergo regular checks to ensure that
hygiene requirements are being complied with.
If the inspection or inspections referred to in the first subparagraph
show that hygiene is inadequate, the competent authority shall take
appropriate steps.
2. Member States shall submit to the Commission the measures
which they intend to take for the purposes of the checks provided forin the second indent of the first subparagraph of paragraph 1. The
frequency of these checks must take account of the assessment of risk
on the production holding concerned.
These measures may be amended or supplemented in accordance with
the procedure laid down in Article 31 in order to ensure uniform imple-mentation of this Directive.
3. The general hygiene conditions to be complied with by produc-
tion holdings, in particular the conditions for the upkeep of premisesand those relating to milking, shall be adopted in accordance with theprocedure laid down in Article 31.
Article 14
1. Member States shall ensure that the operator or manager of the
treatment and/or processing establishment takes all necessary measures
to ensure that, at all stages of production, the relevant specifications of
this Directive are complied with.
To that end, the operator or manager of the establishment must
constantly carry out his own checks based on the following principles:
— identification of critical points in the establishment on the basis of
the processes used,
— monitoring and checking of such critical points by appropriate
methods,
— taking samples for analysis in a laboratory recognized by the
competent authority for the purpose of checking cleaning and disin-fection methods and for the purpose of checking compliance with
the standards established by this Directive,
— keeping a written or registered record of the information required in
accordance withth e preceding indents witha view to submitting itto the competent authority. The results of the different checks andtests shall in particular be kept for a period of at least two years,save in the case of milk-based products which cannot be stored at1992L0046 — EN — 26.05.1994 — 002.001 — 11
▼B
ambient temperature, for which this period shall be reduced to two
months after the use-by or minimum durability date,
— when the laboratory examination or any other information at their
disposal reveals that there is a serious health risk, inform thecompetent authority thereof,
— in the event of an immediate human health risk, withdraw from the
market the quantity of products obtained in technologically similarconditions and likely to present the same risk. This withdrawn
quantity must stay under the supervision and control of the compe-
tent authority until it is destroyed, used for purposes other thanhuman consumption or, after authorization by the competentauthority, reprocessed in an appropriate manner to ensure its safety.
In addition, the operator or manager of the establishment must guar-
antee the correct administration of the health marking.
The requirements of the second subparagraph, first and second indents,
and of the third subparagraph must have been communicated to the
competent authority, which must regularly monitor compliance there-
with.
2. The operator or manager of the establishment must apply or orga-
nize a staff training programme enabling workers to comply with
conditions of hygienic production adapted to the production structure,
unless suchstaff already h ave adequate qualifications attested bydiplomas. The competent authority responsible for the establishmentmust be involved in the planning and implementation of theprogramme or, in the case of a programme already in existence on thedate of notification of this Directive, in the monitoring of the
programme.
3. Where there are reasonable grounds for suspecting that the
requirements of this Directive are not being complied with, the compe-tent authority shall carry out the necessary checks and, if that suspicion
is confirmed, take appropriate measures, up to and including the
suspension of approval.
4. The detailed rules for the application of this Article shall, if
necessary, be determined in accordance withth e procedure laid down
in Article 31.
Article 15
1. By 30 June 1993 at the latest Member States shall submit to the
Commission, in accordance withth e principles and rules of Council
Directive 86/469/EEC of 16 September 1986 concerning the examina-
tion of animals and freshmeat for th e presence of residues(
1), the
national measures to be implemented to extend to raw milk, heat-treated milk and milk-based products examination for:
— residues in group III (antibiotics, sulphonamides and similar anti-
microbial substances) in Annex I, A. to that Directive,
— residues in group II (other residues) in Annex I, B. to that Direc-
tive.
2. Member States shall ensure that in the context of the checks
provided for in Article 14 tests are carried out to detect any residuesof substances having a pharmacological or hormonal action, and ofantibiotics, pesticides, detergents and other substances which are
harmful or which might alter the organoleptic characteristics of milk
or milk-based products or make their consumption dangerous orharmful to human health, insofar as those residues exceed the permittedtolerance limits.
If the milk or milk-based products examined show traces of residues
which exceed the permitted tolerances, they must be excluded fromhuman consumption.1992L0046 — EN — 26.05.1994 — 002.001 — 12
(1) OJ No L 275, 26. 9. 1986, p. 36. Amended by Decision 89/187/EEC (OJ No
L 66, 10. 3. 1989, p. 37).
▼B
Examinations for residues must be carried out in accordance with
proven methods which are scientifically recognized, and in particularthose laid down at Community or international level.
3. The competent authority shall make spot checks on compliance
with the requirements of pharagraph 2.
4. The following shall be established in accordance with the proce-
dure laid down in Article 31:
— the detailed rules for and the frequency of the checks provided for
in paragraph3,
— the tolerances and reference methods provided for in paragraph 2.
In accordance withth e same procedure, a decision may be taken to
extend the examinations to substances other than those referred to inparagraph1.
5. Until the entry into force of the implementing measures for this
Article, national rules shall remain applicable, subject to the generalprovisions of the Treaty.
Article 16
1. Milk tanks, premises, installations and working equipment may be
used for other foodstuffs provided that all appropriate measures aretaken to prevent contamination or deterioration of drinking milk ormilk-based products.
2. Tanks used for milk must bear a clear indication that they may be
used only for the transport of foodstuffs.
3. Where establishments produce foodstuffs containing milk or milk-
based products together with other ingredients which have not under-
gone heat treatment or another treatment having an equivalent effect,suchmilk, milk-based products and ingredients must be stored sepa-rately to prevent cross-contamination, and treated or processed inpremises suitable for the purpose.
4. The detailed rules for the application of this Article, and in parti-
cular the conditions relating to washing, cleaning and disinfectingbefore reuse, and the conditions of transport, shall be adopted in accor-dance withth e procedure laid down in Article 31.
Article 17
Experts from the Commission may, in so far as is necessary for the
uniform application of this Directive and in cooperation with thecompetent authorities, make on-site checks. In particular, they mayverify by checking a representative percentage of establishmentswhether the competent authorities are ensuring that approved establish-
ments are complying with this Directive. The Commission shall inform
the Member States of the results of the checks carried out.
A Member State in whose territory a check is being carried out shall
give all the necessary assistance to the experts in carrying out their
duties.
The detailed rules for the application of this Article shall be adopted in
accordance withth e procedure laid down in Article 31.
Article 18
Member States shall ensure that the manufacture of products covered
by this Directive in which some milk constituents are replaced byproducts other than milk-based products is subject to the hygiene ruleslaid down in this Directive.
Article 19
1. The provisions of Directive 89/662/EEC shall apply, in particular
with respect to the organization of and the action to be taken on thechecks carried out by the Member State of destination and the safe-guard measures to be taken.1992L0046 — EN — 26.05.1994 — 002.001 — 13
▼B
2. Without prejudice to the specific provisions of this Directive, the
competent authority shall, where it is suspected that this Directive isnot being complied with or there is doubt as to whether the products
referred to in Article 1 are fit for consumption, carry out any checks
it deems appropriate.
3. Member States shall take the appropriate administrative or penal
measures to penalize any infringement of this Directive, in particular
where it is found that the certificates or documents drawn up do not
correspond to the actual state of the products referred to in Article 1,that the marks on the products concerned do not comply with the rules,that the products have not undergone the checks provided for in thisDirective or that they were not used for the purpose originallyintended.
Article 20
1. In accordance with the procedure laid down in Article 31, the
following may be established:
— the requirements applicable to any product with authorization to be
placed on the market in a Member State but whose composition orpresentation might give rise to differing interpretation in differentMember States,
— the methods for checking that the hermetically sealed containers are
impervious,
— the reference methods and, where necessary, the criteria governing
routine methods of analysis and testing to be used to monitorcompliance with the requirements of this Directive, and themethods of sampling,
— limits and methods to enable a distinction to be made between
different types of heat-treated milk as defined in Annex C, Chapter
I,
— the methods of analysis for the standards referred to in Annex A,
Chapter IV, and in Annex C, Chapter I and II.
Pending the decisions referred to in the first subparagraph, any interna-
tionally accepted analysis and test methods shall be recognized as
reference methods.
2. By way of derogation from Articles 3 and 6, it may be decided, in
accordance with the procedure laid down in Article 31, that someprovisions of this Directive shall not apply to milk-based products
containing other foodstuffs, where percentage of milk or milk-based
product is not essential within the meaning of Article 2 (4).
The derogations referred to in the first subparagraph may not relate to:
(a) the animal health requirements laid down in Annex A, Chapter I
and the conditions for approval of establishments laid down in
Annex B, Chapter I;
(b) the marking requirements laid down in Annex C, Chapter IV;
(c) the inspection requirements laid down in Annex C, Chapter VI.
In granting derogations both the nature and the composition of the
product shall be taken into account.
3. Notwithstanding paragraph 2, Member States shall ensure that all
milk-based products placed on the market are wholesome productsprepared from milk or from milk-based products meeting the require-
ments of this Directive.
Article 21
The Council, acting by a qualified majority on a proposal from the
Commission, shall amend the Annexes as necessary, in particular toadapt them to take account of scientific and technological progress.1992L0046 — EN — 26.05.1994 — 002.001 — 14
▼B
CHAPTER III
Importsfromthirdcountries
Article 22
The conditions applicable to imports from third countries of raw milk,
heat-treated milk and milk-based products covered by this Directive
must be at least equivalent to those laid down in Chapter II forCommunity production.
Article 23
1. For the purposes of uniform application of Article 22, the provi-
sions of the following paragraphs shall apply.
2. In order to be imported into the Community, milk or milk-based
products must:
(a) come from a third country on the list to be drawn up in accordance
withparagraph3 (a);
(b) be accompanied by a health certificate corresponding to a specimen
to be drawn up in accordance withth e procedure laid down inArticle 31, signed by the competent authority of the exportingcountry and certifying that the milk or milk-based products meet
the requirements of Chapter II or any additional conditions or offer
the equivalent guarantees referred to in paragraph 3 and come fromestablishments offering the guarantees provided for in Annex B.
3. The following shall be established in accordance with the proce-
dure laid down in Article 31:
(a) a provisional list of third countries or parts of third countries able
to provide Member States and the Commission with guaranteesequivalent to those provided for in Chapter II and a list of the
establishments for which they are able to give these guarantees.
This provisional list shall be compiled from the lists of establish-
ments approved and inspected by the competent authorities, once
the Commission has checked that these establishments complywith the principles and general rules laid down in this Directive;
(b) updates of that list in the light of the checks provided for in para-
graph4;
(c) the specific requirements and equivalent guarantees established for
third countries, which may not be more favourable than thoseprovided for in Chapter II;
(d) the types of heat treatment to be prescribed for certain third coun-
tries presenting an animal health risk.
4. Experts from the Commission and the Member States shall carry
out on-the-spot inspections to verify whether the guarantees given bythe third country regarding the conditions of production and placingon the market can be considered equivalent to those applied in theCommunity.
The experts from the Member States responsible for these inspections
shall be appointed by the Commission, acting on a proposal from theMember States.
These inspections shall be made on behalf of the Community, which
shall bear the cost of any expenditure in this connection. The frequencyof and procedure for these inspections, including those to be carried outin the event of a decision in accordance with paragraph 6, shall bedetermined in accordance withth e procedure laid down in Article 31.
5. Pending the organization of the inspections referred to in para-
graph 4, national rules applicable to inspection in third countries shallcontinue to apply, subject to notification, through the Standing Veter-inary Committee, of any failure to comply withh ygiene rules foundduring these inspections.1992L0046 — EN — 26.05.1994 — 002.001 — 15
▼B
6. The Council, acting by a qualified majority on a proposal from
the Commission, may replace individual recognition of treatment orprocessing establishments by recognition, on a reciprocal basis, of
establishments in a third country which are subject to effective, regular
inspection by the competent authority such that the said authority isable to guarantee compliance withth e requirements of paragraph2(b).
Article 24
The principles and general rules laid down in Directive 90/675/EEC
shall apply, with particular reference to the organization of and followup to the inspections to be carried out by the Member States and the
safeguard measures to be implemented.
Article 25
1. Member States shall ensure that the products covered by this
Directive are imported into the Community only if:
— they are accompanied by a certificate to be issued by the competent
authority of the third country at the time of loading.
The specimen certificate shall be drawn up in accordance with the
procedure laid down in Article 31,
— they have satisfied the checks required by Directive 90/675/EEC
and 91/496/EEC(
1).
2. Pending the establishment of detailed rules for the application of
this Article, the national rules applicable to imports from third coun-
tries for which such requirements have not been adopted at
Community level shall continue to apply, provided they are not morefavourable than those laid down in Chapter II.
Article 26
The lists provided for in Article 23 may include only third countries or
parts of third countries:
(a) from which imports are not prohibited as a result of the existence
of diseases as referred to in Annex A or of any other disease exoticto the Community or pursuant to Articles 6, 7 and 14 of Directive72/462/EEC(
2);
(b) which, in view of their legislation and the organization of their
competent authority and of their inspection services, the powers of
such services and the supervision to which they are subject, have
been recognized, in accordance withArticle 3 (2) of Directive 72/462/EEC, as capable of guaranteeing the implementation of theirlegislation in force;
(c) the veterinary services of which are able to guarantee that health
requirements at least equivalent to those laid down in Chapter IIare being complied with.
CHAPTER IV
Finalprovisions
Article 27
1. EachMember State sh all designate one or more national refer-
ence laboratories for the analysis and testing of milk and milk-basedproducts, and shall forward a list thereof to the Commission.1992L0046 — EN — 26.05.1994 — 002.001 — 16
(1) Council Directive 91/496/EEC of 15 July 1991 laying down the principles
governing the organization of veterinary checks on animals entering the
Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC (OJ No L 268, 24. 9. 1991, p. 56).
(
2) Council Directive 72/462/EEC of 12 December 1972 on health and veter-
inary inspection problems upon importation of bovine animals and swine
and freshmeat from th ird countries (OJ No L 302, 31. 12. 1972, p. 28).
Last amended by Directive 91/497/EEC (OJ No L 268, 24. 9. 1991, p. 69).
▼B
These laboratories shall be responsible for:
— coordinating the activities of the laboratories whose task it is to
conduct analyses to check the chemical or bacteriological standards
and to conduct the tests provided for in this Directive,
— assisting the competent authority in organizing the system of
checking milk and milk-based products,
— periodically organizing comparative tests,
— disseminating the information supplied by the Community reference
laboratory referred to in Article 28 to the competent authorities andthe laboratories carrying out analyses and tests on milk and milk-
based products.
2. The Commission shall publish the list of national reference
laboratories and updates thereof in the Official Journal of the European
Communities .
Article 28
The Community reference laboratory for the analysis and testing of
milk and milk products is indicated in Annex D, Chapter I.
The duties and tasks of that laboratory are set out in Chapter II of that
Annex and include the coordination of the activities of the nationalreference laboratories referred to in Article 27.
Article 28 of Council Decision 90/424/EEC of 26 June 1990 on expen-
diture in the veterinary field(
1) shall apply.
Article 29
1. Directive 85/397/EEC is hereby repealed with effect from 1
January 1994.
2. Council Directive 89/384/EEC of 20 June 1989 establishing the
detailed procedures for carrying out checks to ensure that the freezingpoint of untreated milk laid down in Annex A of Directive 85/397/EEC(
2) is complied with, Commission Directive 89/362/EEC of 26
May 1989 on general conditions of hygiene in milk production hold-
ings(3) and Commission Decision 91/180/EEC of 14 February 1991
laying down certain methods of analysis and testing of raw milk andheat-treated milk(
4) shall continue to apply for the purposes of the
present Directive.
In accordance with the procedure laid down in Article 31, these acts
may be amended to adapt the scope thereof to the content of thepresent Directive or to adapt them subsequently to advances in scienceand technology.
Article 30
Directive 89/662/EEC shall be amended as follows:
1. the following indent shall be added to Annex A:
‘— Council Directive 92/46/EEC of 16 June 1992 laying down the
health rules for the production and placing on the market of rawmilk, heat-treated milk and milk-based products (OJ No L 268,14. 9. 1992, p. 1).’;
2. the following indent shall be deleted from Annex A:
‘— Council Directive 85/397/EEC of 5 August 1985 on health and
animal health problems affecting intra-Community trade inheat-treated milk (OJ No L 226, 24. 8. 1985, p. 13), as last1992L0046 — EN — 26.05.1994 — 002.001 — 17
(1) OJ No L 224, 18. 8. 1990, p. 19. Last amended by Decision 91/133/EEC
(OJ No L 66, 13. 3. 1991, p. 18).
(2) OJ No L 181, 28. 6. 1989, p. 50.
(3) OJ No L 156, 8. 6. 1989, p. 30.
(4) OJ No L 93, 13. 4. 1991, p. 1.
▼B
amended by Regulation (EEC) No 3768/85 of 20 December
1985 (OJ No L 362, 31. 12. 1985, p. 8).’;
3. the following indent shall be deleted from Annex B:
‘— raw milk and milk-based products.’.
Article 31
1. Where the procedure laid down in this Article is to be followed,
matters shall without delay be referred to the Standing VeterinaryCommittee set up by Decision 68/361/EEC(
1), hereinafter referred to
as ‘the Committee’, by its Chairman, either on his own initiative or atthe request of the representative of a Member State.
2. The representatives of the Commission, after consulting the
Management Committee for Milk and Milk Products established by
Regulation (EEC) No 804/68 where matters of chemistry or technologyare involved, shall submit to the Committee a draft of the measures tobe taken. The Committee shall deliver its opinion on such measureswithin a time limit which the Chairman may lay down according tothe urgency of the matter. The opinion shall be delivered by the
majority laid down in Article 148 (2) of the Treaty in the case of deci-
sions which the Council is required to adopt on a proposal from theCommission. Within the Committee the votes of the representatives ofthe Member States shall be weighted in the manner set out in Article148 (2) of the Treaty. The Chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged and imple-
ment them immediately if they are in accordance with the
opinion of the Committee.
(b) Where the measures envisaged are not in accordance with the
opinion of the Committee, or if no opinion is delivered, theCommission shall without delay submit to the Council a
proposal relating to the measures to be taken. The Council shall
act by a qualified majority.
If, within three months of the date of referral to the Council, the
Council has not acted, the proposed measures shall be adopted
by the Commission, except where the Council has rejected those
measures by a simple majority.
Article 32
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply withth is Directivebefore 1 January 1994. They shall forthwith inform the Commissionthereof.
When Member States adopt these measures, they shall contain a refer-
ence 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.
2. Member States shall communicate to the Commission the text of
the main provisions of national law which they adopt in the fieldgoverned by this Directive.
3. The setting of the deadline for transposition into national law at 1
January 1994 shall be without prejudice to the abolition of veterinarychecks at frontiers provided for in Directive 89/662/EEC.
Article 33
This Directive is addressed to the Member States.1992L0046 — EN — 26.05.1994 — 002.001 — 18
(1) OJ No L 225, 18. 10. 1968, p. 23.
▼B
ANNEX A
REQUIREMENTSRELATINGTOTHEACCEPTANCEOFRAWMILK
ATTREATMENTAND/ORPROCESSINGESTABLISHMENTS
CHAPTER I
Animalhealthrequirementsforrawmilk
1. Raw milk must originate as follows:
(a) from cows or buffaloes:
(i) belonging to a herd which, pursuant to paragraph 1 of Annex A to
Directive 64/432/EEC, is;
— officially tuberculosis-free,
— brucellosis-free or officially brucellosis-free;
(ii) which do not show any symptoms of infectious diseases communic-
able to human beings through milk;
(iii) incapable of giving the milk abnormal organoleptic characteristics;
(iv) whose general state of health is not impaired by any visible disorder
and which are not suffering from any infection of the genital tract
withdisch arge, enteritis withdiarrh oea and fever, or a recognizable
inflammation of the udder;
(v) which do not show any udder wound likely to affect the milk;
(vi) which, in the case of cows, yield at least two litres of milk per day;
(vii) which have not been treated with substances dangerous or likely to
be dangerous to human health that are transmissible to milk, unless
the milk has complied with an official waiting period laid down in
Community provisions or, if absent, in national provisions;
(b) from sheep and goats:
(i) belonging to a sheep and goat holding officially free or free of
brucellosis ( Brucella melitensis ) within the meaning of Article 2 (4)
and (5) of Directive 91/68/EEC;
(ii) which satisfy the requirements laid down in (a), with the exception
of those in points (i) and (vi).
Milk and milk products must not come from a surveillance zone defined in
accordance with Directive 85/511/EEC unless the milk has undergone
pasteurization (71,7 ºC for 15 seconds) under the supervision of the compe-
tent authority.
2. When different animal species are kept together on the holding, each species
must satisfy the health conditions which would be required if it were alone.
3. If goats are kept together with cows they must undergo a tuberculosis check
in accordance witharrangements to be determined in accordance withth e
procedure laid down in Article 31 of this Directive.
4. Raw milk must be excluded from treatment, processing, sale and consump-
tion if it:
(a) is obtained from animals to which substances within the meaning of
Directives 81/602/EEC(1) and 88/146/EEC(2) have been administered
illegally;
(b) contains residues of substances within the meaning of Article 15 of this
Directive which exceed the permitted level.
CHAPTER II
Hygieneoftheholding
1. The raw milk must come from holdings which are registered and checked in
accordance with Article 13 (1). Where buffaloes, sheep and goats are not1992L0046 — EN — 26.05.1994 — 002.001 — 19
(1) Council Directive 81/602/EEC of 31 July 1981 concerning the prohibition of certain
substances having a hormonal action and of any substances having a thyrostatic action
(OJ No L 222, 7. 8. 1981, p. 32). Last amended by Directive 85/358/EEC (OJ No L191, 23. 7. 1985, p. 46).
(
2) Council Directive 88/146/EEC of 7 March 1988 prohibiting the use in livestock
farming of certain substances having a hormonal action (OJ No L 70, 16. 3. 1988, p.
16).▼M1
▼B
▼B
kept in the open, the premises used must be designed, constructed, main-
tained and managed in sucha way as to ensure:
(a) good conditions of housing, hygiene, cleanliness and health of the
animals; and
(b) satisfactory hygiene conditions for milking, handling, cooling and storing
milk.
2. Premises where milking is performed or milk is stored, handled or cooled
must be so sited and constructed as to avoid all risk of contamination of the
milk. They must be easy to clean and disinfect and have at least:
(a) walls and flooring which are easy to clean in those areas liable to soiling
or infection;
(b) flooring laid in sucha way as to facilitate th e draining of liquids and
satisfactory means of disposing of waste;
(c) adequate ventilation and lighting;
(d) an appropriate and sufficient supply of potable water, complying withth e
parameters laid down in Annexes D and E to Directive 80/778/EEC(1),
for use in milking and in cleaning the equipment and instruments
referred to in Chapter III B of this Annex;
(e) adequate separation from all sources of contamination suchas lavatories
and dung heaps;
(f) fittings and equipment which are easy to wash, clean and disinfect.
In addition, premises for the storage of milk must have suitable milk refrig-
eration 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 freshground wh ichis 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. Where milk-producing animals are kept untethered in the open, the holding
must also have a milking parlour or milking area adequately separated from
the housing area.
5. The isolation of animals which are infected, or suspected of being infected,
with any of the diseases referred to in Chapter I.1 or the separation of the
animals referred to in Chapter I.3 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.
CHAPTER III
Hygiene in milking, the collection of raw milk and its transport from the
production holding to the collection or standardization centre or to the
treatmentestablishmentorprocessingestablishment—Hygiene ofstaff
A.Hygiene in milking
1. Milking must be carried out hygienically and under the conditions estab-
lished by Directive 89/362/EEC.
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 ºC or lower in the case of daily collection or 6 ºC or
lower if collection is not daily. While the milk is being transported to the
treatment and/or processing establishment its temperature must not
exceed 10 ºC.1992L0046 — EN — 26.05.1994 — 002.001 — 20
(1) Council Directive 80/778/EEC of 15 July 1980 relating to the quality of water intended
for human consumption (OJ No L 229, 30. 8. 1980, p. 11). Last amended by Directive
90/656/EEC (OJ No L 353, 17. 12. 1990, p. 59).
▼B
B.Hygiene of premises, equipment and tools
1. Equipment and instruments or their surfaces which are intended to come
into contact withmilk (utensils, containers, tanks, etc., intended for
milking, collection or transport) must be made of smoothmaterial wh ich
is easy to clean and disinfect, resists corrosion and does not transfer
substances to the milk in such quantities as to endanger human health,
impair the composition of the milk or adversely affect its organoleptic
characteristics.
2. After use, the utensils used for milking, the mechanical milking equip-
ment and the containers which come into contact with the milk must be
cleaned and disinfected. After eachjourney, or after eachseries of jour-
neys 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 standar-
dization centre or to the milk treatment or processing establishment must
be cleaned and disinfected before reuse.
C.Staff hygiene
1. Absolute cleanliness shall be required of staff. Specifically:
(a) persons performing milking and handling raw milk must wear
suitable clean milking clothes;
(b) milkers must wash their hands immediately before the milking
commences and keep them clean as far as practicable throughout the
milking.
For this purpose, near the place of milking, suitable facilities are
required to enable persons performing milking or handling raw milk
to wash their hands and arms.
2. The employer shall take all the requisite measures to prevent persons
liable to contaminate raw milk from handling it, until there is evidence
that such persons can do so without risk of contamination.
Any person performing milking or handling raw milk shall be required to
show that there is no medical impediment to such employment. The
medical supervision of such a person shall be governed by the national
legislation in force in the Member State concerned or in the case of third
countries by specific guarantees to be fixed under the procedure laid
down in Article 31 of this Directive.
D.Production hygiene
1. A monitoring system shall be established under the supervision of the
competent authority to prevent water being added to raw milk. This
system shall in particular include regular checks on the freezing point of
milk from eachproduction facility, in accordance withth e following
procedure:
(a) the raw milk of each holding must be checked regularly by random
sampling. Where the milk of a single holding is delivered directly to
a treatment or processing establishment, these samples are to be taken
either when the milk is collected from the holding, provided that
precautions are taken to prevent any fraud during transport, or before
unloading at the treatment or processing establishment when the milk
is delivered there directly by the farmer.
If the results of a check lead the competent authority to suspect that
water is being added, it shall take an authentic sample on the holding.
An authentic sample is a sample representing the milk of one comple-
tely supervised morning or evening milking beginning not less than
eleven hours or more than thirteen hours after the previous milking.
Where milk is delivered from several holdings, samples may only be
taken when the raw milk enters the treatment or processing establish-
ment or collection or standardization centre, provided that spot
checks are, however, carried out on the holdings.
If the results of a check lead to suspicion that water has been added,
samples shall be taken at all holdings which took part in the collec-
tion of the raw milk at issue.
If necessary, the competent authority shall take authentic samples
within the meaning of the second subparagraph above;
(b) if the results of the check show that water has not been added, the
raw milk may be used for producing raw drinking milk, heat-treated
milk or milk for the manufacture of milk-based products for human
consumption.1992L0046 — EN — 26.05.1994 — 002.001 — 21
▼B
2. The treatment and/or processing establishment shall inform the competent
authority when the maximum standards fixed for the plate count and
somatic cell count have been reached. The competent authority shall
take the appropriate measures.
3. If, within three months of notification of the results of the checks referred
to in point 1 (a) and of the investigation provided for in Chapter IV.D,
and after the standards of Chapter IV have been exceeded, milk from
the holding in question does not meet those standards, that holding shall
no longer be authorized to supply raw milk until such milk again meets
the said standards.
Milk must not be used for human consumption if it contains antibiotic
residues in a quantity which, in respect of any one of the substances
referred to in Annexes I and III to Regulation (EEC) No 2377/90(1),
exceeds the levels authorized therein; the combined total of residues of
antibiotic substances may not exceed a value to be fixed in accordance
with the procedure laid down in Article 31 of this Directive.
CHAPTER IV
Standardstobemetforcollectionofrawmilkfromtheproductionholding
orforacceptanceattreatmentorprocessingestablishments
A.Raw cow's milk
Without prejudice to the limits laid down in Annexes I and III to Regulation
(EEC) No 2377/90:
1. Raw cow's milk intended for the production of heat-treated drinking milk,
fermented milk, junket, jellied or flavoured milk and cream must meet
the following standards:
Plate counti 30 ºC (per ml) ≤100000(a)
Somatic cell count (per ml) ≤400000(b)
(a) Geometric average over a period of two months, with at least two samples a
month.
(b) Geometric average over a period of three months, with at least one sample a
month, or, where production levels vary considerably according to season,
method of calculating results to be adjusted in accordance with the procedure
laid down in Article 31 of this Directive.
2. Raw cow's milk for the manufacture of milk-based products other than
those referred to in point 1 must meet the following standards:
from 1. 1. 1994 from 1. 1. 1998
Plate count 30 ºC (per ml) ≤400000 (a) ≤100000(a)
Somatic cell count (per ml) ≤500000 (b) ≤400000(b)
(a) Geometric average over a period of two months, with at least two samples a
month.
(b) Geometric average over a period of three months, with at least one sample a
month, or, where production levels vary considerably according to season,
method of calculating results to be adjusted in accordance with the procedure
laid down in Article 31 of this Directive.1992L0046 — EN — 26.05.1994 — 002.001 — 22
(1) Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community
procedure for the establishment of maximum residue limits of veterinary medicinalproducts in foodstuffs of animal origin (OJ No L 224, 18. 8. 1990, p. 1). Last amended
by Commission Regulation (EEC) No 675/92 (OJ No L 73, 19. 3. 1992, p. 8).
▼B
3. Raw cow's milk intended for direct human consumption and raw cow's
milk for the manufacture of products ‘made with raw milk’ whose manu-
facturing process does not involve any heat treatment must:
(a) meet the standards of point 1;
(b) in addition meet the following standard(1):
Staphylococcus aureus (per ml):
n= 5
m = 500
M = 2 000
c= 2 .
B.Raw buffalo milk
Without prejudice to compliance with the limits laid down in Annexes I and
III to Regulation (EEC) No 2377/90:
1. Raw bufallo milk for the manufacture of milk-based products must meet
the following standards:
from 1. 1. 1994
Plate count 30 ºC (per ml) ≤1000000 (a)
Somatic cell count (per ml) ≤500000 (b)
(a) Geometric average over a period of two months, with at least two samples a
month.
(b) Geometric average over a period of three months, with at least one sample a
month.
The standards for plate count at 30 ºC and somatic cell count to apply as
from 1 January 1998 will be set in accordance withArticle 21 of th is
Directive.
2. Raw bufallo milk intended for the manufacture of products ‘made with
raw milk’ whose manufacturing process does not involve any heat treat-
ment must meet the following requirements:
plate count 30 ºC (per ml): ≤500000
somatic cell count (per ml): ≤400000
staphylococcus aureus: as for cow's milk.
C.Raw goat's milk and sheep's milk:
Without prejudice to compliance with the limits laid down in Annexes I and
III to Regulation (EEC) No 2377/90:
1. Raw goat's milk or sheep's milk intended for the production of heat-
treated drinking milk or for the manufacture of heat-treated milk-based
products must meet the following standards:
from 1. 1. 1994
Plate count 30 ºC (per ml) ≤1 000000 (a)
(a) Geometric average over a period of two months, with at least two samples a
month.1992L0046 — EN — 26.05.1994 — 002.001 — 23
(1) 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 unsatisfac-
tory if the number of bacteria in one or more sample units is ‘M’, or more;
c = number of sample units where the bacteria count may be between ‘m’ and ‘M’,
the sample being considered acceptable if the bacteria count of the other sample
units is ‘m’ or less.
▼B
The standards relating to the plate count and somatic cell count applic-
able as from 1 January 1998 will be determined in accordance with
Article 21 of this Directive.
2. Raw goat's or sheep's milk intended for the manufacture of products
‘made withraw milk’ wh ose manufacturing process does not involve
any heat treatment must meet the following standards:
Plate count 30 ºC (per ml) ≤500000 (a)
Staphylococcus aureus (per ml) as for raw cow's milk
(a) Geometric average over a period of two months, with at least two samples a
month.
D. When the maximum standards laid down in A, B and C are exceeded and
when subsequent investigation indicates a potential danger to health, the
competent authority shall take appropriate measures.
E. Compliance with the standards of A, B and C must be checked by random
sampling, either on collection at the production holding or on acceptance of
the raw milk at the treatment or processing establishment.1992L0046 — EN — 26.05.1994 — 002.001 — 24
▼B
ANNEX B
CHAPTER I
Generalconditionsforapprovaloftreatmentestablishmentsandprocessing
establishments
Treatment establishments and processing establishments shall have at least:
1. working areas of sufficient size for work to be carried out under adequate
hygienic conditions. Their design and layout shall be such as to preclude
contamination of the raw materials and products covered by this Directive.
Production of heat-treated milk or manufacture of milk-based products
which might pose a risk of contamination to other products covered by
this Directive must be carried out in a clearly separated working area;
2. in areas where the raw materials are handled, prepared and processed and
the products referred to in this Directive manufactured:
(a) solid, waterproof flooring which is easy to clean and disinfect and laid
in sucha way as to facilitate th e drainage of water and provided with
equipment to remove water;
(b) walls which have smooth surfaces and are easy to clean, durable and
impermeable, covered witha ligh t-coloured coating;
(c) in premises where exposed, non-packaged raw materials or products are
handled, prepared or processed, ceilings or roof linings which are easy
to clean;
(d) doors in non-corrodible materials which are easy to clean;
(e) adequate ventilation and, where necessary, good steam and water-
vapour extraction facilities;
(f) adequate natural or artificial lighting;
(g) an adequate number of facilities withh ot and cold running water, or
water pre-mixed to a suitable temperature, for cleaning and disinfecting
hands. In work rooms and lavatories taps must not be hand-operable.
These facilities must be provided with cleaning and disinfecting
products and hygienic means of drying hands;
(h) facilities for cleaning tools, equipment and installations;
3. in rooms where the raw materials and the products covered by this Directive
are stored, the same conditions as those at 2, except in:
— chilling and refrigeration rooms, where a floor which is easy to clean
and disinfect and laid in sucha way as to facilitate th e draining of water
is sufficient,
— freezing and deep-freezing rooms, where waterproof and rotproof
flooring which is easy to clean is sufficient.
In suchcases, a sufficiently powerful refrigeration plant to keep th e raw
materials and products at the temperatures prescribed in this Directive
must be available.
The use of wooden walls in the rooms referred to in the second indent of
the first subparagraph does not constitute grounds for withdrawing approval
provided they were built before 1 January 1993.
The capacity of the storerooms must be adequate to store the raw materials
used and the products covered by this Directive;
4. facilities for hygienic handling and protection of raw materials and non-
packaged or wrapped finished products during loading and unloading;
5. appropriate arrangements for protection against pests;
6. instruments and working equipment intended to come into direct contact
withraw materials and products made of corrosion-resistant material and
easy to clean and disinfect;
7. special watertight, non-corrodible containers in which to put raw materials
or products not intended for human consumption. Where such raw materials
or products are removed through conduits, these must be so constructed and
installed as to avoid any risk of contamination of the other raw materials or
products;
8. appropriate facilities for the cleaning and disinfecting of equipment and
utensils;
9. a waste water disposal system which meets hygiene requirements;
10. a supply of potable water only, within the meaning of Directive 80/778/
EEC. However, the supply of non-potable water is authorized in exceptional
cases for steam production, fire-fighting and refrigeration equipment,1992L0046 — EN — 26.05.1994 — 002.001 — 25
▼B
provided that the pipes installed for this purpose preclude the use of this
water for other purposes and present no direct or indirect risk of contamina-
tion of the product. Non-potable water pipes must be clearly distinguished
from those used for potable water;
11. an appropriate number of changing rooms with smooth, waterproof, wash-
able walls and floors, washbasins and flushlavatories. Th e latter must not
open directly on to the work rooms. Wash basins must be equipped for
hand-washing and have hygienic means of drying hands; wash-basin taps
must not be hand-operable;
12. if the volume of products treated requires regular or permanent presence, an
adequately equipped lockable room for the exclusive use of the competent
authority;
13. a room or a secure place for the storage of detergents, disinfectants and
similar substances;
14. a room or cupboard for storing cleaning and maintenance material;
15. adequate facilities for cleaning and disinfecting tanks used for transporting
milk and liquid or powdered milk-based products. However, suchfacilities
are not compulsory if there is a requirement for the means of transport to be
cleaned and disinfected in installations officially approved by the competent
authority.
CHAPTER II
General conditions of hygiene in treatment establishments and processing
establishments
A.General conditions of hygiene applicable to premises, equipment and tools
1. Equipment and instruments used for working on raw materials and
products, floors, ceilings or roof linings, walls and partitions, must be
kept in a satisfactory state of cleanliness and repair, so that they do not
constitute a source of contamination for raw materials or products.
2. No animals may enter rooms in which milk and milk-based products are
manufactured and stored. Rodents, insects and any other vermin must be
systematically exterminated in the premises or on the equipment. Roden-
ticides, insecticides, disinfectants and any other potentially toxic
substances must be stored in rooms or cupboards which can be locked;
their use must not present any risk of contamination of the products.
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.
4. Potable water, within the meaning of Directive 80/778/EEC, must be used
for all purposes. However, by way of exception, non-potable water may
be used for the cooling of equipment, steam production and fire-fighting,
provided that the pipes installed for the purpose preclude the use of such
water for other purposes and present no risk of contamination of the raw
materials and products covered by this Directive.
5. Disinfectants and similar substances must be approved by the competent
authority and used in such a way that they do not have adverse effects on
the machinery, equipment, raw materials and products covered by this
Directive.
Their containers must be clearly identifiable and must bear labels with
instructions for their use.
Their use must be followed by thorough rinsing of such instruments and
working equipment withpotable water.
B.General conditions of hygiene applicable to staff
1. Absolute cleanliness is required of staff. This applies particularly to
persons handling exposed, non-packaged raw materials and products
covered by this Directive. Specifically:
(a) staff must wear suitable clean working clothes and clean headgear
which completely encloses the hair;
(b) staff assigned to the handling and preparation of raw materials and
products covered by this Directive must be required to wash their
hands at least each time work is resumed and/or where contamination
has occurred; wounds to the skin must be covered by a waterproof
dressing;1992L0046 — EN — 26.05.1994 — 002.001 — 26
▼B
(c) smoking, spitting, eating and drinking in rooms where raw materials
and products covered by this Directive are worked on or stored shall
be prohibited.
2. The employer shall take all the requisite measures to prevent persons
liable to contaminate the products covered by this Directive from hand-
ling them, until there is evidence that such persons can do so without
risk of contamination.
When recruited, any person working on and handling the products
covered by this Directive shall be required to prove, by a medical certifi-
cate, that there is no medical impediment to such employment. The
medical supervision of such a person shall be governed by the national
legislation in force in the Member State concerned or, in the case of third
countries, by specific guarantees to be fixed under the procedure laid
down in Article 31 of this Directive.
CHAPTER III
Specialrequirementsforregistrationofcollection centres
In addition to the general requirements laid down in Chapter I, collection
centres must have at least:
(a) cooling equipment or appropriate means for cooling milk and, if milk is
stored at the collection centre, a cold-storage installation;
(b) if milk is purified at the collection centre, centrifuges or any other apparatus
suitable for the physical purification of milk.
CHAPTER IV
Specialrequirementsforregistrationofstandardizationcentres
In addition to the general requirements laid down in Chapter I, 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 apparatus suitable for the physical purification of
milk.
CHAPTER V
Special requirements for the approval of treatment establishments and
processingestablishments
In addition to the general requirements laid down in Chapter I, treatment estab-
lishments and processing 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, insofar as such operations are
carried out there;
(b) equipment for the cooling and cold storage of heat-treated milk, liquid milk-
based products and, in the cases provided for in Annex A, Chapters III and
IV, raw milk, in so far as suchoperations are carried out th ere. Cold stores
must be equipped withcorrectly calibrated temperature-measuring appa-
ratus;
(c) — in the case of wrapping 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 wrapping in re-usable containers, a special area for their
storage and equipment designed to clean and disinfect them mechani-
cally;
(d) containers for storing raw milk, standardization equipment and containers
for storing standardized milk;
(e) if appropriate, centrifuges or any other suitable means for physically puri-
fying 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 ster-
ilized milk withincompletely h eated milk, and1992L0046 — EN — 26.05.1994 — 002.001 — 27
▼B
— an automatic recording device for the safety system referred to in the
preceding indent;
(g) equipment for the cooling, wrapping and storage of frozen milk-based
products in so far as suchoperations are carried out th ere;
(h) equipment for drying and wrapping powdered milk-based products insofar
as suchoperations are carried out th ere.
CHAPTER VI
Hygienerequirementsrelatingtothepremisesequipmentandstaffoftreat-
mentestablishmentsandprocessingestablishments
In addition to the general requirements laid down in Chapter II, establishments
must comply withth e following conditions:
1. Cross-contamination between operations by equipment, ventilation or staff
must be avoided. If appropriate, and in the light of the risk analysis referred
to in Article 14 of this Directive, rooms intended for production processes
shall be divided into wet and dry areas, each having its own operating condi-
tions.
2. As soon as possible after eachjourney, or after eachseries of journeys wh ere
there is only a very short space of time between unloading and the following
loading, but in any event at least once eachworking day, containers and
tanks used for transporting raw milk to the milk collection or standardization
centre or to the milk treatment or processing establishment must be cleaned
and disinfected before reuse.
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 disinfected at the end of each work phase and at least once
eachworking day.
4. The treatment premises must in principle be cleaned at least once each
working day.
5. For the cleaning of other equipment, containers and installations which come
into contact withmicrobiologically stable milk-based products and with
rooms in which such substances are placed, the operator or manager of the
establishment shall draw up a cleaning programme based on the risk analysis
referred to in Article 14 of this Directive. This programme must meet the
requirement referred to in point 1 of this Chapter and must also ensure that
there is no health risk to products covered by this Directive as a result of
inadequate cleaning methods.1992L0046 — EN — 26.05.1994 — 002.001 — 28
▼B
ANNEX C
CHAPTER I
Requirements for the manufacture of heat-treated milk and milk-based
products
A.Requirements for the production of heat-treated drinking milk
1. Heat-treated drinking milk must be obtained from raw milk which
complies with the standards laid down in Annex A, Chapter IV.
2. Upon acceptance at a treatment establishment milk must, unless treated
within four hours of acceptance, be cooled to a temperature not exceeding
+ 6 ºC and maintained at that temperature until heat-treated.
If raw milk is not treated within 36 hours of acceptance, a further test
must be carried out on that milk before it is heat-treated. If it is found
by means of a direct or indirect method that the plate count of that milk
at 30 ºC exceeds 300 000 per ml the milk in question must not be used
for the production of heat-treated drinking milk.
3. The manufacture of heat-treated drinking milk shall include all necessary
measures, in particular random sampling checks, relating to:
(a) the plate count, to ensure that:
— raw milk, if it is not treated within 36 hours of acceptance, does
not exceed immediately before heat treatment a plate count at
30 ºC of 300000 per ml,
— milk which has been subjected to a previous pasteurzation has,
immediately before the second heat treatment, a plate count at
30 ºC not exceeding 100 000 per ml;
(b) the presence of extraneous water in the milk
Heat-treated drinking milk shall be subjected to regular checks for 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 appropriate
measures.
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 III D.1, and in particular their variation and average,
— the effect of storage and processing of milk under Good Manufac-
turing Practices (GMP) on the freezing point.
Member States shall communicate to the Commission all details of
the control system which they apply and its justification before 1
June 1994.
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 met in this regard shall be established in accordance with the
procedure laid down in Article 31 of this Directive.
4. (a)Pasteurized milk must:
(i) have been obtained by means of a treatment involving a high
temperature for a short time (at least 71,7 ºC for 15 seconds or
any equivalent combination) or a pasteurization process using
different time and temperature combinations to obtain an equiva-
lent effect;
(ii) 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 periox-
idase test is authorized, provided that the milk is labelled as
‘high-temperature pasteurized’;
(iii) immediately after pasteurization, have been cooled to a tempera-
ture not exceeding 6 ºC as soon as possible.
(b)UHT milk must:
— have been obtained by applying to the raw milk a continuous flow
of heat entailing the application of a high temperature for a short
time (not less than + 135 ºC for not less than a second) — the
aim being to destroy all residual spoilage micro-organisms and1992L0046 — EN — 26.05.1994 — 002.001 — 29
▼B
their spores — using aseptic opaque containers, or containers
made opaque by the packaging, but so that the chemical, physical
and organoleptic changes are minimal,
— be of preservability suchth at 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 ºC; where necessary,
provision can also be made for a period of seven days in a closed
container at a temperature of + 55 ºC.
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.
(c)Sterilized milk must:
— have been heated and sterilized in hermetically sealed wrappings
or containers, the seal of which must remain intact,
— in the event of random sampling, be of preservability such that no
deterioration can be observed after it has spent 15 days in a
closed container at a temperature of + 30 ºC; where necessary,
provision can also be made for a period of seven days in a closed
container at a temperature of + 55 ºC.
(d) Pasteurized milk which has been subjected to high-temperature
pasteurization, UHT milk and sterilized milk may be produced from
raw milk which has undergone thermization or an initial heat treat-
ment in another establishment. 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 before the second
treatment. Recourse to this practice must be brought to the attention
of the competent authority. Mention of the first treatment must be
made on the document provided for in Article 5 (8) of this Directive.
(e) Heating processes, the temperatures and duration of heating in respect
of pasteurized, UHT and sterilized milk, the types of heating equip-
ment, the flow-diversion valve and the types of temperature
controlling and recording devices shall be approved or authorized by
the competent authority of the Member States in accordance with
Community or international standards.
(f) The data 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 authority to inspect the establishment,
save in the case of microbiologically perishable products, for which
this period may be reduced to two months after the use-by or
minimum durability date.
5.Heat-treated drinking milk must:
(a) meet the microbiological standards laid down in Chapter II;
(b) not contain pharmacologically active substances in quantities higher
than the limits laid down in Annexes I and III to Regulation (EEC)
No 2377/90; the combined total of residues of all antibiotic residues
may not exceed a value to be fixed in accordance withth e procedure
laid down in Regulation (EEC) No 2377/90.
B.Requirements for milk for the manufacture of milk-based products
1. The operator or manager of the processing establishment must take all
necessary steps to ensure that the raw milk is treated, or in the case of
products ‘made with raw milk’ used, within 36 hours of acceptance, if
the milk is kept at a temperature not exceeding 6 ºC, or within 48 hours
of acceptance if the milk is kept at a temperature of 4 ºC or lower.
2. Heat-treated milk intended for the manufacture of milk-based products
must be obtained from raw milk which complies with the standards laid
down in Annex A, Chapter IV.
3. Heat-treated milk must meet the following requirements:
(a)thermized milk must:
(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 ºC prior to thermization which does not exceed
300000 per ml;
(ii) have been obtained by treatment as defined in Article 2 (6) of
this Directive;1992L0046 — EN — 26.05.1994 — 002.001 — 30
▼B
(iii) if it is used for the production of pasteurized, UHT or sterilized
milk, meet the following standards before treatment: plate count
at 30 ºC equal to or less than 100 000 per ml;
(b)pasteurized milk must
(i) have been obtained by means of a treatment involving a high
temperature for a short time (at least 71,7 ºC for 15 seconds or
any equivalent combination) or a pasteurization process usingdifferent time and temperature combinations to obtain an equiva-
lent effect;
(ii) 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 peroxi-
dase test is authorized, provided that the milk is labelled as
‘high-temperature pasteurized’;
(c) UHT milk must have been obtained by applying to the raw milk a
continuous flow of heat entailing the application of a high tempera-
ture for a short time (not less than + 135 ºC for not less than a
second) — the aim being to destroy all residual spoilage micro-
organisms and their spores — so that the chemical, physical and
organoleptic changes are minimal.
CHAPTER II
Microbiological criteria formilk-basedproductsanddrinkingmilk
A.Microbiological criteria for certain milk-based products on removal from the
processing establishment
1. Compulsory criteria: Pathogenic micro-organisms
Type of micro-organism Product Standard (ml, g) (a)
— Listeria monocytogenes — Cheese, other than hard cheese Absent in 25 g (c)
n = 5, c = 0
— Other products (b) Absent in 1 g
— Salmonella spp. — All except milk powder Absent in 25 g (c)
n = 5, c = 0
— Milk powder Absent in 25 g (c)
n = 10, c = 0
In addition, pathogenic micro-organisms and their toxins must not be present in quantities
such as to affect the health of consumers.
(a) 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 where the bacteria count may be between ‘m’ and ‘M’ the sample being
considered acceptable if the bacteria count of the other sample units is ‘m’ or less.
(b) Testing not compulsory for sterilized milk and milk-based products where the heat treatment was applied
after wrapping or packaging.
(c) The 25 g sample to consist of 5 specimens of 5 g taken from different parts of the same product.
If these standards are exceeded, the foodstuffs must be excluded from
human consumption and withdrawn from the market in accordance with
the fifth and sixth indents of Article 14 (1) of this Directive.
Sampling programmes will be drawn up in the light of the nature of the
products and the risk analysis.1992L0046 — EN — 26.05.1994 — 002.001 — 31
▼B
2. Analytical criteria: organisms indicating poor hygiene
Type of micro-organism Product Standard (ml, g)
— Staphylococcus aureus Cheese made from raw milk and
from thermized milkm = 1 000
M = 10000
n= 5
c= 2
Soft cheese (made from heat-
treated milk)m = 100
M = 1 000
n= 5
c= 2
Freshch eese
Powdered milk
Frozen milk-based products
(including ice-cream)m= 1 0
M = 100
n= 5
c= 2/C148/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C150
— Escherichia coli Cheese made from raw milk and
from thermizedm = 10000
M = 100000
n= 5
c= 2
Soft cheese (made from heat-
treated milk)m = 100
M = 1 000
n= 5
c= 2
In all cases where these standards are exceeded there must be a review of
the implementation of the methods for monitoring and checking critical
points applied in the processing establishment pursuant to Article 14 of
this Directive. The competent authority shall be informed of the correc-
tive procedures included in the production monitoring system to prevent
any repetition of the occurrence.
In addition, whenever the standard M is exceeded in the case of cheese
made from raw milk and from thermized milk or soft cheese testing
must be carried out for the possible presence of toxins in such products
by means of a method to be determined in accordance with the procedure
laid down in Article 31 of this Directive.
If strains of enterotoxinogenic Staphylococcus aureus or strains of
Escherichia coli that are presumed to be pathogenic 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.
3. Indicator organisms: guidelines
Type of micro-organism Product Standard (ml, g)
— Coliformes 30 ºC Liquid milk-based products m = 0
M= 5
n= 5
c= 2
Butter made from pasteurized
milk or creamm= 0
M= 1 0
n= 5
c= 2
Soft cheese (made from heat-
treated milk)m = 10000
M = 100000
n= 5
c= 2
Powdered milk-based products m = 0
M= 1 0
n= 5
c= 2
Frozen milk-based products
(including ice-cream)m= 1 0
M = 100
n= 5
c= 21992L0046 — EN — 26.05.1994 — 002.001 — 32
▼B
Type of micro-organism Product Standard (ml, g)
— Plate count Liquid heat-treated unfermented
milk-based products (a)m = 50 000
M = 100000
n= 5
c= 2
Frozen milk-based products(including ice-cream) (b)m = 100000M = 500000
n= 5
c= 2
(a) After incubation at 6 ºC for five days (plate count at 21 ºC).
(b) Plate count at 30 ºC.
These guidelines should help producers in ensuring proper operation of
their establishments and in implementing the system and the procedure
for carrying out their own checks on their production.
4. In addition, heat-treated milk-based products must meet the following
standards after incubation for 15 days at 30 ºC:
(a) plate count at 30 ºC (per 0,1 ml): ≤10,
(b) organoleptic test: normal.
B.Microbiological criteria for drinking milk
1. Raw cow's milk for drinking in that state must meet the following stan-
dards after wrapping:Plate count at 30 ºC (per ml) ≤50 000(
a)
—Staphylococcus aureus (per ml)
m = 100,
M = 500,n= 5 ,c= 2
— Salmonella: absent in 25 g
n= 5 ,c= 0
In addition, pathogenic micro-organisms and their toxins must not be
present in quantities such as to affect the health of consumers.
2. In the random sampling checks carried out in the treatment establishment
pasteurized milk must meet the following microbiological standards(
1):
Pathogenic micro-organisms: absent in 25 g
n = 5, c = 0, m = 0, M = 0
Coliforms (per ml): n = 5, c = 1, m = 0, M = 5
After incubation at 6 ºC for five days
Platecountat21ºC(perml):n=5,c=1,m=5x104,M=5x105.
3. 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 ºC for 15 days:
— plate count (30 ºC): ≤10 (per 0,1 ml)
— organoleptic check: normal1992L0046 — EN — 26.05.1994 — 002.001 — 33
(a) Geometric average over a period of two months, with at least two samples a month.
(1) 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 unsatisfac-
tory if the number of bacteria in one or more sample units is ‘M’ or more;
c = number of sample units where the bacterial count may be between ‘m’ and ‘M’,
the sample still being considered acceptable if the bacterial count of the other
sample units is bacteria ‘m’ or less.
▼B
— pharmacologically active substances: not exceeding the limits set
in Annexes I and III to
Regulation (EEC) No 2377/90.
The combined total of residues of all substances may not exceed a value
to be fixed in accordance withth e procedure laid down in Regulation
(EEC) No 2377/90.
4. When the maximum standards and compulsory criteria are exceeded and
when subsequent investigation indicates a potential danger to health, the
competent authority shall take appropriate measures.
C. Where necessary, detailed rules may be established in accordance with the
procedure laid down in Article 31 of this Directive for the application of
this Chapter and in particular:
— criteria other than those set out in paragraphs A and B in respect of
drinking milk and milk-based products,
— microbiological criteria applicable, under conditions managed and
controlled by the operator or manager of the establishment, to the use-
by date.
CHAPTER III
Wrappingandpackaging
1. Wrapping and packaging must take place under satisfactory hygiene condi-
tions in rooms provided for that purpose.
2. Without prejudice to Directive 89/109/EEC(
1), wrapping and packaging must
comply with all the rules of hygiene, and be strong enough to protect effec-
tively the products covered by this Directive.
3. Bottling, filling of containers withh eat-treated milk and liquid milk-based
products and sealing of containers and of packaging must be carried out auto-
matically.
4. Wrapping or packaging may not be reused for the products covered by this
Directive, with the exception of certain types of containers which may be
reused after thorough cleaning and disinfecting.
Sealing must be carried out in the treatment establishment in which the heat
treatment 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.
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:
— the nature of the heat treatment which the raw milk has undergone,
— an information whereby the date of heat treatment may be established
and, in the case of pasteurized milk, the temperature at which the product
must be stored.
6. Product manufacture and packaging operations may take place in the same
room, notwithstanding point 1, if the packaging is as described in 2 and
subject to the following conditions:
(a) the room must be sufficiently large and so equipped that the hygiene of
the oprations is assured;
(b) the wrapping and packaging must have been brought to the treatment or
processing establishment in a protective cover in which they were placed
immediately after manufacture and which protects them from any
damage during transport to the establishment and must have been stored
there under hygiene conditions in a room intended for that purpose;
(c) the rooms for storing the packaging material must be free from dust and
vermin and separated from rooms containing substances which might
contaminate the products. Packaging must not be placed directly on the
floor;1992L0046 — EN — 26.05.1994 — 002.001 — 34
(1) 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
withfoodstuffs (OJ No L 40, 11. 2. 1989, p. 38).
▼B
(d) packaging must be assembled under hygienic conditions before being
brought into the room. A derogation from this requirement may be
granted in the case of the automatic assembly of packaging, provided
there is no risk of contamination of the products;
(e) packaging must be brought into the room under hygienic conditions and
used without delay. It may not be handled by staff handling unwrapped
products;
(f) immediately after packaging, the products must be placed in the storage
rooms provided for the purpose.
CHAPTER IV
Conditionsgoverninghealthmarkingandlabelling
A.Conditions governing health marking
1. The products covered by this Directive must carry a health mark.
Marking must be carried out during or immediately after manufacture in
the establishment, in an easily visible place. The mark shall be legible,in-
delible and its characters easily distinguishable. The health mark may be
applied to the product or to the wrapping, if the product is individually
wrapped, or to a label affixed to this wrapping. However, where a
product is individually wrapped and packaged, it will suffice for the
health mark to be applied to the packaging.
2. Where products marked in accordance with point 1 are subsequently
placed in a packaging, the health mark must also be applied to the packa-
ging.
3. (a) The health mark must give the following particulars within an oval
surround:
(i) either:
— above: the initial letter or letters of the consigning country in
capitals, i.e. for the Community, the letters, B — DK — D —
E L—E—F—I R L—I—L—NL—P—U K ,
followed by the approval number of the establishment,
— below: one of the following sets of initials: CEE — EØF —
EWG — EOK — EEC — EEG;
(ii) or:
— above, the name of the consigning country in capitals,
— in the centre, the approval number of the establishment,— below, one of the following sets of initials: CEE — EØF —
EWG — EOK — EEC — EEG;
(b) the health mark may be applied to the product, wrapping or packa-
ging by an ink stamp or by branding, or it may be printed on or
applied to a label. In the case of products in hermetically-sealed
containers, the mark must be indelibly applied either to the lid or to
the container;
(c) the health mark may also consist of an irremovable plate of resistant
material complying with all the hygiene requirements and bearing theinformation specified in (a).
B.Conditions governing labelling
Without prejudice to the provisions of Directive 79/112/EEC, the labelling
must clearly show for inspection purposes:
1. the words ‘raw milk’ for raw milk intended for direct human consump-
tion;
2. the words ‘made with raw milk’ for milk-based products manufactured
from raw milk whose manufacturing process does not include any heat
treatment, including thermization;
3. for other milk-based products the nature of any heat treatment applied at
the end of the manufacturing process;
4. for milk-based products in which growth of micro-organisms can occur,
the use-by or minimum durability date.
CHAPTER V
Storageandtransportrequirements
1. Products covered by this Directive which cannot be stored at ambient
temperature must be stored at the temperatures established by the manufac-1992L0046 — EN — 26.05.1994 — 002.001 — 35
▼B
turer to ensure their durability. In particular, the maximum temperature at
which pasteurized milk may be kept until it leaves the establishment and
during transport must be 6 ºC. When stored under cooled conditions the
storage temperatures must be registered and the cooling rate must be such
that the product reaches the required temperature as quickly as possible.
2. 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, impair the composi-
tion 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 withAnnex B, Ch apter VI, 2 and 3,
— they must be hermetically sealed before and during transport by means of
a watertight sealing device.
3. Vehicles and containers used for transporting pasteurized milk must be
designed and equipped in such a way that the required temperatures can be
maintained throughout the period of transport.
4. 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 influ-
ences and may not be used to transport animals.
5. To that end, the competent authority must regularly check that the means of
transport and loading conditions meet the hygiene requirements of this
Chapter.
6. The products covered by this Directive must be dispatched in such a way that
they are protected from anything liable to contaminate them or to cause them
to deteriorate, having regard to the duration and conditions of transport and
the means of transport employed.
7. During transport, the temperature of pasteurized milk transported in tanks or
packed in small containers and in churns must not exceed 6 ºC. However, the
competent authorities may grant a derogation from this requirement for door-
step deliveries.
8. In accordance with the procedure laid down in Article 31 of this Directive,
the Commission may establish additional conditions for the storage and trans-
port of specific milk-based products.
CHAPTER VI
Healthchecksandsupervisionofproduction
1. Establishments shall be subject to supervision by the competent authority,
which must ensure that the requirements of this Directive are met and in
particular:
(a) check:
(i) the cleanliness of the premises and equipment and staff hygiene;
(ii) the efficacy of the checks carried out by the establishment, in
accordance withArticle 14 of th is Directive, notably by examining
the results and taking samples;
(iii) the microbiological and hygienic condition of the milk-based
products;
(iv) the efficacy of the treatment of the milk-based products and heat-
treated drinking milk;
(v) the hermetically sealed containers by means of random sampling;
(vi) the appropriate health marking of the milk-based products;
(vii) storage and transport conditions;
(b) take any samples required for laboratory tests;1992L0046 — EN — 26.05.1994 — 002.001 — 36
▼B
(c) make any other checks it considers necessary to ensure compliance with
this Directive.
2. The competent authority must have free access at all time to the cold stores
and all working premises to check that these provisions are being strictly
complied with.1992L0046 — EN — 26.05.1994 — 002.001 — 37
▼B
ANNEX D
CHAPTER I
Communityreference laboratory
Laboratoire central d'hygiène alimentaire
43 rue de Dantzig
75015 PARIS
CHAPTER II
DutiesandtasksoftheCommunityreference laboratory
1. The Community reference laboratory for the analysis and testing of milk and
milk products shall be responsible for:
— providing national reference laboratories withdetails of analytical
methods and comparative testing,
— coordinating the application, by national reference laboratories, of the
methods referred to in the first indent, in particular by organizing
comparative testing,
— coordinating researchinto new analytical meth ods and informing national
reference laboratories of advances in this field,
— conducting initial and further training courses for the benefit of staff from
national reference laboratories,
— providing scientific and technical assistance to the Commission, including
the Community Bureau of References, especially in cases where the
results of analyses are contested between Member States.
2. The Community reference laboratory shall ensure that the following oper-
ating conditions are maintained.
It must:
— have suitably qualified staff with adequate training in the techniques
applied to the analysis and testing of milk and milk products,
— possess the equipment and substances needed to carry out the tasks
provided for in paragraph1,
— have an appropriate administrative infrastructure,— ensure that its staff respect the confidential nature of certain subjects,
results or communications,
— have sufficient knowledge of international standards and practices,— have available, if appropriate, an updated list of reference substances held
by the Community Bureau of References and an updated list of the manu-
facturers and suppliers of suchsubstances.1992L0046 — EN — 26.05.1994 — 002.001 — 38