COUNCIL DIRECTIVE 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products
THE COUNCIL OF THE EUROPEAN 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 list of products in Annex II to the Treaty; whereas the production of and trade in such milk and products constitute an important source of income 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 of milk 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 establishment 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 regards human 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 rules on 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 necessary to provide for a procedure for the approval of establishments meeting the health conditions laid down in this Directive, to determine the requirements regarding conditions of hygienic production to be complied with by such establishments and to define the criteria to be met by the products covered by this Directive;
Whereas low-capacity establishments should be approved by means of simplified structure and infrastructure criteria, while complying with the 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 a consignment 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 authority should 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 guarantees provided for in this Directive, national rules on checks should be maintained 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 necessary in 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 one Member 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 the national market;
Whereas certain milk-based products may be manufactured from raw milk; whereas, given the nature of these products, it may be necessary to draw up specific conditions applicable thereto and a list of such products as might be marketed;
Whereas account should be taken of certain special cheesemaking techniques;
Whereas Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (7) and Council Directive 89/396/EEC of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs (8) are applicable;
Whereas Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (9), and in particular Annexes I and III thereto, is applicable as regards the maximum residue levels for pharmacologically 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 cooperation between the Commission and the Member States within the Standing Veterinary Committee;
Whereas the adoption of specific rules for the products covered by this Directive is without prejudice to the adoption of rules on food hygiene and 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 veterinary checks 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 from a herd officially free of tuberculosis and officially free or free of brucellosis, or of milk-based products made on his holding with such raw milk, provided that the hygiene conditions of the holding comply with the minimum health rules laid down by the competent authority.
(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).
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 approximation 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 approximation of the laws of the Member States relating to certain lactoproteins (caseins and caseinates) intended for human consumption (³),
- Council Regulation (EEC) No 1898/87 of 2 July 1987 on the protection of designations used in marketing of milk and milk products (& {È%};).
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 been heated 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 raw milk, whether or not it has undergone an authorized physical treatment, 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 treatment 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 in bulk 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 for their 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 part replaces or is intended to replace any milk constituent and of which milk or a milk product is an essential part either in terms of 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 the phosphatase 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 the milk 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 any authority 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 direct contact with the products concerned as well as the initial wrapper or 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 as the container itself;
15. 'hermetically sealed container': container which, when sealed, is intended to protect the contents against the entry of micro-organisms 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, which must be subject to the checks laid down by national rules for retail 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 in bovine animals and swine (10),
- Article 2 of Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (11),
- Article 3 of Regulation (EEC) No 1411/71 of 29 June 1971 laying down additional rules on the common organization of the market in milk and milk products falling within Common Customs Tariff heading 04-01 (12), and
- Article 2 of Regulation (EEC) No 1898/87.
CHAPTER II Rules governing Community production
Article 3
1. Member States shall ensure that raw milk is not used for the manufacture of milk-based products or heat-treated drinking milk unless 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 manufacture of heat-treated milk or for the (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).
(²) OJ No L 46, 19. 2. 1991, p. 19.
(³) 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).
manufacture of milk-based products after heat 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 milk meets 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 with Annex A, Chapter III;
3. it satisfies the requirements of Annex C, Chapter IV;
4. it satisfies any additional requirements which may be set in accordance with the procedure laid down in Article 31. In the meantime national provisions concerning such requirements shall 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 with Article 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;
(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 an establishment fulfilling the conditions laid down in point 2. The Hellenic Republic shall be authorized to submit pasteurized milk from another Member State to a second pasteurization before placing it on the market;
2. it must come from a treatment establishment which meets the conditions laid down in Annex B, Chapters I, II, V and VI and has been checked 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 with Annex C, Chapter IV, and be wrapped in accordance with Annex C, Chapter 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 with Annex C, Chapter 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 treatment and the competent authority responsible for supervising the establishment of origin can be identified, if this is not clear from 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 border inspection post at which the transit formalities are carried out to certify that the heat-treated milk concerned meets the requirements 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 per litre, as determined in whole milk at 20 oC, or the equivalent as determined 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-free dry matter content of not less than 8,50 %.
No later than 1 January 1994, these requirements will, upon a request from a Member State supported by scientific and statistical studies, be re-examined with a view to their amendment, in accordance with the procedure laid down in Article 31 of this Directive, in the light of seasonal considerations, on the understanding that the relationship between the above parameters must be maintained.
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 down in 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 requirements of Annex B, Chapters I, II, V and VI;
(b) has been stored and transported in accordance with the requirements 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 requirements of the present Article;
2. be prepared in a processing establishment that meets the standards and specifications of Annex B, Chapters I, II, V and VI and 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 with Annex C, Chapter 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 with Annex C, Chapter IV;
6. be stored and transported in accordance with Annex C, Chapter V;
7. be checked in accordance with Article 14 and with Annex 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 or involve 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 to ionizing 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 general derogations 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 shall be adopted, as necessary in accordancy with the procedure laid down in Article 31.
2. In accordance with the 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 traditional characteristics, be authorized to grant individual or general derogations from Article 7 A.(1) to (4), provided that the milk used in the 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 subparagraph 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 each specific product shall, if necessary, be determined.
3. A list of products 'made with raw milk' may be drawn up in accordance with the 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 granting temporary and limited derogations from specific community health rules on the production and marketing of raw milk and milk-based products (13):
- 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 with Articles 10 or 11 and that products from such establishments do not bear the health mark provided 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 establishments 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 shall have an approval number.
The competent authority shall not approve the establishments or centres in question unless it is satisfied that they comply with the requirements of this Directive.
Where the competent authority finds an obvious failure to comply with the hygiene rules laid down by this Directive or obstacles to an adequate 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 temporarily 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) have proved 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 the competent authority, the latter shall withdraw approval.
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 supervision of the competent authority on the understanding that the need for permanent or periodic presence of the competent authority in a given establishment or centre will depend on the size of the establishment or centre, the type of product manufactured, risk assessment and the guarantees offered in accordance with the fifth and sixth indents of the second subparagraph of 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 is being complied with and, where there is doubt as to the origin of milk or 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 these analyses, conduct further examinations at all stages of production or on 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 with the procedure laid down in Article 31.
The results of the analyses shall be written up in a report, the conclusions or recommendations of which shall be notified to the operator or manager of the establishment or centre, who shall rectify the shortcomings noted with a view to improving hygiene.
3. In the event of repeated shortcomings, checks shall be increased and, where appropriate, labels or seals bearing the health mark shall be removed.
4. The detailed rules for the application of this Article shall be adopted in accordance with the 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 products whose production is limited.
Member States shall communicate to the Commission not later than three months before the date specified in Article 32 the criteria which they have adopted to assess whether an establishment or a category of establishments 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 with Article 17, the Commission considers that these criteria might jeopardize the uniform application of this Directive, such criteria may be amended or supplemented in accordance with the procedure laid down in Article 31. The conditions under which the competent authority of the Member State shall reclassify the establishments in question shall be laid down by the same procedure.
2. On the basis of the information collected by the Commission in accordance with the second subparagraph of paragraph 1, uniform criteria for the application of this Article shall be established before 1 January 1997 in accordance with the procedure laid down in Article 31.
Article 12
Establishments in operation must apply to the competent authority not later than three months before the date specified in Article 32 for classification 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 classified must not bear the health mark provided for in Annex C, Chapter IV, A.3 and must be marketed at national level.
Article 13
1. Member States shall ensure that:
- animals on production holdings undergo regular veterinary inspections to ensure that the requirements of Annex A, Chapter I, are being 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 requirements laid down in Annex A are not being complied with, the competent authority shall check the general state of health of the dairy animals and, should it prove necessary, shall have an additional 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 for in 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 implementation of this Directive.
3. The general hygiene conditions to be complied with by production holdings, in particular the conditions for the upkeep of premises and those relating to milking, shall be adopted in accordance with the procedure 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 disinfection 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 with the preceding indents with a view to submitting it to the competent authority. The results of the different checks and tests 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 at 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 the competent authority thereof,
- in the event of an immediate human health risk, withdraw from the market the quantity of products obtained in technologically similar conditions and likely to present the same risk. This withdrawn quantity must stay under the supervision and control of the competent authority until it is destroyed, used for purposes other than human consumption or, after authorization by the competent authority, reprocessed in an appropriate manner to ensure its safety.
In addition, the operator or manager of the establishment must guarantee 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 therewith.
2. The operator or manager of the establishment must apply or organize a staff training programme enabling workers to comply with conditions of hygienic production adapted to the production structure, unless such staff already have adequate qualifications attested by diplomas. The competent authority responsible for the establishment must be involved in the planning and implementation of the programme or, in the case of a programme already in existence on the date 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 competent 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 with the 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 with the principles and rules of Council Directive 86/469/EEC of 16 September 1986 concerning the examination of animals and fresh meat for the presence of residues (14), 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 Directive.
2. Member States shall ensure that in the context of the checks provided for in Article 14 tests are carried out to detect any residues of substances having a pharmacological or hormonal action, and of antibiotics, 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 or harmful to human health, insofar as those residues exceed the permitted tolerance limits.
If the milk or milk-based products examined show traces of residues which exceed the permitted tolerances, they must be excluded from human consumption.
Examinations for residues must be carried out in accordance with proven methods which are scientifically recognized, and in particular those 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 procedure laid down in Article 31:
- the detailed rules for and the frequency of the checks provided for in paragraph 3,
- the tolerances and reference methods provided for in paragraph 2.
In accordance with the same procedure, a decision may be taken to extend the examinations to substances other than those referred to in paragraph 1.
5. Until the entry into force of the implementing measures for this Article, national rules shall remain applicable, subject to the general provisions of the Treaty.
Article 16
1. Milk tanks, premises, installations and working equipment may be used for other foodstuffs provided that all appropriate measures are taken to prevent contamination or deterioration of drinking milk or milk-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 undergone heat treatment or another treatment having an equivalent effect, such milk, milk-based products and ingredients must be stored separately to prevent cross-contamination, and treated or processed in premises suitable for the purpose.
4. The detailed rules for the application of this Article, and in particular the conditions relating to washing, cleaning and disinfecting before reuse, and the conditions of transport, shall be adopted in accordance with the 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 the competent authorities, make on-site checks. In particular, they may verify by checking a representative percentage of establishments whether the competent authorities are ensuring that approved establishments 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 with the 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 by products other than milk-based products is subject to the hygiene rules laid 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 the checks carried out by the Member State of destination and the safeguard measures to be taken.
2. Without prejudice to the specific provisions of this Directive, the competent authority shall, where it is suspected that this Directive is not 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 this Directive or that they were not used for the purpose originally intended.
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 or presentation might give rise to differing interpretation in different Member 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 monitor compliance with the requirements of this Directive, and the methods 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 internationally 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 some provisions 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 products prepared from milk or from milk-based products meeting the requirements 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 to adapt them to take account of scientific and technological progress.
CHAPTER III Imports from third countries
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 for Community production.
Article 23
1. For the purposes of uniform application of Article 22, the provisions 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 with paragraph 3 (a);
(b) be accompanied by a health certificate corresponding to a specimen to be drawn up in accordance with the procedure laid down in Article 31, signed by the competent authority of the exporting country 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 from establishments offering the guarantees provided for in Annex B.
3. The following shall be established in accordance with the procedure 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 guarantees equivalent 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 establishments approved and inspected by the competent authorities, once the Commission has checked that these establishments comply with the principles and general rules laid down in this Directive;
(b) updates of that list in the light of the checks provided for in paragraph 4;
(c) the specific requirements and equivalent guarantees established for third countries, which may not be more favourable than those provided for in Chapter II;
(d) the types of heat treatment to be prescribed for certain third countries 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 by the third country regarding the conditions of production and placing on the market can be considered equivalent to those applied in the Community.
The experts from the Member States responsible for these inspections shall be appointed by the Commission, acting on a proposal from the Member States.
These inspections shall be made on behalf of the Community, which shall bear the cost of any expenditure in this connection. The frequency of and procedure for these inspections, including those to be carried out in the event of a decision in accordance with paragraph 6, shall be determined in accordance with the procedure laid down in Article 31.
5. Pending the organization of the inspections referred to in paragraph 4, national rules applicable to inspection in third countries shall continue to apply, subject to notification, through the Standing Veterinary Committee, of any failure to comply with hygiene rules found during these inspections.
6. The Council, acting by a qualified majority on a proposal from the Commission, may replace individual recognition of treatment or processing 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 is able to guarantee compliance with the requirements of paragraph 2(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 follow up 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 (15).
2. Pending the establishment of detailed rules for the application of this Article, the national rules applicable to imports from third countries for which such requirements have not been adopted at Community level shall continue to apply, provided they are not more favourable 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 exotic to the Community or pursuant to Articles 6, 7 and 14 of Directive 72/462/EEC (16);
(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 with Article 3 (2) of Directive 72/462/EEC, as capable of guaranteeing the implementation of their legislation in force;
(c) the veterinary services of which are able to guarantee that health requirements at least equivalent to those laid down in Chapter II are being complied with.
CHAPTER IV Final provisions
Article 27
1. Each Member State shall designate one or more national reference laboratories for the analysis and testing of milk and milk-based products, and shall forward a list thereof to the Commission.
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 and the laboratories carrying out analyses and tests on milk and milk-based products.
(²) Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third 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).
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 national reference laboratories referred to in Article 27.
Article 28
of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (17) 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 freezing point of untreated milk laid down in Annex A of Directive 85/397/EEC (18) is complied with, Commission Directive 89/362/EEC of 26 May 1989 on general conditions of hygiene in milk production holdings (19) and Commission Decision 91/180/EEC of 14 February 1991 laying down certain methods of analysis and testing of raw milk and heat-treated milk (20) 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 the present Directive or to adapt them subsequently to advances in science and 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 raw milk, 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 in heat-treated milk (OJ No L 226, 24. 8. 1985, p. 13), as last 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 Veterinary Committee set up by Decision 68/361/EEC (21), hereinafter referred to as 'the Committee', by its Chairman, either on his own initiative or at the 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 technology are involved, shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on such measures within a time limit which the Chairman may lay down according to the 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 decisions which the Council is required to adopt on a proposal from the Commission. Within the Committee the votes of the representatives of the Member States shall be weighted in the manner set out in Article 148 (2) of the Treaty. The Chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged and implement 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, the Commission 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 with this Directive before 1 January 1994. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed 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 veterinary checks at frontiers provided for in Directive 89/662/EEC.
Article 33
This Directive is addressed to the Member States.
Done at Luxembourg, 16 June 1992.