COUNCIL DIRECTIVE of 21 December 1976 on health problems affecting intra-Community trade in meat products (77/99/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament (1),
Whereas, since the establishment of the common organization of the markets, meat products may move freely within the Community ; whereas, however, intra-Community trade in these products is curbed by the existence of different health requirements in this sector in the various Member States ; whereas, in order to remove such disparities, it is necessary to substitute common provisions for these national requirements;
Whereas, in order to guarantee the quality of the products in question from the health point of view, it is necessary to use, in their manufacture, only that fresh meat obtained in accordance with the Community standards laid down in Council Directive 64/433/EEC of 26 June 1964 on health problems affecting intra-Community trade in fresh meat (2), as last amended by Directive 75/379/EEC (3), Council Directive 71/118/EEC of 15 February 1971 on health problems affecting trade in fresh poultrymeat (4), as last amended by Directive 75/379/EEC, and also 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 (5), as last amended by Directive 75/379/EEC ; whereas meat products must be manufactured, stored and transported in conditions offering every guarantee as regards health ; whereas the need for manufacturing and processing establishments to obtain approval is likely to facilitate supervision of compliance with these conditions ; whereas provision should be made for a procedure intended to settle any disputes which may arise between Member States as to the justification of the approval of a manufacturing establishment;
Whereas, moreover, Community control arrangements should be introduced to ensure that the standards laid down in this Directive are applied uniformly in all Member States ; whereas provision should be made for the procedure for such controls to be determined according to a Community procedure within the Standing Veterinary Committee set up by the Council Decision of 15 October 1968 (6);
Whereas provision should be made for the possibility of derogating from certain provisions of this Directive in respect of certain meat products which contain other foodstuffs and which contain a minimal percentage of meat ; whereas these derogations should be made according to a Community procedure within the Standing Veterinary Committee;
Whereas, as regards intra-Community trade, the issue of a health certificate drafted by the competent authority is considered to be the best way of assuring the competent authorities of the country of destination that a consignment of meat products complies with this Directive ; whereas this certificate must accompany the consignment of these products to the place of destination;
Whereas Member States must have the right to prohibit the introduction into their territory of meat products from another Member State which prove unfit for human consumption or do not comply with Community health provisions;
Whereas, in such cases, the consignor should, at his own request or upon request of his representative, be allowed to have the meat products returned to him unless there are health reasons to the contrary; (1)OJ No C 114, 11.11.1971, p. 40. (2)OJ No 121, 29.7.1964, p. 2012/64. (3)OJ No L 172, 3.7.1975, p. 17. (4)OJ No L 55, 8.3.1971, p. 23. (5)OJ No L 302, 31.12.1972, p. 28. (6)OJ No L 255, 18.10.1968, p. 23.
Whereas, in case of prohibition or restriction, the reasons therefor should be made known to the consignor or his representative and also, in certain cases, to the competent authorities of the exporting country;
Whereas, in the event of a dispute between himself and the authorities of the Member State of destination as to the justification for prohibition or restriction, the consignor should be enabled to obtain the opinion of an expert;
Whereas, in order to facilitate the implementation of the proposed measures, a procedure should be provided for close cooperation between the Member States and the Commission in the Standing Veterinary Committee,
HAS ADOPTED THIS DIRECTIVE:
Article 1
This Directive lays down health requirements for meat products intended for intra-Community trade.
Article 2
1. For the purposes of this Directive, the following definitions shall apply: (a) meat products : products prepared wholly or partly from meat which has undergone treatment to ensure a certain degree of preservation.
However, meat which has only undergone chilling or freezing shall not be regarded as a meat product.
The following are not covered by this Directive: (i) meat extracts, meat consommé and stock, meat sauces and similar products not containing fragments of meat;
(ii) whole, broken or crushed bones, meat peptones, animal gelatin, meat powder, pork-rind powder, blood plasma, dried blood, dried blood plasma, cellular proteins, bone extracts and similar products;
(iii) fats melted down from animal tissues;
(iv) stomachs, bladders and intestines, cleaned and bleached, salted or dried;
(b) meat : meat as defined in: - Article 1 of Directive 64/433/EEC,
- Article 1 of Directive 71/118/EEC,
- Article 2 of Directive 72/462/EEC;
(c) fresh meat : fresh meat as defined in Article 1 of Directives 64/433/EEC and 71/118/EEC and Article 2 of Directive 72/462/EEC;
(d) treatment : the treatment of fresh meat, whether or not combined with other foodstuffs, by heating, salting or drying, or a combination or these processes;
(e) complete treatment : treatment the effects of which are sufficient to guarantee the subsequent wholesomeness of the product at normal ambient temperature;
(f) incomplete treatment : treatment which does not meet the requirements laid down for complete treatment in Annex A, Chapter V (27);
(g) heating : use of dry or damp heat;
(h) salting : use of salt (NaCl);
(i) drying : natural or artificial reduction of the water content;
(j) exporting country : the Member State from which meat products are sent to another Member State;
(k) country of destination : the Member State to which meat products are sent from another Member State;
(l) consignment : a quantity of a meat product which is covered by the same health certificate;
(m) wrapping : the protection of meat products by the use of an initial wrapping or initial container in direct contact with the product concerned as well as the initial wrapper or initial container itself;
(n) packaging : the placing of a wrapped or unwrapped meat product or products in a second container, as well as the container itself.
2. Pending the adoption, following submission of a proposal in accordance with Article 9 (2), of provisions regarding meat which is treated by a process other than heating, salting or drying or which has undergone treatment which does not meet the requirements of Annex A, Chapter V (26), such meat shall be subject to the Directives referred to in paragraph 1 (b).
Article 3
1. Each Member State shall ensure that only meat products complying with the following general conditions are sent from its territory to the territory of another Member State: (1) they must have been prepared in an establishment approved and inspected in accordance with Article 6;
(2) they must have been prepared, stored and transported in accordance with Annex A;
(3) they must have been prepared from: (a) fresh meat as defined in Article 2 (1) (c). This fresh meat may originate: (i) in accordance with Directive 64/433/EEC, in the Member State in which the preparation is carried out or in any other Member State,
(ii) in accordance with Directive 72/462/EEC, in a third country, being imported either directly or by another Member State,
(iii) in accordance with Article 15 of Directive 71/118/EEC, in a third country, in so far as: - products obtained from this meat fulfil the requirements of this Directive,
- the health marking laid down in Annex A, Chapter VII, is not carried out on these products,
- intra-Community trade in these products remains subject to the national provisions of each Member State;
(b) a meat product, provided that it meets the requirements of this Directive;
(4) they must have been prepared by heating, salting or drying, which processes may be combined with smoking or maturing, possibly under specific microclimatic conditions, and associated, in particular, with certain curing agents within the meaning of Article 12. They may also be associated with other foodstuffs and condiments;
(5) they must have been prepared from fresh meat handled in accordance with Annex A, Chapter III;
(6) they must, in accordance with Annex A, Chapter IV, have undergone an inspection carried out by the competent authority ; such inspections may be carried out, in purely routine tasks and in accordance with rules to be defined where necessary under the procedure provided for in Article 18, with the help of aissistants specially trained for the purpose;
(7) they must meet the standards laid down in Annex A, Chapter V;
(8) they must have been wrapped and packaged in accordance with Annex A, Chapter VI, where wrapping and packaging are necessary;
(9) they must bear a health marking in accordance with Annex A, Chapter VII;
(10) they must, in accordance with Annex A, Chapter VIII, be accompanied by a health certificate during transport to the country of destination;
(11) they must be stored and transported to the country of destination under satisfactory health conditions in accordance with Annex A, Chapter IX.
2. Meat products may not have been subjected to ionizing radiation, unless this is justified on medical grounds and unless such procedure is clearly indicated on the product and on the health certificate.
Article 4
1. Meat products which have undergone complete treatment in accordance with Annex A, Chapter V (27), may be stored and transported at normal ambient temperatures.
Products which have been subjected to natural fermentation and maturing for a long period shall be regarded as having undergone complete treatment until the Council, acting, unanimously on a proposal by the Commission, shall have amended the limits given in Annex A, Chapter V (27) (b).
2. For inspection purposes, the producer must ensure that the packaging of meat products which have undergone incomplete treatment bears a clear and legible indication of the temperature at which the products must be transported and stored and the period during which preservation may thus be assured.
3. If necessary, in accordance with the procedure laid down in Article 18, a derogation may be made from paragraph 2 in respect of certain meat products which do not comply with the standards laid down in Annex A, Chapter V (27), subject to certain conditions which shall be verified by the competent authority.
Article 5
Articles 3 and 4 shall not apply to meat products which are imported with the authorization of the country of destination for uses other than human consumption ; in this case, the country of destination shall ensure that these products are used only for the purposes for which they were dispatched to that country.
Article 6
1. Each Member State shall draw up a list of the establishments approved by it and having a veterinary approval number. It shall send this list to the other Member States and to the Commission.
The Commission shall draw up a list of these approved establishments and shall have it published in the Official Journal of the European Communities.
Without prejudice to Article 8, a Member-State shall not approve an establishment unless compliance with this Directive is assured.
The Member State shall withdraw approval if the conditions for approval are no longer fulfilled.
If a check has been made in accordance with Article 7, the Member State concerned shall take account of the conclusions resulting therefrom.
The other Member States and the Commission shall be informed of the withdrawal of approval.
2. Inspection and supervision of approved establishments shall be carried out under the responsibility of the competent authority which may be assisted in purely technical tasks by personnel specially trained for the purpose.
The detailed rules governing this assistance shall be determined in accordance with the procedure provided for in Article 18.
3. If a Member State considers that the conditions for approval are not or are no longer complied with by an establishment in another Member State, it shall so inform the Commission and the competent central authority of the latter Member State.
4. In the case referred to in paragraph 3, the Commission shall forthwith initiate the procedure laid down in Article 7.
If justified by the conclusions of the inspection report, the Member States may be authorized, in accordance with the procedure laid down in Article 19, to refuse entry to their territory of meat products from the establishment in question.
This authorization may be withdrawn in accordance with the same procedure laid down in Article 19, if such action is justified by the findings of a further expert inspection carried out in accordance with Article 7.
Article 7
Experts of the Member States and of the Commission shall carry out regular inspections of the approved establishments to ensure that the latter in fact apply this Directive, and in particular Annex A, Chapters I and II.
They shall provide the Commission with a report on the results of the inspections carried out.
The Member State in whose territory an inspection is carried out shall give the experts all the necessary help in performing their task.
The experts of the Member States who carry out the inspections shall be designated by the Commission acting upon a proposal from the Member States. They must be nationals of a Member State other than that in which the inspection is carried out and, in the case provided for in Article 6 (3) and (4), other than that of the Member States involved in the dispute.
Inspections shall be carried out on behalf of the Community, which shall bear the cost involved.
The frequency and the detailed rules for these inspections shall be determined in accordance with the procedure laid down in Article 18.
Article 8
1. By way of derogation from the conditions stipulated in Article 3, it may be decided, in accordance with the procedure laid down in Article 18, that some provisions of this Directive shall not apply to certain products which contain other foodstuffs and only a small percentage of meat or meat product.
These exceptions shall relate only to: (a) the conditions for approval of establishments as laid down in Annex A, Chapter I;
(b) the inspection requirements described in Annex A, Chapters IV and V;
(c) the requirements for a health marking and health certificate as laid down in paragraphs 9 and 10 of Article 3 (1).
When considering whether to allow exception such as those provided for under this Article, both the nature and the composition of the product shall be taken into account.
Notwithstanding the provisions of this Article, the Member States shall ensure that all meat products intended for intra-Community trade are wholesome products prepared from fresh meat or meat products within the meaning of this Directive.
2. The first subparagraph of paragraph 1 shall be implemented for the first time before the date of implementation of this Directive.
Article 9
1. The Council, acting on a proposal from the Commission, shall determine for the first time, before the implementation of this Directive, the provisions applying to fresh meat which has been minced, ground or similarly broken down into small pieces, with the addition of other foodstuffs and condiments.
Pending the entry into force of the provisions thus adopted, this meat shall remain subject to national laws.
2. The Commission shall submit to the Council, before the date of implementation of this Directive, a proposal dealing with the case of products not having undergone treatment and thus not fulfilling the requirements laid down Annex A, Chapter V (26).
Article 10
The methods required in order to check compliance with the standards laid down in Annex A, Chapter V (26) and (27) and the tolerances to be permitted for these standards, shall be established six months before the date of implementation of this Directive in accordance with the procedure laid down in Article 18.
These methods, standards and tolerances may, if necessary, be altered or updated using the same procedure.
Article 11
1. Without prejudice to the powers resulting from Articles 6 and 7, a Member State on whose territory it has been established in the course of a health inspection that: (a) the meat products imported from another Member State are unfit for human consumption, shall prohibit the marketing of such products within its territory;
(b) Article 3 has not been complied with, may impose such a prohibition.
2. Decisions taken pursuant to paragraph 1 must, at the request of the consignor or his representative, authorize the reconsignment of the meat products, in so far as there are no objections thereto on health grounds. In any event, precautions shall be taken to prevent improper use of these products.
If reconsignment is not possible the products must be destroyed on the territory of the Member State in which the inspection is carried out.
By way of derogation from this provision and at the request of the consignee or his representative, the Member State carrying out the animal health and public health inspections may authorize their entry for use other than for human consumption, to the extent that there is no danger for humans or for animals. These meat products may not leave the territory of that Member State, which must check their destintaion.
These decisions must be communicated to the consignor or his representative together with the reasons for such decisions. These reasoned decisions must, on request, be communicated forthwith in writing, with an indication of the channels of appeal provided for under the current legislation and of their forms and the time limits within which they are open.
3. Where such decisions are based on the establishment of the presence of a contagious disease, deterioration dangerous to human health or a serious infringement of this Directive, they shall also be communicated forthwith, together with the reasons for these decisions, to the competent central authority of the exporting country and to the Commission.
Article 12
Without prejudice to current Community rules on additives authorized for use in foodstuffs, the use of additives in meat products and the detailed rules governing such use shall continue to be subject to national laws until the entry into force of Community provisions on the matter.
Article 13
The Council, acting unanimously on a proposal from the Commission, shall, before 31 December 1978, determine the temperatures to be observed during cutting and initial wrapping as provided for in Annex A, Chapter II (9), and without prejudice to the provisions laid down in Annex A, Chapter III (20).
Article 14
1. The Council, acting on a proposal from the Commission, shall take a unanimous decision on Community rules relating to the methods of detecting trichinae and also to the cases where such detection is unnecessary.
2. Pending the entry into force of such rules, the Member States' legislation on the detection of trichinae in meat products containing pigmeat shall remain applicable.
3. Pigmeat recognized as trichinous must not be used in the manufacture of meat products intended for intra-Community trade.
Article 15
1. This Directive shall not affect the channels of appeal open under the current legislation in Member States against the decisions of the competent authorities provided for in this Directive.
2. Each Member State shall grant consignors of meat products, the movement of which is prohibited pursuant to Article 11 (1), the right to obtain the opinion of an expert. Each Member State shall ensure that, before the competent authorities take any other measures such as destroying the meat, the experts have an opportunity of determining whether the conditions of Article 11 (1) have been fulfilled.
The expert must be a national of a Member State other than the exporting country or country of destination.
Acting on a proposal from the Member States, the Commission shall draw up a panel list of the experts who may be instructed to formulate such opinions. After consulting the Member States, it shall lay down general rules which are to be applied, in particular as regards the procedure for formulating these opinions.
Article 16
Until the entry into force of Community provisions on problems of animal health affecting intra-Community trade in meat products, national rules shall continue to apply in this field.
Article 17
Pending the implementation of Community provisions concerning imports of meat products from third countries, Member States shall apply to such imports provisions which are at least equivalent to those resulting from this Directive.
Article 18
1. Where the procedure laid down in this Article is to be used, the matter shall be referred without delay to the Standing Veterinary Committee (hereinafter referred to as "the Committee"), set up by the Council Decision of 15 October 1968, by the chairman, either on his own initiative or at the request of a Member State.
2. Within the Committee, the votes of the Member States shall be weighted as provided in Article 148 (2) of the Treaty. The chairman shall not vote.
3. The Commission representative shall submit a draft of the measures to be adopted. The Committee shall deliver its opinion on the measures within a period to be determined by the chairman in keeping with the urgency of the question submitted for examination. Opinions shall be delivered by a majority of 41 votes.
4. The Commission shall adopt the measures and shall implement them immediately, where they are in accordance with the opinion of the Committee. Where they 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 on the measures to be adopted. The Council shall adopt the measures by a qualified majority.
If the Council has not adopted any measures within three months from the date on which the proposal was submitted to it, the Commission shall adopt the proposed measures and apply them immediately save where the Council has decided against them by a simple majority.
Article 19
1. Where the procedure laid down in this Article is to be used, the matter shall be referred without delay to the Committee by the chairman, either on his own initiative or at the request of a Member State.
2. Within the Committee, the votes of the Member States shall be weighted as provided in Article 148 (2) of the Treaty. The chairman shall not vote.
3. The Commission representative shall submit a draft of the measures to be adopted. The Committee shall deliver its opinion on such measures within two days. Opinions shall be delivered by a majority of 41 votes.
4. The Commission shall adopt the measures and shall apply them immediately where they are in accordance with the opinion of the Committee. Where they 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 on the measures to be adopted. The Council shall adopt the measures by a qualified majority.
If the Council has not adopted any measures within 15 days from the date on which the proposal was submitted to it, the Commission shall adopt the proposed measures and shall apply them immediately save where the Council has decided against them by a simple majority.
Article 20
Acting on a Commission proposal to be submitted before 1 July 1977, the Council shall adopt before 31 December 1977 the provisions determining who shall be empowered to carry out the supervision and inspections provided for in paragraph 6 of Article 3 (1) and of Articles 4 (3) and 6 (2) and in Annex A, Chapters II, IV, V, VII and VIII.
Article 21
Articles 18 and 19 shall be applicable until 21 June 1981.
Article 22
The Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive on 1 July 1979.
However, in the case of those Member States not requiring annual medical check-ups on the date of adoption of this Directive, pursuant to existing veterinary laws, the medical check-up provided for in Annex A, Chapter II (17), shall be obligatory only from 15 February 1980, unless the Council, acting on a proposal by the Commission, decides before 31 December 1979 to postpone that date in the light of the report which the Commission will submit to it.
Article 23
This Directive is addressed to the Member States.
Done at Brussels, 21 December 1976.
For the Council
The President
A.P.L.M.M. van der STEE
ANNEX A
CHAPTER I ConDITIONS FOR THE APPROVAL OF ESTABLISHMENTS MANUFACTURING MEAT PRODUCTS
1. Establishments must, throughout the period for which the approval is valid, comprise at least: (a) suitable rooms large enough for the separate storage: (i) under refrigeration: - of fresh meat within the meaning of Article 2 (1) (c),
- of meat other than that referred to in Article 2 (1) (c);
(ii) at ambient temperature or, where appropriate, under refrigeration: - of meat products fulfilling the requirements of the Directive,
- of other products prepared wholly or partly from meat;
(b) facilities enabling the veterinary inspection and supervision operations prescribed by the Directive to be carried out efficiently at any time;
(c) in the vicinity of the work rooms, an adequately equipped lockable room for the exclusive use of the competent authority;
(d) suitable rooms sufficiently large for the preparation of meat products;
(e) a lockable room for the storage of certain ingredients such as condiments;
(f) an installation enabling an adequate supply, under pressure, of potable water only ; however, an installation supplying non-potable water shall be authorized in exceptional cases for steam production, fire-fighting and the cooling of refrigeration equipment, provided that the pipes installed for this purpose preclude the use of this water for other purposes.
Non-potable water pipes must be easily distinguishable from those used for potable water and may not pass through rooms where fresh meat or meat products are worked or stored.
However, for five years from the date of implementation of the Directive, exceptional authorization may be given for non-potable water pipes to pass through rooms containing meat and meat products in establishments carrying on their activities before adoption of the Directive, provided that there are no outlets on the sections of the pipes which pass through the aforesaid rooms;
(g) an installation providing an adequate supply of hot potable water under pressure;
(h) a waste water disposal system which meets hygiene requirements;
(i) an adequate number of changing rooms, wash basins, showers and flush lavatories. The latter shall not open directly on to the work rooms. The wash basins must have hot and cold running water or water premixed to a suitable temperature (from a premixing tap), materials for cleaning and disinfecting the hands and disposable hand towels ; the wash basins must be near the lavatories and must not have hand-operated taps;
(j) facilities meeting hygiene requirements for: - handling fresh meat and meat products,
- storing the containers used for these products in such a way that neither the fresh meat or meat product nor the containers come into direct contact with the ground;
(k) proper equipment for protection against pests such as insects and rodents;
(l) a room for final packaging and for dispatch;
(m) special air- and water-tight non-corrodible containers, with lids and fasteners to prevent access by unauthorized persons, for fresh meat, meat products or trimmings thereof not intended for human consumption, or a lockable room for such meat, meat products or trimmings if they are in sufficiently large quantities to necessitate this or if they are not removed or destroyed at the end of each working day;
(n) a room for the storage of cleaning and maintenance tools and products;
(o) a room for cleaning both maintenance and cleaning equipment.
2. Depending on the type of product involved the establishment must have: (a) a cutting room;
(b) a room: - for cooking ; equipment for heat treatment must be fitted with a recording thermometer or telethermometer,
- for retorting ; the retorts must be fitted with a recording thermometer or telethermometer, and a direct-reading control thermometer;
(c) a room for the rendering down of fats;
(d) a room for smoking;
(e) a room for drying and maturing;
(f) a room for desalting, soaking or otherwise treating natural guts;
(g) a curing room, if necessary with air-conditioning facilities enabling a temperature not exceeding + 10 oC to be maintained;
(h) a room, if necessary with air-conditioning facilities, for slicing or cutting and for the wrapping of meat products intended for sale in pre-packed form;
(i) a storeroom for empty cans and a device for conveying such cans hygienically to the work room;
(j) an apparatus enabling cans to be thoroughly cleaned immediately before filling;
(k) an apparatus for washing cans in potable water after they are hermetically sealed and before retorting;
(l) facilities for the incubation of samples of meat products in hermetically sealed containers.
However, provided that the equipment used can have no deleterious effect on the fresh meat and meat products, the same room may be used for the operations to be carried out in the separate rooms referred to in (b), (c), (d) and (e).
3. The rooms referred to in 1 (a) and 2 (b) to (i) must have: - waterproof flooring which is easy to clean and disinfect, rotproof and laid in such a way as to facilitate the draining of water,
- smooth walls with light-coloured washable coating or paint up to a height of at least 2 m and with rounded angles and corners.
4. The rooms referred to in 1 (d) and 2 (a) must comprise: - waterproof flooring which is easy to clean and disinfect, rotproof, and laid in such a way as to facilitate the draining of water ; the water must be channelled under cover towards drains fitted with traps and gratings,
- smooth walls with light-coloured washable coating or paint up to storage height and at least up to 2 m and with rounded angles and corners.
5. Rooms where work on fresh meat and meat products is undertaken must have at least: - adequate ventilation and if necessary, good extraction of steam,
- adequate natural or artificial lighting which does not distort colours;
- equipment, which must be as near as possible to the work stations, for cleaning and disinfecting hands and working materials. Taps may not be hand-operable. For washing hands, these facilities must have hot and cold running water or water premixed to a suitable temperature (from a premixing tap), cleaning and disinfecting products and disposable hand towels. For cleaning tools, the temperature of the water must be not less than + 82 oC,
- instruments and working equipment such as cutting tables, tables with detachable cutting surfaces, containers, conveyor belts and saws, of non-corrodible material, not liable to taint meat and easy to clean and disinfect. The use of wood in particular is forbidden.
CHAPTER II HYGIENE REQUIREMENTS FOR STAFF, ROOMS, EQUIPMENT AND INSTRUMENTS IN ESTABLISHMENTS
6. The highest possible standard of cleanliness shall be required of staff, rooms, equipment and instruments. (a) All persons entering rooms in which work on fresh meat and meat products is undertaken must, in particular, wear clean, light-coloured and easy-to-wash working clothes and headgear with, where necessary, a neck shield. Staff engaged in manufacture shall wash and disinfect their hands several times during each working day, each time they resume work, and when their hands have been soiled. Smoking shall be forbidden in work rooms and storerooms.
(b) No animals shall be allowed inside the establishment. Rodents, insects and any other vermin must be systematically destroyed.
(c) Equipment and instruments used in manufacture must be carefully cleaned and disinfected several times during each working day, at the end of the day's work and before being used again, if they have been contaminated.
However, continuous production machines should only be cleaned when work has been finished or in cases where contamination is suspected.
7. Rooms, instruments and working equipment must be used only for the preparation of meat products.
However, they may be used for the preparation of other foodstuffs either simultaneously or at different times following authorization by the competent authority, provided that all appropriate measures are taken to prevent contamination or adverse changes in the products covered by this Directive.
8. Fresh meat and meat products, their ingredients and containers shall not: - come into direct contact with the ground,
- be deposited or handled under conditions which might contaminate them.
Care must be taken to ensure that there is no contact between raw materials and finished products.
9. While they are in use, the rooms referred to in 2 (g) and (h) must be kept at a temperature not exceeding + 10 oC.
10. The temperature laid down in 9 may be disregarded if the competent authority agrees and if it considers it permissible to do so in order to fulfil technical conditions of preparation.
11. Cans and similar containers must be thoroughly cleaned immediately before filling by means of the cleaning apparatus referred to in 2 (j).
12. If necessary, cans and similar containers must be washed in potable water, after they are hermetically sealed and before retorting, by means of the apparatus referred to in 2 (k).
13. Products for maintenance and cleaning must be kept in rooms provided for this purpose.
14. The use of detergents, disinfectants and pesticides must not affect the wholesomeness of the fresh meat or meat products.
15. Potable water must be used for all purposes including in the retorts. However, non-potable water may in exceptional cases be used in closed circuit for steam production, fire-fighting and the cooling of refrigeration equipment, provided that the pipes installed for this purpose preclude the use of this water for other purposes.
16. Persons who may contaminate fresh meat and meat products shall be prohibited from working on or handling them, in particular, persons: (a) suffering from or suspected of suffering from typhoid fever, paratyphoid A and B, infectious enteritis (salmonellosis), dysentery, infective hepatitis, scarlet fever, or who are carriers of these diseases;
(b) suffering from or suspected of suffering from infectious tuberculosis;
(c) suffering from or suspected of suffering from an infectious skin disease;
(d) exercising at the same time an activity which might cause microbial contamination of the fresh meat or meat products;
(e) wearing a bandage on the hands, other than a waterproof dressing protecting a non-infected wound.
17. A medical certificate shall be required from every person working on fresh meat or meat products. It shall attest that there is no impediment to such employment ; it shall be renewed annually and each time the competent authority so requests ; it shall be kept at the disposal of the latter.
CHAPTER III REQUIREMENTS FOR FRESH MEAT TO BE USED FOR THE MANUFACTURE OF MEAT PRODUCTS
18. Fresh meat which comes from a slaughterhouse, cutting establishment, cold store or another processing establishment in the same country as the establishment concerned must be transported to it under satisfactory sanitary conditions in accordance with the provisions of the Council Directives referred to in Article 2 (1) (b) except those on sealing.
19. Meat which does not comply with the conditions of Article 2 (1) (c) may be held in approved establishments only if stored in separate places ; it must be used in other places or at other times than meat which does comply with these conditions. The competent authority must at all times have free access to cold stores and to all work rooms in order to verify strict observance of these provisions.
20. As soon as it arrives at the establishment and until it is used, fresh meat intended for the manufacture of meat products must be stored in a room where it is kept at a constant internal temperature of not more than + 7 oC ; however, for offal the temperature shall be not more than + 3 oC and for poultrymeat not more than + 4 oC.
CHAPTER IV SUPERVISION OF PRODUCTION
21. Establishments shall be subject to supervision by a competent authority who must be given due notice before work on meat products intended for intra-Community trade is undertaken.
22. Constant supervision by the competent authority shall include the following: - inspection of the entry and exit register for fresh meat and meat products,
- sanitary inspection of fresh meat intended for the manufacture of meat products for intra-Community trade and, in the case referred to in paragraph 3 (b) of Article 3 (1), of meat products,
- inspection of meat products on dispatch from the establishment;
- filling in and issuing the health certificate provided for in 34,
- verification of the cleanliness of the premises, facilities and instruments and of staff hygiene as provided for in Chapter II,
- taking of any samples required for laboratory tests,
- any supervision measures considered necessary by the competent authority to ensure compliance with this Directive.
The results of such tests shall be recorded in a register.
23. In the manufacture of meat products in hermetically sealed containers the competent authority must ensure that: - the producer samples the daily output, at intervals determined in advance, to ensure the efficacy of the sealing,
- the producer uses control markers to check that the containers have in fact undergone suitable heat-treatment,
- products in hermetically sealed containers are removed from the heating equipment at a sufficiently high temperature to ensure rapid evaporation of humidity and are not touched by hand until completely dry.
24. The results of the various processing controls and tests carried out by the producer must be kept for presentation on request to the competent authority.
CHAPTER V CHECK ON THE EFFECTIVENESS OF TREATMENTS
25. The competent authority must check the effectiveness of the treatment of meat products, if necessary by taking samples, to ensure that: - the products have undergone treatment as defined in Article 2 (1) (d),
- the treatment may be considered as complete within the meaning of Article 2 (1) (e) or incomplete in accordance with Article 2 (1) (f).
26. A product has been treated within the meaning of Article 2 (1) (d) when either the aw value is less than 0 797 or the cut surface shows that the product no longer has the characteristics of fresh meat.
27. A product has undergone complete treatment: (a) if it has undergone heat treatment in a hermetically sealed container, when the Fo value exceeds or equals 3 700 or, in Member States in which this value is not customarily applied when the check on the treatment has been carried out by means of a seven-day incubation test at 37 oC or a 10-day test at 35 oC;
(b) if it has undergone a treatment other than that referred to in (a), when: (i) the aw value does not exceed 0 795 and the pH does not exceed 5 72,
(ii) or the aw value does not exceed 0 791,
(iii) or the pH value is less than 4 75.
If the conditions referred to in (a) and (b) are not fulfilled in the treatment, the product shall be regarded as having undergone incomplete treatment.
CHAPTER VI WRAPPING AND PACKAGING OF MEAT PRODUCTS
28. Wrapping and packaging must take place under satisfactory hygienic conditions in rooms intended for this purpose.
29. Wrapping and packaging must comply with all rules of hygiene, including the following: - it must not be such as to alter the organoleptic characteristics of the meat products,
- it must not be capable of transmitting to the meat products substances harmful to human health,
- it must be strong enough to protect the meat products adequately.
30. Wrappings may not be re-used for meat products, with the exception of certain special types of earthenware-which may be re-used after cleaning and disinfecting.
CHAPTER VII HEALTH MARKING
31. Meat products must be marked. This marking must be carried out under the responsibility of the competent authority during or immediately after manufacture in an easily visible place. The mark must be legible, indelible and its characters easily distinguishable.
32. However: (a) where the meat product is individually wrapped and packaged, it shall suffice for the health mark to be put on the packaging;
(b) where the meat products are to be dispatched in a second container the mark must also be put on that second container;
(c) the health marking may also consist of an irremovable disc of resistant material complying fully with hygiene requirements and bearing the information specified in 33 (a).
33. (a) The health mark must give the following particulars within an oval surround: - above:
the initial(s) of the exporting country in capitals, i.e. B - D - DK - F - IRL - I - L - NL - UK, followed by the approval number of the establishment;
- below:
one of the following sets of initials : CEE - EEG - EWG - EEC - E?F.
(b) The health mark may be applied to the product, wrapping or packaging by inking or branding, or it may be printed on or applied to a label. The mark must be destroyed when the package is opened. Non-destruction of this mark may be tolerated only when the package is destroyed on being opened.
CHAPTER VIII HEALTH CERTIFICATE
34. The original copy of the health certificate which must accompany meat products during their transportation to the country of destination must be issued by the competent authority at the time of loading.
It must correspond in form and content to the model in Annex B. It must be written at least in the language(s) of the country of destination and must be supplemented by the particulars specified. It must be drawn up on a single sheet of paper.
CHAPTER IX STORAGE AND TRANSPORT
35. Meat products intended for intra-Community trade must be stored in the premises referred to in 1 (a).
36. Meat products for which certain storage temperatures are indicated in accordance with Article 4 must be maintained at these temperatures.
37. Meat products must be dispatched in such a way that they are adequately protected during transportation from anything which may de detrimental to them or contaminate them, taking into account the length of the journey, the means of transport and the weather conditions.
38. Meat products must be transported in vehicles equipped to enable them to be transported when necessary under refrigeration, the temperatures indicated in accordance with Article 4 not being exceeded.
ANNEX B
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THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament (1),
Whereas, since the establishment of the common organization of the markets, meat products may move freely within the Community ; whereas, however, intra-Community trade in these products is curbed by the existence of different health requirements in this sector in the various Member States ; whereas, in order to remove such disparities, it is necessary to substitute common provisions for these national requirements;
Whereas, in order to guarantee the quality of the products in question from the health point of view, it is necessary to use, in their manufacture, only that fresh meat obtained in accordance with the Community standards laid down in Council Directive 64/433/EEC of 26 June 1964 on health problems affecting intra-Community trade in fresh meat (2), as last amended by Directive 75/379/EEC (3), Council Directive 71/118/EEC of 15 February 1971 on health problems affecting trade in fresh poultrymeat (4), as last amended by Directive 75/379/EEC, and also 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 (5), as last amended by Directive 75/379/EEC ; whereas meat products must be manufactured, stored and transported in conditions offering every guarantee as regards health ; whereas the need for manufacturing and processing establishments to obtain approval is likely to facilitate supervision of compliance with these conditions ; whereas provision should be made for a procedure intended to settle any disputes which may arise between Member States as to the justification of the approval of a manufacturing establishment;
Whereas, moreover, Community control arrangements should be introduced to ensure that the standards laid down in this Directive are applied uniformly in all Member States ; whereas provision should be made for the procedure for such controls to be determined according to a Community procedure within the Standing Veterinary Committee set up by the Council Decision of 15 October 1968 (6);
Whereas provision should be made for the possibility of derogating from certain provisions of this Directive in respect of certain meat products which contain other foodstuffs and which contain a minimal percentage of meat ; whereas these derogations should be made according to a Community procedure within the Standing Veterinary Committee;
Whereas, as regards intra-Community trade, the issue of a health certificate drafted by the competent authority is considered to be the best way of assuring the competent authorities of the country of destination that a consignment of meat products complies with this Directive ; whereas this certificate must accompany the consignment of these products to the place of destination;
Whereas Member States must have the right to prohibit the introduction into their territory of meat products from another Member State which prove unfit for human consumption or do not comply with Community health provisions;
Whereas, in such cases, the consignor should, at his own request or upon request of his representative, be allowed to have the meat products returned to him unless there are health reasons to the contrary; (1)OJ No C 114, 11.11.1971, p. 40. (2)OJ No 121, 29.7.1964, p. 2012/64. (3)OJ No L 172, 3.7.1975, p. 17. (4)OJ No L 55, 8.3.1971, p. 23. (5)OJ No L 302, 31.12.1972, p. 28. (6)OJ No L 255, 18.10.1968, p. 23.
Whereas, in case of prohibition or restriction, the reasons therefor should be made known to the consignor or his representative and also, in certain cases, to the competent authorities of the exporting country;
Whereas, in the event of a dispute between himself and the authorities of the Member State of destination as to the justification for prohibition or restriction, the consignor should be enabled to obtain the opinion of an expert;
Whereas, in order to facilitate the implementation of the proposed measures, a procedure should be provided for close cooperation between the Member States and the Commission in the Standing Veterinary Committee,
HAS ADOPTED THIS DIRECTIVE:
Article 1
This Directive lays down health requirements for meat products intended for intra-Community trade.
Article 2
1. For the purposes of this Directive, the following definitions shall apply: (a) meat products : products prepared wholly or partly from meat which has undergone treatment to ensure a certain degree of preservation.
However, meat which has only undergone chilling or freezing shall not be regarded as a meat product.
The following are not covered by this Directive: (i) meat extracts, meat consommé and stock, meat sauces and similar products not containing fragments of meat;
(ii) whole, broken or crushed bones, meat peptones, animal gelatin, meat powder, pork-rind powder, blood plasma, dried blood, dried blood plasma, cellular proteins, bone extracts and similar products;
(iii) fats melted down from animal tissues;
(iv) stomachs, bladders and intestines, cleaned and bleached, salted or dried;
(b) meat : meat as defined in: - Article 1 of Directive 64/433/EEC,
- Article 1 of Directive 71/118/EEC,
- Article 2 of Directive 72/462/EEC;
(c) fresh meat : fresh meat as defined in Article 1 of Directives 64/433/EEC and 71/118/EEC and Article 2 of Directive 72/462/EEC;
(d) treatment : the treatment of fresh meat, whether or not combined with other foodstuffs, by heating, salting or drying, or a combination or these processes;
(e) complete treatment : treatment the effects of which are sufficient to guarantee the subsequent wholesomeness of the product at normal ambient temperature;
(f) incomplete treatment : treatment which does not meet the requirements laid down for complete treatment in Annex A, Chapter V (27);
(g) heating : use of dry or damp heat;
(h) salting : use of salt (NaCl);
(i) drying : natural or artificial reduction of the water content;
(j) exporting country : the Member State from which meat products are sent to another Member State;
(k) country of destination : the Member State to which meat products are sent from another Member State;
(l) consignment : a quantity of a meat product which is covered by the same health certificate;
(m) wrapping : the protection of meat products by the use of an initial wrapping or initial container in direct contact with the product concerned as well as the initial wrapper or initial container itself;
(n) packaging : the placing of a wrapped or unwrapped meat product or products in a second container, as well as the container itself.
2. Pending the adoption, following submission of a proposal in accordance with Article 9 (2), of provisions regarding meat which is treated by a process other than heating, salting or drying or which has undergone treatment which does not meet the requirements of Annex A, Chapter V (26), such meat shall be subject to the Directives referred to in paragraph 1 (b).
Article 3
1. Each Member State shall ensure that only meat products complying with the following general conditions are sent from its territory to the territory of another Member State: (1) they must have been prepared in an establishment approved and inspected in accordance with Article 6;
(2) they must have been prepared, stored and transported in accordance with Annex A;
(3) they must have been prepared from: (a) fresh meat as defined in Article 2 (1) (c). This fresh meat may originate: (i) in accordance with Directive 64/433/EEC, in the Member State in which the preparation is carried out or in any other Member State,
(ii) in accordance with Directive 72/462/EEC, in a third country, being imported either directly or by another Member State,
(iii) in accordance with Article 15 of Directive 71/118/EEC, in a third country, in so far as: - products obtained from this meat fulfil the requirements of this Directive,
- the health marking laid down in Annex A, Chapter VII, is not carried out on these products,
- intra-Community trade in these products remains subject to the national provisions of each Member State;
(b) a meat product, provided that it meets the requirements of this Directive;
(4) they must have been prepared by heating, salting or drying, which processes may be combined with smoking or maturing, possibly under specific microclimatic conditions, and associated, in particular, with certain curing agents within the meaning of Article 12. They may also be associated with other foodstuffs and condiments;
(5) they must have been prepared from fresh meat handled in accordance with Annex A, Chapter III;
(6) they must, in accordance with Annex A, Chapter IV, have undergone an inspection carried out by the competent authority ; such inspections may be carried out, in purely routine tasks and in accordance with rules to be defined where necessary under the procedure provided for in Article 18, with the help of aissistants specially trained for the purpose;
(7) they must meet the standards laid down in Annex A, Chapter V;
(8) they must have been wrapped and packaged in accordance with Annex A, Chapter VI, where wrapping and packaging are necessary;
(9) they must bear a health marking in accordance with Annex A, Chapter VII;
(10) they must, in accordance with Annex A, Chapter VIII, be accompanied by a health certificate during transport to the country of destination;
(11) they must be stored and transported to the country of destination under satisfactory health conditions in accordance with Annex A, Chapter IX.
2. Meat products may not have been subjected to ionizing radiation, unless this is justified on medical grounds and unless such procedure is clearly indicated on the product and on the health certificate.
Article 4
1. Meat products which have undergone complete treatment in accordance with Annex A, Chapter V (27), may be stored and transported at normal ambient temperatures.
Products which have been subjected to natural fermentation and maturing for a long period shall be regarded as having undergone complete treatment until the Council, acting, unanimously on a proposal by the Commission, shall have amended the limits given in Annex A, Chapter V (27) (b).
2. For inspection purposes, the producer must ensure that the packaging of meat products which have undergone incomplete treatment bears a clear and legible indication of the temperature at which the products must be transported and stored and the period during which preservation may thus be assured.
3. If necessary, in accordance with the procedure laid down in Article 18, a derogation may be made from paragraph 2 in respect of certain meat products which do not comply with the standards laid down in Annex A, Chapter V (27), subject to certain conditions which shall be verified by the competent authority.
Article 5
Articles 3 and 4 shall not apply to meat products which are imported with the authorization of the country of destination for uses other than human consumption ; in this case, the country of destination shall ensure that these products are used only for the purposes for which they were dispatched to that country.
Article 6
1. Each Member State shall draw up a list of the establishments approved by it and having a veterinary approval number. It shall send this list to the other Member States and to the Commission.
The Commission shall draw up a list of these approved establishments and shall have it published in the Official Journal of the European Communities.
Without prejudice to Article 8, a Member-State shall not approve an establishment unless compliance with this Directive is assured.
The Member State shall withdraw approval if the conditions for approval are no longer fulfilled.
If a check has been made in accordance with Article 7, the Member State concerned shall take account of the conclusions resulting therefrom.
The other Member States and the Commission shall be informed of the withdrawal of approval.
2. Inspection and supervision of approved establishments shall be carried out under the responsibility of the competent authority which may be assisted in purely technical tasks by personnel specially trained for the purpose.
The detailed rules governing this assistance shall be determined in accordance with the procedure provided for in Article 18.
3. If a Member State considers that the conditions for approval are not or are no longer complied with by an establishment in another Member State, it shall so inform the Commission and the competent central authority of the latter Member State.
4. In the case referred to in paragraph 3, the Commission shall forthwith initiate the procedure laid down in Article 7.
If justified by the conclusions of the inspection report, the Member States may be authorized, in accordance with the procedure laid down in Article 19, to refuse entry to their territory of meat products from the establishment in question.
This authorization may be withdrawn in accordance with the same procedure laid down in Article 19, if such action is justified by the findings of a further expert inspection carried out in accordance with Article 7.
Article 7
Experts of the Member States and of the Commission shall carry out regular inspections of the approved establishments to ensure that the latter in fact apply this Directive, and in particular Annex A, Chapters I and II.
They shall provide the Commission with a report on the results of the inspections carried out.
The Member State in whose territory an inspection is carried out shall give the experts all the necessary help in performing their task.
The experts of the Member States who carry out the inspections shall be designated by the Commission acting upon a proposal from the Member States. They must be nationals of a Member State other than that in which the inspection is carried out and, in the case provided for in Article 6 (3) and (4), other than that of the Member States involved in the dispute.
Inspections shall be carried out on behalf of the Community, which shall bear the cost involved.
The frequency and the detailed rules for these inspections shall be determined in accordance with the procedure laid down in Article 18.
Article 8
1. By way of derogation from the conditions stipulated in Article 3, it may be decided, in accordance with the procedure laid down in Article 18, that some provisions of this Directive shall not apply to certain products which contain other foodstuffs and only a small percentage of meat or meat product.
These exceptions shall relate only to: (a) the conditions for approval of establishments as laid down in Annex A, Chapter I;
(b) the inspection requirements described in Annex A, Chapters IV and V;
(c) the requirements for a health marking and health certificate as laid down in paragraphs 9 and 10 of Article 3 (1).
When considering whether to allow exception such as those provided for under this Article, both the nature and the composition of the product shall be taken into account.
Notwithstanding the provisions of this Article, the Member States shall ensure that all meat products intended for intra-Community trade are wholesome products prepared from fresh meat or meat products within the meaning of this Directive.
2. The first subparagraph of paragraph 1 shall be implemented for the first time before the date of implementation of this Directive.
Article 9
1. The Council, acting on a proposal from the Commission, shall determine for the first time, before the implementation of this Directive, the provisions applying to fresh meat which has been minced, ground or similarly broken down into small pieces, with the addition of other foodstuffs and condiments.
Pending the entry into force of the provisions thus adopted, this meat shall remain subject to national laws.
2. The Commission shall submit to the Council, before the date of implementation of this Directive, a proposal dealing with the case of products not having undergone treatment and thus not fulfilling the requirements laid down Annex A, Chapter V (26).
Article 10
The methods required in order to check compliance with the standards laid down in Annex A, Chapter V (26) and (27) and the tolerances to be permitted for these standards, shall be established six months before the date of implementation of this Directive in accordance with the procedure laid down in Article 18.
These methods, standards and tolerances may, if necessary, be altered or updated using the same procedure.
Article 11
1. Without prejudice to the powers resulting from Articles 6 and 7, a Member State on whose territory it has been established in the course of a health inspection that: (a) the meat products imported from another Member State are unfit for human consumption, shall prohibit the marketing of such products within its territory;
(b) Article 3 has not been complied with, may impose such a prohibition.
2. Decisions taken pursuant to paragraph 1 must, at the request of the consignor or his representative, authorize the reconsignment of the meat products, in so far as there are no objections thereto on health grounds. In any event, precautions shall be taken to prevent improper use of these products.
If reconsignment is not possible the products must be destroyed on the territory of the Member State in which the inspection is carried out.
By way of derogation from this provision and at the request of the consignee or his representative, the Member State carrying out the animal health and public health inspections may authorize their entry for use other than for human consumption, to the extent that there is no danger for humans or for animals. These meat products may not leave the territory of that Member State, which must check their destintaion.
These decisions must be communicated to the consignor or his representative together with the reasons for such decisions. These reasoned decisions must, on request, be communicated forthwith in writing, with an indication of the channels of appeal provided for under the current legislation and of their forms and the time limits within which they are open.
3. Where such decisions are based on the establishment of the presence of a contagious disease, deterioration dangerous to human health or a serious infringement of this Directive, they shall also be communicated forthwith, together with the reasons for these decisions, to the competent central authority of the exporting country and to the Commission.
Article 12
Without prejudice to current Community rules on additives authorized for use in foodstuffs, the use of additives in meat products and the detailed rules governing such use shall continue to be subject to national laws until the entry into force of Community provisions on the matter.
Article 13
The Council, acting unanimously on a proposal from the Commission, shall, before 31 December 1978, determine the temperatures to be observed during cutting and initial wrapping as provided for in Annex A, Chapter II (9), and without prejudice to the provisions laid down in Annex A, Chapter III (20).
Article 14
1. The Council, acting on a proposal from the Commission, shall take a unanimous decision on Community rules relating to the methods of detecting trichinae and also to the cases where such detection is unnecessary.
2. Pending the entry into force of such rules, the Member States' legislation on the detection of trichinae in meat products containing pigmeat shall remain applicable.
3. Pigmeat recognized as trichinous must not be used in the manufacture of meat products intended for intra-Community trade.
Article 15
1. This Directive shall not affect the channels of appeal open under the current legislation in Member States against the decisions of the competent authorities provided for in this Directive.
2. Each Member State shall grant consignors of meat products, the movement of which is prohibited pursuant to Article 11 (1), the right to obtain the opinion of an expert. Each Member State shall ensure that, before the competent authorities take any other measures such as destroying the meat, the experts have an opportunity of determining whether the conditions of Article 11 (1) have been fulfilled.
The expert must be a national of a Member State other than the exporting country or country of destination.
Acting on a proposal from the Member States, the Commission shall draw up a panel list of the experts who may be instructed to formulate such opinions. After consulting the Member States, it shall lay down general rules which are to be applied, in particular as regards the procedure for formulating these opinions.
Article 16
Until the entry into force of Community provisions on problems of animal health affecting intra-Community trade in meat products, national rules shall continue to apply in this field.
Article 17
Pending the implementation of Community provisions concerning imports of meat products from third countries, Member States shall apply to such imports provisions which are at least equivalent to those resulting from this Directive.
Article 18
1. Where the procedure laid down in this Article is to be used, the matter shall be referred without delay to the Standing Veterinary Committee (hereinafter referred to as "the Committee"), set up by the Council Decision of 15 October 1968, by the chairman, either on his own initiative or at the request of a Member State.
2. Within the Committee, the votes of the Member States shall be weighted as provided in Article 148 (2) of the Treaty. The chairman shall not vote.
3. The Commission representative shall submit a draft of the measures to be adopted. The Committee shall deliver its opinion on the measures within a period to be determined by the chairman in keeping with the urgency of the question submitted for examination. Opinions shall be delivered by a majority of 41 votes.
4. The Commission shall adopt the measures and shall implement them immediately, where they are in accordance with the opinion of the Committee. Where they 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 on the measures to be adopted. The Council shall adopt the measures by a qualified majority.
If the Council has not adopted any measures within three months from the date on which the proposal was submitted to it, the Commission shall adopt the proposed measures and apply them immediately save where the Council has decided against them by a simple majority.
Article 19
1. Where the procedure laid down in this Article is to be used, the matter shall be referred without delay to the Committee by the chairman, either on his own initiative or at the request of a Member State.
2. Within the Committee, the votes of the Member States shall be weighted as provided in Article 148 (2) of the Treaty. The chairman shall not vote.
3. The Commission representative shall submit a draft of the measures to be adopted. The Committee shall deliver its opinion on such measures within two days. Opinions shall be delivered by a majority of 41 votes.
4. The Commission shall adopt the measures and shall apply them immediately where they are in accordance with the opinion of the Committee. Where they 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 on the measures to be adopted. The Council shall adopt the measures by a qualified majority.
If the Council has not adopted any measures within 15 days from the date on which the proposal was submitted to it, the Commission shall adopt the proposed measures and shall apply them immediately save where the Council has decided against them by a simple majority.
Article 20
Acting on a Commission proposal to be submitted before 1 July 1977, the Council shall adopt before 31 December 1977 the provisions determining who shall be empowered to carry out the supervision and inspections provided for in paragraph 6 of Article 3 (1) and of Articles 4 (3) and 6 (2) and in Annex A, Chapters II, IV, V, VII and VIII.
Article 21
Articles 18 and 19 shall be applicable until 21 June 1981.
Article 22
The Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive on 1 July 1979.
However, in the case of those Member States not requiring annual medical check-ups on the date of adoption of this Directive, pursuant to existing veterinary laws, the medical check-up provided for in Annex A, Chapter II (17), shall be obligatory only from 15 February 1980, unless the Council, acting on a proposal by the Commission, decides before 31 December 1979 to postpone that date in the light of the report which the Commission will submit to it.
Article 23
This Directive is addressed to the Member States.
Done at Brussels, 21 December 1976.
For the Council
The President
A.P.L.M.M. van der STEE
ANNEX A
CHAPTER I ConDITIONS FOR THE APPROVAL OF ESTABLISHMENTS MANUFACTURING MEAT PRODUCTS
1. Establishments must, throughout the period for which the approval is valid, comprise at least: (a) suitable rooms large enough for the separate storage: (i) under refrigeration: - of fresh meat within the meaning of Article 2 (1) (c),
- of meat other than that referred to in Article 2 (1) (c);
(ii) at ambient temperature or, where appropriate, under refrigeration: - of meat products fulfilling the requirements of the Directive,
- of other products prepared wholly or partly from meat;
(b) facilities enabling the veterinary inspection and supervision operations prescribed by the Directive to be carried out efficiently at any time;
(c) in the vicinity of the work rooms, an adequately equipped lockable room for the exclusive use of the competent authority;
(d) suitable rooms sufficiently large for the preparation of meat products;
(e) a lockable room for the storage of certain ingredients such as condiments;
(f) an installation enabling an adequate supply, under pressure, of potable water only ; however, an installation supplying non-potable water shall be authorized in exceptional cases for steam production, fire-fighting and the cooling of refrigeration equipment, provided that the pipes installed for this purpose preclude the use of this water for other purposes.
Non-potable water pipes must be easily distinguishable from those used for potable water and may not pass through rooms where fresh meat or meat products are worked or stored.
However, for five years from the date of implementation of the Directive, exceptional authorization may be given for non-potable water pipes to pass through rooms containing meat and meat products in establishments carrying on their activities before adoption of the Directive, provided that there are no outlets on the sections of the pipes which pass through the aforesaid rooms;
(g) an installation providing an adequate supply of hot potable water under pressure;
(h) a waste water disposal system which meets hygiene requirements;
(i) an adequate number of changing rooms, wash basins, showers and flush lavatories. The latter shall not open directly on to the work rooms. The wash basins must have hot and cold running water or water premixed to a suitable temperature (from a premixing tap), materials for cleaning and disinfecting the hands and disposable hand towels ; the wash basins must be near the lavatories and must not have hand-operated taps;
(j) facilities meeting hygiene requirements for: - handling fresh meat and meat products,
- storing the containers used for these products in such a way that neither the fresh meat or meat product nor the containers come into direct contact with the ground;
(k) proper equipment for protection against pests such as insects and rodents;
(l) a room for final packaging and for dispatch;
(m) special air- and water-tight non-corrodible containers, with lids and fasteners to prevent access by unauthorized persons, for fresh meat, meat products or trimmings thereof not intended for human consumption, or a lockable room for such meat, meat products or trimmings if they are in sufficiently large quantities to necessitate this or if they are not removed or destroyed at the end of each working day;
(n) a room for the storage of cleaning and maintenance tools and products;
(o) a room for cleaning both maintenance and cleaning equipment.
2. Depending on the type of product involved the establishment must have: (a) a cutting room;
(b) a room: - for cooking ; equipment for heat treatment must be fitted with a recording thermometer or telethermometer,
- for retorting ; the retorts must be fitted with a recording thermometer or telethermometer, and a direct-reading control thermometer;
(c) a room for the rendering down of fats;
(d) a room for smoking;
(e) a room for drying and maturing;
(f) a room for desalting, soaking or otherwise treating natural guts;
(g) a curing room, if necessary with air-conditioning facilities enabling a temperature not exceeding + 10 oC to be maintained;
(h) a room, if necessary with air-conditioning facilities, for slicing or cutting and for the wrapping of meat products intended for sale in pre-packed form;
(i) a storeroom for empty cans and a device for conveying such cans hygienically to the work room;
(j) an apparatus enabling cans to be thoroughly cleaned immediately before filling;
(k) an apparatus for washing cans in potable water after they are hermetically sealed and before retorting;
(l) facilities for the incubation of samples of meat products in hermetically sealed containers.
However, provided that the equipment used can have no deleterious effect on the fresh meat and meat products, the same room may be used for the operations to be carried out in the separate rooms referred to in (b), (c), (d) and (e).
3. The rooms referred to in 1 (a) and 2 (b) to (i) must have: - waterproof flooring which is easy to clean and disinfect, rotproof and laid in such a way as to facilitate the draining of water,
- smooth walls with light-coloured washable coating or paint up to a height of at least 2 m and with rounded angles and corners.
4. The rooms referred to in 1 (d) and 2 (a) must comprise: - waterproof flooring which is easy to clean and disinfect, rotproof, and laid in such a way as to facilitate the draining of water ; the water must be channelled under cover towards drains fitted with traps and gratings,
- smooth walls with light-coloured washable coating or paint up to storage height and at least up to 2 m and with rounded angles and corners.
5. Rooms where work on fresh meat and meat products is undertaken must have at least: - adequate ventilation and if necessary, good extraction of steam,
- adequate natural or artificial lighting which does not distort colours;
- equipment, which must be as near as possible to the work stations, for cleaning and disinfecting hands and working materials. Taps may not be hand-operable. For washing hands, these facilities must have hot and cold running water or water premixed to a suitable temperature (from a premixing tap), cleaning and disinfecting products and disposable hand towels. For cleaning tools, the temperature of the water must be not less than + 82 oC,
- instruments and working equipment such as cutting tables, tables with detachable cutting surfaces, containers, conveyor belts and saws, of non-corrodible material, not liable to taint meat and easy to clean and disinfect. The use of wood in particular is forbidden.
CHAPTER II HYGIENE REQUIREMENTS FOR STAFF, ROOMS, EQUIPMENT AND INSTRUMENTS IN ESTABLISHMENTS
6. The highest possible standard of cleanliness shall be required of staff, rooms, equipment and instruments. (a) All persons entering rooms in which work on fresh meat and meat products is undertaken must, in particular, wear clean, light-coloured and easy-to-wash working clothes and headgear with, where necessary, a neck shield. Staff engaged in manufacture shall wash and disinfect their hands several times during each working day, each time they resume work, and when their hands have been soiled. Smoking shall be forbidden in work rooms and storerooms.
(b) No animals shall be allowed inside the establishment. Rodents, insects and any other vermin must be systematically destroyed.
(c) Equipment and instruments used in manufacture must be carefully cleaned and disinfected several times during each working day, at the end of the day's work and before being used again, if they have been contaminated.
However, continuous production machines should only be cleaned when work has been finished or in cases where contamination is suspected.
7. Rooms, instruments and working equipment must be used only for the preparation of meat products.
However, they may be used for the preparation of other foodstuffs either simultaneously or at different times following authorization by the competent authority, provided that all appropriate measures are taken to prevent contamination or adverse changes in the products covered by this Directive.
8. Fresh meat and meat products, their ingredients and containers shall not: - come into direct contact with the ground,
- be deposited or handled under conditions which might contaminate them.
Care must be taken to ensure that there is no contact between raw materials and finished products.
9. While they are in use, the rooms referred to in 2 (g) and (h) must be kept at a temperature not exceeding + 10 oC.
10. The temperature laid down in 9 may be disregarded if the competent authority agrees and if it considers it permissible to do so in order to fulfil technical conditions of preparation.
11. Cans and similar containers must be thoroughly cleaned immediately before filling by means of the cleaning apparatus referred to in 2 (j).
12. If necessary, cans and similar containers must be washed in potable water, after they are hermetically sealed and before retorting, by means of the apparatus referred to in 2 (k).
13. Products for maintenance and cleaning must be kept in rooms provided for this purpose.
14. The use of detergents, disinfectants and pesticides must not affect the wholesomeness of the fresh meat or meat products.
15. Potable water must be used for all purposes including in the retorts. However, non-potable water may in exceptional cases be used in closed circuit for steam production, fire-fighting and the cooling of refrigeration equipment, provided that the pipes installed for this purpose preclude the use of this water for other purposes.
16. Persons who may contaminate fresh meat and meat products shall be prohibited from working on or handling them, in particular, persons: (a) suffering from or suspected of suffering from typhoid fever, paratyphoid A and B, infectious enteritis (salmonellosis), dysentery, infective hepatitis, scarlet fever, or who are carriers of these diseases;
(b) suffering from or suspected of suffering from infectious tuberculosis;
(c) suffering from or suspected of suffering from an infectious skin disease;
(d) exercising at the same time an activity which might cause microbial contamination of the fresh meat or meat products;
(e) wearing a bandage on the hands, other than a waterproof dressing protecting a non-infected wound.
17. A medical certificate shall be required from every person working on fresh meat or meat products. It shall attest that there is no impediment to such employment ; it shall be renewed annually and each time the competent authority so requests ; it shall be kept at the disposal of the latter.
CHAPTER III REQUIREMENTS FOR FRESH MEAT TO BE USED FOR THE MANUFACTURE OF MEAT PRODUCTS
18. Fresh meat which comes from a slaughterhouse, cutting establishment, cold store or another processing establishment in the same country as the establishment concerned must be transported to it under satisfactory sanitary conditions in accordance with the provisions of the Council Directives referred to in Article 2 (1) (b) except those on sealing.
19. Meat which does not comply with the conditions of Article 2 (1) (c) may be held in approved establishments only if stored in separate places ; it must be used in other places or at other times than meat which does comply with these conditions. The competent authority must at all times have free access to cold stores and to all work rooms in order to verify strict observance of these provisions.
20. As soon as it arrives at the establishment and until it is used, fresh meat intended for the manufacture of meat products must be stored in a room where it is kept at a constant internal temperature of not more than + 7 oC ; however, for offal the temperature shall be not more than + 3 oC and for poultrymeat not more than + 4 oC.
CHAPTER IV SUPERVISION OF PRODUCTION
21. Establishments shall be subject to supervision by a competent authority who must be given due notice before work on meat products intended for intra-Community trade is undertaken.
22. Constant supervision by the competent authority shall include the following: - inspection of the entry and exit register for fresh meat and meat products,
- sanitary inspection of fresh meat intended for the manufacture of meat products for intra-Community trade and, in the case referred to in paragraph 3 (b) of Article 3 (1), of meat products,
- inspection of meat products on dispatch from the establishment;
- filling in and issuing the health certificate provided for in 34,
- verification of the cleanliness of the premises, facilities and instruments and of staff hygiene as provided for in Chapter II,
- taking of any samples required for laboratory tests,
- any supervision measures considered necessary by the competent authority to ensure compliance with this Directive.
The results of such tests shall be recorded in a register.
23. In the manufacture of meat products in hermetically sealed containers the competent authority must ensure that: - the producer samples the daily output, at intervals determined in advance, to ensure the efficacy of the sealing,
- the producer uses control markers to check that the containers have in fact undergone suitable heat-treatment,
- products in hermetically sealed containers are removed from the heating equipment at a sufficiently high temperature to ensure rapid evaporation of humidity and are not touched by hand until completely dry.
24. The results of the various processing controls and tests carried out by the producer must be kept for presentation on request to the competent authority.
CHAPTER V CHECK ON THE EFFECTIVENESS OF TREATMENTS
25. The competent authority must check the effectiveness of the treatment of meat products, if necessary by taking samples, to ensure that: - the products have undergone treatment as defined in Article 2 (1) (d),
- the treatment may be considered as complete within the meaning of Article 2 (1) (e) or incomplete in accordance with Article 2 (1) (f).
26. A product has been treated within the meaning of Article 2 (1) (d) when either the aw value is less than 0 797 or the cut surface shows that the product no longer has the characteristics of fresh meat.
27. A product has undergone complete treatment: (a) if it has undergone heat treatment in a hermetically sealed container, when the Fo value exceeds or equals 3 700 or, in Member States in which this value is not customarily applied when the check on the treatment has been carried out by means of a seven-day incubation test at 37 oC or a 10-day test at 35 oC;
(b) if it has undergone a treatment other than that referred to in (a), when: (i) the aw value does not exceed 0 795 and the pH does not exceed 5 72,
(ii) or the aw value does not exceed 0 791,
(iii) or the pH value is less than 4 75.
If the conditions referred to in (a) and (b) are not fulfilled in the treatment, the product shall be regarded as having undergone incomplete treatment.
CHAPTER VI WRAPPING AND PACKAGING OF MEAT PRODUCTS
28. Wrapping and packaging must take place under satisfactory hygienic conditions in rooms intended for this purpose.
29. Wrapping and packaging must comply with all rules of hygiene, including the following: - it must not be such as to alter the organoleptic characteristics of the meat products,
- it must not be capable of transmitting to the meat products substances harmful to human health,
- it must be strong enough to protect the meat products adequately.
30. Wrappings may not be re-used for meat products, with the exception of certain special types of earthenware-which may be re-used after cleaning and disinfecting.
CHAPTER VII HEALTH MARKING
31. Meat products must be marked. This marking must be carried out under the responsibility of the competent authority during or immediately after manufacture in an easily visible place. The mark must be legible, indelible and its characters easily distinguishable.
32. However: (a) where the meat product is individually wrapped and packaged, it shall suffice for the health mark to be put on the packaging;
(b) where the meat products are to be dispatched in a second container the mark must also be put on that second container;
(c) the health marking may also consist of an irremovable disc of resistant material complying fully with hygiene requirements and bearing the information specified in 33 (a).
33. (a) The health mark must give the following particulars within an oval surround: - above:
the initial(s) of the exporting country in capitals, i.e. B - D - DK - F - IRL - I - L - NL - UK, followed by the approval number of the establishment;
- below:
one of the following sets of initials : CEE - EEG - EWG - EEC - E?F.
(b) The health mark may be applied to the product, wrapping or packaging by inking or branding, or it may be printed on or applied to a label. The mark must be destroyed when the package is opened. Non-destruction of this mark may be tolerated only when the package is destroyed on being opened.
CHAPTER VIII HEALTH CERTIFICATE
34. The original copy of the health certificate which must accompany meat products during their transportation to the country of destination must be issued by the competent authority at the time of loading.
It must correspond in form and content to the model in Annex B. It must be written at least in the language(s) of the country of destination and must be supplemented by the particulars specified. It must be drawn up on a single sheet of paper.
CHAPTER IX STORAGE AND TRANSPORT
35. Meat products intended for intra-Community trade must be stored in the premises referred to in 1 (a).
36. Meat products for which certain storage temperatures are indicated in accordance with Article 4 must be maintained at these temperatures.
37. Meat products must be dispatched in such a way that they are adequately protected during transportation from anything which may de detrimental to them or contaminate them, taking into account the length of the journey, the means of transport and the weather conditions.
38. Meat products must be transported in vehicles equipped to enable them to be transported when necessary under refrigeration, the temperatures indicated in accordance with Article 4 not being exceeded.
ANNEX B
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