Avis juridique important

|

31992L0005

Council Directive 92/5/EEC of 10 February 1992 amending and updating Directive 77/99/EEC on health problems affecting intra-Community trade in meat products and amending Directive 64/433/EEC

Official Journal L 057 , 02/03/1992 P. 0001 - 0026 Finnish special edition: Chapter 3 Volume 41 P. 0046  Swedish special edition: Chapter 3 Volume 41 P. 0046

COUNCIL DIRECTIVE 92/5/EEC of 10 February 1992 amending and updating Directive 77/99/EEC on health problems affecting intra-Community trade in meat products and amending Directive 64/433/EECTHE 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 opinion of the European Parliament (2),Having regard to the opinion of the Economic and Social Committee (3),Whereas meat from bovine animals, swine, sheep and goats and domestic solipeds, poultrymeat, game meat and treated products derived from such meat are included in the list of products in Annex II to the Treaty; whereas production of and trade in these products constitute an important source of income for part of the farming population;Whereas, in order to ensure the rational development of this sector and to increase productivity, public health rules governing production and placing on the market must be laid down at Community level;Whereas the Community has to adopt measures for the progressive establishment of the internal market over a period expiring on 31 December 1992;Whereas Directive 77/99/EEC (4) laid down the health requirements to be complied with in intra-Community trade in meat products;Whereas Directive 89/662/EEC (5) laid down rules on the checks to be applied with a view to the completion of the internal market, and in particular abolished veterinary checks at frontiers between Member States;Whereas to take account of the abolition of the said checks and of the introduction of more stringent guarantees at origin when it is no longer possible to distinguish between products for the domestic market and products to be marketed in another Member State, the requirements of Directive 77/99/EEC should be adapted and extended to all production;Whereas the object of this adaptation must be in particular to standardize health requirements for the production, storage and transport of meat products and other products of animal origin intended for human consumption;Whereas a system of approval should be introduced for the establishments which meet the health requirements laid down by this Directive, together with a Community inspection procedure to ensure that the conditions for such approval are observed;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 meat 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 the health certificate should be maintained for the purposes of verifying the destination of certain products;Whereas the rules, principles and safeguard measures established by Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (6) should apply here;Whereas, in the context of intra-Community trade, the rules laid down in Directive 89/662/EEC should also be applied;Whereas the Commission should be entrusted with the task of adopting certain measures for implementing this Directive; whereas, to that end, procedures should be laid down establishing close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee;Whereas in view of the particular supply difficulties arising from its geographical situation special derogations should be permitted for the Hellenic Republic; whereas for the same reasons remote regions should be given additional time to comply with the requirements of this Directive;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 for the sake of clarity Directive 77/99/EEC should be updated and Directive 64/433/EEC (7) on health problems affecting intra-Community trade in fresh meat should be adapted,HAS ADOPTED THIS DIRECTIVE:Article 1As from 1 January 1993 the title, Articles 1 to 21 and the Annexes to Directive 77/99/EEC shall be replaced by the text annexed to this Directive.Article 2Directive 91/497/EEC is hereby amended as follows:1. In the title, the words 'amending and consolidating` shall be replaced by 'amending and updating` and the words 'and amending Directive 72/462/EEC` shall be added.2. Article 1 shall be replaced by the following:'Article 1As from 1 January 1993 the title and Articles of Directive 64/433/EEC shall be replaced in accordance with the Annex to this Directive.`3. In the Annex, in the title of Directive 64/433/EEC, the reference to '26 June 1964` shall be deleted.4. In Chapter XII of Annex I to Directive 64/433/EEC, in the third paragraph of point 60, the following sentence shall be added:'This requirement may be waived for frozen meat intended to be used without further processing as a raw material for the products referred to in Directive 77/99/EEC or Directive 88/657/EEC.`Article 3Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1993, except in the case of:- remote regions recognized in accordance with Article 17 of Directive 90/675/EEC, including - as regards the Kingdom of Spain - the Canary Islands, and with Article 13 of Directive 91/496/EEC,and- establishments situated in the new Laender of the Federal Republic of Germany covered by restructuring plans,in respect of which they shall comply with this Directive not later than 1 January 1995.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.Article 4This Directive is addressed to the Member States.Done at Brussels, 10 February 1992.For the CouncilThe PresidentArlindo MARQUES CUNHA(1) OJ N° C 84, 2. 4. 1990, p. 89, OJ N° C 327, 30. 12. 1989, p. 25, OJ N° C 262, 14. 10. 1981, p. 3, OJ N° C 267, 11. 10. 1982, p. 59, OJ N° C 296, 5. 11. 1991, p. 8.(2) OJ N° C 240, 16. 9. 1991, p. 6, OJ N° C 113, 7. 5. 1990, p. 205.(3) OJ N° C 332, 31. 12. 1990, p. 94, OJ N° C 62, 2. 3. 1990, p. 25, OJ N° C 168, 10. 7. 1990, p. 8, OJ N° C 124, 21. 5. 1990, p. 15.(4) OJ N° L 26, 31. 1. 1977, p. 85. Directive as last amended by Directive 85/328/EEC (OJ N° L 168, 28. 6. 1985, p. 28).(5) OJ N° L 395, 30. 12. 1989, p. 13. Directive as amended by Directive 90/675/EEC (OJ N° L 373, 31. 12. 1990, p. 1).(6) OJ N° L 373, 31. 12. 1990, p. 1.(7) OJ N° 121, 29. 7. 1964, p. 2012/64. Directive as last amended by Directive 91/497/EEC (OJ N° L 268, 24. 9. 1991, p. 69).ANNEX Council Directive on health problems affecting the production and marketing of meat products and certain other products of animal origin Article 11.  This Directive lays down health rules for the production and placing on the market of meat products and other products of animal origin intended, after treatment, for human consumption or for the preparation of other foodstuffs.2.  This Directive shall not apply to the preparation and storage, in retail shops or in premises adjacent to sales points, of meat products and other products of animal origin intended for human consumption, where the preparation and storage are performed solely for the purpose of supplying the consumer directly.Article 2For the purposes of this Directive the following definitions shall apply:(a) meat products: products prepared from or with meat which has undergone treatment such that the cut surface shows that the product no longer has the characteristics of fresh meat.However, the following shall not be regarded as meat products:(i) meat which has undergone only cold treatment; such meat shall remain subject to the rules in the Directives referred to in (d);(ii) products subject to Council Directive 88/657/EEC of 14 December 1988 laying down the requirements for the production of, and trade in, minced meat, meat in pieces of less than 100 grams and meat preparations and amending Directives 64/433/EEC, 71/118/EEC and 72/462/EEC (¹);(b) other products of animal origin:(i) meat extracts;(ii) rendered animal fat: fat derived from rendering meat, including bones, and intended for human consumption;(iii) greaves: the protein-containing residue of rendering, after partial separation of fat and water;(iv) gelatin;(¹) OJ N° L 382, 31. 12. 1988, p. 3.(v) meat powder, powdered rind, salted or dried blood, salted or dried blood plasma;(vi) stomachs, bladders and intestines, cleaned, salted or dried, and/or heated;(c) prepared meat meals; wrapped meat products corresponding to culinary preparations, cooked or pre-cooked and preserved by cold;(d) meat: meat as defined in:- Article 2 (a) of Directive 64/433/EEC,- Article 2 of Directive 71/118/EEC,- Article 2 of Directive 72/461/EEC,- Article 2 of Directive 72/462/EEC,- Article 2 of Directive 88/657/EEC,- Article 2 (1) and (2) of Directive 91/495/EEC;(e) raw material: any animal product used as an ingredient to obtain products referred to in (a) and (b) or used in the preparation of prepared meals;(f) treatment: chemical or physical process such as heating, smoking, salting, marinating, curing or drying, intended to lengthen the preservation of meat or animal products whether or not associated with other foodstuffs, or a combination of these various processes;(g) heating: use of dry or damp heat;(h) salting: use of salt;(i) curing: distribution of salts throughout the product;(j) maturing: treatment of salted raw meat, applied under climatic conditions which, in the course of a slow and gradual reduction of humidity, are capable of generating natural fermentation or enzymatic processes, involving changes over a period of time which give the product typical organoleptic characteristics and ensure its preservation and wholesomeness at normal ambient temperature;(k) drying: natural or artificial reduction of the water content;(l) batch: a quantity of a meat product which is covered by the same accompanying commercial document or health certificate;(m) 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 product concerned as well as the initial wrapper or initial container itself;(n) 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;(o) hermetically sealed container: container intended to protect the contents against the entry of micro-organisms during and after heat treatment and which is impermeable to air;(p) establishment: any undertaking manufacturing the products referred to in (a), (b) and (c);(q) rewrapping centre: a workshop or depot where batches intended for placing on the market are reassembled and/or rewrapped;(r) 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;(s) competent authority: the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that competence.Article 3A. Each Member State shall ensure - without prejudice to the conditions laid down in Article 4 - that meat products placed on the market:1. have been prepared and stored in an establishment approved and supervised:- in accordance with Article 8, and meeting the requirements of this Directive, in particular those of Annex A and Chapters I and II of Annex B,or- in accordance with Article 9, in the case of establishments which do not have an industrial structure or production capacity;2. have been prepared from meat as defined in Article 2 (d), on the understanding that:(i) meat imported from a third country must have been inspected in accordance with Directive 90/675/EEC;(ii) meat imported in accordance with Article 15 of Directive 71/118/EEC and the second paragraph of Article 17 of Directive 91/495/EEC may not be used unless:- products obtained from this meat fulfil the requirements set out in this Directive,- these products do not bear the health marking laid down in Chapter VI of Annex B,- the placing on the market of these products remains subject to the national provisions of the Member State of destination.Meat declared unfit for consumption in compliance with the requirements of Articles 5 and 6 of Directive 64/433/EEC and the following items may not be used in the preparation of meat products:(a) genital organs of female or male animals, except testicles;(b) urinary organs, except the kidneys and the bladder;(c) the cartilage of the larynx, the trachea and the extralobular bronchi;(d) eyes and eyelids;(e) the external, auditory meatus;(f) corneous tissues;(g) in poultry, the head, - except the comb and the ears, the wattles and caruncles - the oesophagus, the crop, the intestines and the genital organs.Items may be added to or removed from this list in accordance with the procedure laid down in Article 20;3. have been prepared in accordance with the requirements of Chapter III of Annex B and, in the case of pasteurized or sterilized products in hermetically sealed containers or of prepared meals, comply with the requirements of Annex B, Chapter VIII, or Chapter IX respectively;4. have undergone the establishment's own checks provided for in Article 7 and are supervised by the competent authority in accordance with Chapter IV of Annex B;5. if necessary, also meet the requirements laid down in Article 7 (2);6. where wrapping, packaging or labelling take place, have been wrapped, packaged or labelled in accordance with Chapter V of Annex B on the spot or in wrapping centres specially approved by the competent authority for that purpose.However, pending the adoption of Community rules, the provisions of this Directive concerning the sales description of meat products shall not apply to products of designated origin or to typical products;7. without prejudice to the marking requirements of Directive 80/215/EEC, have been marked, on the responsibility of the operator or manager of the establishment, with:- a national health mark, where the raw material used is marketed with that mark,- a mark to be determined in accordance with the procedure laid down in Article 20 where the meat used must, under Community law, be marketed locally,- in other cases, a health mark in accordance with Chapter VI of Annex B.The mark must be printed on the label or affixed to the product or the wrapping, on the understanding that the printing or reprinting of labels or marks must be authorized by the competent authority;8. have been handled, stored and transported in accordance with Chapter VII of Annex B and, if they are stored in a cold-storage plant separate from the establishment, this plant must have been approved and inspected in accordance with Article 10 of Directive 64/433/EEC;9. are accompanied during transportation by:(a) until 30 June 1993, for intra-Community trade in meat products other than those referred to in the second subparagraph of (b) (ii), the health certificate issued by the competent authority at the time of loading, which must correspond in form and content to the model in Annex D. It must be drawn up in the official language or languages of the country of destination at least. It must consist of a single sheet of paper;(b) from 1 July 1993:(i) an accompanying commercial document which must:- in addition to the particulars provided for in Annex B, Chapter VI, point 4, bear a code number by which the competent authority responsible for supervising the establishment of origin can be identified,- 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 1996, in the case of the meat products referred to in the second subparagraph of (ii) below intended for the Hellenic Republic 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 meat products concerned meet the requirements of this Directive;(ii) a health certificate in accordance with Annex D, in the case of products referred to in Article 1 obtained from meat from a slaughterhouse situated in a region or area subject to a restriction on animal health grounds, or from meat referred to in Article 6 of Directive 64/433/EEC, or from products to be sent to another Member State, after transit through a third country in a sealed means of transport.This obligation shall not apply to meat products in hermetically sealed containers and having undergone one of the treatments referred to in Annex B, Chapter VIII, point B, first indent, if the health mark is indelibly marked on the container in accordance with the provisions to be drawn up under the procedure laid down in Article 20.Detailed rules for applying (ii), and in particular those concerning the allocation of code numbers and the compilation of one or more lists identifying the competent authorities, shall be adopted in accordance with the procedure laid down in Article 20.B. Pending possible Community rules on ionization, meat products may not have been subjected to ionizing radiation.This provision shall not affect national rules applicable to ionization for medical purposes.Article 4Member States shall ensure that, in addition to the general requirements laid down in Article 3:1. meat products:(a) have been prepared by heating, curing, marinating or drying, which processes may be combined with smoking or maturing, possibly under specific microclimatic conditions, and have been associated, in particular, with certain curing agents in compliance with Article 16 (2). The meat products may also be associated with other foodstuffs and condiments;(b) have, if appropriate, been obtained from a meat product or from a meat preparation;2. until the expiry of the derogations provided for in Directive 71/118/EEC and Directive 91/498/EEC, premises, tools and equipment used for the preparation of meat products from or with meat bearing the EEC health mark may only be used for the preparation of meat products from or with meat which does not bear that mark following authorization from the competent authority and provided that all precautions are taken, to the satisfaction of that authority, to avoid any confusion between products from meat with and without the mark;3. the meat products referred to in the first and second indents of Article 3 (7) cannot be sent to the territory of another Member State and their national or local marketing is strictly supervised.Article 5The Council, acting by a qualified majority on a proposal from the Commission, shall lay down the health and hygiene rules to be met by prepared meals, other than prepared meat meals, obtained from raw materials of animal origin not covered by this Directive. Pending the Council's decision, Member States shall ensure that, where they are manufactured in an establishment defined in Article 2 (p), the prepared meals in question comply with the hygiene rules laid down in Annex A, Chapter II, and that such meals also meet the specific requirements set out in Annex B, Chapter IX, and are supervised in accordance with Article 7.Article 61.  Member States shall ensure that other products of animal origin:- have been obtained in establishments which meet the requirements of Article 7, have been authorized and registered in accordance with Article 11, meet the standards of Annex A and are inspected in accordance with Article 8,- are manufactured in accordance with the specific conditions laid down in Annex C,- are inspected as provided for in Chapter IV of Annex B,- are accompanied, as provided for in Article 3 (9) (b) (i), by a commercial document specifying the origin of the products.2.  In accordance with the procedure provided for in Article 20, special health conditions shall be adopted before 31 December 1992 for the preparation of gelatin intended for human consumption.In accordance with the same procedure, additional conditions may be laid down for other products of animal origin in order to protect public health.Article 71.  Member States shall ensure that the operator or manager of the establishment or the rewrapping centre takes all necessary measures to ensure that, at all stages of production or rewrapping, the specifications of this Directive are complied with.To that end, the said persons must constantly carry out their own checks based on the following principles:- identification of critical points in their establishment on the basis of the processes used,- establishment and implementation of methods for monitoring and checking such critical points,- taking samples for analysis in a laboratory approved 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 the products referred to in paragraph 2 for which this period may be reduced to six months after the minimum conservation date of the product,- guarantees as regards the administration of the health marking, particularly the labels bearing the health mark,- 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,- the requirements of the first and second indents must have been drawn up in conjunction with the competent authority, which must regularly monitor compliance therewith.2.  For inspection purposes, the operator or manager of the establishment or the rewrapping centre must ensure that the packaging of meat products which cannot be stored at ambient temperatures bears a clear and legible indication of the temperature at which the products must be transported and stored, as well as the minimum durability date or, in the case of microbiologically perishable products, the use-by date.3.  The operator or manager of the establishment must arrange or establish 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. This training programme may be of a specific type for the establishments referred to in Article 9.The competent authority responsible for the establishment must be involved in the planning and implementation of the programme.Article 81.  Each Member State shall draw up a list of approved establishments, other than those referred to in Article 11, each establishment having an approval number. This list shall be sent to the other Member States and to the Commission.A single approval number may be given to:(i) an establishment or rewrapping centre processing or rewrapping products obtained from or with raw materials covered by several of the Directives referred to in Article 2 (d);(ii) an establishment located on the same site as an establishment approved in accordance with one of the Directives referred to in Article 2 (d).The competent authority shall not approve an establishment unless it is satisfied that it complies with this Directive with respect to the nature of its activities. However, if an establishment seeking approval pursuant to this Directive forms an integral part of an establishment approved under Directive 64/433/EEC, 71/118/EEC, 91/493/EEC or 91/495/EEC, the premises, equipment and installations for staff and all premises where there is no risk of contamination of raw materials or unwrapped products may be common to both establishments.Where the competent authority finds an obvious failure to comply with the hygiene rules laid down by this Directive or obstacles to an adequate health inspection:(i) it shall be empowered to act in respect of the use of equipment or premises and to take any requisite measures which may go as far as reducing the rate of production or temporarily suspending the production process;(ii) where these measures or the measures provided for in the penultimate indent of Article 7 (1) have proved insufficient to remedy the situation, it shall temporarily suspend approval, if appropriate, for the type of production in question.If the operator or manager of the establishment does not make good the shortcomings noted within the period fixed by the competent authority, the latter shall withdraw approval.The competent authority in question shall in particular be obliged to comply with the conclusions of any check carried out in accordance with Article 12.The other Member States and the Commission shall be informed of the suspension or withdrawal of approval.2.  Inspection and supervision of establishments shall be carried out by the competent authority.The establishment 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 will depend on the size of the establishment, the type of product manufactured, risk assessment and the guarantees offered in accordance with the fifth and last indents of the second subparagraph of Article 7 (1).The competent authority must at all times have free access to all parts of establishments in order to ensure that this Directive is being complied with and, where there is doubt as to the origin of meat, to accounting documents which enable the slaughterhouse or holding of origin of the raw material to be traced.The competent authority must regularly analyse the results of the checks provided for in Article 7 (1). It may, on the basis of these analyses, conduct further examinations at all stages of production or on the products.The nature of these checks, their frequency and the methods of sampling and of carrying out microbiological examinations shall be established under the procedure laid down in Article 20.The results of these 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, 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 arrangements for implementing this Article shall be adopted in accordance with the procedure laid down in Article 20.Article 91.  Member States may, for the purpose of their approval, grant establishments manufacturing meat products without an industrial structure or production capacity derogations from the requirements of Chapter I of Annex B and from those of Annex A, Chapter I, point 2 (g) (as regards taps) and point 11 (to substitute lockers for changing rooms).Moreover, derogations may be granted from point 3 of Annex A, Chapter I, as regards rooms where the raw materials and finished products are stored. However, in this case, the establishment must have at least:(i) a room or a secure place, where appropriate refrigerated, for the storage of raw materials, if such storage takes place;(ii) a room or a secure place, where appropriate refrigerated, for the storage of finished products, if such storage takes place.2.  Where the establishments referred to in:- Article 4 (1) of Directive 64/433/EEC, where the requirements laid down in the second subparagraph of Article 13 (1) of that Directive are met,- Article 4 (2) and the second subparagraph of Article 13 (1) of Directive 64/433/EEC,produce meat products, Member States may extend to them the derogation provided for in the first paragraph, on the understanding that the treatment of the products in such establishments must satisfy the other requirements of this Directive.3.  The provisions of Annex B, Chapter VII shall not apply to storage operations in the establishments referred to in paragraph 1, nor to the transporting of products other than those referred to in Article 7 (2).4.  Member States shall communicate to the Commission before 1 October 1992 the criteria which they have adopted to assess whether an establishment or a category of establishments are covered by the provisions of this Article.If after examination of these criteria or following the checks carried out in accordance with Article 12, the Commission considers that the criteria adopted might jeopardize the uniform application of this Directive, such criteria may be amended or supplemented, for the first time before 1 January 1993, in accordance with the procedure laid down in Article 20. The conditions under which the competent authorities of the Member State shall reclassify such establishments shall also be laid down by the same procedure.5.  On the basis of the information collected by the Commission in accordance with the first subparagraph of paragraph 4, uniform criteria for the application of this Article shall be laid down before 1 January 1993 in accordance with the procedure laid down in Article 20.Article 10Establishments currently benefiting from national approval must apply to the competent authority before 1 October 1992 for classification either under Article 8 or under Article 9.Until such time as a decision has been taken by the competent authority of the Member State and until 1 January 1996 at the latest, all products coming from an establishment which has not been classified must still bear the national health mark.As regards the establishments referred to in Article 8, at the request of a Member State accompanied by appropriate justification, an additional period expiring on 1 January 1996 may be granted in accordance with the procedure laid down in Article 20 for compliance with the requirements of Annex B, Chapter I, 1 (a). Products from such an establishment must bear the national health mark.Article 111.  By way of derogation from Article 8, and where the products concerned are not produced in an establishment approved in accordance with Article 8, Member States shall authorize and register all establishments producing other products of animal origin defined in Article 2 (b) and give each of them a specific official number for inspection purposes and in order to be able to trace the establishment of origin of the products concerned.However, where production takes place in premises adjacent to an approved slaughterhouse, this approval shall, provided the requirements of this Directive are complied with, be extended to cover the premises in question.2.  The inspection and monitoring of establishments shall be carried out by the competent authority, which shall at all times have free access to all parts of the establishments, in order to ensure compliance with the requirements of this Directive.3.  If such inspections reveal that the requirements of this Directive are not being met, the competent authority shall take appropriate action, up to and including the measures provided for in Article 8 (1), third and fourth subparagraphs.4.  The analyses and tests must be carried out in accordance with proven and scientifically recognized methods, in particular those laid down in Community provisions or international standards.The Commission shall establish the reference methods in accordance with the procedure laid down in Article 20.Article 121.  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. To do this, they may verify by checking a representative percentage of establishments whether the competent authorities are verifying 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 general provisions for implementing this Article shall be adopted in accordance with the procedure laid down in Article 20.2.  Before 1 January 1995 the Council shall review this Article on the basis of a report from the Commission, which may be accompanied by proposals.Article 131.  By way of derogation from the conditions stipulated in Article 3, it may be decided, in accordance with the procedure laid down in Article 20, that some provisions of this Directive shall not apply to meat products which contain other foodstuffs and only a small percentage of meat, meat product or meat preparation.These derogations shall relate only to:(a) the conditions for approval of establishments as laid down in Annex A, Chapter I and in Annex B, Chapter I;(b) the inspection requirements described in Annex B, Chapter IV;(c) the marking requirements laid down in Annex B, Chapter VI and, until 1 July 1993, the health certificate provided for in Annex D.When considering whether to grant derogations 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, Member States shall ensure that all meat products placed on the market are wholesome products prepared from fresh meat, meat products or products covered by Directive 88/657/EEC.2.  Until such time as a decision is taken in accordance with paragraph 1, Directive 82/201/EEC shall continue to apply.Article 14The provisions of Council Directive 89/662/EEC concerning veterinary checks in intra-Community trade with a view to the completion of the internal market 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 applied.Article 15After obtaining the opinions of the Member States in the Standing Veterinary Committee, the Commission may, if it deems necessary, draw up recommendations containing guidelines on good manufacturing practices applicable at the different stages of the production and placing on the market of the products referred to in Article 1.Article 161.  Pending the adoption of Community regulations on health rules applicable to the placing on the market of wild game, the national rules on the use of such meat in the establishments referred to in this Directive and to the placing on the market of meat products containing such meat shall continue to apply, in compliance with the general provisions of the Treaty.2.  Pending compilation, in the context of Community legislation on additives, of the list of foodstuffs to which the additives authorized for use may be added and establishment of the conditions under which they may be added and, where appropriate, a limit on the technological purpose of their use, the national rules and the bilateral arrangements existing on the date on which Directive 88/658/EEC was brought into effect restricting the use of additives in the products covered by this Directive shall remain applicable, with due regard for the general provisions of the Treaty, provided that they apply without distinction to domestic production and to trade.Until that list is drawn up, the national rules and the bilateral arrangements governing the use of additives for the products referred to in this Directive shall remain in force, in compliance with the general provisions of the Treaty and the Community rules in force in the field of additives.Article 17In accordance with the procedure laid down in Article 20, the following may be established:- special conditions for the approval of establishments situated in wholesale markets and of rewrapping centres,- rules for the marking of products from a rewrapping centre and supervision procedures enabling the establishment of origin of the raw materials to be traced,- at the request of a Member State or on the Commission's initiative the relevant requirements in this Directive which would apply 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 containers referred to in Chapter VIII, point 1 (f), of Annex B are correctly sealed,- microbiological standards including sampling plans and methods of analysis for the products referred to in Article 7 (2).Article 181.  Without prejudice to the specific provisions of this Directive, the competent authority shall, where it is suspected that the provisions of this Directive have not been 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.2.  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 19The Annexes to this Directive shall be amended by the Council acting by a qualified majority on a proposal from the Commission, in particular to adapt them to advances in technology.Article 201.  Where the procedure laid down in this Article is to be followed, matters shall without delay be referred to the Standing Veterinary Committee by its chairman, either on his own initiative or at the request of the representative of a Member State.2.  The Commission representative shall submit a draft of the measures to be adopted. 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. Opinions shall be delivered by a majority of 54 votes, the votes of the Member States being weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote.3.  The Commission shall adopt the measures and 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 propose to the Council the measures to be adopted. The Council shall adopt the measures by a qualified majority.If, within three months from the date on which a proposal was submitted to it, the Council has not adopted any measures, the Commission shall adopt the proposed measures and apply them immediately, save where the Council has rejected these measures by a simple majority.Article 21Acting in accordance with the procedure laid down in Article 43 of the Treaty, the Council shall take a decision before 1 January 1993 on the incorporation into meat products of starch or proteins of animal or vegetable origin and the maximum percentages permissible from a technological viewpoint.ANNEX A GENERAL CONDITIONS CHAPTER I General conditions for approval of establishments Establishments shall afford at least the following facilities: 1. working areas of sufficient size for work to be carried out under adequate hygienic conditions. Their design and layout shall be such as to preclude contamination of the raw materials and the products referred to in this Directive; 2. in areas where the raw materials are handled, prepared and processed and the products referred to in this Directive manufactured:(a) solid, waterproof flooring which is easy to clean and disinfect and laid in such a way as to facilitate the drainage of the water or provided with equipment to remove water;(b) walls which have smooth surfaces and are easy to clean, durable and impermeable, covered with a light-coloured, washable coating up to a height of at least two metres, or at least storage height in refrigeration and storage rooms;(c) ceilings or roof linings which are easy to clean;(d) doors in non-corrodible materials which are easy to clean;(e) adequate ventilation and, where necessary, good steam and water-vapour extraction facilities;(f) adequate natural or artificial lighting;(g) an adequate number of facilities with hot and cold running water, or water pre-mixed to a suitable temperature, for cleaning and disinfecting hands. In work rooms and lavatories, taps must not be hand-operable. These facilities must be provided with cleaning and disinfecting products and hygienic means of drying hands;(h) facilities for cleaning tools, equipment and utensils; 3. in rooms where the raw materials and the products covered by this Directive are stored, the same conditions as those at 2 apply, except in:- chilling and refrigeration rooms, where a floor which is easy to clean and disinfect, laid in such a way as to facilitate the draining of water is sufficient,- freezing and deep-freezing rooms, where waterproof and rotprof flooring which is easy to clean is sufficient,in that case, a sufficiently powerful refrigeration plant to keep the raw materials and products at the temperatures prescribed in this Directive must be available.The use of wooden walls in the rooms referred to in the second indent does not constitute grounds for withdrawing approval provided they were built before 1 January 1983.The capacity of the store rooms must be adequate to store the raw materials used and the products referred to in this Directive; 4. facilities for hygienic handling and protection of raw materials and non-packaged or wrapped finished products during loading and unloading; 5. appropriate arrangements for protection against pests such as insects, rodents, birds, etc.; 6. instruments and working equipment such as cutting tables, containers, conveyor belts, saws and knives, intended to come into direct contact with raw materials and products made of corrosion-resistant material and easy to clean and disinfect; 7. special watertight, non-corrodible containers, with lids and fasteners to prevent unauthorized persons from removing things from them, in which to put raw materials or products not intended for human consumption, or a lockable room for such purposes if the quantities are large enough to necessitate this or if they are not removed or destroyed at the end of each stage of work. Where such raw materials or products are removed through conduits, these must be so constructed and installed as to avoid any risk of contamination of the other raw materials or products; 8. appropriate facilities for the cleaning and disinfecting of equipment and utensils; 9. a waste water disposal system which meets hygiene requirements;10. a supply of potable water only, within the meaning of Council Directive 80/778/EEC of 15 July 1980 on the quality of water intended for human consumption (¹). However, the use of non-potable water is authorized in exceptional cases for steam production, fire fighting and refrigeration equipment, provided that the pipes installed for this purpose preclude the use of this water for other purposes and present no direct or indirect risk of contamination of the product. Non-potable water pipes must be clearly distinguished from those used for potable water;11. an appropriate number of changing rooms with smooth, waterproof washable walls and floors, wash basins and flush lavatories. The latter must not open directly on to the work rooms. Wash basins must be equipped for hand-washing and have hygienic means of drying hands; wash-basin taps must not be hand operable;12. if the volume of products treated requires regular or permanent presence, an adequately equipped lockable room for the exclusive use of the inspection service;13. a room or a secure place for the storage of detergents, disinfectants and similar substances;14. a room or cupboard for storing cleaning and maintenance material;15. adequate facilities for cleaning and disinfecting means of transport. However, such facilities are not compulsory if there is a requirement for the means of transport to be cleaned and disinfected in installations officially authorized by the competent authority;CHAPTER II General conditions of hygiene A. General conditions of hygiene applicable to premises, equipment and tools1. Equipment and instruments used for working on raw materials and products, floors, walls and partitions, ceilings or roof linings, must be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination for raw materials or products. Water for cleaning tools must be at a temperature of not less than + 82 oC.2. N° animals may enter the establishments. Rodents, insects and any other vermin must be systematically exterminated in the premises or on the equipment; rodenticides, insecticides, disinfectants and any other potentially toxic substances must be stored in premises or cupboards which can be locked; their use must not present any risk of contamination of the products.3. Working areas, instruments and working equipment must be used only for work on products for which approval has been granted. However, following authorization by the competent authority, they may be used at the same time or other times for work on other foodstuffs fit for human consumption. This restriction does not apply to transport equipment used in premises where no work is done on raw materials or products covered by this Directive.(¹) OJ N° L 229, 30. 8. 1980, p. 11.4. Potable water, within the meaning of Directive 80/778/EEC, must be used for all purposes. However, by way of exception, non-potable water may be used for steam production, fire-fighting and the cooling of equipment, provided that the pipes installed for the purpose preclude the use of such water for other purposes and present no risk of contamination of the raw materials and products.5. Detergents, disinfectants and similar substances must be approved by the competent authority and used in such a way that they do not have adverse effects on the machinery, equipment, raw materials and products.Their use must be followed by thorough rinsing of such instruments and working equipment with potable water. Products for maintenance and cleaning must be kept in the room provided for in Chapter I (14).6. The spreading of sawdust or any other similar substance on the floor of the workrooms and storage rooms for the raw materials and products referred to in this Directive is prohibited.B. General conditions of hygiene applicable to staff1. Absolute cleanliness is required of staff. Specifically:(a) staff must wear suitable clean working clothes and headgear which completely encloses the hair. This applies particularly to persons handling exposed, non-packaged raw materials and products;(b) staff assigned to the handling and preparation of raw materials and products must be required to wash their hands at least each time work is resumed and/or where contamination has occurred; wounds to the hands must be covered by a waterproof dressing;(c) smoking, spitting, eating and drinking in rooms where raw materials and products are worked on or stored is prohibited.2. The employer shall take all the requisite measures to prevent persons liable to contaminate raw materials and products from handling them, until there is evidence that such persons can do so without risk.When recruited, any person working on and handling raw materials and products shall be required to prove, by a medical certificate, that there is no impediment to such employment. The medical supervision of such a person shall be governed by the national legislation in force in the Member State concerned or in the case of third countries by specific guarantees to be fixed under the procedure laid down in Article 20.ANNEX B SPECIAL CONDITIONS FOR MEAT PRODUCTS CHAPTER I Special conditions for approval of establishments preparing meat products 1. In addition to the general requirements laid down in Annex A, Chapter I, establishments manufacturing, handling and wrapping meat products shall have at least:(a) suitable rooms large enough for the separate storage:(i) of raw materials, under refrigeration; and(ii) of meat products at ambient temperature or, where appropriate, depending on the nature of the products, under refrigeration;on the understanding that non-packaged raw materials, meat products and other products of animal origin must be stored separately from packaged raw materials and products;(b) one or more appropriate rooms large enough for the manufacture and wrapping of meat products. Provided these operations constitute a single production cycle complying with the requirements of this Directive and guaranteeing the safety of the raw materials and finished products, and provided the design and dimensions of the manufacturing room allow, they may be carried out in the same room;(c) a room or a secure place for the storage of certain ingredients such as food additives;(d) a room for packaging, unless the conditions laid down for packaging in Chapter V, point 3 are fulfilled, and for dispatch;(e) a room for the storage of wrapping and packaging materials;(f) a room for cleaning equipment and instruments, such as hooks and containers.2. Depending on the type of product involved, the establishment must have:(a) a room or - of there is no danger of contamination - an area where packaging is removed;(b) a room or - if there is no danger of contamination - an area for thawing raw materials;(c) a cutting room;(d) a room or equipment for drying or maturing;(e) a room or equipment for smoking;(f) a room for desalting, soaking and any other treatment, particularly of natural guts, where these raw materials have not undergone such operations in the establishment of origin;(g) a room for the prior cleaning of the raw materials needed to prepare meat products;(h) a room for salting, if necessary with air-conditioning facilities to maintain the temperature provided for in Chapter II (4);(i) a room for the prior cleaning, if necessary, of meat products to be sliced or cut and wrapped;(j) a room, if necessary with air-conditioning facilities, for slicing or cutting and packaging of meat products intended for sale in pre-packed form;(k) the specific rooms provided for in Annex C, where the products referred to therein are manufactured in the establishments referred to in this Chapter;(l) where the conditions laid down in 1 (b) are met, it may be decided following agreement by the competent authority, that some of these operations may be carried out in the same room.Where the conditions laid down in 1 (b) are not met, operations which might constitute a health risk in the case of certain products manufactured simultaneously and operations associated with excessive heat production must be carried out in a separate room.CHAPTER II Special conditions of hygiene for establishments preparing meat products 1. Rooms used for storing or working on foodstuffs other than meat or meat products, liable to form part of the composition of meat products, must be subject to the general rules on hygiene laid down in this Directive.2. Raw materials and the ingredients forming part of the composition of meat products as well as the products themselves and products of animal origin and their containers shall not come into direct contact with the ground and shall be handled under conditions which preclude any risk of contamination. Care must be taken to ensure that there is no contact between raw materials and finished products.3. The use of wood is permitted in rooms in which meat products are smoked, cured, matured, pickled, stored or dispatched, when essential for technological reasons, provided there is no risk of the products being contaminated. Wooden pallets may be brought into the said rooms solely for transporting packaged meat or meat products and for no other purposes. In addition, the use of galvanized metals may be authorized for the drying of hams and sausages, provided that they are not corroded and do not come into contact with the meat products.4. The temperature in rooms or parts of rooms where work on meat, minced meat used as a raw material, meat products and meat preparations is carried out must ensure hygienic production; if necessary, such rooms or parts of rooms must be provided with air-conditioning facilities.During cutting, slicing and curing operations rooms for cutting and curing must be kept at a temperature not exceeding 12o C, except in the case of the establishments referred to in Article 9.However, in the case of other establishments the competent authority may derogate from this requirement where it considers such a derogation justified in the light of the technology used in preparing the meat product.CHAPTER III Requirements for raw materials to be used for the manufacture of meat products 1. Meat which is to be used for the manufacture of meat products must:- come from an establishment approved in accordance with the Directives referred to in Article 2 (d) and have been transported under satisfactory hygiene conditions in accordance with the said Directives,- from the time of its arrival in the processing establishment until the time of its use, be kept in accordance with the requirements of the Directives referred to in Article 2 (d).However, until 31 December 1995, meat obtained from establishments granted derogations under Directive 91/498/EEC may be held in approved establishments. Until that date, meat which does not comply with the conditions set out in the Directives referred to in Article 2 (d) may be held in approved establishments only if stored in separate places; it must not be used in the same place or at the same time as meat which does comply with these conditions. Meat products obtained from such meat must bear the national mark.2. Minced meat and meat preparations, unless produced in the manufacturing room referred to in Chapter I (1) (b), must:- come from an establishment approved in accordance with Directive 88/657/EEC and have been transported under satisfactory health conditions in accordance with that Directive,- from the time of their arrival in the processing establishment until the time of their use, be kept in accordance with the requirements of Directive 88/657/EEC.3. The inclusion of fishery products in the preparation of meat products is permitted where such products comply with the requirements of Directive 91/493/EEC.CHAPTER IV Supervision of production 1. Establishments shall be subject to supervision by the competent authority, which must ensure that the requirements of this Directive are met and in particular:(a) check:(i) the cleanliness of the premises and equipment and staff hygiene;(ii) the efficacy of the checks carried out by the establishment, in accordance with Article 7, notably by examining the results and taking samples;(iii) the microbiological and hygienic condition of the products of animal origin;(iv) the efficacy of the treatment of the meat products;(v) the hermetically sealed containers by means of random sampling;(vi) the appropriate health marking of the meat products and identification of products declared unfit for human consumption and what is done with the latter;(vii) the storage and transport conditions;(b) take any samples required for laboratory tests;(c) make any other checks it considers necessary to ensure compliance with this Directive;(d) establish whether a meat product has been made from meat in which other foodstuffs, additives or condiments have been incorporated, by submitting it to an appropriate inspection and establishing whether it complies with the production criteria laid down by the producer and especially whether the composition of the product truly corresponds to the information on the label, in particular where the sales description referred to in Chapter V (4) is used.2. The competent authority must have free access at all times to the cold stores and all working premises to check that these provisions are being strictly complied with.CHAPTER V Wrapping, packaging and labelling 1. Wrapping, packaging and labelling must take place under satisfactory hygiene conditions in rooms provided for that purpose.Without prejudice to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (¹), wrapping and packaging must comply with all the rules of hygiene, and be strong enough to protect the meat products effectively.(¹) OJ N° L 40, 11. 2. 1989, p. 38.2. Wrapping or packaging may not be re-used for meat products, with the exception of certain special types of containers such as earthenware, glass or plastic containers which may be re-used after thorough cleaning and disinfecting.3. Manufacture of meat products and packaging operations may take place in the same room if the packaging is as described in 2 or subject to the following conditions:(a) the room must be sufficiently large and so equipped that the hygiene of the operations is assured;(b) the packaging and wrapping must be enclosed in a sealed protective cover immediately after manufacture; this cover must be protected from damage during transport to the establishment and stored under hygienic conditions in a room intended for that purpose;(c) the rooms for storing the packaging material must be free from dust and vermin and have no atmospheric connection with rooms containing substances which might contaminate meat, minced meat, meat preparations or meat products. Packaging must not be placed directly on the floor;(d) packaging must be assembled under hygienic conditions before being brought into the room. A derogation from this requirement may be granted in the case of the automatic assembly of packaging, provided there is no risk of contamination of the meat products;(e) packaging must be brought to the room under hygienic conditions and used without delay. It may not be handled by staff handling unwrapped meat, minced meat, meat preparations or meat products;(f) immediately after packaging, the meat products must be placed in the storage rooms provided for the purpose.4. In addition to the requirements of 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 (¹), the following information (²) must be visible and legibly displayed on the wrapping or on the label of meat products:- where it is not clear from the sales description of the product or from the list of ingredients in accordance with Directive 79/112/EEC, the species from which the meat was obtained,- a reference permitting identification of a quantity of products obtained in technologically similar conditions and likely to present the same risk,- for packaging not intended for the final consumer, the date of preparation,- the sales description followed by a reference to the national standard or legislation (³) authorizing it,- where the legislation of a Member State authorizes the use of proteins or starch, a reference to such use in connection with the sales description other than that which is authorized in accordance with Article 21.CHAPTER VI Health mark 1. Meat products must carry a health mark. Marking must be carried out during or immediately after manufacture in the establishment or wrapping centre, in an easily visible place. The mark shall be legible, indelible and its characters easily distinguishable. The health mark may be applied to the product or to the (¹) OJ N° L 33, 8. 2. 1979, p. 1. Directive as last amended by Directive 89/395/EEC (OJ N° L 186, 30. 6. 1989, p. 17).(²) This information must accompany the meat products up to the final consumer stage, except in the case referred to in the third indent.(³) The words "national standard or legislation" cover:(a) the conditions of production or preparation authorized under national law;(b) the particular rules of national law imposing specific constraints on conditions of production or preparation for certain products;(c) all sales descriptions which, in the absence of national standards limiting them, are permitted by the law of a Member State or in a Member State where that description has been confirmed by usage.wrapping, if the meat product is individually wrapped, or to a label affixed to this wrapping in accordance with point 4 (b). However, where a meat product is individually wrapped and packaged, it will suffice for the health mark to be applied to the packaging.2. Where meat products marked in accordance with point 1 are subsequently placed in a packaging, the health mark must also be applied to the packaging.3. By way of derogation from points 1 and 2, the health marking of meat products in palletized consignments intended for further processing or wrapping in an approved establishment is not necessary provided that:- the said consignments containing the meat products bear the health mark in accordance with point 4 (a) on the external surface,- the recipient establishment maintains a separate record of the quantities, type and origin of meat products received in accordance with this point,- the destination and intended use of meat products are clearly indicated on the external surface of the outer packaging except when this is transparent.However, where a consignment of wrapped products is contained in a transparent packaging, it is not necessary to health mark the packaging as long as the health mark on the wrapped products is clearly visible through the packaging.4. (a) The health mark must give the following particulars within an oval surround:(i) either:- above: the initial letter or letters of the consigning country in printed capitals, i.e.:B - DK - D - EL - E - F - IRL - I - L - NL - P - UK, followed by the approval number of the establishment or, in accordance with rules to be adopted under the second indent of Article 17, the rewrapping centre, if necessary accompanied by a code number stating the type of product for which the establishment is approved,- below: one of the following sets of initials: CEE - EOEF - EWG - EOK - EEC - EEG;(ii) or:- above, the name of the consigning country in capitals,- in the centre, the approval number of the establishment or, in accordance with rules to be adopted under the second indent of Article 17, the rewrapping centre, if necessary accompanied by a code number stating the type of product for which the establishment is approved,- below, one of the following sets of initials: CEE - EOEF - EWG - EOK - EEC - EEG;(b) the health mark may be applied to the product, wrapping or packaging by an ink stamp or by branding, or it may be printed on or applied to a label. If it is applied to the packaging, the mark must be destroyed when the package is opened. Non-destruction of this mark may be tolerated only when the packaging is destroyed by being opened. In the case of products in hermetically sealed containers, the mark must be indelibly applied either to the lid or to the can;(c) the health mark may also consist of an irremovable plate of resistant material complying with all the hygiene requirements and bearing the information specified in (a).CHAPTER VII Storage and transport 1. Meat products must be stored in the rooms provided for in Annex B, Chapter I, point 1 (a).However, meat products which can be kept at ambient temperature may be stored in stores, of solid construction and easy to clean and disinfect, approved by the competent authority.2. Meat products for which certain storage temperatures are indicated in accordance with Article 7 (2) must be maintained at those temperatures.3. Meat products must be dispatched in such a way that they are protected during transportation from anything which might contaminate or adversely affect them. For this purpose account shall be taken of the length of the journey, the means of transport employed and the weather conditions.4. Meat products must, if the product so requires, be transported in vehicles equipped to ensure that they can be transported at the required temperatures and in particular that the temperatures indicated in accordance with Article 7 (2) are not exceeded.CHAPTER VIII Special conditions for pasteurized or sterilized products in hermetically sealed containers A. In addition to the conditions laid down in Annex A, establishments manufacturing pasteurized or sterilized products in hermetically sealed containers1. must have:(a) a device for conveying empty cans hygienically to the work room;(b) equipment enabling cans to be thoroughly cleaned immediately before filling;(c) equipment for washing containers in potable water hot enough to remove grease after they have been hermetically sealed and before retorting;(d) a suitable room, area or installation for cooling and drying containers after heat treatment;(e) facilities for the incubation of samples taken from meat products packed in hermetically sealed containers;(f) adequate facilities for checking whether containers are hermetically sealed and undamaged;2. must ensure that:(a) 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;(b) containers in which gas appears to be present undergo a further examination;(c) the thermometers of heating equipment are checked against calibrated thermometers;(d) containers are:- rejected if damaged or badly made,- rejected or cleaned if they are dirty and, in the case of cans, thoroughly cleaned immediately before filling, by means of the cleaning equipment referred to in 1 (b); the use of stagnant water is not authorized,- if necessary, drained for a sufficiently long time after cleaning and before filling,- if necessary, washed in potable water, sufficiently hot to remove grease if appropriate, after they have been hermetically sealed and before retorting, by means of the equipment referred to in 1 (c),- cooled, after heating, in water meeting the requirements in the fifth indent of B,- handled, before and after heat treatment, in such a way that any damage or contamination is avoided.B. The operator or manager of an establishment manufacturing meat products in hermetically sealed containers must also check by sampling that:- a process is applied to meat products intended for storing at ambient temperature which results in an Fc value equal to or exceeding 3,00, unless the same stability of the product has been obtained by curing, or that a heat treatment procedure is applied which is at least equivalent to pasteurization, the parameters being approved by the competent authority,- empty containers meet production standards,- checks on the daily output are carried out at intervals determined in advance, to ensure the efficacy of the sealing. To this end, suitable equipment must be available for examining perpendicular sections of the seams of the sealed containers,- the necessary checks are carried out, using in particular control markers to ensure that the containers have undergone adequate heat treatment,- the necessary checks are carried out to ensure that the cooling water contains a residual level of chlorine after use. Member States may, however, grant a derogation from this requirement if the water fulfils the requirements of Directive 80/778/EEC.- seven-day incubation tests at 37 oC or 10-day incubation tests at 35 oC are carried out on preserved meat products in hermetically sealed containers which have undergone heat treatment,- pasteurized products in hermetically sealed containers satisfy criteria recognized by the competent authority.C. The competent authority may authorize the addition of certain substances to the water used in retorts in order to prevent corrosion of cans and to soften and disinfect the water. A list of these substances will be drawn up in accordance with the procedure laid down in Article 20.The competent authority may allow the use of recirculated water for cooling heat-processed containers. Such water must be purified and have either been treated with chlorine or undergone some other treatment approved in accordance with the procedure laid down in Article 20. The purpose of such treatment is to make the recirculated water comply with the standards laid down in Annex I (E) to Directive 80/778/EEC so that it cannot contaminate the products and does not constitute a hazard to human health.The recirculated water shall circulate in closed circuit so that it cannot be used for other purposes.Where there is no risk of contamination, the water used for cooling containers and water from retorts may be used at the end of a working period for cleaning floors.CHAPTER IX Special conditions for meat-based prepared meals In addition to the general conditions in Annex A and in Chapters I, II and III of this Annex:1. establishments manufacturing prepared meals must have a separate room for the preparation and wrapping of prepared meals; a separate room is not required where meat products and meat are handled at separate times, provided the rooms used for these operations are cleaned and disinfected between use for each type of product;2. (a) the meat product contained in the prepared meal must, as soon as it has been cooked:(i) either be immediately mixed with the other ingredients; in that event the time during which the temperature of the meat product is between 10 and 63 oC must be kept to a minimum;(ii) or be refrigerated to 10 oC or less before being mixed with the other ingredients;(b) the meat product and the prepared meal must be refrigerated to an internal temperature of + 10 oC or less within a period of not more than two hours after the end of cooking and to the storage temperature as soon as possible. However, the competent authority may authorize the establishment to derogate from the two-hour period where a longer period is justified for reasons connected with the production technology employed, provided that the safety of the end product is guaranteed;(c) the prepared meal must, where appropriate, be frozen or quick-frozen immediately after cooling;3. labelling of prepared meals must comply with Directive 79/112/EEC. The list of ingredients shall, for the purpose of this Directive, include an indication of the animal species.Prepared meals shall bear the date of manufacture very clearly on one of the outer surfaces of the wrapping in addition to the information already specified;4. the results of the various checks to be carried out by the operator or manager must be kept, so that they can be shown on receipt of any request from the competent authority, for a minimum period to be specified by the competent authority according to the durability of the product concerned.ANNEX C SPECIFIC HYGIENE STANDARDS FOR THE MANUFACTURE OF OTHER PRODUCTS OF ANIMAL ORIGIN CHAPTER I General conditions The premises may be used for the production of products not intended for human consumption only under the following conditions:(a) raw materials unfit for human consumption must be stored in a completely separate room or separate reception area;(b) they must be processed in separate rooms using separate installations and equipment, except where the processing takes place in completely enclosed installation or equipment used exclusively for this purpose;(c) the final products from these raw materials must be stored in a different room or separate tanks which are labelled appropriately and must not go for human consumption.CHAPTER II Special conditions for rendered animal fats, greaves and by-products In addition to the conditions in Annex A, the following conditions apply:A. Standards applicable to establishments collecting or processing raw materials1. Centres for the collection of raw materials and further transport to processing establishments must be equipped with a cold store to store raw materials at a temperature of 7 oC or less, unless the raw materials are collected and rendered within the time limits laid down in B (3) (b) and (c).2. The processing establishment must have at least:(a) a cold store, unless the raw materials are collected and rendered within the time limits laid down in B (3) (b);(b) a room or place to receive raw materials;(c) an installation to facilitate the visual inspection of raw materials;(d) if appropriate, an installation to crush raw materials;(e) equipment for the rendering of raw materials by heat or pressure or other appropriate method;(f) containers or tanks in which the fat can be kept in liquid state;(g) apparatus for plastification or crystallization of the fat to facilitate market preparation and packaging, unless the establishment dispatches liquid rendered animal fat only;(h) a dispatch room, unless the establishment dispatches melted animal fat only by means of tankers;(i) watertight containers for the disposal of raw materials unfit for human consumption;(j) if appropriate, suitable equipment for the preparation of products consisting of rendered animal fat mixed with other foodstuffs and/or seasonings;(k) if greaves are intended for human consumption, suitable facilities ensuring hygienic collection, wrapping and packaging and storage under the conditions laid down in B (9).B. Additional hygiene requirements relating to the preparation of rendered animal fat, greaves and by-products1. Raw materials shall originate from animals which, after ante and post mortem inspection, have been found fit for human consumption.2. The raw materials shall consist of adipose tissues or bones found fit for human consumption and which are reasonably free from blood and impurities. They must not show signs of deterioration and must be obtained under hygienic conditions.3. (a) For the preparation of rendered animal fat, only adipose tissues or bones, collected at slaughterhouses, cutting plants or meat processing establishments shall be used. Raw materials shall be transported and stored until rendering in hygienic conditions and at an internal temperature of 7 oC or less;(b) by way of derogation from (a), raw materials may be stored and transported unrefrigerated provided that they are rendered within twelve hours after the day on which they were obtained;(c) by way of derogation from (a), raw materials collected at retail shops or in premises adjacent to sales points, where the cutting and the storage of meat or poultrymeat is performed for the sole purpose of supplying the final consumer directly, may be used for the preparation of rendered animal fat, provided they are in satisfactory hygienic condition and properly packed. When the raw materials are collected daily the temperature requirements laid down in (a) and (b) must be complied with. If the raw materials are not collected daily, they must be refrigerated immediately after they have been obtained.4. Vehicles and containers for the collection and transport of raw materials must have smooth internal surfaces, easy to wash, dean and disinfect and vehicles must be adequately covered. Vehicles for refrigerated transport must have been designed in such a way that the temperature required can be maintained throughout the period of transport.5. Before rendering, raw materials shall be inspected for the presence of raw materials unfit for human consumption, or extraneous matter. When present these must be removed.6. Raw materials shall be rendered by heat, pressure or other appropriate method, followed by separation of the fat by decantation, centrifugation, filtration or other appropriate method. The use of dissolvents is prohibited.7. Rendered animal fat which is prepared in accordance with points 1, 2, 3, 5 and 6 may for the production of raw materials be refined in the same or another establishment to improve its physico-chemical quality when the fat for refining satisfies the standards laid down in point 8.8. Rendered animal fat, depending on type, shall meet the following standards:>TABLE>9. Greaves intended for human consumption shall be stored:(i) when rendered at a temperature of 70 oC or less: at a temperature of less than 7 oC for a period not exceeding 24 hours or at  18 oC or lower;(ii) when rendered at a temperature of more than 70 oC and having a moisture content of 10 % (m/m) or more:- at a temperature of less than 7 oC for a period not exceeding 48 hours or at a time/temperature ratio offering an equivalent guarantee,- at  18 oC or lower;(iii) when rendered at a temperature of more than 70 oC and having a moisture content of less than 10 % (m/m): no specific requirement.CHAPTER III Special conditions for stomachs, bladders and intestines In addition to the conditions in Annex A, and Chapters I, II and III of Annex B, establishments treating stomachs, bladders and intestines must comply with the following conditions:1. premises, instruments and tools must be used only for work on the products concerned; there must be a clear division between clean and unclean sections;2. the use of wood is forbidden; however the use of wooden pallets is authorized for the transport of the containers of the products concerned;3. premises must be provided for storing wrapping and packaging materials;4. wrapping and packaging must take place under hygienic conditions in a room or in a place intended for that purpose;5. products which cannot be kept at ambient temperature must be stored until their dispatch in premises intended for that purpose.In particular, products which are not salted or dried must be kept at a temperature not exceeding 3 oC;6. Raw materials must be transported from the slaughterhouse of origin to the establishment under satisfactory hygiene conditions and, where appropriate in the light of the period between slaughter and the collection of the raw materials, refrigerated. Vehicles and containers for transporting such materials must have smooth internal surfaces which are easy to wash, clean and disinfect. Vehicles for refrigerated transport must have been designed in such a way that the temperature required can be maintained throughout the period of transport.ANNEX D HEALTH CERTIFICATE FOR MEAT PRODUCTS (¹) No (²) .Exporting country: .Ministry: .Department concerned: .Reference (²): .I. Identification of meat productsProducts manufactured with meat from: .(Animal species) Nature of products (³): .Nature of packaging: .Number of individual items or of packages: .Storage and transport temperature (³): .Storage life (%): .Net weight: .II. Origin of meat productsAddress(es) and approval number(s) of approved processing establishment(s) ...If necessary:Address(es) and approval number(s) of approved cold store(s): ....III. Destination of meat productsThe meat products are to be sentfrom:   .(Place of dispatch)to: .(Country of destination)by the following means of transport (& ): .Name and address of consignor: ..Name and address of consignee: ..(¹) Within the meaning of Article 2 of Directive 77/99/EEC.(²) Optional.(³) Mention any ionizing radiation for medical reasons.(%) To be completed where an indication is given in accordance with Article 7 of the Directive 77/99/EEC.(& ) Indicate the number or registration number (railway wagons and lorries), the flight number (aircraft) or the name (ship).IV. Health attestationI, the undersigned, certify that the meat products described above:(a) were manufactured from fresh meat or meat products under the specific conditions laid down in Directive 77/99/EEC (¹);(b) were prepared with meat from animal species other than those referred to in Article 2 (d) of Directive 77/99/EEC (¹);(c) are intended for the Hellenic Republic  (¹).V. If necessary:In the event of unloading and reloading in an approved establishment or approved cold store, indicate:(a) the place of unloading and reloading (address and approval number):...(b) the means of transport (²):.. Done at., on.(place)(date)Stamp.(Signature of competent authority)(Name in capital letters)(¹) Delete as appropriate .(²) Indicate the number or registration number (railway wagons and lorries), the flight number (aircraft) or the name (ship).'


title: Commission Directive 2010/91/EU of 10 December 2010 amending Council Directive 91/414/EEC to include metosulam as active substance and amending Decision 2008/934/EC  Text with EEA relevance

text:
               11.12.2010

               EN

               Official Journal of the European Union

               L 327/40

         COMMISSION DIRECTIVE 2010/91/EU
   of 10 December 2010
   amending Council Directive 91/414/EEC to include metosulam as active substance and amending Decision 2008/934/EC
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Commission Regulations (EC) No 451/2000 (2) and 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included metosulam.

               (2)

               In accordance with Article 11e of Regulation (EC) No 1490/2002 the applicant withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within two months from receipt of the draft assessment report. Consequently, Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances (4) was adopted on the non-inclusion of metosulam.

               (3)

               Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter “the applicant”) submitted a new application requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5).

               (4)

               The application was submitted to France, which had been designated rapporteur Member State by Regulation (EC) No 451/2000. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/934/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

               (5)

               France evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 7 August 2009. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on metosulam to the Commission on 23 April 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 October 2010 in the format of the Commission review report for metosulam.

               (6)

               It has appeared from the various examinations made that plant protection products containing metosulam may be expected to satisfy, in general, the requirements laid down in Article 5(1) (a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include metosulam in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

               (7)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the applicant submit further information to confirm the results of the risk assessment on the basis of most recent scientific knowledge as regards the potential pH dependence of soil adsorption, groundwater leaching and surface water exposure for metabolites M01 and M02, potential genotoxicity of one impurity and on the specification of the active substance as manufactured.

               (8)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

               (9)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing metosulam to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (10)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (7) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.

               (11)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (12)

               Decision 2008/934/EC provides for the non-inclusion of metosulam and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning metosulam in the Annex to that Decision.

               (13)

               It is therefore appropriate to amend Decision 2008/934/EC accordingly.

               (14)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   The line concerning metosulam in the Annex to Decision 2008/934/EC is deleted.
   Article 3
   Member States shall adopt and publish by 31st October 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 November 2011.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 4
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing metosulam as an active substance by 1 November 2011. By that date they shall in particular verify that the conditions in Annex I to that Directive relating to metosulam are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing metosulam as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 April 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning metosulam. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing metosulam as the only active substance, where necessary, amend or withdraw the authorisation by 30 April 2015 at the latest; or

               (b)

               in the case of a product containing metosulam as one of several active substances, where necessary, amend or withdraw the authorisation by 30 April 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 5
   This Directive shall enter into force on 1 May 2011.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 10 December 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 55, 29.2.2000, p. 25.

      (3)  OJ L 224, 21.8.2002, p. 23.

      (4)  OJ L 333, 11.12.2008, p. 11.

      (5)  OJ L 15, 18.1.2008, p. 5.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance metosulam. EFSA Journal 2010; 8(5):1592. [67 pp.]. doi:10.2903/j.efsa.2010.1592. Available online: www.efsa.europa.eu

      (7)  OJ L 366, 15.12.1992, p. 10.

      ANNEX
      The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘317

                     Metosulam
                     CAS No: 139528-85-1

                     CIPAC No: 707

                        2′,6′-dichloro-5,7-dimethoxy-3′-methyl[1,2,4]triazolo

                        [1,5-a]pyrimidine-2-sulfonanilide

                     ≥ 980 g/kg

                     1 May 2011

                     30 April 2021

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on metosulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 —

                                 the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

                                 —

                                 the risk to aquatic organisms;

                                 —

                                 the risk to non-target plants in the off-field area.

                           Conditions of use shall include risk mitigation measures, where appropriate.
                     The Member States concerned shall ensure that the applicant submits to the Commission, by 30 October 2011, further information on the specification of the active substance as manufactured.
                     The Member States concerned shall ensure that the applicant submits to the Commission, by 30 April 2013, confirmatory information as regards:

                                 —

                                 potential pH dependence of soil adsorption, groundwater leaching and surface water exposure for metabolites M01 and M02;

                                 —

                                 potential genotoxicity of one impurity.’

         (1)  Further details on identity and specification of active substance are provided in the review report.