1977L0099 — EN — 05.01.1993 — 014.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE
of21December 1976
►M12 on healthproblemsaffecting the productionandmarketing ofmeat productsandcertain
otherproductsofanimalorigin ◄
(77/99/EEC)
(OJ L 26, 31.1.1977, p. 85)
Amended by:
Official Journal
No page date
►M1Council Directive 80/214/EEC of 22 January 1980 L 47 3 21.2.1980
►M2Council Directive 81/476/EEC of 24 June 1981 L 186 20 8.7.1981
►M3Council Directive 85/327/EEC of 12 June 1985 L 168 49 28.6.1985
►M4Council Directive 85/328/EEC of 20 June 1985 L 168 50 28.6.1985
►M5Council Directive 85/586/EEC of 20 December 1985 L 372 44 31.12.1985
►M6Council Regulation (EEC) No 3768/85 of 20 December 1985 L 362 8 31.12.1985
►M7Council Regulation (EEC) No 3805/87 of 15 December 1987 L 357 1 19.12.1987
►M8Council Directive 88/658/EEC of 14 December 1988 L 382 15 31.12.1988
►M9Council Directive 89/227/EEC of 21 March 1989 L 93 25 6.4.1989
►M10Council Directive 89/662/EEC of 11 December 1989 L 395 13 30.12.1989
►M11Council Directive 92/45/EEC of 16 June 1992 L 268 35 14.9.1992
►M12Council Directive 92/5/EEC of 10 February 1992 L 57 1 2.3.1992
►M13Council Directive 92/116/EEC of 17 December 1992 L 62 1 15.3.1993
Amended by:
►A1Act of Accession of Greece L 291 17 19.11.1979
Corrected by:
►C1Corrigendum, OJ L 68, 15.3.1977, p. 35 (77/99/EEC)
►C2Corrigendum, OJ L 76, 24.3.1977, p. 26 (77/99/EEC)
►C3Corrigendum, OJ L 44, 20.2.1990, p. 34 (88/658/EEC)
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COUNCILDIRECTIVE
of21December 1976
►M12 onhealthproblemsaffectingtheproductionandmarketing
ofmeatproductsandcertainotherproductsofanimalorigin ◄
(77/99/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Articles 43 and 100 thereof,
Having regard to the proposal from the Commission,Having regard to the opinion of the European Parliament (
1),
Whereas, since the establishment of the common organization of the
markets, meat products may move freely within the Community;
whereas, however, intra-Community trade in these products is curbed
by the existence of different health requirements in this sector in thevarious Member States; whereas, in order to remove such disparities,it is necessary to substitute common provisions for these nationalrequirements;
Whereas, in order to guarantee the quality of the products in question
from the health point of view, it is necessary to use, in their manufac-
ture, only that fresh meat obtained in accordance with the Communitystandards laid down in Council Directive 64/433/EEC of 26 June 1964on health problems affecting intra-Community trade in fresh meat (
2),
as last amended by Directive 75/379/EEC (3), Council Directive 71/
118/EEC of 15 February 1971 on health problems affecting trade in
fresh poultrymeat (4), as last amended by Directive 75/379/EEC, and
also Council Directive 72/462/EEC of 12 December 1972 on healthand veterinary inspection problems upon importation of bovine animalsand swine and fresh meat from third countries (
5), as last amended by
Directive 75/379/EEC; whereas meat products must be manufactured,
stored and trasnported in conditions offering every guarantee as regards
health; whereas the need for manufacturing and processing establish-ments to obtain approval is likely to facilitate supervision ofcompliance with these conditions; whereas provision should be madefor a procedure intended to settle any disputes which may arisebetween Member States as to the justification of the approval of a
manufacturing establishment;
Whereas, moreover, Community control arrangements should be intro-
duced to ensure that the standards laid down in this Directive areapplied uniformly in all Member States; whereas provision should bemade for the procedure for such controls to be determined accordingto a Community procedure within the Standing Veterinary Committee
set upby the Council Decision of 15 October 1968(
6);
Whereas provision should be made for the possibility of derogating
from certain provisions of this Directive in respect of certain meatproducts which contain other foodstuffs and which contain a minimalpercentage of meat; whereas these derogations should be madeaccording to a Community procedure within the Standing VeterinaryCommittee;
Whereas, as regards intra-Community trade, the issue of a health certi-
ficate drafted by the competent authority is considered to be the best
way of assuring the competent authorities of the country of destinationthat a consignment of meat products complies with this Directive;1977L0099 — EN — 05.01.1993 — 014.001 — 2
(1) OJ No C 114, 11. 11. 1971, p. 40.
(2) OJ No 121, 29. 7. 1964, p. 2012/64.
(3) OJ No L 172, 3. 7. 1975, p. 17.
(4) OJ No L 55, 8. 3. 1971, p. 23.
(5) OJ No L 302, 31. 12. 1972, p. 28.
(6) OJ No L 255, 18. 10. 1968, p. 23.
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whereas this certificate must accompany the consignment of these
products to the place of destination;
Whereas Member States must have the right to prohibit the introduc-
tion into their territory of meat products from another Member State
which prove unfit for human consumption or do not comply withCommunity health provisions;
Whereas, in such cases, the consignor should, at his own request or
upon request of his representative, be allowed to have the meat
products returned to him unless there are health reasons to the contrary;
Whereas, in case of prohibition or restriction, the reasons therefor
should be made known to the consignor or his representative and also,in certain cases, to the competent authorities of the exporting country;
Whereas, in the event of a dispute between himself and the authorities
of the Member State of destination as to the justification for prohibition
or restriction, the consignor should be enabled to obtain the opinion of
an expert;
Whereas, in order to facilitate the implementation of the proposed
measures, a procedure should be provided for close cooperation betwenthe Member States and the Commission in the Standing Veterinary
Committee,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive lays down health rules for the production and
placing on the market of meat products and other products of animalorigin intended, after treatment, for human consumption or for thepreparation 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 productsand other products of animal origin intended for human consumption,where the preparation and storage are performed solely for the purposeof supplying the consumer directly.
Article 2
For 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 theproduct 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 toin (d);
(ii) products subject to Council Directive 88/657/EEC of 14
December 1988 laying down the requirements for the produc-
tion of, and trade in, minced meat, meat in pieces of less than100 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;1977L0099 — EN — 05.01.1993 — 014.001 — 3
(1) OJ No L 382, 31. 12. 1988, p. 3.
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(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 bycold;
(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 dampheat;
(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 timewhich give the product typical organoleptic characteristics andensure its preservation and wholesomeness at normal ambienttemperature;
(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 wrapperor 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 asthe container itself;
(o) hermetically sealed container: container intended to protect the
contents against the entry of microorganisms during and afterheat 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 inthe 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 whichit has delegated that competence.1977L0099 — EN — 05.01.1993 — 014.001 — 4
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Article 3
A. Each Member State shall ensure — without prejudice to the condi-
tions laid down in Article 4 — that meat products placed on themarket:
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 ChaptersI 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 capa-
city;
2. have been prepared from fresh meat as defined in Article 2 (d),
on the understanding that meat imported from a third countrymust meet the minimum requirements of Chapter III of Directive
71/118/EEC and have been inspected in accordance with Direc-
tive 90/675/EEC.
Meat declared unfit for consumption in compliance with the
requirements of Articles 5 and 6 of Directive 64/433/EEC
►
M13and the third subparagraph of Article 4 (1), and Chapter
IX of Annex I to Directive 71/118/EEC, and in general any meatdeclared unfit for human consumption under Communityrules◄and the following items may not be used in the prepara-
tion 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 intes-tines 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 steri-lized 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 accor-dance 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 ofAnnex 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 provi-
sions of this Directive concerning the sales description of meatproducts shall not apply to products of designated origin or totypical products;1977L0099 — EN — 05.01.1993 — 014.001 — 5
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7. without prejudice to the marking requirements of Directive 80/
215/EEC, have been marked, on the responsibility of theoperator 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 repri-
nting 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-storageplant separate from the establishment, this plant must have beenapproved and inspected in accordance with Article 10 of Direc-
tive 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 subpara-
graph of (b) (ii), the health certificate issued by the
competent authority at the time of loading, which mustcorrespond in form and content to the model in Annex D. Itmust be drawn upin the official language or languages ofthe 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 whichthe competent authority responsible for supervisingthe 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 competentauthority,
— 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 aftertransit through the territory of a third country, beapproved by the competent authority of the borderinspection 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, orfrom meat referred to in Article 6 of Directive 64/433/EEC, or from products to be sent to another MemberState, after transit through a third country in a sealedmeans of transport.
This obligation shall not apply to meat products in
hermetically sealed containers and having undergoneone of the treatments referred to in Annex B, ChapterVIII, point B, first indent, if the health mark is indelibly
marked on the container in accordance with the provi-
sions to be drawn upunder the p rocedure laid down inArticle 20.
Detailed rules for applying (ii), and in particular those
concerning the allocation of code numbers and the compila-tion of one or more lists identifying the competent1977L0099 — EN — 05.01.1993 — 014.001 — 6
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authorities, shall be adopted in accordance with the proce-
dure 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 4
Member States shall ensure that, in addition to the general require-
ments 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 beenassociated, in particular, with certain curing agents in compli-ance 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 usedfor the preparation of meat products from or with meat bearing theEEC health mark may only be used for the preparation of meatproducts 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 avoidany confusion between products from meat with and without themark;
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 Stateand their national or local marketing is strictly supervised.
Article 5
The 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. Pendingthe Council's decision, Member States shall ensure that, where they aremanufactured in an establishment defined in Article 2 (p), the preparedmeals 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 withArticle 7.
Article 6
1. 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 accordancewith Article 11, meet the standards of Annex A and are inspectedin 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 publichealth.1977L0099 — EN — 05.01.1993 — 014.001 — 7
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Article 7
1. Member States shall ensure that the operator or manager of the
establishment or the rewrapping centre takes all necessary measures toensure that, at all stages of production or rewrapping, the specificationsof 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 compe-
tent authority for the purpose of checking cleaning and disinfectionmethods and for the purpose of checking compliance with the stan-dards 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 itto the competent authority. The results of the different checks andtests shall in particular be kept for a period of at least two years,save in the case of 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 thecompetent authority thereof,
— in the event of an immediate human health risk, withdraw from the
market the quantity of products obtained in technologically similarconditions and likely to present the same risk. This withdrawnquantity must stay under the supervision and control of the compe-tent 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 upin conjunction with the comp etent authority, which must
regularly monitor compliance therewith.
2. For inspection purposes, the operator or manager of the establish-
ment 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 betransported and stored, as well as the minimum durability date or, inthe 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 withconditions 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 8
1. Each Member State shall draw up a list of approved establish-
ments, other than those referred to in Article 11, each establishmenthaving an approval number. This list shall be sent to the other MemberStates 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 severalof the Directives referred to in Article 2 (d);1977L0099 — EN — 05.01.1993 — 014.001 — 8
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(ii) an establishment located on the same site as an establishment
approved in accordance with one of the Directives referred to inArticle 2 (d).
The competent authority shall not approve an establishment unless it is
satisfied that it complies with this Directive with respect to the natureof its activities. However, if an establishment seeking approvalpursuant to this Directive forms an integral part of an establishmentapproved 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 materialsor 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 theproduction process;
(ii) where these measures or the measures provided for in the penulti-
mate indent of Article 7 (1) have proved insufficient to remedy thesituation, it shall temporarily suspend approval, if appropriate, forthe 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 permanentor periodic presence of the competent authority in a given establish-
ment will depend on the size of the establishment, the type of product
manufactured, risk assessment and the guarantees offered in accordancewith 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, toaccounting documents which enable the slaughterhouse or holding oforigin 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 basisof these
analyses, conduct further examinations at all stages of production oron 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 upin a rep ort, the conclu-
sions or recommendations of which shall be notified to the operator ormanager of the establishment, who shall rectify the shortcomings notedwith 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 beremoved.
4. The arrangements for implementing this Article shall be adopted
in accordance with the procedure laid down in Article 20.1977L0099 — EN — 05.01.1993 — 014.001 — 9
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Article 9
1. 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 changingrooms).
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 Directiveare 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 deroga-
tion provided for in the first paragraph, on the understanding that thetreatment of the products in such establishments must satisfy the otherrequirements 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 whetheran establishment or a category of establishments are covered by theprovisions of this Article.
If after examination of these criteria or following the checks carried out
in accordance with Article 12, the Commission considers that thecriteria adopted might jeopardize the uniform application of this Direc-tive, such criteria may be amended or supplemented, for the first timebefore 1 January 1993, in accordance with the procedure laid down inArticle 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 criteriafor the application of this Article shall be laid down before 1 January1993 in accordance with the procedure laid down in Article 20.
Article 10
Establishments 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 classi-fied 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 additionalperiod expiring on 1 January 1996 may be granted in accordance withthe procedure laid down in Article 20 for compliance with the require-ments of Annex B, Chapter I, 1 (a). Products from such anestablishment must bear the national health mark.1977L0099 — EN — 05.01.1993 — 014.001 — 10
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Article 11
1. By way of derogation from Article 8, and where the products
concerned are not produced in an establishment approved in accor-
dance with Article 8, Member States shall authorize and register all
establishments producing other products of animal origin defined inArticle 2 (b) and give each of them a specific official number forinspection purposes and in order to be able to trace the establishmentof origin of the products concerned.
However, where production takes place in premises adjacent to an
approved slaughterhouse, this approval shall, provided the requirementsof this Directive are complied with, be extended to cover the premisesin 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 appropriateaction, upto and including the measures p rovided 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 laiddown in Community provisions or international standards.
The Commission shall establish the reference methods in accordance
with the procedure laid down in Article 20.
Article 12
1. Experts from the Commission may, in so far as is necessary for
the uniform application of this Directive and in cooperation with thecompetent authorities, make on-site checks. To do this, they may verifyby checking a representative percentage of establishments whether thecompetent 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 theirduties.
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 accompaniedby proposals.
Article 13
1. By way of derogation from the conditions stipulated in Article 3,
it may be decided, in accordance with the procedure laid down in
Article 20, that some provisions of this Directive shall not apply to
meat products which contain other foodstuffs and only a small percen-tage 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 theproduct shall be taken into account.1977L0099 — EN — 05.01.1993 — 014.001 — 11
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Notwithstanding the provisions of this Article, Member States shall
ensure that all meat products placed on the market are wholesomeproducts 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 para-
graph 1, Directive 82/201/EEC shall continue to apply.
Article 14
The 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 organiza-tion of and the action to be taken on the checks carried out by theMember State of destination and the safeguard measures to be applied.
Article 15
After obtaining the opinions of the Member States in the Standing
Veterinary Committee, the Commission may, if it deems necessary,draw uprecommendations containing guidelines on good manufac-turing practices applicable at the different stages of the production andplacing on the market of the products referred to in Article 1.
Article 16
1. Pending the adoption of Community regulations on health rules
applicable to the placing on the market of wild game, the national ruleson the use of such meat in the establishments referred to in this Direc-tive and to the placing on the market of meat products containing suchmeat 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 foruse may be added and establishment of the conditions under whichthey 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 intoeffect restricting the use of additives in the products covered by thisDirective shall remain applicable, with due regard for the generalprovisions of the Treaty, provided that they apply without distinctionto domestic production and to trade.
Until that list is drawn up, the national rules and the bilateral arrange-
ments governing the use of additives for the products referred to in thisDirective shall remain in force, in compliance with the general provi-sions of the Treaty and the Community rules in force in the field ofadditives.
Article 17
In 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 theraw 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 giverise 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).1977L0099 — EN — 05.01.1993 — 014.001 — 12
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Article 18
1. Without prejudice to the specific provisions of this Directive, the
competent authority shall, where it is suspected that the provisions ofthis Directive have not been complied with or there is doubt as towhether 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 particularwhere it is found that the certificates or documents drawn updo notcorrespond to the actual state of the products referred to in Article 1,
that the marks on the products concerned do not comply with the rules,
that the products have not undergone the checks provided for in thisDirective or that they were not used for the purpose originallyintended.
Article 19
The Annexes to this Directive shall be amended by the Council acting
by a qualified majority on a proposal from the Commission, in parti-cular to adapt them to advances in technology.
Article 20
1. Where the procedure laid down in this Article is to be followed,
matters shall without delay be referred to the Standing VeterinaryCommittee by its chairman, either on his own initiative or at therequest 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 onsuch measures within a time limit which the chairman may lay downaccording 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 notvote.
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 theCommittee, or if no opinion is delivered, the Commission shall withoutdelay propose to the Council the measures to be adopted. The Councilshall 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, theCommission shall adopt the proposed measures and apply them imme-diately, save where the Council has rejected these measures by a
simple majority.
Article 21
Acting 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 orvegetable origin and the maximum percentages permissible from atechnological viewpoint.
Article 22
The Member States shall bring into force the laws, regulations and
administrative provisions necessary for them to comply with this Direc-
tive on 1 July 1979.
Article 23
This Directive is addressed to the Member States.1977L0099 — EN — 05.01.1993 — 014.001 — 13
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Article 24
The Rules laid down in Directive 89/662/EEC (1) concerning veterinary
checks applicable in intra-Community trade, with a view to the
completion of the internal market, shall apply in particular to checks
at origin, to the organization of and follow-upto the checks to becarried out by the Member State of destination, and to the protectivemeasures to be implemented.1977L0099 — EN — 05.01.1993 — 014.001 — 14
(1) OJ No L 395, 30. 12. 1989, p. 13.
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ANNEX A
GENERALCONDITIONS
CHAPTER I
Generalconditionsforapprovalofestablishments
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 Directivemust 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 neces-
sitate 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;1977L0099 — EN — 05.01.1993 — 014.001 — 15
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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 equip-
ment, 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 wash-
able 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 offi-
cially authorized by the competent authority;
CHAPTER II
Generalconditionsofhygiene
A.General conditions of hygiene applicable to premises, equipment and tools
1. 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. No 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 poten-
tially 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.
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.1977L0099 — EN — 05.01.1993 — 014.001 — 16
(1) OJ No L 229, 30. 8. 1980, p. 11.
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B.General conditions of hygiene applicable to staff
1. 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 20.1977L0099 — EN — 05.01.1993 — 014.001 — 17
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ANNEX B
SPECIALCONDITIONSFORMEATPRODUCTS
CHAPTER I
Specialconditionsforapprovalofestablishmentspreparingmeatproducts
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 opera-
tions 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 main-
tain 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 manufac-
tured simultaneously and operations associated with excessive heat
production must be carried out in a separate room.1977L0099 — EN — 05.01.1993 — 014.001 — 18
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CHAPTER II
Specialconditionsofhygieneforestablishmentspreparingmeatproducts
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 andshall 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 technolo-
gical 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 condi-
tions 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 Direc-
tive 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.1977L0099 — EN — 05.01.1993 — 014.001 — 19
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CHAPTER IV
Supervisionofproduction
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 put 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 identifica-
tion 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 descriptionreferred 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,packagingandlabelling
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.
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 disin-
fecting.
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 prepara-
tions 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 be1977L0099 — EN — 05.01.1993 — 014.001 — 20
(1) OJ No L 40, 11. 2. 1989, p. 38.
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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 prepara-
tion,
— 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
Healthmark
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 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 wrap-
ping 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 trans-
parent.
However, where a consignment of wrapped products is contained in a trans-
parent 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 packa-
ging.
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.:1977L0099 — EN — 05.01.1993 — 014.001 — 21
(1) OJ No L 33, 8. 2. 1979, p. 1. Directive as last amended by Directive 89/395/EEC (OJ
No 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 descrip-
tion has been confirmed by usage.
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B—D K—D—E L—E—F—I R L—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 establish-
ment is approved,
— below: one of the following sets of initials: CEE — EØF —
EWG — EOK — EEC — EEG;
(ii) or:
— above, the name of the consigning country in capitals,
— in the centre, the approval number of the establishment 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 estab-
lishment is approved,
— below, one of the following sets of initials: CEE — EØF —
EWG — EOK — EEC — EEG;
(b) the health mark may be applied to the product, wrapping or 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 toler-
ated 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
Storageandtransport
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 accor-
dance 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
sealedcontainers
A. In addition to the conditions laid down in Annex A, establishments manufac-
turing pasteurized or sterilized products in hermetically sealed containers
1. 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;1977L0099 — EN — 05.01.1993 — 014.001 — 22
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2. must ensure that:
(a) hermetically sealed containers are removed from the heating equip-
ment 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, thor-
oughly 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 upin accor-
dance 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 accor-
dance 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.1977L0099 — EN — 05.01.1993 — 014.001 — 23
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CHAPTER IX
Specialconditionsformeat-basedpreparedmeals
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 estab-
lishment 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 speci-
fied;
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.1977L0099 — EN — 05.01.1993 — 014.001 — 24
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ANNEX C
SPECIFIC HYGIENE STANDARDS FOR THE MANUFACTURE OF
OTHERPRODUCTSOFANIMALORIGIN
CHAPTER I
Generalconditions
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
Specialconditionsforrenderedanimalfats,greavesandby-products
In addition to the conditions in Annex A, the following conditions apply:
A.Standards applicable to establishments collecting or processing raw mate-
rials
1. Centres for the collection of raw materials and further transport to proces-
sing 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-products
1. 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 impu-
rities. They must not show signs of deterioration and must be obtained
under hygienic conditions.1977L0099 — EN — 05.01.1993 — 014.001 — 25
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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 prepara-
tion 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 prohib-
ited.
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 stan-
dards:
Bovines Pigs Other animal fat
Edible tallowTallow
for
refiningEdible
lard (2)Lard for
refiningEdibleFor
refining Premier
jus (1)Other
FFA (m/m %
oleic acid)
maximum 0,75 1,25 3,0 0,75 2,0 1,25 :3,00
Peroxyd
maximum4 meq/kg 4 meq/kg 6 meq/kg 4 meq/kg 6 meq/kg 4 meq/kg 10 meq/kg
Moisture and
impuritiesmaximum 0,5 %
Odour, taste,
colournormal
(1) Rendered animal fat obtained by the low-temperature rendering of fresh fat from the heart, caul, kidneys
and mesentery of bovine animals, and fat from cutting rooms.
(2) Fresh fat obtained from rendering the adipose tissues of swine.
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 guar-
antee,
— 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.1977L0099 — EN — 05.01.1993 — 014.001 — 26
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CHAPTER III
Specialconditionsforstomachs,bladdersandintestines
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 author-
ized 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 mate-
rials 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.1977L0099 — EN — 05.01.1993 — 014.001 — 27
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ANNEX D
1977L0099 — EN — 05.01.1993 — 014.001 — 28
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1977L0099 — EN — 05.01.1993 — 014.001 — 29