1977L0099 — EN — 01.05.2004 — 020.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL DIRECTIVE
of 21 December 1976
►M12 on health problems affecting the production and marketing of meat products and certain
other products of animal origin ◄
(77/99/EEC)
(OJ L 26, 31.1.1977, p. 85)
Amended by:
Official Journal
No page date
►M1 Council Directive 80/214/EEC of 22 January 1980 L 47 3 21.2.1980
►M2 Council Directive 81/476/EEC of 24 June 1981 L 186 20 8.7.1981
►M3 Council Directive 85/327/EEC of 12 June 1985 L 168 49 28.6.1985
►M4 Council Directive 85/328/EEC of 20 June 1985 L 168 50 28.6.1985
►M5 Council Directive 85/586/EEC of 20 December 1985 L 372 44 31.12.1985
►M6 Council Regulation (EEC) No 3768/85 of 20 December 1985 L 362 8 31.12.1985
►M7 Council Regulation (EEC) No 3805/87 of 15 December 1987 L 357 1 19.12.1987
►M8 Council Directive 88/658/EEC of 14 December 1988 L 382 15 31.12.1988
►M9 Council Directive 89/227/EEC of 21 March 1989 L 93 25 6.4.1989
►M10 Council Directive 89/662/EEC of 11 December 1989 L 395 13 30.12.1989
►M11 Council Directive 92/45/EEC of 16 June 1992 L 268 35 14.9.1992
►M12 Council Directive 92/5/EEC of 10 February 1992 L 57 1 2.3.1992
►M13 Council Directive 92/116/EEC of 17 December 1992 L 62 1 15.3.1993
►M14 Council Directive 92/118/EEC of 17 December 1992 L 62 49 15.3.1993
►M15 Council Directive 95/68/EC of 22 December 1995 L 332 10 30.12.1995
►M16 Council Directive 97/76/EC of 16 December 1997 L 10 25 16.1.1998
►M17 Council Regulation (EC) No 807/2003 of 14 April 2003 L 122 36 16.5.2003
Amended by:
►A1 Act of Accession of Greece L 291 17 19.11.1979
►A2 Act of Accession of Austria, Sweden and Finland C 241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.1995
►A3 Act concerning the conditions of accession of the Czech Republic, the
Republic of Estonia, the Republic of Cyprus, the Republic of Latvia,
the Republic of Lithuania, the Republic of Hungary, the Republic of
Malta, the Republic of Poland, the Republic of Slovenia and the SlovakRepublic and the adjustments to the Treaties on which the EuropeanUnion is foundedL 236 33 23.9.2003
Corrected by:
►C1 Corrigendum, OJ L 68, 15.3.1977, p. 35 (77/99/EEC)
►C2 Corrigendum, OJ L 76, 24.3.1977, p. 26 (77/99/EEC)
►C3 Corrigendum, OJ L 44, 20.2.1990, p. 34 (88/658/EEC)1977L0099 — EN — 01.05.2004 — 020.001 — 2
▼B
COUNCIL DIRECTIVE
of 21 December 1976
►M12 on health problems affecting the production and marketing
of meat products and certain other products of animal origin ◄
(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 up by the Council Decision of 15 October 1968 (
6);
Whereas provision should be made for the possibility of derogating
from certain provisions of this Directive in respect of certain 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 — 01.05.2004 — 020.001 — 3
(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.
▼B
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 meatproducts 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 prohibitionor restriction, the consignor should be enabled to obtain the opinion ofan expert;
Whereas, in order to facilitate the implementation of the proposed
measures, a procedure should be provided for close cooperation betwen
the Member States and the Commission in the Standing VeterinaryCommittee,
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 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 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 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 toin (d);
(ii) products subject to Council Directive ►
M16 94/65/EC ◄of
14 December 1994 laying down the requirements for theproduction of, and trade in, minced meat, meat in pieces ofless 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;1977L0099 — EN — 01.05.2004 — 020.001 — 4
(1) OJ No L 382, 31. 12. 1988, p. 3.▼M12
▼M14
►M14 (iv)◄ meat powder, powdered rind, salted or dried
blood, salted or dried blood plasma;
►M14 (v)◄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 ►
M16 94/65/EC ◄,
— 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 thepreservation of meat or animal products whether or not associatedwith 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 reductionof humidity, are capable of generating natural fermentation orenzymatic processes, involving changes over a period of timewhich 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 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 — 01.05.2004 — 020.001 — 5
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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 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 ChaptersI and II of Annex B,
or
—►
M16 in accordance with Article 9(1) ◄, in the case of
establishments which do not have an industrial structure orproduction capacity;
or, which have been registered and inspected in accordance with
Article 9(2);
2. have been prepared from fresh meat as defined in Article 2 (d),
on the understanding that meat imported from a third country
must meet the minimum requirements of Chapter III of Directive71/118/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►
M13 and the third subparagraph of Article 4 (1), and Chapter
IX of Annex I to Directive 71/118/EEC, and in general any meat
declared unfit for human consumption under Community
rules◄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 preparedmeals, 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 approvedby the competent authority for that purpose.
However, pending the adoption of Community rules, the provi-
sions of this Directive concerning the sales description of meat1977L0099 — EN — 01.05.2004 — 020.001 — 6
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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 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, underCommunity 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-storage
plant separate from the establishment, this plant must have been
approved and inspected in accordance with Article 10 of Direc-tive 64/433/EEC;
9. are accompanied during transportation by:
►M16 (a)◄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 competent
authority,
— until 31 December 1996, in the case of the meat
products referred to in the second subparagraph of(b) 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;
►
M16 (b)◄ 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 aregion or area subject to a restriction on animal healthgrounds, or from meat referred to in Article 6 of Direc-tive 64/433/EEC, or from products to be sent to anotherMember 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 indeliblymarked on the container in accordance with the provi-sions to be drawn up under the procedure laid down inArticle 20.
Detailed rules for applying (b), and in particular those
concerning the allocation of code numbers and the compila-tion of one or more lists identifying the competentauthorities, 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.1977L0099 — EN — 01.05.2004 — 020.001 — 7
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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 beassociated 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 meatproducts from or with meat which does not bear that mark followingauthorization from the competent authority and provided that allprecautions are taken, to the satisfaction of that authority, to avoidany 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 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 metby prepared meals, other than prepared meat meals, obtained fromraw materials of animal origin not covered by this Directive. Pendingthe 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 AnnexA, Chapter II, and that such meals also meet the specific requirementsset 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 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. Under the procedure laid down in Article 20, additional condi-
tions may be set for the other products of animal origin so as toensure the protection of public health.
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.1977L0099 — EN — 01.05.2004 — 020.001 — 8
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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 disinfection
methods 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 similar
conditions 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 thanhuman consumption or, after authorization by the competentauthority, 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 establish-
ment or the rewrapping centre must ensure that the packaging of meatproducts 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, 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 theestablishments 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);
(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 natureof its activities. However, if an establishment seeking approvalpursuant to this Directive forms an integral part of an establishment1977L0099 — EN — 01.05.2004 — 020.001 — 9
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approved under Directive 64/433/EEC, 71/118/EEC, 91/493/EEC or
91/495/EEC, the premises, equipment and installations for staff andall 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 asreducing 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 accordancewith 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 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 beingcomplied 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 theseanalyses, 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 conclu-
sions 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 beremoved.
4. The arrangements for implementing this Article shall be adopted
in accordance with the procedure laid down in Article 20.
Article 9
1. Member States may, for the purpose of their approval, grant
establishments manufacturing meat products without an industrialstructure or production capacity derogations from the requirements ofChapter I of Annex B and from those of Annex A, Chapter I, point 21977L0099 — EN — 01.05.2004 — 020.001 — 10
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(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 finishedproducts 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. Member States may extend the derogation provided for in para-
graph 1 to the establishments referred to in Article 4, section A, point
(a)(i), and sections C, D and E of Directive 64/433/EEC, on the under-standing that the processing of products in those establishments mustmeet 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, norto 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 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 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 theMember 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 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 ►
A2 except
for:◄
— Sweden, where the date to be adopted shall be 1 January 1997,
— Austria and Finland, where the date to be adopted shall be 1
January 1998,
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 ►A2 except for: ◄
— Sweden, where the date to be adopted shall be 1 January 1997,
— Austria and Finland, where the date to be adopted shall be 1
January 1998,1977L0099 — EN — 01.05.2004 — 020.001 — 11
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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 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 allestablishments producing other products of animal origin defined inArticle 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 compliancewith 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 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 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 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
►
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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.
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 coveredby Directive ►
M16 94/65/EC ◄.
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 theinternal 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 up recommendations 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 for
use may be added and establishment of the conditions under whichthey may be added and, where appropriate, a limit on the technologicalpurpose of their use, the national rules and the bilateral arrangementsexisting 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 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 of
additives.
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 toany product with authorization to be placed on the market in aMember 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,1977L0099 — EN — 01.05.2004 — 020.001 — 13
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— microbiological standards including sampling plans and methods of
analysis for the products referred to in Article 7 (2).
Article 18
1. 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 particularwhere it is found that the certificates or documents drawn up do 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. The Commission shall be assisted by the Standing Committee on
the Food Chain and Animal Health set up by Article 58 of Regulation
(EC) No 178/2002 (
1).
2. Where reference is made to this Article, Articles 5 and 7 of Deci-
sion 1999/468/EC (2) shall apply.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be
set at three months.
3. The committee shall adopt its rules of procedure.
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.
Article 24
The Rules laid down in Directive 89/662/EEC (3) concerning veterinary
checks applicable in intra-Community trade, with a view to the
completion of the internal market, shall apply in particular to checksat origin, to the organization of and follow-up to the checks to becarried out by the Member State of destination, and to the protectivemeasures to be implemented.1977L0099 — EN — 01.05.2004 — 020.001 — 14
(1) OJ L 31, 1.2.2002, p. 1.
(2) OJ L 184, 17.7.1999, p. 23.
(3) OJ No L 395, 30. 12. 1989, p. 13.▼M17
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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 in order to eliminate as far as possible
condensation on surfaces such as walls and ceilings or roof linings;
(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 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;1977L0099 — EN — 01.05.2004 — 020.001 — 15
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8. appropriate facilities for the cleaning and disinfecting of equipment and
utensils; ►M15 for disinfecting equipment and utensils, water of a
temperature of not less than 82º C, or other disinfection methods approved
by the competent authority, must be used; ◄
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;►M15 where the competent authority is not required to be present
at all times, a lockable device of sufficient capacity for storage of equip-
ment and materials is sufficient; ◄
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 desinfecting means of transport; unless,
with the agreement of the competent authority, facilities not situated in the
establishment may be used;
16. where the treatment applied requires the absence of water for manufacture
of the products, certain requirements of this Chapter, in particular those laid
down in points 2 (a) and (g), may be adjusted. Should recourse be had to
such a derogation, cleaning and disinfecting processes which do not make
use of water may, with the authorization of the competent authority, be
applied in the parts of the establishment concerned.
CHAPTER II
General conditions of hygiene
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.
►M15 Cleaning and disinfecting must be performed with a frequency
and by means of processes which are in line with the principles set out
in Article 7 of the Directive. ◄
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 such1977L0099 — EN — 01.05.2004 — 020.001 — 16
(1) OJ No L 229, 30. 8. 1980, p. 11.▼M15
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water for other purposes and present no risk of contamination of the raw
materials and products.
5. Detergents, disinfectants and similar substances must be used in accor-
dance with the manufacturers' instructions 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 instru-
ments and working equipment with potable water except where the
directions for use of such substances render such rinsing unnecessary.
Products for maintenance and cleaning must be kept in the room or
facility provided for in Chapter I (14) of this Annex.
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 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 — 01.05.2004 — 020.001 — 17
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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 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 — 01.05.2004 — 020.001 — 18
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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 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
►M16 94/65/EC ◄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►M16 94/65/EC ◄.
3. The presence of products of animal origin, other than meat as defined in
Article 2 (d) of the Directive contained in the meat products, is authorized
only if these products comply with the requirements laid down in the relevant
Community legislation.1977L0099 — EN — 01.05.2004 — 020.001 — 19
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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 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, 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.
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 — 01.05.2004 — 020.001 — 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 preparation
or a code which can be interpreted by the recipient and by the competent
authority allowing the identification of that date,
— the sales description followed by a reference to the national standard or
legislation (3) authorizing it,
— where the legislation of a Member State authorises the use of starch or of
proteins of animal or vegetable origin for other than technological
purposes, a reference to such use in connection with the sales description.
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 in legible and indelible characters which are easy to
distinguish. The health mark may be applied directly to the product or to its
wrapping if the meat product is individually wrapped, or to a label affixed to
the wrapping, in accordance with point 4 (b). However, where a meat product
is wrapped and packaged individually, a health mark applied to the packa-
ging is sufficient.
2. Where meat products carrying a health mark in accordance with point 1 are
then packaged, 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 is not necessary:
(a) where the health mark, in compliance with point 4, is applied to the
external surface of each sales unit containing them;
(b) where, for meat products in consignments intended for further processing
or wrapping in an approved establishment:
— the said consignments bear the health mark of the approved establish-
ment consigning them in a visible place on the external surface,
together with a clear indication of the intended destination,
— the recipient establishment maintains a record of the quantities, type
and origin of meat products received in accordance with this point
and stores that record for the period laid down in the fourth indent
of the second subparagraph of Article 7 (1) of the Directive.
However, meat products in large packagings which are intended for1977L0099 — EN — 01.05.2004 — 020.001 — 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-
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immediate sale without further processing or wrapping must bear a
health mark in compliance with point 1, 2 or 3 (a);
(c) where, for meat products which are not wrapped or packaged but sold in
bulk by the manufacturer directly to a retailer:
— the health mark, in compliance with point 1, is applied to the
container carrying them,
— the manufacturer maintains a record of the quantities and type of the
meat products consigned in accordance with this point and of the
name of the recipient and stores that record for the period laid down
in the fourth indent of the second subparagraph of Article 7 (1) of the
Directive.
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 - CZ - DK - D - EE - EL - E - F - IRL
- I - CY - LV - LT - L - HU - MT - NL - AT - PL - P - SI - SK -
FI - S - UK, followed by the approval number of the establish-
ment, or the rewrapping centre in accordance with Decision 94/
837/EC, 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 - EØF - EWG -
EOK - EEC - EEG - ETY - EHS - EMÜ - EEK - EEB - EGK -
KEE - EGS;
(ii) or:
— above: the name of the consigning country in capitals,
— in the centre: the approval number of the establishment or the
rewrapping centre, in accordance with Decision 94/837/EC, 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 - EØF - EWG -
EOK - EEC - EEG - ETY - EHS - EMÜ - EEK - EEB - EGK -
KEE - EGS;
(b) the health mark may be applied directly to the product by authorized
means or be pre-printed on its wrapping or packaging, or to a label
affixed to the product, its wrapping or packaging. Where it is applied to
the wrapping, the stamp must be destroyed when the wrapping is opened.
Failure to destroy the stamp can be tolerated only where the wrapping is
destroyed by opening it. In the case of products in hermetically sealed
containers, the stamp must be applied indelibly on either the lid or the
can;
(c) the health mark may also consist of an irremovable plate of resistant
material, complying with all the hygiene requirements and containing
all the information listed in point (a).
5. Where a meat product contains other foodstuffs of animal origin such as
fishery products, dairy products or egg products, only one health mark must
be applied.
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 may also be stored outside the rooms provided for
in that point on the following conditions:
(a) meat products which cannot be kept at ambient temperatures may be
stored in cold storage plant as referred to in Article 3 (A) (8) of the
Directive or in cold storage plant approved in accordance with the other
relevant Directives;
(b) meat products which can be kept at ambient temperatures may be stored
in stores of solid construction, easy to clean and disinfect, and approved
by the competent authority.1977L0099 — EN — 01.05.2004 — 020.001 — 22
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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 adverselyaffect 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.
5. The commercial document referred to in Article 3 A (9) (b) (i) of the Direc-
tive must accompany meat products during the first stage of marketing.
For transport and marketing at subsequent stages, the products must be
accompanied by a commercial document bearing the approval number of
the consigning establishment identifying the competent authority responsible
for control.
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 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;
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.1977L0099 — EN — 01.05.2004 — 020.001 — 23
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B. The operator or manager of an establishment manufacturing meat products in
hermetically sealed containers must also check by sampling that:
(1) a heat treatment is applied to meat products intended for storing at
ambient temperature which is capable of destroying or inactivating
pathogenic germs and the spores of pathogenic micro-organisms. A
register of manufacturing parameters such as duration of heating,
temperature, filling, size of containers, etc. must be kept.
The heat treatment apparatus must be fitted with control devices making
it possible to check that containers have undergone effective heat treat-
ment;
(2) the material used for the containers meets Community requirements
relating to materials intended to come into contact with foodstuffs;
(3) 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 and
the seams of the sealed containers;
(4) additional checks by sampling are carried out by the manufacturer to
ensure that:
(a) sterilized products have undergone effective treatment, by means of:
— incubation tests. Incubation must be performed at a least 37º C
for seven days or at at least 35º C for 10 days, or any other
time/temperature combination recognized as equivalent by the
competent authority,
— microbiological examination of the contents and the containers
in the establishment's laboratory or in another approved labora-
tory;
(b) pasteurized products in hermetically sealed containers satisfy criteria
recognized by the competent authority,
(5) 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.
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 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.
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 mixed with the other ingredients as soon as practically
possible; in that event the time during which the temperature of the
meat products is between 10º C and 60º C must be kept to a
maximum of two hours;1977L0099 — EN — 01.05.2004 — 020.001 — 24
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(ii) or be refrigerated to 10º C or less before being mixed with the other
ingredients.
Where other preparation methods are applied, these must be approved by
the competent authority, which shall inform the Commission accordingly;
(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 — 01.05.2004 — 020.001 — 25
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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 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) and B (3) (c);
(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 — 01.05.2004 — 020.001 — 26
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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 ►M15 ◄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, must meet the following stan-
dards:
Bovines Pigs Other animal fat
Edible tallow
Tallow
for
refiningEdible pig fat Lard
and
other
pork fat
for
refiningEdibleFor
refining Premier
jus (1)Other Lard (2)Other
fat
FFA (m/m %
oleic acid)
maximum
Maximum
peroxide0,75
4 meq/
kg1,25
4 meq/
kg3,0
6 meq/
kg0,75
4 meq/
kg1,25
6 meq/
kg2,0
6 meq/
kg1,25
4 meq/
kg3,0
10 meq/
kg
Moisture and
impuritiesmax 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) Melted 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;1977L0099 — EN — 01.05.2004 — 020.001 — 27
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(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.
CHAPTER III
Conditions governing the production, placing on the market and import of
cleaned, salted or dried and/or heated stomachs, bladders and intestines
In addition to the conditions in Annex A and Chapter II of Annex B, establish-
ments treating stomachs, bladders and intestines must comply with the following
conditions:
1. raw materials must come from animals which, following ante-mortem and
post-mortem inspection have been judged suitable for human consumption;
2. 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 of less than 3 ºC;
3. 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 that are easy to wash, clean and
disinfect. Vehicles for refrigerated transport must be designed in such a way
that the required temperature can be maintained throughout the period of
transport;
4. premises must be provided for the storage of wrapping and packaging mate-
rials;
5. wrapping and packaging must take place under hygienic conditions in a room
or in a place intended for that purpose;
6. the use of wood is forbidden; however, the use of wooden pallets is
authorised for the transport of the containers of the products concerned.1977L0099 — EN — 01.05.2004 — 020.001 — 28
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ANNEX D
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