1977L0099—EN—01.01.1993—013.001—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)
(OJL26,31.1.1977,p.85)
Amendedby:
OfficialJournal
No page date
►M1CouncilDirective80/214/EECof22January1980 L47 3 21.2.1980
►M2CouncilDirective81/476/EECof24June1981 L186 20 8.7.1981
►M3CouncilDirective85/327/EECof12June1985 L168 49 28.6.1985
►M4CouncilDirective85/328/EECof20June1985 L168 50 28.6.1985
►M5CouncilDirective85/586/EECof20December1985 L372 44 31.12.1985
►M6CouncilRegulation(EEC)No3768/85of20December1985 L362 8 31.12.1985
►M7CouncilRegulation(EEC)No3805/87of15December1987 L357 1 19.12.1987
►M8CouncilDirective88/658/EECof14December1988 L382 15 31.12.1988
►M9CouncilDirective89/227/EECof21March1989 L93 25 6.4.1989
►M10CouncilDirective89/662/EECof11December1989 L395 13 30.12.1989
►M11CouncilDirective92/45/EECof16June1992 L268 35 14.9.1992
►M12CouncilDirective92/5/EECof10February1992 L57 1 2.3.1992
Amendedby:
►A1ActofAccessionofGreece L291 17 19.11.1979
Correctedby:
►C1Corrigendum,OJL68,15.3.1977,p.35(77/99/EEC)
►C2Corrigendum,OJL76,24.3.1977,p.26(77/99/EEC)
►C3Corrigendum,OJL44,20.2.1990,p.34(88/658/EEC)
▼B
COUNCILDIRECTIVE
of21December 1976
►M12 onhealthproblemsaffectingtheproductionandmarketing
ofmeatproductsandcertainotherproductsofanimalorigin ◄
(77/99/EEC)
THECOUNCILOFTHEEUROPEANCOMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community,andinparticularArticles43and100thereof,
HavingregardtotheproposalfromtheCommission,HavingregardtotheopinionoftheEuropeanParliament(
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
fromthehealthpointofview,itisnecessarytouse,intheirmanufac-
ture,onlythatfreshmeatobtainedinaccordance withtheCommunitystandardslaiddowninCouncilDirective64/433/EECof26June1964on 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 healthandveterinaryinspectionproblemsuponimportationofbovineanimalsand swine and fresh meat from third countries(
5), as last amended by
Directive 75/379/EEC; whereas meat products must be manufactured,
storedandtrasnportedinconditionsofferingeveryguaranteeasregards
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
manufacturingestablishment;
Whereas,moreover,Communitycontrolarrangements shouldbeintro-
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
setupbytheCouncilDecisionof15October1968(
6);
Whereas provision should be made for the possibility of derogating
fromcertain provisions of this Directive in respect of certain m eatproducts 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,asregardsintra-Communitytrade,theissueofahealthcerti-
ficate drafted by the competent authority is considered to be the best
wayofassuringthecompetentauthoritiesofthecountryofdestinationthat a consignment of meat products complies with this Directive;1977L0099—EN—01.01.1993—013.001—2
(1) OJNoC114,11.11.1971,p.40.
(2) OJNo121,29.7.1964,p.2012/64.
(3) OJNoL172,3.7.1975,p.17.
(4) OJNoL55,8.3.1971,p.23.
(5) OJNoL302,31.12.1972,p.28.
(6) OJNoL255,18.10.1968,p.23.
▼B
whereas this certificate must accompany the consignment of these
productstotheplaceofdestination;
Whereas Member States must have the right to prohibit the introduc-
tion into their territory of meat products from another Member Statewhich prove unfit for human consumption or do not comply withCommunityhealthprovisions;
Whereas, in such cases, the consignor should, at his own request or
upon request of his representative, be allowed to have the meatproductsreturnedtohimunlesstherearehealthreasonstothecontrary;
Whereas, in case of prohibition or restriction, the reasons therefor
shouldbemadeknowntotheconsignororhisrepresentativeandalso,
incertaincases,tothecompetentauthoritiesoftheexportingcountry;
Whereas,intheeventofadisputebetweenhimselfandtheauthorities
oftheMemberStateofdestinationastothejustificationforprohibitionorrestriction,theconsignorshouldbeenabledtoobtaintheopinionofanexpert;
Whereas, in order to facilitate the implementation of the proposed
measures,aprocedureshouldbeprovidedforclosecooperationbetwenthe Member States and the Commission in the Standing VeterinaryCommittee,
HASADOPTEDTHISDIRECTIVE:
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 thepreparationofotherfoodstuffs.
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,wherethepreparationandstorageareperformedsolelyforthepurposeofsupplyingtheconsumerdirectly.
Article 2
ForthepurposesofthisDirectivethefollowingdefinitionsshallapply:(a) meat products: products prepared from or with meat which has
undergone treatment such that the cut surface shows that the
productnolongerhasthecharacteristicsoffreshmeat.
However,thefollowingshallnotberegardedasmeatproducts:
(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
December1988layingdowntherequirementsfortheproduc-tionof,andtradein,mincedmeat,meatinpiecesoflessthan100gramsandmeatpreparationsandamendingDirectives64/433/EEC,71/118/EECand72/462/EEC(
1);
(b) otherproductsofanimalorigin:
(i) meatextracts;
(ii) rendered animal fat: fat derived from rendering meat,
includingbones,andintendedforhumanconsumption;
(iii) greaves: the protein-containing residue of rendering, after
partialseparationoffatandwater;
(iv) gelatin;1977L0099—EN—01.01.1993—013.001—3
(1) OJNoL382,31.12.1988,p.3.▼M12
▼M12
(v) meat powder, powdered rind, salted or dried blood, salted or
driedbloodplasma;
(vi) stomachs, bladders and intestines, cleaned, salted or dried,
and/orheated;
(c) prepared meat meals; wrapped meat products corresponding to
culinary preparations, cooked or pre-cooked and preserved bycold;
(d) meat:meatasdefinedin:
— Article2(a)ofDirective64/433/EEC,
— Article2ofDirective71/118/EEC,— Article2ofDirective72/461/EEC,— Article2ofDirective72/462/EEC,— Article2ofDirective88/657/EEC,— Article2(1)and(2)ofDirective91/495/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
preparedmeals;
(f) treatment: chemical orphysicalprocesssuchasheating,smoking,
salting, marinating, curing or drying, intended to lengthen the
preservationofmeatoranimalproductswhetherornotassociated
withotherfoodstuffs,oracombinationofthesevariousprocesses;
(g) heating:useofdryordampheat;
(h) salting:useofsalt;(i) curing:distributionofsaltsthroughouttheproduct;
(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:naturalorartificialreductionofthewatercontent;(l) batch:aquantityofameatproductwhichiscoveredbythesame
accompanyingcommercialdocumentorhealthcertificate;
(m) wrapping:theprotectionoftheproductsreferredtoinArticle1(1)
by the use of an initial wrapping or initial container in direct
contact with the product concerned as well as the initial wrapperorinitialcontaineritself;
(n) packaging: the placing of one or more wrapped or unwrapped
products as referred to in Article 1 (1) in a container, as well asthecontaineritself;
(o) hermetically sealed container: container intended to protect the
contents against the entry of microorganisms during and afterheattreatmentandwhichisimpermeabletoair;
(p) establishment: any undertaking manufacturing the products
referredtoin(a),(b)and(c);
(q) rewrapping centre: a workshop or depot where batches intended
forplacingonthemarketarereassembledand/orrewrapped;
(r) placingonthemarket:thestockingordisplaywithaviewtosale,
offeringforsale,sale,deliveryoranyothermannerofdisposalintheCommunity,withtheexceptionofretailsale;
(s) competent authority: the central authority of a Member State
competenttocarryoutveterinarychecksoranyauthoritytowhichithasdelegatedthatcompetence.1977L0099—EN—01.01.1993—013.001—4
▼M12
Article 3
A. EachMemberStateshallensure—withoutprejudicetothecondi-
tions laid down in Article 4 — that meat products placed on themarket:
1. havebeenpreparedandstoredinanestablishmentapprovedand
supervised:
— in accordance with Article 8, and meeting the requirements
ofthisDirective,inparticularthoseofAnnexAandChapters
IandIIofAnnexB,
or
— in accordance with Article 9, in the case of establishments
whichdonothaveanindustrialstructureorproductioncapa-city;
2. havebeenpreparedfrommeatasdefinedinArticle2(d),onthe
understandingthat:
(i) meat imported from a third country must have been
inspectedinaccordancewithDirective90/675/EEC;
(ii) meatimportedinaccordancewithArticle15ofDirective71/
118/EECandthesecondparagraphofArticle17ofDirective91/495/EECmaynotbeusedunless:
— products obtained from this meat fulfil the requirements
setoutinthisDirective,
— theseproductsdonotbearthehealthmarkinglaiddown
inChapterVIofAnnexB,
— the placing on the market of these products remains
subject to the national provisions of the Member Stateofdestination.
Meat declared unfit for consumption in compliance with the
requirements of Articles 5 and 6 of Directive 64/433/EEC and
the followingitems may notbe usedin the preparation of meat
products:
(a) genitalorgansoffemaleormaleanimals,excepttesticles;
(b) urinaryorgans,exceptthekidneysandthebladder;(c) the cartilage of the larynx, the trachea and the extralobular
bronchi;
(d) eyesandeyelids;(e) theexternal,auditorymeatus;
(f) corneoustissues;
(g) in poultry, the head, — except the comb and the ears, the
wattlesandcaruncles—theoesophagus,thecrop,theintes-tinesandthegenitalorgans.
Items may be added to or removed from this list in accordance
withtheprocedurelaiddowninArticle20;
3. have been prepared in accordance with the requirements of
Chapter III ofAnnexBand, in the case ofpasteurized or steri-lized products in hermetically sealed containers or of preparedmeals,complywiththerequirementsofAnnexB,ChapterVIII,orChapterIXrespectively;
4. have undergone the establishment's own checks provided for in
Article7andaresupervisedbythecompetentauthorityinaccor-dancewithChapterIVofAnnexB;
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 orlabelled inaccordance withChapterVofAnnex B on the spot or in wrapping centres specially approvedbythecompetentauthorityforthatpurpose.
However, pending the adoption of Community rules, the provi-
sions of this Directive concerning the sales description of meat1977L0099—EN—01.01.1993—013.001—5
▼M12
products shall not apply to products of designated origin or to
typicalproducts;
7. without prejudice to the marking requirements of Directive 80/
215/EEC, have been marked, on the responsibility of theoperatorormanageroftheestablishment,with:
— a national health mark, where the raw material used is
marketedwiththatmark,
— a mark to be determined in accordance with the procedure
laid down in Article 20 where the meat used must, underCommunitylaw,bemarketedlocally,
— inothercases,ahealth markinaccordance withChapter VI
ofAnnexB.
Themarkmustbeprintedonthelabeloraffixedtotheproduct
orthewrapping,ontheunderstandingthattheprintingorrepri-
nting of labels or marks must be authorized by the competent
authority;
8. have been handled, stored and transported in accordance with
ChapterVIIofAnnexBand,iftheyarestoredinacold-storage
plantseparatefromtheestablishment,thisplantmusthavebeenapproved andinspected inaccordance with Article 10ofDirec-tive64/433/EEC;
9. areaccompaniedduringtransportationby:
(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 must
correspondinformandcontenttothemodelinAnnexD.Itmust be drawn up in the official language or languages ofthecountryofdestinationatleast.Itmustconsistofasinglesheetofpaper;
(b) from1July1993:
(i) anaccompanyingcommercialdocumentwhichmust:
— in addition to the particulars provided for in Annex
B,ChapterVI,point4,bearacodenumberbywhichthe competent authority responsible for supervising
theestablishmentoforigincanbeidentified,
— bekeptbytheconsigneeforatleastoneyearsothat
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 after
transit through the territory of a third country, be
approved by the competent authority of the borderinspection post at which the transit formalities arecarried out to certify that the meat productsconcernedmeettherequirementsofthisDirective;
(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, orfromm eat referred to in Article 6 of Directive 64/433/EEC, or fromproducts to be sent to another Mem berState, after transit through a third country in a sealed
meansoftransport.
This obligation shall not apply to meat products in
hermetically sealed containers and having undergoneone of the treatments referred to in Annex B, ChapterVIII,pointB,firstindent,ifthehealthmarkisindeliblymarked on the container in accordance with the provi-sions to be drawn up under the procedure laid down in
Article20.
Detailed rules for applying (ii), and in particular those
concerning the allocation ofcodenumbersandthecompila-1977L0099—EN—01.01.1993—013.001—6
▼M12
tion of one or more lists identifying the competent authori-
ties, shall be adopted in accordance with the procedure laiddowninArticle20.
B. Pending possible Community rules on ionization, meat products
maynothavebeensubjectedtoionizingradiation.
Thisprovisionshallnotaffectnationalrulesapplicabletoionization
formedicalpurposes.
Article 4
Member States shall ensure that, in addition to the general require-
mentslaiddowninArticle3:
1. meatproducts:
(a) have been prepared by heating, curing, marinating or drying,
which processes may be combined with smoking or maturing,
possiblyunderspecificmicroclimatic conditions,andhavebeenassociated, in particular, with certain curing agents in compli-ance with Article 16 (2). The meat products may also beassociatedwithotherfoodstuffsandcondiments;
(b) have,ifappropriate,beenobtainedfromameatproductorfrom
ameatpreparation;
2. untiltheexpiryofthederogationsprovidedforinDirective71/118/
EECandDirective91/498/EEC,premises,toolsandequipmentusedforthepreparation ofmeat productsfromorwithmeat bearing theEEC health mark may only be used for the preparation of meat
productsfromorwithmeatwhichdoesnotbearthatmarkfollowing
authorization fromthe com petent authority and provided that allprecautions are taken, to the satisfaction of that authority, to avoidany confusion between products fromm eat with and without themark;
3. the meat products referred to in the first and second indents of
Article3(7)cannotbesenttotheterritoryofanotherMemberStateandtheirnationalorlocalmarketingisstrictlysupervised.
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 fromraw materials of animal origin not covered by this Directive. PendingtheCouncil'sdecision,MemberStatesshallensurethat,wheretheyaremanufacturedinanestablishmentdefinedinArticle2(p),thepreparedmeals in question comply with the hygiene rules laid down in Annex
A,ChapterII,andthatsuchmealsalsomeetthespecificrequirements
setoutinAnnexB,ChapterIX,andaresupervisedinaccordancewithArticle7.
Article 6
1. MemberStatesshallensurethatotherproductsofanimalorigin:
— have been obtained inestablishments whichmeet the requirements
of Article 7, have been authorized and registered in accordancewith Article 11, meet the standards of Annex A and are inspectedinaccordancewithArticle8,
— are manufactured in accordance with the specific conditions laid
downinAnnexC,
— areinspectedasprovidedforinChapterIVofAnnexB,
— are accompanied, as provided for in Article 3 (9) (b) (i), by a
commercialdocumentspecifyingtheoriginoftheproducts.
2. In accordance with the procedure provided for in Article 20,
special health conditions shall be adopted before 31 December 1992forthepreparationofgelatinintendedforhumanconsumption.1977L0099—EN—01.01.1993—013.001—7
▼M12
In accordance with the same procedure, additional conditions may be
laiddownforotherproductsofanimalorigininordertoprotectpublichealth.
Article 7
1. Member States shall ensure that the operator or manager of the
establishmentortherewrappingcentretakesallnecessarymeasurestoensurethat,atallstagesofproductionorrewrapping,thespecificationsofthisDirectivearecompliedwith.
To that end, the said persons must constantly carry out their own
checksbasedonthefollowingprinciples:
— identificationofcriticalpointsintheirestablishmentonthebasisof
theprocessesused,
— establishment and implementation of methods for monitoring and
checkingsuchcriticalpoints,
— takingsamplesforanalysisinalaboratoryapprovedbythecompe-
tentauthorityforthepurposeofcheckingcleaninganddisinfectionmethodsandforthepurposeofcheckingcompliancewiththestan-dardsestablishedbythisDirective,
— keepingawrittenorregisteredrecordoftheinformationrequiredin
accordance withtheprecedingindentswithaviewtosubmittingitto the competent authority. The results of the different checks and
tests shall in particular be kept for a period of at least two years,
saveinthecaseoftheproductsreferredtoinparagraph2forwhichthis period may be reduced to six months after the minimumconservationdateoftheproduct,
— guarantees as regards the administration of the health marking,
particularlythelabelsbearingthehealthmark,
— when the laboratory examination or any other information at their
disposal reveals that there is a serious health risk, informthe
competentauthoritythereof,
— intheeventofanimmediatehumanhealthrisk,withdrawfromthe
market the quantity ofproductsobtained intechnologically similarconditions and likely to present the same risk. This withdrawnquantitymuststayunderthesupervisionandcontrolofthecompe-tent authority until it is destroyed, used for purposes other than
human consumption or, after authorization by the competent
authority,reprocessedinanappropriatemannertoensureitssafety,
— the requirements of the first and second indents must have been
drawnupinconjunction withthecompetent authority, whichmustregularlymonitorcompliancetherewith.
2. Forinspectionpurposes,theoperatorormanageroftheestablish-
mentortherewrappingcentremustensurethatthepackagingofmeat
productswhichcannotbestoredatambienttemperatures bearsaclear
andlegibleindicationofthetemperatureatwhichtheproductsmustbetransported and stored, as well as the minimum durability date or, inthecaseofmicrobiologicallyperishableproducts,theuse-bydate.
3. The operator or manager of the establishment must arrange or
establish a staff training programme enabling workers to comply with
conditions of hygienic production adapted to the production structure,unless such staff already have adequate qualifications attested bydiplomas. This training programme may be of a specific type for theestablishmentsreferredtoinArticle9.
The competent authority responsible for the establishment must be
involvedintheplanningandimplementationoftheprogramme.
Article 8
1. Each Member State shall draw up a list of approved establish-
ments, other than those referred to in Article 11, each establishmenthavinganapprovalnumber.ThislistshallbesenttotheotherMemberStatesandtotheCommission.1977L0099—EN—01.01.1993—013.001—8
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Asingleapprovalnumbermaybegivento:
(i) an establishment or rewrapping centre processing or rewrapping
products obtained fromor with raw m aterials covered by severaloftheDirectivesreferredtoinArticle2(d);
(ii) an establishment located on the same site as an establishment
approved in accordance with one of the Directives referred to inArticle2(d).
Thecompetentauthorityshallnotapproveanestablishmentunlessitis
satisfied that it complies withthisDirective withrespecttothenatureof 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 materialsorunwrappedproductsmaybecommontobothestablishments.
Wherethecompetentauthorityfindsanobviousfailuretocomplywith
the hygiene rules laid down by this Directive or obstacles to an
adequatehealthinspection:
(i) itshallbeempoweredtoactinrespectoftheuseofequipmentor
premisesandtotakeanyrequisitemeasureswhichmaygoasfarasreducing the rate of production or temporarily suspending the
productionprocess;
(ii) wherethesemeasuresorthemeasuresprovidedforinthepenulti-
mateindentofArticle7(1)haveprovedinsufficienttoremedythesituation, it shall temporarily suspend approval, if appropriate, forthetypeofproductioninquestion.
Iftheoperatorormanageroftheestablishmentdoesnotmakegoodthe
shortcomingsnotedwithintheperiodfixedbythecompetentauthority,
thelattershallwithdrawapproval.
The competent authority in question shall in particular be obliged to
comply with the conclusions of any check carried out in accordancewithArticle12.
TheotherMemberStatesandtheCommissionshallbeinformedofthe
suspensionorwithdrawalofapproval.
2. Inspection and supervision of establishments shall be carried out
bythecompetentauthority.
Theestablishmentshallremainunderthepermanentsupervisionofthe
competent authority on the understanding that the need for permanent
or periodic presence of the competent authority in a given establish-mentwilldependonthesizeoftheestablishment,thetypeofproductmanufactured,riskassessmentandtheguaranteesofferedinaccordancewiththefifthandlastindentsofthesecondsubparagraphofArticle7(1).
Thecompetentauthoritymustatalltimeshavefreeaccesstoallparts
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 oforiginoftherawmaterialtobetraced.
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 orontheproducts.
The nature of these checks, their frequency and the methods of
sampling and of carrying out microbiological examinations shall be
establishedundertheprocedurelaiddowninArticle20.
Theresultsoftheseanalysesshallbewrittenupinareport,theconclu-
sionsorrecommendationsofwhichshallbenotifiedtotheoperatorormanageroftheestablishment,whoshallrectifytheshortcomingsnotedwithaviewtoimprovinghygiene.1977L0099—EN—01.01.1993—013.001—9
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3. In the event of repeated shortcomings, checks shall be increased
and,whereappropriate,labelsorsealsbearingthehealthmarkshallberemoved.
4. The arrangements forimplementing thisArticle shall be adopted
inaccordancewiththeprocedurelaiddowninArticle20.
Article 9
1. Member States may, for the purpose of their approval, grant
establishments manufacturing meat products without an industrialstructure or production capacity derogations fromthe requirem ents of
Chapter IofAnnexBandfromthoseofAnnexA,Chapter I,point2
(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 finishedproducts are stored. However, in this case, the establishment musthaveatleast:
(i) a roomor a secure place, where appropriate refrigerated, for the
storageofrawmaterials,ifsuchstoragetakesplace;
(ii) a roomor a secure place, where appropriate refrigerated, for the
storageoffinishedproducts,ifsuchstoragetakesplace.
2. Wheretheestablishmentsreferredtoin:
— Article4(1)ofDirective64/433/EEC,wheretherequirementslaid
downinthesecondsubparagraphofArticle13(1)ofthatDirectivearemet,
— Article 4 (2) and the second subparagraph of Article 13 (1) of
Directive64/433/EEC,
producemeatproducts,MemberStatesmayextendtothemthederoga-
tion provided for in the first paragraph, on the understanding that the
treatmentoftheproductsinsuchestablishmentsmustsatisfytheotherrequirementsofthisDirective.
3. The provisions of Annex B, Chapter VII shall not apply to
storageoperationsintheestablishmentsreferredtoinparagraph1,nortothetransportingofproductsotherthanthosereferredtoinArticle7(2).
4. Member States shall communicate to the Commission before 1
October 1992 the criteria which they have adopted to assess whether
an establishment or a category of establishments are covered by the
provisionsofthisArticle.
Ifafterexaminationofthesecriteriaorfollowingthecheckscarriedout
in accordance with Article 12, the Commission considers that thecriteriaadoptedmightjeopardizetheuniformapplicationofthisDirec-tive,suchcriteria maybeamended orsupplemented, forthefirsttimebefore1January1993,inaccordance withtheprocedurelaiddowninArticle20.Theconditionsunderwhichthecompetentauthoritiesofthe
Member State shall reclassify such establishments shall also be laid
downbythesameprocedure.
5. On the basis of the information collected by the Commission in
accordancewiththefirstsubparagraphofparagraph4,uniformcriteriaforthe application ofthis Article shall be laid downbefore 1January1993inaccordancewiththeprocedurelaiddowninArticle20.
Article 10
Establishments currently benefiting from national approval mustapply
to the competent authority before 1 October 1992 for classificationeitherunderArticle8orunderArticle9.
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-fiedmuststillbearthenationalhealthmark.1977L0099—EN—01.01.1993—013.001—10
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AsregardstheestablishmentsreferredtoinArticle8,attherequestof
aMemberStateaccompaniedbyappropriatejustification,anadditionalperiodexpiringon1January1996maybegrantedinaccordance with
theprocedurelaiddowninArticle20forcompliancewiththerequire-
ments of Annex B, Chapter I, 1 (a). Products from such anestablishmentmustbearthenationalhealthmark.
Article 11
1. By way of derogation fromArticle 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 in
Article 2 (b) and give each of thema specific official num ber forinspection purposes and in order to be able to trace the establishmentoforiginoftheproductsconcerned.
However, where production takes place in premises adjacent to an
approvedslaughterhouse,thisapprovalshall,providedtherequirements
ofthisDirectivearecompliedwith,beextendedtocoverthepremises
inquestion.
2. The inspection and monitoring of establishments shall be carried
out by the competent authority, which shall at all times have freeaccesstoallpartsoftheestablishments,inordertoensurecompliancewiththerequirementsofthisDirective.
3. If such inspections reveal that the requirements of this Directive
are not being met, the competent authority shall take appropriate
action,uptoandincludingthemeasuresprovidedforinArticle8(1),thirdandfourthsubparagraphs.
4. The analyses and tests must be carried out in accordance with
proven and scientifically recognized methods, in particular those laiddowninCommunityprovisionsorinternationalstandards.
The Commission shall establish the reference methods in accordance
withtheprocedurelaiddowninArticle20.
Article 12
1. Experts from the Commission may, in so far as is necessary for
the uniformapplication of this Directive and in cooperation with thecompetentauthorities,makeon-sitechecks.Todothis,theymayverifybychecking a representative percentage ofestablishments whether thecompetent authorities are verifying that approved establishments are
complying with this Directive. The Commission shall inform the
MemberStatesoftheresultsofthecheckscarriedout.
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
inaccordancewiththeprocedurelaiddowninArticle20.
2. Before 1 January 1995 the Council shall review this Article on
thebasisofareportfromtheCommission,whichmaybeaccompaniedbyproposals.
Article 13
1. BywayofderogationfromtheconditionsstipulatedinArticle3,
it may be decided, in accordance with the procedure laid down inArticle 20, that some provisions of this Directive shall not apply tomeatproductswhichcontainotherfoodstuffsandonlyasmallpercen-
tageofmeat,meatproductormeatpreparation.
Thesederogationsshallrelateonlyto:(a) the conditions for approval of establishments as laid down in
AnnexA,ChapterIandinAnnexB,ChapterI;
(b) theinspectionrequirementsdescribedinAnnexB,ChapterIV;1977L0099—EN—01.01.1993—013.001—11
▼M12
(c) the marking requirementslaid downin AnnexB,Chapter VIand,
until1July1993,thehealthcertificateprovidedforinAnnexD.
Whenconsideringwhethertograntderogationssuchasthoseprovided
for under this Article, both the nature and the composition of theproductshallbetakenintoaccount.
Notwithstanding the provisions of this Article, Member States shall
ensure that all meat products placed on the market are wholesomeproductspreparedfromfreshmeat,meat productsorproductscovered
byDirective88/657/EEC.
2. Until such time as a decision is taken in accordance with para-
graph1,Directive82/201/EECshallcontinuetoapply.
Article 14
TheprovisionsofCouncilDirective89/662/EECconcerningveterinary
checksinintra-Community tradewithaviewtothecompletion ofthe
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 theMemberStateofdestinationandthesafeguardmeasurestobeapplied.
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-turingpracticesapplicableatthedifferentstagesoftheproductionandplacingonthemarketoftheproductsreferredtoinArticle1.
Article 16
1. Pending the adoption of Community regulations on health rules
applicabletotheplacingonthemarketofwildgame,thenationalrules
ontheuseofsuchmeatintheestablishmentsreferredtointhisDirec-tiveandtotheplacingonthemarketofmeatproductscontainingsuchmeatshallcontinuetoapply,incompliancewiththegeneralprovisionsoftheTreaty.
2. Pendingcompilation, inthecontextofCommunitylegislation on
additives,ofthelistoffoodstuffstowhichtheadditivesauthorizedforuse may be added and establishment of the conditions under whichtheymaybeaddedand,whereappropriate,alimitonthetechnologicalpurpose of their use, the national rules and the bilateral arrangementsexisting onthe date onwhich Directive 88/658/EEC wasbrought 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 distinctiontodomesticproductionandtotrade.
Untilthatlistisdrawnup,thenationalrulesandthebilateral arrange-
mentsgoverningtheuseofadditivesfortheproductsreferredtointhis
Directive 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
followingmaybeestablished:
— special conditions for the approval of establishments situated in
wholesalemarketsandofrewrappingcentres,
— rules for the marking of products from a rewrapping centre and
supervision procedures enabling the establishment of origin of the
rawmaterialstobetraced,
— attherequestofaMemberStateorontheCommission'sinitiative
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 giverisetodifferinginterpretationindifferentMemberStates,1977L0099—EN—01.01.1993—013.001—12
▼M12
— themethodsforcheckingthatthecontainersreferredtoinChapter
VIII,point1(f),ofAnnexBarecorrectlysealed,
— microbiologicalstandardsincludingsamplingplansandmethodsof
analysisfortheproductsreferredtoinArticle7(2).
Article 18
1. WithoutprejudicetothespecificprovisionsofthisDirective,the
competent authority shall, where it is suspected that the provisions of
this Directive have not been complied with or there is doubt as towhether the products referred to in Article 1 are fit for consumption,carryoutanychecksitdeemsappropriate.
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,thatthemarksontheproductsconcerneddonotcomplywiththerules,
that the products have not undergone the checks provided for in this
Directive or that they were not used for the purpose originallyintended.
Article 19
TheAnnexestothisDirectiveshallbeamendedbytheCouncilacting
by a qualified majority on a proposal from the Commission, in parti-culartoadaptthemtoadvancesintechnology.
Article 20
1. Where the procedure laid downinthisArticle istobe followed,
matters shall without delay be referred to the Standing VeterinaryCommittee by its chairman, either on his own initiative or at therequestoftherepresentativeofaMemberState.
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 downaccordingtotheurgencyofthematter.Opinionsshallbedeliveredbyamajorityof54votes,thevotesoftheMemberStatesbeingweighted
asprovidedforinArticle148(2)oftheTreaty.Thechairmanshallnot
vote.
3. The Commission shall adopt the measures and implement them
immediately where they are in accordance with the opinion of the
Committee. Where they are notin accordance with the opinion of the
Committee,orifnoopinionisdelivered,theCommissionshallwithoutdelayproposetotheCouncilthemeasurestobeadopted.TheCouncilshalladoptthemeasuresbyaqualifiedmajority.
If, within three months from the date on which a proposal was
submitted to it, the Council has not adopted any measures, theCommissionshalladopttheproposedmeasuresandapplythemimme-diately, save where the Council has rejected these measures by asimplemajority.
Article 21
ActinginaccordancewiththeprocedurelaiddowninArticle43ofthe
Treaty,theCouncilshalltakeadecisionbefore1January1993ontheincorporation into meat products of starch or proteins of animal or
vegetable origin and the maximum percentages permissible from a
technologicalviewpoint.
Article 22
The Member States shall bring into force the laws, regulations and
administrativeprovisionsnecessaryforthemtocomplywiththisDirec-tiveon1July1979.1977L0099—EN—01.01.1993—013.001—13
▼B
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Article 23
ThisDirectiveisaddressedtotheMemberStates.
Article 24
TheRuleslaiddowninDirective89/662/EEC(1)concerningveterinary
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 protectivemeasurestobeimplemented.1977L0099—EN—01.01.1993—013.001—14
(1) OJNoL395,30.12.1989,p.13.▼B
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ANNEX A
GENERALCONDITIONS
CHAPTERI
Generalconditionsforapprovalofestablishments
Establishmentsshallaffordatleastthefollowingfacilities:
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
theproductsreferredtointhisDirectivemanufactured:
(a) solid,waterproofflooringwhichiseasytoclean anddisinfectandlaid
insuchawayastofacilitatethedrainageofthewaterorprovidedwith
equipmenttoremovewater;
(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 ofat least twometres, orat least storage height in refrigeration
andstoragerooms;
(c) ceilingsorroofliningswhichareeasytoclean;(d) doorsinnon-corrodiblematerialswhichareeasytoclean;(e) adequate ventilation and, where necessary, good steamand water-
vapourextractionfacilities;
(f) adequatenaturalorartificiallighting;(g) an adequate number of facilities with hot and cold running water, or
waterpre-mixedtoasuitabletemperature,forcleaninganddisinfecting
hands. In work rooms and lavatories, taps must not be hand-operable.
These facilities must be provided with cleaning and disinfecting
productsandhygienicmeansofdryinghands;
(h) facilitiesforcleaningtools,equipmentandutensils;
3. inroomswheretherawmaterialsandtheproductscoveredbythisDirective
arestored,thesameconditionsasthoseat2apply,exceptin:
— chilling and refrigeration rooms, where a floor which is easy to clean
anddisinfect,laidinsuchawayastofacilitatethedrainingofwateris
sufficient,
— freezinganddeep-freezingrooms,wherewaterproofandrotprofflooring
whichiseasytocleanissufficient,
in that case, a sufficiently powerful refrigeration plant to keep the raw
materials and products at the temperatures prescribed in this Directivemustbeavailable.
Theuseofwoodenwallsintheroomsreferredtointhesecondindentdoes
not constitute grounds for withdrawing approval provided they were built
before1January1983.
Thecapacityofthestoreroomsmustbeadequatetostoretherawmaterials
usedandtheproductsreferredtointhisDirective;
4. facilities for hygienic handling and protection of raw materials and non-
packagedorwrappedfinishedproductsduringloadingandunloading;
5. appropriate arrangements for protection against pests such as insects,
rodents,birds,etc.;
6. instruments and working equipment such as cutting tables, containers,
conveyorbelts,sawsandknives,intended tocomeintodirect contact with
rawmaterialsandproductsmadeofcorrosion-resistantmaterialandeasyto
cleananddisinfect;
7. special watertight, non-corrodible containers, with lids and fasteners to
preventunauthorizedpersonsfromremovingthingsfromthem,inwhichto
put raw materials or products not intended for human consumption, or a
lockableroomforsuchpurposesifthequantitiesarelargeenoughtoneces-
sitatethisoriftheyarenotremoved ordestroyedattheendofeachstage
of work. Where such raw materials or products are removed through
conduits,thesemustbesoconstructedandinstalledastoavoidanyriskof
contaminationoftheotherrawmaterialsorproducts;
8. appropriate facilities for the cleaning and disinfecting of equipment and
utensils;1977L0099—EN—01.01.1993—013.001—15
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9. awastewaterdisposalsystemwhichmeetshygienerequirements;
10. asupplyofpotablewateronly,withinthemeaningofCouncilDirective80/
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
exceptionalcasesforsteamproduction,firefightingandrefrigerationequip-
ment,providedthatthepipesinstalled forthispurposepreclude theuseof
this water for other purposes and present no direct or indirect risk of
contamination of the product. Non-potable water pipes must be clearly
distinguishedfromthoseusedforpotablewater;
11. an appropriate number of changing rooms with smooth, waterproof wash-
ablewallsandfloors,washbasinsandflushlavatories.Thelattermustnot
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
mustnotbehandoperable;
12. ifthevolumeofproductstreatedrequiresregularorpermanentpresence,an
adequately equipped lockable roomfor the exclusive use of the inspection
service;
13. a roomor a secure place for the storage of detergents, disinfectants and
similarsubstances;
14. aroomorcupboardforstoringcleaningandmaintenancematerial;
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-
ciallyauthorizedbythecompetentauthority;
CHAPTERII
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
constituteasourceofcontaminationforrawmaterialsorproducts.Water
forcleaningtoolsmustbeatatemperatureofnotlessthan+82ºC.
2. Noanimalsmayentertheestablishments.Rodents,insectsandanyother
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
theproducts.
3. Workingareas,instrumentsandworkingequipmentmustbeusedonlyfor
work on products for which approval has been granted. However,
followingauthorization bythe competent authority, they may beusedat
the same time orother times forworkonother foodstuffsfitfor human
consumption.Thisrestrictiondoesnotapplytotransportequipmentused
inpremiseswherenoworkisdoneonrawmaterialsorproductscovered
bythisDirective.
4. Potablewater,withinthemeaningofDirective80/778/EEC,mustbeused
for all purposes. However, by way of exception, non-potable water may
beusedforsteamproduction,fire-fightingandthecoolingofequipment,
providedthatthepipesinstalledforthepurposeprecludetheuseofsuch
waterforotherpurposesandpresentnoriskofcontaminationoftheraw
materialsandproducts.
5. Detergents,disinfectantsandsimilarsubstancesmustbeapprovedbythe
competentauthorityandusedinsuchawaythattheydonothaveadverse
effectsonthemachinery,equipment,rawmaterialsandproducts.
Theirusemustbefollowedbythoroughrinsingofsuchinstrumentsand
working equipment with potable water. Products for maintenance and
cleaningmustbekeptintheroomprovidedforinChapterI(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
referredtointhisDirectiveisprohibited.1977L0099—EN—01.01.1993—013.001—16
(1) OJNoL229,30.8.1980,p.11.
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B.General conditions of hygiene applicable to staff
1. Absolutecleanlinessisrequiredofstaff.Specifically:
(a) staff must wear suitable clean working clothes and headgear which
completely encloses the hair. This applies particularly to persons
handlingexposed,non-packagedrawmaterialsandproducts;
(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
tothehandsmustbecoveredbyawaterproofdressing;
(c) smoking,spitting, eating and drinkinginroomswhererawmaterials
andproductsareworkedonorstoredisprohibited.
2. The employer shall take all the requisite measures to prevent persons
liable to contaminate raw materials and products from handling them,
untilthereisevidencethatsuchpersonscandosowithoutrisk.
When recruited, any person working on and handling raw materials and
productsshallberequiredtoprove,byamedicalcertificate,thatthereis
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
guaranteestobefixedundertheprocedurelaiddowninArticle20.1977L0099—EN—01.01.1993—013.001—17
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ANNEX B
SPECIALCONDITIONSFORMEATPRODUCTS
CHAPTERI
Specialconditionsforapprovalofestablishmentspreparingmeatproducts
1. In addition to the general requirements laid down in Annex A, Chapter I,
establishments manufacturing, handling and wrapping meat products shall
haveatleast:
(a) suitableroomslargeenoughfortheseparatestorage:
(i) ofrawmaterials,underrefrigeration;and
(ii) of meat products at ambient temperature or, where appropriate,
dependingonthenatureoftheproducts,underrefrigeration;
ontheunderstandingthatnon-packagedrawmaterials,meatproductsand
otherproductsofanimaloriginmustbestoredseparatelyfrompackaged
rawmaterialsandproducts;
(b) one or more appropriate rooms large enough for the manufacture and
wrappingofmeatproducts.Providedtheseoperationsconstituteasingle
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,
theymaybecarriedoutinthesameroom;
(c) a roomor a secure place for the storage of certain ingredients such as
foodadditives;
(d) a roomfor packaging, unless the conditions laid down for packaging in
ChapterV,point3arefulfilled,andfordispatch;
(e) aroomforthestorageofwrappingandpackagingmaterials;
(f) a room for cleaning equipment and instruments, such as hooks and
containers.
2. Dependingonthetypeofproductinvolved,theestablishmentmusthave:
(a) a roomor — of there is no danger of contam ination — an area where
packagingisremoved;
(b) a roomor — if there is no danger of contam ination — an area for
thawingrawmaterials;
(c) acuttingroom;
(d) aroomorequipmentfordryingormaturing;(e) aroomorequipmentforsmoking;(f) a roomfor desalting, soaking and any other treatm ent, particularly of
natural guts, where these rawmaterials have not undergone suchopera-
tionsintheestablishmentoforigin;
(g) aroomforthepriorcleaningoftherawmaterialsneededtopreparemeat
products;
(h) a roomfor salting, if necessary with air-conditioning facilities to m ain-
tainthetemperatureprovidedforinChapterII(4);
(i) aroomforthepriorcleaning,ifnecessary,ofmeatproductstobesliced
orcutandwrapped;
(j) aroom,ifnecessarywithair-conditioningfacilities,forslicingorcutting
andpackagingofmeatproductsintendedforsaleinpre-packedform;
(k) thespecificroomsprovidedforinAnnexC,wheretheproductsreferred
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
operationsmaybecarriedoutinthesameroom.
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
productionmustbecarriedoutinaseparateroom.1977L0099—EN—01.01.1993—013.001—18
▼M12
CHAPTERII
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
subjecttothegeneralrulesonhygienelaiddowninthisDirective.
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 andshallbehandledunderconditionswhichprecludeanyriskofcontamination.
Caremustbetakentoensurethatthereisnocontact betweenrawmaterials
andfinishedproducts.
3. Theuseofwoodispermittedinroomsinwhichmeatproductsaresmoked,
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
withthemeatproducts.
4. The temperature in rooms or parts of rooms where work on meat, minced
meatusedasarawmaterial, meatproductsandmeatpreparationsiscarried
out must ensure hygienic production; if necessary, such rooms or parts of
roomsmustbeprovidedwithair-conditioningfacilities.
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
theestablishmentsreferredtoinArticle9.
However, in the case of other establishments the competent authority may
derogatefromthisrequirementwhereitconsiderssuchaderogationjustified
inthelightofthetechnologyusedinpreparingthemeatproduct.
CHAPTERIII
Requirements for raw materials to be used for the manufacture of meat
products
1. Meatwhichistobeusedforthemanufactureofmeatproductsmust:
— come from an establishment approved in accordance withthe Directives
referred to in Article 2 (d) and have been transported under satisfactory
hygieneconditionsinaccordancewiththesaidDirectives,
— fromthetimeofitsarrivalintheprocessingestablishmentuntilthetime
ofitsuse,bekeptinaccordance withtherequirements oftheDirectives
referredtoinArticle2(d).
However, until 31 December 1995, meat obtained from establishments
granted derogations under Directive 91/498/EEC may be held in approved
establishments.Untilthatdate,meatwhichdoesnotcomplywiththecondi-
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
withtheseconditions.Meatproductsobtainedfromsuchmeatmustbearthe
nationalmark.
2. Minced meat and meat preparations, unless produced in the manufacturing
roomreferredtoinChapterI(1)(b),must:
— come from an establishment approved in accordance with Directive 88/
657/EEC and have been transported under satisfactory health conditions
inaccordancewiththatDirective,
— from the time of their arrival in the processing establishment until the
time oftheiruse,bekept inaccordance withthe requirements ofDirec-
tive88/657/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—01.01.1993—013.001—19
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CHAPTERIV
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) thecleanlinessofthepremisesandequipmentandstaffhygiene;
(ii) the efficacy of the checks carried put by the establishment, in
accordance with Article 7, notably by examining the results and
takingsamples;
(iii) the microbiological and hygienic condition of the products of
animalorigin;
(iv) theefficacyofthetreatmentofthemeatproducts;
(v) thehermeticallysealedcontainersbymeansofrandomsampling;
(vi) theappropriatehealthmarkingofthemeatproductsandidentifica-
tionofproductsdeclaredunfitforhumanconsumptionandwhatis
donewiththelatter;
(vii) thestorageandtransportconditions;
(b) takeanysamplesrequiredforlaboratorytests;
(c) makeanyotherchecksitconsidersnecessarytoensurecompliancewith
thisDirective;
(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 descriptionreferredtoinChapterV(4)isused.
2. Thecompetentauthoritymusthavefreeaccessatalltimestothecoldstores
and all working premises to check that these provisions are being strictly
compliedwith.
CHAPTERV
Wrapping,packagingandlabelling
1. Wrapping, packaging and labelling must take place under satisfactory
hygieneconditionsinroomsprovidedforthatpurpose.
WithoutprejudicetoCouncilDirective89/109/EECof21December1988on
theapproximationofthelawsoftheMemberStatesrelatingtomaterialsand
articles intended to come into contact with foodstuffs(
1), wrapping and
packaging mustcomply withall therules ofhygiene, and bestrongenough
toprotectthemeatproductseffectively.
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
orplasticcontainerswhichmaybere-usedafterthoroughcleaninganddisin-
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
followingconditions:
(a) theroommustbesufficiently largeandsoequippedthatthehygiene of
theoperationsisassured;
(b) the packaging and wrapping must be enclosed in a sealed protective
cover immediately after manufacture; thiscovermustbeprotected from
damage during transport to the establishment and stored under hygienic
conditionsinaroomintendedforthatpurpose;
(c) theroomsforstoringthepackagingmaterialmustbefreefromdustand
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—01.01.1993—013.001—20
(1) OJNoL40,11.2.1989,p.38.
▼M12
granted in the case of the automatic assembly of packaging, provided
thereisnoriskofcontaminationofthemeatproducts;
(e) packaging must be brought to the room under hygienic conditions and
usedwithout delay. It may not be handled by staff handling unwrapped
meat,mincedmeat,meatpreparationsormeatproducts;
(f) immediately after packaging, the meat products must be placed in the
storageroomsprovidedforthepurpose.
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
andlegiblydisplayedonthewrappingoronthelabelofmeatproducts:
— whereitisnotclearfromthesalesdescriptionoftheproductorfromthe
list of ingredients in accordance with Directive 79/112/EEC, the species
fromwhichthemeatwasobtained,
— areferencepermittingidentificationofaquantityofproductsobtainedin
technologicallysimilarconditionsandlikelytopresentthesamerisk,
— 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)authorizingit,
— wherethelegislationofaMemberStateauthorizestheuseofproteinsor
starch, a reference to such use in connection with the sales description
otherthanthatwhichisauthorizedinaccordancewithArticle21.
CHAPTERVI
Healthmark
1. Meatproductsmustcarryahealthmark.Markingmustbecarriedoutduring
orimmediatelyaftermanufactureintheestablishmentorwrappingcentre,in
aneasilyvisibleplace.Themarkshallbelegible,indelibleanditscharacters
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
healthmarktobeappliedtothepackaging.
2. Where meat products marked in accordance with point 1 are subsequently
placedinapackaging,thehealthmarkmustalsobeappliedtothepackaging.
3. By way of derogation from points 1 and 2, the health marking of meat
productsinpalletized consignmentsintendedforfurtherprocessingorwrap-
pinginanapprovedestablishmentisnotnecessaryprovidedthat:
— thesaidconsignmentscontainingthemeatproductsbearthehealthmark
inaccordancewithpoint4(a)ontheexternalsurface,
— the recipient establishment maintains a separate record of the quantities,
typeandoriginofmeatproductsreceivedinaccordancewiththispoint,
— thedestinationandintendeduseofmeatproductsareclearlyindicatedon
the external surface of the outer packaging except when this is trans-
parent.
However,whereaconsignmentofwrappedproductsiscontainedinatrans-
parentpackaging,itisnotnecessarytohealthmarkthepackagingaslongas
thehealthmarkonthewrappedproductsisclearlyvisiblethroughthepacka-
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
printedcapitals,i.e.:1977L0099—EN—01.01.1993—013.001—21
(1) OJNoL33,8.2.1979,p.1.DirectiveaslastamendedbyDirective89/395/EEC(OJ
NoL186,30.6.1989,p.17).
(2) This information must accompany the meat products up to the final consumer stage,
exceptinthecasereferredtointhethirdindent.
(3) Thewords‘nationalstandardorlegislation’cover:
(a) theconditionsofproductionorpreparationauthorizedundernationallaw;
(b) the particular rules of national law imposing specific constraints on conditions of
productionorpreparationforcertainproducts;
(c) allsalesdescriptionswhich,intheabsenceofnationalstandardslimitingthem,are
permittedbythelawofaMemberStateorinaMemberStatewherethatdescrip-
tionhasbeenconfirmedbyusage.
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B—DK—D—EL—E—F—IRL—I—L—NL—P
—UK,followedbytheapprovalnumberoftheestablishmentor,
inaccordancewithrulestobeadoptedunderthesecondindentof
Article17,therewrappingcentre,ifnecessaryaccompaniedbya
codenumberstatingthetypeofproductforwhichtheestablish-
mentisapproved,
— below: one of the following sets of initials: CEE — EØF —
EWG—EOK—EEC—EEG;
(ii) or:
— above,thenameoftheconsigningcountryincapitals,
— 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-
lishmentisapproved,
— below, one of the following sets of initials: CEE — EØF —
EWG—EOK—EEC—EEG;
(b) thehealthmarkmaybeappliedtotheproduct,wrappingorpackagingby
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
whenthepackageisopened.Non-destructionofthismarkmaybetoler-
atedonlywhenthepackagingisdestroyedbybeingopened.Inthecase
ofproductsinhermeticallysealedcontainers,themarkmustbeindelibly
appliedeithertothelidortothecan;
(c) the health mark may also consist of an irremovable plate of resistant
material complying with all the hygiene requirements and bearing the
informationspecifiedin(a).
CHAPTERVII
Storageandtransport
1. MeatproductsmustbestoredintheroomsprovidedforinAnnexB,Chapter
I,point1(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,
approvedbythecompetentauthority.
2. Meatproductsforwhichcertainstoragetemperaturesareindicatedinaccor-
dancewithArticle7(2)mustbemaintainedatthosetemperatures.
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,themeansoftransportemployedandtheweatherconditions.
4. Meat products must, if the product so requires, be transported in vehicles
equippedtoensurethattheycanbetransportedattherequiredtemperatures
andinparticularthatthetemperaturesindicatedinaccordancewithArticle7
(2)arenotexceeded.
CHAPTERVIII
Special conditions for pasteurized or sterilized products in hermetically
sealedcontainers
A. InadditiontotheconditionslaiddowninAnnexA,establishmentsmanufac-
turingpasteurizedorsterilizedproductsinhermeticallysealedcontainers
1. musthave:
(a) adeviceforconveyingemptycanshygienicallytotheworkroom;
(b) equipment enabling cans to be thoroughly cleaned immediately
beforefilling;
(c) equipment for washing containers in potable water hot enough to
remove grease after they have been hermetically sealed and before
retorting;
(d) asuitableroom,areaorinstallationforcoolinganddryingcontainers
afterheattreatment;
(e) facilities for the incubation of samples taken from meat products
packedinhermeticallysealedcontainers;
(f) adequate facilities for checking whether containers are hermetically
sealedandundamaged;1977L0099—EN—01.01.1993—013.001—22
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2. mustensurethat:
(a) hermetically sealed containers are removed from the heating equip-
ment at a sufficiently high temperature to ensure rapid evaporation
ofhumidityandarenottouchedbyhanduntilcompletelydry;
(b) containers in which gas appears to be present undergo a further
examination;
(c) thethermometersofheatingequipmentarecheckedagainstcalibrated
thermometers;
(d) containersare:
— rejectedifdamagedorbadlymade,
— rejectedorcleanediftheyaredirtyand,inthecaseofcans,thor-
oughly cleaned immediately before filling, by means of the
cleaningequipmentreferredtoin1(b);theuseofstagnantwater
isnotauthorized,
— if necessary, drained for a sufficiently long time after cleaning
andbeforefilling,
— if necessary, washed inpotable water, sufficiently hot to remove
greaseifappropriate,aftertheyhavebeenhermeticallysealedand
beforeretorting,bymeansoftheequipmentreferredtoin1(c),
— cooled, after heating, in water meeting the requirements in the
fifthindentofB,
— handled, before and after heat treatment, in such a way that any
damageorcontaminationisavoided.
B. Theoperatorormanagerofanestablishmentmanufacturingmeatproductsin
hermeticallysealedcontainersmustalsocheckbysamplingthat:
— 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,
unlessthesamestability oftheproducthasbeenobtained bycuring,or
thataheattreatmentprocedureisappliedwhichisatleastequivalentto
pasteurization, the parameters being approved by the competent
authority,
— emptycontainersmeetproductionstandards,— 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
theseamsofthesealedcontainers,
— thenecessarychecksarecarriedout,usinginparticular controlmarkers
toensurethatthecontainershaveundergoneadequateheattreatment,
— 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 fromthis requirem ent if the water fulfils
therequirementsofDirective80/778/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
containerswhichhaveundergoneheattreatment,
— pasteurized products in hermetically sealed containers satisfy criteria
recognizedbythecompetentauthority.
C. Thecompetentauthoritymayauthorizetheadditionofcertainsubstancesto
thewaterusedinretortsinordertopreventcorrosionofcansandtosoften
anddisinfectthewater.Alistofthesesubstanceswillbedrawnupinaccor-
dancewiththeprocedurelaiddowninArticle20.
Thecompetentauthoritymayallowtheuseofrecirculatedwaterforcooling
heat-processedcontainers.Suchwatermustbepurifiedandhaveeitherbeen
treatedwithchlorineorundergonesomeothertreatment approvedinaccor-
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
downinAnnexI(E)toDirective80/778/EECsothatitcannotcontaminate
theproductsanddoesnotconstituteahazardtohumanhealth.
The recirculated water shall circulate in closed circuit so that it cannot be
usedforotherpurposes.
Where there is no risk of contamination, the water used for cooling
containers and water fromretorts m ay be used at the end of a working
periodforcleaningfloors.1977L0099—EN—01.01.1993—013.001—23
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CHAPTERIX
Specialconditionsformeat-basedpreparedmeals
InadditiontothegeneralconditionsinAnnexAandinChaptersI,IIandIIIof
thisAnnex:
1. establishmentsmanufacturing preparedmealsmusthaveaseparateroomfor
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
betweenuseforeachtypeofproduct;
2. (a) themeatproductcontainedinthepreparedmeal must,assoonasithas
beencooked:
(i) eitherbeimmediatelymixedwiththeotheringredients;inthatevent
the time during which the temperature of the meat product is
between10and63ºCmustbekepttoaminimum;
(ii) orberefrigeratedto10ºCorlessbeforebeingmixedwiththeother
ingredients;
(b) the meat product and the prepared meal must be refrigerated to an
internaltemperatureof+10ºCorlesswithinaperiodofnotmorethan
twohoursaftertheendofcookingandtothestoragetemperatureassoon
as possible. However, the competent authority may authorize the estab-
lishment to derogate from the two-hourperiod where a longer period is
justifiedforreasonsconnectedwiththeproductiontechnologyemployed,
providedthatthesafetyoftheendproductisguaranteed;
(c) the prepared meal must, where appropriate, be frozen or quick-frozen
immediatelyaftercooling;
3. labellingofpreparedmealsmustcomplywithDirective79/112/EEC.Thelist
ofingredientsshall,forthepurposeofthisDirective,includeanindicationof
theanimalspecies.
Preparedmealsshallbearthedateofmanufactureveryclearlyononeofthe
outer surfaces of the wrapping in addition to the information already speci-
fied;
4. theresultsofthevariouscheckstobecarriedoutbytheoperatorormanager
mustbekept,sothat theycanbeshownonreceipt ofanyrequest fromthe
competentauthority,foraminimumperiodtobespecifiedbythecompetent
authorityaccordingtothedurabilityoftheproductconcerned.1977L0099—EN—01.01.1993—013.001—24
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ANNEX C
SPECIFIC HYGIENE STANDARDS FOR THE MANUFACTURE OF
OTHERPRODUCTSOFANIMALORIGIN
CHAPTERI
Generalconditions
The premises may be used for the production of products not intended for
humanconsumptiononlyunderthefollowingconditions:
(a) rawmaterials unfitforhumanconsumptionmustbestoredinacompletely
separateroomorseparatereceptionarea;
(b) they must be processed in separate rooms using separate installations and
equipment,exceptwheretheprocessingtakesplaceincompletelyenclosed
installationorequipmentusedexclusivelyforthispurpose;
(c) the final products from these raw materials must be stored in a different
roomor separate tanks which are labelled appropriately and m ust not go
forhumanconsumption.
CHAPTERII
Specialconditionsforrenderedanimalfats,greavesandby-products
InadditiontotheconditionsinAnnexA,thefollowingconditionsapply:
A.Standards applicable to establishments collecting or processing raw mate-
rials
1. Centresforthecollectionofrawmaterialsandfurthertransporttoproces-
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 andrenderedwithinthetimelimitslaiddowninB(3)(b)and
(c).
2. Theprocessingestablishmentmusthaveatleast:
(a) a cold store, unless the raw materials are collected and rendered
withinthetimelimitslaiddowninB(3)(b);
(b) aroomorplacetoreceiverawmaterials;
(c) aninstallationtofacilitatethevisualinspectionofrawmaterials;
(d) ifappropriate,aninstallationtocrushrawmaterials;(e) equipment for the rendering of raw materials by heat or pressure or
otherappropriatemethod;
(f) containersortanksinwhichthefatcanbekeptinliquidstate;(g) apparatus for plastification or crystallization of the fat to facilitate
market preparation and packaging, unless the establishment
dispatchesliquidrenderedanimalfatonly;
(h) a dispatch room, unless the establishment dispatches melted animal
fatonlybymeansoftankers;
(i) watertight containers for the disposal of raw materials unfit for
humanconsumption;
(j) if appropriate, suitable equipment for the preparation of products
consisting ofrendered animal fatmixed withother foodstuffsand/or
seasonings;
(k) if greaves are intended for human consumption, suitable facilities
ensuring hygienic collection, wrapping and packaging and storage
undertheconditionslaiddowninB(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
morteminspection,havebeenfoundfitforhumanconsumption.
2. The raw materials shall consist of adipose tissues or bones found fit for
humanconsumptionandwhicharereasonablyfreefrombloodandimpu-
rities. They must not show signs of deterioration and must be obtained
underhygienicconditions.1977L0099—EN—01.01.1993—013.001—25
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3. (a) For the preparation of rendered animal fat, only adipose tissues or
bones,collectedatslaughterhouses,cuttingplantsormeatprocessing
establishments shall beused.Rawmaterials shall betransported and
stored until rendering in hygienic conditions and at an internal
temperatureof7ºCorless;
(b) by way of derogation from (a), raw materials may be stored and
transported unrefrigerated provided that they are rendered within
twelvehoursafterthedayonwhichtheywereobtained;
(c) bywayofderogationfrom(a),rawmaterialscollectedatretailshops
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 andproperlypacked.Whentherawmaterials are
collecteddailythetemperaturerequirementslaiddownin(a)and(b)
must be complied with. If the raw materials are not collected daily,
theymustberefrigeratedimmediatelyaftertheyhavebeenobtained.
4. Vehicles andcontainers forthecollection andtransportofrawmaterials
musthavesmoothinternalsurfaces,easytowash,deananddisinfectand
vehicles must be adequately covered. Vehicles for refrigerated transport
must have been designed in such a way that the temperature required
canbemaintainedthroughouttheperiodoftransport.
5. Beforerendering,rawmaterialsshallbeinspectedforthepresenceofraw
materials unfit for human consumption, or extraneous matter. When
presentthesemustberemoved.
6. Raw materials shall be rendered by heat, pressure or other appropriate
method, followedbyseparation ofthefat bydecantation, centrifugation,
filtration or other appropriate method. The use of dissolvents is prohib-
ited.
7. Renderedanimalfatwhichispreparedinaccordancewithpoints1,2,3,
5and6mayfortheproductionofrawmaterialsberefinedinthesameor
another establishment to improve its physico-chemical quality when the
fatforrefiningsatisfiesthestandardslaiddowninpoint8.
8. Rendered animal fat, depending on type, shall meet the following stan-
dards:
Bovines Pigs Otheranimalfat
EdibletallowTallow
for
refiningEdible
lard(2)Lardfor
refiningEdibleFor
refining Premier
jus(1)Other
FFA(m/m%
oleicacid)
maximum 0,75 1,25 3,0 0,75 2,0 1,25 :3,00
Peroxyd
maximum4meq/kg 4meq/kg 6meq/kg 4meq/kg 6meq/kg 4meq/kg 10meq/kg
Moistureand
impuritiesmaximum0,5%
Odour,taste,
colournormal
(1) Renderedanimalfatobtainedbythelow-temperaturerenderingoffreshfatfromtheheart,caul,kidneys
andmesenteryofbovineanimals,andfatfromcuttingrooms.
(2) Freshfatobtainedfromrenderingtheadiposetissuesofswine.
9. Greavesintendedforhumanconsumptionshallbestored:
(i) whenrenderedatatemperatureof70ºCorless:atatemperatureof
lessthan7ºCforaperiodnotexceeding24hoursorat−18ºCor
lower;
(ii) when rendered at a temperature of more than 70 ºC and having a
moisturecontentof10%(m/m)ormore:
— atatemperatureoflessthan7ºCforaperiodnotexceeding48
hoursoratatime/temperature ratioofferinganequivalent guar-
antee,
— at−18ºCorlower;
(iii) when rendered at a temperature of more than 70 ºC and having a
moisturecontentoflessthan10%(m/m):nospecificrequirement.1977L0099—EN—01.01.1993—013.001—26
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CHAPTERIII
Specialconditionsforstomachs,bladdersandintestines
InadditiontotheconditionsinAnnexA,andChaptersI,IIandIIIofAnnexB,
establishments treating stomachs,bladdersand intestines mustcomply withthe
followingconditions:
1. premises,instrumentsandtoolsmustbeusedonlyforworkontheproducts
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-
izedforthetransportofthecontainersoftheproductsconcerned;
3. premisesmustbeprovidedforstoringwrappingandpackagingmaterials;
4. wrappingandpackagingmusttakeplaceunderhygienicconditionsinaroom
orinaplaceintendedforthatpurpose;
5. products which cannot be kept at ambient temperature must be stored until
theirdispatchinpremisesintendedforthatpurpose.
In particular, products which are not salted or dried must be kept at a
temperaturenotexceeding3ºC;
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.Vehiclesforrefrigeratedtransportmusthavebeendesignedinsuch
awaythatthetemperaturerequiredcanbemaintainedthroughouttheperiod
oftransport.1977L0099—EN—01.01.1993—013.001—27
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ANNEX D
1977L0099—EN—01.01.1993—013.001—28
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1977L0099—EN—01.01.1993—013.001—29