1992L0118—EN—19.11.2002—011.001—1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE92/118/EEC
of17December 1992
laying down animal health and public health requirements governing trade in and imports into
theCommunityofproductsnotsubjecttothesaidrequirementslaiddowninspecificCommunityrules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive
90/425/EEC
(OJL62,15.3.1993,p.49)
Amendedby:
OfficialJournal
No page date
►M1CommissionDecision94/466/ECof13July1994 L190 26 26.7.1994
►M2CommissionDecision94/723/ECof26October1994 L288 48 9.11.1994
►M3CommissionDecision95/338/ECof26July1995 L200 35 24.8.1995
►M4CommissionDecision95/339/ECof27July1995 L200 36 24.8.1995
►M5CommissionDecision96/103/ECof25January1996 L24 28 31.1.1996
►M6CommissionDecision96/340/ECof10May1996 L129 35 30.5.1996
►M7CommissionDecision96/405/ECof21June1996 L165 40 4.7.1996
►M8CouncilDirective96/90/ECof17December1996 L13 24 16.1.1997
►M9CouncilDirective97/79/ECof18December1997 L24 31 30.1.1998
►M10CommissionDecision1999/724/ECof28October1999 L290 32 12.11.1999
►M11CommissionDecision2001/7/ECof19December2000 L2 27 5.1.2001
►M12Directive2002/33/ECoftheEuropeanParliamentandoftheCouncilof
21October2002L315 14 19.11.2002
Amendedby:
►A1ActofAccessionofAustria,SwedenandFinland C241 21 29.8.1994
(adaptedbyCouncilDecision95/1/EC,Euratom,ECSC) L1 1 1.1.1995
▼B
COUNCILDIRECTIVE92/118/EEC
of17December 1992
laying down animal health and public health requirements
governing trade in and imports into the Community of productsnotsubjecttothesaidrequirements laid downinspecific Commu-nity rules referred to in AnnexA (I) to Directive 89/662/EEC and,
asregardspathogens,toDirective 90/425/EEC
THECOUNCILOFTHEEUROPEANCOMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community,andinparticularArticle43thereof,
HavingregardtotheproposalsfromtheCommission(1),
HavingregardtotheopinionsoftheEuropeanParliament(2),
Having regard to the opinions of the Economic and Social
Committee(3),
Whereas productsofanimal originare included inthelist ofproducts
in Annex II to the Treaty; whereas the placing on the market of such
products constitutes an important source of income for part of the
farmingpopulation;
Whereas in order to ensure rational development in this sector and
increase productivity, animal health and public health rules for theproductsinquestionshouldbelaiddownatCommunitylevel;
Whereas the Community must adopt the measures intended progres-
sively to establish the internal market consisting of an area withoutinternalfrontiers,overaperiodexpiringon31December1992;
WhereasinviewoftheabovementionedobjectivestheCouncilhaslaid
down animal health rules applicable to fresh meat, poultrymeat, meatproducts,gamemeat,rabbitmeatandmilkproducts;
Whereas, save where otherwise provided, trade in products of animal
origin must be liberalized, without prejudice to recourse to possible
safeguardmeasures;
Whereas, given the significant risk of the spread of diseases to which
animals are exposed, for certain products of animal origin particular
requirements should be specified to be imposed when they are placedonthemarketforthepurposesoftrade,particularlywhenintendedforregionswithahighhealthstatus;
Whereas, when Directive 92/65/EEC was adopted, the Commission
agreed to disassociate the animal health aspects applicable to animalsfromthoseapplicabletoproducts;
Whereas, so as to allow checks at borders between Member States to
beabolishedon1January1993,animal healthandpublichealthrulesshouldbefixedtoapplytoallproductssubjecttosuchcheckstradein
and imports of which have not yet been harmonized at Community
level;
Whereas, to achieve this objective, certain existing rules should be
adaptedfortheadoptionoftheaforesaidmeasures;
Whereasasystemofapprovalshouldbeintroducedforthethirdcoun-
triesandestablishmentswhichmeettherequirementslaiddownbythisDirective, together with a Community inspection procedure to ensurethattheconditionsforsuchapprovalareobserved;
Whereas the accompanying document for products is the best way of
satisfying the competent authority of the place of destination that aconsignment complies with the provisions of this Directive; whereas1992L0118—EN—19.11.2002—011.001—2
(1) OJNoC327,30.12.1989,p.29;andOJNoC84,2.4.1990,p102.
(2) OJNoC113,7.5.1990,p.205;andOJNoC149,18.6.1990,p.259.
(3) OJNoC124,21.5.1990,p.15;andOJNoC182,23.7.1990,p.250.
▼B
the public health oranimal health certificate shouldbemaintained for
thepurposesofverifyingthedestinationofcertainimportedproducts;
Whereas the rules, principles and safeguard measures established by
Council Directive 90/675/EEC of 10December 1990 laying down the
principlesgoverningtheorganization ofveterinary checksonproductsenteringtheCommunityfromthirdcountries(
1)shouldapplyhere;
Whereas,inthecontextofintra-Communitytrade,theruleslaiddown
inDirective89/662/EECshouldalsobeapplied;
WhereastheCommissionshouldbeentrustedwiththetaskofadopting
certainmeasuresforimplementingthisDirective;whereas,tothatend,
procedures shouldbe laid downestablishing close andeffective coop-
eration between the Commission and the Member States within theStandingVeterinaryCommittee;
Whereas, in view of the particular supply difficulties arising fromits
geographical situation, special derogations shouldbe permitted fortheHellenicRepublic;
Whereastheadoptionofspecificrulesfortheproductscoveredbythis
Directiveiswithoutprejudicetotheadoptionofrulesonfoodhygiene
and safety in general, on which the Commission has submitted aproposalforaframeworkDirective,
HASADOPTEDTHISDIRECTIVE:
CHAPTERI
General provisions
Article 1
This Directive lays down the animal health and public health require-
mentsgoverningtradeinandimportsintotheCommunityofproductsof animal origin (including trade samples taken from such products)
not subject to the said requirements laid down in specific Community
rules referred to in Annex A (I) to Directive 89/662/EEC(
2) and, as
regardspathogenicagents,toDirective90/425/EEC.
This Directive shall be without prejudice to the adoption of more
detailed rules on animal health in the framework of the aforesaidspecific rules nor the maintenance of restrictions on trade or imports
of products covered by the specific rules referred to in the first para-
graphbasedontherulesofpublichealth.
Article 2
1. ForthepurposesofthisDirective:
(a)trademeans trade as defined byArticle 2 (2)ofDirective 89/
662/EEC;
(b)trade samplemeansasampleofnocommercialvalue,takenon
behalf oftheownerorthepersonresponsibleforanestablish-
ment, which is representative of a given product of animalorigin produced by that establishment, or constitutes aspecimen of a product of animal origin the manufacture ofwhich is contemplated, and which, for the purposes of subse-quent examination, must bear a reference to the type of
product,itscompositionandthespeciesofanimal fromwhich
itwasobtained;
(c)serious transmissible disease means all diseases covered by
Directive82/894/EEC(
3)1992L0118—EN—19.11.2002—011.001—3
(1) OJNoL373,31.12.1990,p.1.
(2) OJ No L 395, 30. 12. 1989, p. 13. Directive as last amended by Directive
91/496/EEC(OJNoL268,24.9.1991,p.56).
(3) OJNoL378,31.12.1982,p.58.DirectiveaslastamendedbyDecision90/
134/EEC(OJNoL76,22.3.1990,p.23).
▼B
(d)pathogenic agents jmeans any collection or culture of organ-
ismsoranyderivative,presenteitheraloneorintheformofamanipulated combination of such a collection or culture of
organismscapableofcausingdiseaseinanylivingbeing(other
than man) and any modified derivatives of these organisms,which can carry ortransmit an animal pathogen, or the tissue,cell culture, secretions or excreta by which or by means ofwhich an animal pathogen can be carried or transmitted; this
definition does not include the immunological veterinary
medicinal products authorized pursuant to Directive 90/677/EEC(
1);
(f)processed animal protein intended for human consumption
means greaves, meatmeal and pork-rind powder referred to in
Article2(b)ofDirective77/99/EEC(2).
2. In addition, the definitions contained in Article 2 of Directives89/662/EEC, 90/425/EEC and 90/675/EEC shall apply mutatis
mutandis.
Article 3
MemberStatesshallensurethat:
— trade in and imports of products of animal origin referred to in
Article 1 ►
M12 ◄are not prohibited or restricted
for animal health or public health reasons other than those arising
fromthe application of this Directive or fromCom m unity legisla-tion,andinparticularanysafeguardmeasurestaken,
— anynewproductofanimaloriginintendedforhumanconsumption
whoseplacingonthemarketinaMemberStateisauthorisedafterthedateprovidedforinArticle20maynotbethesubjectoftradeor importation until a decision has been taken in accordance withthe first paragraph of Article 15 after evaluation, if appropriate in
the light of the opinion of the Scientific Veterinary Committee set
upbyDecision81/651/EEC,oftherealriskofthespreadofserioustransmissible diseases which could result from movement of theproduct,notonlyforthespeciesfromwhichtheproductoriginatesbutalsoforother specieswhichcouldcarry thedisease, become afocusofdiseaseorarisktohumanhealth,
— the other products of animal origin referred to in Article 2 (b) of
Directive77/99/EECmaynotbethesubjectoftradeorimportation
from third countries unless they meet the requirements of that
DirectiveandtherelevantrequirementsofthisDirective.
CHAPTERII
Provisionsapplicabletotrade
Article 4
MemberStatesshalltakethenecessarymeasurestoensurethat,forthe
purposesofapplyingArticle4(1)ofDirective89/662/EECandArticle
4 (1) (a) of Directive 90/425/EEC, the products of animal originreferred to in Annexes I and II and the second and third indents of1992L0118—EN—19.11.2002—011.001—4
(1) OJNoL373,31.12.1990,p.26
(2) OJ No L 26, 31. 1. 1977, p. 85. Directive updated by Directive 92/5/EEC
(OJ No L 57, 2. 3. 1992, p. 1), and last amended by Directive 92/45/EEC
(OJNoL268,14.9.1992,p.35)▼M12
▼B
▼M12
▼B
▼M12
▼B
▼B
Article 3 of this Directive may, without prejudice to the particular
provisions to be adopted in implementation of Articles 10(3)and 11,bethesubjectoftradeonlyiftheysatisfythefollowingrequirements:
1. they must meet the requirements of Article 5 and the specific
requirementslaiddowninAnnexIasregardsanimalhealthaspectsandAnnexIIasregardspublichealthaspects,
2. theymustcomefromestablishmentswhich:
(a) undertake,inthelightofthespecificrequirementslaiddownin
AnnexesIandIIfortheproductstheestablishmentproduces,to:
— comply with the specific production requirements set out in
thisDirective,
— establish and implement methods of monitoring and
checking the critical points on the basis of the processesused,
— depending on the products, take samples for analysis in a
laboratory recognized by the competent authority for thepurpose of checking compliance with the standards estab-lishedbythisDirective,
— keeparecord,whetherwrittenorotherwiserecorded,ofthe
information obtained pursuant to the preceding indents for
presentation to the competent authority. The results of thevarious checks and tests in particular shall be kept for atleasttwoyears,
— guaranteetheadministrationofmarkingandlabelling,
— shouldthe result ofthe laboratory examination oranyother
information available to them reveal the existence of aserious animal health or public health hazard, inform thecompetentauthority,
— consign, for purposes of trade, only products accompanied
by a commercial document indicating the nature of the
product, the name and, where appropriate, the veterinaryapprovalnumberoftheestablishmentofproduction;
(b) theyareundersupervisionbythecompetentauthoritytoensure
thattheoperatorormanageroftheestablishmentcomplieswiththerequirementsofthisDirective;
(c) theywereregistered bythecompetent authority onthebasisof
assurancesfromtheestablishmentguaranteeingcompliancewiththerequirementsofthisDirective.
Article 5
Member States shall ensure that every necessary measure is taken to
guarantee that products of animal origin referred to in Annexes I andII are not dispatched for purposes of trade fromany holding, situated
inazonesubjecttorestrictionsbecauseoftheoccurrenceofadisease
towhichthespeciesfromwhichtheproductisderivedissusceptibleorfromanyestablishmentorzonefromwhichmovementsortradewouldconstitute a risk to the animal health status of the Member Statesexceptwhereproductsareheat-treated inaccordance withCommunity
legislation.
Particular assurances permitting, by way of derogation from the first
paragraph, the movement of certain products may be adopted underthe procedure laid down in Article 18 within the framework of safe-
guardmeasures.
Article 6
MemberStatesshallensurethattradeinpathogenicagentsissubjectto
strictrulestobedefinedundertheprocedurelaiddowninArticle18.
Article 7
1. TherulesonchecksestablishedbyDirective89/662/EECand,as
regards pathogenic agents, by Directive 90/425/EEC shall apply, in1992L0118—EN—19.11.2002—011.001—5
▼B
particularasregardstheorganizationofandfollow-uptothechecksto
becarriedout,totheproductscoveredbythisDirective.
2. Article 10 of Directive 90/425/EEC shall apply to the products
coveredbythisDirective.
3. For the purposes of trade, the provisions of Article 12 of Direc-
tive 90/425/EEC shall be extended to establishments supplying
productsofanimalorigincoveredbythisDirective.
4. WithoutprejudicetothespecificprovisionsofthisDirective,the
competentauthorityshallcarryoutanychecksitmaydeemappropriatewhereitissuspectedthatthisDirectiveisnotbeingcompliedwith.
5. 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 not
correspondtothe actual stateoftheproductsreferred toinAnnexesI
andII,orthattheproductsinquestiondonotsatisfytherequirementsofthisDirectiveorhavenotundergonethechecksprovidedfortherein.
Article 8
InChapter1(1)ofAnnexAtoDirective 92/46/EEC(
1)thefollowing
subparagraphisadded:
‘Milk and milk products must not come from a surveillance zone
defined in accordance with Directive 85/511/EEC unless the milkhas undergone pasteurization (71,7 ºC for 15 seconds) under the
supervisionofthecompetentauthority.’
CHAPTERIII
ProvisionsapplicabletoimportsintotheCommunity
Article 9
The requirements applicable to imports of products covered by this
DirectivemustofferatleasttheguaranteesprovidedforinChapterII,
including those established in implementation of Article 6, and thoselaiddowninthesecondandthirdindentsofArticle3.
Article 10
1. For the purposes of uniformapplication of Article 9, the
followingprovisionsshallapply.
2. The products referred to in Annexes I and II and in the second
and third indents of Article 3 may be imported into the Communityonlyiftheysatisfythefollowingrequirements:
(a) unless otherwise specified in Annexes I and II, they must come
fromathirdcountryorpartofathirdcountryonalisttobedrawn
up and updated in accordance with the procedure provided for in
Article18;
(b) unless otherwise specified in Annex II, products must come from
establishments onaCommunity list tobedrawnupinaccordance
withtheprocedurelaiddowninArticle18;
(c) inthecasesspecificallyprovidedforinAnnexesIandIIandinthe
secondandthirdindentsofArticle3,theymustbeaccompaniedby
an animal health or public health certificate corresponding to aspecimen to be drawn up under the procedure provided for inArticle 18, certifying that the products meet the additional condi-tions or offer the equivalent guarantees referred to in paragraph 3(a) and come from establishments offering such guarantees, and1992L0118—EN—19.11.2002—011.001—6
(1) OJNoL268,14.9.1992,p.1.▼M12
▼B
▼B
signed by an official veterinarian or, as appropriate, by any other
competentauthorityrecognizedunderthesameprocedure.
3. UndertheprocedureprovidedforinArticle18:
(a) specific requirements shall be established — in particular for the
protection of the Community from certain exotic diseases or
diseasestransmissible toman—orguarantees equivalent tothose
conditions.
Thespecificrequirementsandequivalentguaranteesestablishedfor
thirdcountriesmaynotbemorefavourablethanthoselaiddowninAnnexesIandIIandinthesecondandthirdindentsofArticle3.
Pendingthefixingofthedetailedrulesofapplicationprovidedfor
in the fourth and fifth indents of Chapter 2 of Annex II, MemberStates shall ensure that imports of products referred to therein aresubject to compliance with the minimum guarantees laid down inthesaidindents;
(c) the nature of any treatment or the measures to be taken to avoid
recontamination ofanimal casings,eggsandeggproductsshallbe
established.
4. The decisions provided for in paragraphs 2 and 3 must be taken
onthebasisofevaluationand,ifappropriate,theopinionoftheScien-tific Veterinary Committee, of the real risk of the spread of serious
transmissiblediseasesorofdiseasestransmissibletomanwhichcould
result from movement of the product, not only for the species fromwhich the product originates but also for other species which couldcarry the disease or become a focus of disease or a risk to publichealth.
5. ExpertsfromtheCommissionandtheMemberStatesshallcarry
out on-the-spot inspections to verify whether the guarantees given bythe third country regarding the conditions of production and placingon the market can be considered equivalent to those applied in theCommunity.
The experts fromthe Mem ber States responsible for these inspections
shall be appointed by the Commission, acting on proposals from theMemberStates.
These inspections shall be made on behalf of the Community, which
shallbearthecostofanyexpenditureinvolved.
Pendingorganizationoftheinspectionsreferredtointhefirstsubpara-
graph, national rules applicable to inspection in third countries shallcontinue to apply, subject to notification, through the Standing Veter-inaryCommittee, ofanyfailuretocomplywiththeguaranteesofferedinaccordancewithparagraph3foundduringtheseinspections.
6. Pendingcompilationofthelistsprovidedfor ►
M8inparagraph
2(a)and(b)secondindent ◄,MemberStatesareauthorizedtomain-
tainthecontrolsprovidedforinArticle11(2)ofDirective90/675/EECand the national certificate required by products imported underexistingnationalrules.1992L0118—EN—19.11.2002—011.001—7
▼M8
▼B
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Article 11
The procedure provided for in Article 18 shall be used to stipulate
specific animal health requirements for imports into the Communityand the nature and content of accompanying documents for productsreferredtoinAnnexIintendedforexperimentallaboratories.
Article 12
1. TheprinciplesandruleslaiddowninDirectives90/675/EECand
91/496/EEC(
1) shall apply, with particular reference to the organiza-
tion of and follow-up to the inspections to be carried out by theMemberStatesandthesafeguardmeasurestobeimplemented.
However, for certain types of product of animal origin, derogations
maybeadoptedinaccordancewiththeprocedurelaiddowninArticle18, fromthe physical check provided for in ►
M9Article 4(4)(b) of
Directive97/78/EC ◄.
Article 13
1. MemberStatesmay,byissuinganappropriatelicence,permitthe
importation from third countries of products of animal origin referredtoinAnnexesIandIIintheformoftradesamples.
2. The licence mentioned in paragraph 1 must accompany the
consignment and contain full details of the specific conditions underwhich the consignment may be imported, including any derogationsfromthechecksprovidedforbyDirective90/675/EEC.
3. Where the consignment enters one Member State for onward
transmission to a second Member State, the first Member State shallensurethattheconsignmentisaccompaniedbytheappropriatelicence.
MovementshalltakeplaceinaccordancewiththeprovisionsofArticle
11(2)ofDirective90/675/EEC.Theresponsibilityforensuringthattheconsignment complies withthe conditions ofthe licence (andwhetherentryintoitsterritoryshouldbepermitted)shallrestwiththeMemberStatewhichissuesthelicence.
CHAPTERIV
Commonfinalprovisions
Article 14
1. Article3(d)ofDirective72/461/EEC(2)shallbedeleted.
Commission Decisions 92/183/EEC(3) and 92/187/EEC(4) shall
continuetoapplyfortherequirementsofthisDirective,withoutpreju-dice to any amendments to be made to them under the procedureprovidedforinArticle18.
2. Directive90/667/EECisherebyamendedasfollows:
(a) inArticle13thefollowingparagraphshallbeadded:
‘2. With a view to ensuring that the controls provided for in
paragraph1arefollowedup:
(a) processed products obtained fromlow-risk or high-risk m ate-
rials mustsatisfythe requirementsofChapter 6ofAnnexItoDirective92/118/EEC(*);1992L0118—EN—19.11.2002—011.001—8
(1) OJNoL268,24.9.1991,p.56.
(2) OJ No L 302, 31. 12. 1972, p. 24. Directive as last amended by Directive
91/687/EEC(OJNoL377,31.12.1991,p.16).
(3) OJNoL84,31.3.1992,p.33.
(4) OJNoL87,2.4.1992,p.20.▼M9
▼B
▼B
(b) low-risk materials, high-risk materials intended for processing
in a plant designated in another Member State in accordancewith the second sentence of Article 4 (1) and processed
productsobtainedfromhigh-riskorlow-riskmaterialsmustbe
accompanied:
— if they come from a plant approved in accordance with
Article4or5,byacommercialdocumentspecifying;
— ifappropriate,thenatureofthetreatment,
— whethertheproductcontainsruminantproteins,
— iftheycomefromanotherplant,byacertificateissuedand
signedbyanofficialveterinarianindicating:
— themethodsoftreatmentusedontheconsignment,
— theresultofthesalmonellatests,
— —whethertheproductcontainsruminantproteins.
(*) OJNoL62,15.3.1993,p.49.’;
(b) inArticle6,‘shallbeestablishedundertheprocedurelaiddownin
Article19’shallbereplacedby‘arelaiddownunderChapter10of
AnnexItoDirective92/118/EEC’;
(c) inArticle14thefirstparagraphshallbedeleted.
Article 15
The Council, acting by a qualified majority on a proposal from the
Commission,shalladoptanynewAnnexlayingdownspecificrequire-
mentsforotherproductscapableofpresentingarealriskofspreadingserioustransmissiblediseasesorarealrisktohumanhealth.
TheAnnexesshall,wheretheneedarises,beamendedundertheproce-
dure provided for in Article 18 in compliance with the general
principlessetoutinthesecondindentofArticle3.
Article 16
1. Member States shall be authorized to make the entry into their
territory of products of animal origin referred to in Annexes I and IIandinthe second andthird indents ofArticle 3whichwere producedintheterritoryofaMemberStateandhavepassedthroughtheterritoryof a third country subject to production of an animal health or publichealth certificate certifying compliance with the requirements of this
Directive.
2. Member States which have recourse to the possibility laid down
inparagraph1shallsoinformtheCommissionandtheotherMemberStates within the Standing Veterinary Committee set up by Decision
68/361/EEC(
1).
Article 17
1. Annexes A and B to Directives 89/662/EEC and 90/425/EEC
shallbereplacedbythetextssetoutinAnnexIIItothisDirective.
2. Directive77/99/EECisherebyamendedasfollows:
— in Article 2 (b), point (iv) shall be deleted and points (v) and (vi)
shallbecome(iv)and(v)respectively;
— Article6(2)shallread:
‘2. Under the procedure laid down in Article 20, additional
conditionsmaybesetfortheotherproductsofanimaloriginsoastoensuretheprotectionofpublichealth.’1992L0118—EN—19.11.2002—011.001—9
(1) OJNoL255,18.10.1968,p.23.
▼B
Article 18
WherereferenceismadetotheprocedureprovidedforinthisArticle,
the Standing Veterinary Committee shall act in accordance with the
ruleslaiddowninArticle17ofDirective89/662/EEC.
Article 19
Under the procedure provided for in Article 18, transitional measures
may be adopted fora period ofupto three years beginning on1July
1993tofacilitatethetransitiontothenewarrangementsestablishedbythisDirective.
Article 20
1. Member States shall bring into force the laws, regulations and
administrativeprovisionsnecessarytocomplywithArticles12(2)and17by1January1993andwiththeotherrequirementsofthisDirectivebefore 1 January 1994. They shall forthwith inform the Commission
thereof.
When these measures are adopted by the Member States, they shall
contain a reference to this Directive or shall be accompanied by suchreference ontheoccasionoftheirofficial publication. ThemethodsofmakingsuchareferenceshallbelaiddownbytheMemberStates.
2. MemberStatesshallcommunicatetotheCommissionthetextsof
the main provisions of national law which they adopt in the fieldgovernedbythisDirective.
3. Thesettingofthedeadlinefortranspositionintonationallawat1
January 1994 shall be without prejudice to the abolition of veterinary
checksatfrontiersprovidedforbyDirectives89/662/EECand90/425/EEC.
Article 21
ThisDirectiveisaddressedtotheMemberStates.1992L0118—EN—19.11.2002—011.001—10
▼B
ANNEX I
SPECIFICANIMALHEALTHREQUIREMENTS
CHAPTER2
Animalcasings
A.Trade
Trade in animal casings is subject to production of a document specifying
theplantoforiginwhichmustbe:
— where the casings are salted or dried at the point of origin and where
salted or dried casings are subsequently handled for other purposes, a
plantapprovedbythecompetentauthority,
— in other cases, a plant approved in accordance with Directive 64/433/
EEC(1),provided the casings are transported in sucha wayasto avoid
contamination.
B.Imports from third countries
Imports of animal casings from any third country are subject to production
of the certificate referred to in Article 10 (2) (c), issued and signed by an
officialveterinarianoftheexportingthirdcountry,statingthat:
(i) the casings come from plants approved by the competent authority of
theexportingcountry;
(ii) the casings have been cleaned, scraped and then either salted or
bleached (or as an alternative to salting or bleaching, that they have
beendriedafterscraping);
(iii) after the treatment in (ii), effective steps were taken to prevent the
recontaminationofthecasings.
CHAPTER5
Bones and bone products (excluding bone meal), horns and horn products
(excluding hornmeal) andhooves andhoofproducts(excluding hoofmeal)
►M12 intendedforhumanconsumption ◄
Trade in and imports of the products in question are subject to the following
conditions:
1. where trade is concerned, bones, horns and hooves are subject to the
animalhealthrequirementslaiddowninDirective72/461/EEC;
2. wheretradeisconcerned,boneproducts,hornproductsandhoofproducts
are subject to the animal health requirements provided for in Directive
80/215/EEC(2);
3. whereimportsareconcerned,bones,boneproducts,horns,hornproducts,
hoovesandhoofproductsaresubjecttotherequirementsofDirective72/
462/EEC(3).1992L0118—EN—19.11.2002—011.001—11
(1) OJ No 121, 29. 7. 1964, p. 2012/64. Directive as last amended by Directive 91/497/
EEC(OJNoL268,24.9.1991,p.69).
(2) OJNoL47,21.2.1980,p.4.DirectiveaslastamendedbyDirective91/687/EEC(OJ
NoL377,31.12.1991,p.16).
(3) OJNoL302,31.12.1972,p.28.DirectiveaslastamendedbyDirective91/688/EEC
(OJNoL377,31.12.1991,p.18).▼M12
▼B
▼M12
▼B
▼M12
▼B
▼M12
▼B
CHAPTER6
Processedanimalprotein ►M12 intendedforhumanconsumption ◄
I. Without prejudice to any restrictions imposed as regards BSE or to the
restrictions on the feedings of ruminant protein to ruminants, trade in and
importsofprocessedanimalproteinaresubject:
A. as regards trade, to the production of the document or certificate
provided for in Directive 77/99/EEC, stating that the requirements of
thatDirectivehavebeencompliedwith;
B. asregardsimports:
1. toproductionofahealthcertificate asprovidedforinArticle10(2)
(c), signed by the official veterinarian of the country of origin and
statingthat:
a) theproductsfulfiltherequirementsofDirective80/215/EEC;
(b) every precaution has been taken after treatment to prevent
contaminationoftheproducttreated;
(c) samples have been taken and tested for salmonella when the
consignmentleftthecountryoforigin;
(d) theresultsofthesetestsarenegative;
2. following document checks of the certificate referred to in 1, to
sampling by the competent authority at the border inspection post
withoutprejudicetopointII:
(i) ofeachconsignmentofproductssubmittedinbulk;
(ii) atrandomofconsignmentsofproductspackagedinthemanufac-
turingplant;
3. for release for free circulation in Community territory of consign-
ments of processed animal protein, to prove that the results of the
sampling carried out pursuant to B (1) (c) have proved negative, if
necessaryafterreprocessing;
C. national rules existing on the date of notification of this Directive
concerning the requirements applicable as regards BSE and scrapie for
animal proteins may be maintained pending a decision on the type of
heattreatmentcapableofdestroyingtheagentresponsible.
Trade in and imports of meat meal and bone meal remain subject to
Article 5 (2) of Directive 89/662/EEC and Article 11 (2) of Directive
90/675/EEC.
II. MemberStatesmaycarryoutrandomsamplingofbulkconsignmentsorigi-
nating in a third country fromwhich the last six consecutive tests have
provednegative.Whereduringoneofthesechecksaresulthasprovedposi-
tive, the competent authority ofthe countryoforigin mustbeinformed so
that it can take appropriate measures to remedy the situation. These
measuresmustbebroughttotheattentionofthecompetentauthorityrespon-
siblefortheimportchecks.Intheeventofafurtherpositiveresultfromthe
samesource,furthertestsmustbecarriedoutonallconsignmentsfromthe
samesourceuntiltherequirementslaiddowninthefirstsentenceareagain
satisfied.
III. MemberStatesmustkeeprecordsoftheresultsofsamplingcarriedouton
allconsignmentswhichhaveundergonesampling.
IV. Inaccordance withArticle3(3)ofDirective89/662/EEC,transhipment of
consignments is permitted only through ports which have been approved
undertheprocedurelaiddowninArticle18,providedthatabilateralagree-
ment has been reached between Member States to allow checking of the
consignments to be deferred until they reach the border inspection post of
theMemberStateoffinaldestination.
V. Whereaconsignmentprovestobepositiveforsalmonella,itiseither:
(a) re-exportedfromtheCommunity;
(b) usedforpurposesotherthananimalfeeds.Inthiscase,theconsignment
may leave the port or storage depot only on condition that it is not
incorporatedintoanimalfeedingstuffs;
(c) re-processed in a treatment plant approved pursuant to Directive 90/
667/EEC or any plant approved for decontamination. Movement from
theportorstoragedepotshallbecontrolledbypermitfromthecompe-
tent authority and the consignment shall not be released until it has1992L0118—EN—19.11.2002—011.001—12
▼M12
▼B
▼M12
▼B
▼B
beentreated,testedforsalmonellabythecompetentauthorityinaccor-
dance with Annex II, Chapter III, to Directive 90/667/EEC and a
negativeresultobtained.
CHAPTER7
Bloodandbloodproductsofungulatesandpoultry
(withtheexceptionofserumfromequidae)
I.Fresh blood and blood products intended for human consumption
A. Trade
1. Tradeinfreshbloodofungulatesandpoultryintendedforhumanconsump-
tion is subject to the animal health conditions applicable to trade in fresh
meat pursuant to Council Directives 72/461/EEC(1), 91/494/EEC(2) or 91/
495/EEC(3).
2. Trade in blood products intended for human consumption is subject to the
animalhealthconditionslaiddowninChapter11ofthisDirective.
B. Imports
1. Importsoffreshbloodofdomesticungulatesintendedforhumanconsump-
tionareprohibitedpursuanttoCouncilDirective72/462/EEC(4).
Importsoffreshbloodofdomesticpoultryintendedforhumanconsumption
are subject to the animal health conditions laid down in Directive 91/494/
EEC.
Importsoffreshbloodofrearedgameintendedforhumanconsumptionare
subject to the animal health conditions laid down in Chapter 11 of this
Annex.
2. Importsofbloodproductsforhuman consumption, including thosereferred
toinCouncilDirective77/99/EEC(5),aresubjecttotheanimalhealthcondi-
tionsapplicabletomeatproductspursuanttoDirective72/462/EECandthis
Directive, without prejudice to the rules on blood-based processed animal
proteinproductsreferredtoinChapter6ofthisAnnex.
III.General provisions
The detailed rules for the application of this Chapter are to be adopted,
wherenecessary,inaccordancewiththeprocedurelaiddowninArticle18.
CHAPTER9
Lardandrenderedfats
1. Member States shall authorize the importation into the Community of lard
andrenderedfatsfromthirdcountriesappearingonthelistannexedtoDeci-
sion 79/542/EEC from which the importation of fresh meat of the species
concernedispermitted.
2. Where there has been an outbreak of a serious transmissible disease in the
previous 12 months before export in a country mentioned in paragraph 1,
eachconsignmentoflardorrenderedfatsmustbeaccompaniedbyacertifi-
catereferredtoinArticle10(2)ofthisDirectivestatingthat:
A. thelardorrenderedfatshavebeensubjectedtooneofthefollowingheat
treatmentprocesses:
(i) atleast70ºCforatleast30minutes;or
(ii) atleast90ºCforatleast15minutes;or
(iii) aminimumtemperatureof80ºCinacontinuousrenderingsystem;1992L0118—EN—19.11.2002—011.001—13
(1) OJNoL302,31.12.1972,p.24.
(2) OJNoL268,24.9.1991,p.35.
(3) OJNoL268,24.9.1991,p.41.
(4) OJNoL302,31.12.1972,p.28.
(5) OJNoL26,31.1.1977,p.85.▼M7
▼M12
▼M7
▼M12
▼B
▼B
B. where the lard of rendered fats are packaged, they have been packed in
new containers and all precautions have been taken to prevent their
recontamination;
C. where bulk transport of the product is intended, the pipes, pumps and
bulktankandanyotherbulkcontainertanksorbulkroadtankerusedin
the transportation of the products fromthe m anufacturing plant either
directly on to the ship or into shore tanks or direct to establishments
wereinspectedandfoundtobecleanbeforeuse.
CHAPTER11
Rabbitmeatandfarmedgamemeat
MemberStatesshallensurethatrabbitmeatandfarmedgamemeatareimported
onlyif:
(a) theycomefromthirdcountriesincluded:
(i) forfurredfarmgame,onthelistofcountriesfromwhichfreshmeatof
the corresponding species may be imported pursuant to Directive 72/
462/EEC;
(ii) forfeatherfarmedgame,onthelistofcountriesfromwhichfreshpoul-
trymeatmaybeimportedpursuanttoDirective91/494/EEC(1);
(iii) forrabbitmeat,onalisttobedrawnupundertheprocedurelaiddown
inArticle18;
(b) they satisfy at least the requirements laid down in Chapters II and III
respectivelyofDirective91/495/EEC(2);
(c) they come from establishments offering the guarantees provided for in (b)
and recognized under the procedure provided for in Article 18 or, pending
thelistreferredtoin(a)(iii),fromestablishmentsapprovedbythecompe-
tentauthorities;
(d) eachbatchofmeatisaccompaniedbythehealthcertificate providedforin
Article10(2)(c).1992L0118—EN—19.11.2002—011.001—14
(1) OJNoL268,24.9.1991,p.25.
(2) OJNoL268,24.9.1991,p.41.▼M12
▼B
▼M12
▼B
ANNEX II
SPECIFICPUBLICHEALTHCONDITIONS
CHAPTER1
Importsfrom third countries of meat productsobtainedfrom poultrymeat,
farmedgamemeat,wildgamemeatandrabbitmeat
Member States shall ensure that meat products obtained from poultrymeat,
farmedgamemeat,wildgamemeatandrabbitmeatarenotimportedunless:
(a) eithertheycomefromathirdcountrylistedinaccordancewith:
(i) Article9ofDirective91/494/EECforpoultrymeat;
(ii) Article16ofDirective92/45/EECforwildgamemeat;
(iii) Chapter2ofAnnexItothisDirectiveforrabbitmeatandfarmedgame
meat,
eithertheycomefromathirdcountrylistedintheAnnex,PartIofDecision
79/542/EEC. In this case they must have undergone a heat treatment in a
sealed container, the Fovalue being equal or over 3,00. However for meat
products made from species other than swine, this treatment may be
replacedbyaheattreatmentwhichbringstheinternaltemperaturetoatleast
70ºC.
(b) the fresh meat used meets the appropriate requirements of Article 14 of
Directive 71/118/EEC for poultrymeat, Article 16 of Directive 92/45/EEC
forwildgamemeat,Article3ofDirective91/495/EECforrabbitmeatand
Article6ofthatDirectiveforfarmed-gamemeat;
(c) they come from an establishment offering the same guarantees as those
referred to in Directive 77/99/EEC and approved in accordance with the
procedure provided for in Article 18 or, pending the adoption of such a
decision, by the competent authority of the Member State with imports of
these products remaining subject to the rules in Article 11(2) of Directive
90/675/EEC;
(d) theyare prepared, checked and handled inaccordance withtheappropriate
requirementsprovidedforinDirective77/99/EEC;
(e) each consignment of meat products is accompanied by a health certificate
establishedinaccordancewiththeprocedureprovidedforinArticle18.
CHAPTER2
►M8Before1July1997 ◄,thehealthconditionsapplicabletothefollowing
shallbeestablishedinaccordancewiththeprocedurelaiddowninArticle18:
— putting on the market in and imports of eggs and imports of egg products
intended for human consumption, without prejudice to the rules laid down
withintheframeworkofthecommonorganizationofthemarket.
InrespectofsalmonellaandpendingtheadoptionofCommunityprovisions,
thefollowingrulesshallapplyforeggsintendedforFinlandandSweden:
(a) consignments of eggs may be subject to additional general or limited
guaranteesdefinedbytheCommissionfollowingtheprocedureprovided
forinArticle18;
(b) theguaranteesprovidedforin(a)shallnotbecarriedoutforeggsorigi-
nating in an establishment subject to a programme recognized as
equivalent tothat referred toin (c),pursuantto theprocedure provided
forinArticle18;
(c) theguaranteesprovidedforin(a)shallapplyonlyafterapprovalbythe
Commission of an operational programme to be presented by Finland
and Sweden. The Commission decisions must be taken before the date
of entry into force of the Accession Treaty in order for the operational
programmes and the guarantees provided for in (a) to be applicable as
fromthedateofentryintoforceoftheAccessionTreaty,1992L0118—EN—19.11.2002—011.001—15
▼M3
▼B
▼A1
▼M10
— trade in and import of honey ►M6 ◄intended for human
consumption,
— trade in and imports of milk and milk-based products intended for human
consumption, obtained from species not covered by Directive 92/46/EEC;
depending on the species, specific requirements may be laid down as
regards:
— animal health and the health status of dairy herds, in particular with
regardtotuberculosisandbrucellosis;
— hygieneinrespectof
— milking,
— thecollection,transport,treatmentandprocessingofmilk,
— staff,
— testing for residues of pharmacologically and/or hormonally active
substances,antibiotics,pesticidesorotherharmfulsubstancesinmilkor
milkproducts,
— criteriaapplicabletorawmilkasarawmaterial,— microbiologicalcriteriaapplicabletofinishedproducts,
— theproduction,placingonthemarketandimportationofmeatofspeciesnot
coveredbyspecificrequirements,andinparticularreptilemeatandproducts
thereof,intendedforhumanconsumption.
Depending on the species, specific requirements may be laid down as
regards:
— microbiologicalandparasitologicalcriteria,
— hygieneduringslaughter,— testingforresidues.
CHAPTER3
I.Specific public health conditions applicable to trade in and imports of
snailsintendedforhumanconsumption
A. WithoutprejudicetoCommunity,nationalorinternational provisionson
theprotectionofwildlife,forthepurposeofthisChapter,‘snails’means
terrestrial gastropods of the species Helix pomatia Linné, Helix aspersa
Muller, Helix lucorum andspeciesofthefamilyof Achatinidae.
B. Member States must ensure that shelled, cooked and prepared or
preserved snails are traded for human consumption only if they meet
thefollowingconditions:
(1) Theymustcomefromestablishments:
— whichmeettherequirementsofArticle4(2)ofthisDirective,
— which are approved by the competent authority in accordance
with the requirements of Chapters III and IV of the Annex to
Directive91/493/EEC,
— whichundergomonitoringbythecompetentauthorityofproduc-
tion conditions and health checks in accordance with Chapter V
(I)(3)and(5)and(II),(3)and(4)ofDirective91/493/EEC,
— which conduct own checks in accordance with the provisions of
CommissionDecision94/356/EC.
(2) They must be subjected to organoleptic checks carried out by
sampling. If the organoleptic examination reveals that the snails are
notfitforhumanconsumption,measuresmustbetakentowithdraw
themfromthemarketanddenatureinsuchawaythattheycannotbe
re-usedforhumanconsumption.
(3) Forthepreparationofshelledsnailmeat,
(a) dependingonthescaleoftheoperation,establishmentsmustset
asidespecialroomsorareasfor:
— thestorageofpackagingandwrappingmaterials,
— thereceptionandstorageoflivesnails,— washing,blanchingorboiling,shellingandtrimming,— the storage and, where necessary, cleaning and treatment of
shells,
— theheattreatmentofthesnailmeat,wherenecessary,— thewrappingorpackagingofthesnailmeat,
— thestorageofthefinishedproductincoldstores;1992L0118—EN—19.11.2002—011.001—16
▼B
▼M8
▼M6
▼M6
(b) thesnailsmustbecheckedbeforebeingboiled.Deadsnailsmust
notbepreparedforhumanconsumption;
(c) followingshelling,thehepatopancreasremovedduringtrimming
mustnotbeusedforhumanconsumption.
(4)Canned snails
Establishments must satisfy the conditions laid down in Chapter IV
(IV)(4)oftheAnnextoDirective91/493/EEC.
(5)Cooked and prepared snails
(a) Dependingonthescaleoftheoperation,establishmentsmustset
asidespecialroomsorareasfor:
— thestorageofshelledsnailmeatincoldstores,
— thestorageofcleanshells,— thestorageofbreadingproducts,— thepreparationofstuffing,— cookingandcooling,— the filling of the shells with snailmeat and stuffing, and
packaginginacontrolled-temperatureroom,
— whereapplicable,freezing,— thestorageoffinishedproductsincoldstores;
Products must satisfy the relevant conditions set out in Chapter
IXofAnnexBtoDirective77/99/EEC.
(b) Snailmeat used to fill shells prior to cooking must satisfy the
conditionslaiddowninrespectofshelledsnailmeat.
(6) In accordance with the procedure laid down in Article 18 of this
Directive, microbiological criteria, including sampling plans and
methods of analysis, may be laid down when there is a need to
protectpublichealth.
(7) The snails must be put up, packaged, stored and transported under
the appropriate hygiene conditions laid down in Chapters VI and
VIIIoftheAnnextoDirective91/493/EEC.
(8) The packaging and wrapping of snails must bear an identification
markcontainingthefollowingparticulars:
thenameoftheconsigningcountryincapitalsortheinitialletteror
lettersoftheconsigningcountryinprintedcapitals,i.e.:AT,B,DK,
D,EL,E,F,FI,IRL,I,L,NL,P,SE,UKfollowedbytheapproval
numberoftheestablishment,andoneofthefollowingsetsofinitials:
CE,EC,EF,EG,EK,EY.
C. Forimports:
(1) the packaging and wrapping of shelled, cooked and prepared or
preserved snailsmustcarry thenameorISOcodeofthecountryof
origin and the approval number of the production establishment in
indelibleprint;
(2) the following is an example of the specimen health certificate laid
downinArticle10(2)(c)ofthisDirective, whichmustaccompany
every consignment of shelled, cooked and prepared or preserved
snailsoriginatinginthirdcountries.1992L0118—EN—19.11.2002—011.001—17
▼M6
SPECIMEN HEALTH CERTIFICATE FOR SHELLED, COOKED, PREPARED OR PRESERVED
SNAILS ORIGINATING IN THIRD COUNTRIES AND INTENDED FOR THE EUROPEAN
COMMUNITY
Note to the importer: thiscertificateisforveterinarypurposesonlyandmustaccompanytheconsign-
mentuntilitreachestheborderinspectionpoint.
1992L0118—EN—19.11.2002—011.001—18
▼M6
1992L0118—EN—19.11.2002—011.001—19
▼M6
II.Specific public health conditions applicable to trade in and imports of
frogs'legsintendedforhumanconsumption
A. WithoutprejudicetoCommunity,nationalorinternational provisionson
theprotection ofwildlife, forthe purposesofthis Chapter, ‘Frogs'legs’
meansthebackpartofthebodydividedbyatransversalcutbehindthe
front limbs, eviscerated and skinned, of the species Ranaspp. (family
Ranidae),presentedfresh,frozenorprocessed.
B. Member States must ensure that frogs' legs are traded for human
consumptiononlyiftheymeetthefollowingconditions:
(1) The frogs must have been slaughtered, bled, prepared and, where
appropriate,chilled,frozen,processed,packagedandstoredinestab-
lishmentswhich:
— meettherequirementsofArticle4,point2ofthisDirective,
— are approved by the competent authority in accordance with the
requirements of Chapters III and IV of the Annex to Directive
91/493/EEC,
— undergo monitoring by the competent authority of production
conditions and health checks in accordance with Chapter V (I)
(3) and (5) and (II) (3) and (4) of the Annex to Directive 91/
493/EEC,
— conduct own checks in accordance with the provisions of Deci-
sion94/356/EC.
(2) The frogslegs must be subjected to organoleptic checks carried out
by sampling. If the organoleptic examination reveals that the frogs
legs are not fit for human consumption, measures must be taken to
withdraw themfromthe m arket and denature in such a way that
theycannotbere-usedforhumanconsumption.
(3) In addition, a special roomm ust be set aside for the storage and
washingoflivefrogs,andfortheirslaughterandbleeding.Thedeath
offrogsmustonlybecarriedoutbyslaughterinanapprovedestab-
lishment. Frogs which are found to be dead prior to slaughter must
not be prepared for human consumption. The special room must
meet the requirements of Chapter III, paragraph I, point 2 of the
Annex to Directive 91/493/EEC and must be physically separated
fromthepreparationroom.
(4) Immediately following preparation, the frogs' legs must be washed
very fully in running drinking water and immediately chilled at the
temperature of melting ice, frozen at a temperature of at least −
18ºCorprocessed.
(5) Where the frogs' legs are processed, this must be carried out in
accordance with the rules laid down in Chapter IV of the Annex toDirective91/493/EEC.
(6)Microbiological controls
In accordance with the procedure laid down in Article 18 of this
Directive, microbiological criteria, including sampling plans and
methods of analysis, may be laid down when there is a need to
protectpublichealth.
(7) The frogs' legs must be put up, packaged, stored and transported
under the appropriate hygiene conditions laid down in Chapters VI
andVIIIofDirective91/493/EEC.
(8) Thepackaging andcontainers offrogs'legsmustbearanidentifica-
tionmarkcontainingthefollowingparticulars:
Thenameoftheconsigningcountryincapitals,ortheinitialletteror
lettersoftheconsigningcountryinprintedcapitals,i.e.:AT,B,DK,
D,EL,E,F,FI,IRL,I,L,NL,P,SE,UKfollowedbytheapproval
number of the establishment, and, one of the following sets of
initials:CE,EC,EF,EG,EK,EY.
C. Forimports:
(1) The packaging and wrapping of frogs' legs must carry the name or
ISO code of the country of origin and the approval number of the
productionestablishmentinindelibleprint.
(2) The following is an example of the specimen health certificate laid
downinArticle10(2)(c)ofthisDirective, whichmustaccompany
everyconsignmentoffrogs'legsoriginatinginthirdcountries:1992L0118—EN—19.11.2002—011.001—20
▼M6
SPECIMEN HEALTH CERTIFICATE FOR CHILLED, FROZEN OR PREPARED FROGS' LEGS
ORIGINATINGINTHIRDCOUNTRIESANDINTENDEDFORTHEEUROPEANCOMMUNITY
Note to the importer: Thiscertificateisforveterinarypurposesonlyandmustaccompanytheconsign-
mentuntilitreachestheborderinspectionpoint.
1992L0118—EN—19.11.2002—011.001—21
▼M6
1992L0118—EN—19.11.2002—011.001—22
▼M10
CHAPTER4
SPECIFIC HEALTH CONDITIONS FOR THE GELATINE INTENDED
FORHUMANCONSUMPTION
Thischapterlaysdownthehealthconditionsapplicabletoputtingonthemarket
and for imports of gelatine intended for human consumption, but excluding
gelatinedestinedtopharmaceutical,cosmeticorothertechnicaluseandmedical
devices.
Forthepurposeofthischapter,thefollowingdefinitionsapply:
— gelatine: natural, soluble protein, gelling or non-gelling, obtained by the
partialhydrolysisofcollagenproducedfrombones,hidesandskins,tendons
andsinewsofanimals(includingfishandpoultry),
— hidesandskins:allcutaneousandsubcutaneoustissues,
— tanning: the hardening of hides, using vegetable tanning agents, chromium
salts or other substances such as aluminium salts, ferric salts, silicic salts,
aldehydesandquinones,orothersynthetichardeningagents,
— category 1 country or region: country or region classified as BSE free in
accordancewithCommunitylegislation,
— category 2 country or region: country or region classified as provisionally
BSEfreewithaccordancetoCommunitylegislation,
— category3countryorregion:countryorregionclassifiedaslowBSEriskin
accordancewithCommunitylegislation,
— category 4countryor region: countryor region classified ashighBSErisk
inaccordancewithCommunitylegislation.
Gelatine intended for human consumption shall comply with the following
conditions:
I.Conditionsforestablishmentsproducinggelatine
Gelatine intended for human consumption shall come from establishments
which:
1. complywiththeconditionslaiddowninChaptersI,II,V,VI,VII,VIII,IX
andXoftheAnnextoDirective93/43/EEC;
2. are authorised andregistered inaccordance withArticle 11ofDirective 77/
99/EEC;
3. are subject to supervision of production conditions by the competent
authority in accordance with Chapter IV of Annex B to Directive 77/99/
EECasappropriate;
4. carryoutanown-checksprogrammeinaccordancewithArticle7(1)and(3)
ofDirective77/99/EEC;
5. keep recordsfor twoyears on the sourcesof all incoming rawmaterial and
onalloutgoingproducts;
6. introduceandimplementasystemthatmakesitpossibletolinkeachproduc-
tion batch dispatched, the incoming raw material consignments, the
productionconditionsandthetimeofproduction.
II.Requirementsforrawmaterialstobeusedfortheproductionofgelatine
1. For the production of gelatine intended for human consumption, the
followingrawmaterialsmaybeused:
— bones,
— hidesandskinsoffarmedruminantanimals,
— pigskins,
— poultryskin,
— tendonsandsinews,
— wildgamehidesandskins,— fishskinandbones.
2. Theuseofbonesobtainedfromruminantanimalsborn,rearedorslaughtered
incategory4countriesorregionsisprohibited.
3. Theuseofhidesandskinssubmittedtotanningprocessesisprohibited.4. Rawmaterialslistedinthefirstfiveindentsofparagraph1shallbederived
fromanim als which have been slaughtered in a slaughterhouse and whose
carcases have been found fit for human consumption following ante and
postmorteminspection.
5. Rawmaterial listedinthesixthindentofparagraph1shallbederivedfrom
killed animals whose carcases have been found fit for human consumption1992L0118—EN—19.11.2002—011.001—23
▼M10
followingtheinspectionslaiddowninArticle3ofCouncilDirective92/45/
EEC(1).
6. Rawmaterials listed inthe first sixindentsofparagraph 1 shall come from
slaughterhouses, cutting plants, meat processing establishments, wild game
processingplants,bonedegreasingplants,tanneries,collectioncentres,retail
shops,orpremisesadjacenttosalespointswherethecuttingandthestorage
of meat and poultrymeat is performed for the sole purposeofsupplyingthe
finalconsumerdirectly.
7. Rawmaterial listedinthelastindentofparagraph1shallcomefromplants
manufacturing fish products for human consumption approved or registered
inaccordancewithCouncilDirective91/493/EEC(2).
8. Thecollectioncentresandtannerieswhichintendtosupplyrawmaterialfor
the production of gelatine intended for human consumption shal be specifi-
cally authorisedforthispurposeandregistered bythecompetent authorities
andfulfilthefollowingrequirements:
(a) they must have storage rooms withhard floors and smooth wallswhich
areeasytocleananddisinfect;
(b) whereappropriate,theymustbeprovidedwithrefrigerationfacilities;
(c) thestorageroomsmustbekeptinasatisfactorystateofcleanlinessand
repair,sothattheydonotconsituteasourceofcontaminationfortheraw
materials;
(d) ifrawmaterialnotinconformitytothispartisstoredand/orprocessedin
these premises, it must be segregated throughout the period of receipt,
storage,processinganddispatchfromrawmaterial inconformitytothis
part;
(e) theymustbeinspectedbythecompetentauthorityatregularintervalsin
order to ensure that this chapter is being complied with and to check
accounting documents and/or health certificates which enable the origin
oftherawmaterialtobetraced.
9. Imports into the Community of raw material destined to the production of
gelatineintendedforhumanconsumptionaresubjecttothefollowingprovi-
sions:
— Member States shall authorise the importation of this raw material only
fromthirdcountrieswhichappearonthelistlaiddowninCouncilDeci-
sion 79/542/EEC(3) or in Commission Decision 94/85/EC(4)o ri n
Commission Decision 97/296/EC(5) or in Decision 94/86/EC(6), as
appropriate,
— each consignment is accompanied by a certificate that conforms to the
modellaiddowninaccordancewiththeprocedureprovidedforinArticle
18ofthisDirective.
III.Transportandstorageofrawmaterials
1. Transports of raw materials destined to the production of gelatine must be
carriedoutundercleanconditionsusingappropriatemeansoftransport.
Duringtransportation, atthetime ofdelivery inthecollection centre andin
thetanneryandinthegelatineprocessingestablishment,rawmaterialsmust
be accompanied by a commercial document in conformity with the model
laiddowninPartVIIIofthischapter.
2. Raw materials must be transported and stored chilled or frozen, unless they
areprocessedwithin24hoursaftertheirdeparture.
Bywayofderogationfromtheprecedingsubparagraph,degreasedanddried
bonesorossein,salted,driedandlimedhidesandskinsandhidesandskins
treatedwithalkalioracidmaybetransportedandstoredatambienttempera-
ture.
3. The storage rooms must be kept in a satisfactory state of cleanliness and
repair, so that they do not constitute a source of contamination for the raw
materials.1992L0118—EN—19.11.2002—011.001—24
(1) OJL268,14.9.1992,p.35.
(2) OJL268,24.9.1991,p.15.
(3) OJL146,14.6.1979,p.15.
(4) OJL44,17.2.1994,p.31.
(5) OJL122,14.5.1997,p.21.
(6) OJL44,17.2.1994,p.33.
▼M10
IV.Conditionstobecompliedwithforthemanufactureofgelatine
1. Gelatinemustbeproducedbyaprocesswhichensuresthat:
— all ruminant bone material which is derived from animals born, reared
and slaughtered in category 3 countries or regions is subjected to a
process which ensures that all bone material is finely crushed and
degreased with hot water and treated with dilute hydrochloric acid (at
minimum concentration of 4 % and pH < 1,5) over a period of at least
two days, followed by an alkaline treatment of saturated lime solution
(pH > 12,5) for a period of at least 20 days with a sterilisation step of
138-140 ºC during four seconds or by an equivalent process approved
by the Commission after consultation of the appropriate Scientific
Committee,
— other raw material is subjected to a treatment with acid or alkali,
followed by one or more rinses.The pHmustbe adjusted subsequently.
Gelatinemustbeextractedbyheatingoneorseveraltimesinsuccession,
followedbypurificationbymeansoffiltrationandsterilisation.
2. After having been subjected to the processes listed in paragraph 1, gelatine
mayundergoadryingprocessand,whereappropriate,aprocessofpulverisa-
tionorlamination.
3. Theuseofpreservatives,otherthansulphurdioxideandhydrogenperoxide,
isprohibited.
4. Provided the requirements for gelatine not intended for human consumption
are exactly the same as for gelatine intended for human consumption,
productionandstoragemaybeundertakeninthesameestablishment.
V.Requirementsforfinishedproducts
Each production batch of gelatine shall be subjected to tests to ensure that it
meetsthefollowingcriteria:
1.Microbiological criteria
Microbiologicalparameters Limit
Totalaerobicbacteria 103/g
Coliforms(30ºC) 0/g
Coliforms(44,5ºC) 0/10g
Anaerobic sulphite-reducing bacteria (no gas
production)10/g
Clostridium perfringens 0/g
Staphylococcus aureus 0/g
Salmonella 0/25g
2.Residues
Elements Limit
As 1ppm
Pb 5ppmCd 0,5ppm
Hg 0,15ppm
Cr 10ppm
Cu 30ppm
Zn 50ppm
Moisture(105ºC) 15%
Ash(550ºC) 2%
SO
2(ReithWilliems) 50ppm
H2O2(EuropeanPharmacopia1986(V2O2)) 10ppm1992L0118—EN—19.11.2002—011.001—25
▼M10
VI.Packaging,storageandtransport
1. Gelatineintendedforhumanconsumptionmustbewrapped,packaged,stored
andtransportedundersatisfactoryhygieneconditions,inparticular:
— aroommustbeprovidedforstoring,wrappingandpackagingmaterials,
— wrappingandpackagingmusttakeplaceinaroomorinaplaceintended
forthatpurpose.
2. Wrappingsandpackagescontaininggelatinemust:
— bearanidentificationmarkgivingthefollowingparticulars:
the name or initial letter or letters of the consigning country in printed
capitals,i.e.:AT-B-DK-D-EL-E-F-FI-IRL-I-L-NL-P-SE-UK,followedby
theregistrationnumberoftheestablishmentandoneofthefollowingsets
ofinitials:CE-EC-EF-EG-EK-EY
and
— carrythewords‘Gelatineforhumanconsumption’.
3. Gelatine mustbe accompanied duringtransportation by acommercial docu-
ment, in accordance with Article 3(A)(9)(a) of Directive 77/99/EEC, which
must bear the words ‘Gelatine for human consumption’ and the date of
preparation.
VII.Importationofgelatinefromthirdcountries
A. MemberStates shall ensurethat gelatine destined tohumanconsumption is
importedonlyif:
— itcomesfromthirdcountrieswhichappearonthelistofPartXIIIofthe
AnnextoCommissionDecision94/278/EC(1),
— itcomesfromestablishmentsmeetingtheconditionslaiddowninPartI
ofthischapter,
— it has been produced from raw material which met the requirements of
PartsIIandIIIofthischapter,
— it has been manufactured in compliance with the conditions set out in
PartIVofthischapter,
— itsatisfiesthecriteriaofPartVandtherequirementsofpartVI.1ofthis
chapter,
— itbearsonitswrappingsandpackagesanidentificationmarkgivingthe
followingparticulars:
theISOCodereferenceofthecountryoforiginfollowedbytheregistra-
tionnumberoftheestablishment
and
— itisaccompanied byacertificate thatconformstothemodellaiddown
in accordance with the procedure provided for in Article 18 of this
Directive.
B. In accordance with the procedure of Article 18 of this Directive, the
Commission may recognise the health measures applied by a third country
totheproductionofgelatineforhumanconsumption,asofferingguarantees
equivalent to those applied for putting on the market in the Community, if
thethirdcountrysuppliesobjectiveproofinthisrespect.
When the Commission recognises such equivalence of the health measures
of a third country, it shall adopt in accordance with the same procedure,
theconditionsgoverningtheimportationofgelatineforhumanconsumption
includingthehealthcertificatewhichmustaccompanytheproduct.1992L0118—EN—19.11.2002—011.001—26
(1) OJL120,11.5.1994,p.44.
▼M10
VIII.Modelofcommercialdocumentforrawmaterialdestinedtotheproductionofgelatinefor
humanconsumption
1992L0118—EN—19.11.2002—011.001—27
▼M10
1992L0118—EN—19.11.2002—011.001—28
▼B
ANNEX III
I
CONSOLIDATED VERSION OF ANNEXES A AND B TO DIRECTIVE
89/662/EEC
‘ANNEX A
VETERINARYLEGISLATION
CHAPTERI
— CouncilDirective64/433/EECof26June1964onhealthproblemsaffecting
intra-Communitytradeinfreshmeat(OJNo121,29.7.1964,p.2012/64).
— Council Directive 71/118/EEC of 15 February 1971 on health problems
affectingtradeinfreshpoultrymeat(OJNoL55,8.3.1971,p.23).
— Council Directive 72/461/EEC of 12 December 1972 on health problems
affectingintra-Community tradeinfreshmeat(OJNoL302,31.12.1972,
p.24).
— Council Directive 77/99/EEC of 21 December 1976 on health problems
affecting intra-Community trade in meat products (OJ No L 26, 31. 1.
1977,p.85).
— Council Directive 80/215/EEC of 22 January 1980 on animal health
problems affecting intra-Community trade in meat products (OJ No L 47,
21.2.1980,p.4).
— Council Directive 88/657/EEC of 14 December 1988 laying down the
requirements for the production of, and trade in, minced meat, meat in
piecesoflessthan100gramsandmeatpreparations(OJNoL382,31.12.
1988,p.3).
— Council Directive 89/437/EEC of 20 June 1989 on hygiene and health
problems affecting the production and the placing on the market of egg
products(OJNoL212,22.7.1989,p.87).
— Council Directive 91/67/EEC of 28 January 1991 concerning the animal
health conditions governing the placing on the market of aquaculture
animalsandproducts(OJNoL46,19.2.1991,p.1).
— Council Directive 91/492/EEC of 15 July 1991 laying down the health
conditions for the production and the placing on the market of live bivalve
molluscs(OJNoL268,24.9.1991,p.1).
— Council Directive 91/493/EEC of 22 July 1991 laying down the health
conditions for the production and the placing on the market of fishery
products(OJNoL268,24.9.1991,p.15).
— CouncilDirective91/494/EECof26June1991onanimalhealthconditions
governing intra-Community trade in and imports from third countries of
freshpoultrymeat(OJNoL268,24.9.1991,p.35).
— Council Directive 91/495/EEC of 27 November 1991 concerning public
health and animal health problems affecting the production and placing on
the market of rabbit meat and farmed game meat (OJ No L 268, 24. 9.
1991,p.41).
— Council Directive 92/45/EEC of 16 June 1992 on public health and animal
health problemsrelating tothekilling ofwildgame andtheplacing onthe
marketofwild-gamemeat(OJNoL268,14.9.1992,p.35).
— CouncilDirective92/46/EECof16June1992layingdownthehealthrules
fortheproductionandplacingonthemarketofrawmilk,heat-treated milk
andmilk-basedproducts(OJNoL268,14.9.1992,p.1).
CHAPTERII
— Council Directive 92/118/EEC of 17 December 1992 laying down animal
health and public health requirements governing trade in and imports into
the Community of products not subject to the said requirements laid down
in specific Community rules referred to in Annex A (I) to Directive 89/
662/EEC and, as regards pathogens, to Directive 90/425/EEC (with the
exceptionofpathogens).1992L0118—EN—19.11.2002—011.001—29
▼B
ANNEX B
PRODUCTS NOT SUBJECT TO COMMUNITY HARMONIZATION,
BUT TRADE IN WHICH WOULD BE SUBJECT TO THE CHECKS
PROVIDEDFORBYTHISDIRECTIVE
Other products of animal origin included neither in Annex B to this Directive
norintheAnnextoDirective90/425/EEC:theseproductswillbedefinedunder
theprocedurelaiddowninArticle18.’
II
CONSOLIDATED VERSION OF ANNEXES A AND B TO DIRECTIVE
90/425/EEC
‘ANNEX A
CHAPTERI
VETERINARYLEGISLATION
Section1
— Council Directive 64/432/EEC of 26 June 1964 on animal health problems
affecting intra-Community trade in bovine animals and swine (OJ No 121,
29.7.1964,p.1977/64).
— Council Directive 88/407/EEC of 14 June 1988 laying down the animal
health requirements applicable to intra-Community trade in and imports of
deep-frozen semen of domestic animals of the bovine species (OJ No L
194,22.7.1988,p.10).
— Council Directive 89/556/EEC of 25 September 1989 on animal health
conditions governing intra-Community trade in and importation from third
countries of embyros of domestic animals of the bovine species (OJ No L
302,19.10.1989,p.1).
— Council Directive 90/426/EEC of26June1990onthehealth policy condi-
tions governing the movement of equidae and their import from third
countries(OJNoL224,18.8.1990,p.42).
— Council Directive 90/429/EEC of 26 June 1990 laying down the animal
health requirements applicable to intra-Community trade in and imports of
semen of domestic animals of the porcine species (OJ No L 224, 18. 8.1990,p.62).
— Council Directive 90/539/EEC of15October1990onanimal health condi-
tionsgoverningintra-Community trade in,and importsfrom third countries
of,poultryandhatchingeggs(OJNoL303,31.10.1990,p.6).
— CouncilDirective90/667/EECof27November1990layingdowntheveter-
inaryrulesforthedisposalandprocessingofanimalwaste,foritsplacingon
the market and for the prevention of pathogens in feedstuffs of animal or
fish origin and amending Directive 90/425/EEC (OJ No L 363, 27. 12.
1990,p.51).
— Council Directive 91/67/EEC of 28 January 1991 concerning the animal
health conditions governing the placing on the market of aquaculture
animalsandproducts(OJNoL46,19.2.1991,p.1).
— Council Directive 91/68/EEC of 28 January 1991 on animal health condi-
tions governing intra-Community trade in ovine and caprine animals (OJ
NoL46,19.2.1991,p.19).
— Council Directive 91/628/EEC of 19 November 1991 on the protection of
animals during transport and amending Directives 90/425/EEC and 91/496/
EEC(OJNoL340,11.12.1991,p.17).
Section2
Council Directive 92/65/EEC of 13 July 1992 laying down animal health
requirements governing trade in and imports into the Community of animals,
semen, ova and embryos not subject to animal health requirements laid down
in specific Community rules referred to in Annex A (I) (1) to Directive 90/
425/EEC(OJNoL268,14.9.1992,p.54).
—Forpathogens:
CouncilDirective92/118/EECof17December1992layingdownanimalhealth
andpublichealthrequirementsgoverningtradeinandimportsintotheCommu-
nity of products not subject to the said requirements laid down in specific1992L0118—EN—19.11.2002—011.001—30
▼B
Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as
regardspathogens,toDirective90/425/EEC.
CHAPTERII
ZOOTECHNICALLEGISLATION
— Council Directive 77/504/EEC of 25 July 1977 on pure-bred breeding
animalsofthebovinespecies(OJNoL206,12.8.1977,p.8).
— Council Directive 88/661/EEC of 19 December 1988 on the zootechnical
standards applicable to breeding animals of the porcine species (OJ No L
382,31.12.1988,p.36).
— Council Directive 89/361/EEC of 30 May 1989 concerning pure-bred
breedingsheepandgoats(OJNoL153,8.6.1989,p.30).
— Council Directive 90/427/EEC of 26 June 1990 on the zootechnical and
genealogical conditions governing intra-Community trade in equidae (OJ
NoL224,18.8.1990,p.55).
— CouncilDirective 91/174/EECof25March1991layingdownzootechnical
andpedigreerequirementsforthemarketingofpure-bredanimals(OJNoL
85,5.4.1991,p.37).1992L0118—EN—19.11.2002—011.001—31
▼B
ANNEX B
ANIMALS ANDPROD UCTS NOT SUBJECT TO HARMONIZATION
BUT TRADE IN WHICH WILL BE SUBJECT TO THE CHECKS
PROVIDEDFORINTHISDIRECTIVE
CHAPTERI
Veterinarylegislation—otherliveanimalsnotlistedinAnnexA,ChapterI.
CHAPTERII
Veterinary legislation — semen, ova and embryos not listed in Annex A,
ChapterI.’1992L0118—EN—19.11.2002—011.001—32