1992L0118—EN—01.01.2001—010.001—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
►
M7CommissionDecision96/405/ECof21June1996L165404.7.1996
►M6CommissionDecision96/340/ECof10May1996L1293530.5.1996
►M8CouncilDirective96/90/ECof17December1996L132416.1.1997
►M9CouncilDirective97/79/ECof18December1997 L24 31 30.1.1998
►M10CommissionDecision1999/724/ECof28October1999 L290 32 12.11.1999
►M11CommissionDecision2001/7/ECof19December2000 L2 27 5.1.2001
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—01.01.2001—010.001—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—01.01.2001—010.001—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);
(e)processed animal protein intended for animal consumption
meansanimalproteinwhichhasbeentreatedsoastorenderit
suitablefordirectuseasafeedingstufforasaningredientinafeedingstuffforanimals.Itincludesfishmeal,meatmeal, bone-meal,hoofmeal,hornmeal,bloodmeal,feathermeal,drygreavesand other similar products including mixtures containing these
products;
(f)processed animal protein intended for human consumption
means greaves, meatmeal and pork-rind powder referred to inArticle2(b)ofDirective77/99/EEC(
2);
(g)apiculture product meanshoney,beeswax,royaljelly,propolis
orpollen,notintendedforhumanconsumptionorforindustrialuse.
2. In addition, the definitions contained in Article 2 of Directives
89/662/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 together with gelatins not intended for human consump-
tion are not prohibited or restricted for animal health or publichealth reasons other than those arising fromthe application of thisDirective or from Community legislation, and in particular anysafeguardmeasurestaken,
— anynewproductofanimaloriginwhoseplacingonthemarketina
MemberStateisauthorizedafterthedateprovidedforinArticle20
maynotbethesubjectoftradeorimportation untiladecisionhas
beentakeninaccordancewiththefirstparagraphofArticle15afterevaluation and, if appropriate, the opinion of the Scientific Veter-inary Committee set up by Decision 81/651/EEC(
3), of the real
risk of the spread of serious transmissible diseases which couldresult from movement of the product, not only for the species
fromwhichtheproduct originates butalsoforotherspecieswhich
could carry the disease, become a focus of disease or a risk tohumanhealth,
— the other products of animal origin referred to in Article 2 (b) of
Directive77/99/EECmaynotbethesubjectoftradeorimportationfrom third countries unless they meet the requirements of thatDirectiveandtherelevantrequirementsofthisDirective.1992L0118—EN—01.01.2001—010.001—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)
(3) OJNoL233,19.8.1981,p.32.
▼B
CHAPTERII
Provisionsapplicabletotrade
Article 4
MemberStatesshalltakethenecessarymeasurestoensurethat,forthe
purposesofapplyingArticle4(1)ofDirective89/662/EECandArticle
4 (1) (a) of Directive 90/425/EEC, the products of animal origin
referred to in Annexes I and II and the second and third indents ofArticle 3 of this Directive may, without prejudice to the particularprovisions 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 forpresentation to the competent authority. The results of thevarious checks and tests in particular shall be kept for at
leasttwoyears,
— 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 theproduct, 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.1992L0118—EN—01.01.2001—010.001—5
▼B
Article 6
MemberStatesshallensurethattradeinpathogenicagentsissubjectto
strictrulestobedefinedundertheprocedurelaiddowninArticle18.
Article 7
1. TherulesonchecksestablishedbyDirective89/662/EECand,as
regards pathogenic agents, by Directive 90/425/EEC shall apply, inparticular as regards the organization of and follow-up to the checkstobecarriedout,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 supplyingproductsofanimalorigincoveredbythisDirective.
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 notcorrespondtothe actual stateoftheproductsreferred toinAnnexesIandII,orthattheproductsinquestiondonotsatisfytherequirements
ofthisDirectiveorhavenotundergonethechecksprovidedfortherein.
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 milk
has 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 those
laiddowninthesecondandthirdindentsofArticle3.
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 Community
onlyiftheysatisfythefollowingrequirements:
(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) unlessotherwisespecifiedinAnnexII,
— the products referred to in Chapters 3, 5 (B), 12, 13, 14 (I)
(unprocessed slurry) and 15 of Annex I and honey must come1992L0118—EN—01.01.2001—010.001—6
(1) OJNoL268,14.9.1992,p.1.▼M8
▼M8
fromanestablishmentthathasbeenregisteredbythecompetent
authorityofthethirdcountry;
— products other than those referred to in the first indent must
comefromestablishmentsonaCommunitylisttobedrawnupinaccordancewiththeprocedurelaiddowninArticle18;
(c) inthecasesspecificallyprovidedforinAnnexesIandIIandinthe
secondandthirdindentsofArticle3,theymustbeaccompaniedbyan animal health or public health certificate corresponding to a
specimen to be drawn up under the procedure provided for in
Article 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, andsigned 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 ordiseasestransmissible toman—orguarantees equivalent tothoseconditions.
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 in
thesaidindents;
(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 serioustransmissiblediseasesorofdiseasestransmissibletomanwhichcouldresult 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 public
health.
5. ExpertsfromtheCommissionandtheMemberStatesshallcarry
out on-the-spot inspections to verify whether the guarantees given by
the third country regarding the conditions of production and placing
on 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/EEC1992L0118—EN—01.01.2001—010.001—7
▼B
▼M8
▼B
▼B
and the national certificate required by products imported under
existingnationalrules.
Article 11
The procedure provided for in Article 18 shall be used to stipulate
specific animal health requirements for imports into the Community
and the nature and content of accompanying documents for products
referredtoinAnnexIintendedforexperimentallaboratories.
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
maybeadoptedinaccordancewiththeprocedurelaiddowninArticle
18, 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 referred
toinAnnexesIandIIintheformoftradesamples.
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 shall
ensurethattheconsignmentisaccompaniedbytheappropriatelicence.MovementshalltakeplaceinaccordancewiththeprovisionsofArticle11(2)ofDirective90/675/EEC.Theresponsibilityforensuringthattheconsignment complies withthe conditions ofthe licence (andwhetherentryintoitsterritoryshouldbepermitted)shallrestwiththeMember
Statewhichissuesthelicence.
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:1992L0118—EN—01.01.2001—010.001—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
‘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 6ofAnnexIto
Directive92/118/EEC(*);
(b) low-risk materials, high-risk materials intended for processing
in a plant designated in another Member State in accordance
with the second sentence of Article 4 (1) and processed
productsobtainedfromhigh-riskorlow-riskmaterialsmustbeaccompanied:
— 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‘arelaiddownunderChapter10ofAnnexItoDirective92/118/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 generalprinciplessetoutinthesecondindentofArticle3.
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 producedintheterritoryofaMemberStateandhavepassedthroughtheterritory
of a third country subject to production of an animal health or public
health certificate certifying compliance with the requirements of thisDirective.
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:1992L0118—EN—01.01.2001—010.001—9
(1) OJNoL255,18.10.1968,p.23.
▼B
‘2. Under the procedure laid down in Article 20, additional
conditionsmaybesetfortheotherproductsofanimaloriginsoastoensuretheprotectionofpublichealth.’
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 on1July1993tofacilitatethetransitiontothenewarrangementsestablishedbythisDirective.
Article 20
1. Member States shall bring into force the laws, regulations and
administrativeprovisionsnecessarytocomplywithArticles12(2)and17by1January1993andwiththeotherrequirementsofthisDirective
before 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 field
governedbythisDirective.
3. Thesettingofthedeadlinefortranspositionintonationallawat1
January 1994 shall be without prejudice to the abolition of veterinarychecksatfrontiersprovidedforbyDirectives89/662/EECand90/425/EEC.
Article 21
ThisDirectiveisaddressedtotheMemberStates.1992L0118—EN—01.01.2001—010.001—10
▼B
ANNEX I
SPECIFICANIMALHEALTHREQUIREMENTS
CHAPTERI
Milk,milkproductsandcolostrumnotintendedforhumanconsumption
Intra-Communitytradeinandimportsofmilk,milkproductsandcolostrumnot
intendedforhumanconsumptionaresubjecttothefollowingconditions:
1. anycontainerinwhichtheproductistransportedmustbemarkedtoindicate
thenatureoftheproduct;
2. each consignment must be accompanied, as appropriate, by a commercial
documentasreferredtointhelastindentofArticle4(2)(a)orahealthcerti-
ficate as referred to in Article 10 (2) (c), bearing the name and the
registration number of the processing or treatment plant; the document or
certificatemustbekeptbytheconsigneeforatleastoneyear;
3. thedocumentsandcertificatesreferredtoinparagraph2mustshow:
(a) in the case of raw milk or colostrum, that it has been produced under
conditions offering adequate guarantees as regards animal health. Such
conditions must be established in accordance with the procedure laid
downinArticle18;
(b) inthecaseofmilkortreatedorprocessedmilkproducts,themilkorthe
milkproducthasbeensubjected toaheattreatment ofatleast72ºCfor
atleast15secondsoranycombinationoftemperatureandtimehavingat
least an equivalent heat effect and producing a negative reaction to the
phosphatasetest,followedby:
(i) inthecaseofdriedmilkordriedmilkproducts,adryingprocess;
(ii) inthecaseofanacidified milkproduct,aprocessbywhichthepH
isreducedandkeptforatleastonehouratalevelbelow6,0;
(c) in the case of dried milk or dried milk products, the following require-
mentshavebeenmet:
(i) after completion of the drying process, every precaution has been
takentopreventcontaminationoftheproduct;
(ii) thefinalproducthasbeenpackedinnewcontainers;
(d) inthecaseofbulkcontainers,beforethemilk,milkproductorcolostrum
was loaded into any vehicle or container for conveyance to its destina-
tion, the said vehicle or container was disinfected using a product
approvedbythecompetentauthorities.
4. Inadditiontotherequirementssetoutinpoints1,2and3,importsofmilk,
milk products and colostrum not intended for human consumption may be
authorized only fromthird countries or parts of third countries included on
the listsprovided for in Article 23 ofDirective 92/46/EEC and meeting the
conditionssetoutinArticle26ofthatDirective.Whereariskofintroduction
ofanexoticdiseaseoranyotherrisktoanimalhealthisidentified,additional
conditions for the protection of animal health may be established in accor-
dancewiththeprocedurelaiddowninArticle18.
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.1992L0118—EN—01.01.2001—010.001—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).▼M4
▼B
▼B
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.
CHAPTER3
Hidesandskinsofungulates (1)notcoveredbyDirective64/433/EECor72/
462/EECandwhichhavenotundergonecertain tanningprocesses
I. A. Theprovisionsofthischapterdonotapplyto:
— hidesorskinsofungulatescoveredbyDirective64/433/EECor72/
462/EEC,
— hidesorskinshavingundergonethecompleteprocessoftanning,— ‘wetblue’,
— ‘pickledpelts’,
— ‘limedhides’(treatedwithlimeandinbrineatapHof12to13for
atleasteighthours).
B. Within the scope defined in A, the provisions of this chapter apply to
fresh,chilledandtreatedhidesandskins.
Forthepurposeofthis Decision, ‘treated hidesand skins’means hides
andskinswhichhavebeen:
— dried,or
— dry-saltedorwet-saltedforatleast14dayspriortodispatch,or
— saltedforsevendaysinseasaltwiththeaddition ofsodiumcarbo-
nateto2%,or
— dryingfor42daysatatemperatureofatleast20ºC,or
— preservedbyaprocessotherthantanning,tobedeterminedinaccor-
dancewiththeprocedurelaiddowninArticle18.
II.Intra-Community trade
A. Trade in fresh or chilled hides and skins is subject to the same animal
healthconditionsasthoseapplicabletofreshmeatpursuanttoDirective
72/461/EEC.
B. Trade in treated hides and skins is authorized on condition that each
consignment is accompanied by a commercial document as provided
forinthelastindentofArticle4(2)(a)certifyingthat:
— the hidesand skinshave been treated inaccordance withpoint I.B,
and
— the consignment has not been in contact with any other animal
productorliveanimalspresentingariskofspreadingaserioustrans-
missibledisease.
III.Importations
A. Freshorchilledhidesandskinsmayonlybeimportedfromthirdcoun-
triesorapartofathirdcountryfromwhichimportsofallcategoriesof
fresh meat of the corresponding species are authorized pursuant to
Communitylegislation.
B. Imports of fresh or chilled hides and skins must meet animal health
conditions to be determined in accordance with the procedure laid
downinArticle18andmustbeaccompaniedbyananimalhealthcerti-
ficateasprovidedforinArticle10(2)(c).
C. ImportsoftreatedhidesorskinsfromthethirdcountrieslistedinPart1
of the Annex to Decision 79/542/EEC(
2) are authorized on condition
thateachconsignmentisaccompaniedbyacertificate ofamodeltobe1992L0118—EN—01.01.2001—010.001—12
(1) ‘Hidesandskinsofungulates’meanstheintegumentsofungulates.
(2) OJNoL146,14.06.1979,p.15.DecisionaslastamendedbyCommissionDecision
94/59/EC(OJNoL27,1.2.1994,p.53).▼M2
▼M2
determined by the Commission in accordance with the procedure laid
downinArticle18,totheeffectthat:
(a) either where the hides orskinscome from animals originating in a
regionofathirdcountryorinathirdcountrynotsubject,pursuant
toCommunity regulations, torestrictionsasaresult ofanoutbreak
of a serious transmissible disease to which the animals of the
species concerned are susceptible, they have been treated in accor-
dancewithpointI.B;
or
wherethehidesorskinscomefromotherregionsofathirdcountry
or other third countries, they are treated as laid down in point I.B,
thirdandfourthindents;
and
(b) the consignment has not been in contact with any other animal
productorwithliveanimalspresentingariskofspreadingaserious
transmissibledisease.
D. However,inthecaseofimportsfromanythirdcountryofhidesorskins
ofruminantstreated inaccordance withpointI.Bandwhichhavebeenkept separate for 21 days or have undergone transport for 21 uninter-
rupted days, the certificate provided for in point C is replaced by a
declaration to the effect that or proving that those requirements have
been met, of a model to be determined by the Commission in accor-
dancewiththeprocedurelaiddowninArticle18.
CHAPTER4
Pet food containing low-risk materials within the meaning of Directive 90/
667/EEC
1. Each consignment of petfood in hermetically sealed containers must be
accompaniedbyacertificate issuedandsignedbyanofficialveterinarianof
thecountryoforiginstatingthattheproducthasbeensubjectedtoheattreat-
menttoaminimumFcvalueof3,0.
2. Eachconsignmentofsemi-moistpetfoodmustbeaccompaniedeitherbythe
commercial documentorbythecertificate providedforinArticle13(2)(b)
ofDirective90/667/EECstatingthat:
(i) therawmaterialsofanimaloriginfromwhichthepetfoodwasmanufac-
tured were obtained solely from healthy slaughtered animals, the meat
fromwhichhadbeenpassedasfitforhumanconsumption;
(ii) theingredientsofanimaloriginhavebeensubjectedtoaheattreatment
ofatleast90ºCthroughouttheirsubstance;
(iii) after processing, effective steps were taken to ensure that the consign-
mentwasnotexposedtorecontamination.
3. Driedpetfoodmustsatisfythefollowingrequirements:
(a) the raw materials from which the petfood was manufactured were low-
risk materials in accordance with Articles 2, 5 and 17 of Directive 90/
667/EEC;
(b) each consignment isaccompanied byacommercial document orcertifi-
cate provided for in Article 13 (2) (b) of Directive 90/667/EEC stating
that:
(i) thedriedpetfoodconsistedofproductsofslaughteredanimalsheat-
treatedsoastoachieveatemperaturethroughouttheirsubstanceof
at least 90 ºC, on the understanding that the treatment was not
necessaryforfinishedproductstheingredientsofwhichhadunder-
gonesuchtreatment;
(ii) after heat treatment, every precaution was taken to ensure that the
productwasnotcontaminatedinanywaypriortoshipment;
(iii) theproductispackedinnewcontainers(bagsorsacks);
(iv) the production process has been tested, with satisfactory results, in
accordance with Chapter III (2) of Annex II to Directive 90/667/
EEC.
4. Each consignment of products manufactured from processed hides must be
accompaniedbyacommercialdocumentorcertificateprovidedforinArticle
13 (2) (b) of Directive 90/667/EEC stating that the products have been
subjected to a heat treatment during processing sufficient to destroy patho-
genic organisms (including salmonella) and that effective steps were taken
afterprocessingtopreventcontaminationoftheproducts.1992L0118—EN—01.01.2001—010.001—13
▼B
▼B
CHAPTER5
Bones and bone products (excluding bone meal), horns and horn products
(excludinghornmeal)andhoovesandhoofproducts(excludinghoofmeal)
Trade in and imports of the products in question are subject to the following
conditions:
A. wheretheyareintendedforhumanoranimalconsumption:
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(1);
3. whereimportsareconcerned,bones,boneproducts,horns,hornproducts,
hoovesandhoofproductsaresubjecttotherequirementsofDirective72/
462/EEC(2);
B. wherethey are intended for usesother than human or animal consumption,
includingthoseintendedtobeprocessedwithaviewtothemanufacture of
gelatins:
1. MemberStatesshallauthorizetheimportationofboneandboneproducts
(excluding bone meal), horns and horn products (excluding horn meal)
andhoovesandhoofproducts(exludinghoofmeal)providedthat:
(i) theproductsaredriedbeforeexportandnotchilledorfrozen;
(ii) theproductsareconveyedonlybylandandseafromtheircountryof
origin direct to a border inspection post in the Community and are
nottranshippedatanyportorplaceoutsidetheCommunity;
(iii) following the document checks provided for in Directive 90/675/
EEC,theproductsareconveyeddirectlytothemanufacturingplant;
2. each consignment must be accompanied by an undertaking from the
importer that products imported under this chapter will not be diverted
fordirectuseinhumanoranimalfood.
Adeclaration tothiseffect mustbepresentedtotheofficial veterinarian
atthe borderinspection postatfirst point ofentry ofthe goodsinto the
Communityandbeannotatedbyhim,andthereaftershallaccompanythe
consignmenttoitsdestination.
3. under the procedure provided for in Article 18 of this Directive, in the
light of the animal health situations and guarantees as regards controls
on origin offered by a third country, derogations fromsom e of these
requirementsmaybepermitted.
CHAPTER6
Processedanimalprotein
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. asregardstrade:
— in processed animal protein intended for human foodstuffs, to the
production of the document or certificate provided for in Directive
77/99/EECstatingthattherequirementsofthatDirectivehavebeen
compliedwith,
— in processed animal proteins intended for animal feedingstuffs, to
theproductionofthedocumentorcertificateprovidedforinArticle
13ofDirective90/667/EEC;
B. asregardsimports:
1. toproductionofahealthcertificate asprovidedforinArticle10(2)
(c), signed by the official veterinarian of the country of origin and
statingthat:
(a) theproduct:
(i) whereitisintended foranimal consumption, hasundergone
appropriate heat treatment with the result that it complies1992L0118—EN—01.01.2001—010.001—14
(1) OJNoL47,21.2.1980,p.4.DirectiveaslastamendedbyDirective91/687/EEC(OJ
NoL377,31.12.1991,p.16).
(2) OJNoL302,31.12.1972,p.28.DirectiveaslastamendedbyDirective91/688/EEC
(OJNoL377,31.12.1991,p.18).
▼B
withthebiologicalstandardslaiddowninAnnexII,Chapter
IIItoDirective90/667/EEC;
(ii)whereitisintendedforhumanconsumption,fulfilsthe
requirementsofDirective80/215/EEC;
(b)everyprecautionhasbeentakenaftertreatmenttoprevent
contaminationoftheproducttreated;
(c)sampleshavebeentakenandtestedforsalmonellawhenthe
consignmentleftthecountryoforigin;
(d)theresultsofthesetestsarenegative;
2.followingdocumentchecksofthecertificatereferredtoin1,to
samplingbythecompetentauthorityattheborderinspectionpostwithoutprejudicetopointII:
(i)ofeachconsignmentofproductssubmittedinbulk;
(ii)atrandomofconsignmentsofproductspackagedinthemanufac-
turingplant;
3.forreleaseforfreecirculationinCommunityterritoryofconsign-
mentsofprocessedanimalprotein,toprovethattheresultsofthesamplingcarriedoutpursuanttoB(1)(c)haveprovednegative,if
necessaryafterreprocessing;
C.nationalrulesexistingonthedateofnotificationofthisDirective
concerningtherequirementsapplicableasregardsBSEandscrapiefor
animalproteinsmaybemaintainedpendingadecisiononthetypeof
heattreatmentcapableofdestroyingtheagentresponsible.
Tradeinandimportsofmeatmealandbonemealremainsubjectto
Article5(2)ofDirective89/662/EECandArticle11(2)ofDirective
90/675/EEC.
II.MemberStatesmaycarryoutrandomsamplingofbulkconsignmentsorigi-
natinginathirdcountryfromwhichthelastsixconsecutivetestshaveprovednegative.Whereduringoneofthesechecksaresulthasprovedposi-
tive,thecompetentauthorityofthecountryoforiginmustbeinformedso
thatitcantakeappropriatemeasurestoremedythesituation.These
measuresmustbebroughttotheattentionofthecompetentauthorityrespon-
siblefortheimportchecks.Intheeventofafurtherpositiveresultfromthe
samesource,furthertestsmustbecarriedoutonallconsignmentsfromthe
samesourceuntiltherequirementslaiddowninthefirstsentenceareagain
satisfied.
III.MemberStatesmustkeeprecordsoftheresultsofsamplingcarriedouton
allconsignmentswhichhaveundergonesampling.
IV.InaccordancewithArticle3(3)ofDirective89/662/EEC,transhipmentof
consignmentsispermittedonlythroughportswhichhavebeenapproved
undertheprocedurelaiddowninArticle18,providedthatabilateralagree-
menthasbeenreachedbetweenMemberStatestoallowcheckingofthe
consignmentstobedeferreduntiltheyreachtheborderinspectionpostof
theMemberStateoffinaldestination.
V.Whereaconsignmentprovestobepositiveforsalmonella,itiseither:
(a)re-exportedfromtheCommunity;
(b)usedforpurposesotherthananimalfeeds.Inthiscase,theconsignment
mayleavetheportorstoragedepotonlyonconditionthatitisnot
incorporatedintoanimalfeedingstuffs;
(c)re-processedinatreatmentplantapprovedpursuanttoDirective90/
667/EECoranyplantapprovedfordecontamination.Movementfromtheportorstoragedepotshallbecontrolledbypermitfromthecompe-
tentauthorityandtheconsignmentshallnotbereleaseduntilithas
beentreated,testedforsalmonellabythecompetentauthorityinaccor-
dancewithAnnexII,ChapterIII,toDirective90/667/EECanda
negativeresultobtained.
CHAPTER7
Bloodandbloodproductsofungulatesandpoultry
(withtheexceptionofserumfromequidae)
I.Freshbloodandbloodproductsintendedforhumanconsumption
A.Trade
1.Tradeinfreshbloodofungulatesandpoultryintendedforhumanconsump-
tionissubjecttotheanimalhealthconditionsapplicabletotradeinfresh1992L0118—EN—01.01.2001—010.001—15
▼M7
▼M7
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.
II.Fresh blood and blood products not intended for human consumption
A. Definitions
Forthepurposesofthispoint,thefollowingdefinitionsshallapplyblood:
— whole blood defined as ‘low-risk material’ within the meaning of Directive
90/667/EEC;
blood products:
— fractions of blood which may have undergone treatment other than that
providedforinDirective90/667/EEC,
or
— bloodwhichhasundergonetreatment otherthanthatprovidedforinDirec-
tive90/667/EEC;
products used for in vitro diagnosis:
— a packaged product, ready for use by the end user, containing a blood
product, and used as a reagent, reagent product, calibrator, kit or any other
system,whetherusedalone orincombination, intended to beused in vitrofor
the examination of samples of human or animal origin, with the exception ofdonatedorgansorblood,solelyorprincipallywithaviewtothediagnosisofa
physiological state, state of health, disease or genetic abnormality or to deter-
minesafetyandcompatibilitywithreagents;
laboratory reagent:
— a packaged product, ready for use by the end user, containing a blood
product, and intended for laboratory use as a reagent or reagent product,
whetherusedaloneorincombination;
full treatment:
— heattreatmentatatemperatureof65ºCforatleastthreehours,followedby
aneffectivenesscheck,
or
— irradiationat2,5megaradsorbygammarays,followedbyaneffectiveness
check,or
— changeinpHtopH5fortwohours,followedbyaneffectivenesscheck,
or
— thetreatmentprovidedforinChapter4ofthisAnnex,
or
— anyothertreatmentorprocesstobelaiddowninaccordancewiththeproce-
durelaiddowninArticle18.1992L0118—EN—01.01.2001—010.001—16
(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
B. Trade
Tradeinbloodandbloodproductsissubjecttotheanimalhealthconditions
laiddowninChapterIIofthisDirectiveandtotheconditionslaiddownin
Directive90/667/EEC.
C. Imports
1. Imports of blood are subject to the animal health conditions laid down in
Chapter10ofthisAnnex.
2. (a) Imports of blood products are authorized provided that each consign-
ment is accompanied by a certificate, the form of which is to be fixed
pursuanttotheprocedurelaiddowninArticle18,certifyingthat:
— the products originate in a third country in which no case of foot-
and-mouth disease hasbeen recorded within at least 24 monthsand
no case of vesicular stomatitis, swine vesicular disease, rinderpest,
peste des petits ruminants, Rift Valley fever, blue tongue, African
horsesickness,classicalswinefever,Africanswinefever,Newcastle
disease or avian influenza has been recorded for 12 months in the
susceptible species and in which vaccination has not been carried
outagainstthosediseasesforatleast12months.Thehealthcertifi-
catemaybemadeoutaccordingtothespeciesofanimalfromwhich
thebloodproductsarederived,
or
— in the case of blood products derived frombovine anim als, they
originate in an area of a third country fulfilling the conditions set
out in the first indent from which imports of bovine animals, their
fresh meat or their sperm are authorized pursuant to Community
legislation. The blood fromwhich such products are m anufactured
must be from bovine animals from that area of the third country
andmusthavebeencollected:
— in slaughterhouses approved in accordance with Community
legislation,
or
— in slaughterhouses approved and supervised by the competent
authorities of the third country. The Commission and Member
States must be notified of the address and approval number of
suchslaughterhouses,
or
— inthecaseofbloodproductsderivedfrombovineanimals,theyhave
undergone full treatment guaranteeing the absence of pathogens ofthebovinediseasesreferredtointhefirstindent,
or
— in the case of blood products derived frombovine anim als, they
fulfiltheconditionslaiddowninChapter10ofthisAnnex.Insuch
cases, the packaging may not be opened during storage and the
processingundertakingmustcarryoutfulltreatment oftheproducts
concerned.
(b) Thespecificconditionsrelatingtoimportsofproductsforusein in vitro
diagnosisandlaboratory reagents shallbeestablished, wherenecessary,inaccordancewiththeprocedurelaiddowninArticle18.
III.General provisions
The detailed rules for the application of this Chapter are to be adopted,
wherenecessary,inaccordancewiththeprocedurelaiddowninArticle18.
CHAPTER8
Serumfromequidae
1. In order to be the subject of trade, serum must come from equidae which
show none of the serious transmissible diseases referred to in Directive 90/
426/EEC(
1) or of the serious transmissible diseases to which equidae are
susceptibleandhavebeenobtainedinbodiesorcentresnotsubjecttohealthrestrictionspursuanttothatDirective.
2. Serumfromequidaemaybeimportedonlyifitcomesfromequidaebornand
raisedinathirdcountryfromwhichtheimportationofhorsesforslaughteris1992L0118—EN—01.01.2001—010.001—17
(1) OJNo L 224, 18. 8. 1990, p. 42. Directive as last amended by Decision 92/130/EEC
(OJNoL47,22.2.1992,p.26).▼B
▼B
authorized and was obtained, processed and dispatched in conditions to be
specifiedundertheprocedurelaiddowninArticle18.
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;
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.
CHAPTER10
Raw material for the manufacture of animal feedingstuffs and pharmaceu-
ticalortechnical products
1. Raw material means fresh meat, glands, organs and other offal as well as
intestinal mucuses which are not intended for human consumption. Raw
materialshallberegardedasfreshifithasonlyundergonerefrigerationor
other treatment not resulting in sufficiently safe destruction of pathogenic
agents. The substances involved may only be low-risk substances within
themeaningofDirective90/667/EEC.
2. Raw material must be accompanied by a commercial document or certifi-
cate, provided for in Article 13 (2) of Directive 90/667/EEC, or a
certificate complying with the model to be laid down under the procedure
provided for in Article 18 and must satisfy the requirements of Decision
92/183/EEC.
3. Intradetheoriginalofthehealthcertificate orcommercial documentmust
be submitted to the veterinary authorities responsible for the processing
plantandtheintermediate storagewarehouse—coldstoragefacility —or
sorting facility; in the case of imports into the Community, it must be
submittedtothebordercontrolauthority.
4. The raw material must be transported directly to approved or registered
processing plants which meet the conditions laid down in Directive 90/
667/EEC or to cold-storage facilities approved for intermediate storage.
Prior to processing, raw material for manufacturing pharmaceuticals may
alsobesortedandstoredinfacilitiesspeciallyapprovedforthepurposeby
the Member States. Member States shall inform the Commission of the
approvalofsuchsortingfacilities.
5. Therawmaterialmaybetransportedtotheprocessingplantonlyinwater-
tight and properly sealed containers or vehicles. The legend ‘Only for the
manufacture of petfood’ or ‘Only for the manufacture of pharmaceuticals
or technical products’ must appear on the recipients and accompanying
documents, depending on the intended purpose. The name and address of
theconsigneeundertakingmustappearonthecontainersandaccompanying
papers.
6. The vehicles and containers used to transport the goods, together with all
items of equipment or appliances which have come into contact with the
untreatedrawmaterial,mustbecleanedanddisinfected.Packagingmaterial
mustbeincineratedordisposedofbysomeothermeansinaccordancewith
instructionsfromtheofficialveterinarian.
7. Intermediate storage of the raw material shall be permissible only in cold
storage facilities approved for the purpose, subject to authorization and1992L0118—EN—01.01.2001—010.001—18
▼B
underthesupervisionoftheofficialveterinarian.Therawmaterialmustbe
stored separately fromother goods and in such a way as to prevent any
propagationofepizooticdiseases.
8. Attheprocessingplanttherawmaterialshallbetreatedinsuchawayasto
kill any pathogenic agents and rule out any danger to domestic herds.
Removal of raw material from the plant for safe disposal in processing
plants approved or registered for the purpose in accordance with Directive
90/667/EEC shall be permissible only in exceptional cases and with the
authorization ofthe official veterinarian. The provisionsof points5,6and
9shall apply correspondingly tothe transportation oftherawmaterial and
tothenotificationoftheofficialveterinarianresponsiblefortheprocessing
plant.
9. Whentherawmaterialistransportedfromtheplantoforigin,orbeyondthe
Community'sexternalborder:
— theofficialveterinarianresponsiblefortheplantoforigininthecaseof
intra-Communitytrade,or
— theborderinspection authority inthecaseofimportsintotheCommu-
nity
shall notify the official veterinarian responsible for the processing plant,
intermediate storage warehouse or sorting facility of that fact by means of
the‘Animosystem’,bytelexorbyfax.
10. ImportsintotheCommunityarealsosubjecttothefollowingprovisions:
(a) MemberStates shall authorize theimportation ofrawmaterial intothe
Community only from third countries which appear on the list laid
down in Council Decision 79/542/EEC or in a special Commission
Decisiononaspecificrawmaterial;
(b) following the border check the raw materials shall, under the supervi-
sion of the competent veterinary authority, be transported either
directly to an approved or registered processing plant which is under
theconstantsupervisionofanofficialveterinarianandhasgivenaguar-
anteethattherawmaterialswillbeusedonlyforthepermittedpurpose
andthattheywillnotleavetheplantuntreated,ortoanapprovedinter-
mediatestorageorapprovedsortingfacility;
(c) the health certificate bearing the file mark of the border inspection
authority or a certified copy of that certificate must accompany the
goodsuntiltheyreachthedestinationplant.
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—01.01.2001—010.001—19
(1) OJNoL268,24.9.1991,p.25.
(2) OJNoL268,24.9.1991,p.41.
▼B
CHAPTER12
Apicultureproducts
1. Apicultureproductsintendedexclusivelyforuseinapiculture:
(a) must not come from an area which is the subject of a prohibition order
associatedwithanoccurrenceofAmericanfoulbroodoracarioasis,ifin
thecaseofacarioasistheMemberStateofdestinationhasobtainedaddi-
tional guarantees in accordance with Article 14 (2) of Directive 92/65/
EEC(1);
(b) mustmeettherequirementsimposedbyArticle8(a)ofDirective92/65/
EEC.
2. Anyderogationsmustbeestablished, asnecessary,undertheprocedure laid
downinArticle18ofthisDirective.
CHAPTER13
Gametrophies
A. Without prejudice to the measures adopted pursuant to Regulation (EEC)
3626/82(2),tradeinandimportsofgametrophies:
(i) ofungulatesandbirdshavingundergoneacompletetaxidermytreatment
ensuringtheirpreservationatambienttemperatures;
(ii) ofspeciesotherthanungulatesandbirds;
shallnotbesubjecttoanybanorrestrictionforreasonsofanimalhealth.
B. Without prejudice to the measures adopted pursuant to Regulation (EEC)
No 3626/82, trade in and imports of game trophies of ungulates and birds
not having undergone the treatment mentioned in A (I) shall be subject to
thefollowingconditions:
1. withregardtotrade:
gametrophiesmusteither:— comefromanimalsoriginatinginanareanotsubjecttorestrictionsas
a result of the presence of serious transmissible diseases to which
animalsofthespeciesconcernedaresusceptible,
or:
— comply with the conditions laid down in 2 (b) or (c) if they come
fromanim als originating in an area subject to restrictions as a result
ofthepresence ofserioustransmissible diseasestowhichanimals of
thespeciesconcernedaresusceptible;
2. withregardtoimports:
(a) in respect of game trophies consisting of entire anatomical parts not
havingbeentreatedinanyway:
thetrophiesmust:
— come from animals in respect of which the import into the
Community of all categories of fresh meat of the species
concerned which has not undergone any formof treatm ent is
authorizedpursuanttoCommunityrules,
— be packaged immediately, without being in contact with other
products of animal origin likely to contaminate them, in indivi-
dual, transparent and closed packages so as to avoid any
subsequentcontamination,
— be accompanied by a veterinary certificate certifying that the
aboveconditionshavebeenmet.
Furthermore, duringthe taxidermy treatment, the wastewhich isnot
partofthetrophymustbedestroyed;
(b) inrespectofgametrophiesconsistingsolelyofbone,horns,hooves,
claws,antlersorteeth:
thetrophiesmust:— havebeenimmersedinboilingwaterforanappropriatetimesoas
to ensure that any matter other than bone, horns, hooves, claws,
antlersorteethisremoved,1992L0118—EN—01.01.2001—010.001—20
(1) OJNoL268,14.9.1992,p.54.
(2) OJNoL384,31.12.1982,p.1.▼M1
▼M1
— havebeendisinfectedwithaproductauthorizedbythecompetent
authority in the country of dispatch, in particular with hydrogen
peroxidewherepartsconsistingofboneareconcerned,
— be packaged, immediately after treatment, without being in
contactwithotherproductsofanimaloriginlikelytocontaminate
them, in individual, transparent and closed packages so as to
avoidanysubsequentcontamination,
— be accompanied by a document or certificate certifying that the
aboveconditionshavebeenmet;
(c) inrespectofgametrophiesconsistingsolelyofhideorskin:
— thetrophiesmust:
— havebeeneither:
(i) dried;
or:
(ii) dry-orwet-saltedforaminimumof14daysbeforedispatch;
or:
(iii) preserved by a treatment other than tanning to be fixed
accordingtotheprocedureprovidedforinArticle18,
— be packaged, immediately after treatment, without being in
contactwithotherproductsofanimaloriginlikelytocontaminate
them, in individual, transparent and closed packages so as to
avoidanysubsequentcontamination,
— be accompanied by a document or certificate certifying that the
aboveconditionshavebeenmet.
CHAPTER14
Manure
For the purposesof this Chapter manure means any excrement and/or urine of
cloven-hoofedanimals,equidaeand/orpoultry,withorwithoutlitter,andguano.
I. Unprocessedmanure
A.Trade in unprocessed manure
1. (a) Tradeinunprocessedmanureofspeciesotherthanpoultryorequidaeis
prohibited,exceptformanure:
fromanareaorholdingwhichisnotsubjecttorestrictionsbyvirtueofa
serioustransmissibledisease,
and
intendedforspreadingunderthecontrolofthecompetent authorities on
landformingpartoforbelongingtothesameholding,whetherseparated
ornot,locatedonbothsidesofthefrontierbetweenMemberStatesand
withinadistanceofapproximately20kilometres.Recordsshouldbekept
by the owner of the holding concerning these cross-frontier movements
in order to be approved. The competent authority shall keep a register
ofsuchapprovedholdings.
(b) However, in derogation to (a), a Member State may grant specific
approvalfortheintroductionontoitsterritory:
— of manure intended for processing in an establishment specifically
approved for that purpose by the competent authorities with a view
tothemanufactureoftheproductsreferredtounderIIbelow.When
suchestablishmentsarebeingapproved,accountistobetakenofthe
originofthemanure,or
— of manure intended for spreading on a holding. Such trade can only
occur with the consent of the competent authorities of both the
Member State of origin and of destination. When giving consent,
account is to be taken in particular of the origin of the manure, its
destinationandanimalhealthandsafetyconsiderations.
Insuchcasesthemanureistobeaccompaniedbyahealthcertificatethat
conformstothemodellaiddownintheprocedureprovidedforinArticle
18.
2. Tradeinunprocessedpoultrymanureissubjecttothefollowingconditions:
(a) themanuremustoriginateinanareawhichisnotsubjecttorestrictions
byvirtueofNewcastlediseaseoravianinfluenza;1992L0118—EN—01.01.2001—010.001—21
▼M5
▼M11
▼M5
▼M5
(b) in addition, unprocessed, manure from poultry flocks vaccinated against
Newcastlediseasemustnotbedispatchedtoaregionwhichhasobtained
Newcastle disease non-vaccinating status pursuant to Article 12 (2) of
Directive90/539/EEC;
(c) themanureistobeaccompaniedbyahealthcertificatethatconformsto
themodellaiddownintheprocedureprovidedforinArticle18.
3. Tradeinunprocessedmanureofequidaeisnotsubjecttoanyanimalhealth
conditions.
B.Imports of unprocessed manure
Importsofunprocessedmanurearesubjecttothefollowingconditions:
1. themanuremustsatisfy,accordingtothespeciesconcerned,therequirements
underA(1)(a)above;
2. the manure must be accompanied by a certificate as provided for in Article
10.
II. Processedmanureandprocessedmanureproducts
All organic fertilizers must have been treated to ensure that the product is
pathogen-free.
A. Tradeinprocessedmanureandprocessedmanureproductsissubjecttothe
followingconditions:
1. theymustcomefromanestablishmentapprovedbythecompetentautho-
rities;
2. theymust:
— befreefromsalmonella(nosalmonellain25gtreatedproduct),
— befreefromenterobacteriaceae (basedontheaerobicbacteria count:
<1000cfupergramoftreatedproduct),
— have beensubjected toreduction inspore-formingbacteria andtoxin
formation;
3. theymustbestoredinsuchawaythat,onceprocessed,contaminationor
secondaryinfectionanddampnessisimpossible.
Theymustthereforebestoredin:— well-sealedandinsulatedsilos,or
— properlysealedpacks(plasticbagsor‘bigbags’).
B. Imports of processed manure and processed manure products are subject to
thefollowingconditions:
1. theymustsatisfytherequirementsunderAabove;
2. theymustbeaccompaniedbyacertificateasprovidedforinArticle10.
III. Guano
Tradeinandimportsof‘guano’arenotsubjecttoanyanimalhealthconditions.
CHAPTER15
Unprocessedwool,hair,bristles,feathersandpartsoffeathers
1. Sheep'swool,ruminanthairandpigbristlesshallbeconsideredtobe‘unpro-
cessed’ if they have not undergone factory washing or been obtained from
tanning,andfeathersandpartsoffeathersshallbeconsidered‘unprocessed’
iftheyhavenotbeentreated withasteamcurrentorbysomeothermethod
ensuringthatnopathogensaretransmitted.
2. Unprocessed sheep's wool, ruminant hair, pig bristles, feathers and parts of
feathers (the goods) may only be traded in or imported if they are securely
enclosedinpackaginganddry.However,tradeinandimportsofpigbristles
fromcountries or regions in which African swine fever is endem ic are
prohibitedexceptforpigbristleswhich:
(a) havebeenboiled,dyedorbleached;or
(b) have undergone some other form of treatment which is certain to kill
pathogenic agents, provided that evidence to this effect is submitted in
the formof a certificate fromthe veterinarian responsible for the place
of origin. Factory washing shall not be regarded as a formof treatm ent
forthepurposesofthisprovision.1992L0118—EN—01.01.2001—010.001—22
▼B
▼B
3. Theprovisionsofthischaptershallnotapplytotradeorimportsofdecora-
tivefeathersorfeathers:
(a) carriedbytravellersfortheirprivateuse;or
(b) which are the subject of trade in or imports into the Community in the
formof consignm ents sent to private individuals for non-industrial
purposes.
4. Thegoodsmustbesentdirectlytotheplantofdestinationorthewarehouse
for storage in conditions such that any spread of pathogenic agents is
avoided.1992L0118—EN—01.01.2001—010.001—23
▼B
ANNEXII
SPECIFICPUBLICHEALTHCONDITIONS
CHAPTER1
Importsfromthirdcountriesofmeatproductsobtainedfrompoultrymeat,
farmedgamemeat,wildgamemeatandrabbitmeat
MemberStatesshallensurethatmeatproductsobtainedfrompoultrymeat,
farmedgamemeat,wildgamemeatandrabbitmeatarenotimportedunless:
(a)eithertheycomefromathirdcountrylistedinaccordancewith:
(i)Article9ofDirective91/494/EECforpoultrymeat;
(ii)Article16ofDirective92/45/EECforwildgamemeat;
(iii)Chapter2ofAnnexItothisDirectiveforrabbitmeatandfarmedgame
meat,
eithertheycomefromathirdcountrylistedintheAnnex,PartIofDecision79/542/EEC.Inthiscasetheymusthaveundergoneaheattreatmentina
sealedcontainer,theF
ovaluebeingequalorover3,00.Howeverformeat
productsmadefromspeciesotherthanswine,thistreatmentmaybereplacedbyaheattreatmentwhichbringstheinternaltemperaturetoatleast
70ºC.
(b)thefreshmeatusedmeetstheappropriaterequirementsofArticle14of
Directive71/118/EECforpoultrymeat,Article16ofDirective92/45/EEC
forwildgamemeat,Article3ofDirective91/495/EECforrabbitmeatand
Article6ofthatDirectiveforfarmed-gamemeat;
(c)theycomefromanestablishmentofferingthesameguaranteesasthose
referredtoinDirective77/99/EECandapprovedinaccordancewiththe
procedureprovidedforinArticle18or,pendingtheadoptionofsucha
decision,bythecompetentauthorityoftheMemberStatewithimportsof
theseproductsremainingsubjecttotherulesinArticle11(2)ofDirective
90/675/EEC;
(d)theyareprepared,checkedandhandledinaccordancewiththeappropriate
requirementsprovidedforinDirective77/99/EEC;
(e)eachconsignmentofmeatproductsisaccompaniedbyahealthcertificate
establishedinaccordancewiththeprocedureprovidedforinArticle18.
CHAPTER2
►
M8Before1July1997 ◄,thehealthconditionsapplicabletothefollowing
shallbeestablishedinaccordancewiththeprocedurelaiddowninArticle18:
—puttingonthemarketinandimportsofeggsandimportsofeggproducts
intendedforhumanconsumption,withoutprejudicetotheruleslaiddown
withintheframeworkofthecommonorganizationofthemarket.
InrespectofsalmonellaandpendingtheadoptionofCommunityprovisions,
thefollowingrulesshallapplyforeggsintendedforFinlandandSweden:
(a)consignmentsofeggsmaybesubjecttoadditionalgeneralorlimited
guaranteesdefinedbytheCommissionfollowingtheprocedureprovided
forinArticle18;
(b)theguaranteesprovidedforin(a)shallnotbecarriedoutforeggsorigi-
natinginanestablishmentsubjecttoaprogrammerecognizedas
equivalenttothatreferredtoin(c),pursuanttotheprocedureprovided
forinArticle18;
(c)theguaranteesprovidedforin(a)shallapplyonlyafterapprovalbythe
CommissionofanoperationalprogrammetobepresentedbyFinland
andSweden.TheCommissiondecisionsmustbetakenbeforethedate
ofentryintoforceoftheAccessionTreatyinorderfortheoperational
programmesandtheguaranteesprovidedforin(a)tobeapplicableas
fromthedateofentryintoforceoftheAccessionTreaty,
—tradeinandimportofhoney ►M6 ◄intended for human
consumption,1992L0118—EN—01.01.2001—010.001—24
▼M3
▼B
▼A1
▼M10
▼B
▼M8
—tradeinandimportsofmilkandmilk-basedproductsintendedforhuman
consumption,obtainedfromspeciesnotcoveredbyDirective92/46/EEC;
dependingonthespecies,specificrequirementsmaybelaiddownas
regards:
—animalhealthandthehealthstatusofdairyherds,inparticularwith
regardtotuberculosisandbrucellosis;
—hygieneinrespectof
—milking,
—thecollection,transport,treatmentandprocessingofmilk,—staff,
—testingforresiduesofpharmacologicallyand/orhormonallyactive
substances,antibiotics,pesticidesorotherharmfulsubstancesinmilkor
milkproducts,
—criteriaapplicabletorawmilkasarawmaterial,
—microbiologicalcriteriaapplicabletofinishedproducts,
—theproduction,placingonthemarketandimportationofmeatofspeciesnot
coveredbyspecificrequirements,andinparticularreptilemeatandproducts
thereof,intendedforhumanconsumption.
Dependingonthespecies,specificrequirementsmaybelaiddownas
regards:
—microbiologicalandparasitologicalcriteria,
—hygieneduringslaughter,
—testingforresidues.
CHAPTER3
I.Specificpublichealthconditionsapplicabletotradeinandimportsof
snailsintendedforhumanconsumption
A.WithoutprejudicetoCommunity,nationalorinternationalprovisionson
theprotectionofwildlife,forthepurposeofthisChapter,‘snails’means
terrestrialgastropodsofthespecies HelixpomatiaLinné,Helixaspersa
Muller,Helixlucorum andspeciesofthefamilyof Achatinidae.
B.MemberStatesmustensurethatshelled,cookedandpreparedor
preservedsnailsaretradedforhumanconsumptiononlyiftheymeet
thefollowingconditions:
(1)Theymustcomefromestablishments:
—whichmeettherequirementsofArticle4(2)ofthisDirective,
—whichareapprovedbythecompetentauthorityinaccordance
withtherequirementsofChaptersIIIandIVoftheAnnexto
Directive91/493/EEC,
—whichundergomonitoringbythecompetentauthorityofproduc-
tionconditionsandhealthchecksinaccordancewithChapterV
(I)(3)and(5)and(II),(3)and(4)ofDirective91/493/EEC,
—whichconductownchecksinaccordancewiththeprovisionsof
CommissionDecision94/356/EC.
(2)Theymustbesubjectedtoorganolepticcheckscarriedoutby
sampling.Iftheorganolepticexaminationrevealsthatthesnailsarenotfitforhumanconsumption,measuresmustbetakentowithdraw
themfromthemarketanddenatureinsuchawaythattheycannotbe
re-usedforhumanconsumption.
(3)Forthepreparationofshelledsnailmeat,
(a)dependingonthescaleoftheoperation,establishmentsmustset
asidespecialroomsorareasfor:
—thestorageofpackagingandwrappingmaterials,
—thereceptionandstorageoflivesnails,
—washing,blanchingorboiling,shellingandtrimming,
—thestorageand,wherenecessary,cleaningandtreatmentof
shells,
—theheattreatmentofthesnailmeat,wherenecessary,—thewrappingorpackagingofthesnailmeat,
—thestorageofthefinishedproductincoldstores;
(b)thesnailsmustbecheckedbeforebeingboiled.Deadsnailsmust
notbepreparedforhumanconsumption;
(c)followingshelling,thehepatopancreasremovedduringtrimming
mustnotbeusedforhumanconsumption.1992L0118—EN—01.01.2001—010.001—25
▼M6
▼M6
(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 andmethods 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—01.01.2001—010.001—26
▼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—01.01.2001—010.001—27
▼M6
1992L0118—EN—01.01.2001—010.001—28
▼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 frogslegs 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.Thedeathoffrogsmustonlybecarriedoutbyslaughterinanapprovedestab-
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 to
Directive91/493/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 VIandVIIIofDirective91/493/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 theproductionestablishmentinindelibleprint.
(2) The following is an example of the specimen health certificate laid
downinArticle10(2)(c)ofthisDirective, whichmustaccompanyeveryconsignmentoffrogs'legsoriginatinginthirdcountries:1992L0118—EN—01.01.2001—010.001—29
▼M6
SPECIMEN HEALTH CERTIFICATE FOR CHILLED, FROZEN OR PREPARED FROGS' LEGS
ORIGINATINGINTHIRDCOUNTRIESANDINTENDEDFORTHEEUROPEANCOMMUNITY
Note to the importer: Thiscertificateisforveterinarypurposesonlyandmustaccompanytheconsign-
mentuntilitreachestheborderinspectionpoint.
1992L0118—EN—01.01.2001—010.001—30
▼M6
1992L0118—EN—01.01.2001—010.001—31
▼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—01.01.2001—010.001—32
▼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—01.01.2001—010.001—33
(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—01.01.2001—010.001—34
▼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—01.01.2001—010.001—35
(1) OJL120,11.5.1994,p.44.
▼M10
VIII.Modelofcommercialdocumentforrawmaterialdestinedtotheproductionofgelatinefor
humanconsumption
1992L0118—EN—01.01.2001—010.001—36
▼M10
1992L0118—EN—01.01.2001—010.001—37
▼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—01.01.2001—010.001—38
▼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—01.01.2001—010.001—39
▼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—01.01.2001—010.001—40
▼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—01.01.2001—010.001—41