1993L0099—EN—20.11.2003—001.001—1
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►B COUNCILDIRECTIVE93/99/EEC
of29October1993
onthesubjectofadditionalmeasuresconcerningtheofficial controloffoodstuffs
(OJL290,24.11.1993,p.14)
Amendedby:
OfficialJournal
No page date
►M1Regulation (EC) No 1882/2003 of the European Parliament and of the
Councilof29September2003L284 1 31.10.2003
▼B
COUNCILDIRECTIVE93/99/EEC
of29October 1993
on the subject of additional measures concerning the official
controloffoodstuffs
THECOUNCILOFTHEEUROPEANCOMMUNITIES,
Having reagard to the Treaty establishing the European EconomicCommunity,andinparticularArticle100athereof,
HavingregardtotheproposalfromtheCommission(
1),
IncooperationwiththeEuropeanParliament(2),
Having regard to the opinion of the Economic and Social
Committee(3),
Whereasitisnecessarytoadoptmeasuresinthecontextoftheinternal
market;whereastheinternalmarketcomprisesanareawithoutinternalfrontiers in which the free movement of goods, persons, services andcapitalisensured;
Whereas trade in foodstuffs occupies a very important place in the
internalmarket;
Whereas it is therefore essential that the application of Council direc-
tive 89/397/EEC of 14 June 1989 on the official control of
foodstuffs(
4) is uniformthroughout the Mem ber States; whereas this
Directivelaysdowngeneralrulesontheofficialcontroloffoodstuffs;
Whereas there is a need for additional rules designed to improve the
controlproceduresinforceintheCommunity;
WhereasMemberStatesshouldtakethenecessaryactiontoensurethat
the staff of the competent authorities have sufficient technical andadministrativecompetence;
Whereas,inordertoguarenteethequalityofthetestdata,asystemof
qualitystandardsshouldbeintroducedforlaboratoriesentrustedbythe
Member States with the official control of foodstuffs; whereas such asystemshouldcomplywithgenerallyacceptedandstandardizednorms;whereas,inaddition,itisessentialthattheselaboratoriesusevalidatedmethodsofanalysis,wheneverpossible;
Whereas the development of trade in foodstuffs between the various
Member States necessitates closer cooperation between the authorities
involvedinthecontroloffoodstuffs;
WhereasgeneralrulesarerequiredfortheCommissionofficialsspecia-
lized inthecontrol offoodstuffswhocooperate withspecific officialsof the Member States in order to ensure the uniform application oflegislationonfoodstuffs;
Whereas provisions should be laid down under which the national
authorities and the Commission must provide mutual administrative
assistancewithaviewtoensuringproperapplicationofthelegislation
onfoodstuffs,inparticularthroughpreventiveactionandthedetectionofinfringementsorbehavioursuspectedofinfringingtherules;
Whereas,inviewofthenatureoftheinformation exchangedpursuant
tothisDirective,itshouldbecoveredbytherequirementsofcommer-cialorprofessionalsecrecy;
Whereasaprocedureshouldbeprovidedfortoestablishclosecoopera-
tionbetweentheMemberStatesandtheCommission,1993L0099—EN—20.11.2003—001.001—2
(1) OJNoC51,26.2.1992,p.20.
(2) OJ No C 337, 21. 12. 1992, p. 143 and Decision of 27 October 1993 (not
yetpublishedintheOfficialJournal).
(3) OJNoC332,16.12.1992,p.5.
(4) OJNoL186,30.6.1989,p.23.
▼B
HASADOPTEDTHISDIRECTIVE:
Article 1
1. ThisDirectivesupplementsDirective89/397/EEC.
2. ForthepurposesofthisDirective,theprovisionsofArticle1(2),
(3)and(4)ofDirective89/397/EECapply.
Article 2
Member States shall ensure that the competent authorities have, or
have access to, a sufficient number of suitably qualified and experi-enced staff, in particular in areas such as chemistry, food chemistry,veterinary medicine, medicine, food microbiology, food hygiene, foodtechnology and law so that the controls referred to in Article 5 of
Directive89/397/EECcanbecarriedoutadequately.
Article 3
1. Member States shall take all measures necessary to ensure that
the laboratories referred to in Article 7 of Directive 89/397/EECcomplywiththegeneralcriteriafortheoperationoftestinglaboratorieslaid down in European Standard EN 45001 supplemented by standardoperating procedures and the randomaudit of their com pliance byquality assurance personnel, in accordance with the OECD principles
No 2 and 7 of good laboratory practice as set out in Section II of
Annex2totheDecisionoftheCounciloftheOECDof12May1981concerning the mutual acceptance ofdata inthe assessment ofchemi-cals.
2. In assessing the laboratories referred to in Article 7 of Directive
89/397/EEC,MemberStatesshall:
(a) applythecriterialaiddowninEuropeanStandardEN45002;and
(b) requiretheuseofproficiencytestingschemesasfarasappropriate.
Laboratoriesmeetingtheassessmentcriteriashallbepresumedtofulfil
thecriteriareferredtoinparagraph1.
Laboratories which do not meet the assessment criteria shall not be
consideredaslaboratoriesreferredtoinArticle7ofthesaidDirective.
3. Member States shall designate bodies responsible for the assess-
ment of laboratories as referred to in Article 7 of Directive 89/397/
EEC.ThesebodiesshallcomplywiththegeneralcriteriaforlaboratoryaccreditationbodieslaiddowninEuropeanStandardEN45003.
4. The accreditation and assessment of testing laboratories referred
tointhisArticlemayrelatetoindividualtestsorgroupsoftests.Any
appropriate deviation in the way in which the standards referred to inparagraphs1,2and3areappliedshallbeadoptedinaccordance withtheprocedurelaiddowninArticle8.
Article 4
Member States shall ensure that the validation of methods of analysis
usedwithin the context ofofficial control offoodstuffsbythe labora-tories referred to in Article 7 of Directive 89/397/EEC comply
whenever possible with the provisions of paragraphs 1 and 2 of the
Annex to Council Directive 85/591/EEC of 23 December 1985concerning the introduction of Community methods of sampling andanalysisforthemonitoringoffoodstuffsintendedforhumanconsump-tion(
1).
Article 5
1. The Commission shall appoint and designate specific officials to
cooperate with the competent authorities of the Member States to1993L0099—EN—20.11.2003—001.001—3
(1) OJNoL372,31.12.1985,p.50.
▼B
monitorandevaluatetheequivalenceandeffectivenessofofficialfood
control systems operated by the competent authorities of the MemberStates. The Commission shall send regular reports to the Member
Statesconcernedontheworkofitsspecificofficials.
The Commission shall ensure that such officials are suitably qualified
andpossesstheappropriateknowledgeandexperiencetocarryoutthistask; detailed rules of application may be adopted in accordance withtheprocedurelaiddowninArticle8.
The competent authorities of the Member States shall cooperate with
theCommission'sdesignated officialsandgiveallthenecessaryassis-
tancetoenablethemtoaccomplishtheirtasks.
2. Inpursuante ofthedutiessetoutinparagraph 1,MemberStates
shall permit the Commission's designated officials to accompany theofficials of their competent authorities carrying out the operationsprovided for in Article 5 of Directive 89/397/EEC. In any event, the
officialsofthecompetentauthoritiesoftheMemberStatesshallremain
responsibleforthecarryingoutofthecontroloperations.
TheCommission shallgiveMember Statesatleast fiveworkingdays'
noticebeforethestartoftheseoperations.Aftertheexecution ofeachoperationreferredtointhisparagraphtheCommissionshallforwardareport on the work of its specific officials to the Member States
concerned.
For the purpose of the operations referred to in this paragraph, the
Commission's designated officials shall produce written authorizationspecifyingtheiridentityandstatus.
TheCommission'sdesignatedofficialsshallcomplywiththerulesand
practices which officials of the competent authorities of the Member
Statesmustfollow.
3. The Commission shall present an annual report to the Member
States and to the European Parliament on the implementation of thisArticle.
Article 6
1. ThecompetentauthoritiesoftheMemberStatesshallaffordeach
otheradministrativeassistanceinallsupervisoryproceduresinconnec-tionwithlegalprovisionsandqualitystandardsapplicabletofoodstuffs
andinallproceedingsforinfringementsofthelawapplicabletofood-
stuffs.
2. To facilitate this administrative assistance each Member State
shalldesignateasingleliaisonbody.ItshallbeforthebodydesignatedbytheMemberStatetoliaiseasappropriatewiththeliaisonbodiesofotherMemberStates.Theroleofthebodiesshallbetoassistandcoor-
dinatecommunicationand,inparticular,thetransmissionandreception
ofrequestsforassistance.
3. Member States shall inform the Commission of all the relevant
details of their designated liaison body. The list of designated liaisonbodies and the relevant details shall be published in the ‘C’ series oftheOfficial Journal of the European Communities .
4. Upon receiving a reasoned request, the body concerned shall be
responsible for ensuring that the requesting body is provided with all
necessaryinformation,exceptthatwhichcannotbereleasedbecauseitis the subject of legal proceedings, enabling that body to guaranteecompliance with legal provisions and quality standards applicable tofoodstuffswithinitsjurisdiction.
5. Theinformationanddocumentsprovidedpursuanttoparagraph4
shallbeforwardedwithoutunduedelayeitherthroughtheliaisonbody
or directly, as appropriate. When original documents cannot be sent,copiesofthedocumentsmaybetransmitted.
6. When, duringtheexchange ofinformation, itbecomes clear that
theremayhavebeenacaseofnon-compliance ofCommunitylawsorrules or national law of either the receiving Member State or the1993L0099—EN—20.11.2003—001.001—4
▼B
sendingMemberState,thecompetentauthorityintheMemberStatein
whoseterritorytheallegednon-compliancehastakenplaceshallinduetimereportbacktothecompetentauthorityintheotherMemberState
— on any action that may have been undertaken to deal with the
allegednon-compliance,andalso
— on any action which has taken, including any action to try to
preventareoccurrenceoftheallegednon-compliance.
Sucha report may also be copied to the Commission onthe initiative
ofeitherthetransmittingorthereceivingMemberState.
7. ThisArticleshallapplywithoutprejudicetoCouncilDecision89/
45/EEC of 21 December 1988 on dangers arising from the use of
consumer products(
1) and Council Directive 92/59/EEC on general
productsafety(2).
Article 7
1. Information forwarded pursuant to Article 6 of this Directive, in
whateverform,iscoveredbyprofessionalsecrecy.Incriminalproceed-ings, the information can be used only with the prior consent of the
sending Member State in accordance with, for those Member States
whoare parties to them, the international conventions and agreementsinforceonmutualassistanceincriminalaffairs.
2. Where a Member State has rules permitting free access by
persons to information held by competent authorities, this fact mustbe revealed at the time of the request to another Member State orduring the exchange of information if no such request occurs. If thesending Member State indicates that the information involves matters
of professional or commercial secrecy, the receiving Member State
shall ensure that the information is not divulged more widely than isprovided under paragraph 1. If it is not possible for the receivingMemberStatetorestrictthegivingoutoftheinformationinthisway,it shall not be contrary to the terms of this Directive for the sending
MemberStatetowithholdtheinformation.
3. Anyrefusaltoprovideinformationaccordingtotheprovisionsof
thisArticlemustbejustified.
Article 8
1. TheCommissionshallbeassistedbytheStandingCommitteeon
theFoodChainandAnimalHealth,setupbyArticle58ofRegulation(EC)No178/2002(
3),hereinafterreferredtoas‘theCommittee’.
2. WherereferenceismadetothisArticle,Articles5and7ofDeci-
sion 1999/468/EC(4) shall apply, having regard to the provisions of
Article8thereof.
TheperiodlaiddowninArticle5(6)ofDecision1999/468/ECshallbe
setatthreemonths.
3. TheCommitteeshalladoptitsrulesofprocedure.
Article 9
1. Member States shall bring into force the laws, regulations and
administrativeprovisionsnecessarytocomply
— withthisDirective,exceptforArticle3,before1May1995,1993L0099—EN—20.11.2003—001.001—5
(1) OJNoL17,21.1.1989,p.51.Decisionasamended byDecision90/352/
EEC(OJNoL173,6.7.1990,p.49).
(2) OJNoL228,11.8.1992,p.24.
(3) OJL31,1.2.2002,p.1.
(4) CouncilDecision1999/468/ECof28June1999layingdowntheprocedures
forthe exercise ofimplementing powersconferred onthe Commission(OJ
L184,17.7.1999,p.23).▼M1
▼B
▼B
— withArticle3before1November1998.
TheyshallforthwithinformtheCommissionthereof.WhenMemberStatesadoptthesemeasures,theyshallcontainarefer-
encetothisDirectiveorshallbeaccompaniedbysuchreferenceonthe
occasion of their official publication. The methods of making such a
referenceshallbelaiddownbytheMemberStates.
2. MemberStatesshallcommunicatetotheCommissionthetextsof
the provisions of national law which they adopt in the field governedbythisDirective.
Article 10
ThisDirectiveisaddressedtotheMemberStates.1993L0099—EN—20.11.2003—001.001—6