1995L0053 — EN — 25.03.1999 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL DIRECTIVE 95/53/EC
of 25October 1995
fixing the principles governing the organization of official inspections in the field of animal
nutrition
(OJ L 265, 8.11.1995, p. 17)
Amended by:
Official Journal
No page date
►M1Council Directive 1999/20/EC of 22 March 1999 L80 20 25.3.1999
1995L0053 — EN — 25.03.1999 — 001.001 — 2
▼B
COUNCIL DIRECTIVE 95/53/EC
of 25October 1995
fixing the principles governing the organization of official inspec-
tions in the field of animal nutrition
THE COUNCIL OF THE EUROPEAN UNION,
HavingregardtotheTreatyestablishingtheEuropeanCommunity,andin particular Article 43 thereof,
Having regard to the proposal from the Commission(
1),
Having regard to the opinion of the European Parliament(2),
HavingregardtotheopinionoftheEconomicandSocialCommittee(3),
Whereas animal nutrition has become a very important aspect of
Community agriculture;
WhereasfixingatCommunityleveltheprinciplesgoverningtheorgan-
ization of official inspections in the field of animal nutrition helpssafeguardanimalhealth,humanhealthandtheenvironment,ensurethefairness of commercial transactions and protect the interests ofconsumers;
Whereasrulesmustbelaiddownfortheorganizationofofficialinspec-
tionsoffeedingstuffsinviewoftheverywiderangeofproductsused,the large volume of consignments of goods commercially traded, theintegrated structure of the sector and, in particular, the need to ensureboththewholesomenessofthefeedingstufftobeconsumedbyanimalsand the quality of the foodstuff;
Whereas,inordertoattainthedesiredobjective,theruleslaiddownin
this Directive must cover all products and substances used in animalnutrition in the Community; whereas inspections should therefore beorganized to cover products imported into or released for free circula-tion in the Community;
Whereas the definition of ‘competent authority' does not prevent
MemberStatesfromdelegatinginwholeorinparttheresponsibilityoftheauthorityforthepurposeofcarryingoutofficialschecksinthefieldofanimalnutrition,providedthatinspectionscontinuetobecarriedoutunder their authority;
Whereas, to be effective, inspections must be carried out regularly;
whereastheymustnotberestrictedastothesubject,stageormomentatwhich they are carried out; whereas they must take the most suitableforms to ensure their effectiveness;
Whereas,inordertoensurethatinspectionproceduresarenotevaded,it
isnecessarytoprovidethatMemberStatesshallnotexcludeaproductfromappropriateinspectiononthegroundsthatitisintendedforexportoutside the Community;
Whereas products from third countries must be subject to random
documentaryandidentitychecksonentryintotheCommunityterritory;
Whereas provision should be made for Member States to have the
possibility of designating entry points in order to ensure the efficientconduct of inspections of imported products, without prejudice to theprovisionslaiddowninotherrelevantCommunitylegislation,inpartic-
(1) OJ No C 313, 19. 11. 1993, p. 10.
(2) OJ No C 128, 9. 5. 1994, p. 97.
(3) OJ No C 127, 7. 5. 1994, p. 10.
1995L0053 — EN — 25.03.1999 — 001.001 — 3
▼B
ular Directives 90/675/EEC(1) and 92/118/EEC(2) concerning veter-
inary checks and animal health and public health requirements;
Whereas principles should be laid down to govern the organization of
andstepstobetakenfollowingthephysicalcheckstobecarriedoutbythe competent authorities;
Whereas,asregardsintra-Communitytrade,emphasisshouldbeplaced
onthecheckstobecarriedoutattheplaceoforigin;whereas,however,intheeventofapresumptionofirregularity,thecheckmay,exception-ally, be carried out while the products are in transit or at the place ofdestination;
Whereas this solution requires greater confidence in the inspections
carriedoutbytheMemberStateofdispatch;whereastheMemberStateof dispatch must ensure that such checks are carried out in an appro-priate fashion;
Whereasprovisionshouldbemadeforactiontobetakenwhereacheck
discloses that a consignment is irregular;
Whereas, for reasons of effectiveness, it is for the Member State of
dispatch to ensure that the products comply with Community rules;whereas,intheeventofinfringements,theCommissionmustbeabletotakeaction,incooperationwiththeMemberStatesconcerned,particu-larlybymakingon-the-spotvisitsandadoptingmeasuresappropriatetothe situation;
Whereas, in accordance with Council Directive 70/373/EEC(
3), all
methodsofsamplingandmethodsofanalysisnecessaryforcarryingoutofficialchecksonfeedingstuffsshouldbeadoptedatCommunitylevel;
Whereas, although undertakings should not have the right to oppose
inspections, their legitimate rights must nevertheless be preserved, inparticular the right to manufacturing secrecy and the right of appeal;
Whereastheauthoritiesresponsibleforinspectionsmaydifferfromone
Member State to another; whereas it is therefore desirable to publish alistofthecompetentauthoritiesinthefieldineachMemberState,withan indication of the territories for which they are competent and thelaboratories authorized to carry out analyses in connection with suchinspections;
Whereas, although it is primarily for the Member States to lay down
their inspection programmes, it is necessary, with a view to the properfunctioning of the internal market, to arrange also for coordinatedprogrammes at Community level;
WhereastheCommissionshouldbeentrustedwiththetaskofadopting
measures for applying this Directive,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
INTRODUCTORY PROVISIONS
Article 1
1. ThisDirectivesetsouttheprinciplesgoverningtheorganizationof
official inspections in the field of animal nutrition.
(1) OJ No L 373, 31. 12. 1990, p. 1. Directive as last amended by Regulation
(EEC) No 1601/92 (OJ No L 173, 27. 6. 1992, p. 13).
(2) OJ No L 62, 15. 3. 1993, p. 49. Directive as last amended by Commis-
sion Decision 94/723/EC (OJ No L 288, 9. 11. 1994, p. 48).
(3) OJ No L 170, 3. 8. 1970, p. 2. Directive as last amended by Regulation
(EEC) No 3768/85 (OJ No L 362, 31. 12. 1985, p. 8).
1995L0053 — EN — 25.03.1999 — 001.001 — 4
▼B
2. This Directive shall apply without prejudice to more specific
Community rules, in particular Community customs rules andCommunity veterinary rules.
Article 2
1. For the purposes of this Directive the following definitions shall
apply:
(a) ‘official inspection in the field of animal nutrition', hereinafter
called ‘inspection',means an inspection by the competent authori-tiestocheckcompliancewiththeCommunityprovisionslaiddownin:
— Council Directive 70/524/EEC of 23 November 1970
concerning additives in feedingstuffs(
1),
— Council Directive 74/63/EEC of 17 December 1973 on the
fixing of maximum permitted levels for undesirable substancesand products in feedingstuffs(
2),
▼M1
— CouncilDirective96/25/ECof29April1996onthecirculation
offeedmaterials,amendingDirectives70/524/EEC,74/63/EEC,82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC,
▼
B
— CouncilDirective79/373/EECof2April1979onthemarketing
of compound feedingstuffs(3),
— Council Directive 82/471/EEC of 30 June 1982 concerning
certain products used in animal nutrition(4),
— CouncilDirective93/74/EECof13September1993onfeeding-
stuffs intended for particular nutritional purposes(5), and
— any other rules in the field of animal nutrition in which provi-
sionismadeforofficialinspectionstobecarriedoutinaccord-ance with the provisions of this Directive;
(b) ‘documentarycheck'meansverificationofthedocumentsaccompa-
nying a product or of any other information provided on theproduct;
(c) ‘identity check'means verification, by visual inspection only, for
consistencybetweenthedocuments,thelabellingandtheproducts;
(d) ‘physical check' means a check of the product itself, including,
where appropriate, sampling and laboratory testing;
(e) ‘product' means feedingstuffs and all substances used in animal
nutrition;
(f) ‘competent authority'means the Member State’s authority respon-
sibleforcarryingoutofficialchecksinthefieldofanimalnutrition;
(g) ‘establishment'meansanyundertakingwhichproducesormanufac-
turesaproductorwhichholdstheproductatanintermediatestagebefore marketing or which markets the products;
(h) ‘marketing'meanstheholdingofproductswithaviewtotheirsale
orotherformsofdisposaltoothers,bywayofgiftorinreturnforpayment, and also sale and other forms of disposal themselves.
2. ThedefinitionsgivenintheCommunitylegislationrelatingtothe
field of animal nutrition shall apply where appropriate.
(1) OJ No L 270, 14. 12. 1970. Directive as last amended by Commission
Directive 94/77/EC (OJ No L 350, 31. 12. 1994, p. 113).
(2) OJ No L 38, 11. 2. 1974, p. 31. Directive as last amended by Commis-
sion Directive 94/16/EC (OJ No L 104, 23. 4. 1994, p. 32).
(3) OJ No L 86, 6. 4. 1979, p. 30. Directive as last amended by Directive
93/74/EEC (OJ No L 237, 22. 9. 1993, p. 23).
(4) OJ No L 213, 21. 7. 1982, p. 8. Directive as last amended by Directive
93/74/EEC (OJ No L 237, 22. 9. 1993, p. 23).
(5) OJ No L 237, 22. 9. 1993, p. 23.
1995L0053 — EN — 25.03.1999 — 001.001 — 5
▼B
Article 3
1. MemberStatesshalltakeallthenecessarymeasurestoensurethat
inspections are carried out in accordance with this Directive.
2. Member States shall not exclude a product from appropriate
inspection on the grounds that it is intended for export.
Article 4
1. Inspections shall be carried out:
(a) at regular intervals;
(b) where non-compliance is suspected;
(c) using means proportionate to the desired objective and particularly
in the light of the risks and of experience gained.
2. Inspections shall cover all stages of production and manufacture,
the intermediate stages prior to marketing, including importation, andthe use of products.
The competent authority shall select the stage or stages most appro-
priate for the intended purpose of the inspection.
3. As a general rule, inspections shall be carried out without prior
warning.
4. Inspections shall also cover uses prohibited in relation to animal
nutrition.
CHAPTER II
IMPORTS FROM THIRD COUNTRIES
Article 5
Notwithstanding Article 4 (1), Member States shall take all the neces-
sarystepstoensurethatwhenproductsareintroducedintothecustomsterritoryoftheCommunitytheyaresubjectedbythecompetentauthori-ties to a documentary check of each batch and to random identitychecks in order to verify:
— their nature,
— their origin,— their geographical destination,
so as determine the customs procedure applicable to them.
Article 6
ForthepurposeofthechecksprovidedforinArticle5,MemberStates
may designate particular entry points in their territory for the varioustypes of products.
Tothesameendtheymayrequirenoticetobegiventothemofarrival
of products at a particular entry point.
Article 7
Member States shall ensure the conformity of products by means of
random physical checks before they are marketed.
Article 8
1. Where the checks show that products do not meet the require-
ments of the rules, the Member State shall prohibit their entry ormarketingandordertheirredispatchoutofCommunityterritory;itshallimmediately inform the Commission and the other Member States thatit has rejected the products, indicating the infringements found.
2. Notwithstanding paragraph 1, Member States may authorize the
carryingout,undertheconditionslaiddownbythecompetentauthority,of one of the following operations:
1995L0053 — EN — 25.03.1999 — 001.001 — 6
▼B
— bringingtheproductsintolinewiththerequirementswithinadead-
line to be determined, or
— decontamination where appropriate, or— processing in any other suitable manner, or— use for other purposes, or— destruction of the products.
Member States shall ensure that the operations listed in the first
subparagraph do not give rise to any adverse effects on human andanimal health or on the environment.
3. The costs incurred in the measures taken in accordance with
paragraphs 1 and 2 shall be borne by the authorization holder or hisrepresentative.
Article 9
1. Where products are not marketed in the territory of the Member
State which carries out the checks referred to in Article 5 and, whereappropriate, a physical check, that Member State shall provide thepersonconcernedwithadocumentindicatingthetypeofcheckcarriedoutanditsoutcome.Commercialdocumentsshallcontainareferencetothis document.
However, the right of the Member State of destination to carry out
random checks on products shall not be affected.
2. Astandarddocumentand,whereappropriate,detailedrulesforthe
application of paragraph 1 shall be adopted in accordance with theprocedure laid down in Article 23 before the 30 April 1998.
CHAPTER III
TRADE WITHIN THE COMMUNITY
Article 10
MemberStatesshalltakeallnecessarymeasurestoensurethatproducts
intended for dispatch to another Member State are inspected with thesame care as those intended to be marketed in their own territory.
Section 1
Checks at source
Article 11
1. Member States shall ensure that the competent authority carries
out checks on establishments in order to satisfy itself that they meettheir obligations under Community rules and that products intended tobe marketed comply with Community requirements.
2. Where there are grounds for suspecting that requirements are not
beingmet,thecompetentauthorityshallcarryoutthenecessarychecksand, if the suspicion is confirmed, take the appropriate measures.
Section 2
Control at destination
Article 12
1. ThecompetentauthorityoftheMemberStateofdestinationmay,
at places of destination, check the compliance of products with theprovisions of Article 2 (1) (a) by means of non-discriminatory randomchecks.
2. However, where the competent authority of the Member State of
transitortheMemberStateofdestinationhasinformationleadingittosuspect an infringement, checks may also be carried out during thetransport of products in its territory.
1995L0053 — EN — 25.03.1999 — 001.001 — 7
▼B
Article 13
1. If, during a check carried out at the place of destination of a
consignment or during transport, a Member State establishes the non-compliance of the products with the provisions of Article 2 (1) (a), itshalltaketheappropriatemeasuresandformallyrequiretheconsignor,the consignee or any other person entitled to carry out, under theconditions laid down by the competent authority, one of the followingoperations:
— bringing of the products into compliance within a deadline to be
determined, or
— decontamination where appropriate, or— processing in any other suitable manner, or— use for other purposes, or— redispatch to the country of origin, after informing the competent
authority of the country of the establishment of origin, or
— destruction of the products.
2. The costs incurred in the measures taken in accordance with
paragraph 1 shall be borne by the consignor or any other personentitled, including where appropriate the consignee.
Section 3
Cooperation in the event of infringements
Article 14
Intheeventofthedestruction,useforotherpurposes,redispatchtothe
countryoforiginordecontaminationoftheproductsasprovidedforinArticle 13 (1), the Member State of destination shall contact theMember State of dispatch without delay. In other cases, the MemberState of destination may contact the Member State of dispatch. TheMember State of dispatch shall take all necessary measures and notifythe Member State of destination of the nature and outcome of thechecks carried out, the decisions taken and the reasons for such deci-sions.
If the Member State of destination fears that such measures are inade-
quate, the two Member States shall together seek ways and means ofremedying the situation; if appropriate this may involve a joint on-the-spot inspection.
Where the checks carried out in accordance with Article 12 show
repeatedirregularities,theMemberStateofdestinationshallinformtheCommission and the other Member States.
Article 15
1. At the request of the Member State of destination or on its own
initiative, taking into account the nature of the infringements estab-lished, the Commission may:
— send representatives, in cooperation with the Member State
concerned, to the establishment in question,
— request the Member State of dispatch to intensify its checks on the
products of the establishment concerned.
2. TheCommissionshallinformtheMemberStatesconcernedofits
findings.
PendingtheCommission’sfindings,theMemberStateofdispatchmust,
ifsorequestedbytheMemberStateofdestination,intensifychecksonproducts coming from the establishment in question.
The Member State of destination may, for its part, intensify checks on
products coming from the same establishment.
3. The Commission may review the situation within the Committee
referredtoinArticle23.Itmayadoptthenecessarydecisions,including
1995L0053 — EN — 25.03.1999 — 001.001 — 8
▼B
those relating to intra-Community movements of products, in accord-
ance with the procedure laid down in the same Article.
Section 4
Inspections on holdings
Article 16
Member States shall ensure that the competent authority has access to
places where agricultural production is carried on and where the prod-ucts are manufactured or used in order to carry out the prescribedchecks.
CHAPTER IV
GENERAL PROVISIONS
Article 17
1. MemberStatesshallensurethatinspectionsarecarriedoutinsuch
a way that delays in the delivery of products are minimized and thatinspections do not result in unjustified obstacles to the marketingthereof.
2. Member States shall provide that officials responsible for inspec-
tion are subject to professional confidentiality.
Article 18
1. Whereproductsaresampledforthepurposeofanalysis,Member
States shall adopt the provisions necessary:
— to ensure that those subject to checks are entitled to a second
opinion,
— to ensure that officially sealed reference samples are preserved.
2. MemberStatesshalldrawupalistoflaboratoriesresponsiblefor
carryingoutanalyses;theyshallensurethatsuchlaboratoriesaredesig-nated on account of their capabilities.
3. MemberStatesshallensurethatsamplingandanalysisarecarried
out in accordance with Community rules.
However, in the absence of Community rules and methods, Member
States shall take all necessary steps to satisfy themselves that inspec-tions are carried out:
— in accordance with standards recognized by international bodies,
— in the absence of such standards, in accordance with scientifically
recognized national rules which comply with the general principlesof the Treaty.
4. DetailedrulesfortheapplicationofthisArticlemaybeadoptedin
accordance with the procedure laid down in Article 23.
Article 19
Each Member State shall take the measures required to ensure that all
theprovisionsofthisDirectiveareappliedinfull.Penaltiesmustbelaiddown for the event of a failure to comply with those measures. Suchpenalties shall be effective, shall be commensurate with their purposeand shall have an adequate deterrent effect.
Article 20
RightsofappealexistingunderthelawsinforceintheMemberStates
against decisions by the competent authorities shall not be affected bythis Directive.
Decisions taken by the competent authority where an infringement has
been found and the reasons for such decisions must be notified to theoperator concerned by such decisions or his representative.
1995L0053 — EN — 25.03.1999 — 001.001 — 9
▼B
If the operator concerned or his representative so requests, the said
decisions and reasons must be communicated to him in writing withdetailsoftherightsofappealwhichareavailabletohimunderthelawin force in the Member State performing the checks and of the proce-dure and time limits applicable.
Article 21
Each Member State shall communicate to the Commission one year
after this Directive enters into force:
— the competent authority or authorities, their geographical coverage
and their sphere of competence,
— the laboratory or laboratories referred to in Article 18 (2),— where appropriate, the list of entry points referred to in Article 6.
This information, together with subsequent amendments, shall be
published in the ‘C' series of the Official Journal of the European
Communities.
Article 22
1. By 1 October 1998 at the latest, Member States shall drawn up
programmessettingoutthenationalmeasurestobetakentoachievetheaim of this Directive.
Theseprogrammesmusttakeintoaccountthespecificsituationofeach
Member State and specify the type and frequency of the inspections,which must be performed regularly.
2. Before 1 April each year and before 1 April 2000 for the first
time, the Member States shall transmit to the Commission all relevantinformationconcerningtheimplementationoftheprogrammesreferredto in paragraph 1 during the previous year, specifying:
— the criteria used in drawing up the programmes,
— the number and type of inspections carried out,— the results of the inspections, in particular the number and type of
infringements found,
— action taken where infringements have been found.
3. Before1Octobereachyearandbefore1October2000forthefirst
time, the Commission shall submit an overall summary report on theresults of inspections carried out at Community level, together with aproposal for a recommendation concerning a coordinated inspectionprogrammeforthefollowingyear,foradoptioninaccordancewiththeprocedureunderArticle23.Thisrecommendationmaybeamendedatalater date as required by the implementation of the coordinatedprogramme.
The coordinated programme shall indicate, in particular, the priority
criteria to be followed for its implementation.
The information provided for in paragraph 2 shall contain a separate
section specifically concerning implementation of the coordinatedprogramme.
Article 23
1. TheCommissionshallbeassistedbytheStandingCommitteefor
Feedingstuffs, set up by Decision 70/372/EEC(
1), hereinafter referred
to as ‘the Committee'.
2. The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The Committee shalldeliver its opinion on the draft within a time limit which the chairmanmaylaydownaccordingtotheurgencyofthematter.TheopinionshallbedeliveredbythemajoritylaiddowninArticle148(2)oftheTreatyin the case of decisions which the Council is required to adopt on a
(1) OJ No L 170, 3. 8. 1970, p. 1.
1995L0053 — EN — 25.03.1999 — 001.001 — 10
▼B
proposal from the Commission. The votes of the representatives of theMember States within the Committee shall be weighted in the mannerset out in that Article. The chairman shall not vote.
3. (a) TheCommissionshalladoptthemeasuresenvisagediftheyare
in accordance with the opinion of the Committee.
(b) Ifthemeasuresenvisagedarenotinaccordancewiththeopinion
oftheCommittee,orifnoopinionisdelivered,theCommissionshall,withoutdelay,submittotheCouncilaproposalrelatingtothe measures to be taken. The Council shall act by a qualifiedmajority.
If,ontheexpiryofaperiodofthreemonthsfromthedateofreferralto
theCouncil,theCouncilhasnotacted,theproposedmeasuresshallbeadopted by the Commission, save where the Council has decidedagainst the said measures by a simple majority.
Article 24
1. MemberStatesshalladoptthelaws,regulationsandadministrative
provisions necessary to comply with this Directive not later than 30April 1998. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a refer-
encetothisDirectiveorshallbeaccompaniedbysuchreferenceontheoccasion of their official publication. The methods of making suchreference shall be laid down by Member States.
2. Member States shall communicate to the Commission the text of
theprovisionsofnationallawwhichtheyadoptintheareacoveredbythis Directive.
Article 25
ThisDirectiveshallenterintoforceonthedayfollowingitspublication
in the Official Journal of the European Communities .
Article 26
This Directive is addressed to the Member States.