1999L0002—EN—20.11.2003—001.001—1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B DIRECTIVE1999/2/ECOFTHEEUROPEANPARLIAMENTANDOFTHECOUNCIL
of22February1999
on the approximation of the laws of the Member States concerning foods and food ingredients
treatedwithionisingradiation
(OJL66,13.3.1999,p.16)
Amendedby:
OfficialJournal
No page date
►M1Regulation (EC) No 1882/2003 of the European Parliament and of the
Councilof29September2003L284 1 31.10.2003
▼B
DIRECTIVE 1999/2/EC OF THE EUROPEAN PARLIAMENT
ANDOFTHECOUNCIL
of22February1999
ontheapproximationofthelawsoftheMemberStatesconcerning
foodsandfoodingredientstreated withionisingradiation
TheEUROPEANPARLIAMENTANDTHECOUNCILOFTHEEUROPEAN
UNION,
HavingregardtotheTreatyestablishingtheEuropeanCommunity,and
inparticularArticle100athereof,
HavingregardtotheproposalfromtheCommission(1),
Having regard to the opinion of the Economic and Social
Committee(2),
Actinginaccordance withtheprocedure laiddowninArticle 189bof
theTreaty(3),inthelightofthejointtextapprovedbytheConciliation
Committeeon9December1998,
(1)Whereas differences between national lawsrelating tothe treat-
mentoffoodstuffsbyionisingradiationanditsconditionsofuse
hinder the free movement of foodstuffs and may create condi-tions of unequal competition, thereby directly affecting theoperationoftheinternalmarket;
(2)Whereas it is necessary to adopt measures aimed at the smooth
operation of the internal market; whereas the internal market
comprises an area without internal frontiers in which the freemovement of goods, persons, services and capital is ensured;whereasthisisnotthecaseatpresentbecauseofthedifferencesintreatmentintheMemberStates,irradiationoffoodstuffsbeingallowedinsomeandbannedinothers;
(3)Whereas this framework Directive will be completed by Direc-tive 1999/3/EC of the European Parliament and of the Councilof 22 February 1999 on the establishment of a Community listoffoods andfoodingredients treated with ionising radiation(
4),
hereinafterreferredtoas‘theimplementingDirective’;
(4)Whereas in several Member States foodstuff irradiation consti-tutes a sensitive issue in public debate, and whereas consumersmay have cause for concern about the consequences of the useoffoodirradiation;
(5)Whereas, until the entry into force of the Community positivelist of foodstuffs which may be treated with ionising radiation,
it is appropriate that Member States may, in compliance with
the rules of the Treaty, continue to apply existing nationalrestrictions or bans on ionising radiation of foodstuffs and ontradeinirradiatedfoodstuffswhicharenotincludedintheinitialpositivelistestablishedbytheimplementingDirective;
(6)Whereas rules relating to the use of ionising radiation for thetreatment of foodstuffs should take account primarily of humanhealth requirements but also, within the limits required for theprotectionofhealth,ofeconomicandtechnicalneeds;
(7)Whereas Council Directive 96/29/Euratomof 13 May 1996laying down basic safety standards for the protection of the1999L0002—EN—20.11.2003—001.001—2
(1) OJC336,30.12.1988,p.7andOJC303,2.12.1989,p.15.
(2) OJC194,31.7.1989,p.14.
(3) OpinionoftheEuropeanParliamentof11October1989(OJC291,20.11.
1989,p.58),CouncilCommonPositionof27October1997(OJC389,22.12. 1997, p. 36) and Decision of the European Parliament of 18 February
1998(OJC80,16.3.1998,p.130).CouncilDecisionof25January1999.
DecisionoftheEuropeanParliamentof28January1999.
(
4) Seepage24ofthisOfficialJournal.
▼B
health of workers and the general public against the dangers
arisingfromionisingradiation(1)isapplicable;
(8)Whereasapprovedirradiation unitsshouldbesubjecttoanoffi-
cial control, through an inspection systemto be created for the
needsofthisDirective;
(9)Whereas approved units should keep records to ensure that therulesofthisDirectivehavebeenrespected;
(10)Whereas Council Directive 79/112/EEC of 18 December 1978ontheapproximation ofthelawsoftheMemberStatesrelating
to the labelling, presentation and advertising of foodstuffs for
sale to the ultimate consumer(
2) has already laid down rules
concerning the labelling of irradiated foodstuffs for sale to theultimateconsumer;
(11)Whereasappropriaterulesmustalsobelaiddownforthelabel-lingoffoodstuffstreatedwithionisingradiationnotintendedfor
theultimateconsumer;
(12)Whereas, without prejudice to the decision-making procedures
laid down in the Treaty establishing the European Communityor in this Directive, the Scientific Committee for Food set upbyDecision74/234/EEC(
3)shouldbeconsultedonanyquestion
relating to this Directive which may have an effect on public
health;
(13)Whereasfoodstuffsmayonlybetreatedbytheactionofionising
radiationifthereisafoodhygieneneed,orademonstrabletech-nological or other advantage, or benefit to the consumer and ifthey are wholesome and in a proper condition, since ionisingradiationshouldnotbeusedasasubstituteforhygieneorhealth
practicesorgoodmanufacturingoragriculturalpractice;
(14)Whereastheprocessshouldnotbeusedasasubstituteforgood
manufacturing practice, and whereas this condition is fulfilledforfoodstuffslistedintheAnnextotheimplementingDirective;
(15)Whereas,inallcaseswheretheCouncilempowerstheCommis-sion to implement rules relating to food irradiation, provisionshould be made for a procedure instituting close cooperation
betweenMemberStatesandtheCommissionwithintheStanding
Committee on Foodstuffs, and, where necessary, the StandingVeterinary Committee or the Standing Committee on PlantHealth;
(16)Whereas should the use of the process or of a foodstuff treatedwith ionising radiation authorised on the basis of this Directive
appear to constitute a health risk, Member States should be
authorised to suspendor limit suchuse, orto reduce the limits,pendingadecisionatCommunitylevel;
(17)WhereasCouncil Directive 89/397/EEC of14June1989ontheofficial control of foodstuffs(
4) leaves the choice of means and
methods to the national enforcement authorities; whereas
CouncilDirective93/99/EECof29October1993onthesubject
of additional measures concerning the official control of food-stuffs(
5) lays down quality standards for laboratories and
requires the use of validated methods of analysis where avail-able; whereas Article 5 of the latter Directive is applicable to
themonitoringoftheimplementationofthisDirective;
(18)Whereasa modus vivendi betweentheEuropeanParliament, the
Council and the Commission concerning the implementingmeasuresforactsadoptedinaccordancewiththeprocedurelaid1999L0002—EN—20.11.2003—001.001—3
(1) OJL159,29.6.1996,p.1.
(2) OJL 33, 8. 2. 1979,p. 1. Directive as last amended by Directive 97/4/EC
(OJL43,14.2.1997,p.21).
(3) OJL136,20.5.1974,p.1.
(4) OJL186,30.6.1989,p.23.
(5) OJL290,24.11.1993,p.14.
▼B
down in Article 189b of the Treaty(1) was concluded on 20
December1994,
HAVEADOPTEDTHISDIRECTIVE:
Article 1
1. This Directive shall apply to the manufacture, marketing and
importation of foods and food ingredients, hereinafter called ‘food-
stuffs’,treatedwithionisingradiation.
2. ThisDirectiveshallnotapplyto:
(a) foodstuffsexposedtoionisingradiationgeneratedbymeasuringor
inspection devices, provided that the dose absorbed is not greaterthan 0,01 Gy for inspection devices which utilise neutrons and
0,5 Gy in other cases, at a maximum radiation energy level of
10 MeV in the case of X-rays, 14 MeV in the case of neutronsand5MeVinothercases;
(b) the irradiation of foodstuffs which are prepared for patients
requiringsteriledietsundermedicalsupervision.
Article 2
Member States shall take all measures necessary to ensure that irra-
diated foodstuffs can be placed on the market only if they complywiththeprovisionsofthisDirective.
Article 3
1. The conditions which must be fulfilled for authorisation of the
treatment of foodstuffs with ionising radiation are set out in Annex I.At the time of treatment such foodstuffsmust be in a suitably whole-
somestate.
2. Irradiationmaybecarriedoutonlybymeansofthesourceslisted
in Annex II and in accordance with the requirements of the Code ofPractice referredtoinArticle 7(2).TheoverallaverageabsorbeddoseshallbecalculatedinaccordancewithAnnexIII.
Article 4
1. The Community list of foodstuffs which may be treated with
ionising radiation to the exclusion of all others and the maximum
radiation dosesauthorisedshallbedefinedintheimplementing Direc-tive, which shall be adopted in accordance with the procedure laiddowninArticle100aoftheTreatytakingaccountoftheauthorisationconditionssetoutinAnnexI.
2. Thislistshallbeestablishedinstages.3. The Commission shall examine the national authorisations in
force and, after consulting the Scientific Committee for Food, submit
in accordance with the procedure laid down in Article 100a of theTreatyproposalsaimingatestablishingthelist.
Atthe latest 31December 2000,the Commission shall, in accordance
withArticle100aoftheTreaty,submitaproposalintendedtocompletethepositivelistprovidedforinparagraph1.
4. UntilentryintoforceoftheDirectiveadoptedonthebasisofthe
proposal referred to in the second subparagraph of paragraph 3,Member States may maintain existing authorisations concerning thetreatmentoffoodstuffswithionisingradiationprovidedthat:
(a) the treatment of the foodstuff concerned has been subject to a
favourableopinionoftheScientificCommitteeforFood;1999L0002—EN—20.11.2003—001.001—4
(1) OJC102,4.4.1996,p.1.
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(b) the overall average absorbed radiation dose does not exceed the
limitvaluesrecommendedbytheScientificCommitteeforFood;
(c) ionisingradiation andplacingonthemarket areeffected inaccor-
dancewiththisDirective.
5. UntilentryintoforceoftheDirectiveadoptedonthebasisofthe
proposal referred to in the second subparagraph of paragraph 3, any
MemberStatemayalsoauthorisethetreatmentoffoodstuffsforwhichauthorisationshavebeenmaintainedbyanotherMemberStateinaccor-dancewithparagraph4,wheretheconditionsreferredtoinparagraph4arefulfilled.
6. Member States shall forthwith notify the Commission and the
other Member States of authorisations maintained under paragraph 4orgrantedunderparagraph5andofconditionsattachingtothem.The
Commissionshallpublishthesenotifications inthe Official Journal of
the European Communities .
7. UntiltheentryintoforceoftheDirectiveadoptedonthebasisof
the proposal referred to in the second subparagraph of paragraph 3,
Member States may, in compliance with the rules of the Treaty,continue to apply existing national restrictions or bans on ionisingradiation of foodstuffs and on trade in irradiated foodstuffs which arenotincludedintheinitialpositivelistestablishedbytheimplementing
Directive.
Article 5
1. The maximum radiation dose for foodstuffs may be given in
partial doses; however, the maximum radiation dose fixed in accor-dance with Article 4 must not be exceeded. Irradiation treatment maynot be used in combination with any chemical treatment having the
samepurposeasthattreatment.
2. Exceptionstoparagraph1maybedecidedoninaccordancewith
theprocedurelaiddowninArticle12.
Article 6
The labelling of foodstuffs treated with ionising radiation shall be
governedbythefollowingprovisions:
1. inthecaseofproductsintendedfortheultimateconsumerandmass
caterers:
(a) if the products are sold as items, the words ‘irradiated’ or
‘treated with ionising radiation’ shall appear on the label asprovidedforinArticle5(3)ofDirective79/112/EEC.
In the case of products sold in bulk, these words shall appear
together with the name of the product on a display or noticeaboveorbesidethecontainerinwhichtheproductsareplaced;
(b) ifanirradiatedproductisusedasaningredient,thesamewords
shallaccompanyitsdesignationinthelistofingredients.
In the case of products sold in bulk, these words shall appear
together with the name of the product on a display or noticeaboveorbesidethecontainerinwhichtheproductsareplaced;
(c) by way of derogation fromArticle 6(7) of Directive 79/112/
EEC, the same words shall be required in order to indicate the
irradiated ingredients used in compound ingredients in food-
stuffs, even if these constitute less than 25 % of the finishedproduct;
2. in the case of products not intended for the ultimate consumer and
masscaterers:
(a) the words provided for in the previous paragraph shall be used
to indicate treatment of both the foods and the ingredientscontainedinanon-irradiatedfoodstuff;1999L0002—EN—20.11.2003—001.001—5
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(b) either the identity and address of the facility which carried out
theirradiationoritsreferencenumberasprovidedforinArticle7shallbeindicated;
3. the indication of treatment shall in all cases be given on the docu-
mentswhichaccompanyorrefertoirradiatedfoodstuffs.
Article 7
1. Member States shall inform the Commission of the competent
authorityorauthoritiesresponsiblefor:
— priorapprovalofirradiationfacilities,
— theallocation ofanofficial referencenumberforapprovedirradia-
tionfacilities,
— officialcontrolandinspection,— withdrawalormodificationofapproval.
2. Approvalshallbegrantedonlyifthefacility:
— meetstherequirementsoftheJointFAO/WHOCodexAlimentarius
Commission Recommended International Code of Practice for theoperation of irradiation facilities used for the treatment of foods(referenceFAO/WHO/CAC,vol.XVedition1),andanysupplemen-tary requirements which may be adopted in accordance with theprocedurelaiddowninArticle12ofthisDirective,
— designates a person responsible for compliance with all the condi-
tionsnecessaryforapplicationoftheprocess.
3. EachMemberStateshallforwardtotheCommission:
— thenames,addressesandreferencenumbersoftheirradiationfacil-
itieswhichithasapproved,thetextoftheapprovaldocument,and
anydecisionsuspendingorwithdrawingapproval.
FurthermoretheMemberStatesshallforwardtotheCommissionevery
year:
— theresultsofcheckscarriedoutintheionisingirradiationfacilities,
in particular regarding the categories and quantities of products
treatedandthedosesadministered,
— the results of checks carried out at the product marketing stage.
Member States shall ensure that the methods used to detect treat-ment with ionising radiation comply with paragraphs 1 and 2 oftheAnnextoDirective85/591/EEC(
1)andarestandardisedorvali-
datedeitheralreadyorassoonaspossible,upto1January2003at
the latest. Member States shall inform the Commission of the
methodsusedandtheCommissionshallassesstheuseanddevelop-mentofthesemethodshavingregardtoanopinionoftheScientificCommitteeforFood.
4. Onthebasisofthedatasuppliedinaccordancewithparagraph3,
the Commission shall publish in the Official Journal of the European
Communities:
— thedetailsofthefacilitiesaswellasanychangesintheirstatus,
— a report based on the information provided every year by the
nationalsupervisoryauthorities.
Article 8
1. Irradiation facilities approved inaccordance with Article 7must,
for each source of ionising radiation used, keep a record showing for
eachbatchoffoodstuffstreated:
(a) thenatureandquantityoffoodstuffsirradiated;
(b) thebatchnumber;
(c) thepersonorderingtheirradiationtreatment;
(d) therecipientofthetreatedfoodstuffs;1999L0002—EN—20.11.2003—001.001—6
(1) OJL372,31.12.1985,p.50.
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(e) thedateofirradiation;
(f) thepackagingmaterialsusedduringtreatment;
(g) the data for control of the irradiation process as provided for in
Annex III, the dosimetric checks carried out and the resultsobtained, with details in particular of the limits, lower and upper,ofthedoseabsorbedandthetypeofionisingradiation;
(h) referencetotheinitialdosevalidationmeasurements.
2. Therecordsreferred toinparagraph 1mustbekeptforaperiod
offiveyears.
3. Detailed rulesfortheapplication ofthisArticle shallbeadopted
inaccordancewiththeprocedurelaiddowninArticle12.
Article 9
1. A foodstuff treated with ionising radiation may not be imported
fromathirdcountryunlessit:
— complieswiththeconditionswhichapplytothosefoodstuffs,
— isaccompaniedbydocumentsshowingthenameandaddressofthe
facilitywhichcarriedouttheirradiationtreatmentandprovidingtheinformationreferredtoinArticle8,
— was treated in an irradiation facility approved by the Community
andappearingonthelistreferredtoinparagraph2ofthisArticle.
2. (a) In accordance with the procedure laid down in Article 12, the
Commission shall draw up the list of approved facilities forwhich official supervision guarantees that the requirements ofArticle7arecompliedwith.
For the purpose of drawing up this list, the Commission may
instruct experts to carry out, under its authority, evaluations
and inspections of irradiation facilities in third countries in
accordancewithArticle5ofDirective93/99/EEC.
The Commission shall publish that list and any amendments
theretointhe Official Journal of the European Communities .
(b) TheCommissionmayconcludetechnicalarrangementswiththe
competent organisations in third countries on the procedures
whereby the evaluations and inspections referred to in (a) aretobecarriedout.
Article 10
Materials used for packaging foodstuffs to be irradiated must be
suitableforthepurpose.
Article 11
AmendmentstotheAnnexestotakeaccountofscientificandtechnical
progressshall be adopted inaccordance with the procedure laid down
inArticle100aoftheTreaty.
Article 12
1. TheCommissionshallbeassistedbytheStandingCommitteeon
theFoodChainandAnimalHealth,setupbyArticle58ofRegulation(EC)No178/2002(
1),hereinafterreferredtoas‘theCommittee’.
2. WherereferenceismadetothisArticle,Articles5and7ofDeci-
sion 1999/468/EC(2) shall apply, having regard to the provisions of
Article8thereof.1999L0002—EN—20.11.2003—001.001—7
(1) OJL31,1.2.2002,p.1.
(2) CouncilDecision1999/468/ECof28June1999layingdowntheprocedures
forthe exercise ofimplementing powersconferred onthe Commission(OJ
L184,17.7.1999,p.23).▼M1
▼M1
TheperiodlaiddowninArticle5(6)ofDecision1999/468/ECshallbe
setatthreemonths.
3. TheCommitteeshalladoptitsrulesofprocedure.
Article 13
The Scientific Committee for Food shall be consulted on any matter
falling within the scope of this Directive likely to have an effect on
publichealth.
Article 14
1. Where a Member State, as a result of new information or of a
reassessment of existing information made since this Directive wasadopted,hasclearproofthattheirradiationofcertainfoodstuffsendan-gers human health although it complies with the provisions of thisDirective,thatMemberStatemaytemporarilysuspendorrestrictappli-
cationoftheprovisionsinquestioninitsterritory.Itshallimmediately
inform the other Member States and the Commission thereof, givinggroundsforitsdecision.
2. The Commission shall examine the grounds referred to in para-
graph 1 as soon as possible within the Standing Committee onFoodstuffs; it shall take the appropriate measures in accordance withthe procedure laid down in Article 12. The Member State which took
the decision referred to in paragraph 1 may maintain it until the
measureshaveenteredintoforce.
3. Amendments to this Directive or to the implementing Directive
may be made in accordance with the procedure laid down in Article12onlytotheextentnecessarytoensuretheprotectionofpublichealthand shall in any event be limited to prohibitions or restrictions as
comparedtothepreviouslegalsituation.
Article 15
MemberStatesshallbringintoforcetheirlaws,regulationsandadmin-
istrativeprovisionstocomplywiththisDirectiveinsuchawayasto:
— permit the marketing and use of irradiated foodstuffs by 20
September2000,
— prohibit the marketing and use of irradiated foodstuffs not
complyingwiththisDirectiveby20March2001.
TheyshallinformtheCommissionthereof.WhenMemberStatesadoptthesemeasures,theyshallcontainarefer-
encetothisDirectiveorshallbeaccompaniedbysuchreferenceonthe
occasion of their official publication. The methods of making such
referenceshallbelaiddownbyMemberStates.
Article 16
This Directive shall enter into force on the seventh day following its
publicationinthe Official Journal of the European Communities .
Article 17
ThisDirectiveisaddressedtotheMemberStates.1999L0002—EN—20.11.2003—001.001—8
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ANNEX I
CONDITIONSFORAUTHORISINGFOODIRRADIATION
1. Foodirradiationmaybeauthorisedonlyif:
— thereisareasonabletechnologicalneed,
— it presents no health hazard and is carried out under the conditions
proposed,
— itisofbenefittotheconsumer,— itisnotusedasasubstituteforhygieneandhealthpracticesorforgood
manufacturingoragriculturalpractice.
2. Foodirradiationmaybeusedonlyforthefollowingpurposes:
— to reduce the incidence of food-borne disease by destroying pathogenic
organisms,
— toreducespoilageoffoodstuffsbyretardingorarrestingdecayprocesses
anddestroyingspoilageorganisms,
— to reduce loss of foodstuffs by premature ripening, germination or
sprouting,
— toridfoodstuffsoforganismsharmfultoplantorplantproducts.1999L0002—EN—20.11.2003—001.001—9
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ANNEX II
SOURCESOFIONISINGRADIATION
Foodstuffsmaybetreatedonlybythefollowingsourcesofionisingradiation:
(a) gammaraysfromradionuclides60Coor137Cs;
(b) X-rays generated from machine sources operated at or below a nominal
energy(maximumquantumenergy)levelof5MeV;
(c) electrons generated from machine sources operated at or below a nominal
energy(maximumquantumenergy)levelof10MeV.1999L0002—EN—20.11.2003—001.001—10
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ANNEX III
1. DOSIMETRY
Overall averageabsorbeddoseItcanbeassumedforthepurposeofthedetermination ofthewholesome-
ness of foodstuffs treated with an overall average dose of 10 kGy or less
thatall radiation chemical effects inthat particular doserangearepropor-
tionaltothedose.
Theoverall average dose,
D;isdefined bythefollowing integral overthe
totalvolumeofthegoods:
D¼1
MZ
px ;y;zðÞdx ;y;zðÞdV
where M = thetotalmassofthetreatedsample
p = thelocaldensityatthepoint(x,y,z)d = thelocalabsorbeddoseatthepoint(x,y,z)
dV = dx dy dz, the infinitesimal volume element which in real
casesisrepresentedbythevolumefractions.
Theoverallaverageabsorbeddosecanbedetermineddirectlyforhomoge-
nous products or for bulk goods of homogenous apparent density by
distributing anadequate numberofdosimeters strategically and at random
throughoutthevolumeofthegoods.Fromthedosedistributiondetermined
in this manner an average can be calculated which is the overall average
absorbeddose.
Iftheshapeofthedosedistributioncurvethroughtheproductiswelldeter-
mined, the positions of minimum and maximum dose are known.
Measurementsofthedistributionofdoseinthesetwopositionsinaseries
of samples of the product can be used to give an estimate of the overall
averagedose.
Insomecases,themeanvalueoftheaveragevaluesoftheminimumdose
(
Dmin)andmaximumdose( Dmax)willbeagoodestimate oftheoverall
dose:i.e.,inthesecases:
overallaveragedose /C25Dmax þDmin
2
TheratioofDmax
Dminshouldnotexceed3.
2. PROCEDURES
2.1. Beforeroutineirradiationofagivencategoryoffoodstuffbeginsataradia-
tion facility, the locations of the minimum and maximum doses are
determined bymakingdosemeasurementsthroughouttheproductvolume.
These validation measurements must be carried out a suitable number of
times (e.g. 3-5) in order to make allowance for variations in product
densityorgeometry.
2.2. Measurementsmustberepeatedwhenevertheproduct,itsgeometryorthe
irradiationconditionsarechanged.
2.3. During the process,routine dosemeasurements are carried out in order to
ensure that the dose limits are not exceeded. Measurements should be
carried out by placing dosimeters at the positions of the maximum or
minimum dose, or at a reference position. The dose at the reference posi-
tionmustbequantitativelylinkedtothemaximumandminimumdose.The
reference position should be located at a convenient point in or on the
product,wheredosevariationsarelow.
2.4. Routine dose measurements must be carried out on each batch and at
regularintervalsduringproduction.
2.5. Incaseswhereflowing,non-packagedgoodsareirradiated,thelocationsof
theminimumandmaximumdosescannotbedetermined.Insuchacaseit
is preferable to use random dosimeter sampling to ascertain the values of
thesedoseextremes.
2.6. Dose measurements should be carried out by using recognised dosimetry
systems,andthemeasurementsshouldbetraceabletoprimarystandards.
2.7. During irradiation, certain facility parameters must be controlled and
continuously recorded. For radionuclide facilities the parameters include1999L0002—EN—20.11.2003—001.001—11
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product transport speed or time spent in the radiation zone and positive
indication for correct position of the source. For accelerator facilities, the
parameters include product transport speed and energy level, electron
currentandscannerwidthofthefacility.1999L0002—EN—20.11.2003—001.001—12