2002L0042—EN—11.06.2002—000.002—1
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►B COMMISSIONDIRECTIVE2002/42/EC
of17May2002
amendingtheAnnexestoCouncilDirectives86/362/EEC,86/363/EECand90/642/EECasregards
the fixing of maximum levels for pesticide residues (bentazone and pyridate) in and on cereals,
foodstuffsofanimaloriginandcertain productsofplantorigin, includingfruitandvegetables
(TextwithEEArelevance)
(OJL134,22.5.2002,p.29)
Correctedby:
►C1Corrigendum,OJL140,30.5.2002,p.39(2002/42/EC)
►C2Corrigendum,OJL271,22.10.2003,p.26(2002/42/EC)
▼B
COMMISSIONDIRECTIVE2002/42/EC
of17May2002
amending the Annexes to Council Directives 86/362/EEC, 86/363/
EEC and 90/642/EEC as regards the fixing of maximum levels forpesticideresidues(bentazoneandpyridate)inandoncereals,food-stuffs of animal origin and certain products of plant origin,
includingfruitandvegetables
(TextwithEEArelevance)
THECOMMISSIONOFTHEEUROPEANCOMMUNITIES,
HavingregardtotheTreatyestablishingtheEuropeanCommunity,
HavingregardtoCouncilDirective86/362/EECof24July1986onthe
fixingofmaximumlevelsforpesticideresiduesinandoncereals(1),as
last amended by Commission Directive 2002/23/EC(2), and in parti-
cularArticle10thereof,
HavingregardtoCouncilDirective86/363/EECof24July1986onthe
fixingofmaximumlevelsforpesticideresiduesinandonfoodstuffsofanimal origin(
3), as last amended by Directive 2002/23/EC, and in
particularArticle10thereof,
HavingregardtoCouncilDirective90/642/EECof27November1990
on fixing of maximum levels for pesticide residues in and on certain
products of plant origin, including fruit and vegetables(4), as last
amendedbyDirective2002/23/EC,andinparticularArticle7thereof,
Having regard to Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on the market(5),
aslastamendedbyCommissionDirective2002/37/EC(6),andinparti-
cularArticle4(1)(f)thereof,
Whereas:
(1)The existing active substances bentazone and pyridate were
included in Annex I to Directive 91/414/EEC by CommissionDirectives2000/68/EC(
7)and2001/21/EC(8),foruseasaherbi-
cideoncereals,vegetablesandforage.
(2)TheinclusioninAnnexItoDirective 91/414/EECoftheactivesubstancesconcerned wasbasedontheassessmentoftheinfor-mation submitted concerning the proposed uses. Informationrelating to these uses has been submitted by certain Member
States in accordance with Article 4(1)(f) of Directive 91/414/
EEC.Theinformation available hasbeenreviewed andissuffi-cient to allow certain maximum residue levels (MRLs) to befixed.
(3)WherenoCommunityMRLorprovisionalMRLexists,MemberStatesaretoestablishanationalprovisionalMRLinaccordancewithArticle4(1)(f)ofDirective91/414/EECbeforeplantprotec-tion products containing these active substances may beauthorised.
(4)With respect to the inclusion in Annex I to Directive 91/414/EEC of the active substances concerned, the related technicalandscientificevaluationswerefinalisedintheformofCommis-sionreviewreports.Thereportswerefinalisedon13July2000,
in the case of bentazone and on 12 December 2000 in the case
of pyridate. They fixed the acceptable daily intake (ADI) forbentazoneat0,1mg/kgbw/dayandforpyridateat0,036mg/kg2002L0042—EN—11.06.2002—000.002—2
(1) OJL221,7.8.1986,p.37.
(2) OJL64,7.3.2002,p.13.
(3) OJL221,7.8.1986,p.43.
(4) OJL350,14.12.1990,p.71.
(5) OJL230,19.8.1991,p.1.
(6) OJL117,4.5.2002,p.10.
(7) OJL276,28.10.2000,p.41.
(8) OJL69,10.3.2001,p.17.
▼B
bw/day. The lifetime exposure of consumers of food products
treated with the active substances concerned has been assessedand evaluated in accordance with Community procedures.
Account has also been taken of guidelines published by the
World Health Organisation(
1) and the opinion of the Scientific
Committee for Plants(2) on the methodology employed. It is
concluded that the MRLs proposed will not lead to those ADIsbeingexceeded.
(5)Noacutetoxiceffectsrequiringthesettingofanacutereference
dose were noted during the evaluations and discussions
preceding the inclusion of pyridate in Annex I to Directive 91/414/EEC. The acute reference dose for bentazone was estab-lished at 0,25 mg/kg bw/day. According to the exposureassessmenttheMRLsproposedwillnotleadtoanunacceptable
acuteexposureofconsumers.
(6)In order to ensure that the consumer is adequately protected
fromexposure to residues in or on products, for which noauthorisation has been granted, it is prudent to set provisionalMRLsatthelowerlimitofanalytical determination forallsuchproducts covered by Directives 86/362/EEC, 86/363/EEC and
90/642/EEC.
(7)ThesettingatCommunity level ofsuchprovisionalMRLsdoes
not prevent the Member States from establishing provisionalMRLs for bentazone and pyridate in accordance with Article4(1)(f) of Directive 91/414/EEC and Annex VI thereto. It isconsidered that a period of four years is sufficient to permitmostfurtherusesoftheactivesubstancesconcerned.Theprovi-
sionalMRLshouldthenbecomedefinitive.
(8)The Annexes to Directives 86/362/EEC, 86/363/EEC and 90/
642/EECshouldthereforebeamendedaccordingly.
(9)The Commission notified this Directive in draft form to theWorldTradeOrganisationandnocommentshavebeenreceived.The possibility of fixing import tolerance MRLs for specific
pesticide/crop combinations will be examined by the Commis-
siononthebasisoftheacceptabledatasubmitted.
(10)ThisDirectiveisinaccordancewiththeopinionoftheStandingCommitteeontheFoodChainandAnimalHealth,
HASADOPTEDTHISDIRECTIVE:
Article 1
ThefollowingmaximumpesticideresiduelevelsareaddedtoPartAof
AnnexIItoDirective86/362/EEC:
‘Pesticideresidue Maximumlevelinmg/kg
Bentazone (sumof bentazone and the conjugates of
6-OH-and8-OH-bentazoneexpressedasbentazone)0,1(p)(*) Cereals
Pyridate (sumof pyridate, its hydrolysis product CL
9673 (6-chloro-4-hydroxy-3-phenylpyridazin) and
hydrolysable conjugates of CL 9673 expressed as
pyridate)0,05(p)(*) Cereals2002L0042—EN—11.06.2002—000.002—3
(1) Guidelines for predicting dietary intake of pesticide residues (revised),
prepared by the GEMS/Food Programme in collaboration with the Codex
CommitteeonPesticideResidues,publishedbytheWorldHealthOrganisa-tion1997(WHO/FSF/FOS/97.7).
(
2) Opinion of the Scientific Committee on Plants regarding questions relating
to amending the annexes to Council Directives 86/362/EEC, 86/363/EEC
and90/642/EEC(OpinionexpressedbytheScientificCommitteeonPlants,
14July1998)(http.//europa.eu.int/comm/food/fs/sc/out21_en.html).
▼B
(p) Indicates provisional maximum residue level in accordance with Article 4(1)(f) of Directive
91/414/EEC:unlessamended,thislevelwillbecomedefinitivewitheffectfrom4yearsfrom
dateofcomingintoforceoftheDirectiveintroducingthisamendment.
(*)Indicateslowerlimitofanalyticaldetermination.’
Article 2
ThefollowingmaximumpesticideresiduelevelsareaddedtoPartBof
AnnexIItoDirective86/363/EEC:
‘PesticideresidueMaximumlevel(mg/kg)
Ofmeat,includingfat,
preparationsofmeat,offals
andanimalfatsaslistedin
AnnexIwithinCNcodes
0201,0202,0203,0204,
02050000,0206,0207,
ex 0208,020900,0210,
160100and1602Formilkandmilk
productslistedin
AnnexIwithinCN
codes0401,0402,
040500and0406Ofshelledfresh
eggs,forbirds'eggs
andeggyolkslisted
inAnnexIwithin
CNcodes040700
and0408
Bentazone 0,05(p)(*) 0,02(p)(*) 0,05(p)(*)
Pyridate(sumofpyridate
anditshydrolysisproduct
CL 9673 (6-chloro-4-
hydroxy-3-phenylpyri-
dazin) expressed as
pyridate)Kidneyexceptpoultry
0,4(p)
►C2Otherproducts
0,05(p)(*)◄0,05(p)(*) 0,05(p)(*)
(p) Indicates provisional maximum residue level in accordance with Article 4(1)(f) of Directive
91/414/EEC:unlessamended,thislevelwillbecomedefinitivewitheffectfrom4yearsfrom
dateofcomingintoforceoftheDirectiveintroducingthisamendment.
(*)Indicateslowerlimitofanalyticaldetermination.’
Article 3
The maximum pesticide residue levels for bentazone and pyridate as
showninthe AnnextothisDirective are added to AnnexIItoDirec-tive90/642/EEC.
Article 4
Member States shall bringinto force the laws,regulations andadmin-
istrative provisions necessary to comply with this Directive by 31
December2002atthelatest.TheyshallforthwithinformtheCommis-
sionthereof.
Theyshallapplytheseprovisionswitheffectfrom1January2003.WhenMemberStatesadoptthoseprovisions,theyshallcontainarefer-
ence to this Directive or be accompanied by such a reference on theoccasion of their official publication. Member States shall determinehowsuchreferenceistobemade.
Article 5
ThisDirective shall enterinto forceonthe 20thdayfollowingthat of
itspublicationinthe Official Journal of the European Communities .
Article 6
ThisDirectiveisaddressedtotheMemberStates.2002L0042—EN—11.06.2002—000.002—4
▼B
ANNEX
GroupsandexamplesofindividualproductstowhichtheMRLs
applyPesticideresiduesandmaximumresidue
levels
(mg/kg)
Bentazone(sumof
bentazoneandthe
conjugatesof6-OH-
and8-OH-benta-
zoneexpressedas
bentazone)Pyridate(sumof
pyridate,itshydro-
lysisproductCL
9673(6-chloro-4-
hydroxy-3-phenyl-
pridazin)andhydro-
lysableconjugates
ofCL9673
expressedaspyri-
date)
1.Fruits, fresh, dried or uncooked, preserved by
freezing, notcontainingaddedsugar:nuts0,1(p)(*) 0,05(p)(*)
(i) CITRUSFRUIT
Grapefruit
LemonsLimesMandarins(includingclementinesandother
hybrids)
OrangesPomelosOthers
(ii) TREENUTS(shelledorunshelled)
Almonds
Brazilnuts
Cashewnuts
ChestnutsCoconutsHazelnutsMacadamiaPecansPinenuts
Pistachios
WalnutsOthers
(iii) POMEFRUIT
Apples
PearsQuincesOthers
(iv) STONEFRUIT
Apricots
Cherries
Peaches(includingnectarinesandsimilarhybrids)PlumsOthers
(v) BERRIESANDSMALLFRUIT
(a)Tableandwinegrapes
TablegrapesWinegrapes
(b)Strawberries(otherthanwild)(c)Canefruit(otherthanwild)
BlackberriesDewberriesLoganberriesRaspberriesOthers
(d)Othersmallfruitandberries(otherthanwild)
BilberriesCranberries2002L0042—EN—11.06.2002—000.002—5
▼B
GroupsandexamplesofindividualproductstowhichtheMRLs
applyPesticideresiduesandmaximumresidue
levels
(mg/kg)
Bentazone(sumof
bentazoneandthe
conjugatesof6-OH-
and8-OH-benta-
zoneexpressedas
bentazone)Pyridate(sumof
pyridate,itshydro-
lysisproductCL
9673(6-chloro-4-
hydroxy-3-phenyl-
pridazin)andhydro-
lysableconjugates
ofCL9673
expressedaspyri-
date)
Currants(red,blackandwhite)
Gooseberries
Others
(e)Wildberriesandwildfruit
(vi) MISCELLANEOUS
Avocados
BanansDatesFigsKiwiKumquatsLitchis
Mangoes
OlivesPassionfruitPineapplesPomegranateOthers
2.Vegetables,freshoruncooked,frozenordry
(i)ROOTANDTUBERVEGETABLES 0,1(p)(*) 0,05(p)(*)
Beetroot
CarrotsCeleriacHorseradishJerusalemartichokesParsnipsParsleyroot
Radishes
SalsifySweetpotatoesSwedesTurnipsYamOthers
(ii)BULBVEGETABLES 0,1(p)(*) 0,05(p)(*)
Garlic
OnionsShallotsSpringonions
Others
(iii)FRUITINGVEGETABLES 0,1(p)(*) 0,05(p)(*)
(a)Solanacea
TomatoesPeppers
Aubergines
Others
(b)Cucurbits—ediblepeel
Cucumbers
Gherkins
CourgettesOthers2002L0042—EN—11.06.2002—000.002—6
▼B
GroupsandexamplesofindividualproductstowhichtheMRLs
applyPesticideresiduesandmaximumresidue
levels
(mg/kg)
Bentazone(sumof
bentazoneandthe
conjugatesof6-OH-
and8-OH-benta-
zoneexpressedas
bentazone)Pyridate(sumof
pyridate,itshydro-
lysisproductCL
9673(6-chloro-4-
hydroxy-3-phenyl-
pridazin)andhydro-
lysableconjugates
ofCL9673
expressedaspyri-
date)
(c)Cucurbits—inediblepeel
MelonsSquashesWatermelonsOthers
(d)Sweetcorn
(iv)BRASSICAVEGETABLES 0,1(p)(*)
(a)Floweringbrassica 0,05(p)(*)
BroccoliCauliflowerOthers
(b)Headbrassica 0,05(p)(*)
BrusselssproutsHeadcabbageOthers
(c)Leafybrassica
ChinesecabbageKale 0,2(p)Others 0,05(p)(*)
(d)Kohlrabi 0,05(p)(*)
(v)LEAFVEGETABLESANDFRESHHERBS 0,05(p)(*)
(a)Lettuceandsimilar 0,1(p)(*)
CressLamb'slettuceLettuceScaroleOthers
(b)Spinachandsimilar 0,1(p)(*)
SpinachBeetleaves(chard)Others
(c)Watercress 0,1(p)(*)
(d)Witloof 0,1(p)(*)(e)Herbs 0,1(p)(*)
ChervilChivesParsleyCeleryleavesOthers
(vi)LEGUMEVEGETABLES(fresh) 0,05(p)(*)
Beans(withpods)
Beans(withoutpods)Peas(withpods) 0,5(p)
Peas(withoutpods) 0,2(p)
Others 0,1(p)(*)
(vii)STEMVEGETABLES(fresh) 0,1(p)(*)
Asparagus
CardoonsCeleryFennel
Globeartichokes
Leek 1(p)Rhubarb2002L0042—EN—11.06.2002—000.002—7
▼B
GroupsandexamplesofindividualproductstowhichtheMRLs
applyPesticideresiduesandmaximumresidue
levels
(mg/kg)
Bentazone(sumof
bentazoneandthe
conjugatesof6-OH-
and8-OH-benta-
zoneexpressedas
bentazone)Pyridate(sumof
pyridate,itshydro-
lysisproductCL
9673(6-chloro-4-
hydroxy-3-phenyl-
pridazin)andhydro-
lysableconjugates
ofCL9673
expressedaspyri-
date)
Others 0,05(p)(*)
(viii)FUNGI 0,1(p)(*) 0,05(p)(*)
(a)Cultivatedmushrooms
(b)Wildmushrooms
3.Pulses 0,1(p)(*) 0,05(p)(*)
Beans
LentilsPeasOthers
4.Oilsseeds 0,05(p)(*)
Linseed
PeanutsPoppyseedSesameseedSunflowerseedRapeseed
Soyabean 0,1(p)
MustardseedCottonseedOthers 0,1(p)(*)
5.Potatoes 0,1(p)(*) 0,05(p)(*)
Earlypotatoes
Warepotatoes
6.Tea(leavesandstems,dried,fermentedorotherwise,of
Camellia sinensis )0,1(p) 0,1(p)(*)
7.Hops(dried), including hop pellets and unconcentrated
powder0,1(p)(*) 0,1(p)(*)
►C1(p) IndicatesprovisionalmaximumresiduelevelinaccordancewithArticle4(1)(f)ofDirective91/414/EEC:
unlessamended,thislevelwillbecomedefinitivewitheffectfrom4yearsfromdateofcomingintoforceoftheDirectiveintroducingthisamendment. ◄
(*) Indicateslowerlimitofanalticaldetermination.2002L0042—EN—11.06.2002—000.002—8