1992R3600 — EN — 30.06.1997 — 002.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COMMISSION REGULATION (EEC) No 3600/92
of 11 December 1992
layingdownthedetailedrulesfortheimplementationofthefirststageoftheprogrammeofwork
referred to in Article 8 (2) of Council Directive 91/414/EEC concerning the placing of plant
protection products on the market
(OJ L 366, 15.12.1992, p. 10)
Amended by:
Official Journal
No page date
►M1Commission Regulation (EC) No 491/95 of 3 March 1995 L49 50 4.3.1995
►M2Commission Regulation (EC) No 1199/97 of 27 June 1997 L170 19 28.6.1997
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▼B
COMMISSION REGULATION (EEC) No 3600/92
of 11 December 1992
laying down the detailed rules for the implementation of the first
stage of the programme of work referred to in Article 8 (2) ofCouncil Directive 91/414/EEC concerning the placing of plant
protection products on the market
THE COMMISSIONOF THE EUROPEANCOMMUN ITIES,
Having regard to the Treaty establishing the European EconomicCommunity,
Having regard to Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on the market(
1),
and in particular Article 8 (2) thereof,
WhereastheCommissionistocommenceaprogrammeofworkforthe
gradual examination of active substances available on the market twoyears after the date of notification of Directive 91/414/EEC;
Whereas, given the very high number of active substances on the
market on that date, a selection has already been made, taking intoaccount in a balanced manner such aspects as health and/or environ-mental concern, the possibility of residues in treated products, theimportance of the preparations containing these substances for agricul-ture,anymanifestdatagaps(or,conversely,thepresenceofacomplete,updated data package), and any similarity of chemical or biologicalproperties;
Whereas the relationship between producers, Member States and the
Commission and the obligations on each of the parties for the imple-mentation of the programme should be laid down;
Whereasanotificationprocedurehastobeprovidedbywhichinterested
producers have the right to inform the Commission of their interest insecuringtheinclusionofanactivesubstanceinAnnexItotheDirectiveand of their undertaking to submit all the requisite information for aproperevaluationof,anddecisionon,thatactivesubstanceinthelightofthecriteriaforinclusionsetoutinArticle5ofDirective91/414/EEC;
Whereasitisnecessarytodefinetheobligationsofnotifierswithregard
totheformats,theperiodsandtherecipientauthoritiesfortheinforma-tion to be submitted; whereas the administrative consequences whichshall follow if these obligations are not satisfied have to be defined;
Whereas technical or scientific information about the potentially
dangerouseffectsofanactivesubstanceoritsresiduessubmittedwithinthe relevant time-limits by any other interested parties should also betaken into consideration for this evaluation;
Whereas the evaluation studies should be distributed among the
competent authorities of the Member States; whereas, therefore, foreach active substance a rapporteur Member State should be designatedtoexamineandevaluatetheinformationsubmitted,incloseconsultationwithexpertsfromotherMemberStates,andtopresenttotheCommis-siontheresultsoftheassessmentandarecommendationthatadecisionbe taken with regard to the active substance concerned;
Whereas the proceedings established under this Regulation should not
prejudice proceedings to be undertaken in the framework of otherCommunity legislations;
Whereas,inordertoavoidduplicationofwork,andinparticularexperi-
ments involving vertebrate animals, specific provisions have to beprovided to stimulate producers to submit collective dossiers;
(1) OJ No L 230, 19. 8. 1991, p. 1, as corrected inOJ No L 170, 25. 6. 1992,
p. 40.
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Whereas the procedures under the Regulation should not prejudice the
possibility of investigation and prohibitory action under CouncilDirective 79/117/EEC(
1), as last amended by Commission Directive
91/188/EEC(2), where information becomes available to the Commis-
sion showing that the requirements for prohibition provided for inDirective79/117/EECmaybesatisfied;whereasatthetimeofadoptionofthisRegulationsuchinformationregardingAtrazinandQuintozeneisunder particular examination;
Whereas procedural and administrative measures have to be taken at
thistimeinordertoensurethattheevaluationofactivesubstancescaneffectively start from the date of implementation of Directive 91/414/EEC;
WhereasthemeasuresprovidedforinthisRegulationareinaccordance
with the opinion of the Standing Committee on Plant Health,
HAS ADOPTED THIS REGULATION:
Article 1
1. This Regulation lays down detailed rules for the implementation
ofthefirststageoftheprogrammeofworkreferredtoinArticle8(2)ofDirective91/414/EEC(hereinafterreferredtoasthe‘Directive').ThefirststageinvolvesanassessmentofthesubstanceslistedinAnnexItothis Regulation with a view to their possible inclusion in Annex I toDirective 91/414/EEC. The provisions of Article 6 (2) and (3) and thesecondsubparagraphofArticle6(4)oftheDirectiveshallnotapplytoa substance listed in Annex I to this Regulation as long as the proced-ures provided in this Regulation with regard to such a substance havenot been finalized.
2. This Regulation shall apply without prejudice to:
(a) reviews conducted by Member States, and in particular reviews
with a view to authorization renewals under Article 4 (4) of theDirective;
(b) reviews by the Commission pursuant to Article 5 (5) of the
Directive;
(c) assessments carried out under Directive 79/117/EEC.
Article 2
1. For the purpose of this Regulation, ‘plant protection products',
‘substances',‘active substances',‘preparations'and‘authorization of aplantprotectionproduct'shallhavethemeaningssetoutinArticle2ofthe Directive.
2. The following definitions shall also apply for the purpose of this
Regulation:
(a) ‘Producers'means
— for active substances produced within the Community, the
manufacturer or a person established within the Communitydesignated by the manufacturer as his sole representative,
— for active substances produced outside the Community, the
personestablishedwithintheCommunityanddesignatedbythemanufacturer as his sole representative or, whenever suchperson has not been designated, the importer(s) into theCommunity of the active substance, either on its own or in apreparation;
(b) ‘Committee' means the Standing Committee on Plant Health,
referred to in Article 19 of the Directive.
(1) OJ No L 33, 8. 2. 1979, p. 36.
(2) OJ No L 92, 13. 4. 1991, p. 42.
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Article 3
Member States shall designate an authority to coordinate cooperation
with producers, other Member States and the Commission, and gener-ally for the implementation of the programme of work referred to inArticle8(2)oftheDirective.TheyshallinformtheCommissionofthename of the designated authority.
Article 4
1. Any producer wishing to secure the inclusion of an active
substance referred to in Annex I hereto, or any salts, esters or aminesthereof, in Annex I to the Directive, shall so notify the Commissionwithin six months of the date of entry into force of this Regulation.
Withoutprejudicetotheforegoingsubparagraph,producersofanactive
substance listed in Annex I are also bound to inform the CommissionwithinthesameperiodwhentheynolongerseekitsinclusioninAnnexI to the Directive.
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M1
1a. Notwithstandingtheprovisionsofparagraph1,producershavinga permanent office in Austria, Finland or Sweden may notify theCommission by 30 April 1995 at the latest.
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B
2. Notification must be made to the Commission, DG VI, rue de laLoi200,B-1049Brussels,inaccordancewiththenotificationasshownin Annex II hereto, completed and containing the undertaking referredto in part 5 of the specimen notification.
3. Any producer who has not notified in time any given active
substance referred to in paragraph 1 will be permitted to participate inthe programme referred to in Article 1 only collectively with othernotifiersofthatactivesubstanceor,inthecasereferredtoinparagraph4hereof,inassistingthenotifyingMemberState,withtheagreementofthe original notifiers.
4. The Commission shall inform the Member States through the
Committee when, for any given active substance, no producer haspresentedanotificationinaccordancewithparagraph2.MemberStatesshall be able to declare their interest in securing the inclusion of theactivesubstanceinAnnexItotheDirective,bymeansofthespecimennotificationshowninAnnexIIhereto.NotificationmustbesenttotheCommission as quickly as possible, and no later than six months afterthe Member States have been informed by the Commission. TheMember State having presented the notification shall carry out theduties of a producer as set out in Articles 5 to 8 hereof.
5. When, following the above procedure, no producer or Member
Statehasnotifiedaninterestinobtainingtheinclusionofagivenactivesubstance in Annex I to the Directive, a decision not to include thatactive substance may be taken in accordance with the final subpara-graph of Article 8 (2) of the Directive.
Article 5
1. The Commission shall examine with the Committee the notifica-
tions referred to in Article 4 (2) and (4).
2. Following the examination referred to in paragraph 1, decisions
shall be adopted on the following, according to the procedure underArticle 19 of the Directive, in the form of a regulation:
(a) the list of active substances adopted for assessment with a view to
their possible inclusion in Annex I to the Directive;
(b) designationofarapporteurMemberStateforeachactivesubstance
included in the list referred to in (a).
3. In the list referred to in paragraph 2 (a), certain substances with
similarstructuresorchemicalpropertiesmaybegroupedtogether;ifanactive substance has been notified with different compositions which
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mayleadtodifferenttoxicologicalpropertiesorhavedifferentenviron-mental effects, these may be listed separately.
4. Foreachsubstanceadoptedforassessment,theregulationreferred
to in paragraph 2 shall give:
— the names of all producers who have presented a notification in
accordance with Article 2 (1), or, where appropriate, the MemberStates which have presented a notification under Article 4 (4),
— the name of the Member State designated as rapporteur,— the deadline for the submission to the rapporteur Member State of
thedossiersreferredtoinArticle6hereof,generallylayingdownaperiod of 12 months for the compilation of the documents, and forthe submission by any interested parties of technical or scientificinformation with regard to the potentially dangerous effects of thesubstance or its residues on human and/or animal health and/or onthe environment.
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M2
4A. From the time of the adoption of the Regulation referred to inparagraph 2, if a Member State envisages to take action to withdrawfrom the market or to restrict severely the use of a plant protectionproduct containing an active substance listed in that regulation, wherethatactionisbasedoninformationcontainedinthedossiersreferredtoinArticle6orthereportreferredtoinArticle7,theMemberStateshallas soon as possible inform the Commission and the other MemberStates, citing the reasons for its intended action.
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B
5. When, during the reassessment referred to in Articles 6, 7 and 8hereof,animbalancebecomesapparentintheresponsibilitiesbornebythe Member States as rapporteurs, it may be decided, using the proce-dureunderArticle19oftheDirective,todesignateadifferentMemberState as rapporteur for a particular substance.
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M1
WheresuchadifferentMemberStatehasbeendesignatedasrapporteurMember State, the original Member State shall inform thereof thenotifiersconcernedandshalltransfertothenewlydesignatedrapporteurMemberStateallcorrespondenceandinformationwhichithasreceivedas rapporteur Member State for the active substance concerned.
6. Whenanotifierdecidestoenditsparticipationintheprogramme
ofworksforanactivesubstance,heshallinformthereoftherapporteurMemberState,theCommissionandtheothernotifiersforthesubstanceconcerned.
When a notifier agrees with another producer that he shall be replaced
for the purposes of further participation in the programme of worksunderthisRegulation,thenotifierandsuchotherproducershallinformthe rapporteur Member State and the Commission by a commondeclaration agreeing that such other producer shall replace the originalnotifierincarryingoutthenotifier’sdutiesassetoutinArticles6to8;theyshallassurethattheothernotifiersforthesubstanceconcernedareinformed as well.
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B
Article 6
1. Within the time-limit referred to in the third indent of Article 5
(4), the notifiers specified in the regulation referred to in that Articlemust, individually or collectively, send to the designated authority ofthe rapporteur Member State, for any given active substance:
(a) the summary dossier referred to in paragraph 2 hereof; and
(b) the complete dossier referred to in paragraph 3 hereof.
They shall also send this information to the experts as referred to in
Article7(2),and,ifsorequested,tothecompetentauthorityreferredtoin Article 3 of each Member State.
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Where for any substance the regulation as envisaged in Article 5 (4)
indicates several notifications, the notifiers concerned shall take allreasonable steps to present collectively the dossiers referred to in thefirst subparagraph. Where a dossier was not presented by all notifiersconcerned,itshallmentiontheeffortsmadeandthereasonswhycertainproducers have not participated.
2. The summary dossier shall include the following:
(a) acopyofthenotification;inthecaseofajointapplicationmadeby
several producers, a copy of the notifications presented in accord-ance with Article 4 and the name of the person designated by theproducers concerned as being responsible for the joint dossier andthe processing of the dossier in accordance with this Regulation;
(b) the recommended conditions for the use of an active substance, to
beconsideredinrelationtoitsinclusioninAnnexItotheDirective;
(c) foreachpointofAnnexIItotheDirective,theavailablesummaries
and results of trials, the name of the person or institute that hascarriedoutthetrials;thesameinformationforeachpointofAnnexIIItotheDirectiverelevanttotheassessmentofthecriteriareferredto in Article 5 of the Directive and for one or more preparationswhich are representative for the conditions of use referred to insubparagraph (b);
(d) when the information referred to in certain points of subparagraph
(c) is not available:
— either, in accordance with the introductory provisions of
Annexes II and III of the Directive, the scientific or technicalreasons demonstrating that the information is not necessary forthe assessment of the active substance according to the criteriareferred to in Article 5 of the Directive,
— or an undertaking by the producer or producers submitting the
dossierthatthemissinginformationwillbesentatalaterdate;a detailed timetable and documents showing that the under-taking can be fulfilled must be submitted.
3. Thecompletedossiershallcontaintheprotocolsandthecomplete
study reports concerning all the information referred to in paragraph 2(c).
4. Where, for any given active substance, the dossiers referred to in
paragraph1arenotsentwithinthetime-limitlaiddowninArticle5(4)or where the dossiers sent clearly do not satisfy the requirements laiddown in paragraphs 2 and 3 hereof, the rapporteur Member State shallinform the Commission, giving the reasons pleaded by the notifiers.
5. OnthebasisofthereportoftherapporteurMemberStatereferred
to in paragraph 4, the Commission shall present to the Committee adraftdecisionnottoincludetheactivesubstanceinAnnexI,inaccord-ance with the final subparagraph of Article 8 (2) of the Directive,unless:
▼
M1— a new time-limit has been granted for the submission of a dossier
fulfilling the requirements of paragraphs 2 and 3; a new time-limitwillonlybegrantedwherethedelayisprovedtohavebeencausedby efforts to present collective dossiers, or by additional efforts tobe made by the notifier (or notifiers) on account of a decision todesignate another rapporteur Member State in accordance withArticle 5 (5),
▼
B
— a Member State informs the Commission of its wish to secure the
inclusion of the active substance concerned in Annex I to theDirectiveanditsreadinesstoensurethecompositionofthedossiersas referred to in paragraph 1 hereof and to carry out the duties ofnotifier as set out in Articles 7 and 8 hereof.
Article 7
1. Foreachactivesubstanceforwhichithasbeendesignatedrappor-
teur, the Member State shall:
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(a) examinethedossiersreferredtoinArticle6(2)and(3),intheorder
inwhichtheyarereceivedfromthenotifierornotifiersconcerned,as well as any information as referred to in the third indent ofArticle5(4)andanyotheravailableinformation;ifseveraldossiersare presented for one active substance, the dossier presented lastwill determine the order of its examination; ►
M1the order of
examination is, however, not affected by dossiers presented bynotifiers referred to in Article 4 (1) (a); ◄
(b) immediately after examining a dossier, ensure that notifiers submit
theupdatedsummarydossiertotheotherMemberStatesandtotheCommission;
(c) send the Commission, as quickly as possible and at the latest 12
monthsafterreceiptofadossierasreferredtoinArticle6(2)and(3),areportofitsassessmentofthedossier,includingarecommen-dation:
— to include the active substance in Annex I to the Directive,
stating the conditions for its inclusion, or
— to remove the active substance from the market, or— tosuspendtheactivesubstancefromthemarket,withtheoption
ofreconsideringtheinclusionoftheactivesubstanceinAnnexIafter submission of the results of additional trials or of addi-tional information specified in the report, or
— to postpone any decision on possible inclusion pending the
submission of the results of additional trials or informationspecified in the report;
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M2
(d) inparticular,includeinthereportareferencetoeachtestandstudy
report,foreachpointofAnnexIItotheDirective,reliedonfortheassessment in the form of a list of test and study reports includingthe title, the author(s), the date of the study or test and the date ofpublication,thestandardtowhichthetestorstudywasconducted,the holder’s name and, if any, the claim made by the holder ornotifier for data protection.
2. From the start of the examination referred to in paragraph 1, the
rapporteur Member State may request the notifiers to improve theirdossiers, or add to them. Moreover, the rapporteur Member State may,from the start of this examination, consult with experts from otherMemberStates,andmayrequestadditionaltechnicalorscientificinfor-mation from other Member States in order to assist the evaluation.
3. After receiving the summary dossier and the report referred to in
paragraph1,theCommissionshallreferthedossierandthereporttotheCommittee for examination.
BeforereferringthedossierandreporttotheCommittee,theCommis-
sion shall circulate the rapporteur’s report to the Member States forinformation.TheMemberStatesshallmakeavailableatspecificrequestor keep available for consultation by interested parties the informationreferred to in point (d) of paragraph 1, except the elements thereofwhichhavebeenacceptedasconfidentialinaccordancewithArticle14of the Directive, as well as the name and content of the activesubstance.
BeforethedossierandreportarereferredtotheCommittee,aconsulta-
tion of experts from the Member States may be organized and theCommission may consult some or all of the notifiers of activesubstancesspecifiedintheregulationreferredtoinArticle5(2)onthereport or parts of the report on the relevant active substance.
3A. After the examination referred to in paragraph 3, the Commis-
sionshall,withoutprejudicetoanyproposalitmaysubmitwithaviewto amending the Annex to Directive 79/117/EEC, present to theCommittee:
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(a) a draft directive to include the active substance in Annex I to the
Directive, setting out where appropriate the conditions, includingthe time-limit, for such inclusion;
(b) a draft decision addressed to the Member States to withdraw the
authorizations of plant protection products containing the activesubstance, pursuant to the fourth subparagraph of Article 8 (2) ofthe Directive, whereby that active substance is not included inAnnex I to the Directive;
(c) a draft decision addressed to the Member States to suspend plant
protectionproductscontainingtheactivesubstancefromthemarket,with the option of reconsidering the inclusion of the activesubstanceinAnnexItotheDirectiveaftersubmissionoftheresultsof additional trials or of additional information; or
(d) a draft decision to postpone inclusion of the active substance in
Annex I to the Directive pending the submission of the results ofadditional trials or information.
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4. However, where, following the examination referred to in para-graph 3, the submission of the results of certain additional trials or ofadditional information is required, the Commission shall determine:
— the time-limit within which the results or information concerned
must be submitted to the rapporteur Member State and the expertsdesignated according to paragraph 2 above,
— the time-limit within which the notifiers concerned must communi-
cate to the rapporteur Member State and to the Commission theirundertakingtosubmittherequiredresultsorinformationwithinthetime-limit laid down in the first indent.
5. The Commission shall submit to the Committee a draft decision
for non-inclusion in Annex I to the Directive in accordance with thefinal subparagraph of Article 8 (2) thereof, where:
— thenotifiersconcernedhavenotcommunicatedtheirundertakingto
submit the required results within the time-limit referred to in thesecond indent of paragraph 4,
— therapporteurMemberStatehasinformedtheCommissionthatthe
results referred to in the first indent of paragraph 4 have not beensubmitted within the time-limit laid down.
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6. Where the Commission presents a draft directive or a draftdecisioninaccordancewithparagraph3Aoradraftinaccordancewithparagraph 5, it shall at the same time present the conclusions of theCommittee’sexaminationintheformatofanup-datedreviewreporttobe noted in the summary record of the meeting.
The review report, excluding any parts which refer to confidential
informationcontainedinthedossiersanddeterminedassuchinaccord-ance with Article 14 of the Directive, shall be made available by eachMemberStateonspecificrequest,orshallbekeptavailableforconsul-tation by interested parties.
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Article 8
1. Afterreceivingtheresultsoftheadditionaltrialsortheadditional
information, the rapporteur Member State must:
(a) examine it in conjunction with the results of the dossier already
submitted for the substance concerned;
(b) immediatelyaftersuchexamination,ensurethatthesummaryofthe
additional trials and the results of those trials or the additionalinformationaresentbythenotifiertotheotherMemberStatesandto the Commission;
(c) communicateasquicklyaspossible,andwithinninemonthsatthe
latest following receipt of the results or information, to theCommission, the report of its assessment of the whole dossierincluding a recommendation:
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— toincludetheactivesubstanceinAnnexIstatingtheconditions
for such inclusion, or
— wherethesubstanceisalreadyincludedinAnnexI,tomaintain
or amend the conditions for inclusion, or
— to remove the active substance from the market, or— tosuspendtheactivesubstancefromthemarket,withtheoption
ofreconsideringtheinclusionoftheactivesubstanceinAnnexIafter submission of certain additional trials or information inordertoclarifyanyinconclusivepointsresultingfromtheaddi-tionaltrialsorinformationsubmittedinaccordancewithArticle7 (4),
— or, where the results of the additional trials or information do
not permit definite conclusions to be drawn, to postpone thedecisionpendingthesubmissionofcertainfurthertrialsinorderto clarify any inconclusive points resulting from the additionaltrials submitted in accordance with Article 7 (4).
2. The procedure provided for in Article 7 (2) is applicable to the
examinations referred to in paragraph 1 (a) hereof.
3. Afterreceivingthesummaryandreportreferredtoinparagraph1,
the Commission shall refer them to the Committee for examination inthe light of the examination already carried out in accordance with thefirst subparagraph of Article 7 (3).
Afterthisexamination,theCommissionshall,withoutprejudicetoany
proposalitmaysubmitwithaviewtoamendingtheAnnextoDirective79/117/EEC,presenttotheCommitteeeitheradraftdecisiontoincludethe active substance in Annex I to the Directive, setting out (whereappropriate) the conditions for such inclusion, or else a draft decisionpursuant to the final subparagraph of Article 8 (2) of the Directive,wherebythatactivesubstanceisnotincludedinAnnexIthereto.Inthecase of an active substance already listed in the said Annex, the draftdecision may amend the conditions governing inclusion.
4. Where,followingtheexaminationbytheCommitteereferredtoin
thefirstsubparagraphofparagraph3above,theresultsoffurthertrialsappearnecessary,Article7(4)and(5)andArticle8(1)shallapply.Insuch cases, the Commission shall give the notifiers concerned itsdetailed reasons for requesting additional trials.
Article 9
Where, in respect of a substance mentioned in Annex A, the Commis-
sion presents a proposal for a total prohibition under Directive 79/117/EEC, the periods provided in this Regulation shall be suspendeduntil a decision on this proposal has been taken. Where the Councildecides on the total prohibition of the substance in the Annex toDirective 79/117/EEC, the procedure under this Regulation will beterminated.
Article 10
This Regulation shall enter into force on 1 February 1993.
ThisRegulationshallbebindinginitsentiretyanddirectlyapplicablein
all Member States.
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ANNEX I
LIST OF SUBSTANCES COVERED BY THE FIRST STAGE OF THE
WORK PROGRAMME PROVIDED FOR IN ARTICLE 8 (2) OF
DIRECTIVE 91/414/EEC
Name
1. Acephate
2. Methamidophos3. Aldicarb4. Amitraz5. Azinphos-ethyl6. Azinphos-methyl7. Carbendazim8. Benomyl9. Thiophanate-methyl
10. Chlorpyriphos11. Chlorpyriphos-methyl12. Cyfluthrin13. Beta-cyfluthrin14. Cyhalothrin15. Lambda-cyhalothrin16. Cypermethrin17. Alpha-cypermethrin18. DNOC19. Deltamethrin20. Dinoterb21. Endosulfan22. Fenthion23. Fenvalerate24. Esfenvalerate25. Lindane26. Parathion27. Parathion-methyl28. Permethrin
29. Benalaxyl30. Metalaxyl31. Chlorothalonil32. Dinocap33. Fenarimol34. Fentin acetate35. Fentin hydroxide36. Flusilazole37. Imazalil38. Mancozeb39. Maneb40. Zineb41. Metiram42. Propineb43. Thiram44. Ferbam45. Ziram46. Propiconazole
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47. Pyrazophos
48. Quintozene49. Thiabendazole50. Vinclozolin51. Procymidone52. Iprodione53. Chlozolinate
54. Chlorpropham55. Propham56. Daminozide57. Maleic hydrazide58. Tecnazene
59. Alachlor
60. Amitrole (Aminotriazole)61. Atrazine62. Simazine63. Bentazone64. Chlorotoluron65. 2,4-D66. 2,4-D-B67. Ethofumesate68. Fluroxypyr69. Glyphosate70. Ioxynil71. Bromoxynil72. Isoproturon73. MCPA74. MCPB75. Mecoprop76. Mecoprop-P77. Metsulfuron78. Tifensulfuron79. Triasulfuron80. Molinate81. Monolinuron82. Linuron83. Paraquat84. Diquat85. Pendimethalin86. Desmedipham87. Phenmedipham88. Propyzamide89. Pyridate90. Warfarin
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ANNEX II
MODEL
Notification of an active substance according to Article 4 (1) of Regulation
(EEC) No 3600/92
1. Identification data on the notifier
1.1 Manufactureroftheactivesubstance(name,address,includinglocation
of plant):
1.2 Notifying company (name, address, etc. ) (if different from 1. 1):1.2.a. Acting as:
— sole representative designated by the manufacturer,— importer not designated as sole representative of the manufacturer.
1.3. Name of the (physical) person responsible for the notification and
further engagements resulting from Regulation (EEC) No 3600/92.
1.3.1. Address for correspondence:1.3.2. (a) Telephone No:
(b) Telex No:(c) Telefax No:
1.3.3. (a) Contact:
(b) Alternative:
2. Information to facilitate identification
2.1 Common name proposed or ISO-accepted, and synonyms, specifying,
where relevant, any salts or esters produced by the manufacturer.
2.2 Chemical name (IUPAC nomenclature).2.3 Manufacturer’s development code number(s).2.4 CAS, CIPAC and EEC numbers (if available).2.5 Empirical and structural formula, molecular mass.2.6 Specification of purity of the active substance in g/kg or g/l as appro-
priate.
2.7 Identity of isomers, impurities and additives (e. g. stabilizers), together
with the structural formula and the possible range expressed in g/kg org/l.
3. Information on use conditions to be covered by the inclusion in Annex I
and supported by the applicant
3.1 Function, e. g. fungicide, herbicide, insecticide, repellant, growth regu-
lator.
3.2 Field of use envisaged, e. g. field, glasshouse, food or feed storage,
home garden.
3.3 Any specific health, agricultural, plant health or environmental condi-
tions under which the active substance may or should not be used.
3.4 Harmfulorganismscontrolledandcropsorproductsprotectedortreated.
4. Information on authorized uses known to the notifier
4.1 Countries where there is registration (EC).4.2 Countries where there is registration (non EC).4.3 Registered uses in EC, including all relevant conditions.4.4 Formulation name, type (GIFAP/FAO code) and content of active
substance (in g/kg or g/l).
5. Undertaking to submit dossier
The notification confirms that the above information is honest and
correct. He agrees to submit to the competent authorities of the desig-nated reporting Member State the dossiers as set out in Article 6 ofRegulation (EEC) No 3600/92 within a period of 12 months of the
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Commission decision provided for in Article 5 (4) of this Regulation.
Whenever this decision mentions several notifiers for this activesubstance, the notifier will undertake all reasonable efforts to present asingle dossier collectively with the other notifiers.
Signature (of the person competent to act for the company mentioned
under 1. 1).