1992R3600 — EN — 01.11.2000 — 004.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COMMISSIONREGULATION(EEC)No3600/92
of11December 1992
layingdownthedetailedrulesfortheimplementationofthefirststageoftheprogrammeofwork
referred to in Article 8 (2) of Council Directive 91/414/EEC concerning the placing of plant
protection productsonthemarket
(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 L 49 50 4.3.1995
►M2Commission Regulation (EC) No 1199/97 of 27 June 1997 L 170 19 28.6.1997
►M3Commission Regulation (EC) No 1972/1999 of 15 September 1999 L 244 41 16.9.1999
►M4Commission Regulation (EC) No 2266/2000 of 12 October 2000 L 259 27 13.10.2000
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COMMISSIONREGULATION(EEC)No3600/92
of11December 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 productsonthemarket
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
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,
Whereas the Commission is to commence a programme of work for the
gradual examination of active substances available on the market two
years 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 into account in a
balanced manner such aspects as health and/or environmental concern,the possibility of residues in treated products, the importance of thepreparations containing these substances for agriculture, any manifestdata gaps (or, conversely, the presence of a complete, updated datapackage), and any similarity of chemical or biological properties;
Whereas the relationship between producers, Member States and the
Commission and the obligations on each of the parties for the
implementation of the programme should be laid down;
Whereas a notification procedure has to be provided by which interested
producers have the right to inform the Commission of their interest in
securing the inclusion of an active substance in Annex I to the Directive
and of their undertaking to submit all the requisite information for aproper evaluation of, and decision on, that active substance in the lightof the criteriafor inclusion set out in Article 5 of Directive 91/414/EEC;
Whereas it is necessary to define the obligations of notifiers with regard
to the formats, the periods and the recipient authorities for theinformation to be submitted; whereas the administrative consequenceswhich shall follow if these obligations are not satisfied have to be
defined;
Whereas technical or scientific information about the potentially
dangerous effects of an active substance or its residues submitted
within the relevant time-limits by any other interested parties should alsobe taken 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 designatedto examine and evaluate the information submitted, in close consultationwith experts from other Member States, and to present to the
Commission the results of the assessment and a recommendation that
a decision be 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, in order to avoid duplication of work, and in particular
experiments involving vertebrate animals, specific provisions have to beprovided to stimulate producers to submit collective dossiers;
Whereas the procedures under the Regulation should not prejudice the
possibility of investigation and prohibitory action under Council1992R3600 — EN — 01.11.2000 — 004.001 — 2
(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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Directive 79/117/EEC(1), as last amended by Commission Directive 91/
188/EEC(2), where information becomes available to the Commission
showing that the requirements for prohibition provided for in Directive
79/117/EEC may be satisfied; whereas at the time of adoption of this
Regulation such information regarding Atrazin and Quintozene is underparticular examination;
Whereas procedural and administrative measures have to be taken at this
time in order to ensure that the evaluation of active substances caneffectively start from the date of implementation of Directive 91/414/
EEC;
Whereas the measures provided for in this Regulation are in accordance
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 of
the first stage of the programme of work referred to in Article 8 (2) of
Directive 91/414/EEC (hereinafter referred to as the ‘Directive’). The
first stage involves an assessment of the substances listed in Annex I tothis Regulation with a view to their possible inclusion in Annex I toDirective 91/414/EEC. The provisions of Article 6 (2) and (3) and thesecond subparagraph of Article 6 (4) of the Directive shall not apply to a
substance listed in Annex I to this Regulation as long as the procedures
provided in this Regulation with regard to such a substance have notbeen 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 the Directive;
(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 aplant protection product’ shall have the meanings set out in Article 2 ofthe 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
person established within the Community and designated by themanufacturer as his sole representative or, whenever such personhas not been designated, the importer(s) into the Community ofthe active substance, either on its own or in a preparation;
(b) ‘Committee’ means the Standing Committee on Plant Health,
referred to in Article 19 of the Directive.
Article 3
Member States shall designate an authority to coordinate cooperation
with producers, other Member States and the Commission, and generallyfor the implementation of the programme of work referred to in Article 81992R3600 — EN — 01.11.2000 — 004.001 — 3
(1) OJ No L 33, 8. 2. 1979, p. 36.
(2) OJ No L 92, 13. 4. 1991, p. 42.
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(2) of the Directive. They shall inform the Commission of the name 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.
Without prejudice to the foregoing subparagraph, producers of an active
substance listed in Annex I are also bound to inform the Commissionwithin the same period when they no longer seek its inclusion in Annex Ito the Directive.
1a. Notwithstanding the provisions of paragraph 1, producers having
a permanent office in Austria, Finland or Sweden may notify theCommission by 30 April 1995 at the latest.
2. Notification must be made to the Commission, DG VI, rue de la
Loi 200, B-1049 Brussels, in accordance with the notification as shownin Annex II hereto, completed and containing the undertaking referred to
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 othernotifiers of that active substance or, in the case referred to in paragraph 4
hereof, in assisting the notifying Member State, with the agreement of
the original notifiers.
4. The Commission shall inform the Member States through the
Committee when, for any given active substance, no producer haspresented a notification in accordance with paragraph 2. Member States
shall be able to declare their interest in securing the inclusion of the
active substance in Annex I to the Directive, by means of the specimennotification shown in Annex II hereto. Notification must be sent to theCommission as quickly as possible, and no later than six months afterthe Member States have been informed by the Commission. The
Member State having presented the notification shall carry out the duties
of aproducer a s set out in Articles 5 to 8 hereof.
5. When, following the above procedure, no producer or Member
State has notified an interest in obtaining the inclusion of a given activesubstance in Annex I to the Directive, a decision not to include that
active substance may be taken in accordance with the final subparagraph
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 aregula tion:
(a) the list of active substances adopted for assessment with a view to
their possible inclusion in Annex I to the Directive;
(b) designation of a rapporteur Member State for each active substance
included in the list referred to in (a).
3. In the list referred to in paragraph 2 (a), certain substances with
similar structures or chemical properties may be grouped together; if anactive substance has been notified with different compositions whichmay lead to different toxicological properties or have differentenvironmental effects, these may be listed separately.1992R3600 — EN — 01.11.2000 — 004.001 — 4
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4. For each substance adopted for assessment, the regulation referred
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
the dossiers referred to in Article 6 hereof, generally laying down aperiod of 12 months for the compilation of the documents, and for
the submission by any interested parties of technical or scientific
information with regard to the potentially dangerous effects of thesubstance or its residues on human and/or animal health and/or onthe environment.
4A. From the time of the adoption of the Regulation referred to in
paragraph 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, wherethat action is based on information contained in the dossiers referred to
in Article 6 or the report referred to in Article 7, the Member State shall
as soon as possible inform the Commission and the other MemberStates, citing the reasons for its intended action.
5. When, during the reassessment referred to in Articles 6, 7 and 8
hereof, an imbalance becomes apparent in the responsibilities borne by
the Member States as rapporteurs, it may be decided, using theprocedure under Article 19 of the Directive, to designate a differentMember State as rapporteur for a particular substance.
Where such a different Member State has been designated as rapporteur
Member State, the original Member State shall inform thereof thenotifiers concerned and shall transfer to the newly designated rapporteurMember State all correspondence and information which it has receivedas rapporteur Member State for the active substance concerned.
6. When a notifier decides to end its participation in the programme
of works for an active substance, he shall inform thereof the rapporteur
Member State, the Commission and the other notifiers for the substanceconcerned.
When a notifier agrees with another producer that he shall be replaced
for the purposes of further participation in the programme of works
under this Regulation, the notifier and such other producer shall inform
the rapporteur Member State and the Commission by a commondeclaration agreeing that such other producer shall replace the originalnotifier in carrying out the notifier's duties as set out in Articles 6 to 8;they shall assure that the other notifiers for the substance concerned areinformed as well.
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 Article must,individually or collectively, send to the designated authority of therapporteur 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
Article 7 (2), and, if so requested, to the competent authority referred to
in Article 3 of each Member State.
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 notifiers1992R3600 — EN — 01.11.2000 — 004.001 — 5
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concerned, it shall mention the efforts made and the reasons why certain
producers have not participated.
2. The summary dossier shall include the following:
(a) a copy of the notification; in the case of a joint application made by
several producers, a copy of the notifications presented inaccordance with Article 4 and the name of the person designated
by the producers concerned as being responsible for the joint dossier
and the processing of the dossier in accordance with this Regulation;
(b) the recommended conditions for the use of an active substance, to be
considered in relation to its inclusion in Annex I to the Directive;
it has to be demonstrated by the notifier that, on the basis of the
information submitted for one or more preparations for a limitedrange of representative uses, the requirements of the Directive inrelation to the criteria referred to in Article 5 thereof can be met;
(c) for each point of Annex II to the Directive, the available summaries
and results of trials, the name of the person or institute that hascarried out the trials; the same information for each point of AnnexIII to the Directive relevant to the assessment of the criteria referredto in Article 5 of the Directive and for one or more preparations
which are representative for the conditions of use referred to in
subparagraph (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 technical
reasons 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
dossier that the missing information will be sent at a later date; adetailed timetable and documents showing that the undertakingcan be fulfilled must be submitted.
3. The complete dossier shall contain the protocols and the complete
study reports concerning all the information referred to in paragraph 2
(c).
4. Where, for any given active substance, the dossiers referred to in
paragraph 1 are not sent within the time-limit laid down in Article 5 (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. On the basis of the report of the rapporteur Member State referred
to in paragraph 4, the Commission shall present to the Committee a draftdecision not to include the active substance in Annex I, in accordance
with the final subparagraph of Article 8 (2) of the Directive, unless:
— a new time-limit has been granted for the submission of a dossier
fulfilling the requirements of paragraphs 2 and 3; a new time-limitwill only be granted where the delay is proved to have been caused
by efforts to present collective dossiers, or by additional efforts to be
made by the notifier (or notifiers) on account of a decision todesignate another rapporteur Member State in accordance withArticle 5 (5),
— aMember Sta te informs the Commission of its wish to secure the
inclusion of the active substance concerned in Annex I to theDirective and its readiness to ensure the composition of the dossiersas referred to in paragraph 1 hereof and to carry out the duties ofnotifier as set out in Articles 7 and 8 hereof.1992R3600 — EN — 01.11.2000 — 004.001 — 6
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Article 7
1. For each active substance for which it has been designated
rapporteur, the Member State shall:
(a) examine the dossiers referred to in Article 6 (2) and (3), in the order
in which they are received from the notifier or notifiers concerned,as well as any information as referred to in the third indent of Article5 (4) and any other available information; if several dossiers are
presented for one active substance, the dossier presented last will
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
the updated summary dossier to the other Member States and to theCommission;
(c) send the Commission, as quickly as possible and at the latest 12
months after receipt of a dossier as referred to in Article 6 (2) and(3), areport of its a ssessment of the dossier, including arecommendation:
— 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— to suspend the active substance from the market, with the option
of reconsidering the inclusion of the active substance in Annex I
after submission of the results of additional trials or of additional
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;
(d) in particular, include in the report a reference to each test and study
report, for each point of Annex II to the Directive, relied on for the
assessment in the form of a list of test and study reports including
the title, the author(s), the date of the study or test and the date ofpublication, the standard to which the test or study was conducted,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 otherMember States, and may request additional technical or scientific
information from other Member States in order to assist the evaluation.
3. After receiving the summary dossier and the report referred to in
paragraph 1, the Commission shall refer the dossier and the report to theCommittee for examination.
Before referring the dossier and report to the Committee, the
Commission shall circulate the rapporteur's report to the Member States
for information.
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M3The Rapporteur Member State shall make available at specific
request or keep available for consultation by interested parties thefollowing:
— the information referred to in point (d) of paragraph 1, except the
elements thereof which have been accepted as confidential inaccordance with Article 14 of the Directive;
— the name of the active substance;— the content of the pure active substance in the manufactured
material;
— the list of any data required for consideration of the possible
inclusion of the active substance into Annex I to the Directive, firstas contained in the rapporteur's report and secondly as finalised afterthe consultation by the Commission of the experts referred to in thenext subparagraph. ◄1992R3600 — EN — 01.11.2000 — 004.001 — 7
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Before the dossier and report are referred to the Committee, a
consultation of experts from the Member States may be organized andthe Commission may consult some or all of the notifiers of active
substances specified in the regulation referred to in Article 5 (2) on the
report or parts of the report on the relevant active substance.
3A. After the examination referred to in paragraph 3, the Commission
shall, without prejudice to any proposal it may submit with a view toamending the Annex to Directive 79/117/EEC, present to the
Committee:
(a) a draft directive to include the active substance in Annex I to the
Directive, setting out where appropriate the conditions, including thetime-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) of theDirective, whereby that active substance is not included in Annex I
to the Directive;
(c) a draft decision addressed to the Member States to suspend plant
protection products containing the active substance from the market,with the option of reconsidering the inclusion of the active substance
in Annex I to the Directive after submission of the results of
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 of
additional trials or information.
4. However, where, following the examination referred to in
paragraph 3, the submission of the results of certain additional trials
or of additional information is required, the Commission shalldetermine:
— 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, ►
M4this time limit
will be 25 May 2002 unless an earlier time limit is established by theCommission for a particular active substance except for the results oflong-term studies, identified as being necessary by the rapporteur
Member State and the Commission during the examination of the
dossier and which are not expected to be fully completed by thedeadline established, provided that the information submittedcontains evidence that such studies have been commissioned andthat their results will be submitted at the latest on 25 May 2003. In
exceptional cases, where it has not been possible for the rapporteur
Member State and the Commission to identify such studies by 25May 2001, an alternative date may be established for the completionof such studies, provided the notifier supplies the rapporteur MemberState with evidence that such studies have been commissionedwithin three months of the request to undertake the studies, and with
a protocol and progress report of the study by 25 May 2002. ◄
— the time-limit within which the notifiers concerned must commu-
nicate to the rapporteur Member State and to the Commission theirundertaking to submit the required results or information within thetime-limit laid down in the first indent.
Without prejudice to Article 7 of the Directive, submission of new
studies will not be accepted. The rapporteur Member State, with theagreement of the Commission, may request the notifiers to submitfurther data necessary to clarify the dossier.
For active substances for which the results or information referred to in
the first indent have not been submitted within the established time limitthe rapporteur Member State shall immediately inform the Commission.The Commission shall decide, as provided for in Article 8(2), lastsubparagraph, of the Directive, not to include in Annex I to the Directivesuch active substances mentioning the reasons for the non-inclusion.1992R3600 — EN — 01.11.2000 — 004.001 — 8
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Member States shall withdraw by 25 July 2003 authorisations of plant
protection products containing these active substances.
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:
— the notifiers concerned have not communicated their undertaking to
submit the required results within the time-limit referred to in thesecond indent of paragraph 4,
— the rapporteur Member State has informed the Commission that the
results referred to in the first indent of paragraph 4 have not been
submitted within the time-limit laid down.
6. Where the Commission presents adra ft directive or adra ft
decision in accordance with paragraph 3A or a draft in accordance withparagraph 5, it shall at the same time present the conclusions of the
Committee's examination in the format of an up-dated review report to
be noted in the summary record of the meeting.
The review report, excluding any parts which refer to confidential
information contained in the dossiers and determined as such in
accordance with Article 14 of the Directive, shall be made available by
each Member State on specific request, or shall be kept available forconsultation by interested parties.
Article 8
1. After receiving the results of the additional trials or the additional
information, the rapporteur Member State must:
(a) examine it in conjunction with the results of the dossier already
submitted for the substance concerned;
(b) immediately after such examination, ensure that the summary of the
additional trials and the results of those trials or the additional
information are sent by the notifier to the other Member States andto the Commission;
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M4communicate to the Commission as quickly as possible, and
within six months at the latest following receipt of all the requiredinformation, its evaluation of the dossier as an addendum to theevaluation report already submitted to the Commission. The reportshall be presented in the format recommended by the Commission in
the framework of the Standing Committee on Plant Health and shall
include arecommenda tion:
— either to include the active substance in Annex I to the Directive
stating the conditions for inclusion,
— or not to include the active substance in Annex I to the Directive,
mentioning the reasons for the non-inclusion. ◄
2. The procedure provided for in Article 7 (2) is applicable to the
examinations referred to in paragraph 1 (a) hereof.
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M4After receiving the summary and the report referred to in
paragraph 1, the Commission shall refer it to the Committee forexamination.
Before referring the dossier and report to the Committee, the
Commission shall circulate the rapporteur's report to the Member Statesfor information and may organise a consultation of experts from one orseveral Member States. The Commission may consult some or all of thenotifiers of active substances on the report or parts of the report on therelevant active substance. The rapporteur Member State shall provide
the necessary technical and scientific assistance during these consulta-
tions.
Without prejudice to Article 7 of the Directive, submission of new
studies will not be accepted. The rapporteur Member State, after1992R3600 — EN — 01.11.2000 — 004.001 — 9
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consultation with the Commission, may request the notifiers to submit
further data necessary to clarify the dossier.
After the examination referred to in Article 7(3), the Commission shall,
without prejudice to any proposal it may submit with a view to
amending the Annex to Directive 79/117/EEC, present to theCommittee:
(a) a draft directive to include the active substance in Annex I to the
Directive, setting out where appropriate the conditions, including thetime limit, for such inclusion; or
(b) a draft decision addressed to the Member States to withdraw the
authorisations of plant protection products containing the activesubstance, pursuant to the fourth subparagraph of Article 8(2) of theDirective, whereby that active substance is not included in Annex Ito the Directive, mentioning the reasons for the non-inclusion. ◄
Article 9
Where, in respect of asubsta nce mentioned in Annex A, the
Commission presents aproposa l for atota l prohibition under Directive79/117/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 to
Directive 79/117/EEC, the procedure under this Regulation will be
terminated.
Article 10
This Regulation shall enter into force on 1 February 1993.
This Regulation shall be binding in its entirety and directly applicable in
all Member States.1992R3600 — EN — 01.11.2000 — 004.001 — 10
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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
DIRECTIVE91/414/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. Parathion
27. Parathion-methyl
28. Permethrin
29. Benalaxyl30. Metalaxyl31. Chlorothalonil32. Dinocap33. Fenarimol34. Fentin acetate35. Fentin hydroxide36. Flusilazole37. Imazalil38. Mancozeb39. Maneb40. Zineb41. Metiram42. Propineb43. Thiram44. Ferbam45. Ziram46. Propiconazole1992R3600 — EN — 01.11.2000 — 004.001 — 11
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47. Pyrazophos
48. Quintozene49. Thiabendazole50. Vinclozolin
51. Procymidone
52. Iprodione53. Chlozolinate
54. Chlorpropham55. Propham56. Daminozide57. Maleic hydrazide
58. Tecnazene
59. Alachlor
60. Amitrole (Aminotriazole)
61. Atrazine
62. Simazine
63. Bentazone64. Chlorotoluron65. 2,4-D
66. 2,4-D-B
67. Ethofumesate68. Fluroxypyr69. Glyphosate
70. Ioxynil
71. Bromoxynil72. Isoproturon
73. MCPA
74. MCPB75. Mecoprop76. Mecoprop-P
77. Metsulfuron
78. Tifensulfuron79. Triasulfuron
80. Molinate
81. Monolinuron82. Linuron83. Paraquat
84. Diquat
85. Pendimethalin86. Desmedipham
87. Phenmedipham
88. Propyzamide89. Pyridate90. Warfarin1992R3600 — EN — 01.11.2000 — 004.001 — 12
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ANNEX II
MODEL
Notification of an active substance according to Article 4 (1) of Regulation
(EEC)No3600/92
1.Identification data on the notifier
1.1 Manufacturer of the active substance (name, address, including location 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 appropriate.
2.7 Identity of isomers, impurities and additives (e. g. stabilizers), together
with the structural formula and the possible range expressed in g/kg or g/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
regulator.
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 conditions
under which the active substance may or should not be used.
3.4 Harmful organisms controlled and crops or products protected or treated.
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 designated
reporting Member State the dossiers as set out in Article 6 of Regulation
(EEC) No 3600/92 within aperiod of 12 months of the Commission1992R3600 — EN — 01.11.2000 — 004.001 — 13
▼B
decision provided for in Article 5 (4) of this Regulation. Whenever this
decision mentions several notifiers for this active substance, the notifier
will undertake all reasonable efforts to present a single dossier collectively
with the other notifiers.
Signature (of the person competent to act for the company
mentioned under 1. 1).1992R3600 — EN — 01.11.2000 — 004.001 — 14