Commission Regulation (EEC) No 3600/92Dangos y teitl llawn

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) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community,

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 the preparations containing these substances for agriculture, any manifest data gaps (or, conversely, the presence of a complete, updated data package), 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 a proper evaluation of, and decision on, that active substance in the light of the criteria for 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 the information to be submitted; whereas the administrative consequences which 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 also be taken into consideration for this evaluation;

Whereas the evaluation studies should be distributed among the competent authorities of the Member States; whereas, therefore, for each active substance a rapporteur Member State should be designated to examine and evaluate the information submitted, in close consultation with 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 other Community legislations;

Whereas, in order to avoid duplication of work, and in particular experiments involving vertebrate animals, specific provisions have to be provided to stimulate producers to submit collective dossiers;

Whereas the procedures under the Regulation should not prejudice the possibility of investigation and prohibitory action under Council Directive 79/117/EEC(2), as last amended by Commission Directive 91/188/EEC(3), 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 under particular examination;

Whereas procedural and administrative measures have to be taken at this time in order to ensure that the evaluation of active substances can effectively 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 U.K.

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 to this Regulation with a view to their possible inclusion in Annex I to Directive 91/414/EEC. The provisions of Article 6 (2) and (3) and the second 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 not 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 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 U.K.

1. For the purpose of this Regulation, ‘plant protection products’, ‘substances’, ‘active substances’, ‘preparations’and ‘authorization of a plant protection product’ shall have the meanings set out in Article 2 of the Directive.

2. The following definitions shall also apply for the purpose of this Regulation:

(a) ‘Producers’ means

• (a) for active substances produced within the Community, the manufacturer or a person established within the Community designated by the manufacturer as his sole representative,

• for active substances produced outside the Community, the person established within the Community and designated by the manufacturer as his sole representative or, whenever such person has not been designated, the importer(s) into the Community of the 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 U.K.

Member States shall designate an authority to coordinate cooperation with producers, other Member States and the Commission, and generally for the implementation of the programme of work referred to in Article 8 (2) of the Directive. They shall inform the Commission of the name of the designated authority.

Article 4 U.K.

1. Any producer wishing to secure the inclusion of an active substance referred to in Annex I hereto, or any salts, esters or amines thereof, in Annex I to the Directive, shall so notify the Commission within 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 Commission within the same period when they no longer seek its inclusion in Annex I to the Directive.

[F1 1a. Notwithstanding the provisions of paragraph 1, producers having a permanent office in Austria, Finland or Sweden may notify the Commission 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 shown in 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 in the programme referred to in Article 1 only collectively with other notifiers 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 has presented 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 specimen notification shown in Annex II hereto. Notification must be sent to the Commission as quickly as possible, and no later than six months after the Member States have been informed by the Commission. The Member State having presented the notification shall carry out the duties of a producer as 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 active substance 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.

Textual Amendments

F1 Inserted by Commission Regulation (EC) No 491/95 of 3 March 1995 amending Regulation (EEC) No 3600/92 and Regulation (EC) No 933/94, in particular with regard to the integration of the designated public authorities and the producers in Austria, Finland and Sweden in the implementation of the first stage of the programme of work referred to in Article 8 (2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

Article 5 U.K.

1. The Commission shall examine with the Committee the notifications 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 under Article 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) 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 an active substance has been notified with different compositions which may lead to different toxicological properties or have different environmental effects, these may be listed separately.

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 Member States 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 a period 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 the substance or its residues on human and/or animal health and/or on the environment.

[F2 4A. From the time of the adoption of the Regulation referred to in paragraph 2, if a Member State envisages to take action to withdraw from the market or to restrict severely the use of a plant protection product containing an active substance listed in that regulation, where that 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 Member States, 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 the procedure under Article 19 of the Directive, to designate a different Member State as rapporteur for a particular substance.

[F1 Where such a different Member State has been designated as rapporteur Member State, the original Member State shall inform thereof the notifiers concerned and shall transfer to the newly designated rapporteur Member State all correspondence and information which it has received as rapporteur Member State for the active substance concerned.]

[F1 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 substance concerned.

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 common declaration agreeing that such other producer shall replace the original notifier 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 are informed as well.]

Textual Amendments

F1 Inserted by Commission Regulation (EC) No 491/95 of 3 March 1995 amending Regulation (EEC) No 3600/92 and Regulation (EC) No 933/94, in particular with regard to the integration of the designated public authorities and the producers in Austria, Finland and Sweden in the implementation of the first stage of the programme of work referred to in Article 8 (2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

F2 Inserted by Commission Regulation (EC) No 1199/97 of 27 June 1997 amending Regulation (EEC) No 3600/92 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8 (2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

Article 6 U.K.

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 the 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 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 all reasonable steps to present collectively the dossiers referred to in the first subparagraph. Where a dossier was not presented by all notifiers 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 in accordance 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;

[F3 it has to be demonstrated by the notifier that, on the basis of the information submitted for one or more preparations for a limited range of representative uses, the requirements of the Directive in relation 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 has carried out the trials; the same information for each point of Annex III to the Directive relevant to the assessment of the criteria referred to 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:

• (d) 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 for the assessment of the active substance according to the criteria referred 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; a detailed timetable and documents showing that the undertaking can 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 laid down in paragraphs 2 and 3 hereof, the rapporteur Member State shall inform 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 draft decision not to include the active substance in Annex I, in accordance with the final subparagraph of Article 8 (2) of the Directive, unless:

• [F4 a new time-limit has been granted for the submission of a dossier fulfilling the requirements of paragraphs 2 and 3; a new time-limit will 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 to designate another rapporteur Member State in accordance with Article 5 (5),]

• a Member State informs the Commission of its wish to secure the inclusion of the active substance concerned in Annex I to the Directive and its readiness to ensure the composition of the dossiers as referred to in paragraph 1 hereof and to carry out the duties of notifier as set out in Articles 7 and 8 hereof.

Textual Amendments

F3 Inserted by Commission Regulation (EC) No 2266/2000 of 12 October 2000 amending Regulation (EEC) No 3600/92 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

F4 Substituted by Commission Regulation (EC) No 491/95 of 3 March 1995 amending Regulation (EEC) No 3600/92 and Regulation (EC) No 933/94, in particular with regard to the integration of the designated public authorities and the producers in Austria, Finland and Sweden in the implementation of the first stage of the programme of work referred to in Article 8 (2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

Article 7 U.K.

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 Article 5 (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; [F1 the order of examination is, however, not affected by dossiers presented by notifiers 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 the Commission;

(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), a report of its assessment of the dossier, including a recommendation:

• (c) 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 information specified in the report [F5 ;]

[F2 (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 of publication, the standard to which the test or study was conducted, the holder's name and, if any, the claim made by the holder or notifier for data protection.]

[F5 2. From the start of the examination referred to in paragraph 1, the rapporteur Member State may request the notifiers to improve their dossiers, or add to them. Moreover, the rapporteur Member State may, from the start of this examination, consult with experts from other Member 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 the Committee 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.

[F6 The Rapporteur Member State shall make available at specific request or keep available for consultation by interested parties the following:

• the information referred to in point (d) of paragraph 1, except the elements thereof which have been accepted as confidential in accordance 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, first as contained in the rapporteur's report and secondly as finalised after the consultation by the Commission of the experts referred to in the next subparagraph.]

Before the dossier and report are referred to the Committee, a consultation of experts from the Member States may be organized and the 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.]

[F2 3A. After the examination referred to in paragraph 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 the Committee:

(a) a draft directive to include the active substance in Annex I to the Directive, setting out where appropriate the conditions, including the time-limit, for such inclusion;

(b) a draft decision addressed to the Member States to withdraw the authorizations of plant protection products containing the active substance, pursuant to the fourth subparagraph of Article 8 (2) of the Directive, 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 shall determine:

• [F7 the time limit within which the results or information concerned must be submitted to the rapporteur Member State and the experts designated according to paragraph 2 above, this time limit will be 25 May 2002 , however, as regards metalaxyl the time limit will be at the latest 31 October 2008 , unless an earlier time limit is established by the Commission for a particular active substance except for the results of long-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 the deadline established, provided that the information submitted contains evidence that such studies have been commissioned and that 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 25 May 2001 , an alternative date may be established for the completion of such studies, provided the notifier supplies the rapporteur Member State with evidence that such studies have been commissioned within 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 communicate to the rapporteur Member State and to the Commission their undertaking to submit the required results or information within the time limit laid down in the first indent. However, as regards metalaxyl that time limit shall be one month after the entering into force of this Regulation.]

[F3 Without prejudice to Article 7 of the Directive, submission of new studies will not be accepted. The rapporteur Member State, with the agreement of the Commission, may request the notifiers to submit further 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 limit the rapporteur Member State shall immediately inform the Commission. The Commission shall decide, as provided for in Article 8(2), last subparagraph, of the Directive, not to include in Annex I to the Directive such active substances mentioning the reasons for the non-inclusion. 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 the final 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 the second 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.

[F2 6. Where the Commission presents a draft directive or a draft decision in accordance with paragraph 3A or a draft in accordance with paragraph 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 for consultation by interested parties.]

Textual Amendments

F1 Inserted by Commission Regulation (EC) No 491/95 of 3 March 1995 amending Regulation (EEC) No 3600/92 and Regulation (EC) No 933/94, in particular with regard to the integration of the designated public authorities and the producers in Austria, Finland and Sweden in the implementation of the first stage of the programme of work referred to in Article 8 (2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

F2 Inserted by Commission Regulation (EC) No 1199/97 of 27 June 1997 amending Regulation (EEC) No 3600/92 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8 (2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

F3 Inserted by Commission Regulation (EC) No 2266/2000 of 12 October 2000 amending Regulation (EEC) No 3600/92 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

F5 Substituted by Commission Regulation (EC) No 1199/97 of 27 June 1997 amending Regulation (EEC) No 3600/92 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8 (2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

F6 Substituted by Commission Regulation (EC) No 1972/1999 of 15 September 1999 amending Regulation (EEC) No 3600/92 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

F7 Substituted by Commission Regulation (EC) No 416/2008 of 8 May 2008 amending Regulation (EEC) No 3600/92 as regards the assessment of the active substance metalaxyl in the framework of Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance).

Article 8 U.K.

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 and to the Commission;

(c)

[F8 communicate to the Commission as quickly as possible, and within six months at the latest following receipt of all the required information, its evaluation of the dossier as an addendum to the evaluation report already submitted to the Commission. The report shall be presented in the format recommended by the Commission in the framework of the Standing Committee on Plant Health and shall include a recommendation:

• (c) 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.

3. [F8 After receiving the summary and the report referred to in paragraph 1, the Commission shall refer it to the Committee 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 and may organise a consultation of experts from one or several Member States. The Commission may consult some or all of the notifiers of active substances on the report or parts of the report on the relevant active substance. The rapporteur Member State shall provide the necessary technical and scientific assistance during these consultations.

Without prejudice to Article 7 of the Directive, submission of new studies will not be accepted. The rapporteur Member State, after 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 the Committee:

(a) a draft directive to include the active substance in Annex I to the Directive, setting out where appropriate the conditions, including the time limit, for such inclusion; or

(b) a draft decision addressed to the Member States to withdraw the authorisations of plant protection products containing the active substance, pursuant to the fourth subparagraph of Article 8(2) of the Directive, whereby that active substance is not included in Annex I to the Directive, mentioning the reasons for the non-inclusion.]

F9 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F8 Substituted by Commission Regulation (EC) No 2266/2000 of 12 October 2000 amending Regulation (EEC) No 3600/92 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

F9 Deleted by Commission Regulation (EC) No 2266/2000 of 12 October 2000 amending Regulation (EEC) No 3600/92 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

Article 9 U.K.

Where, in respect of a substance mentioned in Annex A, the Commission presents a proposal for a total prohibition under Directive 79/117/EEC, the periods provided in this Regulation shall be suspended until a decision on this proposal has been taken. Where the Council decides 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 U.K.

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.

ANNEX I U.K. LIST OF SUBSTANCES COVERED BY THE FIRST STAGE OF THE WORK PROGRAMME PROVIDED FOR IN ARTICLE 8 (2) OF DIRECTIVE 91/414/EEC

Name U.K.

1.

Acephate

2.

Methamidophos

3.

Aldicarb

4.

Amitraz

5.

Azinphos-ethyl

6.

Azinphos-methyl

7.

Carbendazim

8.

Benomyl

9.

Thiophanate-methyl

10.

Chlorpyriphos

11.

Chlorpyriphos-methyl

12.

Cyfluthrin

13.

Beta-cyfluthrin

14.

Cyhalothrin

15.

Lambda-cyhalothrin

16.

Cypermethrin

17.

Alpha-cypermethrin

18.

DNOC

19.

Deltamethrin

20.

Dinoterb

21.

Endosulfan

22.

Fenthion

23.

Fenvalerate

24.

Esfenvalerate

25.

Lindane

26.

Parathion

27.

Parathion-methyl

28.

Permethrin

29.

Benalaxyl

30.

Metalaxyl

31.

Chlorothalonil

32.

Dinocap

33.

Fenarimol

34.

Fentin acetate

35.

Fentin hydroxide

36.

Flusilazole

37.

Imazalil

38.

Mancozeb

39.

Maneb

40.

Zineb

41.

Metiram

42.

Propineb

43.

Thiram

44.

Ferbam

45.

Ziram

46.

Propiconazole

47.

Pyrazophos

48.

Quintozene

49.

Thiabendazole

50.

Vinclozolin

51.

Procymidone

52.

Iprodione

53.

Chlozolinate

54.

Chlorpropham

55.

Propham

56.

Daminozide

57.

Maleic hydrazide

58.

Tecnazene

59.

Alachlor

60.

Amitrole (Aminotriazole)

61.

Atrazine

62.

Simazine

63.

Bentazone

64.

Chlorotoluron

65.

2,4-D

66.

2,4-D-B

67.

Ethofumesate

68.

Fluroxypyr

69.

Glyphosate

70.

Ioxynil

71.

Bromoxynil

72.

Isoproturon

73.

MCPA

74.

MCPB

75.

Mecoprop

76.

Mecoprop-P

77.

Metsulfuron

78.

Tifensulfuron

79.

Triasulfuron

80.

Molinate

81.

Monolinuron

82.

Linuron

83.

Paraquat

84.

Diquat

85.

Pendimethalin

86.

Desmedipham

87.

Phenmedipham

88.

Propyzamide

89.

Pyridate

90.

Warfarin

ANNEX II U.K. MODEL

Notification of an active substance according to Article 4 (1) of Regulation (EEC) No 3600/92 U.K.

1. Identification data on the notifier U.K.

1.1 Manufacturer of the active substance (name, address, including location of plant): U.K.

1.2 Notifying company (name, address, etc. ) (if different from 1. 1): U.K.

1.2.a. Acting as: U.K.

• 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. U.K.

1.3.1. Address for correspondence: U.K.

1.3.2.

(a)

Telephone No:

(b)

Telex No:

(c)

Telefax No:

1.3.3.

(a)

Contact:

(b)

Alternative:

2. Information to facilitate identification U.K.

2.1 Common name proposed or ISO-accepted, and synonyms, specifying, where relevant, any salts or esters produced by the manufacturer. U.K.

2.2 Chemical name (IUPAC nomenclature). U.K.

2.3 Manufacturer's development code number(s). U.K.

2.4 CAS, CIPAC and EEC numbers (if available). U.K.

2.5 Empirical and structural formula, molecular mass. U.K.

2.6 Specification of purity of the active substance in g/kg or g/l as appropriate. U.K.

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. U.K.

3. Information on use conditions to be covered by the inclusion in Annex I and supported by the applicant U.K.

3.1 Function, e. g. fungicide, herbicide, insecticide, repellant, growth regulator. U.K.

3.2 Field of use envisaged, e. g. field, glasshouse, food or feed storage, home garden. U.K.

3.3 Any specific health, agricultural, plant health or environmental conditions under which the active substance may or should not be used. U.K.

3.4 Harmful organisms controlled and crops or products protected or treated. U.K.

4. Information on authorized uses known to the notifier U.K.

4.1 Countries where there is registration (EC). U.K.

4.2 Countries where there is registration (non EC). U.K.

4.3 Registered uses in EC, including all relevant conditions. U.K.

4.4 Formulation name, type (GIFAP/FAO code) and content of active substance (in g/kg or g/l). U.K.

5. Undertaking to submit dossier U.K.

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 a period of 12 months of the Commission 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).

(1)

OJ No L 230, 19.8.1991, p. 1, as corrected inOJ No L 170, 25.6.1992, p. 40.

(2)

OJ No L 33, 8.2.1979, p. 36.

(3)

OJ No L 92, 13.4.1991, p. 42.