1999L0073 — EN — 21.08.1999 — 000.001 — 1
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►B COMMISSION DIRECTIVE 1999/73/EC
of 19 July 1999
including an active substance (spiroxamine) in Annex I to Council Directive 91/414/EEC
concerning the placing of plant protection products on the market
(Text with EEA relevance)
(OJ L 206, 5.8.1999, p. 16)
Corrected by:
►C1Corrigendum, OJ L 221, 21.8.1999, p. 19 (99/73)
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▼B
COMMISSION DIRECTIVE 1999/73/EC
of 19 July 1999
including an active substance (spiroxamine) in Annex I to Council
Directive 91/414/EEC concerning the placing of plant protection
products on the market
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on the market(1), as
last amended by Council Directive 99/1/EC (2), hereafter referred to as
the Directive, and in particular Article 6(1);
(1)Whereas in accordance with Article 6(2) of Directive 91/414/EEC Germany received on 13 October 1995 an applicationfrom Bayer AG, hereafter referred to as the applicant, for theinclusion of the active substance spiroxamine in Annex I to theDirective;
(2)Whereas in accordance with the provisions of Article 6(3) of theDirective the Commission confirmed in Decision 96/522/EC of29 July 1996 recognising in principle the completeness of thedossier submitted for detailed examination in view of the possibleinclusion of spiroxamine in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products onthe market(
3) that the dossier submitted for spiroxamine could be
considered as satisfying, in principle, the data and informationrequirements of Annex II and for a plant protection productcontaining this active substance, of Annex III to the Directive;
(3)Whereas, in accordance with Article 5(1) of the Directive, anactive substance should be included for a period not exceeding 10years in Annex I when it may be expected that there will not beany harmful effects on human or animal health or on ground-water or any unacceptable influence on the environment;
(4)Whereas for spiroxamine, the effects on human health and theenvironment have been assessed, in accordance with the provi-sions of Article 6(2) and (4) of the Directive, for the usesproposed by the applicant; whereas Germany acting as nominatedrapporteur Member State, has submitted to the Commission on 5February 1997the assessment report concerned;
(5)Whereas the submitted report has been reviewed by the MemberStates and the Commission within the Standing Committee onPlant Health; whereas this review has been finalised on 12 May1999 in the format of the Commission review report for spiroxa-mine; whereas it may be necessary to update this report to takeaccount of technical and scientific developments; whereas in suchcase the conditions for the inclusion of spiroxamine in Annex I toDirective 91/414/EEC will also need to be amended pursuant toArticle 6(1) of that Directive;
(6)Whereas the dossier and the information from the review havealso been submitted to the Scientific Committee on Plants foropinion; whereas this Committee has given its opinion on 18December 1998 (
4); whereas this Committee identified potential
risks to algae, sediment - dwelling organisms and possibly plants;whereas therefore, where appropriate, risk mitigation measuresmust be taken; whereas for operator exposure, this Committeeconcluded that with the use of personal protective equipment
(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 21, 28.1.1999, p. 21.
(3) OJ L 220, 30.8.1996, p. 23.
(4) SCP/Spirox/004-final dated l8 January 1999.
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▼B
(PPE), the estimated operator exposure was acceptable; whereas
therefore appropriate protective measures will need to be taken inorder to ensure operator safety; whereas these conclusions arealso consistent with the issues highlighted in the review carriedout within the framework of the Standing Committee on PlantHealth;
(7)Whereas it has appeared from the various examinations made thatplant protection products containing the active substanceconcerned may be expected to satisfy in general the requirementslaid down in Article 5(1)(a), (b) and (3) of the Directive, inparticular with regard to the uses which were examined; whereastherefore it is necessary to include the active substance concernedin Annex I, in order to ensure that in all Member States theauthorisations of plant protection products containing the activesubstance concerned can be granted in accordance with the provi-sions of the said Directive;
(8)Whereas after inclusion a reasonable period is necessary topermit Member States to implement the provisions of Directive91/414/EEC on plant protection products containing spiroxamineand in particular to review, within this period, existing provi-sional authorisations or to grant, by the end of this period at thelatest, new authorisations in accordance with the provisions of theDirective; whereas a longer period may also be required for plantprotection products containing spiroxamine and other activesubstances included in Annex I;
(9)Whereas it is appropriate to provide that the finalised reviewreport (except for confidential information in the meaning ofArticle 14 of the Directive) is kept available or made available bythe Member States for consultation by any interested parties;
(10)Whereas the review report is required for the proper implementa-tion by the Member States, of several sections of the uniformprinciples laid down in Annex VI to the Directive, where theseprinciples refer to the evaluation of the Annex II data which weresubmitted for the purpose of the inclusion of the active substancein Annex I of the Directive;
(11)Whereas the measures provided for in this Directive are inaccordance with the opinion of the Standing Committee on PlantHealth delivered on the 12 May 1999;
HAS ADOPTED THIS DIRECTIVE:
Article 1
Spiroxamine is hereby designated as an active substance in Annex I to
Directive 91/414/EEC, as set out in the Annex hereto.
Article 2
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directive, at thelatest by 1 January 2000.
2. However, for plant protection products containing spiroxamine
together with another active substance which is in Annex I to Directive91/414/EEC, the period referred to in paragraph 1 is extended to theextent that a longer implementation period is provided for by theprovisions laid down in the Directive concerning the inclusion of theother active substance in Annex I to Directive 91/414/EEC.
3. Member States shall keep available the review report (except for
confidential information in the meaning of Article 14 of the Directive)for consultation by any interested parties or shall make it available tothem on specific request.
4. When Member States adopt the measures, these shall contain a
reference to this Directive or shall be accompanied by such reference at
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▼B
the time of their official publication. The procedure for such referenceshall be laid down by the Member States.
Article 3
This Directive shall enter into force on 1 September 1999.
Article 4
This Directive is addressed to the Member States.
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ANNEX
SPIROXAMINE1. Identity
(IUPAC) (8-tert-Butyl-1,4-dioxa-spiro [4.5] decan-2-ylme-
thyl)-ethyl-propyl-amine
2. Conditions to be fulfilled:
2.1. The active substance shall have a minimum purity of 940 g/kg technical
product (diastereomers A and B combined).
2.2. Only uses as a fungicide may be authorised.2.3. For the implementation of the uniform principles of Annex VI, the
conclusions of the review report on spiroxamine, and in particular theAppendices I and II thereof, as finalised in the Standing Committee onPlant Health on 12 May 1999 shall be taken into account. Furthermore,in this overall assessment Member States:
— must pay particular attention to operator safety and must ensure that
the conditions of authorisation include appropriate protective meas-ures,
and,
— must pay particular attention to the impact on aquatic organisms and
must ensure that the conditions of authorisation include, whereappropriate, risk mitigation measures.
3.►
C1Expiry date of the inclusion: 1 September 2009. ◄