Commission Directive 2002/18/EC of 22 February 2002 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant-protection products on the market to include isoproturon as an active substance
Date: 2002-02-22
Institutions: European Commission
Subjects: marketing, marketing standard, pharmaceutical product, plant health product

26.2.2002

EN

Official Journal of the European Communities

L 55/29

COMMISSION DIRECTIVE 2002/18/EC

of 22 February 2002

amending Annex I to Council Directive 91/414/EEC concerning the placing of plant-protection
products on the market to include isoproturon as an active substance

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 Commission Directive 2001/103/EC (2), and in particular
Article 6(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

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 (3), as last
amended by Regulation (EC) No 2266/2000 (4), provides for the adoption of a list of active
substances of plant-protection products to be assessed, with a view to their possible inclusion in
Annex I to Directive 91/414/EEC. That list is contained in Commission Regulation (EC) No 933/94
of 27 April 1994 laying down the active substances of plant-protection products and designating the
rapporteur Member State for the implementation of Commission Regulation (EEC) No 3600/92 (5),
as last amended by Regulation (EC) No 2230/95 (6), and includes isoproturon.

For isoproturon the effects on human health and the environment have been assessed in accordance
with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the
notifiers. Under Regulation (EC) No 933/94, Germany was designated as rapporteur Member State.
The rapporteur Member State submitted the relevant assessment reports and recommendations to
the Commission on 30 July 1999 in accordance with Article 7(1)(c) of Regulation (EEC) No
3600/92.

This assessment report has been reviewed by the Member States and the Commission within the
Standing Committee on Plant Health. The review was finalised on 7 December 2001 in the format of
the Commission review report for isoproturon.

The review did not reveal any open questions or concerns, which would have required a consultation
of the Scientific Committee on Plants.

It has appeared from the various examinations made that plant-protection products containing the
active substance concerned may be expected to satisfy, in general, the requirements laid down in
Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were
examined and detailed in the Commission review report. It is therefore appropriate to include the
active substance concerned in Annex I to that Directive, in order to ensure that in all Member States
the authorisations of plant-protection products containing the active substances concerned can be
granted in accordance with the provisions of Directive 91/414/EEC.

A period should be specified following the inclusion of isoproturon in Annex I to Directive
91/414/EEC, during which Member States must grant, vary or withdraw, as appropriate, the
authorisations of
In particular,
plant-protection products should not be authorised unless account is taken of the conditions
associated with the inclusion of the active substance in Annex I and the uniform principles laid
down in the Directive on the basis of a dossier satisfying the prescribed data requirements.

the plant-protection products containing this active substance.

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 313, 30.11.2001, p. 37.
(3) OJ L 366, 15.12.1992, p. 10.
(4) OJ L 259, 13.10.2000, p. 27.
(5) OJ L 107, 28.4.1994, p. 8.
(6) OJ L 225, 22.9.1995, p. 1.

L 55/30

EN

Official Journal of the European Communities

26.2.2002

(7)

(8)

The Commission review report is required for the proper implementation by the Member States, of
several sections of the uniform principles laid down in Directive 91/414/EEC. It is, therefore,
appropriate to provide that the finalised review report, except for confidential information, is kept
available or made available by the Member States for consultation by any interested parties. If the
review report has to be updated to take account of technical and scientific developments, the
conditions for the inclusion of the substance concerned in Annex I to Directive 91/414/EEC should
also be amended in accordance with that Directive.

A reasonable period must be provided for before an active substance is included in Annex I in order
to permit Member States and the interested parties to prepare themselves to meet the new require-
ments which will result from the inclusion. Moreover, after inclusion, a reasonable period is
necessary to permit Member States to implement the provisions of Directive 91/414/EEC on
plant-protection products containing isoproturon. In particular, Member States must, within that
period, review existing authorisations and, where appropriate, grant new authorisations in accord-
ance with the provisions of Directive 91/414/EEC. A longer period should be provided for the
submission and assessment of the complete dossier of each plant-protection product in accordance
with the uniform principles laid down in Directive 91/414/EEC. For plant-protection products
containing several active substances, the complete evaluation on the basis of the uniform principles
can only be carried out when all the active substances concerned have been included in Annex I to
Directive 91/414/EEC.

(9)

The measures provided for in this Directive are in accordance with the opinion of the Standing
Committee on Plant Health,

HAS ADOPTED THIS DIRECTIVE:

Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.

Article 1

Article 2

Member States shall keep available the review report for isoproturon, except for confidential information
within the meaning of Article 14 of Directive 91/414/EEC, for consultation by any interested parties or
shall make it available to them on specific request.

Article 3

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to
comply with this Directive, by 30 June 2003 at the latest. They shall forthwith inform the Commission
thereof.

In particular they shall, in accordance with Directive 91/414/EEC, where necessary, amend or withdraw
existing authorisations for plant-protection products containing isoproturon as active substance by that
date.

When Member States adopt this provision, they shall contain a reference to this Directive or shall be
accompanied by such a reference on the occasion of their official publication. Member States shall
determine how such reference is to be made.

2. With regard to evaluation and decision-making pursuant to the uniform principles provided for in
Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III
thereto, the deadline for amending or withdrawing authorisations for plant-protection products containing
isoproturon as the only active substance shall be 1 January 2007.

3.
For plant-protection products containing isoproturon together with another active substance which is
in Annex I to Directive 91/414/EEC, the period for amending or withdrawing authorisations shall expire
four years after the entry into force of the Directive which amended Annex I to Directive 91/414/EEC so as
to add the last of those substances to it.

26.2.2002

EN

Official Journal of the European Communities

L 55/31

This Directive shall enter into force on 1 January 2003.

Article 4

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 22 February 2002.

For the Commission

David BYRNE

Member of the Commission

The following entries shall be added at the end of the table in Annex I to Directive 91/414/EC:

ANNEX

No

Common name, identification
numbers

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

‘28

Isoproturon

3-(4-isopropylphenyl)-1,1-dimethylurea

970 g/kg

1 January 2003

31 December 2012

Only uses as herbicide may be authorised

CAS No 34123-59-6

CIPAC No 336

(1) Further details on identity and specification of active substance are provided in the review report.’

For the implementation of the uniform prin-
ciples of Annex VI, the conclusions of the
review report on isoproturon, and in partic-
ular Appendices I and II thereto, as finalised
in the Standing Committee on Plant Health
on 7 December 2001 shall be taken into
account. In this overall assessment Member
States:

— must pay particular attention to the
protection of the groundwater, when the
active substance is applied in regions with
vulnerable soil and/or climatic conditions
or
than those
rates higher
described in the review report and must
apply risk mitigation measures, where
appropriate,

at use

— must pay particular attention to the
protection of aquatic organisms and must
ensure that
the conditions of author-
isation include, where appropriate, risk
mitigation measures

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