Commission Directive 2000/49/EC of 26 July 2000 including an active substance (metsulfuron-methyl) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market
Date: 2000-07-26
Institutions: European Commission
Subjects: marketing, pharmaceutical product, plant health product

L 197/32

EN

Official Journal of the European Communities

3.8.2000

COMMISSION DIRECTIVE 2000/49/EC

of 26 July 2000

including an active substance (metsulfuron-methyl) in Annex I to 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
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 2000/
10/EC (2), and in particular Article 6(1) and the fourth subpara-
graph of Article 8(2) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

Commission Regulation (EEC) No 3600/92 (3), as last
amended by Regulation (EC) No 1972/1999 (4), has laid
down the 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
to that Regulation,
Commission Regulation (EC) No 933/94 (5), as last
amended by Regulation (EC) No 2230/95 (6), lays down
the list of active substances of plant protection products
to be assessed, with a view to their possible inclusion in
Annex I to the Directive.

‘the Directive’). Pursuant

Those active substances should be included in that
Annex when it may be expected that there will not be
any harmful effects on human or animal health or on
groundwater or any unacceptable influence on the envir-
onment.

Such inclusions should be made for a period not
exceeding 10 years.

Article 8(2) of the Directive provides that after inclusion
of an active substance in its Annex I, Member States
shall, within a prescribed period, grant, vary or with-
draw, as appropriate, the authorisations of the plant
protection products containing the active substance. In
particular, Articles 4(1) and 13(1) of
the Directive
require that plant protection products are not 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 Annex VI on the basis
of a dossier satisfying the data requirements laid down
in its Article 13.

For metsulfuron-methyl 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 number of uses proposed by the notifiers.
France, acting as designated rapporteur Member State

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 57, 2.3.2000, p. 28.
(3) OJ L 366, 15.12.1992, p. 10.
(4) OJ L 244, 16.9.1999, p. 41.
(5) OJ L 107, 28.4.1994, p. 8.
(6) OJ L 225, 22.9.1995, p. 1.

(6)

(7)

(8)

(9)

under Regulation (EC) No 933/94 submitted to the
Commission on 25 June 1997 the relevant assessment
report.

The said report has been reviewed by the Member States
and the Commission within the Standing Committee on
Plant Health. This review was finalised on 16 June 2000
in the format of
for
metsulfuron-methyl.

the Commission review report

The dossier and the information from the review have
also been submitted to the Scientific Committee for
Plants for consultation. The Scientific Committee for
Plants in its opinion (7), confirmed that the substance
can be used without unacceptable risk but noted that
Member States should assess the leaching potential to
groundwater in particularly vulnerable locations and
should apply risk mitigation measures to protect the
aquatic environment.

It appears from the assessments made that plant protec-
tion 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 the Directive, in
particular with regard to the uses which were examined.
the active
Therefore
substance concerned in Annex I, in order to ensure that
in all Member States the granting, varying or with-
drawing, as appropriate, of the authorisations of plant
protection products containing metsulfuron-methyl can
be organised in accordance with the provisions of the
Directive.

is appropriate

to include

it

Before inclusion, a reasonable deadline is necessary to
permit Member States and the interested parties to
prepare themselves to meet the new requirements which
will result from the inclusion. Moreover, after inclusion,
a reasonable period is necessary for the Member States
to implement the Directive and in particular to vary or
withdraw, as appropriate, existing authorisations or
grant new authorisations in accordance with the provi-
sions of Directive 91/414/EEC. A longer period should
be provided for the submission and assessment of the
complete Annex III dossier of each plant protection
product in accordance with the uniform principles laid
down in Annex VI to the Directive. For plant protection
products
the
complete evaluation on the basis of the uniform princi-
ples can only be carried out when all
the active
substances concerned have been included in Annex I to
the Directive.

containing several

substances,

active

(7) Scientific Committee for Plants SCP/METSU/002-final, 5 April 2000.

3.8.2000

EN

Official Journal of the European Communities

L 197/33

(10)

(11)

(except

It is appropriate to provide that the finalised review
report
information in the
meaning of Article 14 of the Directive) is kept available
or made available by the Member States for consultation
by any interested parties.

for confidential

The review report is required for the proper imple-
mentation by the Member States of several sections of
the uniform principles laid down in Annex VI to the
Directive, where these principles refer to the evaluation
of the Annex II data which were submitted for the
purpose of
the active substance in
Annex I to the Directive.

the inclusion of

(12)

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

HAS ADOPTED THIS DIRECTIVE:

Article 1

Metsulfuron-methyl 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 the latest by 31 December 2001. In particular they
shall,
in accordance with the provisions of Directive 91/
414/EEC, where necessary, amend or withdraw existing author-
isations for plant protection products containing metsulfuron-
methyl as an active substance within such period.

2.
However, 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 period laid down in the
first paragraph is extended:

— for plant protection products containing metsulfuron-
methyl as the only active substance to four years from the
entry into force of this Directive,

— for plant protection products containing metsulfuron-
methyl together with another active substance which is in
Annex I to Directive 91/414/EEC, to four years from the
entry into force of such Directive as shall include the last of
those substances in Annex I.

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 to them on specific request.

4. When Member States adopt the provisions referred to in
paragraph 1, these shall contain a reference to this Directive or
shall be accompanied by such reference at the time of their
official publication. The procedure for such reference shall be
adopted by Member States.

Article 3

This Directive shall enter into force on 1 July 2001.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 26 July 2000.

For the Commission

David BYRNE

Member of the Commission

L 197/34

EN

Official Journal of the European Communities

3.8.2000

ANNEX

Metsulfuron-methyl

1.

Identity:

Common name:

IUPAC name:

Metsulfuron-methyl

Methyl 2-(4-methoxy-6-methyl-1,3,5,-triazin-2-ylcarbamoylsulfamoyl)
benzoate

2.

Particular conditions to be fulfilled:

2.1. The active substance as manufactured shall have a minimum purity of 960 g/kg.

2.2. Only uses as herbicide may be authorised.

2.3. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on metsulfuron-
methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 16
June 2000 shall be taken into account. In this overall assessment Member States:

— must pay particular attention to the protection of groundwater,
— must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of

authorisation include, where appropriate, risk mitigation measures.

3.

Expiry date of the inclusion: 30 June 2011.