Commission Directive 2002/37/EC of 3 May 2002 amending Council Directive 91/414/EEC to include ethofumesate as an active substance (Text with EEA relevance)
Date: 2002-05-03
Institutions: European Commission
Subjects: market approval, marketing standard, plant health product

L 117/10

EN

Official Journal of the European Communities

4.5.2002

COMMISSION DIRECTIVE 2002/37/EC

of 3 May 2002

amending Council Directive 91/414/EEC to include ethofumesate as an active substance

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

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

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 2002/
18/EC (2), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

(3)

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 Regula-
tion (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 protec-
tion products and designating the rapporteur Member
States for the implementation of Commission Regula-
tion (EEC) No 3600/92 (5), as last amended by Regula-
tion (EC) No 2230/95 (6), and includes ethofumesate.

For ethofumesate 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. By Regula-
tion (EC) No 933/94, as amended by Regulation (EC) No
491/95 (7), Sweden was designated as
rapporteur
Member State. Sweden submitted the relevant assess-
ment reports and recommendations to the Commission
on 2 October 1998 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 the Food Chain and Animal Health. The
review was finalised on 26 February 2002 in the format
of the Commission review report for ethofumesate.

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 55, 26.2.2002, p. 29.
(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.
(7) OJ L 49, 4.3.1995, p. 50.

(5)

(6)

(7)

(8)

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

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 infor-
mation,
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 should be allowed to elapse before
an active substance is included in Annex I in order to
permit Member States and the interested parties to take
the requisite preparatory steps.

After inclusion, Member States should be allowed a
reasonable period within which to implement the provi-
sions of Directive 91/414/EEC as regards plant protec-
tion products containing ethofumesate, and in partic-
ular,
to review existing authorisations in accordance
with the provisions of Directive 91/414/EEC to ensure
that the conditions regarding ethofumesate set out in
Annex I to Directive 91/414/EEC are satisfied. A longer
period should be provided within which a complete
dossier for each such plant protection product, satisfying
the requirements of Annexes II and III to Directive 91/
414/EEC should be submitted and that product re-eval-
uated in accordance with the uniform principles laid
down in Directive 91/414/EEC.

4.5.2002

EN

Official Journal of the European Communities

L 117/11

(9)

(10)

It is therefore necessary to amend Directive 91/414/EEC
accordingly.

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

Article 2

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

for confidential

Article 4

1. Member States shall review the authorisation for each
plant protection product containing ethofumesate to ensure
that the conditions relating to ethofumesate set out in Annex I
to Directive 91/414/EEC are complied with. Where necessary,
they shall amend or withdraw the authorisation in accordance
with Directive 91/414/EEC before 1 September 2003.

2. Member States shall, for each authorised plant protection
product containing ethofumesate as either the only active
substance or as one of several active substances all of which
were listed in Annex I to Directive 91/414/EEC by 1 March
2003, re-evaluate the product in accordance with 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. On the basis of that evaluation, they shall determine
whether the product satisfies the conditions set out in Article
4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where neces-
sary and by 28 February 2007 at the latest, they shall amend or
withdraw the authorisation for each such plant protection
product.

Article 3

This Directive shall enter into force on 1 March 2003.

Article 5

Member States shall adopt and publish by 31 August 2003 at
the latest the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
inform the Commission thereof.

They shall apply those provisions from 1 September 2003.

those provisions,

When Member States adopt
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.

This Directive is addressed to the Member States.

Article 6

Done at Brussels, 3 May 2002.

For the Commission

David BYRNE

Member of the Commission

Ιn Annex I the following row is added at the end of the table:

ANNEX

No

Common name,
Identification numbers

‘29

Ethofumesate

CAS No 26225-79-6

CICAP No 223

IUPAC Name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

(±)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzo-
furan-5-ylmethanesulfonate

960 g/kg

1 March 2003

28 February 2013

Only uses as herbicide may be authorised

thereof, as

For the implementation of the uniform principles
of Annex VI, the conclusions of the review report
on ethofumesate, and in particular Appendices I
and II
finalised in the Standing
Committee on the Food Chain and Animal Health
on 26 February 2002 shall be taken into account.
In this overall assessment Member States may pay
particular attention to the protection of
the
groundwater, when the active substance is applied
in regions with vulnerable soil and/or climatic
conditions and must apply risk mitigation meas-
ures, where appropriate.

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

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