Commission Directive 2001/49/EC of 28 June 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include DPX KE 459 (flupyrsulfuron-methyl) as an active substance
Date: 2001-06-28
Institutions: European Commission
Subjects: herbicide, marketing, pharmaceutical product, plant health product

29.6.2001

EN

Official Journal of the European Communities

L 176/61

COMMISSION DIRECTIVE 2001/49/EC

of 28 June 2001

amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection
products on the market to include DPX KE 459 (flupyrsulfuron-methyl) as an active substance

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

(6)

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

Whereas:

(1)

(2)

(3)

(4)

(5)

In accordance with Article 6(2) of Directive 91/414/EEC
(hereinafter referred to as ‘the Directive’) on 26 October
1995 France received an application from Du Pont de
Nemours SAS, (‘the applicant’) for the inclusion of the
active substance DPX KE 459 (flupyrsulfuron-methyl) in
Annex I to the Directive.

In accordance with the provisions of Article 6(3) of the
Directive Commission Decision 97/164/EC (3) concluded
that
the dossier submitted for flupyrsulfuron-methyl
could be considered as satisfying, in principle, the data
and information requirements of Annex II, and for a
plant
active
containing
substance, of Annex III to the Directive.

protection

product

this

The effects of
flupyrsulfuron-methyl on human and
animal health and the environment have been assessed
by France, acting as nominated rapporteur Member
State, in accordance with the provisions of Article 6(2)
and (4) of the Directive, for the uses proposed by the
applicant France submitted its draft assessment report
concerning the substance to the Commission on 2
December 1997.

The dossier and the information from the review of
also submitted to the
flupyrsulfuron-methyl were
Scientific Committee on Plants for opinion on 15 July
1999. This Committee gave
its opinion on 20
November 2000 (4).

In the light of these examinations, it appears that plant
protection products containing flupyrsulfuron-methyl
may be expected to satisfy, in general, the requirements
laid down in Article 5(1) and (3) of the Directive, in
particular with regard to the uses which were examined
and detailed in the Commission review reports. It is
therefore appropriate to include it in Annex I to the
Directive, in order to ensure that in all Member States

plant protection products containing it can be author-
ised in accordance with the Directive.

After inclusion, a reasonable period is necessary to
permit Member States to implement the provisions of
this Directive and in particular to review, provisional
authorisations granted for plant protection products
containing flupyrsulfuron-methyl, which should be
replaced by authorisations granted under Article 4 of
Directive 91/414/EEC. A longer period may also be
required for plant protection products containing flupyr-
sulfuron-methyl and other active substances included in
Annex I.

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 which refer to the evaluation of the data which
were submitted for the purpose of the inclusion of the
active substance in Annex I to the Directive. It is appro-
priate to provide that the finalised review report (except
for confidential 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
party.

Should this review report be updated to take account of
technical and scientific developments, the conditions for
the inclusion of flupyrsulfuron-methyl in Annex I to the
Directive may also need to be amended in accordance
with the procedure specified in the Directive.

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on Plant Health delivered on 27 April 2001,

(7)

(8)

(9)

HAS ADOPTED THIS DIRECTIVE:

Article 1

The table in Annex I to Directive 91/414/EEC shall be amended
to include the entry in respect of DPX KE 459 (flupyrsulfuron-
methyl) set out in the Annex hereto.

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 164, 20.6.2001, p. 1.
(3) OJ L 64, 5.3.1997, p. 7.
(4) Opinion of the Scientific Committee on Plants regarding the evalua-
tion of
in the context of Directive 91/
414/EEC concerning the placing of plant protection products on the
market. SCP/FLUPYR/002, final dated 11 December 2000.

flupyrsulfuron-methyl

Article 2

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. They shall
forthwith inform the Commission thereof.

L 176/62

EN

Official Journal of the European Communities

29.6.2001

those provisions,

they shall
When Member States adopt
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.

Article 4

Member States shall keep available the review report for DPX
KE 459 flupyrsulfuronmethyl (except for confidential informa-
tion within the meaning of Article 14 of the Directive) for
consultation by any interested parties or shall make it available
to them on specific request.

Article 3

Article 5

However, with regard to the review of provisional author-
isations granted in the light of the review report and for the
application of the Uniform Principles provided in Annex VI to
Directive 91/414/EEC, the provisional authorisations shall be
withdrawn and where appropriate, replaced by a full author-
isation by 30 November 2002. However for plant protection
products containing DPX KE 459 (flupyrsulfuron-methyl)
together with another active substance not yet in Annex I, the
period referred to above is extended to the extent that a longer
implementation period is provided for by the provisions laid
down in the Directive amending Annex I to Directive 91/
414/EEC to include the other substance in the Annex.

This Directive shall enter into force on 1 July 2001.

This Directive is addressed to the Member States.

Article 6

Done at Brussels, 28 June 2001.

For the Commission

David BYRNE

Member of the Commission

ENTRY TO BE INSERTED IN THE TABLE IN ANNEX I TO DIRECTIVE 91/414/EEC

ANNEX

No

Common name,
identification numbers

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

‘DPX KE 459 (flupyrsul-
furon-methyl)
CAS No 144740-54-5
CIPAC No 577

2-(4,6-dimethoxypyrimidin-2-ylcarba-
moylsulfamoyl)-6-trifluromethylnicotinate
monosodium salt

903 g/kg

1 July 2001

30 June 2011

Only uses as a herbicide may be authorised.

In decision-making according to the Uniform Princi-
ples Member States must pay particular attention to
the protection of groundwater.

Date of Standing Committee on Plant Health at
which the review report was finalised: 27 April 2001.

(1) Further details on identity and specification of active substances are provided in the review report for DPX KE 459 (flupyrsulfuron-methyl) (5050/VI/97).’

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