Commission Directive 2001/28/EC of 20 April 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include KBR 2738 (fenhexamid) as an active substance
Date: 2001-04-20
Institutions: European Commission
Subjects: exchange of information, marketing standard, pesticide, plant health product

24.4.2001

EN

Official Journal of the European Communities

L 113/5

COMMISSION DIRECTIVE 2001/28/EC

of 20 April 2001

amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection
products on the market to include KBR 2738 (fenhexamid) 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/
21/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’)
the United
Kingdom received on 8 May 1997 an application from
Bayer plc (‘the applicant’) for the inclusion of the active
substance KBR 2738 (fenhexamid) in Annex I to the
Directive.

In accordance with the provisions of Article 6(3) of the
Directive the Commission confirmed in its Decision 98/
398/EC (3) that the dossier submitted for KBR 2738
(fenhexamid) could be considered as satisfying, in prin-
ciple, the data and information requirements of Annex II
and for a plant protection product containing this active
substance, of Annex III to the Directive.

In accordance with Article 5(1) of the Directive, an
active substance should be included in Annex I for a
period not exceeding 10 years if it may be expected that
neither the use of, or residues from, plant protection
products containing the active substance will have any
harmful effects on human or animal health or on
groundwater or any unacceptable influence on the
environment.

For KBR 2738 (fenhexamid),
the effects on human
in
health and the environment have been assessed,
accordance with the provisions of Article 6(2) and (4) of
the Directive, for the uses proposed by the applicant.
The United Kingdom acting as nominated rapporteur
Member State, submitted a draft assessment
report
concerning the substance to the Commission on 15
October 1998.

That assessment
report has been reviewed by the
Member States and the Commission within the Standing
Committee on Plant Health. The review was finalised on
19 October 2000 in the format of the Commission
review report for KBR 2738 (fenhexamid). If the review
report has to be updated to take account of technical
and scientific developments, the conditions for the inclu-
to the
sion of KBR 2738 (fenhexamid)

in Annex I

(6)

(7)

(8)

(9)

(10)

Directive will also need to be amended in accordance
with the Directive.

The dossier and the information from the review were
submitted to the Scientific Committee on Plants for
opinion on 31 March 2000. This Committee has given
its opinion on 20 July 2000 in the minutes of the
meeting (SCP/REPT/021 final) (4) where it was stated that
the Committee did not wish to raise any issues with
regard to this active substance. The Committee also
noted that national authorisations would involve specific
risk management in line with Annex VI (5)
(Uniform
principles) of the Directive.

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), (b)
and (3) of the Directive, in particular with regard to the
uses which were examined and detailed in the Commis-
sion review report. It is therefore appropriate to include
the active substance concerned in Annex I, in order to
ensure that in all Member States the authorisations of
active
plant
substance concerned can be granted in accordance with
the provisions of the said Directive.

containing

protection

products

the

After inclusion, a reasonable period is necessary to
permit Member States to implement the provisions of
the Directive on plant protection products containing
KBR 2738 (fenhexamid) and in particular to review,
within this period, existing provisional authorisations or
to grant, by the end of this period at the latest, new
authorisations in accordance with the provisions of the
Directive. A longer period may also be required for plant
protection products containing KBR 2738 (fenhexamid)
and other active substances included in Annex I.

(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 those principles 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.

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 69, 10.3.2001, p. 17.
(3) OJ L 176, 20.6.1998, p. 34.

(4) Minutes of the 21st meeting of the Scientific Committee on Plants,

Brussels, 20 July 2000.

(5) OJ L 265, 27.9.1997, p. 87.

L 113/6

EN

Official Journal of the European Communities

24.4.2001

(11)

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on Plant Health delivered on 19 October 2000,

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 KBR 2738 (fenhexamid) 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 1 August 2001. They shall forthwith
inform the Commission thereof.

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.

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 existing provisional author-

isations of plant protection products containing KBR 2738
(fenhexamid) to 1 August 2002.

However for plant protection products containing KBR
3.
together with another active substance
2738 (fenhexamid)
the period
which is in Annex I
referred to in paragraph 1 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 substance in the Annex.

to Directive 91/414/EEC,

4. Member States shall keep available the review report for
KBR 2738 (fenhexamid) (except for confidential
information
within the meaning of Article 14 of the Directive) for consulta-
tion by any interested parties or shall make it available to them
on specific request.

This Directive shall enter into force on 1 June 2001.

Article 3

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 20 April 2001.

For the Commission

David BYRNE

Member of the Commission

No

Common name, identification
numbers

‘13

(fenhexamid)

CAS No 126833-17-8

CIPAC No 603

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

ANNEX

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

N-(2,3-dichloro-4-hydroxyphenyl)-1-methyl-
cyclohexanecarboxamide

≥ 950 g/kg

1 June 2001

31 May 2011

Only uses as a fungicide may be authorised.

In decision making according to the Uniform
Principles Member States must pay particular
attention to the potential
impact on aquatic
organisms and must ensure that the conditions
of authorisation include, where appropriate, risk
mitigation measures.

Date of Standing Committee on Plant Health at
which the review report was
finalised: 19
October 2000

(1) Further details on identity and specification of active substance are provided in the review report (doc. 6797/VI/99 rev. 2).’

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