Commission Directive 2002/81/EC of 10 October 2002 amending Council Directive 91/414/EEC to include flumioxazine as active substance (Text with EEA relevance)
Date: 2002-10-10
Institutions: European Commission
Subjects: administrative formalities, confidentiality, exchange of information, marketing standard, plant health product, testing

L 276/28

EN

Official Journal of the European Communities

12.10.2002

COMMISSION DIRECTIVE 2002/81/EC

of 10 October 2002

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

(Text with EEA relevance)

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

Whereas:

(1)

(2)

(3)

(4)

In accordance with Article 6(2) of Directive 91/414/EEC,
France received on 2 May 1994 an application from
Sumitomo SA for the inclusion of the active substance
flumioxazine in Annex I
to Directive 91/414/EEC.
Commission Decision 97/631/EC (3) of 12 September
1997 confirmed that the dossier was ‘complete’ in the
sense that it could be considered as satisfying, in prin-
ciple, the data and information requirements of Annexes
II and III to Directive 91/414/EEC.

For this active substance, the effects on human health
and the environment have been assessed, in accordance
with the provisions of Article 6(2) and (4) of Directive
91/414/EEC, for the uses proposed by the applicant. The
nominated rapporteur Member State, submitted a draft
assessment
report concerning the substance to the
Commission on 20 January 1998.

The draft 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 28 June 2002 in the format of
the Commission review report for flumioxazine.

The dossier and the information from the review were
also submitted to the Scientific Committee for Plants.
The Committee was asked to comment on the test proto-
cols used in higher tier studies to assess effects of the
active substance on aquatic plants and earthworms and
on development effects seen in animal studies. In its
opinion (4) the Committee noted that the available higher
tier study in aquatic plants is insufficient for a full assess-
ment of exposure/effect relationships. The studies in
earthworms and those on developmental toxicity were
considered sufficient and adequate to support the risk
assessments.
Scientific
observations
Committee were taken into consideration in formulating
this Directive and the relevant review report. A revised
risk assessment for aquatic plants was made on the basis
of the available standard study.

The

the

of

be expected to satisfy, in general, the requirements laid
down in Article 5(1)(a) and (b) and Article 5(3) of Direc-
tive 91/414/EEC, in particular with regard to the uses
which were examined and detailed in the Commission
review report.
is therefore appropriate to include
flumioxazine in Annex I, in order to ensure that in all
Member States the authorisations of plant-protection
products containing this active substance can be granted
in accordance with the provisions of that Directive.

It

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, should be kept available or made available by
the Member States for consultation by any interested
parties.

After inclusion, Member States should be allowed a
reasonable period to implement the provisions of Direc-
tive 91/414/EEC as regards plant-protection products
containing flumioxazine and in particular
to review
existing provisional authorisations and, by the end of
this period at the latest, to transform those authorisa-
tions into full authorisations, to amend them or to with-
draw them in accordance with the provisions of Direc-
tive 91/414/EEC.

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

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

(6)

(7)

(8)

(9)

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

(5)

It has appeared from the various examinations made that
plant protection products containing flumioxazine may

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 189, 18.7.2002, p. 27.
(3) OJ L 262, 24.9.1997, p. 7.
(4) Opinion of the Scientific Committee on Plants regarding the inclu-
sion of flumioxazine in Annex I to Council Directive 91/414/EEC
concerning the placing of plant-protection products on the market
(SCP/FLUMIO/002 — final, 23.5.2001).

Article 2

for
Member States shall keep available the review report
flumioxazine, except for confidential
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.

12.10.2002

EN

Official Journal of the European Communities

L 276/29

Article 3

Member States shall adopt and publish by 30 June 2003 at the
latest the laws, regulations and administrative provisions neces-
sary to comply with this Directive. They shall forthwith inform
the Commission thereof.

They shall apply those provisions from 1 July 2003.

When Member States adopt those provisions, 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.

Article 4

1. Member States shall review the authorisation for each
plant-protection product containing flumioxazine to ensure that
the conditions relating to this active substance 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 30 June 2003.

2. Member States shall, for each authorised plant-protection
product containing flumioxazine 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 January

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 30 June 2004 at the latest, they shall amend or
withdraw the authorisation for each such plant-protection
product.

This Directive shall enter into force on 1 January 2003.

Article 5

This Directive is addressed to the Member States.

Article 6

Done at Brussels, 10 October 2002.

For the Commission

David BYRNE

Member of the Commission

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

ANNEX

No

Common name,
identification Nos

‘39

Flumioxazine

CAS No 103361-09-7

CICAP No 578

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-
benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide

960 g/kg

1 January 2003

31 December 2012

Only uses as herbicide may be authorised.

For the implementation of the uniform princi-
ples of Annex VI, the conclusions of the review
report on flumioxazine, and in particular
Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and
Animal Health on 28 June 2002 shall be taken
into account.
assessment
Member States:

In this overall

— must carefully consider the risk to aquatic
plants and algae. Conditions of author-
isation must include risk mitigation meas-
ures, where appropriate.

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

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