Commission Directive 2004/60/EC of 23 April 2004 amending Council Directive 91/414/EEC to include quinoxyfen as active substance (Text with EEA relevance)
Date: 2004-04-23
Institutions: European Commission
Subjects: exchange of information, marketing standard, plant health product

24.4.2004

EN

Official Journal of the European Union

L 120/39

COMMISSION DIRECTIVE 2004/60/EC

of 23 April 2004

amending Council Directive 91/414/EEC to include quinoxyfen 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 2003/
82/EC (2), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

the inclusion of

In accordance with Article 6(2) of Directive 91/414/EEC
the United Kingdom received on 1 August 1995 an
application from Dow Elanco Europe (now Dow Agro
the active substance
for
Sciences),
quinoxyfen in Annex I
to Directive 91/414/EEC.
Commission Decision 96/457/EEC (3) confirmed that the
dossier was ‘complete’
it could be
considered as satisfying, in principle, the data and infor-
mation requirements of Annexes II and III to Directive
91/414/EEC.

in the sense that

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 11 October 1996.

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 November 2003 in the
format of the Commission review report for quinoxyfen.

impact.

environmental

In its opinion (4),

The documents and information were also submitted to
the Scientific Committee for Plants for separate consulta-
tion. The Committee was asked to comment on the
accumulation of the substance in soil and on its poten-
tial
the
Committee noted that the available studies and the field
study on organic matter degradation (litter bag study) in
particular did not convincingly demonstrate an accep-
table impact on the environment, mainly due to insuffi-
cient statistical power of the experimental design. The
Committee further noted that a fraction of the applied
quinoxyfen may volatilise after application to a crop.
Although available results indicate a rapid decomposi-
tion of the substance in air, the Committee suggested
that measurements of the half-life should be repeated

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 77, 13.3.2004, p. 50.
(3) OJ L 189, 30.7.1996, p. 112.
(4) Opinion of the Scientific Committee on Plants regarding the inclu-
sion of quinoxyfen in Annex I to Council Directive 91/414/EEC
concerning the placing of plant protection products on the market.
(SCP/QUINOX/002-final, adopted 7 March 2001).

(5)

(6)

(7)

(8)

after appropriate schemes have been developed for asses-
sing the environmental risks of atmospheric transport of
plant protection products. This recommendation of the
Committee was taken into account in the review report
of the active substance.

The insufficient field study on organic matter breakdown
was repeated with an upgraded test protocol. No effect
of quinoxyfen on organic matter decomposition was
detected.

In accordance with Article 6(4) of Directive 91/414/EEC
and in view of a possible unfavourable decision for
quinoxyfen the Commission organised a
tripartite
meeting with the main data submitter and the rappor-
teur Member State on 13 February 2003. The main data
submitter provided further data in order to meet the
initial concerns.

It has appeared from the various examinations made
that plant protection products containing quinoxyfen
may be expected to satisfy, in general, the requirements
laid down in Article 5(1)(a) and (b) and Article 5(3) of
Directive 91/414/EEC, in particular with regard to the
uses which were examined and detailed in the Commis-
sion review report. It is therefore appropriate to include
quinoxyfen 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.

is

required for

the
The Commission review report
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 within the meaning of Article 14 of Directive
91/414/EEC, 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 quinoxyfen 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.

L 120/40

EN

Official Journal of the European Union

24.4.2004

(9)

(10)

It is therefore appropriate 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 adopt and publish, by 28 February 2005
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 March 2005.

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 3

1. Member States shall review the authorisation for each
plant protection product containing quinoxyfen 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 28 February 2005.

2. Member States shall, for each authorised plant protection
the only active
product containing quinoxyfen as either
substance or as one of several active substances all of which
were listed in Annex I to Directive 91/414/EEC by 31 August
2004, 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 2006 at the latest, they shall amend
or withdraw the authorisation for each such plant protection
product.

This Directive shall enter into force on 1 September 2004.

Article 4

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 23 April 2004.

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, Identifica-
tion Numbers

‘83

Quinoxyfen

CAS No 124495-18-7

CIPAC No 566

IUPAC Name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

5, 7-dichloro-4 (ρ-fluorophenoxy)
quinoline

970 g/kg

1 September 2004

31 August 2014

Only uses as fungicide may be authorised.

the implementation of

the uniform principles of
For
Annex VI, the conclusions of the review report on quinox-
yfen, and in particular Appendices I and II thereto, as fina-
lised in the Standing Committee on the Food Chain and
Animal Health on 28 November 2003, shall be taken into
account.

Member States should pay particular attention to the
protection of aquatic organisms. Risk mitigation measures
must be applied and monitoring programmes must be
initiated in vulnerable zones where appropriate.

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

.

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