2007/437/EC: Commission Decision of 19 June 2007 concerning the non-inclusion of haloxyfop-R in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (notified under document number C(2007) 2548) (Text with EEA relevance)
Date: 2007-06-19
Institutions: European Commission
Subjects: environmental protection, market approval, marketing, plant health product

L 163/22

EN

Official Journal of the European Union

23.6.2007

COMMISSION

COMMISSION DECISION

of 19 June 2007

concerning the non-inclusion of haloxyfop-R in Annex I to Council Directive 91/414/EEC and the
withdrawal of authorisations for plant protection products containing that substance

(notified under document number C(2007) 2548)

(Text with EEA relevance)

(2007/437/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on the
market (1), and in particular
fourth subparagraph of
Article 8(2) thereof,

the

Whereas:

(1)

(2)

Article 8(2) of Directive 91/414/EEC provides that a
Member State may, during a period of 12 years
that Directive, authorise
following the notification of
the placing on the market of plant protection products
containing active substances not listed in Annex I of that
Directive that are already on the market two years after
the date of notification, while those substances are
gradually being examined within the framework of a
programme of work.

implementation of

(EC) No 451/2000 (2) and
Commission Regulations
(EC) No 703/2001 (3)
lay down the detailed rules for
the
the
the
programme of work referred to in Article 8(2) of
Directive 91/414/EEC and establish a list of active
substances to be assessed with a view to their possible
inclusion in Annex I to Directive 91/414/EEC. That list
includes haloxyfop-R.

second stage of

(1) OJ L 230, 19.8.1991, p. 1. Directive as

last amended by

Commission Directive 2007/31/EC (OJ L 140, 1.6.2007, p. 44).
(2) OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regu-

lation (EC) No 1044/2003 (OJ L 151, 19.6.2003, p. 32).

(3) OJ L 98, 7.4.2001, p. 6.

For haloxyfop-R the effects on human health and the
environment have been assessed in accordance with the
provisions laid down in Regulations (EC) No 451/2000
and (EC) No 703/2001 for a range of uses proposed by
the notifier. Moreover, those Regulations designate the
the
rapporteur Member States which have to submit
relevant assessment
reports and recommendations to
the European Food Safety Authority (EFSA) in accordance
with Article 8(1) of Regulation (EC) No 451/2000. For
haloxyfop-R the rapporteur Member State was Denmark
submitted on 21
information was
relevant
and all
November 2003.

(4)

(5)

The assessment report was peer reviewed by the Member
States and the EFSA and presented to the Commission
on 28 July 2006 in the format of the EFSA conclusion
regarding the peer review of the pesticide risk assessment
of the active substance haloxyfop-R (4). This report was
reviewed by the Member States and the Commission
within the Standing Committee on the Food Chain and
Animal Health and finalised on 24 November 2006 in
for
the
haloxyfop-R.

the Commission review report

format of

During the evaluation of this active substance, a number
of concerns were identified. The risk assessment
for
groundwater contamination could not be concluded. In
particular it was found that the use of haloxyfop-R, in
led to the
the scenarios presented by the notifier,
appearance of a number of metabolites which are
persistent and can leach easily into the water table,
with potentially negative effects on drinking water. This
raised concerns which could not be resolved on the basis
of the data presented within the legal deadlines by the
notifier. Moreover, based on the available data, concerns
remain as regards the risk assessment
for mammals.
Consequently,
it was not possible to conclude on the
basis of the information available that haloxyfop-R met
the criteria for
to Directive
91/414/EEC.

inclusion in Annex I

(4) EFSA Scientific Report (2006) 87, 1-96, Conclusion regarding the

peer review of pesticide risk assessment of haloxyfop-R.

23.6.2007

EN

Official Journal of the European Union

L 163/23

(6)

(7)

(8)

(9)

(10)

(11)

to submit

submitted its

its
The Commission invited the notifier
comments on the results of the peer review and on its
intention or not to further support the substance. The
notifier
comments which have been
carefully examined. However, despite the arguments
advanced, the above concerns remained unsolved, and
the information
assessments made on the basis of
the EFSA expert
submitted and evaluated during
meetings have not demonstrated that
it may be
expected that, under the proposed conditions of use,
plant
haloxyfop-R
satisfy in general the requirements laid down in Article
5(1)(a) and (b) of Directive 91/414/EEC.

containing

protection

products

Haloxyfop-R should therefore not be included in Annex I
to Directive 91/414/EEC.

for

plant

Measures should be taken to ensure that authorisations
containing
granted
haloxyfop-R are withdrawn within a fixed period of
time and are not renewed and that no new authorisations
for such products are granted.

protection products

Any period of grace granted by a Member State for the
disposal, storage, placing on the market and use of
existing stocks of plant protection products containing
haloxyfop-R, should be limited to 12 months in order to
allow existing stocks to be used in one further growing
season.

This Decision does not prejudice the submission of an
application for haloxyfop-R according to the provisions
of Article 6(2) of Directive 91/414/EEC in view of a
possible inclusion in its Annex I.

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DECISION:

Article 1

Haloxyfop-R shall not be included as an active substance in
Annex I to Directive 91/414/EEC.

Article 2

Member States shall ensure that:

(a) authorisations

for plant protection products containing

haloxyfop-R are withdrawn by 19 December 2007;

(b) no authorisations for plant protection products containing
haloxyfop-R are granted or renewed from the date of publi-
cation of this Decision.

Article 3

Any period of grace granted by Member States in accordance
with the provisions of Article 4(6) of Directive 91/414/EEC,
shall be as short as possible and shall expire on 19 December
2008 at the latest.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 19 June 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission