2005/864/EC: Commission Decision of  2 December 2005  concerning the non-inclusion of endosulfan in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing this active substance  (notified under document number C(2005) 4611) Text with EEA relevance
Date: 2005-12-02
Institutions: European Commission
Subjects: health risk, market approval, marketing restriction, pesticide, plant health legislation, plant health product

3.12.2005

EN

Official Journal of the European Union

L 317/25

COMMISSION DECISION

of 2 December 2005

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

(notified under document number C(2005) 4611)

(Text with EEA relevance)

(2005/864/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

State to act as rapporteur in respect of the assessment of
each substance and identified the producers of each
active substance who submitted a notification in due
time.

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 provided for the
Commission to carry out a programme of work for the
examination of
the active substances used in plant
protection products which were already on the market
on 25 July 1993. Detailed rules for the carrying out of
this programme were established in Commission Regu-
lation (EEC) No 3600/92 of 11 December 1992 laying
down the detailed rules for the implementation of the first
stage of the programme of work referred to in Article 8(2)
of Council Directive 91/414/EEC concerning the placing
of plant protection products on the market (2).

Commission Regulation (EC) No 933/94 of 27 April
substances of plant
1994 laying down the active
protection products and designating the
rapporteur
Member States for the implementation of Commission
Regulation (EEC) No 3600/92 (3), designated the active
substances which should be assessed in the framework of
Regulation (EEC) No 3600/92, designated a Member

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

last amended by
Commission Directive 2005/58/EC (OJ L 246, 22.9.2005, p. 17).
(2) OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regu-

lation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 27).

(3) OJ L 107, 28.4.1994, p. 8. Regulation as last amended by Regu-

lation (EC) No 2230/95 (OJ L 225, 22.9.1995, p. 1).

(3)

Endosulfan is one of the 89 active substances designated
in Regulation (EC) No 933/94.

(4)

(5)

(6)

(7)

In accordance with Article 7(1)(c) of Regulation (EEC)
No 3600/92, Spain, being the designated rapporteur
Member State, submitted on 22 February 2000 to the
Commission the report of its assessment of the infor-
mation submitted by the notifiers in accordance with
Article 6(1) of that Regulation.

On receipt of the report of the rapporteur Member State,
the Commission undertook consultations with experts of
the Member States as well as with the main notifiers
Bayer CropScience and Makhteshim Agan as provided
for in Article 7(3) of Regulation (EEC) No 3600/92. It
appeared that further data were required. Commission
Decision 2001/810/EC (4) laid down a deadline for data
submission by the notifier, which expired 25 May 2002.
The same decision set a further deadline of 31 May 2003
for specified long term studies.

The Commission organised a tripartite meeting with the
main data submitters and the rapporteur Member State
for this active substance on 17 May 2004.

The assessment
report prepared by Spain has been
reviewed by the Member States and the Commission
within the Standing Committee on the Food Chain and
Animal Health. This review was finalised on 15 February
2005 in the format of the Commission review report for
endosulfan.

(4) OJ L 305, 22.11.2001, p. 32.

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Official Journal of the European Union

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(8)

During the evaluation of this active substance, a number
of areas of concern have been identified. This was in
particular the case concerning its environmental
fate
and behaviour as the route of degradation of the active
substance is not completely clear and unknown meta-
bolites were found in soil degradation, water/sediment
In ecotoxicology
degradation and mesocosm studies.
many concerns remain since the long term risk,
in
particular, due to the presence of the abovementioned
metabolites, cannot be sufficiently addressed with the
available information. In addition exposure of operators
under indoor conditions has not been considered to be
sufficiently addressed with the available information.
Moreover endosulfan is volatile,
its main metabolite is
persistent and it has been found in monitoring results
of regions where the substance was not used. Conse-
quently, as these concerns remain unsolved, assessments
made on the basis of the information submitted have not
demonstrated that it may be expected that, under the
proposed conditions of use, plant protection products
containing endosulfan satisfy in general the requirements
laid down in Article 5(1)(a) and (b) of Directive
91/414/EEC.

substance within the

framework of Council
active
Directive 79/117/EEC of 21 December 1978 prohibiting
the placing on the market and use of plant protection
products containing certain active substances (1),

(14)

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

(15)

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:

(9)

Endosulfan should therefore not be included in Annex I
to Directive 91/414/EEC.

Article 1

Endosulfan shall not be included as active substance in Annex I
to Directive 91/414/EEC.

(10) Measures should be taken to ensure that existing author-
isations for plant protection products containing endo-
sulfan are withdrawn within a prescribed period and are
not renewed and that no new authorisations for such
products are granted.

Article 2

Member States shall ensure that:

(11)

there is a need for further use of

In the light of
the information submitted to the
Commission it appears that, in the absence of efficient
alternatives for certain limited uses in certain Member
States,
the active
substance so as to enable the development of alter-
natives.
It is therefore justified in the present circum-
stances to prescribe under strict conditions aimed at
minimising risk a longer period for the withdrawal of
existing authorisations for the limited uses considered
as essential
for which no efficient alternatives appear
currently to be available for the control of harmful
organisms.

(12) Any period of grace for disposal, storage, placing on the
market and use of existing stocks of plant protection
products containing endosulfan allowed by Member
States, should be limited to a period no longer than 12
months to allow existing stocks to be used in no more
than one further growing season.

1. authorisations

for plant protection products containing

endosulfan are withdrawn by 2 June 2006;

2. from 3 December 2005 no authorisations

for plant
protection products containing endosulfan are granted or
renewed under the derogation provided for in Article 8(2)
of Directive 91/414/EEC;

3.

in relation to the uses listed in column B of the Annex, a
Member State specified in column A may maintain in force
authorisations
for plant protection products containing
endosulfan until 30 June 2007 provided that it:

(a) ensures that such plant protection products remaining
on the market are relabelled in order to match the
restricted use conditions;

(13)

This Decision does not prejudice
any action the
Commission may undertake at a later stage for this

(1) OJ L 33, 8.2.1979, p. 36. Directive as last amended by Regulation
(EC) No 850/2004 of the European Parliament and of the Council
(OJ L 158, 30.4.2004, p. 7).

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(b) imposes all appropriate risk mitigation measures

to
reduce any possible risks
to ensure the
protection of human and animal health and the envir-
onment; and

in order

(c) ensures that alternative products or methods for such
uses are being seriously sought, in particular, by means
of action plans.

The Member State concerned shall inform the Commission on
31 December 2005 at the latest on the application of this
paragraph and in particular on the actions taken pursuant to
points (a) to (c) and provide on a yearly basis estimates of the
amounts of endosulfan used for essential uses pursuant to this
Article.

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:

(a)

for the uses for which the authorisation is to be withdrawn
on 2 June 2006, shall expire not later than 2 June 2007;

(b) for the uses for which the authorisation is to be withdrawn
by 30 June 2007, shall expire not later than 31 December
2007.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 2 December 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX

List of authorisations referred to in Article 2(3)

Column A

Member State

Column B

Use

Greece

Spain

Italy

Poland

Cotton, tomato, peppers, pears, potato, alfa-alfa

Hazel nut, cotton, tomato

Hazel nut

Hazel nut, strawberry, gerbera, ornamental bulbs