2007/366/EC: Commission Decision of 25 May 2007 concerning the non-inclusion of thiodicarb 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) 2165) (Text with EEA relevance)
Date: 2007-05-25
Institutions: European Commission
Subjects: dangerous substance, marketing restriction, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

L 139/28

EN

Official Journal of the European Union

31.5.2007

COMMISSION DECISION

of 25 May 2007

concerning the non-inclusion of thiodicarb 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) 2165)

(Text with EEA relevance)

(2007/366/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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)

(3)

Article 8(2) of Directive 91/414/EEC provides that a
Member State may, during a period of 12 years
following the notification of
that Directive, authorise
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.

Commission Regulations (EC) No 451/2000 (2) and (EC)
No 703/2001 (3)
lay down the detailed rules for the
implementation of the second stage of 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 thio-
dicarb.

For thiodicarb the effects on human health and the envir-
onment 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
rapporteur Member States which have to submit
the
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

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

last amended by

Commission Directive 2007/25/EC (OJ L 106, 24.4.2007, p. 34).
(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.

(4)

(5)

(6)

thiodicarb the rapporteur Member State was the United
Kingdom and all relevant information was submitted on
19 January 2004.

The assessment report has been peer reviewed by the
Member States and the EFSA within its Working Group
Evaluation and presented to the Commission on
14 December 2005 in the format of the EFSA conclusion
regarding the peer review of the pesticide risk assessment
the active substance thiodicarb (4). This report has
of
been reviewed
the
the Member
Commission within the Standing Committee on the
Food Chain and Animal Health and finalised on
14 July 2006 in the format of the Commission review
report for thiodicarb.

States

and

by

for

and

grapes

During the evaluation of this active substance, a number
of concerns were identified. The risk assessment
for
insecticidal use indicated an acute dietary risk for
resulting from the consumption of
toddlers
treated
from the
adults
table
consumption of wine. Furthermore, the risk assessment
shown
for use of
important data gaps,
the
operator exposure and possible groundwater contami-
nation, and so it was not possible to conclude on the
basis of the information available that thiodicarb met the
criteria for inclusion in Annex I to Directive 91/414/EEC.

thiodicarb as a molluscicide has
in particular

resulting

regards

as

to submit

submitted its

The Commission invited the notifier
its
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 put
forward by the notifier, the concerns identified could not
be eliminated, and assessments made on the basis of the
information submitted and evaluated during the EFSA
expert meetings have not demonstrated that it may be
expected that, under the proposed conditions of use,
plant protection products containing thiodicarb satisfy
in general the requirements laid down in Article 5(1)(a)
and (b) of Directive 91/414/EEC.

(4) EFSA Scientific Report (2005) 55, 1-76,

‘Conclusion regarding the
peer review of the pesticide risk assessment of the active substance
thiodicarb’.

31.5.2007

EN

Official Journal of the European Union

L 139/29

(7)

(8)

(9)

(10)

(11)

(12)

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

HAS ADOPTED THIS DECISION:

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

Article 1

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

Article 2

Member States shall ensure that:

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
thiodicarb, should be limited to 12 months in order to
allow existing stocks to be used in one further growing
season.

(a) authorisations for plant protection products containing thio-

dicarb are withdrawn by 25 November 2007;

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

substance within the

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

This Decision does not prejudice the submission of an
application for thiodicarb 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

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
on
possible
25 November 2008 at the latest.

expire

short

shall

and

be

as

as

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 25 May 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

(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), corrected in OJ L 229, 29.6.2004, p. 5.