2004/247/EC: Commission Decision of 10 March 2004 concerning the non-inclusion of simazine in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing this active substance (Text with EEA relevance) (notified under document number C(2004) 727)
Date: 2004-03-10
Institutions: European Commission
Subjects: herbicide, market approval, plant health control, withdrawal from the market

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Official Journal of the European Union

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COMMISSION

COMMISSION DECISION

of 10 March 2004

concerning the non-inclusion of simazine 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(2004) 727)

(Text with EEA relevance)

(2004/247/EC)

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/
119/EC (2), and in particular the third and the fourth sub-
paragraph of Article 8(2) thereof,

Having regard to Commission Regulation (EEC) No 3600/92 of
11 December 1992 laying down the detailed rules for the
the first stage of the program of work
implementation of
referred to in Article 8(2) of Council Directive 91/414/EEC
concerning the placing of plant protection products on the
market (3), as last amended by Regulation (EC) No 2266/
2000 (4), and in particular Article 7(3A)(b) thereof,

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 Regulation (EEC) No
3600/92.

Commission Regulation (EC) No 933/94 of 27 April
1994 laying down the active substances of plant protec-
tion products and designating the rapporteur Member
States for the implementation of Commission Regulation
(EEC) No 3600/92 (5), as last amended by Regulation

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 325, 12.12.2003, p. 41.
(3) OJ L 366, 15.12.1992, p. 10.
(4) OJ L 259, 13.10.2000, p. 27.
(5) OJ L 107, 28.4.1994, p. 8.

(EC) No 2230/95 (6), designated the active substances
which should be assessed in the framework of Regu-
lation (EEC) No 3600/92, designated a Member 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.

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

In accordance with Article 7(1)(c) of Regulation (EEC)
No 3600/92, the United Kingdom, being the designated
rapporteur Member State, submitted on 20 December
1996 to the Commission the report of its assessment of
the information submitted by the notifiers in accordance
with Article 6(1) of that Regulation.

the report of

the rapporteur Member
On receipt of
State,
the Commission undertook consultations with
experts of the Member States as well as with the main
notifier Syngenta as provided for in Article 7(3) of Regu-
lation (EEC) No 3600/92.

The Commission organised a tripartite meeting with the
main data submitter and the rapporteur Member State
for this active substance on 6 June 2003.

The assessment report prepared by the United Kingdom
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 3 October 2003 in the format of the Commission
review report for simazine.

(3)

(4)

(5)

(6)

(7)

(6) OJ L 225, 22.9.1995, p. 1.

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(8)

(9)

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 aspects of
possible contamination of groundwater by simazine. In
its opinion (1), the Scientific Committee on Plants did
the environ-
the reported calculations of
not accept
mental concentrations in groundwater. The Committee
is also of the opinion that available monitoring data
does not demonstrate that concentrations of simazine or
its breakdown products will not exceed 0,1 µg/l
in
groundwater.

the information
Assessments made on the basis of
submitted have not demonstrated that
it may be
expected that, under the proposed conditions of use,
plant protection products containing simazine satisfy in
general the requirements laid down in Article 5(1)(a) and
In particular available
(b) of Directive 91/414/EEC.
monitoring data were insufficient to demonstrate that in
large areas concentrations of the active substance and its
breakdown products will not exceed 0,1 µg/l in ground-
water. Moreover it cannot be assured that continued use
in other areas will permit a satisfactory recovery of
already
groundwater
exceed 0,1 µg/l
the
active substance exceed the limits in Annex VI to Direc-
tive 91/414/EEC and would have an unacceptable effect
on groundwater.

in groundwater. These levels of

quality where

concentrations

(10)

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

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

(12)

In the light of the information submitted to the Commis-
sion it appears that, in the absence of efficient alterna-
tives for certain limited uses in certain Member States,
there is a need for further use of the active substance so
as to enable the development of alternatives. It is there-
fore justified in the present circumstances 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 effi-
cient alternatives appear currently to be available for the
control of harmful organisms.

(13) Any period of grace for disposal, storage, placing on the
market and use of existing stocks of plant protection
products containing simazine allowed by Member States,

(1) Opinion of the Scientific Committee on Plants on specific questions
from the Commission concerning the evaluation of simazine in the
context of Council Directive 91/414/EEC — SCP/SIMAZINE/002-
Final — adopted on 30 January 2003.

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.

(14)

This Decision does not prejudice any action the
Commission may undertake at a later stage for this
active substance within the framework of Council Direc-
tive 79/117/EEC of 21 December 1978 prohibiting the
placing on the market and use of plant protection
products containing certain active substances (2), as last
amended by Regulation (EC) No 807/2003 (3)

(15)

The measures provided for in this Decision are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

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

Article 2

Member States shall ensure that:

1. authorisations

for plant protection products containing

simazine are withdrawn by 10 September 2004;

2. from 16 March 2004 no authorisations for plant protection
products containing simazine 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
simazine 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;

(b) imposes all appropriate risk mitigation measures to
reduce any possible risks in order to ensure the protec-
tion of human and animal health and the environment;
and

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

(2) OJ L 33, 8.2.1979, p. 36.
(3) OJ L 122, 16.5.2003, p. 36.

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The Member State concerned shall inform the Commission on
31 December 2004 at the latest on the application of this para-
graph and in particular on the actions taken pursuant to points
(a)
the
to (c) and provide on a yearly basis estimates of
amounts of simazine 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 10 September 2004, shall expire not later than 10
September 2005;

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

This Decision is addressed to the Member States.

Article 4

Done at Brussels, 10 March 2004.

For the Commission

David BYRNE

Member of the Commission

ANNEX

List of authorisations referred to in Article 2(3)

Column A

Member State

Column B

Use

Greece

United Kingdom

The Netherlands

Ireland

Belgium

Spain

Olives

Beans, asparagus, rhubarb, hardy ornamental nursery stock

Strawberry

Potatoes, field beans, rhubarb, asparagus, soft fruit, tree
fruit, ornamentals/amenity

Scorsonera, asparagus, ornamentals, rhubarb

Pome fruit, citrus, hazelnut and vineyard