2003/199/EC: Council Decision of 18 March 2003 concerning the non-inclusion of aldicarb in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing this active substance
Date: 2003-03-18
Institutions: Council of the European Union
Subjects: dangerous substance, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

22.3.2003

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Official Journal of the European Union

L 76/21

COUNCIL

COUNCIL DECISION

of 18 March 2003

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

(2003/199/EC)

(4)

(5)

(6)

THE COUNCIL OF THE EUROPEAN UNION,

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) and in particular the third and fourth subpara-
graphs 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
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) and in particular Article 7(3A)(b) thereof,

Having regard to the proposal from the Commission,

Whereas:

(1)

(2)

Article 8(2) of Directive 91/414/EEC provided for the
Commission to carry out a programme of work for the
the active substances used in plant
examination of
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 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 State to act as
rapporteur
each
substance and identified the producers of each active
substance who submitted a notification in due time.

in respect of

assessment of

the

(3)

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

(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commis-

sion Directive 2003/5/EC (OJ L 8, 14.1.2003, p. 7).

(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 Regula-

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

In accordance with Article 7(1)(c) of Regulation (EEC)
No 3600/92, the United Kingdom, being the designated
rapporteur Member State, submitted on 30 April 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.

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 notifier
Rhône-Poulenc,
(now Bayer CropScience) as provided
for in Article 7(3) of Regulation (EEC) No 3600/92.

the

products

protection

containing

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.
It appeared that the
information submitted was not sufficient to determine
whether or not, under the proposed conditions of use,
plant
active
substance concerned would satisfy in general the require-
ments laid down in Article 5(1)(a) and (b) of Directive
91/414/EEC. 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
ecotoxicological risk assessment,
including the risk to
small birds. The Committee noted that the risk assess-
ment for the exposure of small birds to granules criti-
cally depends on the assumption that more than 99 % of
the granules are incorporated into the soil. Whilst this
may be achieved under ideal conditions, the Committee
believed that this high degree of incorporation is not
consistently achievable under normal agricultural use
conditions and therefore advised that a re-assessment is
necessary. In relation to other non-target organisms the
Committee is not able to assess from the data available
whether the use of aldicarb should continue pending the
generation, submission and evaluation of further data.

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Official Journal of the European Union

22.3.2003

the Commission invited the notifier

to
Therefore,
complete its dossier by 31 December 2001 at the latest
for a limited range of representative uses. Upon receipt
of the additional information, the review was finalised
on 18 October 2002 in the format of the Commission
in accordance with Article
review report for aldicarb,
7(6) of Regulation (EEC) No 3600/92.

(11) Any period of grace for disposal, storage, placing on the
market and use of existing stocks of plant protection
products containing aldicarb allowed by Member States,
in accordance with Article 4(6) of Directive 91/414/EEC
should be limited to a short period to allow existing
stocks to be used in no more than one further growing
season.

(7)

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 aldicarb satisfy in
general the requirements laid down in Article 5(1)(a) and
(b) of Directive 91/414/EEC, in particular with regard to
its possible impact on non-target organisms. It is appro-
priate to take this decision in view of the high risk of
aldicarb in its present granular formulation in particular
to small birds. Data submitted by the notifier for the
proposed representative uses indicate that granules will
remain on the soil surface after treatment. The possibi-
lity of a lethal intake of granules by small birds cannot
be
risk assessment was
prepared by the notifier and evaluated by the rapporteur
Member State who concluded that effects on national
populations would not be expected although some local
impact might occur. It must be taken into consideration
that agreed criteria for the interpretation of such a prob-
abilistic risk assessment are not yet consolidated and it
would not be appropriate, in view of the possible risks,
to delay decision-making further until such criteria are
agreed. Moreover, the review has identified a risk to
earthworms, and the available information from field
studies is still insufficient to fully resolve these concerns.

excluded. A probabilistic

(8)

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

(9)

(10)

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

In the light of the information before the Council
it
appears that, in the absence of efficient alternatives 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 therefore
justified in the present circumstances to prescribe under
strict conditions aimed at minimising risk (for example
stewardship programmes) a longer period for the with-
drawal 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)

(13)

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 (1).

In the absence of a favourable opinion of the Standing
Committee on the Food Chain and Animal Health, the
Commission has been unable to adopt the provisions it
envisaged under the procedure laid down in Article 19
of Council Directive 91/414/EEC,

HAS ADOPTED THIS DECISION:

Article 1

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

Article 2

Member States shall ensure that:

1. authorisations for plant protection products containing aldi-

carb are withdrawn by 18 September 2003;

2. from 18 March 2003 no authorisations for plant protection
products containing aldicarb 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 aldi-
carb 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.

(1) OJ L 33, 8.2.1979, p. 36. Directive as last amended by the Act of

Accession of 1994.

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The Member State concerned shall inform the Commission on
31 December 2004 at the latest on the application of this
Article and in particular on the actions taken pursuant to
points (a) to (c) and provide on a yearly basis estimates of the
amounts of aldicarb 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 18 September 2003, shall expire not later than 18
September 2004;

(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, 18 March 2003.

For the Council

The President

G. DRYS

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Official Journal of the European Union

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ANNEX

List of authorisations referred to in Article 2(3)

Column A

Member State

Column B

Use

Belgium

Greece

Spain

France

Italy

Netherlands

Portugal

United Kingdom

Beet

Potatoes
Tobacco

Cotton
Citrus (young plantations)
Woody nurseries

Sugar beet
Vineyards

Sugar beet
Tobacco
Nurseries

Ornamentals
Sugar beet
Potatoes (seed and starch)

Citrus
Floriculture
Vineyards

Potatoes
Carrots (including parsnips)
Onions
Ornamentals