2004/141/EC: Commission Decision of 12 February 2004 concerning the non-inclusion of amitraz 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) 332)
Date: 2004-02-12
Institutions: European Commission
Subjects: EU Member State, dangerous substance, marketing standard, pharmaceutical product, plant health product, withdrawal from the market

17.2.2004

EN

Official Journal of the European Union

L 46/35

COMMISSION DECISION

of 12 February 2004

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

(notified under document number C(2004) 332)

(Text with EEA relevance)

(2004/141/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
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 (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
(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.

(3)

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

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

(4)

(5)

(6)

(7)

(8)

In accordance with Article 7(1)(c) of Regulation (EEC)
No 3600/92, Austria, being the designated rapporteur
Member State, submitted on 6 January 1998 to the
Commission the report of its assessment of the informa-
tion 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 Bayer CropScience, as provided for in Article
7(3) of Regulation (EEC) No 3600/92.

The Commission organised two tripartite meeting with
the main data submitter and the rapporteur Member
State for this active substance on 9 June 2000 and on
21 March 2003.

The assessment report prepared by Austria 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 4 July 2003
for
in the format of
amitraz.

the Commission review report

the information
Assessments made on the basis of
it may be
submitted have not demonstrated that
expected that, under the proposed conditions of use,
plant protection products containing amitraz satisfy in
general the requirements laid down in Article 5(1)(a) and
(b) of Directive 91/414/EEC. In particular, Article 5(2)(b)
provides that an acceptable daily intake (ADI) for man
must be taken into account in deciding on the inclusion
of an active substance in Annex I. In setting the ADI the
possible neurological effects of amitraz had to be consid-
ered. These effects were also considered for setting the
Acute Reference Dose, i.e. the estimate of the amount of
the substance that can be ingested over a short period of
time without appreciable health risk to the consumer. It
has not been demonstrated for the proposed uses that
consumers might not be exposed to amitraz exceeding
the Acute Reference Dose. A probabilistic risk assess-
ment was prepared by the notifier. It must however be
taken into consideration that agreed criteria for the inter-
pretation of such a probabilistic risk assessment are not
yet established and it would not be appropriate, in view
of the possible risks, to delay decision-making further
until such criteria are agreed.

(9)

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

L 46/36

EN

Official Journal of the European Union

17.2.2004

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

for

(11)

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.

(12) Any period of grace for disposal, storage, placing on the
market and use of existing stocks of plant protection
products containing amitraz 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.

(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), as last
amended by Regulation (EC) No 807/2003 (2).

(14)

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

Amitraz 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

amitraz are withdrawn by 12 August 2004;

2. from 17 February 2004 no authorisations for plant protec-
tion products containing amitraz are granted or renewed
under the derogation provided for in Article 8(2) of Direc-
tive 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
amitraz 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.

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 amitraz 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 12 August 2004, shall expire not later than 12 August
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, 12 February 2004.

For the Commission

David BYRNE

Member of the Commission

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

17.2.2004

EN

Official Journal of the European Union

L 46/37

ANNEX

List of authorisations referred to in Article 2(3)

Column A

Member State

Column B

Use

Greece

The Netherlands

United Kingdom

Portugal

Cotton

Tree nursery, strawberry (only propagating material), pear
trees after harvest

Pear trees after harvest

Pear trees after harvest