2003/219/EC: Commission Decision of 25 March 2003 concerning the non-inclusion of acephate 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(2003) 868)
Date: 2003-03-25
Institutions: European Commission
Subjects: dangerous substance, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

L 82/40

EN

Official Journal of the European Union

29.3.2003

COMMISSION DECISION

of 25 March 2003

concerning the non-inclusion of acephate 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(2003) 868)

(Text with EEA relevance)

(2003/219/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/
5/EC (2), and in particular the fourth subparagraph 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)

(3)

(4)

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 15 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 Regula-
tion (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.

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

In accordance with Article 7(1)(c) of Regulation (EEC)
Italy, being the designated rapporteur
No 3600/92,
Member State, submitted on 30 September 1996 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.

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 8, 14.1.2003, p. 7.
(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.

(5)

(6)

(7)

(8)

(9)

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
(Tomen France SA) as provided for in Article 7(3) of
Regulation (EEC) No 3600/92.

It

the

appeared that

The assessment
report prepared by Italy has been
reviewed by the Member States and the Commission
within the Standing Committee on the Food Chain and
Animal Health.
information
submitted was not sufficient to determine whether or
not, under the proposed conditions of use, plant protec-
tion products containing the active substance concerned
would satisfy in general the requirements laid down in
Article 5(1)(a) and (b) of Directive 91/414/EEC. There-
fore, Commission Decision 2001/134/EC of 14 February
2001 concerning the decision on the possible inclusion
of certain active substances into Annex I to Council
Directive 91/414/EEC (7) allowed the notifier to complete
its dossier by 31 March 2001 at the latest for a limited
range of representatives uses. Upon receipt of the addi-
tional information, the review was finalised on 28 June
2002 in the format of the Commission review report for
acephate, in accordance with Article 7(6) of Regulation
(EEC) No 3600/92.

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 acephate satisfy in
general the requirements laid down in Article 5(1)(a) and
(b) of Directive 91/414/EEC, in particular with regard to
the safety of consumers potentially exposed to acephate
and with regard to its possible impact on non-target
organisms.

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

for plant protection products

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

(7) OJ L 49, 20.2.2001, p. 13.

29.3.2003

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Official Journal of the European Union

L 82/41

(10) Any period of grace for disposal, storage, placing on the
market and use of existing stocks of plant protection
products containing acephate allowed by Member States,
in accordance with Article 4(6) of Directive 91/414/EEC
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.

(11)

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 the Act of Accession of Austria, Finland
and Sweden.

(12)

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

HAS ADOPTED THIS DECISION:

Article 1

Acephate is not included as active substance in Annex I to
Directive 91/414/EEC.

Member States shall ensure that:

Article 2

(a) authorisations for plant protection products containing
acephate are withdrawn within a period of six months from
the date of adoption of this Decision;

(b) from the date of adoption of this Decision no authorisa-
tions for plant protection products containing acephate will
be granted or renewed under the derogation provided for
in Article 8(2) of Directive 91/414/EEC.

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 not longer than 18 months
from the date of adoption of this Decision.

This Decision is addressed to the Member States.

Article 4

Done at Brussels, 25 March 2003.

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 33, 8.2.1979, p. 36.