2006/966/EC: Commission Decision of 18 December 2006 concerning the non-inclusion of alachlor 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(2006) 6567)   (Text with EEA relevance)
Date: 2006-12-18
Institutions: European Commission
Subjects: dangerous substance, marketing restriction, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

L 397/28

EN

Official Journal of the European Union

30.12.2006

COMMISSION

COMMISSION DECISION

of 18 December 2006

concerning the non-inclusion of alachlor 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(2006) 6567)

(Text with EEA relevance)

(2006/966/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

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

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 mar-
ket (1), and in particular the fourth subparagraph of Article 8(2)
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 protec-
tion 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 of 11 December 1992 laying down the
detailed rules for the implementation of the first stage of
the program of work referred to in Article 8(2) of Coun-
cil Directive 91/414/EEC concerning the placing of plant
protection products on the market (2).

Commission Regulation (EC) No 933/94 of 27 April 1994
laying down the active substances of plant protection
products and designating the rapporteur Member States
for the implementation of Commission 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 rappor-
teur in respect of
the assessment of each substance
and identified the producers of each active substance who
submitted a notification in due time.

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

Directive 2006/75/EC (OJ L 248, 12.9.2006, p. 3).

(2) OJ L 366, 15.12.1992, p. 10, Regulation as last amended by Regula-

tion (EC) N° 2266/2000 (OJ L 259, 13.10.2000, p. 27.)

(3) OJ L 107, 28.4.1994, p. 8, Regulation as last amended by Regulation

(4)

(5)

(6)

(7)

In accordance with Article 7(1)(c) of Regulation (EEC)
No 3600/92, Spain, being the designated rapporteur Mem-
ber State, submitted on 20 July 1999 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 notifiers
as provided for in Article 7(3) of Regulation (EEC)
No 3600/92. It appeared that further data were required.
Commission Decision 2001/810/EC (4) laid down a dead-
line for data submission by the notifier, which expired
25 May 2002. The same decision set a further deadline of
31 December 2002 for specified long term studies.

The Commission organised a tripartite meeting with the
main data submitters and the rapporteur Member State
for this active substance on 19 December 2003.

The assessment report prepared by Spain 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 April 2006
in the format of
for
alachlor.

the Commission review report

(EC) N° 2230/95 (OJ L 225, 22.9.1995, p. 1.).

(4) OJ L 305, 22.11.2001, p. 32.

30.12.2006

EN

Official Journal of the European Union

L 397/29

(8)

(9)

The review of alachlor revealed a number of open ques-
tions which were addressed by the Scientific Panel on Plant
health, Plant protection products and their Residues. The
Scientific Panel was asked to comment on two questions.
The first question was whether the occurrence of nasal
turbinate tumours observed in the rat carcinogenicity
study was relevant to humans and, if so, whether a geno-
toxic mechanism is involved. The second question was
whether the information presented for the metabolites 65,
85, 54, 25, 76 and 51, which exceed the level of 0,1 µg/l,
was sufficient to demonstrate that they are not relevant.
In its opinion (1) on the first question, the Scientific Panel
concluded that the strength of the evidence suggests that
a mode of action other than genotoxicity is involved in
the occurrence of nasal turbinate tumours observed in the
rat carcinogenicity studies. While the mode of action could
be relevant to humans, it is extremely unlikely that con-
centrations of the active metabolite would be achieved
to initiate the chain of events terminating in cancer. On
the second question, the Scientific Panel concluded that
metabolites 65, 54 and 25 have been adequately tested for
toxicity, but the toxicity database is inadequate in the case
of the soil metabolites 85, 76 and 51. The genotoxicity
database is also inadequate for soil metabolites 85, 76
and 51. For metabolite 25 the Scientific Panel was unable
to conclude that this metabolite was safe from the point
of view of genotoxicity. It is concluded that while the
information presented for metabolites 65 and 54 is suffi-
cient to demonstrate that they are not relevant, a similar
conclusion cannot be reached for metabolites 85, 76, 51
and 25.

During the evaluation of this active substance, other areas
of concern have been identified. It was found that the
expected concentration in groundwater of some of the
above metabolites exceed the maximum acceptable limit
of 0,1 µg/l. In addition, it could not be precluded that
alachlor has a carcinogenic potential. In this context,
alachlor has been classified as a carcinogen of category 3
by Commission Directive 2004/73/EC (2) of 29 April
2004 adapting to technical progress for the 29th time
Council Directive 67/548/EEC (3) on the approximation of
the laws, regulations and administrative provisions relat-
ing to the classification, packaging and labelling of
dangerous substances. In this case,
it was considered
appropriate to increase the safety factors used in the set-
ting of an acceptable operator exposure level (AOEL). The
exposure resulting from the handling of the substance
and its application at the rates, i.e. the intended doses per
hectare, proposed by the notifier, would exceed this level
and, in other words, lead to an unacceptable risk for the
operators.

(10)

Consequently, as these concerns remain unresolved,
assessments made on the basis of the information submit-
ted have not demonstrated that it may be expected that,
under the proposed conditions of use, plant protection
products containing alachlor satisfy in general the require-
ments laid down in Article 5(1)(a) and (b) of Directive
91/414/EEC

(11) Alachlor should therefore not be included in Annex I to

Directive 91/414/EEC.

(12) Measures should be taken to ensure that existing authori-
sations for plant protection products containing alachlor
are withdrawn within a prescribed period and are not
renewed and that no new authorisations for such prod-
ucts are granted.

(13) Any period of grace for disposal, storage, placing on the
market and use of existing stocks of plant protection prod-
ucts containing alachlor 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.

(14)

This Decision does not prejudice any action the Commis-
sion may undertake at a later stage for this active sub-
stance within the framework of Council Directive
79/117/EEC of 21 December 1978 prohibiting the plac-
ing on the market and use of plant protection products
containing certain active substances (4), as last amended
by Regulation (EC) No 850/2004 (5).

(15)

This decision does not prejudice the submission of an
application for alachlor according to the provisions of
Article 6 (2) of Directive 91/414/EEC in view of a pos-
sible inclusion in its Annex I.

(16)

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

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

Article 2

Member States shall ensure that:

(1) Opinion of the Scientific Panel on Plant health, Plant protection prod-
ucts and their Residues on a request from the Commission related to
the evaluation of alachlor in the context of Council Directive
91/414/EEC (Question No EFSA-Q-2004-48) adopted on 28 Octo-
ber 2004.

(a) Authorisations for plant protection products containing

alachlor are withdrawn by 18 June 2007;

(2) OJ L 152, 30.4.2004, p. 1.
(3) OJ 196, 16.8.1967, p. 1.

(4) OJ L 33, 8.2.1979, p. 36.
(5) OJ L 158, 30.4.2004, p. 7.

L 397/30

EN

Official Journal of the European Union

30.12.2006

(b)

from 19 December 2006 no authorisations for plant protec-
tion products containing alachlor are granted or renewed
under the derogation provided for in Article 8(2) of Direc-
tive 91/414/EEC.

Article 4

This Decision is addressed to the Member States.

Article 3

Done at Brussels, 18 December 2006.

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 shall expire not later than
18 June 2008.

For the Commission

Markos KYPRIANOU

Member of the Commission