Commission Directive 2005/53/EC of 16 September 2005 amending Council Directive 91/414/EEC to include chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl as active substances   (Text with EEA relevance)
Date: 2005-09-16
Institutions: European Commission
Subjects: market approval, marketing standard, plant health product, toxicology

17.9.2005

EN

Official Journal of the European Union

L 241/51

COMMISSION DIRECTIVE 2005/53/EC

of 16 September 2005

amending Council Directive 91/414/EEC to include chlorothalonil, chlorotoluron, cypermethrin,
daminozide and thiophanate-methyl as active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

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 Article 6(1) thereof,

Whereas:

(1)

(2)

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), establishes a list of active
substances to be assessed, with a view to their possible
inclusion in Annex I to Directive 91/414/EEC. That list
includes
cypermethrin,
chlorothalonil,
daminozide and thiophanate-methyl.

chlorotoluron,

3600/92 (3),

For those active substances the effects on human health
and the environment have been assessed in accordance
with the provisions laid down in Regulation (EEC) No
3600/92 for a range of uses proposed by the notifiers.
By Commission Regulation (EC) No 933/94 of 27 April
substances of plant
1994 laying down the active
protection products and designating the
rapporteur
the implementation of Regulation
Member State for
rapporteur
following
(EEC) No
Member
turn
submitted the relevant assessment reports and recom-
mendations
to the Commission in accordance with
Article 7(1)(c) of Regulation (EEC) No 3600/92. For
chlorothalonil
the rapporteur Member State was the
Netherlands, and all relevant information was submitted
on 31 January 2000. For chlorotoluron, the rapporteur
Member State was Spain and all relevant information was
submitted on 7 May 1999. For cypermethrin the
rapporteur Member State was Belgium and all relevant
information was submitted on 25 October 1999. For

designated, which

States were

the

in

(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Regulation
(EC) No 396/2005 of the European Parliament and of the Council
(OJ L 70, 16.3.2005, p. 1).

(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 Regu-

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

daminozide the rapporteur Member State was the Neth-
erlands and all relevant information was submitted on 30
July 1999.
rapporteur
thiophanate-methyl,
Member State was Germany and all relevant information
was submitted on 21 November 1997.

For

the

(3)

(4)

(5)

(6)

reports have been reviewed by the
The assessment
Member
the Commission within the
and
States
Standing Committee on the Food Chain and Animal
Health.

The reviews of all active substances were finalised on 15
February 2005 in the format of the Commission review
reports for chlorothalonil, chlorotoluron, cypermethrin,
daminozide and thiophanate-methyl.

The review of chlorothalonil, chlorotoluron and cyper-
to be
methrin did not
addressed by the Scientific Committee on Plants or the
European Food Safety Authority (EFSA) which has taken
over the role of the latter.

reveal any open questions

The review of daminozide revealed a number of open
questions which were addressed by the EFSA. The
Scientific Panel on Plant Health, Plant Protection
Products and their Residues (PPR Panel) of the EFSA
was asked to comment on the mechanism of action of
the carcinogenic response of rodents to 1,1-dimethylhy-
drazide (UDMH) and to indicate whether or not a
threshold could be derived for this effect. If yes, it was
requested to indicate this value. The PPR Panel, having
regard to the submitted questions, concluded (4) that, on
the basis of
is not possible to
identify the mechanism responsible for the carcinogenic
action of UDMH in rodents. There is no in vitro evidence
of genotoxicity of pure and oxidation-protected UDMH
and in vivo studies are not available. In addition, the PPR
Panel noted an apparent discrepancy in that daminozide
long-term studies did not give rise to carcinogenicity in
rats and mice at doses
that should have produced
internal doses of metabolically-formed UDMH at least
one order of magnitude higher than those proven to
In addition, methylation
be effective on direct testing.

the available data,

it

(4) Opinion of the Scientific Panel on Plant Health, Plant Protection
Products and their Residues on a request from the Commission
related to the evaluation of daminozide in the context of Council
Directive 91/414/EEC (The EFSA Journal (2004), 61, 1-27), adopted
on 11 May 2004.

L 241/52

EN

Official Journal of the European Union

17.9.2005

the PPR Panel

of N7 guanine was found to be 50-fold higher in one
study following oral administration of UDMH to rats,
when compared to the corresponding data for dami-
nozide. Thus,
any
conclusion on the mechanism of carcinogenicity of
orally administered UDMH should be
regarded to
a degree of uncertainty. The PPR Panel
include
concluded that
the weight of evidence is against a
genotoxic mechanism.

considered that

to genotoxicity, but

altered
Among possible non-genotoxic mechanisms,
imbalance
regulation of cell proliferation or hormonal
are plausible alternatives
these
mechanisms have not been specifically investigated and
thus a more definitive conclusion on the mechanism
involved is not possible at the moment. In experimental
testing of UDMH for carcinogenicity in rats and mice, no
effects were observed at 0,09 mg/kg bw/day and
1,41 mg/kg bw/day, respectively.

If the observed UDMH carcinogenicity is due to a non-
genotoxic mechanism, the above indicated doses should
be considered to be toxicological thresholds. However,
taking together
the uncertainties associated with the
mechanism and the possibility that UDMH in greenhouse
conditions may form oxidised derivatives that might be
genotoxic, the PPR Panel is of the opinion that any use
of these doses as thresholds should be undertaken only
with due caution. The opinion was taken into consid-
eration by the Standing Committee that concluded that
the use of daminozide is acceptable under the specified
conditions.

(8)

(9)

of

the

spindle

induced by any of these substances. Carcinogenicity is
not a concern. The known effects of these fungicides
upon reproduction are explicable by interaction with
the microtubules
apparatus. The
mechanism of aneuploidy induction is well understood
and consists of inhibition of polymerisation of tubulin,
the protein that is essential for the segregation of chro-
mosomes during cell division:
it does not involve any
interaction with DNA. Since multiple copies of tubulin
in the
molecules are present
presence of
the fungicides a
limited number of
tubulin molecules will be affected
and consequently no toxicological adverse effects will
ensue. Consequently, a clear no adverse effect level
is
recognisable and both an ADI and an AOEL can be
established.

low concentration of

in proliferating cells,

It has appeared from the various examinations made that
containing chlorothalonil,
plant protection products
and thio-
cypermethrin, daminozide
chlorotoluron,
phanate-methyl may be expected to satisfy,
in general,
the requirements laid down in Article 5(1)(a) and (b) of
in particular with regard to the
Directive 91/414/EEC,
examined and detailed in the
uses which were
is therefore appropriate
Commission review report.
to include this active substance in Annex I, in order to
ensure that in all Member States the authorisations of
plant
active
substance
can be granted in accordance with the
provisions of that Directive.

containing

protection

products

this

It

A reasonable period should be allowed to elapse before
an active substance is included in Annex I in order to
permit Member States and the interested parties to
the new requirements
prepare
which will result from the inclusion.

themselves

to meet

(7)

and

daily

(ADI)

The review of thiophanate-methyl revealed a number of
open questions which were addressed by the Scientific
Committee on Plants. The Scientific Committee was
asked to comment on the advisability of establishing
an acceptable
acceptable
intake
operator exposure level (AOEL) having regard particularly
to the results of mutagenicity, carcinogenicity and repro-
for benomyl, carbendazim and thio-
ductive studies
phanate-methyl.
that
substance
carbendazim is
common to these
in
is metabolised
particular, but also thiophanate-methyl,
substances produce
to carbendazim and all
in
(aneuploidy)
numerical
mammalian cells, exposed in vivo. There is no evidence
is
that any other form of damage to genetic material

active
substances. Benomyl

Committee (1)

chromosomal

biologically

aberrations

The
the

noted

three

three

(1) Opinion of the Scientific Committee on Plants (SCP/BENOMY/002
— final, SCP/CARBEN/002 — final, SCP/THIOPHAN/002 — final)
of 23 March 2001 regarding
evaluation of benomyl,
carbendazim and thiophanate-methyl
in the context of Council
Directive 91/414/EEC concerning the placing of plant protection
products on the market
(Opinion adopted by the Scientific
Committee on Plants on 7 March 2001).

the

the

requirements

six months after

in Annex I, Member States

(10) Without prejudice to the obligations defined by Directive
including an active
91/414/EEC as a consequence of
should be
substance
inclusion to
allowed a period of
review existing
authorisations of plant protection
products containing chlorothalonil, chlorotoluron, cyper-
to ensure
methrin, daminozide or thiophanate-methyl
laid
that
by Directive
in its Article 13 and the
91/414/EEC,
relevant conditions set out
in Annex I, are satisfied.
Member States should vary, replace or withdraw, as
appropriate, existing authorisations,
in accordance with
the provisions of Directive 91/414/EEC. By derogation
from the above deadline, a longer period should be
provided for
the
complete Annex III dossier of each plant protection
product for each intended use in accordance with the
uniform principles laid down in Directive 91/414/EEC.

the submission and assessment of

in particular

down

17.9.2005

EN

Official Journal of the European Union

L 241/53

(11)

(12)

(13)

The experience gained from previous inclusions in Annex
I to Directive 91/414/EEC of active substances assessed
in the framework of Regulation (EEC) No 3600/92 has
shown that difficulties can arise in interpreting the duties
of holders of existing authorisations in relation to access
to data. In order to avoid further difficulties it therefore
appears necessary to clarify the duties of the Member
States, especially the duty to verify that the holder of
to a dossier
an authorisation demonstrates
to that
satisfying
Directive. However,
impose
any new obligations on Member States or holders of
authorisations compared to the directives which have
been adopted until now amending Annex I.

this clarification does not

requirements of Annex

access

the

II

is

It
therefore
91/414/EEC accordingly.

appropriate

to

amend Directive

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

met, with the exception of those identified in part B of the
entries concerning those active substances, and that the holder
of the authorisation has, or has access to, a dossier satisfying the
requirements of Annex II to that Directive in accordance with
the conditions of Article 13 of that Directive.

2.
By derogation from paragraph 1, for each authorised plant
protection product containing chlorothalonil, chlorotoluron,
cypermethrin, daminozide or thiophanate-methyl as either the
only active substance or as one of several active substances all
of which were listed in Annex I to Directive 91/414/EEC by
28 February 2006 at the latest, Member States shall re-evaluate
the product in accordance with the uniform principles provided
for in Annex VI to Directive 91/414/EEC, on the basis of a
dossier satisfying the requirements of Annex III to that Directive
and taking into account part B of the entries in Annex I to that
Directive
cyper-
chlorothalonil,
methrin, daminozide and thiophanate-methyl. On the basis of
the product
that evaluation,
satisfies the conditions set out in Article 4(1)(b), (c), (d) and
(e) of Directive 91/414/EEC.

they shall determine whether

chlorotoluron,

concerning

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 91/414/EEC is amended as set out in the
Annex to this Directive.

Article 2

Member States shall adopt and publish by 31 August 2006 at
the latest the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
communicate to the Commission the text of those provisions
and a correlation table between those provisions and this
Directive.

They shall apply those provisions from 1 September 2006.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

Following that determination Member States shall:

(a)

in the case of a product containing chlorothalonil, chloro-
toluron, cypermethrin, daminozide or thiophanate-methyl as
the only active substance, where necessary, amend or
withdraw the authorisation by 28 February 2010 at the
latest; or

(b) in the case of a product containing chlorothalonil, chloro-
toluron, cypermethrin, daminozide or thiophanate-methyl as
one of several active substances, where necessary, amend or
withdraw the authorisation by 28 February 2010 or
by the date fixed for such an amendment or withdrawal
in the respective Directive or Directives which added the
relevant substance or substances to Annex I to Directive
91/414/EEC, whichever is the latest.

Article 4

This Directive shall enter into force on 1 March 2006.

Article 3

Article 5

shall

States

in accordance with Directive
1. Member
91/414/EEC, where necessary, amend or withdraw existing
authorisations for plant protection products containing chlor-
othalonil, chlorotoluron, cypermethrin, daminozide or
thio-
phanate-methyl as active substances by 31 August 2006.

This Directive is addressed to the Member States.

Done at Brussels, 16 September 2005.

By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to chlorothalonil, chloro-
toluron, cypermethrin, daminozide and thiophanate-methyl are

For the Commission

Markos KYPRIANOU
Member of the Commission

L 241/54

EN

Official Journal of the European Union

17.9.2005

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