Commission Directive 2006/135/EC of 11 December 2006 amending Council Directive 91/414/EEC to include carbendazim as active substance Text with EEA relevance
Date: 2006-12-11
Institutions: European Commission
Subjects: derogation from EU law, marketing standard, pesticide, pharmaceutical product, plant health legislation, plant health product

12.12.2006

EN

Official Journal of the European Union

L 349/37

COMMISSION DIRECTIVE 2006/135/EC

of 11 December 2006

amending Council Directive 91/414/EEC to include carbendazim as active substance

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

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 carbendazim.

For carbendazim 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 notifier. By
Commission Regulation (EC) No 933/94 of 27 April
1994 laying down the active
substances of plant
protection products and designating the Rapporteur
Member State for the implementation of Commission
3600/92 (3), Germany was
Regulation
designated as Rapporteur Member State. Germany
submitted the relevant assessment report and recommen-
dations to the Commission on 10 February 1998 in
accordance with Article 7(1)(c) of Regulation (EEC)
No 3600/92.

(EEC) No

(5)

the

three

three

(ADI)

noted

aberrations

biologically

chromosomal

addressed by

The Committee (4)

active
substances. Benomyl

The review of carbendazim revealed a number of open
the Scientific
questions which were
Committee on Plants. The Scientific Committee was
asked to comment on the advisability of establishing
an Acceptable Daily Intake
and Acceptable
Operator Exposure Level
(AOEL) having regard parti-
cularly to the results of mutagenicity, carcinogenicity
and reproductive studies for benomyl, carbendazim and
thiophanate-methyl.
that
substance
carbendazim is
in
common to these
is metabolised
particular, but also thiophanate-methyl,
substances produce
to carbendazim and all
numerical
in
(aneuploidy)
mammalian cells, exposed in vivo. There is no evidence
is
that any other form of damage to genetic material
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
molecules are present
in the
presence of
the fungicides a
limited number of
tubulin molecules will be affected
and consequently no toxicologically adverse effects will
is
ensue. Consequently, a clear no adverse effect level
recognisable and both an ADI and an AOEL can be
established.

low concentration of

in proliferating cells,

spindle

the

of

Articles 5(4) and 6(1) of Directive 91/414/EEC provide
that inclusion of a substance in Annex I may be subject
to restrictions and conditions. In this case, restrictions on
the inclusion period and on the authorised crops are
deemed necessary. The original measures presented to
the Standing Committee on the Food Chain and
the
Animal Health,
inclusion period to seven years, so that Member States
would give priority to reviewing plant protection
products already on the market containing carbendazim.
In order to avoid discrepancies in the high level of
protection sought, the inclusion in Annex I to Directive
91/414/EEC was intended to be limited to the uses of
carbendazim that have been actually assessed within the

restriction

proposed

the

of

(3)

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

(1) OJ L 230, 19.8.1991, p. 1. Directive as

last amended by

Commission Directive 2006/85/EC (OJ L 293, 24.10.2006, p. 3).
(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. 10).

(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).

(4) Opinion of the Scientific Committee on Plants (SCP/BENOMY/002
— final, SCP/CARBEN/002 — final, SCP/THIOPHAN/002 — final
002) dated 23 March 2001 regarding the 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).

L 349/38

EN

Official Journal of the European Union

12.12.2006

implies

to be subject

Community evaluation and for which the proposed uses
were considered to comply with the conditions of
Directive 91/414/EEC. This
that other uses,
which were not or only partially covered by this
to a complete
assessment, had first
assessment, before
inclusion in Annex I of
Directive 91/414/EEC could be considered. Finally, due
to the hazardous nature of
it was
considered necessary to provide for a minimum harmo-
nisation at Community level of certain risk mitigation
measures that were to be applied by Member States
when granting authorisations.

carbendazim,

their

(10) As with all substances included in Annex I to Directive
carbendazim could be
status of
91/414/EEC,
the
reviewed under Article 5(5) of
that Directive in the
light of any new data becoming available. Equally, the
this substance in Annex I
fact
expires on a particular date does not prevent
the
inclusion being renewed according to the procedures
laid down in the Directive.

the inclusion of

that

(6)

(7)

(8)

of

laid

active

down

approval

procedures
the

by Directive
Under
the
91/414/EEC,
substances,
including the definition of risk management measures,
is decided by the Commission. Member States bear the
responsibility for the implementation, application and
control of the measures intended to mitigate the risks
generated by plant protection products. Concerns
expressed by
their
that additional restrictions are necessary to
judgment
reduce the risk to a level
that can be considered
and consistent with the high level of
acceptable
protection that
is sought within the Community. At
present, it is a question of risk management to set the
adequate level of safety and protection for the continued
production, commercialisation and use of carbendazim.

several Member

reflect

States

sustainable

As a consequence of
the Commission re-
the above,
examined its position. In order to correctly reflect the
high level of protection of human and animal health
the
a
and
in
Community,
in addition to
the principles set out in Recital 5, to further reduce the
period of inclusion to three instead of seven years. This
further
reduces any risk by ensuring a priority re-
assessment of this substance.

it considered appropriate,

environment

sought

carbendazim satisfy

It may be expected that plant protection products
containing
requirements
laid down in Article 5(1)(a) and (b) of Directive
91/414/EEC, with regard to the uses which were
examined and detailed in the Commission review
report and providing that the necessary risk mitigation
measures are applied.

the

(9) Without prejudice to the conclusion that plant protection
products containing carbendazim may be expected to
satisfy the requirements laid down in Article 5(1)(a)
it is appropriate to
and (b) of Directive 91/414/EEC,
obtain further information on certain specific points.
Member States should require authorisation holders to
provide
carbendazim
including any information on incidences on operator
health.

information on the use of

(11)

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
satisfying
to that
impose
Directive. However,
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

(12) 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
prepare
the new requirements
which will result from the inclusion.

themselves

to meet

six months after

in Annex I, Member States

replace or withdraw, as appropriate,

(13) 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
authorisations of plant protection
review existing
the
products containing carbendazim to ensure that
requirements laid down by Directive 91/414/EEC,
in
particular in its Article 13 and the relevant conditions
set out in Annex I, are satisfied. Member States should
vary,
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
submission and assessment of 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. Given the hazardous
properties of carbendazim, the period for Member States
to verify whether the plant protection products, which
contain carbendazim as the only active substances or in
combination with other authorised active substances,
comply with the provisions of Annex VI should not
exceed three years.

12.12.2006

EN

Official Journal of the European Union

L 349/39

(14)

(15)

is

therefore
It
91/414/EEC accordingly.

appropriate

to

amend Directive

The Standing Committee on the Food Chain and Animal
Health did not deliver an opinion within the time limit
laid down by its Chairman and the Commission therefore
submitted to the Council a proposal relating to these
measures. On the expiry of the period laid down in the
second subparagraph of Article 19(2) of Directive
91/414/EEC,
adopted the
the Council had neither
proposed implementing act nor indicated its opposition
to the proposal
for implementing measures and it is
accordingly for the Commission to adopt these measures,

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

the

laws,

regulations

Member States shall adopt and publish by 30 June 2007 at the
latest
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.

for

plant

products

protection

containing
authorisations
carbendazim as an active substance by 30 June 2007. By that
date they shall in particular verify that the conditions in Annex I
to that Directive relating to carbendazim are met, with the
exception of those identified in part B of the entry concerning
that active substance, 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.

2.
By derogation from paragraph 1, for each authorised plant
protection product containing carbendazim, 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 entry
in Annex I to that Directive concerning carbendazim. On the
the
basis of
product satisfies the conditions set out in Article 4(1)(b), (c),
(d) and (e) of Directive 91/414/EEC.

they shall determine whether

that evaluation,

Following that determination Member States shall for products
containing carbendazim, where necessary, amend or withdraw
the authorisation by 31 December 2009.

Article 4

This Directive shall enter into force on 1 January 2007.

They shall apply those provisions from 1 July 2007.

Article 5

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.

This Directive is addressed to the Member States.

Done at Brussels, 11 December 2006.

Article 3

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing

States

shall

For the Commission

Markos KYPRIANOU
Member of the Commission

L 349/40

EN

Official Journal of the European Union

12.12.2006

d
n
a

t
f
i
r
d

s
a
e
r
a

d
e
t
a
e
r
t

n
e
e
w
t
e
b

t
p
e
k

f
o

t
o
n

r
o

n
o
i
t
a
c
i
l

p
p
a

e
h
t

e
b

n
o

t
s
u
m

e
c
n
a
t
s
i
d

e
t
a
i
r
p
o
r
p
p
a

n
A

.
s

m

s
i
n
a
g
r
o

d
n
e
p
e
d

y
a
m

e
c
n
a
t
s
i
d

s
i
h
T

.
s
e
i
d
o
b

r
e
t
a
w

c
i
t
a
u
q
a

e
c
a
f
r
u
s

e
d
u
l
c
n

i

l
l
a
h
s

n
o
i
t
a
s
i
r
o
h
t
u
a

f
o

s
n
o
i
t
i
d
n
o
C

.
s

m

s
i
n
a
g
r
o
-
o
r
c
a
m

l
i

o
s

r
e
h
t
o

d
n
a

s

m
r
o
w
h
t
r
a
e

n
o
i
t
a
n
b
m
o
c

i

e
t
a
i
r
p
o
r
p
p
a

t
s
o
m
e
h
t

f
o

n
o
i
t
c
e
l
e
s

e
h
t

s
a

h
c
u
s

,
s
e
r
u
s
a
e
m

n
o
i
t
a
g
i
t
i

m

k
s
i
r

e
h
t

,

y
r
a
s
s
e
c
e
n

f
i

,

d
n
a

,

n
o
i
t
a
c
i
l

p
p
a

f
o

s
e
t
a
r

,

n
o
i
t
a
c
i
l

p
p
a

f
o

g
n
m

i

i
t

d
n
a

s
r
e
b
m
u
n

f
o

,
e
c
n
a
t
s
b
u
s

e
v
i
t
c
a

e
h
t

f
o

n
o
i
t
a
r
t
n
e
c
n
o
c

f
o

e
e
r
g
e
d

n
o
i
t
a
g
i
t
i

m

k
s
i
r

e
d
u
l
c
n

i

l
l
a
h
s

n
o
i
t
a
s
i
r
o
h
t
u
a

f
o

s
n
o
i
t
i
d
n
o
C

.
s
l
a
m
m
a
m

d
n
a

s
d
r
i
b

e
s
o
h
t

f
o

n
o
i
t
c
e
l
e
s

e
h
t

d
n
a

n
o
i
t
a
c
i
l

p
p
a

e
h
t

f
o

g
n
m

i

i
t

s
u
o
i
c
i
d
u

j

a

s
a

h
c
u
s

,
s
e
r
u
s
a
e
m

s
t
n
e
g
a

f
o

e
c
n
e
s
e
r
p

e
h
t

r
o

n
o
i
t
a
t
n
e
s
e
r
p

l
a
c
i
s
y
h
p

r
i
e
h
t

f
o

t
l
u
s
e
r

a

s
a

,

h
c
i
h
w
s
n
o
i
t
a
l
u
m
r
o
f

,
s
e
c
i
v
e
d

r
o

i

s
e
u
q
n
h
c
e
t

g
n
i
c
u
d
e
r

,
s
e
i
c
e
p
s

d
e
n
r
e
c
n
o
c

e
h
t

f
o

e
r
u
s
o
p
x
e

e
h
t

e
s
i

i

m
n
m

i

,
e
c
n
a
d
o
v
a

i

e
t
a
u
q
e
d
a

n
a

e
r
u
s
n
e

t
a
h
t

—

—

—

,
s
r
e
s
u

l
a
n
o
i
s
s
e
f
o
r
p

y
b

r
o
n

r
u
e
t
a
m
a

y
b

r
e
h
t
i
e
n

s
n
o
i
t
a
c
i
l

p
p
a

d
l
e
h
-
d
n
a
h

d
n
a

k
c
a
s
p
a
n
k

.

i

g
n
n
e
d
r
a
g

e
m
o
h

,

n
o
i
t
a
c
i
l

p
p
a

r
i
a

—

—

—

.

d
e
i
l

p
p
a

e
r
a

s
e
r
u
s
a
e
m

n
o
i
t
a
g
i
t
i

m

k
s
i
r

e
t
a
i
r
p
o
r
p
p
a

l
l
a

t
a
h
t

e
r
u
s
n
e

l
l
a
h
s

s
e
t
a
t
S

r
e
b
m
e
M

:
f
o

n
o
i
t
c
e
t
o
r
p

e
h
t

o
t

d
i
a
p

e
b

t
s
u
m

n
o
i
t
n
e
t
t
a

r
a
l
u
c
i
t
r
a
P

:

d
e
s
i
r
o
h
t
u
a

e
b

t
o
n

t
s
u
m

s
e
s
u

i

g
n
w
o

l
l

o
f

e
h
T

,

d
e
e
s
e
p
a
r

d
n
a

s
l
a
e
r
e
c

r
o
f

n
o
i
t
a
c
i
l

p
p
a

r
e
p

e
r
a
t
c
e
h

r
e
p

e
c
n
a
t
s
b
u
s

e
v
i
t
c
a

g
k

5
2
0

,

,
t
e
e
b

r
a
g
u
s

r
o
f

n
o
i
t
a
c
i
l

p
p
a

r
e
p

e
r
a
t
c
e
h

r
e
p

e
c
n
a
t
s
b
u
s

e
v
i
t
c
a

g
k

5
7
0
0

,

.
e
z
i
a
m

r
o
f

n
o
i
t
a
c
i
l

p
p
a

r
e
p

e
r
a
t
c
e
h

r
e
p

e
c
n
a
t
s
b
u
s

e
v
i
t
c
a

g
k

1
0

,

—

—

—

i

g
n
d
e
e
c
x
e

t
o
n

s
e
t
a
r

t
a

d
e
e
s
e
p
a
r

s
l
a
e
r
e
c

t
e
e
b

r
a
g
u
s

e
z
i
a
m

—

—

—

—

:

d
e
s
i
r
o
h
t
u
a

e
b

y
a
m

s
p
o
r
c

i

g
n
w
o

l
l

o
f

e
h
t

n
o

e
d
i
c
i
g
n
u
f

s
a

s
e
s
u

y
l
n
O

A

T
R
A
P

9
0
0
2

r
e
b
m
e
c
e
D

1
3

7
0
0
2

y
r
a
u
n
a
J

1

g
k
/
g
0
8
9

-
2
-
l
o
z
a
d
m
i
z
n
e
b

i

l
y
h
t
e
M

e
t
a
m
a
b
r
a
c
l
y

s
n
o
i
s
i
v
o
r
p

c
i
f
i
c
e
p
S

n
o
i
t
a
r
i
p
x
E

n
o
i
s
u
l
c
n

i

f
o

o
t
n

i

y
r
t
n
E

e
c
r
o
f

)
1
(

y
t
i
r
u
P

e
m
a
n

C
A
P
U

I

,
e
m
a
n

n
o
m
m
o
C

s
r
e
b
m
u
n

n
o
i
t
a
c
i
f
i
t
n
e
d

i

7
-
1
2
-
5
0
6
0
1

o
N

S
A
C

)
y
r
t
s
i

m
e
h
c
o
e
r
e
t
s

3
6
2

o
N

C
A
P
I
C

m
i
z
a
d
n
e
b
r
a
C

d
e
t
a
t
s
n
u
(

o
N

9
4
1

‘

X
E
N
N
A

:

C
E
E
/
4
1
4
/
1
9

e
v
i
t
c
e
r
i

D

o
t

I

x
e
n
n
A

n

i

e
l
b
a
t

e
h
t

f
o

d
n
e

e
h
t

t
a

d
e
d
d
a

e
b

l
l
a
h
s

s
e
i
r
t
n
e

i

g
n
w
o

l
l

o
f

e
h
T

12.12.2006

EN

Official Journal of the European Union

L 349/41

,
s
l
l
a
r
e
v
o
c

,
s
e
v
o
l
g

r
a
l
u
c
i
t
r
a
p

n

i

,

i

g
n
h
t
o
l
c

e
v
i
t
c
e
t
o
r
p

e
l
b
a
t
i
u
s

r
a
e
w

t
s
u
m
o
h
w

,
s
r
o
t
a
r
e
p
o

n
o
i
t
a
c
i
l

p
p
a

,

i

g
n
d
a
o

l

,

g
n
i
x
i
m
g
n
i
r
u
d

s
e
s
s
a
l
g

y
t
e
f
a
s

r
o

n
o
i
t
c
e
t
o
r
p

e
c
a
f

d
n
a

s
t
o
o
b

r
e
b
b
u
r

y
l
e
t
a
u
q
e
d
a

s
i

e
c
n
a
t
s
b
u
s

e
h
t

o
t

e
r
u
s
o
p
x
e

e
h
t

s
s
e
l
n
u

,
t
n
e
m
p
u
q
e

i

e
h
t

f
o

i

g
n
n
a
e
l
c

d
n
a

g
n
i
t
n
u
o
m
e
h
t

y
b

r
o

f
l
e
s
t
i

t
n
e
m
p
u
q
e

i

e
h
t

f
o

n
o
i
t
c
u
r
t
s
n
o
c

d
n
a

n
g
i
s
e
d

e
h
t

y
b

d
e
d
u
l
c
e
r
p

—

.
t
n
e
m
p
u
q
e

i

h
c
u
s

n
o

s
t
n
e
n
o
p
m
o
c

e
v
i
t
c
e
t
o
r
p

c
i
f
i
c
e
p
s

f
o

e
h
t

f
o

s
n
o
i
s
u
l
c
n
o
c

e
h
t

,
I

V

x
e
n
n
A

f
o

s
e
l
p
i
c
n
i
r
p

m
r
o
f
i
n
u

e
h
t

f
o

n
o
i
t
a
t
n
e
m
e
l
p
m

i

e
h
t

r
o
F

e
b

l
l
a
h
s

,
f
o
e
r
e
h
t

I
I

d
n
a

I

s
e
c
i
d
n
e
p
p
A

r
a
l
u
c
i
t
r
a
p

n

i

d
n
a

,

m
i
z
a
d
n
e
b
r
a
c

n
o

t
r
o
p
e
r

w
e
i
v
e
r

.
t
n
u
o
c
c
a

o
t
n

i

n
e
k
a
t

1
3

n
o

t
s
e
t
a
l

e
h
t

t
a

t
r
o
p
e
r

s
r
e
d
o
h

l

n
o
i
t
a
s
i
r
o
h
t
u
a

e
h
t

t
a
h
t

e
r
u
s
n
e

t
s
u
m

s
e
t
a
t
S

r
e
b
m
e
M

y
a
m

s
e
t
a
t
S

r
e
b
m
e
M

.
s

m
e
l
b
o
r
p

h
t
l
a
e
h

r
o
t
a
r
e
p
o

f
o

s
e
c
n
e
d
i
c
n

i

n
o

r
a
e
y

h
c
a
e

f
o

r
e
b
m
e
c
e
D

t
a
h
t

o
s

d
e
d
i
v
o
r
p

e
r
a

,
s
n
r
e
t
t
a
p

e
s
u

f
o

y
e
v
r
u
s

a

d
n
a

a
t
a
d

s
e
l
a
s

s
a

h
c
u
s

,
s
t
n
e
m
e
l
e

t
a
h
t

e
r
i
u
q
e
r

B

T
R
A
P

s
n
o
i
s
i
v
o
r
p

c
i
f
i
c
e
p
S

n
o
i
t
a
r
i
p
x
E

n
o
i
s
u
l
c
n

i

f
o

o
t
n

i

y
r
t
n
E

e
c
r
o
f

)
1
(

y
t
i
r
u
P

e
m
a
n

C
A
P
U

I

,
e
m
a
n

n
o
m
m
o
C

s
r
e
b
m
u
n

n
o
i
t
a
c
i
f
i
t
n
e
d

i

o
N

f
o

t
c
a
p
m

i

l

l
a
c
i
g
o
o
c
i
x
o
t

e
l
b
i
s
s
o
p

e
h
t

d
n
a

s
n
o
i
t
i
d
n
o
c

e
s
u

e
h
t

f
o

e
r
u
t
c
i
p

c
i
t
s
i
l
a
e
r

a

’

.

d
e
n
i
a
t
b
o

e
b

n
a
c

m
i
z
a
d
n
e
b
r
a
c

.
t
r
o
p
e
r

w
e
i
v
e
r

e
h
t

n

i

d
e
d
i
v
o
r
p

e
r
a

e
c
n
a
t
s
b
u
s

e
v
i
t
c
a

f
o

n
o
i
t
a
c
i
f
i
c
e
p
s

d
n
a

y
t
i
t
n
e
d

i

n
o

s
l
i
a
t
e
d

r
e
h
t
r
u
F

)
1
(