Commission Directive 2006/136/EC of 11 December 2006 amending Council Directive 91/414/EEC to include dinocap 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

L 349/42

EN

Official Journal of the European Union

12.12.2006

COMMISSION DIRECTIVE 2006/136/EC

of 11 December 2006

amending Council Directive 91/414/EEC to include dinocap 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 dinocap.

(5)

For dinocap, the effects on human health and the envir-
onment 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
Regulation (EEC) No 3600/92 (3), as amended by Regu-
lation (EC) No 491/95 of 3 March 1995 (4), Austria was
designated
State. Austria
submitted the relevant assessment report and recommen-
dations
to the Commission on 18 May 2000 in
accordance with Article 7(1)(c) of Regulation (EEC)
No 3600/92.

as Rapporteur Member

(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) OJ L 49, 4.3.1995, p. 50.

As regards dinocap, two questions were submitted to the
Scientific Panel on Plant Health, Plant Protection Products
and their Residues of the European Food Safety Authority
(the Scientific Panel). The first question concerned the
relevance to humans of eye effects that have been
observed in dogs and the second related to the appro-
priate value for dermal absorption that could be derived
from the different studies that have been made available
by the notifier. On the first question the Scientific Panel
considered that
information to
there is not sufficient
conclude that the eye effects in dogs would only be
specific to that species and that more research on the
mechanisms involved may be necessary. Consequently, it
is concluded that these effects in dogs cannot be regarded
to be irrelevant to humans. On the second question, the
Scientific Panel (5) considered a value of 10 % dermal
absorption to be appropriate for the purpose of
the
assessment. In both cases, the recommendations of the
Scientific Panel have been taken into consideration in
formulating this Directive and the relevant review report.

of

the

proposed

restriction

to avoid discrepancies

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
Animal Health,
the
inclusion period to seven years, so that Member States
would give priority to reviewing plant protection
products already on the market containing dinocap. In
order
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
dinocap that have been actually assessed within the
Community evaluation and for which the proposed
uses were considered to comply with the conditions of
that other uses,
Directive 91/414/EEC. This
which were not or only partially covered by this
assessment, had first
to a complete
assessment, before
inclusion in Annex I of
Directive 91/414/EEC could be considered. Finally, due
it was considered
to the hazardous nature of dinocap,
necessary to provide for a minimum harmonisation at
Community level of certain risk mitigation measures
that were to be applied by Member States when
granting authorisations.

to be subject

implies

their

(5) Opinion of

the Scientific Committee on Plant Health, Plant
Protection Products and their Residues on a request
from the
Commission related to the evaluation of dinocap in the context of
Council Directive 91/414/EEC (Question No EFSA-Q-2004-26,
Opinion adopted on 30 June 2004).

12.12.2006

EN

Official Journal of the European Union

L 349/43

(6)

(7)

(8)

of

laid

active

down

approval

procedures
the

by Directive
the
Under
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
that can be considered
reduce the risk to a level
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 dinocap.

several Member

reflect

States

sustainable

the Commission re-
the above,
As a consequence of
examined its position. In order to correctly reflect the
high level of protection of human and animal health
and
the
a
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 the need for a
priority reassessment of this substance.

it considered appropriate,

environment

sought

It may be expected that plant protection products
containing dinocap satisfy the 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.

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

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

(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

that

containing

six months after

dinocap to ensure

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
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
existing
vary,
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
for each
dossier of each plant protection product
intended use in accordance with the uniform principles
laid down in Directive 91/414/EEC. Given the hazardous
properties of dinocap, the period for Member States to
verify whether
the plant protection products, which
contain dinocap 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.

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

(14)

(15)

(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

is

It
therefore
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,

L 349/44

EN

Official Journal of the European Union

12.12.2006

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.

They shall apply those provisions from 1 July 2007.

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.

Article 3

for

shall

plant

States

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

protection

products

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 dinocap, 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
the entry in
Directive and taking into account part B of
Annex I to that Directive concerning dinocap. On the basis of
that evaluation,
the product
satisfies the conditions set out in Article 4(1)(b), (c), (d) and
(e) of Directive 91/414/EEC.

they shall determine whether

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

Article 4

This Directive shall enter into force on 1 January 2007.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 11 December 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

12.12.2006

EN

Official Journal of the European Union

L 349/45

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

—

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
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

t
s
u
m
y
e
h
t

f
i

,
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
e
k
r
o
w

d
o
i
r
e
p

y
r
t
n
e
-
e
r

s
i
h
T

.

d
e
r
i
p
x
e

s
a
h

d
o
i
r
e
p

y
r
t
n
e
-
e
r

c
i
f
i
c
e
p
s

e
h
t

e
r
o
f
e
b

a
e
r
a

d
e
t
a
e
r
t

a

r
e
t
n
e

.
s
r
u
o
h

4
2

n
a
h
t

s
s
e
l

e
b

t
o
n

y
a
m

—

—

—

.

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

,
s
r
e
s
u

r
u
e
t
a
m
a

y
b

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

—

—

—

.

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
2
0

,

i

g
n
d
e
e
c
x
e

t
o
n

s
e
t
a
r

t
a

:

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
s
i
r
o
h
t
u
a

e
b

y
a
m

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

s
e
p
a
r
g

e
n
w

i

—

e
r
u
t
x
i
m
a

s
i

l
y
t
c
o

h
c
i
h
w

,
l
y
t
p
e
h
l
y
h
t
e
m
-
1

n

i

f
o

s
p
u
o
r
g

l
y
t
n
e
p
l
y
p
o
r
p
-
1

d
n
a

l
y
x
e
h
l
y
h
t
e
-
1

8
9

o
N

C
A
P
I
C

s
e
t
a
n
o
t
o
r
c

l
y
n
e
h
p
l
y
t
c
o
-
6

)
e
r
u
t
x
i
m

r
e
m
o
s
i

r
o
f
(

-
o
r
t
i
n
d
-
4
2

i

,

d
n
a

s
e
t
a
n
o
t
o
r
c

3
-
5
4
-
0
0
3
9
3

o
N

S
A
C

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
2
9

l
y
n
e
h
p
l
y
t
c
o
-
4
-
o
r
t
i
n
d
-
6
2

i

,

p
a
c
o
n
D

i

0
5
1

‘

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

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

L 349/46

EN

Official Journal of the European Union

12.12.2006

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

n
e
k
a
t

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

,

p
a
c
o
n
d

i

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

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

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

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

p
a
c
o
n
d

i

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

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

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

.
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
(