Commission Directive 2008/81/EC of 29 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include difenacoum as an active substance in Annex I thereto (Text with EEA relevance)
Date: 2008-07-29
Institutions: European Commission
Subjects: chemical product, environmental protection, marketing, public health

L 201/46

EN

Official Journal of the European Union

30.7.2008

DIRECTIVES

COMMISSION DIRECTIVE 2008/81/EC

of 29 July 2008

amending Directive 98/8/EC of the European Parliament and of the Council to include difenacoum
as an active substance in Annex I thereto

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Directive 98/8/EC of the European Parliament
and of the Council of 16 February 1998 concerning the placing
of biocidal products on the market (1), and in particular the
second subparagraph of Article 16(2) thereof,

Whereas:

(1)

(2)

(3)

(4)

(EC) No

1451/2007

Commission Regulation
of
4 December 2007 on the second phase of the 10-year
work programme referred to in Article 16(2) of Directive
98/8/EC of the European Parliament and of the Council
concerning the placing of biocidal products on the
market (2) establishes a list of active substances to be
assessed, with a view to their possible inclusion in
Annex I,
list
includes difenacoum.

IB to Directive 98/8/EC. That

IA or

Pursuant to Regulation (EC) No 1451/2007, difenacoum
has been evaluated in accordance with Article 11(2) of
Directive 98/8/EC for use in product-type 14,
ro­
denticides, as defined in Annex V to Directive 98/8/EC.

Finland was designated as Rapporteur Member State and
submitted the competent authority report, together with
a recommendation, to the Commission on 21 March
2006 in accordance with Article 14(4) and (6) of Regu­
lation (EC) No 1451/2007.

The competent authority report was reviewed by the
Member States and the Commission.
In accordance
with Article 15(4) of Regulation (EC) No 1451/2007,
the findings of
the review were incorporated, within
the Standing Committee on Biocidal Products on
29 November 2007, in an assessment report.

(1) OJ L 123, 24.4.1998, p. 1. Directive as last amended by Directive

2008/31/EC (OJ L 81, 20.3.2008, p. 57).

(2) OJ L 325, 11.12.2007, p. 3.

(5)

(6)

(7)

(8)

(9)

The review of difenacoum did not reveal any open
questions or concerns to be addressed by the Scientific
Committee on Health and Environmental Risks.

It appears from the examinations made that biocidal
products used as rodenticides and containing difenacoum
may be expected not to present a risk to humans except
incidents with children. Regarding non-
for accidental
target animals and the environment a risk has been iden­
tified. However, the target rodents are vermin and thus
constitute a danger to public health. Moreover, it has not
yet been established that
to
difenacoum exist, which are both equally effective and
less damaging to the
therefore
justified to include difenacoum in Annex I for a limited
period,
in all Member States
authorisations for biocidal products used as rodenticides
and containing difenacoum can be granted, modified, or
cancelled in accordance with Article 16(3) of Directive
98/8/EC.

in order to ensure that

environment.

alternatives

adequate

is

It

specific

to require

In the light of the findings of the assessment report, it is
appropriate
risk mitigation
that
measures are applied at product authorisation level to
ro­
products
denticides. Such measures should be aimed at limiting
the risk of primary and secondary exposure of humans
and non-target animals as well as the long-term effects of
the substance on the environment.

containing difenacoum and used as

Because of
the identified risks and its characteristics,
which render it potentially persistent, liable to bioaccu­
mulate and toxic, or very persistent and very liable to
bioaccumulate difenacoum should be included in Annex
I for five years only and should be made subject to a
comparative risk assessment
in accordance with the
second subparagraph of Article 10(5)(i) of Directive
98/8/EC before its inclusion in Annex I is renewed.

It is important that the provisions of this Directive be
applied simultaneously in all the Member States in order
to ensure equal treatment of biocidal products on the
market containing the active substance difenacoum and
also to facilitate the proper operation of the biocidal
products market in general.

30.7.2008

EN

Official Journal of the European Union

L 201/47

themselves

(10) 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
to meet
prepare
applicants who have
that
entailed and to ensure
fully from the 10-year
prepared dossiers can benefit
period of data protection, which,
in accordance with
Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the
date of inclusion.

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 April 2010.

(11) After inclusion, Member States should be allowed a
reasonable period to implement Article 16(3) of
Directive 98/8/EC, and in particular, to grant, modify
in
or
product-type 14 containing difenacoum to ensure that
they comply with Directive 98/8/EC.

authorisations of biocidal products

cancel

(12) Directive

98/8/EC should

therefore

be

amended

accordingly.

(13)

The measures provided for
accordance with
Committee on Biocidal Products,

the

opinion

in this Directive are in
Standing
the

of

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.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 3

This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

HAS ADOPTED THIS DIRECTIVE:

Article 1

This Directive is addressed to the Member States.

Article 4

Annex I to Directive 98/8/EC is amended in accordance with
the Annex to this Directive.

Done at Brussels, 29 July 2008.

Article 2

Transposition

1. Member States shall adopt and publish, by 31 March
the laws, regulations and administrative
2009 at

the latest,

For the Commission

Stavros DIMAS
Member of the Commission

L 201/48

EN

Official Journal of the European Union

30.7.2008

)
*
(

s
n
o
i
s
i
v
o
r
p

c
i
f
i
c
e
p
S

e
p
y
t

t
c
u
d
o
r
P

f
o

e
t
a
d

y
r
i
p
x
E

n
o
i
s
u
l
c
n

i

d
e
r
u
c
e
s

d
n
a

t
n
a
t
s
i
s
e
r

r
e
p
m
a
t

e
s
u

o
t

s
n
o
i
t
a
g

’

.
s
e
x
o
b

t
i
a
b

f
o

e
r
u
s
o
p
x
e

y
r
a
d
n
o
c
e
s

s
a

l
l
e
w

s
a

y
r
a
m

i
r
P

­
i
v
n
e

e
h
t

d
n
a

s
l
a
m
n
a

i

t
e
g
r
a
t
-
n
o
n

g
n
i
r
e
d
i
s
n
o
c

y
b

,

d
e
s
i

i

m
n
m

i

e
r
a

,
s
n
a
m
u
h

t
n
e
m
n
o
r

e
l
b
a
l
i
a
v
a

d
n
a

e
t
a
i
r
p
o
r
p
p
a

l
l
a

g
n
i
y
l
p
p
a

,
e
d
u
l
c
n

i

e
s
e
h
T

.
s
e
r
u
s
a
e
m

n
o
i
t
a
g
i
t
i

m

d
n
a

k
s
i
r

­
s
e
f
o
r
p

o
t

n
o
i
t
c
i
r
t
s
e
r

e
h
t

,
s
r
e
h
t
o

t
s
g
n
o
m
a

o
t

t
i

m

i
l

r
e
p
p
u

n
a

g
n
i
t
t
e
s

,

y
l
n
o

e
s
u

l
a
n
o
i
s

­
i
l

b
o

n
w
o
d

g
n
i
y
a
l

d
n
a

e
z
i
s

e
g
a
k
c
a
p

e
h
t

)

4

(

e
c
n
a
t
s
b
u
s

e
v
i
t
c
a

e
h
t

t
a
h
t

t
c
a
f

e
h
t

f
o

w
e
i
v

n
I

,
t
n
e
t
s
i
s
r
e
p

y
l
l
a
i
t
n
e
t
o
p

t
i

r
e
d
n
e
r

s
c
i
t
s
i
r
e
t
c
a
r
a
h
c

y
r
e
v

r
o

,
c
i
x
o
t

d
n
a

e
t
a
l
u
m
u
c
c
a
o
b

i

o
t

e
l
b
a
i
l

e
h
t

,
e
t
a
l
u
m
u
c
c
a
o
b

i

o
t

e
l
b
a
i
l

y
r
e
v

d
n
a

t
n
e
t
s
i
s
r
e
p

a

o
t

t
c
e
j
b
u
s

e
b

o
t

s
i

e
c
n
a
t
s
b
u
s

e
v
i
t
c
a

e
c
n
a
d
r
o
c
c
a

n

i

t
n
e
m

s
s
e
s
s
a

k
s
i
r

e
v
i
t
a
r
a
p
m
o
c

f
o

s
t
i

e
r
o
f
e
b

C
E
/
8
/
8
9

e
v
i
t
c
e
r
i

D

f
o

)
i
(
)

(

5
0
1

e
l
c
i
t
r
A

h
p
a
r
g
a
r
a
p
b
u
s

d
n
o
c
e
s

e
h
t

h
t
i

w

.

d
e
w
e
n
e
r

s
i

x
e
n
n
A

s
i
h
t

n

i

n
o
i
s
u
l
c
n

i

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

:
s
n
o
i
t
i
d
n
o
c

i

g
n
w
o

l
l

o
f

e
h
t

o
t

t
c
e
j
b
u
s

e
r
a

d
e
e
c
x
e

t
o
n

l
l
a
h
s

s
t
c
u
d
o
r
p

e
h
t

n

i

e
c
n
a
t
s
b
u
s

s
t
c
u
d
o
r
p

e
s
u
-
r
o
f
-
y
d
a
e
r

y
l
n
o

d
n
a

g
k
/
g
m

5
7

e
v
i
t
c
a

e
h
t

f
o

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

i

l
a
n
m
o
n

e
h
T

)

1

(

.

d
e
s
i
r
o
h
t
u
a

e
b

l
l
a
h
s

,

d
n
a

t
n
e
g
a

e
v
i
s
r
e
v
a

n
a

n
i
a
t
n
o
c

l
l
a
h
s

s
t
c
u
d
o
r
P

)

2

(

.
e
y
d

a

,
e
t
a
i
r
p
o
r
p
p
a

e
r
e
h
w

i

g
n
k
c
a
r
t

s
a

d
e
s
u

e
b

t
o
n

l
l
a
h
s

s
t
c
u
d
o
r
P

)

3

(

.
r
e
d
w
o
p

4
1

5
1
0
2

h
c
r
a
M

1
3

2
1
0
2

h
c
r
a
M

1
3

0
1
0
2

l
i
r
p
A

1

g
k
/
g

0
6
9

e
c
n
a
i
l

p
m
o
c

r
o
f

e
n

i
l

d
a
e
D

)

(

3
6
1

e
l
c
i
t
r
A

h
t
i

w

s
t
c
u
d
o
r
p

r
o
f

t
p
e
c
x
e
(

e
n
o

n
a
h
t

e
r
o
m

i

g
n
n
i
a
t
n
o
c

h
c
i
h
w

r
o
f

,
e
c
n
a
t
s
b
u
s

e
v
i
t
c
a

X
E
N
N
A

y
l
p
m
o
c

o
t

e
n

i
l

d
a
e
d

e
h
t

n
o
i
s
u
l
c
n

i

f
o

e
t
a
D

l
a
d
i
c
o
b

i

e
h
t

n

i

e
b

l
l
a
h
s

)

(

3
6
1

e
l
c
i
t
r
A

h
t
i

w

t
s
a
l

e
h
t

n

i

t
u
o

t
e
s

e
n
o

e
h
t

s
n
o
i
s
i
c
e
d

n
o
i
s
u
l
c
n

i

e
h
t

f
o

e
v
i
t
c
a

s
t
i

o
t

g
n
i
t
a
l
e
r

)
s
e
c
n
a
t
s
b
u
s

d
e
c
a
l
p

s
a

t
c
u
d
o
r
p

t
e
k
r
a
m

e
h
t

n
o

f
o

y
t
i
r
u
p

m
u
m
n
M

i

i

e
c
n
a
t
s
b
u
s

e
v
i
t
c
a

e
h
t

:

C
E
/
8
/
8
9

e
v
i
t
c
e
r
i

D

o
t

I

x
e
n
n
A

n

i

d
e
t
r
e
s
n

i

s
i

’

9

o
N

‘

y
r
t
n
e

i

g
n
w
o

l
l

o
f

e
h
T

e
m
a
n

C
A
P
U

I

s
r
e
b
m
u
n

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

e
m
a
n

n
o
m
m
o
C

o
N

,

,

,

-
4
3
2
1
-
l
y
-
4
-
l
y
n
e
h
p
b
-
3
(
-
3

i

-
4
-
)
l
y
h
t
h
p
a
n
-
1
-
o
r
d
y
h
a
r
t
e
t

n
i
r
a
m
u
o
c
y
x
o
r
d
y
h

5
-
7
0
-
3
7
0
6
5

:

o
N

S
A
C

4
-
8
7
9
-
9
5
2

:

o
N

C
E

m
u
o
c
a
n
e
f
i

D

9

‘

.

m
t
h
x
e
d
n
i
/
s
e
d
i
c
o

i

b
/
t
n
e
m
n
o
r
i
v
n
e
/
m
m
o
c
/
u
e
.
a
p
o
r
u
e
.
c
e
/
/
:
p
t
t
h

:
e
t
i
s
b
e
w

n
o
i
s
s
i

m
m
o
C

e
h
t

n
o

e
l
b
a
l
i
a
v
a

e
r
a

s
t
r
o
p
e
r

t
n
e
m

s
s
e
s
s
a

f
o

s
n
o
i
s
u
l
c
n
o
c

d
n
a

t
n
e
t
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

n
o
m
m
o
c

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

)
*
(