Commission Directive 2005/2/EC of 19 January 2005 amending Council Directive 91/414/EEC to include Ampelomyces quisqualis and Gliocladium catenulatum as active substancesText with EEA relevance
Date: 2005-01-19
Institutions: European Commission
Subjects: marketing standard, pesticide, pharmaceutical product, plant health product, public health, testing

22.1.2005

EN

Official Journal of the European Union

L 20/15

COMMISSION DIRECTIVE 2005/2/EC

of 19 January 2005
amending Council Directive 91/414/EEC to include Ampelomyces quisqualis and Gliocladium
catenulatum as active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

assessment
reports concerning the substances to the
Commission on 28 October 1997 (Ampelomyces quis-
qualis) and on 15 June 2000 (Gliocladium catenulatum).

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:

In accordance with Article 6(2) of Directive 91/414/EEC
the French authorities received on 12 April 1996 an
application from JSC International Ltd for the inclusion
of the active substance Ampelomyces quisqualis in Annex I
to the Directive. Commission Decision 97/591/EC (2)
confirmed that the dossier was ‘complete’
in the sense
that it could be considered as satisfying, in principle, the
data and information requirements of Annexes II and III
to Directive 91/414/EEC.

Finland received an application under Article 6(2) of
Directive 91/414/EEC on 19 May 1998 from Kemira
Agro Oy (now: Verdera Oy)
for the inclusion of the
active substance Gliocladium catenulatum in Annex I to
the Directive. Commission Decision 1999/392/EC (3)
confirmed that the dossier was ‘complete’
in the sense
that it could be considered as satisfying, in principle, the
data and information requirements of Annexes II and III
to Directive 91/414/EEC.

(1)

(2)

(3)

(4)

(5)

(6)

(7)

States

reports were reviewed by the
The draft assessment
Member
the Commission within the
and
Standing Committee on the Food Chain and Animal
Health. The review was finalised on 8 October 2004 in
the format of the Commission review reports for Ampe-
lomyces quisqualis and Gliocladium catenulatum.

The dossier and the information from the review of
Ampelomyces
also submitted to the
Scientific Committee on Plants. The report of
this
Committee was formally adopted on 7 March 2001 (4).

quisqualis were

further

concluded that

in the
In its opinion the Committee concluded that
absence of a satisfactory pulmonary study, the risk of
operators had not been adequately addressed. The
Committee
repeated dosing
should in general be part of the primary data set, but
it could be omitted provided that adequate justification is
provided. In the specific case of Ampelomyces quisqualis
the Committee was unable
to comment on the
necessity of repeated dosing due to absence of a satis-
factory pulmonary study.

The Committee finally concluded that although no
reactions against Ampelomyces quisqualis had
allergic
been observed, the possibility of occurrence of allergic
reactions resulting from agricultural exposure to this
organism could not be excluded. The Committee recom-
mended monitoring the health of producers and users as
a prudent post authorisation measure and making these
results available for future re-assessment.

For those active substances, the effects on human health
and the environment have been assessed, in accordance
with the provisions of Article 6(2) and (4) of Directive
91/414/EEC, for the uses proposed by the applicants. The
nominated rapporteur Member States submitted draft

(8)

The recommendations of the Scientific Committee were
taken into account during the further review,
in this
Directive and in the Review Report.

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

last amended by

Commission Decision 2004/99/EC (OJ L 309, 6.10.2004, p. 6).

(2) OJ L 239, 30.8.1997, p. 48.
(3) OJ L 148, 15.6.1999, p. 44.

(4) Opinion of

the scientific Committee on Plants

regarding the
evaluation of Ampelomyces quisqualis
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 20/16

EN

Official Journal of the European Union

22.1.2005

(9)

Standing Committee

A second pulmonary study was performed by the
notifier, as requested by the Scientific Committee. The
study was considered as scientifically sound and valid
further
within the
and
evaluation concluded that Ampelomyces
is
neither pathogenic, nor infectious in mammals and that
also no toxins are involved, and thus the risk of operator
exposure has been adequately addressed according to the
recommendations of the Scientific Committee on Plants.

the
quisqualis

the substance. As a result,

(10) As regards the possibility of allergic reactions, no such
reactions have been documented from an agricultural use
of
there is no reason to
consider that there is any serious risk of such reactions.
However,
allergic
the possibility of occurrence of
reactions cannot be entirely excluded. Such concerns
should not prevent
the substance being included in
Annex I to Directive 91/414/EEC, but could instead be
the Member States established a monitoring
met
programme when they
authorise plant protection
products containing Ampelomyces quisqualis.

if

substances and in particular to review existing provi-
sional authorisations and, by the end of this period at
the latest,
to transform those authorisations into full
authorisations, to amend them or to withdraw them in
accordance with the provisions of Directive 91/414/EEC.

(15)

(16)

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

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

(11)

The evaluation within the Standing Committee therefore
concluded that
there would be no harmful effect on
humans under the proposed conditions of use.

Article 2

(12)

The review of Gliocladium catenulatum did not reveal any
open questions or concerns, which would have required
a consultation of the Scientific Committee on Plants or
of the European Food Safety Authority.

(13)

the

products

protection

containing

It has appeared from the various examinations made that
plant
active
in general, the
substances may be expected to satisfy,
requirements laid down in Article 5(1)(a) and (b) of
Directive 91/414/EEC in the
light of Article 5(3)
thereof,
in particular with regard to the uses which
were examined and detailed in the Commission review
report. It is therefore appropriate to include Ampelomyces
quisqualis and Gliocladium catenulatum in Annex I, in order
to ensure that in all Member States the authorisations of
plant protection products
active
substances can be granted in accordance with the
provisions of that Directive.

containing

these

(14) After inclusion of Ampelomyces quisqualis and Gliocladium
catenulatum in Annex I to Directive 91/414/EEC, Member
States
reasonable period to
the provisions of Directive 91/414/EEC as
implement
containing those
regards plant protection products

should be

allowed a

the latest

1. Member States shall adopt and publish by 30 September
the laws, regulations and administrative
2005 at
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 October 2005.

When Member States adopt those provisions, they shall contain
a reference to this Directive or shall 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

1. Member States shall review the authorisation for each
plant protection product containing Ampelomyces quisqualis or
Gliocladium catenulatum to ensure that the conditions relating
to these active substances set out
to Directive
91/414/EEC are complied with. Where necessary, they shall
amend or withdraw authorisations
in accordance with
Directive 91/414/EEC by 30 September 2005 at the latest.

in Annex I

22.1.2005

EN

Official Journal of the European Union

L 20/17

For each authorised plant protection product containing
2.
Ampelomyces quisqualis or Gliocladium catenulatum 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 31
March 2005 at the latest, Member States shall re-evaluate the
product on the basis of a dossier satisfying the requirements of
Annex III thereto. On the basis of that evaluation, they shall
determine whether the product satisfies the conditions set out in
Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.

Following that determination Member States shall:

(a)

in the case of a product containing Ampelomyces quisqualis or
Gliocladium catenulatum as the only active substance, where
necessary, amend or withdraw the authorisation by 30
September 2006 at the latest; or

(b) in the case of a product containing Ampelomyces quisqualis or
Gliocladium catenulatum as one of several active substances,
where necessary, amend or withdraw the authorisation by

30 September 2006 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 April 2005.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 19 January 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 20/18

EN

Official Journal of the European Union

22.1.2005

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
u
t
a
l
u
n
e
t
a
c

m
u
i
d
a
l
c
o
i
l

G

w
e
i
v
e
r

e
h
t

f
o

s
n
o
i
s
u
l
c
n
o
c

e
h
t

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

g
n
i
t
n
a
r
g

n
o

n
e
h
W

t
r
o
p
e
r

e
h
t

n
o

e
e
t
t
i

m
m
o
C

i

g
n
d
n
a
t
S

e
h
t

n

i

d
e
s
i
l
a
n
i
f

s
a

,
f
o
e
r
e
h
t

I
I

d
n
a

I

e
b

l
l
a
h
s

4
0
0
2

h
c
r
a
M

0
3

n
o

h
t
l
a
e
H

l
a
m
n
A

i

d
n
a

n
i
a
h
C

d
o
o
F

.
t
n
u
o
c
c
a

o
t
n

i

n
e
k
a
t

r
a
l
u
c
i
t
r
a
p

y
a
p

l

d
u
o
h
s

s
e
t
a
t
S

r
e
b
m
e
M

,
t
n
e
m

s
s
e
s
s
a

l
l
a
r
e
v
o

s
i
h
t

n
I

-
i
t
i

m
k
s
i
R

.
s
r
e
k
r
o
w

d
n
a

s
r
o
t
a
r
e
p
o

f
o

n
o
i
t
c
e
t
o
r
p

e
h
t

o
t

n
o
i
t
n
e
t
t
a

.
e
t
a
i
r
p
o
r
p
p
a

e
r
e
h
w

d
e
i
l

p
p
a

e
b

l

d
u
o
h
s

s
e
r
u
s
a
e
m

n
o
i
t
a
g

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

,

s
i
l
a
u
q
s
i
u
q

s
e
c
y
m
o
l
e
p
m
A

w
e
i
v
e
r

e
h
t

f
o

s
n
o
i
s
u
l
c
n
o
c

e
h
t

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

g
n
i
t
n
a
r
g

n
o

n
e
h
W

t
r
o
p
e
r

e
h
t

n
o

e
e
t
t
i

m
m
o
C

i

g
n
d
n
a
t
S

e
h
t

n

i

d
e
s
i
l
a
n
i
f

s
a

,
f
o
e
r
e
h
t

I
I

d
n
a

I

e
b

l
l
a
h
s

4
0
0
2

r
e
b
o
t
c
O

8

n
o

h
t
l
a
e
H

l
a
m
n
A

i

d
n
a

n
i
a
h
C

d
o
o
F

.
t
n
u
o
c
c
a

o
t
n

i

n
e
k
a
t

.

d
e
s
i
r
o
h
t
u
a

e
b

y
a
m

e
d
i
c
i
g
n
u
f

s
a

s
e
s
u

y
l
n
O

5
1
0
2

h
c
r
a
M

1
3

5
0
0
2

l
i
r
p
A

1

e
l
b
a
c
i
l

p
p
a

t
o
N

.

d
e
s
i
r
o
h
t
u
a

e
b

y
a
m

e
d
i
c
i
g
n
u
f

s
a

s
e
s
u

y
l
n
O

5
1
0
2

h
c
r
a
M

1
3

5
0
0
2

l
i
r
p
A

1

e
l
b
a
c
i
l

p
p
a

t
o
N

7
0
8
-
I

M
C
N
C

o
N

n
o
i
t
c
e
l
l

o
c

e
r
u
t
l
u
C

s
i
l
a
u
q
s
i
u
q

s
e
c
y
m
o
l
e
p
m
A

0
1

Q
A

:

n
i
a
r
t
S

d
e
t
a
c
o

l
l
a

t
o
N

o
N

C
A
P
I
C

o
N

4
9

‘

2
1
2
9

M
S
D

o
N

n
o
i
t
c
e
l
l

o
c

e
r
u
t
l
u
C

m
u
t
a
l
u
n
e
t
a
c

m
u
i
d
a
l
c
o
i
l

G

9
9

6
4
4
1

J

:

n
i
a
r
t
S

d
e
t
a
c
o

l
l
a

t
o
N

o
N

C
A
P
I
C

s
n
o
i
s
i
v
o
r
p

c
i
f
i
c
e
p
S

n
o
i
s
u
l
c
n

i

f
o

n
o
i
t
a
r
i
p
x
E

e
c
r
o
f

o
t
n

i

y
r
t
n
E

)
*
(
y
t
i
r
u
P

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

’

.
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

s
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

)
*
(

X
E
N
N
A

:
e
l
b
a
t

e
h
t

f
o

d
n
e

e
h
t

t
a

d
e
d
d
a

s
i

w
o
r

i

g
n
w
o

l
l

o
f

e
h
t

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