Commission Directive 2001/47/EC of 25 June 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include Paecilomyces fumosoroseus (Apopka strain 97, PFR 97 or CG 170, ATCC20874) as an active substance
Date: 2001-06-25
Institutions: European Commission
Subjects: insecticide, marketing, marketing standard, pharmaceutical product, plant health product

28.6.2001

EN

Official Journal of the European Communities

L 175/21

COMMISSION DIRECTIVE 2001/47/EC

of 25 June 2001

amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection
products on the market to include Paecilomyces fumosoroseus (Apopka strain 97, PFR 97 or CG 170,
ATCC20874) as an active substance

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant protection products on
the market (1), as last amended by Commission Directive 2001/
28/EC (2), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

referred to as

In accordance with Article 6(2) of Directive 91/414/EEC
‘the Directive’) Belgium
(hereinafter
received on 18 May 1994 an application from Thermo
Trilogy Corporation, (‘the applicant’) for the inclusion of
the active substance Paecilomyces fumosoroseus (Apopka
strain 97, PFR 97 or CG 170, ATCC20874) in Annex I
to the Directive.

In accordance with the provisions of Article 6(3) of the
Directive,
the Commission confirmed in its Decision
97/164/EC (3) that the dossier submitted for Paecilomyces
fumosoroseus (Apopka strain 97, PFR 97 or CG 170,
ATCC20874) could be considered as satisfying, in prin-
ciple, the data and information requirements of Annex II
and, for a plant protection product containing this active
substance, of Annex III to the Directive.

In accordance with Article 5(1) of the Directive, an
active substance should be included in Annex I for a
period not exceeding 10 years if it may be expected that
neither the use of, or residues from, plant protection
products containing the active substance will have any
harmful effects on human or animal health or on
groundwater or any unacceptable influence on the envir-
onment.

For Paecilomyces fumosoroseus (Apopka strain 97, PFR 97
or CG 170, ATCC20874), the effects on human health
and the environment have been assessed, in accordance
the
with the provisions of Article 6(2) and (4) of
Directive,
the uses proposed by the applicant.
Belgium acting as nominated rapporteur Member State
submitted a draft assessment report concerning the
substance to the Commission on 9 December 1997.

for

The draft assessment report has been reviewed by the
Member States and the Commission within the Standing
Committee on Plant Health. This review was finalised on
27 April 2001 in the format of the Commission review
report for Paecilomyces fumosoroseus (Apopka strain 97,

(6)

(7)

(8)

(9)

PFR 97 or CG 170, ATCC20874). If this review report
has to be updated to take account of technical and
scientific developments, the conditions for the inclusion
of DPX KE 459 Paecilomyces fumosoroseus (Apopka strain
97, PFR 97 or CG 170, ATCC20874) in Annex I to the
Directive will also need to be amended in accordance
with the Directive.

The dossier and the information from the review of
Paecilomyces fumosoroseus (Apopka strain 97, PFR 97 or
CG 170, ATCC20874) were also submitted to the
Scientific Committee on Plants for opinion on 16
December 1999. This Committee has given its opinion
on 30 November 2000 (4).

It has appeared from the various examinations made
that plant protection products containing the active
substance concerned may be expected to satisfy,
in
general, the requirements laid down in Article 5(1)(a), (b)
and (3) of the Directive, in particular with regard to the
uses which were examined and detailed in the Commis-
sion review report. It is therefore appropriate to include
the active substance concerned in Annex I, in order to
ensure that in all Member States the authorisations of
plant
active
substance concerned can be granted in accordance with
the provisions of the said Directive.

containing

protection

products

the

After inclusion, a reasonable period is necessary to
permit Member States to implement the provisions of
the Directive on plant protection products containing
Paecilomyces fumosoroseus (Apopka strain 97, PFR 97 or
CG 170, ATCC20874) and in particular to review,
existing provisional authorisations or to grant, by the
end of this period at the latest, new authorisations in
accordance with the provisions of
the Directive. A
longer period may also be required for plant protection
products containing Paecilomyces fumosoroseus (Apopka
strain 97, PFR 97 or CG 170, ATCC20874) and other
active substances included in Annex I.

it

is appropriate that

As the uniform principles have still to be adopted for
the Member
micro-organisms,
States should apply the general provisions of Article 4 of
the Directive when granting authorisations. It is also
appropriate to provide Member States a reasonable
period of time to re-evaluate authorisations granted in
the light of the uniform principles after their adoption.

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 113, 24.4.2001, p. 5.
(3) OJ L 64, 5.3.1997, p. 17.

(4) Opinion of the Scientific Committee on Plants regarding the evalua-
tion Paecilomyces fumosoroseus in the context of Council Directive 91/
414/EEC concerning the placing of plant protection products on the
market. SCP/PAECIL/002 final dated 11 December 2000.

L 175/22

EN

Official Journal of the European Communities

28.6.2001

(10)

(except

It is appropriate to provide that the finalised review
report
information in the
meaning of Article 14 of the Directive) is kept available
or made available by the Member States for consultation
by any interested parties.

for confidential

(11)

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on Plant Health delivered on 27 April 2001,

HAS ADOPTED THIS DIRECTIVE:

Article 1

The table in Annex I to Directive 91/414/EEC shall be amended
to include the entry in respect of Paecilomyces fumosoroseus
(Apopka strain 97, PFR 97 or CG 170, ATCC20874) set out in
the Annex hereto.

Article 2

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive, at
the latest by 31 December 2001. They shall
forthwith inform the Commission thereof.

those provisions,

When Member States adopt
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.
However, with regard to the review of existing provi-
sional authorisations granted in the light of the review report,
the provisional authorisations shall be withdrawn and where
appropriate, replaced by a full authorisation by 30 November
2002.

However, with regard to the application of the uniform
3.
principles, Member States
re-examine authorisations
shall
granted as soon as possible after their adoption and at the
latest within a period of 12 months from the date of adoption
of such principles.

4.
However, for plant protection products containing Paeci-
lomyces fumosoroseus (Apopka strain 97, PFR 97 or CG 170,
ATCC20874) together with another active substance which is
in Annex I to Directive 91/414/EEC, the period referred to in
paragraph 1 is extended to the extent that a longer imple-
mentation period is provided for by the provisions laid down
in the Directive amending Annex I to Directive 91/414/EEC to
include that other substance in the Annex.

5. Member States shall keep available the review report for
Paecilomyces fumosoroseus (Apopka strain 97, PFR 97 or CG 170,
ATCC20874) (except for confidential information within the
meaning of Article 14 of the Directive) for consultation by any
interested parties or shall make it available to them on specific
request.

This Directive shall enter into force on 1 July 2001.

Article 3

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 25 June 2001.

For the Commission

David BYRNE

Member of the Commission

No

18

ENTRY TO BE INSERTED IN THE TABLE IN ANNEX I TO DIRECTIVE 91/414/EEC

ANNEX

Common name, and identification

IUPAC name

Purity

Entry into force

Expiration of inclusion

Specific provisions

.

.

2
8
6
2
0
0
1

Paecilomyces fumosoroseus
Apopka strain 97, PFR 97
or CG 170, ATCC20874

Not applicable

absence of

secondary
The
be
metabolites
checked in each fermentation
broth by HPLC

should

1 July 2001

30 June 2011

Only uses as an insecticide may be
authorised

E
N

Each fermentation broth should be
checked by HPLC to ensure that no
secondary metabolites are present

Date of Standing Committee on Plant
Health at which the review report was
finalised: 27 April 2001

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
C
o
m
m
u
n
i
t
i
e
s

L

1
7
5
/
2
3