Commission Directive 2004/71/EC of 28 April 2004 amending Council Directive 91/414/EEC to include Pseudomonas chlororaphis as active substance (Text with EEA relevance)
Date: 2004-04-28
Institutions: European Commission
Subjects: marketing standard, plant health product

L 127/104

EN

Official Journal of the European Union

29.4.2004

COMMISSION DIRECTIVE 2004/71/EC

of 28 April 2004

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

(Text with EEA relevance)

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), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

In accordance with Article 6(2) of Directive 91/414/EEC
the Swedish authorities received on 15 December 1994
an application from Bio Agri AB, hereafter referred to as
the applicant, for the inclusion of the active substance
Pseudomonas chlororaphis in Annex I to the Directive.
Decision 97/248/EC (2) of 25 March 1997 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 Direc-
tive 91/414/EEC.

For this active substance, 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 State submitted a
draft assessment report concerning the substance to the
Commission on 7 April 1998.

report was

reviewed by the
The draft assessment
Member States and the Commission within the Standing
Committee on the Food Chain and Animal Health. The
review was finalised on 30 March 2004 in the format of
the Commission review report for Pseudomonas chlorora-
phis.

(5)

The dossier and the information from the review were
also submitted to the Scientific Committee for Plants.
The Committee was asked to comment (a) on residue
levels in food and feed; (b) on operator exposure; (c)
whether with regard to possible hazard to humans a
tiered approach should include repeated dosing as part
of the primary data set; (d) on the toxicological safety of
the antibiotic metabolites of the active substance; (e) on

the necessity to monitor the health of workers; and (f)
on a potential of Pseudomonas chlororaphis to cause
wound infection or other pathogenic effects.

has

chlororaphis

formulations

In its opinion (3) the Committee concluded that (a) the
issue of residues has been adequately addressed that
there is no cause for concern; (b) operator exposure to
been
Pseudomonas
adequately addressed; (c) in the specific case of Pseudo-
monas chlororaphis, and in the light of the results of the
available studies, repeated dosing is not necessary to
assess hazard to humans;
(d) more studies would be
needed for a more complete assessment of the mutageni-
city potential of the metabolite 2,3-deepoxy-2,3-dide-
hydro-rhizoxin (DDR). However, the Committee consid-
ered the potential for human exposure to DDR as well
as to other possible antibiotic metabolites so low that,
even in the absence of further information, no major
concern exists for consumer and operator safety; (e) a
study based on the medical surveillance of workers
should be conveniently carried out when introducing
this agent in the field as a microbial pesticide; (f) there is
no cause for concern for human safety with regard to
wound infection.

The recommendations of the Scientific Committee as
well as further information by the notifier were taken
into account during the further review and in this Direc-
tive and in the Review Report, where the need for moni-
toring of operators and worker based on medical surveil-
lance to detect negative effects without delay as well as
monitoring studies
to quantify DDR contamination
under practical conditions is stressed. The evaluation
within the Standing Committee concluded that
there
would be no unacceptable risk for operators if appro-
priate risk mitigation measures are applied.

It has appeared from the various examinations made
that plant protection products containing Pseudomonas
chlororaphis may be expected to satisfy, in general, the
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 exam-
ined and detailed in the Commission review report. It is
therefore appropriate to include this active substances in
Annex I, in order to ensure that in all Member States the
authorisations of plant protection products containing
this active substance can be granted in accordance with
the provisions of that Directive.

(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commis-

sion Directive 2004/20/EC (OJ L 70, 9.3.2004, p. 32).

(2) OJ L 98, 15.4.1997, p. 15.

(3) Opinion of the Scientific Committee on Plants on specific questions
from the Commission regarding the evaluation of pseudomonas chlor-
in the context of Council Directive 91/414/EEC scp/
oraphis
pseudom/002-final adpoted on 20 December 2001.

29.4.2004

EN

Official Journal of the European Union

L 127/105

(6)

(7)

(8)

After inclusion, Member States should be allowed a
reasonable period to implement the provisions of Direc-
tive 91/414/EEC as regards plant protection products
containing Pseudomonas chlororaphis and in particular to
review existing provisional authorisations and, by the
to transform those
end of
authorisations into full authorisations, to amend them or
to withdraw them in accordance with the provisions of
Directive 91/414/EEC.

this period at

the latest,

It is therefore appropriate to amend Directive 91/414/
EEC accordingly.

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

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 latest

1. Member States shall adopt and publish by 31 March
2005 at
the laws, regulations 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 April 2005.

2. 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.

Article 3

1. Member States shall review the authorisation for each
plant protection product containing Pseudomonas chlororaphis to
ensure that the conditions relating to this active substance set

out in Annex I to Directive 91/414/EEC are complied with.
Where necessary, they shall amend or withdraw authorisations
in accordance with Directive 91/414/EEC by 31 March 2005 at
the latest.

For each authorised plant protection product containing
2.
Pseudomonas chlororaphis 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 30 September 2004 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 Pseudomonas chlororaphis
as the only active substance, where necessary, amend or
withdraw the authorisation by 31 March 2006 at the latest;
or

(b) in the case of a product containing Pseudomonas chlororaphis
as one of several active substances, where necessary, amend
or withdraw the authorisation by 31 March 2006 or by the
in the
date fixed for such an amendment or withdrawal
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 October 2004.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 28 April 2004.

For the Commission

David BYRNE

Member of the Commission

In Annex I the following row is added at the end of the table.

ANNEX

No

‘90

Common name, identifi-
cation numbers

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

Pseudomonas
phis

chlorora-

Not applicable

Strain: MA 342

CIPAC No 574

The amount of the secondary
metabolite 2,3-deepoxy-2,3-dide-
hydro-rhizoxin (DDR) in the
fermentate at the point of formula-
tion of the product must not
exceed the LOQ (2 mg/l).

1 October 2004

30 September 2014

Only uses as fungicide for seed dressing in closed seed dressing
machinery may be authorised.

When granting authorisations, the conclusions of the review
report on Pseudomonas chlororaphis, and in particular Appen-
dices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 30 March 2004
shall be taken into account.

In this overall assessment, Member States should pay particular
attention to the safety of operators and workers. Risk mitiga-
tion measures should be applied where appropriate.

(1) Further details on identity and specification of active substances are provided in the review report.’

L

1
2
7
/
1
0
6

E
N

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
U
n
o
n

i

.

.

2
9
4
2
0
0
4