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30.8.2013 Official
Journal
of
the
European
Union L
232/29
COMMISSION IMPLEMENTING REGULATION (EU) No 829/2013
of 29 August 2013
approving the active substance Pseudomonas sp. strain DSMZ 13134, in accordance with Regulation
(EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant
protection products on the market, and amending the Annex to Commission Implementing
Regulation (EU) No 540/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
were reviewed by the Member States and the
Commission within the Standing Committee on the
Having regard to the Treaty on the Functioning of the European
Food Chain and Animal Health and finalised on
Union,
16 July 2013 in the format of the Commission review
report for Pseudomonas sp. strain DSMZ 13134.
Having regard to Regulation (EC) No 1107/2009 of the
European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the
(5)
It has appeared from the various examinations made that
market and repealing Council Directives 79/117/EEC and
plant protection products containing Pseudomonas sp.
91/414/EEC (
strain DSMZ 13134 may be expected to satisfy, in

1 ), and in particular Article 13(2) and Article 78(2)
thereof,
general, the requirements laid down in Article 5(1)(a)
and (b) and Article 5(3) of Directive 91/414/EEC, in
Whereas:
particular with regard to the uses which were examined
and detailed in the Commission review report. It is
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
therefore appropriate to approve Pseudomonas sp. strain
1107/2009, Council Directive 91/414/EEC (
DSMZ 13134.

2 ) is to apply,
with respect to the procedure and the conditions for
approval, to active substances for which a decision has
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
been adopted in accordance with Article 6(3) of that
1107/2009 in conjunction with Article 6 thereof and in
Directive before 14 June 2011. For Pseudomonas sp.
the light of current scientific and technical knowledge, it
strain DSMZ 13134 the conditions of Article 80(1)(a)
is, however, necessary to include certain conditions and
of Regulation (EC) No 1107/2009 are fulfilled by
restrictions. It is, in particular, appropriate to require
Commission Decision 2008/599/EC ( 3 ).
further confirmatory information.
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
the Netherlands received on 28 August 2007 an appli
(7) A
reasonable
period
should
be
allowed
to
elapse
before
cation from Sourcon-Padena GmbH & Co. KG for the
approval in order to permit Member States and the
inclusion of the active substance Pseudomonas sp. strain
interested parties to prepare themselves to meet the
DSMZ 13134 in Annex I to Directive 91/414/EEC.
new requirements resulting from the approval.
Decision 2008/599/EC confirmed that the dossier was
‘complete’ in the sense that it could be considered as
satisfying, in principle, the data and information
(8) Without
prejudice
to
the
obligations
provided
for
in
requirements of Annexes II and III to Directive
Regulation (EC) No 1107/2009 as a consequence of
91/414/EEC.
approval, taking into account the specific situation
created by the transition from Directive 91/414/EEC to
(3) For
that
active
substance,
the
effects
on
human
and
Regulation (EC) No 1107/2009, the following should,
animal health and the environment have been assessed,
however, apply. Member States should be allowed a
in accordance with the provisions of Article 6(2) and (4)
period of six months after approval to review authori
of Directive 91/414/EEC, for the uses proposed by the
sations of plant protection products containing Pseu
applicant. The designated rapporteur Member State
domonas sp. strain DSMZ 13134. Member States
submitted a draft assessment report on 3 November
should, as appropriate, vary, replace or withdraw auth
2009.
orisations. By way of derogation from that deadline, a
longer period should be provided for the submission and
(4) The
draft
assessment
report
was
reviewed
by
the
Member
assessment of the complete Annex III dossier, as set out
States and the European Food Safety Authority (here
in Directive 91/414/EEC, of each plant protection
inafter ‘the Authority’). The Authority presented to the
product for each intended use in accordance with the
Commission its conclusion ( 4 ) on the pesticide risk
uniform principles.
assessment of the active substance Pseudomonas sp.
strain DSMZ 13134 on 12 November 2012. The draft
assessment report and the conclusion of the Authority
(9) The
experience
gained
from
inclusions
in
Annex
I
to
Directive 91/414/EEC of active substances assessed in
the framework of Commission Regulation (EEC) No
( 1 ) OJ L 309, 24.11.2009, p. 1.
3600/92 of 11 December 1992 laying down the
( 2 ) OJ L 230, 19.8.1991, p. 1.
detailed rules for the implementation of the first stage
( 3 ) OJ L 193, 22.7.2008, p. 14.
( 4 ) EFSA Journal 2012; 10(12):2954. Available online: www.efsa.
of the programme of work referred to in Article 8(2) of
europa.eu
Council Directive 91/414/EEC concerning the placing

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L 232/30
EN
Official Journal of the European Union
30.8.2013
of plant protection products on the market ( 1 ) has shown
91/414/EEC in accordance with the conditions of Article 13(1)
that difficulties can arise in interpreting the duties of
to (4) of that Directive and Article 62 of Regulation (EC) No
holders of existing authorisations in relation to access
1107/2009.
to data. In order to avoid further difficulties it therefore
appears necessary to clarify the duties of the Member
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
States, especially the duty to verify that the holder of
orised plant protection product containing Pseudomonas sp.
an authorisation demonstrates access to a dossier
strain DSMZ 13134 as either the only active substance or as
satisfying the requirements of Annex II to that Directive.
one of several active substances, all of which were listed in the
However, this clarification does not impose any new
Annex to Implementing Regulation (EU) No 540/2011 by
obligations on Member States or holders of authori
31 January 2014 at the latest, Member States shall re-evaluate
sations compared to the Directives which have been
the product in accordance with the uniform principles, as
adopted until now amending Annex I to that Directive
referred to in Article 29(6) of Regulation (EC) No 1107/2009,
or the Regulations approving active substances.
on the basis of a dossier satisfying the requirements of Annex
III to Directive 91/414/EEC and taking into account the column
(10) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
on specific provisions of Annex I to this Regulation. On the
1107/2009, the Annex to Commission Implementing
basis of that evaluation, they shall determine whether the
Regulation (EU) No 540/2011 of 25 May 2011 imple
product satisfies the conditions set out in Article 29(1) of Regu
menting Regulation (EC) No 1107/2009 of the European
lation (EC) No 1107/2009.
Parliament and of the Council as regards the list of
approved active substances
(
Following that determination Member States shall:

2 ) should be amended
accordingly.
(a) in the case of a product containing Pseudomonas sp. strain
DSMZ 13134 as the only active substance, where necessary,
(11) The
measures
provided
for
in
this
Regulation
are
in
amend or withdraw the authorisation by 31 July 2015 at
accordance with the opinion of the Standing
the latest; or
Committee on the Food Chain and Animal Health,
(b) in the case of a product containing Pseudomonas sp. strain
HAS ADOPTED THIS REGULATION:
DSMZ 13134 as one of several active substances, where
Article 1
necessary, amend or withdraw the authorisation by
31 July 2015 or by the date fixed for such an
Approval of active substance
amendment or withdrawal in the respective act or acts
which added the relevant substance or substances to
The active substance Pseudomonas sp. strain DSMZ 13134, as
Annex I to Directive 91/414/EEC or approved that
specified in Annex I, is approved subject to the conditions laid
substance or those substances, whichever is the latest.
down in that Annex.
Article 3
Article 2
Amendments to Implementing Regulation (EU) No
Re-evaluation of plant protection products
540/2011
1. Member
States
shall
in
accordance
with
Regulation
(EC)
The Annex to Implementing Regulation (EU) No 540/2011 is
No 1107/2009, where necessary, amend or withdraw existing
amended in accordance with Annex II to this Regulation.
authorisations for plant protection products containing Pseu
domonas sp. strain DSMZ 13134 as an active substance by
Article 4
31 July 2014.
Entry into force and date of application
By that date they shall in particular verify that the conditions in
This Regulation shall enter into force on the twentieth day
Annex I to this Regulation are met, with the exception of those
following that of its publication in the Official Journal of the
identified in the column on specific provisions of that Annex,
European Union.
and that the holder of the authorisation has, or has access to, a
dossier satisfying the requirements of Annex II to Directive
It shall apply from 1 February 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 August 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 366, 15.12.1992, p. 10.
( 2 ) OJ L 153, 11.6.2011, p. 1.

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30.8.2013 Off
ANNEX I
Common name,
identification numbers
IUPAC name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Pseudomonas sp.
Not applicable Minimum
concentration:
1 February 2014 31
January
2024 For the implementation of the uniform principles as referred to in Article 29(6) of Regu
strain DSMZ 13134
3 × 1014 cfu/kg
lation (EC) No 1107/2009, the conclusions of the review report on Pseudomonas sp. strain
EN
DSMZ 13134, and in particular Appendices I and II thereof, as finalised in the Standing

Collection number:
Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into
DSMZ 13134
account.
In this overall assessment Member States shall pay particular attention to the protection of
operators and workers, taking into account that Pseudomonas sp. strain DSMZ 13134 is to
be considered as a potential sensitizer.
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit information to confirm the absence of an acute intratracheal and
intraperitoneal toxicity/infectivity/pathogenicity potential.
The applicant shall submit to the Commission, the Member States and the Authority that
icial
information by 31 January 2016.
Jour
(1 ) Further details on identity and specification of active substance are provided in the review report.
nal
of
the
European
Union
L
232/31

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L 232/32
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number
Common name,
identification numbers
IUPAC name Purity
(1 ) Date
of
approval
Expiration of
approval
Specific provisions
EN
‘50 Pseudomonas sp.
Not applicable Minimum
1 February 2014 31
January
2024 For the implementation of the uniform principles as referred to in

strain DSMZ 13134
concentration: 3×1014
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the
cfu/kg
review report on Pseudomonas sp. strain DSMZ 13134, and in particular
Collection number:
Appendices I and II thereof, as finalised in the Standing Committee on the
DSMZ 13134
Food Chain and Animal Health on 16 July 2013 shall be taken into account.
In this overall assessment Member States shall pay particular attention to the
protection of operators and workers, taking into account that Pseudomonas sp.
strain DSMZ 13134 is to be considered as a potential sensitizer.
Conditions of use shall include risk mitigation measures, where appropriate.
Off
The applicant shall submit information to confirm the absence of an acute
intratracheal and intraperitoneal toxicity/infectivity/pathogenicity potential.
icial
The applicant shall submit to the Commission, the Member States and the
Jour
Authority that information by 31 January 2016.’
nal
(1 ) Further details on identity and specification of active substance are provided in the review report.
of
the
European
Union
30.8.2013

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