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25.4.2013 Official
Journal
of
the
European
Union L
113/5
II
(Non-legislative acts)
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 378/2013
of 24 April 2013
approving the active substance Paecilomyces fumosoroseus strain FE 9901, 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,
of Directive 91/414/EEC, for the uses proposed by the
applicant. The designated rapporteur Member State
submitted a draft assessment report on 29 March 2007.
Having regard to the Treaty on the Functioning of the European
Union,
(4) The
draft
assessment
report
was
reviewed
by
the
Member
States and the European Food Safety Authority (here
Having regard to Regulation (EC) No 1107/2009 of the
inafter ‘the Authority’). The Authority presented to the
European Parliament and of the Council of 21 October 2009
Commission its conclusion on the review of the pesticide
concerning the placing of plant protection products on the
risk assessment of the active substance Paecilomyces fumo
market and repealing Council Directives 79/117/EEC and
soroseus strain FE 9901 (
91/414/EEC (

4 ) on 20 August 2012. The draft

1 ), and in particular Articles 13(2) and 78(2)
assessment report and the conclusion of the Authority
thereof,
were reviewed by the Member States and the
Commission within the Standing Committee on the
Whereas:
Food Chain and Animal Health and the draft assessment
report was finalised on 15 March 2013 in the format of
the Commission review report for Paecilomyces fumoso
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
roseus strain FE 9901.
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
with respect to the procedure and the conditions for
approval, to active substances for which a decision has
(5)
It has appeared from the various examinations made that
been adopted in accordance with Article 6(3) of that
plant protection products containing Paecilomyces fumoso
Directive before 14 June 2011. For Paecilomyces fumoso
roseus strain FE 9901 may be expected to satisfy, in
roseus strain FE 9901 the conditions of Article 80(1)(a) of
general, the requirements laid down in Article 5(1)(a)
Regulation (EC) No 1107/2009 are fulfilled by
and (b) and Article 5(3) of Directive 91/414/EEC, in
Commission Decision 2008/565/EC ( 3 ).
particular with regard to the uses which were examined
and detailed in the Commission review report. It is
therefore appropriate to approve Paecilomyces fumosoroseus
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
strain FE 9901.
Belgium received on 4 February 2004 an application
from FuturEco S.L. for the inclusion of the active
substance Paecilomyces fumosoroseus strain FE 9901 in
(6) A
reasonable
period
should
be
allowed
to
elapse
before
Annex I to Directive 91/414/EEC. Decision 2008/565/EC
approval in order to permit Member States and the
confirmed that the dossier was ‘complete’ in the sense
interested parties to prepare themselves to meet the
that it could be considered as satisfying, in principle, the
new requirements resulting from the approval.
data and information requirements of Annexes II and III
to Directive 91/414/EEC.
(7) Without
prejudice
to
the
obligations
provided
for
in
Regulation (EC) No 1107/2009 as a consequence of
(3) For
that
active
substance,
the
effects
on
human
and
approval, taking into account the specific situation
animal health and the environment have been assessed,
created by the transition from Directive 91/414/EEC to
in accordance with the provisions of Article 6(2) and (4)
Regulation (EC) No 1107/2009, the following should,
however, apply. Member States should be allowed a
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 4 ) EFSA Journal 2012; 10(9):2869. Available online: www.efsa.europa.
( 3 ) OJ L 181, 10.7.2008, p. 49.
eu

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L 113/6
EN
Official Journal of the European Union
25.4.2013
period of six months after approval to review authori
authorisations for plant protection products containing Paeci
sations of plant protection products containing Paeci
lomyces fumosoroseus strain FE 9901 as an active substance by
lomyces fumosoroseus strain FE 9901. Member States
31 March 2014.
should, as appropriate, vary, replace or withdraw
authorisations. By way of derogation from that
deadline, a longer period should be provided for the
By that date they shall in particular verify that the conditions in
submission and assessment of the update of the
Annex I to this Regulation are met, with the exception of those
complete Annex III dossier, as set out in Directive
identified in the column on specific provisions of that Annex,
91/414/EEC, of each plant protection product for each
and that the holder of the authorisation has, or has access to, a
intended use in accordance with the uniform principles.
dossier satisfying the requirements of Annex II to Directive
91/414/EEC in accordance with the conditions of Article 13(1)
to (4) of that Directive and Article 62 of Regulation (EC) No
(8) The
experience
gained
from
inclusions
in
Annex
I
to 1107/2009.
Directive 91/414/EEC of active substances assessed in
the framework of Commission Regulation (EEC) No
3600/92 of 11 December 1992 laying down the
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
detailed rules for the implementation of the first stage
orised plant protection product containing Paecilomyces fumoso
of the programme of work referred to in Article 8(2) of
roseus strain FE 9901 as either the only active substance or as
Council Directive 91/414/EEC concerning the placing of
one of several active substances, all of which were listed in the
plant protection products on the market ( 1 ) has shown
Annex to Implementing Regulation (EU) No 540/2011 by
that difficulties can arise in interpreting the duties of
30 September 2013 at the latest, Member States shall re-
holders of existing authorisations in relation to access
evaluate the product in accordance with the uniform principles,
to data. In order to avoid further difficulties it therefore
as referred to in Article 29(6) of Regulation (EC) No
appears necessary to clarify the duties of the Member
1107/2009, on the basis of a dossier satisfying the requirements
States, especially the duty to verify that the holder of
of Annex III to Directive 91/414/EEC and taking into account
an authorisation demonstrates access to a dossier
the column on specific provisions of Annex I to this Regulation.
satisfying the requirements of Annex II to that Directive.
On the basis of that evaluation, they shall determine whether
However, this clarification does not impose any new
the product satisfies the conditions set out in Article 29(1) of
obligations on Member States or holders of authori
Regulation (EC) No 1107/2009.
sations compared to the Directives which have been
adopted until now amending Annex I to that Directive
or the Regulations approving active substances.
Following that determination Member States shall:
(9) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No (a) in the case of a product containing Paecilomyces fumosoroseus
1107/2009, the Annex to Commission Implementing
strain FE 9901 as the only active substance, where
Regulation (EU) No 540/2011 of 25 May 2011 imple
necessary, amend or withdraw the authorisation by
menting Regulation (EC) No 1107/2009 of the European
31 March 2015 at the latest; or
Parliament and of the Council as regards the list of
approved active substances
( 2 ) should be amended
accordingly.
(b) in the case of a product containing Paecilomyces fumosoroseus
strain FE 9901 as one of several active substances, where
necessary, amend or withdraw the authorisation by
(10) The
measures
provided
for
in
this
Regulation
are
in
31 March 2015 or by the date fixed for such an
accordance with the opinion of the Standing
amendment or withdrawal in the respective act or acts
Committee on the Food Chain and Animal Health,
which added the relevant substance or substances to
Annex I to Directive 91/414/EEC or approved that
substance or those substances, whichever is the latest.
HAS ADOPTED THIS REGULATION:
Article 3
Article 1
Amendments to Implementing Regulation (EU) No
Approval of active substance
540/2011
The active substance Paecilomyces fumosoroseus strain FE 9901, as
The Annex to Implementing Regulation (EU) No 540/2011 is
specified in Annex I, is approved subject to the conditions laid
amended in accordance with Annex II to this Regulation.
down in that Annex.
Article 4
Article 2
Entry into force and date of application
Re-evaluation of plant protection products
This Regulation shall enter into force on the twentieth day
1. Member
States
shall,
in
accordance
with
Regulation
(EC) following that of its publication in the Official Journal of the
No 1107/2009, where necessary, amend or withdraw existing
European Union.
( 1 ) OJ L 366, 15.12.1992, p. 10.
( 2 ) OJ L 153, 11.6.2011, p. 1.
It shall apply from 1 October 2013.

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EN
25.4.2013 Official
Journal
of
the
European
Union L
113/7
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 April 2013.
For the Commission
The President
José Manuel BARROSO

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L 113/8
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Paecilomyces fumosoroseus
Not applicable Minimum
1,0
×
109 CFU/g
1 October 2013 30
September
2023 For the implementation of the uniform principles as referred to in Article 29(6) of
strain FE 9901
Regulation (EC) No 1107/2009, the conclusions of the review report on Paeci
EN
Maximum 3,0 × 109 CFU/g
lomyces fumosoroseus strain FE 9901, and in particular Appendices I and II thereof,

Collection number:
as finalised in the Standing Committee on the Food Chain and Animal Health on
USDA-ARS collection of
15 March 2013, shall be taken into account.
Entomopathogenic Fungal
Cultures U.S. Plant Soil
In this overall assessment Member States shall pay particular attention to the
and Nutrition laboratory.
protection of operators and workers, taking into account that Paecilomyces fumoso
New York. Accession No
roseus strain FE 9901 is to be considered as a potential sensitiser.
ARSEF 4490
Conditions of use shall include risk mitigation measures, where appropriate.
(1 ) Further details on identity and specification of active substance are provided in the review report.
Off
icial
Jour
nal
of
ANNEX II
the
European
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
(*) Date
of
approval Expiration
of
approval Specific
provisions
Union
‘39 Paecilomyces
fumosoroseus
Not applicable Minimum
1,0
×
109 CFU/g
1 October 2013 30
September
2023 For the implementation of the uniform principles as referred to in
strain FE 9901
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
Maximum 3,0 × 109 CFU/g
the review report on Paecilomyces fumosoroseus strain FE 9901, and in
Collection number:
particular Appendices I and II thereof, as finalised in the Standing
USDA-ARS collection of
Committee on the Food Chain and Animal Health on 15 March
Entomopathogenic Fungal
2013, shall be taken into account.
Cultures U.S. Plant Soil and
Nutrition laboratory. New
In this overall assessment Member States shall pay particular
York. Accession No ARSEF
attention to the protection of operators and workers, taking into
4490
account that Paecilomyces fumosoroseus strain FE 9901 is to be
considered as a potential sensitiser.
Conditions of use shall include risk mitigation measures, where
appropriate.’
(*) Further details on identity and specification of active substance are provided in the review report.
25.4.2013

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