HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 111/30
EN
Official Journal of the European Union
23.4.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 366/2013
of 22 April 2013
approving the active substance Bacillus firmus I-1582, 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,
report and the conclusion of the Authority were reviewed
by the Member States and the Commission within the
Having regard to the Treaty on the Functioning of the European
Standing Committee on the Food Chain and Animal
Union,
Health and the draft assessment report was finalised on
15 March 2013 in the format of the Commission review
report for Bacillus firmus I-1582.
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 Bacillus firmus
91/414/EEC (
I-1582 may be expected to satisfy, in general, the

1 ), and in particular Article 13(2) and Article 78(2)
thereof,
requirements laid down in Article 5(1)(a) and (b) and
Article 5(3) of Directive 91/414/EEC, in particular with
regard to the uses which were examined and detailed in
Whereas:
the Commission review report. It is therefore appropriate
to approve Bacillus firmus I-1582.
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
(6) A
reasonable
period
should
be
allowed
to
elapse
before
with respect to the procedure and the conditions for
approval in order to permit Member States and the
approval, to active substances for which a decision has
interested parties to prepare themselves to meet the
been adopted in accordance with Article 6(3) of that
new requirements resulting from the approval.
Directive before 14 June 2011. For Bacillus firmus
I-1582 the conditions of Article 80(1)(a) of Regulation
(7) Without
prejudice
to
the
obligations
provided
for
in
(EC) No 1107/2009 are fulfilled by Commission Decision
Regulation (EC) No 1107/2009 as a consequence of
2011/123/EU ( 3 ).
approval, taking into account the specific situation
created by the transition from Directive 91/414/EEC to
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
Regulation (EC) No 1107/2009, the following should,
France received on 4 August 2010 an application from
however, apply. Member States should be allowed a
Bayer CropScience AG for the inclusion of the active
period of six months after approval to review authori
substance Bacillus firmus I-1582 in Annex I to Directive
sations of plant protection products containing Bacillus
91/414/EEC. Decision 2011/123/EU confirmed that the
firmus I-1582. Member States should, as appropriate,
dossier was ‘complete’ in the sense that it could be
vary, replace or withdraw authorisations. By way of dero
considered as satisfying, in principle, the data and
gation from that deadline, a longer period should be
information requirements of Annexes II and III to
provided for the submission and assessment of the
Directive 91/414/EEC.
update of the complete Annex III dossier, as set out in
Directive 91/414/EEC, of each plant protection product
for each intended use in accordance with the uniform
(3) For
that
active
substance,
the
effects
on
human
and
principles.
animal 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
(8) The
experience
gained
from
inclusions
in
Annex
I
to
applicant. The designated rapporteur Member State
Directive 91/414/EEC of active substances assessed in
submitted a draft assessment report on 12 July 2011.
the framework of Commission Regulation (EEC) No
3600/92 of 11 December 1992 laying down the
detailed rules for the implementation of the first stage
(4) The
draft
assessment
report
was
reviewed
by
the
Member
of the programme of work referred to in Article 8(2) of
States and the European Food Safety Authority (here
Council Directive 91/414/EEC concerning the placing of
inafter ‘the Authority’). The Authority presented to the
plant protection products on the market (
Commission its conclusion on the review of the pesticide

5 ) has shown
that difficulties can arise in interpreting the duties of
risk assessment of the active substance Bacillus firmus
holders of existing authorisations in relation to access
I-1582 ( 4 ) on 20 August 2012. The draft assessment
to data. In order to avoid further difficulties it therefore
appears necessary to clarify the duties of the Member
( 1 ) OJ L 309, 24.11.2009, p. 1.
States, especially the duty to verify that the holder of
( 2 ) OJ L 230, 19.8.1991, p. 1.
an authorisation demonstrates access to a dossier
( 3 ) OJ L 49, 24.2.2011, p. 40.
( 4 ) EFSA Journal 2012; 10(9):2868. Available online: www.efsa.europa.
eu
( 5 ) OJ L 366, 15.12.1992, p. 10.

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EN
23.4.2013 Official
Journal
of
the
European
Union L
111/31
satisfying the requirements of Annex II to that Directive.
2. By way of derogation from paragraph 1, for each auth
However, this clarification does not impose any new
orised plant protection product containing Bacillus firmus I-1582
obligations on Member States or holders of authori
as either the only active substance or as one of several active
sations compared to the Directives which have been
substances, all of which were listed in the Annex to Imple
adopted until now amending Annex I to that Directive
menting Regulation (EU) No 540/2011 by 30 September
or the Regulations approving active substances.
2013 at the latest, Member States shall re-evaluate the
product in accordance with the uniform principles, as referred
(9) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No to in Article 29(6) of Regulation (EC) No 1107/2009, on the
1107/2009, the Annex to Commission Implementing
basis of a dossier satisfying the requirements of Annex III to
Regulation (EU) No 540/2011 of 25 May 2011 imple
Directive 91/414/EEC and taking into account the column on
menting Regulation (EC) No 1107/2009 of the European
specific provisions of Annex I to this Regulation. On the basis
Parliament and of the Council as regards the list of
of that evaluation, they shall determine whether the product
approved active substances
(
satisfies the conditions set out in Article 29(1) of Regulation

1 ) should be amended
accordingly.
(EC) No 1107/2009.
Following that determination Member States shall:
(10) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(a) in the case of a product containing Bacillus firmus I-1582 as
Committee on the Food Chain and Animal Health,
the only active substance, where necessary, amend or
withdraw the authorisation by 31 March 2015 at the
HAS ADOPTED THIS REGULATION:
latest; or
Article 1
(b) in the case of a product containing Bacillus firmus I-1582 as
one of several active substances, where necessary, amend or
Approval of active substance
withdraw the authorisation by 31 March 2015 or by the
The active substance Bacillus firmus I-1582, as specified in
date fixed for such an amendment or withdrawal in the
Annex I, is approved subject to the conditions laid down in
respective act or acts which added the relevant substance
that Annex.
or substances to Annex I to Directive 91/414/EEC or
approved that substance or those substances, whichever is
the latest.
Article 2
Re-evaluation of plant protection products
Article 3
1. Member
States
shall
in
accordance
with
Regulation
(EC)
Amendments to Implementing Regulation (EU) No
No 1107/2009, where necessary, amend or withdraw existing
540/2011
authorisations for plant protection products containing Bacillus
The Annex to Implementing Regulation (EU) No 540/2011 is
firmus I-1582 as an active substance by 31 March 2014.
amended in accordance with Annex II to this Regulation.
By that date they shall in particular verify that the conditions in
Article 4
Annex I to this Regulation are met, with the exception of those
Entry into force and date of application
identified in the column on specific provisions of that Annex,
and that the holder of the authorisation has, or has access to, a
This Regulation shall enter into force on the twentieth day
dossier satisfying the requirements of Annex II to Directive
following that of its publication in the Official Journal of the
91/414/EEC in accordance with the conditions of Article 13(1)
European Union.
to (4) of that Directive and Article 62 of Regulation (EC) No
1107/2009.
It shall apply from 1 October 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 April 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

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L 111/32
ANNEX I
Common Name, Identification
Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Bacillus firmus I-1582
Not applicable Minimum
concentration:
1 October 2013 30
September
2023 For the implementation of the uniform principles as referred to in Article 29(6)
7,1 × 1010 CFU/g
of Regulation (EC) No 1107/2009, the conclusions of the review report on
EN
Collection number: CNCMI-1582
Bacillus firmus I-1582, and in particular Appendices I and II thereof, as finalised

in the Standing Committee on the Food Chain and Animal Health on
15 March 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 Bacillus firmus
I-1582 is to be considered as a potential sensitiser.
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
the
ANNEX II
European
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Union
Number
Common Name, Identification
Expiration of
Numbers
IUPAC Name Purity
(*)
Date of
approval
approval
Specific provisions
‘36 Bacillus
firmus I-1582
Not applicable Minimum
concentration:
1 October
30 September For the implementation of the uniform principles as referred to in Article 29(6) of
7,1 × 1010 CFU/g
2013
2023
Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus
Collection number:
firmus I-1582, and in particular Appendices I and II thereof, as finalised in the
CNCMI-1582
Standing Committee on the Food Chain and Animal Health on 15 March 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 Bacillus firmus
I-1582 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.
23.4.2013

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