HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 232/18
EN
Official Journal of the European Union
30.8.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 827/2013
of 29 August 2013
approving the active substance Aureobasidium pullulans (strains DSM 14940 and DSM 14941), 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,
submitted a draft assessment report on 17 December
2009. In accordance with Article 11(6) of Commission
Regulation (EU) No 188/2011 ( 4 ) additional information
Having regard to the Treaty on the Functioning of the European
was requested from the applicant on 26 July 2011. The
Union,
evaluation of the additional data by Austria was
submitted in the format of an updated draft assessment
report in January 2012.
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
(4) The
draft
assessment
report
was
reviewed
by
the
Member
market and repealing Council Directives 79/117/EEC and
States and the European Food Safety Authority (here
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
inafter ‘the Authority’). The Authority presented to the
thereof,
Commission its conclusion ( 5 ) on the review of the
pesticide risk assessment of the active substance Aureo
basidium pullulans (strains DSM 14940 and DSM 14941)
Whereas:
on 2 April 2013. The draft assessment report and the
conclusion of the Authority were reviewed by the
Member States and the Commission within the
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
Standing Committee on the Food Chain and Animal
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
Health and finalised on 16 July 2013 in the format of
with respect to the procedure and the conditions for
the Commission review report for Aureobasidium pullulans
approval, to active substances for which a decision has
(strains DSM 14940 and DSM 14941).
been adopted in accordance with Article 6(3) of that
Directive before 14 June 2011. For Aureobasidium
pullulans (strains DSM 14940 and DSM 14941) the
(5)
It has appeared from the various examinations made that
conditions of Article 80(1)(a) of Regulation (EC) No
plant protection products containing Aureobasidium
1107/2009 are fulfilled by Commission Decision
pullulans (strains DSM 14940 and DSM 14941) may be
2008/953/EC ( 3 ).
expected to satisfy, in general, the 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
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
uses which were examined and detailed in the
Austria received on 17 April 2008 an application from
Commission review report. It is therefore appropriate
bio-ferm Biotechnologische Entwicklung und Produktion
to approve Aureobasidium pullulans (strains DSM 14940
GmbH for the inclusion of the active substance Aureo
and DSM 14941).
basidium pullulans (strains DSM 14940 and DSM 14941)
in Annex I to Directive 91/414/EEC. Decision
2008/953/EC confirmed that the dossier was ‘complete’
in the sense that it could be considered as satisfying, in
(6) A
reasonable
period
should
be
allowed
to
elapse
before
principle, the data and information requirements of
approval in order to permit Member States and the
Annexes II and III to Directive 91/414/EEC.
interested parties to prepare themselves to meet the

new requirements resulting from the approval.
(3) For
that
active
substance,
the
effects
on
human
and
animal health and the environment have been assessed,
(7) Without
prejudice
to
the
obligations
provided
for
in
in accordance with the provisions of Article 6(2) and (4)
Regulation (EC) No 1107/2009 as a consequence of
of Directive 91/414/EEC, for the uses proposed by the
approval, taking into account the specific situation
applicant. The designated rapporteur Member State
created by the transition from Directive 91/414/EEC to
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 ) Council Directive 91/414/EEC of 15 July 1991 concerning the
placing of plant protection products on the market (OJ L 230,
( 4 ) Commission Regulation (EU) No 188/2011 of 25 February 2011
19.8.1991, p. 1)
laying down detailed rules for the implementation of Council
( 3 ) Commission Decision 2008/953/EC of 8 December 2008 recog
Directive 91/414/EEC as regards the procedure for the assessment
nising in principle the completeness of the dossiers submitted for
of active substances which were not on the market 2 years after the
detailed examination in view of the possible inclusion of Aureo
date of notification of that Directive (OJ L 53, 26.2.2011, p. 51).
basidium pullulans and disodium phosphonate in Annex I to
( 5 ) EFSA Journal (2013) 11(4):3183. Available online: www.efsa.europa.
Council Directive 91/414/EEC (OJ L 338, 17.12.2008, p. 62)
eu

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EN
30.8.2013 Official
Journal
of
the
European
Union L
232/19
period of six months after approval to review authori
By that date they shall in particular verify that the conditions in
sations of plant protection products containing Aureo
Annex I to this Regulation are met, with the exception of those
basidium pullulans (strains DSM 14940 and DSM
identified in the column on specific provisions of that Annex,
14941). Member States should, as appropriate, vary,
and that the holder of the authorisation has, or has access to, a
replace or withdraw authorisations. By way of derogation
dossier satisfying the requirements of Annex II to Directive
from that deadline, a longer period should be provided
91/414/EEC in accordance with the conditions of Article 13(1)
for the submission and assessment of the complete
to (4) of that Directive and Article 62 of Regulation (EC) No
Annex III dossier, as set out in Directive 91/414/EEC,
1107/2009.
of each plant protection product for each intended use
in accordance with the uniform principles.
2. By way of derogation from paragraph 1, for each auth
(8) The
experience
gained
from
inclusions
in
Annex
I
to orised plant protection product containing Aureobasidium
Directive 91/414/EEC of active substances assessed in
pullulans (strains DSM 14940 and DSM 14941) as either the
the framework of Commission Regulation (EEC) No
only active substance or as one of several active substances, all
3600/92 ( 1 ) has shown that difficulties can arise in inter
of which were listed in the Annex to Implementing Regulation
preting the duties of holders of existing authorisations in
(EU) No 540/2011 by 31 January 2014 at the latest, Member
relation to access to data. In order to avoid further
States shall re-evaluate the product in accordance with the
difficulties it therefore appears necessary to clarify the
uniform principles, as referred to in Article 29(6) of Regulation
duties of the Member States, especially the duty to
(EC) No 1107/2009, on the basis of a dossier satisfying the
verify that the holder of an authorisation demonstrates
requirements of Annex III to Directive 91/414/EEC and taking
access to a dossier satisfying the requirements of Annex
into account the column on specific provisions of Annex I to
II to that Directive. However, this clarification does not
this Regulation. On the basis of that evaluation, they shall
impose any new obligations on Member States or holders
determine whether the product satisfies the conditions set out
of authorisations compared to the Directives which have
in Article 29(1) of Regulation (EC) No 1107/2009.
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
1107/2009, the Annex to Commission Implementing
Regulation (EU) No 540/2011 ( 2 ) should be amended
(a) in the case of a product containing Aureobasidium pullulans
accordingly.
(strains DSM 14940 and DSM 14941) as the only active
substance, where necessary, amend or withdraw the auth
(10) The
measures
provided
for
in
this
Regulation
are
in
orisation by 31 July 2015 at the latest; or
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(b) in the case of a product containing Aureobasidium pullulans
HAS ADOPTED THIS REGULATION:
(strains DSM 14940 and DSM 14941) as one of several
active substances, where necessary, amend or withdraw
the authorisation by 31 July 2015 or by the date fixed
Article 1
for such an amendment or withdrawal in the respective
act or acts which added the relevant substance or substances
Approval of active substance
to Annex I to Directive 91/414/EEC or approved that
The active substance Aureobasidium pullulans (strains DSM
substance or those substances, whichever is the latest.
14940 and DSM 14941), as specified in Annex I, is approved
subject to the conditions laid 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 Aureo
basidium pullulans (strains DSM 14940 and DSM 14941) as an
active substance by 31 July 2014.
Article 4
Entry into force and date of application
( 1 ) Commission Regulation (EEC) No 3600/92 of 11 December 1992
laying down the detailed rules for the implementation of the first
This Regulation shall enter into force on the twentieth day
stage of the programme of work referred to in Article 8(2) of
following that of its publication in the Official Journal of the
Council Directive 91/414/EEC concerning the placing of plant
protection products on the market (OJ L 366, 15.12.1992, p. 10).
European Union.
( 2 ) Commission Implementing Regulation (EU) No 540/2011 of
25 May 2011 implementing Regulation (EC) No 1107/2009 of
the European Parliament and of the Council as regards the list of
approved active substances (OJ L 153, 11.6.2011, p. 1).
It shall apply from 1 February 2014.

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L 232/20
EN
Official Journal of the European Union
30.8.2013
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

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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
Aureobasidium pullulans (strains
Not applicable Minimum
5,0
×
109 CFU/g for
1 February 2014 31
January
2024
For the implementation of the uniform principles as referred
DSM 14940 and DSM 14941)
each strain;
to in Article 29(6) of Regulation (EC) No 1107/2009, the
EN
conclusions of the review report on Aureobasidium pullulans

Collection number:
Maximum 5,0 × 1010 CFU/g for
(strains DSM 14940 and DSM 14941), and in particular
German Collection of
each strain
Appendices I and II thereof, as finalised in the Standing
Microorganisms and cell Cultures
Committee on the Food Chain and Animal Health on
(DSMZ) with the accession
16 July 2013 shall be taken into account.
numbers DSM 14940 and DSM
14941
In this overall assessment Member States shall pay particular
attention to the protection of operators and workers, taking
into account that Aureobasidium pullulans (strains DSM 14940
and DSM 14941) is to be considered as a potential sensitizer.
Conditions of use shall include risk mitigation measures,
icial
where appropriate.
Jour
(1 ) Further details on identity and specification of active substance are provided in the review report.
nal
of
the
European
Union
L
232/21

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L 232/22
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
(*) Date
of
approval
Expiration of
approval
Specific provisions
EN
‘52 Aureobasidium
pullulans
Not applicable Minimum
5,0
×
109 CFU/g 1 February 2014 31
January
2024 For the implementation of the uniform principles as referred to in Article 29(6)

(strains DSM 14940
for each strain;
of Regulation (EC) No 1107/2009, the conclusions of the review report on
and DSM 14941)
Aureobasidium pullulans (strains DSM 14940 and DSM 14941), and in
Maximum 5,0 × 1010 CFU/g
particular Appendices I and II thereof, as finalised in the Standing
Collection number:
for each strain
Committee on the Food Chain and Animal Health on 16 July 2013 shall be
German Collection of
taken into account.
Microorganisms and cell
Cultures (DSMZ) with
In this overall assessment Member States shall pay particular attention to the
the accession numbers
protection of operators and workers, taking into account that Aureobasidium
DSM 14940 and DSM
pullulans (strains DSM 14940 and DSM 14941) is to be considered as a
14941
potential sensitizer.
Off
icial
Conditions of use shall include risk mitigation measures, where appropriate.’
Jour
(*) Further details on identity and specification of active substance are provided in the review report.
nal
of
the
European
Union
30.8.2013

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Document Outline

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