HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 112/10
EN
Official Journal of the European Union
24.4.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 373/2013
of 23 April 2013
approving the active substance Candida oleophila strain O, 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,
risk assessment of the active substance Candida oleophila
strain O ( 4 ) on 24 October 2012. The draft assessment
report and the conclusion of the Authority were reviewed
Having regard to the Treaty on the Functioning of the European
by the Member States and the Commission within the
Union,
Standing Committee on the Food Chain and Animal
Health and the draft assessment report was finalised on
15 March 2013 in the format of the Commission review
Having regard to Regulation (EC) No 1107/2009 of the
report for Candida oleophila strain O.
European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the
market and repealing Council Directives 79/117/EEC and
(5)
It has appeared from the various examinations made that
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
plant protection products containing Candida oleophila
thereof,
strain O may be 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
Whereas:
regard to the uses which were examined and detailed in
the Commission review report. It is therefore appropriate
to approve Candida oleophila strain O.
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
with respect to the procedure and the conditions for
(6) A
reasonable
period
should
be
allowed
to
elapse
before
approval, to active substances for which a decision has
approval in order to permit Member States and the
been adopted in accordance with Article 6(3) of that
interested parties to prepare themselves to meet the
Directive before 14 June 2011. For Candida oleophila
new requirements resulting from the approval.
strain O the conditions of Article 80(1)(a) of Regulation
(EC) No 1107/2009 are fulfilled by Commission Decision
2007/380/EC ( 3 ).
(7) Without
prejudice
to
the
obligations
provided
for
in
Regulation (EC) No 1107/2009 as a consequence of
approval, taking into account the specific situation
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
created by the transition from Directive 91/414/EEC to
the United Kingdom received on 12 July 2006 an appli
Regulation (EC) No 1107/2009, the following should,
cation from Bionext sprl for the inclusion of the active
however, apply. Member States should be allowed a
substance Candida oleophila strain O in Annex I to
period of six months after approval to review authori
Directive 91/414/EEC. Decision 2007/380/EC
sations of plant protection products containing Candida
confirmed that the dossier was ‘complete’ in the sense
oleophila strain O. Member States should, as appropriate,
that it could be considered as satisfying, in principle, the
vary, replace or withdraw authorisations. By way of dero
data and information requirements of Annexes II and III
gation from that deadline, a longer period should be
to Directive 91/414/EEC.
provided for the submission and assessment of the
update of the complete Annex III dossier, as set out in
Directive 91/414/EEC, of each plant protection product
(3) For
that
active
substance,
the
effects
on
human
and
for each intended use in accordance with the uniform
animal health and the environment have been assessed,
principles.
in accordance with the provisions of Article 6(2) and (4)
of Directive 91/414/EEC, for the uses proposed by the
applicant. The designated rapporteur Member State
(8) The
experience
gained
from
inclusions
in
Annex
I
to
submitted a draft assessment report on 15 November
Directive 91/414/EEC of active substances assessed in
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 ( 5 ) has shown
Commission its conclusion on the review of the pesticide
that difficulties can arise in interpreting the duties of
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 4 ) EFSA Journal 2012; 10(11):2944. Available online: www.efsa.europa.
( 2 ) OJ L 230, 19.8.1991, p. 1.
eu
( 3 ) OJ L 141, 2.6.2007, p. 78.
( 5 ) OJ L 366, 15.12.1992, p. 10.

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EN
24.4.2013 Official
Journal
of
the
European
Union L
112/11
holders of existing authorisations in relation to access to
2. By way of derogation from paragraph 1, for each auth
data. In order to avoid further difficulties it therefore
orised plant protection product containing Candida oleophila
appears necessary to clarify the duties of the Member
strain O as either the only active substance or as one of
States, especially the duty to verify that the holder of
several active substances, all of which were listed in the
an authorisation demonstrates access to a dossier
Annex to Implementing Regulation (EU) No 540/2011 by
satisfying the requirements of Annex II to that Directive.
30 September 2013 at the latest, Member States shall re-
However, this clarification does not impose any new
evaluate the product in accordance with the uniform principles,
obligations on Member States or holders of authori
as referred to in Article 29(6) of Regulation (EC) No
sations compared to the Directives which have been
1107/2009, on the basis of a dossier satisfying the requirements
adopted until now amending Annex I to that Directive
of Annex III to Directive 91/414/EEC and taking into account
or the Regulations approving active substances.
the column on specific provisions of Annex I to this Regulation.
On the basis of that evaluation, they shall determine whether
(9) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No the product satisfies the conditions set out in Article 29(1) of
1107/2009, the Annex to Commission Implementing
Regulation (EC) No 1107/2009.
Regulation (EU) No 540/2011 of 25 May 2011 imple
menting Regulation (EC) No 1107/2009 of the European
Parliament and of the Council as regards the list of
Following that determination Member States shall:
approved active substances
( 1 ) should be amended
accordingly.
(a) in the case of a product containing Candida oleophila strain
O as the only active substance, where necessary, amend or
(10) The
measures
provided
for
in
this
Regulation
are
in
withdraw the authorisation by 31 March 2015 at the latest;
accordance with the opinion of the Standing
or
Committee on the Food Chain and Animal Health,
(b) in the case of a product containing Candida oleophila strain
HAS ADOPTED THIS REGULATION:
O as one of several active substances, where necessary,
Article 1
amend or withdraw the authorisation by 31 March 2015
or by the date fixed for such an amendment or withdrawal
Approval of active substance
in the respective act or acts which added the relevant
substance or substances to Annex I to Directive 91/414/EEC
The active substance Candida oleophila strain O, as specified in
or approved that substance or those substances, whichever
Annex I, is approved subject to the conditions laid down in that
is the latest.
Annex.
Article 2
Article 3
Re-evaluation of plant protection products
Amendments to Implementing Regulation (EU) No
540/2011
1. Member
States
shall
in
accordance
with
Regulation
(EC)
No 1107/2009, where necessary, amend or withdraw existing
The Annex to Implementing Regulation (EU) No 540/2011 is
authorisations for plant protection products containing Candida
amended in accordance with Annex II to this Regulation.
oleophila strain O as an active substance by 31 March 2014.
Article 4
By that date they shall in particular verify that the conditions in
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, 23 April 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

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L 112/12
ANNEX I
Common name, identification
Expiration of
numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
Candida oleophila strain O
Not applicable Nominal
content:
3
×
1010 CFU/g
1 October
30 September For the implementation of the uniform principles as referred to in Article 29(6)
EN
Collection number: MUCL40654
dried product
2013
2023
of Regulation (EC) No 1107/2009, the conclusions of the review report on

Range: 6 × 109 – 1 × 1011 CFU/g
Candida oleophila strain O, and in particular Appendices I and II thereto, as
dried product
finalised in the Standing Committee on the Food Chain and Animal Health
on 15 March 2013 shall be taken into account.
(1 ) Further details on identity and specification of active substance are provided in the review report.
ANNEX II
Off
icial
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Jour
Number
Common name, identification
numbers
IUPAC name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
nal
of
‘37 Candida
oleophila strain O
Not applicable
Nominal content: 3 × 1010 CFU/g dried
1 October 2013 30
September
2023
For the implementation of the uniform prin
the
product
ciples as referred to in Article 29(6) of Regu
Collection number:
lation (EC) No 1107/2009, the conclusions of
European
MUCL40654
Range: 6 × 109 – 1 × 1011 CFU/g dried
the review report on Candida oleophila strain O,
product
and in particular Appendices I and II thereto, as
finalised in the Standing Committee on the
Food Chain and Animal Health on 15 March
Union
2013 shall be taken into account.’
(*) Further details on identity and specification of active substance are provided in the review report.
24.4.2013

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