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15.1.2013 Official
Journal
of
the
European
Union
L
9/5
COMMISSION IMPLEMENTING REGULATION (EU) No 17/2013
of 14 January 2013
approving the active substance Trichoderma atroviride strain I-1237, 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 Implementing Regulation (EU) No
540/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Commission within the Standing Committee on the Food
Chain and Animal Health and was finalised on
Having regard to the Treaty on the Functioning of the European
20 November 2012 in the format of the Commission
Union,
review report for Trichoderma atroviride strain I-1237.
Having regard to Regulation (EC) No 1107/2009 of the
(5)
It has appeared from the various examinations made that
European Parliament and of the Council of 21 October 2009
plant protection products containing Trichoderma
concerning the placing of plant protection products on the
atroviride strain I-1237 may be expected to satisfy, in
market and repealing Council Directives 79/117/EEC and
general, the requirements laid down in Article 5(1)(a)
91/414/EEC ( 1 ), and in particular Articles 13(2) and 78(2)
and (b) and Article 5(3) of Directive 91/414/EEC, in
thereof,
particular with regard to the uses which were examined
and detailed in the Commission review report. It is
Whereas:
therefore appropriate to approve Trichoderma atroviride
strain I-1237.
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
1107/2009, Council Directive 91/414/EEC (
(6) A
reasonable
period
should
be
allowed
to
elapse
before

2 ) is to apply,
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 Trichoderma atroviride
strain I-1237 the conditions of Article 80(1)(a) of Regu
(7) Without
prejudice
to
the
obligations
provided
for
in
lation (EC) No 1107/2009 are fulfilled by Commission
Regulation (EC) No 1107/2009 as a consequence of
Decision 2008/565/EC ( 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 28 August 2007 an application from
however, apply. Member States should be allowed a
Agrauxine SA for the inclusion of the active substance
period of six months after approval to review authori
Trichoderma atroviride strain I-1237 in Annex I to
sations of plant protection products containing
Directive 91/414/EEC. Decision 2008/565/EC
Trichoderma atroviride strain I-1237. Member States
confirmed that the dossier was ‘complete’ in the sense
should, as appropriate, vary, replace or withdraw auth
that it could be considered as satisfying, in principle, the
orisations. By way of derogation from that deadline, a
data and information requirements of Annexes II and III
longer period should be provided for the submission and
to Directive 91/414/EEC.
assessment of the 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
(3) For
that
active
substance,
the
effects
on
human
and
accordance with the uniform 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 19 April 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 Trichoderma
holders of existing authorisations in relation to access
atroviride strain I-1237 ( 4 ) on 15 May 2012. The draft
to data. In order to avoid further difficulties it therefore
assessment report and the conclusion of the Authority
appears necessary to clarify the duties of the Member
were reviewed by the Member States and the
States, especially the duty to verify that the holder of
an authorisation demonstrates access to a dossier
( 1 ) OJ L 309, 24.11.2009, p. 1.
satisfying the requirements of Annex II to that Directive.
( 2 ) OJ L 230, 19.8.1991, p. 1.
However, this clarification does not impose any new
( 3 ) OJ L 181, 10.7.2008, p. 49.
( 4 ) EFSA Journal 2012; 10(6):2706. Available online: www.efsa.europa.
eu
( 5 ) OJ L 366, 15.12.1992, p. 10.

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L 9/6
EN
Official Journal of the European Union
15.1.2013
obligations on Member States or holders of authori
strain I-1237 as either the only active substance or as one of
sations compared to the Directives which have been
several active substances, all of which were listed in the Annex
adopted until now amending Annex I to that Directive
to Implementing Regulation (EU) No 540/2011 by 31 May
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
( 1 ) should be amended
satisfies the conditions set out in Article 29(1) of Regulation
accordingly.
(EC) No 1107/2009.
(10) The
measures
provided
for
in
this
Regulation
are
in
Following that determination Member States shall:
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(a) in the case of a product containing Trichoderma atroviride
HAS ADOPTED THIS REGULATION:
strain I-1237 as the only active substance, where necessary,
amend or withdraw the authorisation by 30 November
Article 1
2014 at the latest; or
Approval of active substance
(b) in the case of a product containing Trichoderma atroviride
The active substance Trichoderma atroviride strain I-1237, as
strain I-1237 as one of several active substances, where
specified in Annex I, is approved subject to the conditions
necessary, amend or withdraw the authorisation by
laid down in that Annex.
30 November 2014 or by the date fixed for such an
amendment or withdrawal in the respective act or acts
Article 2
which added the relevant substance or substances to
Annex I to Directive 91/414/EEC or approved that
Re-evaluation of plant protection products
substance or those substances, whichever is the latest.
1. Member
States
shall
in
accordance
with
Regulation
(EC)
No 1107/2009, where necessary, amend or withdraw existing
Article 3
authorisations for plant protection products containing
Trichoderma atroviride strain I-1237 as an active substance by
Amendments to Implementing Regulation (EU) No
30 November 2013.
540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is
By that date they shall in particular verify that the conditions in
amended in accordance with Annex II to this Regulation.
Annex I to this Regulation are met, with the exception of those
identified in the column on specific provisions of that Annex,
Article 4
and that the holder of the authorisation has, or has access to, a
dossier satisfying the requirements of Annex II to Directive
Entry into force and date of application
91/414/EEC in accordance with the conditions of Article 13(1)
to (4) of that Directive and Article 62 of Regulation (EC) No
This Regulation shall enter into force on the twentieth day
1107/2009.
following that of its publication in the Official Journal of the
European Union.
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
orised plant protection product containing Trichoderma atroviride
It shall apply from 1 June 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 January 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

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15.1.2013 Off
ANNEX I
Common Name, Identification Numbers IUPAC
Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Trichoderma atroviride strain I-1237
Not applicable 1
×
109 cfu/g (1 × 1010 spores/g) 1
June
2013 31
May
2023 For
the
implementation
of
the
uniform
principles
as
referred
to in Article 29(6) of Regulation (EC) No 1107/2009, the
CNCM number: I-1237
conclusions of the review report on Trichoderma atroviride
EN
strain I-1237, and in particular Appendices I and II thereof,

as finalised in the Standing Committee on the Food Chain
and Animal Health on 20 November 2012, 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 Trichoderma atroviride strain I-1237 is to be
considered a potential sensitiser.
Conditions of use shall include risk mitigation measures
where appropriate.
icial
Jour
(1 ) Further details on identity and specification of active substance are provided in the review report.
nal
of
the
European
Union
L
9/7

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L 9/8
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number
Common Name, Identification
Expiration of
Numbers
IUPAC Name Purity
(*)
Date of
approval
approval
Specific provisions
EN
‘32 Trichoderma
atroviride strain Not applicable 1
×
109 cfu/g
1 June 2013 31
May
2023 For the implementation of the uniform principles as referred to in

I-1237
(1 × 1010 spores/g)
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the
review report on Trichoderma atroviride strain I-1237, and in particular
CNCM number: I-1237
Appendices I and II thereof, as finalised in the Standing Committee on
the Food Chain and Animal Health on 20 November 2012, 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
Trichoderma atroviride strain I-1237 is to be considered a potential sensi
tiser.
Off
Conditions of use shall include risk mitigation measures where appropri
icial
ate.’
Jour
(*) Further details on identity and specification of active substance are provided in the review report.
nal
of
the
European
Union
15.1.2013

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