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20.12.2012 Official
Journal
of
the
European
Union L
350/59
COMMISSION IMPLEMENTING REGULATION (EU) No 1238/2012
of 19 December 2012
approving the active substance Trichoderma asperellum (strain T34), 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,
assessment report and the conclusion of the Authority
were reviewed by the Member States and the
Having regard to the Treaty on the Functioning of the European
Commission within the Standing Committee on the
Union,
Food Chain and Animal Health and was finalised on
20 November 2012 in the format of the Commission
review report for Trichoderma asperellum (strain T34).
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 Trichoderma
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
asperellum (strain T34) may be expected to satisfy, in
thereof,
general, the requirements laid down in Article 5(1)(a)
and (b) and Article 5(3) of Directive 91/414/EEC, in
Whereas:
particular with regard to the uses which were examined
and detailed in the Commission review report. It is
therefore appropriate to approve Trichoderma asperellum
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
(strain T34).
No 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
(6) A
reasonable
period
should
be
allowed
to
elapse
before
has been adopted in accordance with Article 6(3) of that
approval in order to permit Member States and the
Directive before 14 June 2011. For Trichoderma asperellum
interested parties to prepare themselves to meet the
(strain T34) the conditions of Article 80(1)(a) of Regu
new requirements resulting from the approval.
lation (EC) No 1107/2009 are fulfilled by Commission
Decision 2010/132/EU ( 3 ).
(7) Without
prejudice
to
the
obligations
provided
for
in
Regulation (EC) No 1107/2009 as a consequence of
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
approval, taking into account the specific situation
the United Kingdom received on 22 April 2010 an appli
created by the transition from Directive 91/414/EEC to
cation from Biocontrol Technologies S.L. for the
Regulation (EC) No 1107/2009, the following should,
inclusion of the active substance Trichoderma asperellum
however, apply. Member States should be allowed a
(strain T34) in Annex I to Directive 91/414/EEC.
period of six months after approval to review authori
Decision 2010/132/EU confirmed that the dossier was
sations of plant protection products containing
‘complete’ in the sense that it could be considered as
Trichoderma asperellum (strain T34). Member States
satisfying, in principle, the data and information
should, as appropriate, vary, replace or withdraw auth
requirements of Annexes II and III to Directive
orisations. By way of derogation from that deadline, a
91/414/EEC.
longer period should be provided for the submission and
assessment of the update of the complete Annex III
(3) For
that
active
substance,
the
effects
on
human
and
dossier, as set out in Directive 91/414/EEC, of each
animal health and the environment have been assessed,
plant protection product for each intended use in
in accordance with the provisions of Article 6(2) and (4)
accordance with the uniform principles.
of Directive 91/414/EEC, for the uses proposed by the
applicant. The designated rapporteur Member State
submitted a draft assessment report on 16 May 2011.
(8) The
experience
gained
from
inclusions
in
Annex
I
to
Directive 91/414/EEC of active substances assessed in
the framework of Commission Regulation (EEC) No
(4) The
draft
assessment
report
was
reviewed
by
the
Member
3600/92 of 11 December 1992 laying down the
States and the European Food Safety Authority (here
detailed rules for the implementation of the first stage
inafter ‘the Authority’). The Authority presented to the
of the programme of work referred to in Article 8(2) of
Commission its conclusion on the review of the pesticide
Council Directive 91/414/EEC concerning the placing of
risk assessment of the active substance Trichoderma
plant protection products on the market (
asperellum (strain T34) (

5 ) has shown

4 ) on 20 April 2012. The draft
that difficulties can arise in interpreting the duties of
holders of existing authorisations in relation to access
( 1 ) OJ L 309, 24.11.2009, p. 1.
to data. In order to avoid further difficulties it therefore
( 2 ) OJ L 230, 19.8.1991, p. 1.
appears necessary to clarify the duties of the Member
( 3 ) OJ L 52, 3.3.2010, p. 51.
( 4 ) EFSA Journal 2012; 10(1):2666. Available online: www.efsa.
europa.eu
( 5 ) OJ L 366, 15.12.1992, p. 10.

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L 350/60
EN
Official Journal of the European Union
20.12.2012
States, especially the duty to verify that the holder of an
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
authorisation demonstrates access to a dossier satisfying
orised plant protection product containing Trichoderma
the requirements of Annex II to that Directive. However,
asperellum (strain T34) as either the only active substance or
this clarification does not impose any new obligations on
as one of several active substances, all of which were listed in
Member States or holders of authorisations compared to
the Annex to Implementing Regulation (EU) No 540/2011 by
the Directives which have been adopted until now
31 May 2013 at the latest, Member States shall re-evaluate the
amending Annex I to that Directive or the Regulations
product in accordance with the uniform principles, as referred
approving active substances.
to in Article 29(6) of Regulation (EC) No 1107/2009, on the
basis of a dossier satisfying the requirements of Annex III to
(9) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No Directive 91/414/EEC and taking into account the column on
1107/2009, the Annex to Commission Implementing
specific provisions of Annex I to this Regulation. On the basis
Regulation (EU) No 540/2011 of 25 May 2011 imple
of that evaluation, they shall determine whether the product
menting Regulation (EC) No 1107/2009 of the European
satisfies the conditions set out in Article 29(1) of Regulation
Parliament and of the Council as regards the list of
(EC) No 1107/2009.
approved active substances
( 1 ) should be amended
accordingly.
Following that determination Member States shall:
(10) The
measures
provided
for
in
this
Regulation
are
in
(a) in the case of a product containing Trichoderma asperellum
accordance with the opinion of the Standing
(strain T34) as the only active substance, where necessary,
Committee on the Food Chain and Animal Health,
amend or withdraw the authorisation by 30 November
2014 at the latest; or
HAS ADOPTED THIS REGULATION:
Article 1
(b) in the case of a product containing Trichoderma asperellum
(strain T34) as one of several active substances, where
Approval of active substance
necessary, amend or withdraw the authorisation by
30 November 2014 or by the date fixed for such an
The active substance Trichoderma asperellum (strain T34), as
amendment or withdrawal in the respective act or acts
specified in Annex I, is approved subject to the conditions
which added the relevant substance or substances to
laid down in that Annex.
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
Trichoderma asperellum (strain T34) as an active substance by
The Annex to Implementing Regulation (EU) No 540/2011 is
amended in accordance with Annex II to this Regulation.
30 November 2013.
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 June 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 December 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

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20.12.2012 Off
ANNEX I
Common Name, Identification Numbers IUPAC
Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Trichoderma asperellum (strain T34)
Not applicable 1
×
1010 cfu/g 1
June
2013 31
May
2023
For the implementation of the uniform principles as referred to in
CECT number: 20417
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
the review report on Trichoderma asperellum (strain T34), and in
EN
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 asperellum (strain T34) 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.
icial
Jour
nal
of
the
European
Union
L
350/61

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L 350/62
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
‘29 Trichoderma
asperellum
Not applicable 1
×
1010 cfu/g 1
June
2013 31
May
2023 For the implementation of the uniform principles as referred to in

(strain T34)
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the
CECT number: 20417
review report on Trichoderma asperellum (strain T34), 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 asperellum (strain T34) is to be considered as a potential
sensitiser.
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
20.12.2012

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Document Outline

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