HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 111/36
EN
Official Journal of the European Union
23.4.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 368/2013
of 22 April 2013
approving the active substance Helicoverpa armigera nucleopolyhedrovirus, 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,
draft 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 Food
Union,
Chain and Animal Health and the draft assessment report
was finalised on 15 March 2013 in the format of the
Commission review report for Helicoverpa armigera nucleo
Having regard to Regulation (EC) No 1107/2009 of the
polyhedrovirus.
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 (
plant protection products containing Helicoverpa armigera

1 ), and in particular Article 13(2) and Article 78(2)
thereof,
nucleopolyhedrovirus 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 Helicoverpa armigera nucleopolyhedrovirus.
(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 Helicoverpa armigera
new requirements resulting from the approval.
nucleopolyhedrovirus the conditions of Article 80(1)(a) of
Regulation (EC) No 1107/2009 are fulfilled by
(7) Without
prejudice
to
the
obligations
provided
for
in
Commission Decision 2007/560/EC ( 3 ).
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
Estonia received on 2 January 2007 an application from
Regulation (EC) No 1107/2009, the following should,
Andermatt Biocontrol GmbH for the inclusion of the
however, apply. Member States should be allowed a
active substance Helicoverpa armigera nucleopolyhedrovirus
period of six months after approval to review authori
in Annex I to Directive 91/414/EEC. Decision
sations of plant protection products containing Heli
2007/560/EC confirmed that the dossier was ‘complete’
coverpa armigera nucleopolyhedrovirus. Member States
in the sense that it could be considered as satisfying, in
should, as appropriate, vary, replace or withdraw auth
principle, the data and information requirements of
orisations. By way of derogation from that deadline, a
Annexes II and III to Directive 91/414/EEC.
longer period should be 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
(3) For
that
active
substance,
the
effects
on
human
and
plant protection product for each intended use in
animal health and the environment have been assessed,
accordance with the uniform 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 26 March 2009.
Directive 91/414/EEC of active substances assessed in
the framework of Commission Regulation (EEC) No
3600/92 of 11 December 1992 laying down the
(4) The
draft
assessment
report
was
reviewed
by
the
Member
detailed rules for the implementation of the first stage
States and the European Food Safety Authority (here
of the programme of work referred to in Article 8(2) of
inafter ‘the Authority’). The Authority presented to the
Council Directive 91/414/EEC concerning the placing of
Commission its conclusion on the review of the pesticide
plant protection products on the market (
risk assessment of the active substance Helicoverpa

5 ) has shown
that difficulties can arise in interpreting the duties of
armigera nucleopolyhedrovirus ( 4 ) on 10 August 2012. The
holders of existing authorisations in relation to access
to data. In order to avoid further difficulties it therefore
( 1 ) OJ L 309, 24.11.2009, p. 1.
appears necessary to clarify the duties of the Member
( 2 ) OJ L 230, 19.8.1991, p. 1.
States, especially the duty to verify that the holder of
( 3 ) OJ L 213, 15.8.2007, p. 29.
( 4 ) EFSA Journal 2012; 10(9):2865. 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
111/37
an authorisation demonstrates access to a dossier
2. By way of derogation from paragraph 1, for each auth
satisfying the requirements of Annex II to that Directive.
orised plant protection product containing Helicoverpa armigera
However, this clarification does not impose any new
nucleopolyhedrovirus as either the only active substance or as one
obligations on Member States or holders of authori
of several active substances, all of which were listed in the
sations compared to the Directives which have been
Annex to Implementing Regulation (EU) No 540/2011 by
adopted until now amending Annex I to that Directive
31 May 2013 at the latest, Member States shall re-evaluate
or the Regulations approving active substances.
the product in accordance with the uniform principles, as
referred to in Article 29(6) of Regulation (EC) No 1107/2009,
(9) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No on the basis of a dossier satisfying the requirements of Annex
1107/2009, the Annex to Commission Implementing
III to Directive 91/414/EEC and taking into account the column
Regulation (EU) No 540/2011 of 25 May 2011 imple
on specific provisions of Annex I to this Regulation. On the
menting Regulation (EC) No 1107/2009 of the European
basis of that evaluation, they shall determine whether the
Parliament and of the Council as regards the list of
product satisfies the conditions set out in Article 29(1) of Regu
approved active substances
( 1 ) should be amended
lation (EC) No 1107/2009.
accordingly.
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 Helicoverpa armigera
Committee on the Food Chain and Animal Health,
nucleopolyhedrovirus as the only active substance, where
necessary, amend or withdraw the authorisation by
HAS ADOPTED THIS REGULATION:
30 November 2014 at the latest; or
Article 1
(b) in the case of a product containing Helicoverpa armigera
nucleopolyhedrovirus as one of several active substances,
Approval of active substance
where necessary, amend or withdraw the authorisation by
The active substance Helicoverpa armigera nucleopolyhedrovirus, as
30 November 2014 or by the date fixed for such an
specified in Annex I, is approved subject to the conditions laid
amendment or withdrawal in the respective act or acts
down in that Annex.
which added the relevant substance 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 Heli
coverpa armigera nucleopolyhedrovirus as an active substance by
The Annex to Implementing Regulation (EU) No 540/2011 is
30 November 2013.
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 June 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 111/38
ANNEX I
Common name, identification numbers IUPAC
name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Helicoverpa armigera nucleopolyhedrovirus
Not applicable Minimum
concentration:
1 June 2013 31
May
2023 For
the
implementation
of
the
uniform
1,44 × 1013 OB/l (occlusion bodies/l)
principles as referred to in Article 29(6)
DSMZ number: BV-0003
of Regulation (EC) No 1107/2009, the
EN
conclusions of the review report on

Helicoverpa armigera nucleopolyhedrovirus,
and in particular Appendices I and II
thereto, as 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.
Off
icial
ANNEX II
Jour
nal
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
of
the
Number
Common name, identification
European
numbers
IUPAC name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
‘38 Helicoverpa
armigera
nucleopolyhe Not applicable Minimum
concentration:
1 June 2013 31
May
2023
For the implementation of the uniform principles as referred to in
drovirus
1,44 × 1013 OB/l (occlusion
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
Union
bodies/l)
the review report on Helicoverpa armigera nucleopolyhedrovirus, and in
DSMZ number: BV-0003
particular Appendices I and II thereto, as finalised in the Standing
Committee on the Food Chain and Animal Health on 15 March
2013, shall be taken into account.’
(*) Further details on identity and specification of active substance are provided in the review report.
23.4.2013

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