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23.4.2013 Official
Journal
of
the
European
Union L
111/33
COMMISSION IMPLEMENTING REGULATION (EU) No 367/2013
of 22 April 2013
approving the active substance Spodoptera littoralis 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,
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 the draft assessment
report was finalised on 15 March 2013 in the format of
the Commission review report for Spodoptera littoralis
Having regard to Regulation (EC) No 1107/2009 of the
nucleopolyhedrovirus.
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 Spodoptera littoralis

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
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
to approve Spodoptera littoralis nucleopolyhedrovirus.
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 has
(6) A
reasonable
period
should
be
allowed
to
elapse
before
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 Spodoptera littoralis
nucleopolyhedrovirus the conditions of Article 80(1)(a) of
new requirements resulting from the approval.
Regulation (EC) No 1107/2009 are fulfilled by
Commission Decision 2007/669/EC ( 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
Estonia received on 2 January 2007 an application from
created by the transition from Directive 91/414/EEC to
Andermatt Biocontrol GmbH for the inclusion of the
Regulation (EC) No 1107/2009, the following should,
active substance Spodoptera littoralis nucleopolyhedrovirus
however, apply. Member States should be allowed a
in Annex I to Directive 91/414/EEC. Decision
period of six months after approval to review authori
2007/669/EC confirmed that the dossier was ‘complete’
sations of plant protection products containing
in the sense that it could be considered as satisfying, in
Spodoptera littoralis nucleopolyhedrovirus. Member States
principle, the data and information requirements of
should, as appropriate, vary, replace or withdraw auth
Annexes II and III to Directive 91/414/EEC.
orisations. By way of derogation from that deadline, a
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 26 March 2009.
(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 Spodoptera littoralis
plant protection products on the market (
nucleopolyhedrovirus (

5 ) has shown

4 ) on 10 August 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 274, 18.10.2007, p. 15.
( 4 ) EFSA Journal 2012; 10(9):2864. Available online: www.efsa.europa.
eu
( 5 ) OJ L 366, 15.12.1992, p. 10.

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L 111/34
EN
Official Journal of the European Union
23.4.2013
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 Spodoptera littoralis
the requirements of Annex II to that Directive. However,
nucleopolyhedrovirus as either the only active substance or as
this clarification does not impose any new obligations on
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 Spodoptera littoralis
accordance with the opinion of the Standing
nucleopolyhedrovirus as the only active substance, where
Committee on the Food Chain and Animal Health,
necessary, amend or withdraw the authorisation by
30 November 2014 at the latest; or
HAS ADOPTED THIS REGULATION:
(b) in the case of a product containing Spodoptera littoralis
Article 1
nucleopolyhedrovirus as one of several active substances,
Approval of active substance
where necessary, amend or withdraw the authorisation by
30 November 2014 or by the date fixed for such an
The active substance Spodoptera littoralis nucleopolyhedrovirus, as
amendment or withdrawal in the respective act or acts
specified in Annex I, is approved subject to the conditions laid
which added the relevant substance or substances to
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
The Annex to Implementing Regulation (EU) No 540/2011 is
Spodoptera littoralis nucleopolyhedrovirus as an active substance
amended in accordance with Annex II to this Regulation.
by 30 November 2013.
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 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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23.4.2013 Off
ANNEX I
Common Name,
Expiration of
Identification Numbers
IUPAC Name Purity
(1 )
Date of
approval
approval
Specific provisions
Spodoptera littoralis nucleopolyhedrovirus
Not applicable Maximum
concentration:
1 June 2013 31
May For the implementation of the uniform principles as referred to in
1 × 1012 OB/l (occlusion
2023
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the
EN
DSMZ number: BV-0005
bodies/l)
review report on Spodoptera littoralis nucleopolyhedrovirus, and in particular

Appendices I and II thereof, 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.
ANNEX II
icial
Jour
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
nal
Number Common Name, Identification
of
Numbers
IUPAC Name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
the
‘42 Spodoptera
littoralis
nucleo Not applicable Maximum
concentration:
1 June 2013 31
May
2023
For the implementation of the uniform principles as
European
polyhedrovirus
1 × 1012 OB/l (occlusion
referred to in Article 29(6) of Regulation (EC) No
DSMZ number: BV-0005
bodies/l)
1107/2009, the conclusions of the review report on
Spodoptera littoralis nucleopolyhedrovirus, and in particular
Appendices I and II thereof, as finalised in the Standing
Union
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.
L
111/35

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