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17.8.2012 Official
Journal
of
the
European
Union L
219/15
COMMISSION IMPLEMENTING REGULATION (EU) No 746/2012
of 16 August 2012
approving the active substance Adoxophyes orana granulovirus, 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,
States and the Commission within the Standing
Committee on the Food Chain and Animal Health and
Having regard to the Treaty on the Functioning of the European
was finalised on 13 July 2012 in the format of the
Union,
Commission review report for Adoxophyes orana granu
lovirus.
Having regard to Regulation (EC) No 1107/2009 of the
European Parliament and of the Council of 21 October 2009
(5)
It has appeared from the various examinations made that
concerning the placing of plant protection products on the
plant protection products containing Adoxophyes orana
market and repealing Council Directives 79/117/EEC and
granulovirus may be expected to satisfy, in general, the
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
requirements laid down in Article 5(1)(a) and (b) and
thereof,
Article 5(3) of Directive 91/414/EEC, in particular with
regard to the uses which were examined and detailed in
Whereas:
the Commission review report. It is therefore appropriate
to approve Adoxophyes orana granulovirus.
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
(6) Without
prejudice
to
the
obligations
provided
for
in
with respect to the procedure and the conditions for
Regulation (EC) No 1107/2009 as a consequence of
approval, to active substances for which a decision has
approval, taking into account the specific situation
been adopted in accordance with Article 6(3) of that
created by the transition from Directive 91/414/EEC to
Directive before 14 June 2011. For Adoxophyes orana
Regulation (EC) No 1107/2009, the following should,
granulovirus the conditions of Article 80(1)(a) of Regu
however, apply. Member States should be allowed a
lation (EC) No 1107/2009 are fulfilled by Commission
period of six months after approval to review authori
Decision 2007/669/EC ( 3 ).
sations of plant protection products containing
Adoxophyes orana granulovirus. Member States should, as
appropriate, vary, replace or withdraw authorisations. By
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
Germany received on 29 November 2004 an application
way of derogation from that deadline, a longer period
from Andermatt Biocontrol GmbH for the inclusion of
should be provided for the submission and assessment of
the active substance Adoxophyes orana granulovirus in
the update of the complete Annex III dossier, as set out
Annex I to Directive 91/414/EEC. Decision 2007/669/EC
in Directive 91/414/EEC, of each plant protection
confirmed that the dossier was ‘complete’ in the sense
product for each intended use in accordance with the
that it could be considered as satisfying, in principle, the
uniform principles.
data and information requirements of Annexes II and III
to Directive 91/414/EEC.
(7) The
experience
gained
from
inclusions
in
Annex
I
to
Directive 91/414/EEC of active substances assessed in
(3) For
that
active
substance,
the
effects
on
human
and
the framework of Commission Regulation (EEC) No
animal health and the environment have been assessed,
3600/92 of 11 December 1992 laying down the
in accordance with the provisions of Article 6(2) and (4)
detailed rules for the implementation of the first stage
of Directive 91/414/EEC, for the uses proposed by the
of the programme of work referred to in Article 8(2) of
applicant. The designated rapporteur Member State
Council Directive 91/414/EEC concerning the placing of
submitted a draft assessment report on 13 August 2008.
plant protection products on the market ( 5 ) has shown
that difficulties can arise in interpreting the duties of
holders of existing authorisations in relation to access
(4) The
draft
assessment
report
was
peer
reviewed
by
the
to data. In order to avoid further difficulties it therefore
Member States and the European Food Safety Authority
appears necessary to clarify the duties of the Member
(hereinafter ‘the Authority’). The Authority presented to
States, especially the duty to verify that the holder of
the Commission its conclusion on the peer review of the
an authorisation demonstrates access to a dossier
pesticide risk assessment of the active substance
satisfying the requirements of Annex II to that Directive.
Adoxophyes orana granulovirus ( 4 ) on 4 April 2012. The
However, this clarification does not impose any new
draft assessment report was reviewed by the Member
obligations on Member States or holders of authori
sations compared to the directives which have been
( 1 ) OJ L 309, 24.11.2009, p. 1.
adopted until now amending Annex I to that Directive
( 2 ) OJ L 230, 19.8.1991, p. 1.
or the Regulations approving active substances.
( 3 ) OJ L 274, 18.10.2007, p. 15.
( 4 ) EFSA Journal 2012; 10(4):2654. Available online: www.efsa.europa.
eu
( 5 ) OJ L 366, 15.12.1992, p. 10.

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L 219/16
EN
Official Journal of the European Union
17.8.2012
(8) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No Annex to Implementing Regulation (EU) No 540/2011 by
1107/2009, the Annex to Commission Implementing
31 January 2013 at the latest, Member States shall re-evaluate
Regulation (EU) No 540/2011 of 25 May 2011 imple
the product in accordance with the uniform principles, as
menting Regulation (EC) No 1107/2009 of the European
referred to in Article 29(6) of Regulation (EC) No 1107/2009,
Parliament and of the Council as regards the list of
on the basis of a dossier satisfying the requirements of Annex
approved active substances
( 1 ) should be amended
III to Directive 91/414/EEC and taking into account the column
accordingly.
on specific provisions of Annex I to this Regulation. On the
basis of that evaluation, they shall determine whether the
(9) The
measures
provided
for
in
this
Regulation
are
in product satisfies the conditions set out in Article 29(1) of Regu
accordance with the opinion of the Standing
lation (EC) No 1107/2009.
Committee on the Food Chain and Animal Health,
Following that determination Member States shall:
HAS ADOPTED THIS REGULATION:
(a) in the case of a product containing Adoxophyes orana granu
Article 1
lovirus as the only active substance, where necessary, amend
Approval of active substance
or withdraw the authorisation by 31 July 2014 at the latest;
or
The active substance Adoxophyes orana granulovirus, as specified
in Annex I, is approved subject to the conditions laid down in
(b) in the case of a product containing Adoxophyes orana granu
that Annex.
lovirus as one of several active substances, where necessary,
amend or withdraw the authorisation by 31 July 2014 or
Article 2
by the date fixed for such an amendment or withdrawal in
Re-evaluation of plant protection products
the respective act or acts which added the relevant substance
or substances to Annex I to Directive 91/414/EEC or
1. Member
States
shall
in
accordance
with
Regulation
(EC)
approved that substance or substances, whichever is the
No 1107/2009, where necessary, amend or withdraw existing
latest.
authorisations for plant protection products containing
Adoxophyes orana granulovirus as an active substance by
Article 3
31 July 2013.
Amendments to Implementing Regulation (EU) No
By that date they shall in particular verify that the conditions in
540/2011
Annex I to this Regulation are met, with the exception of those
The Annex to Implementing Regulation (EU) No 540/2011 is
identified in the column on specific provisions of that Annex,
amended in accordance with Annex II to this Regulation.
and that the holder of the authorisation has, or has access to, a
dossier satisfying the requirements of Annex II to Directive
91/414/EEC in accordance with the conditions of Article 13(1)
Article 4
to (4) of that Directive and Article 62 of Regulation (EC) No
Entry into force and date of application
1107/2009.
This Regulation shall enter into force on the twentieth day
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
following that of its publication in the Official Journal of the
orised plant protection product containing Adoxophyes orana
European Union.
granulovirus as either the only active substance or as one of
several active substances, all of which were listed in the
It shall apply from 1 February 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 August 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

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17.8.2012 Off
ANNEX I
Common name,
identification numbers
IUPAC name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Adoxophyes orana granulovirus
Not applicable No
relevant
impurities 1
February
2013 31
January
2023 For
the
implementation
of
the
uniform
principles
as
referred
to
in
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
EN
Culture collection No DSM
the review report on Adoxophyes orana granulovirus, and in particular

BV-0001
Appendices I and II thereof, as finalised in the Standing Committee
CIPAC No 782
on the Food Chain and Animal Health on 13 July 2012 shall be
taken into account.
(1 ) Further details on identity and specification of active substance are provided in the review report.
icial
Jour
nal
of
the
European
Union
L
219/17

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L 219/18
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number Common
name,
identification
numbers IUPAC
name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
‘26 Adoxophyes
orana
granulovirus
Not applicable No
relevant
impurities 1
February
2013 31
January
2023 For the implementation of the uniform principles
EN
as referred to in Article 29(6) of Regulation (EC)

Culture collection No DSM BV-0001
No 1107/2009, the conclusions of the review
CIPAC No 782
report on Adoxophyes orana granulovirus, and in
particular Appendices I and II thereof, as
finalised in the Standing Committee on the
Food Chain and Animal Health on 13 July
2012 shall be taken into account.’
(*) Further details on identity and specification of active substance are provided in the review report.
Off
icial
Jour
nal
of
the
European
Union
17.8.2012

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Document Outline

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