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24.4.2013 Official
Journal
of
the
European
Union L
112/15
COMMISSION IMPLEMENTING REGULATION (EU) No 375/2013
of 23 April 2013
approving the active substance spiromesifen, 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,
(4) In
its
conclusion,
the
Authority
did
not
take
into
account
all information submitted by the applicant before
26 April 2007. The Commission requested the
Having regard to the Treaty on the Functioning of the European
Authority to revise its conclusion and to take into
Union,
account all information submitted.
Having regard to Regulation (EC) No 1107/2009 of the
European Parliament and of the Council of 21 October 2009
(5) The
designated
rapporteur
Member
State
assessed
all
concerning the placing of plant protection products on the
additional information and submitted an Addendum to
market and repealing Council Directives 79/117/EEC and
the draft assessment report on 28 September 2009.
91/414/EEC ( 1 ), and in particular Articles 13(2) and 78(2)
thereof,
(6) The
Addendum
to
the
draft
assessment
report
was
reviewed by the Member States and the Authority. The
Whereas:
Authority presented to the Commission its second
conclusion on the review of the pesticide risk assessment
of the active substance spiromesifen ( 5 ) on 19 September
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
2012. The updated draft assessment report and the
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
conclusion of the Authority were reviewed by the
with respect to the procedure and the conditions for
Member States and the Commission within the
approval, to active substances for which a decision has
Standing Committee on the Food Chain and Animal
been adopted in accordance with Article 6(3) of that
Health and the draft assessment report was finalised on
Directive before 14 June 2011. For spiromesifen the
15 March 2013 in the format of the Commission review
conditions of Article 80(1)(a) of Regulation (EC) No
report for spiromesifen.
1107/2009 are fulfilled by Commission Decision
2003/105/EC ( 3 ).
(7)
It has appeared from the various examinations made that
plant protection products containing spiromesifen may
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
be expected to satisfy, in general, the requirements laid
the United Kingdom received on 18 April 2002 an appli
down in Article 5(1)(a) and (b) and Article 5(3) of
cation from Bayer CropScience AG for the inclusion of
Directive 91/414/EEC, in particular with regard to the
the active substance spiromesifen in Annex I to Directive
uses which were examined and detailed in the
91/414/EEC. Decision 2003/105/EC confirmed that the
Commission review report. It is therefore appropriate
dossier was ‘complete’ in the sense that it could be
to approve spiromesifen.
considered as satisfying, in principle, the data and
information requirements of Annexes II and III to
Directive 91/414/EEC.
(8) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
1107/2009 in conjunction with Article 6 thereof and in
(3) For
that
active
substance,
the
effects
on
human
and
the light of current scientific and technical knowledge, it
animal health and the environment have been assessed,
is, however, necessary to include certain conditions and
in accordance with the provisions of Article 6(2) and (4)
restrictions. It is, in particular, appropriate to require
of Directive 91/414/EEC, for the uses proposed by the
further confirmatory information.
applicant. The designated rapporteur Member State
submitted a draft assessment report on 9 March 2004.
This draft assessment report was reviewed by the
(9) A
reasonable
period
should
be
allowed
to
elapse
before
Member States and the European Food Safety Authority
approval in order to permit Member States and the
(hereinafter ‘the Authority’) and a final discussion took
interested parties to prepare themselves to meet the
place on 26 April 2007. The Authority presented to the
new requirements resulting from the approval.
Commission its conclusion ( 4 ) on the review of the
pesticide risk assessment of the active substance
spiromesifen on 13 June 2007.
(10) Without
prejudice
to
the
obligations
provided
for
in
Regulation (EC) No 1107/2009 as a consequence of
approval, taking into account the specific situation
( 1 ) OJ L 309, 24.11.2009, p. 1.
created by the transition from Directive 91/414/EEC to
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 3 ) OJ L 43, 18.2.2003, p. 45.
( 4 ) EFSA Scientific Report (2007) 105, 1-69. Available online: www.
( 5 ) EFSA Journal 2012; 10(10):2873. Available online: www.efsa.
efsa.europa.eu
europa.eu

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L 112/16
EN
Official Journal of the European Union
24.4.2013
Regulation (EC) No 1107/2009, the following should,
Article 2
however, apply. Member States should be allowed a
period of six months after approval to review authori
Re-evaluation of plant protection products
sations of plant protection products containing spirome
1. Member
States
shall
in
accordance
with
Regulation
(EC)
sifen. Member States should, as appropriate, vary, replace
No 1107/2009, where necessary, amend or withdraw existing
or withdraw authorisations. By way of derogation from
authorisations for plant protection products containing
that deadline, a longer period should be provided for the
spiromesifen as an active substance by 31 March 2014.
submission and 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
accordance with the uniform principles.
By that date they shall in particular verify that the conditions in
Annex I to this Regulation are met, with the exception of those
identified in the column on specific provisions of that Annex,
and that the holder of the authorisation has, or has access to, a
(11) The
experience
gained
from
inclusions
in
Annex
I
to
dossier satisfying the requirements of Annex II to Directive
Directive 91/414/EEC of active substances assessed in
91/414/EEC in accordance with the conditions of Article 13(1)
the framework of Commission Regulation (EEC) No
to (4) of that Directive and Article 62 of Regulation (EC) No
3600/92 of 11 December 1992 laying down the
1107/2009.
detailed rules for the implementation of the first stage
of the programme of work referred to in Article 8(2) of
Council Directive 91/414/EEC concerning the placing of
plant protection products on the market ( 1 ) has shown
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
that difficulties can arise in interpreting the duties of
orised plant protection product containing spiromesifen as
holders of existing authorisations in relation to access
either the only active substance or as one of several active
to data. In order to avoid further difficulties it therefore
substances, all of which were listed in the Annex to Imple
appears necessary to clarify the duties of the Member
menting Regulation (EU) No 540/2011, by 30 September
States, especially the duty to verify that the holder of
2013 at the latest Member States shall re-evaluate the product
an authorisation demonstrates access to a dossier
in accordance with the uniform principles, as referred to in
satisfying the requirements of Annex II to that Directive.
Article 29(6) of Regulation (EC) No 1107/2009, on the basis
However, this clarification does not impose any new
of a dossier satisfying the requirements of Annex III to Directive
obligations on Member States or holders of authori
91/414/EEC and taking into account the column on specific
sations compared to the Directives which have been
provisions of Annex I to this Regulation. On the basis of that
adopted until now amending Annex I to that Directive
evaluation, they shall determine whether the product satisfies
or the Regulations approving active substances.
the conditions set out in Article 29(1) of Regulation (EC) No
1107/2009.
(12) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
1107/2009, the Annex to Commission Implementing
Following that determination Member States shall:
Regulation (EU) No 540/2011 of 25 May 2011 imple
menting Regulation (EC) No 1107/2009 of the European
Parliament and of the Council as regards the list of
approved active substances
( 2 ) should be amended
(a) in the case of a product containing spiromesifen as the only
accordingly.
active substance, where necessary, amend or withdraw the
authorisation by 31 March 2015 at the latest; or
(13) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(b) in the case of a product containing spiromesifen as one of
Committee on the Food Chain and Animal Health,
several active substances, where necessary, amend or
withdraw the authorisation by 31 March 2015 or by the
date fixed for such an amendment or withdrawal in the
respective act or acts which added the relevant substance
HAS ADOPTED THIS REGULATION:
or substances to Annex I to Directive 91/414/EEC or
approved that substance or those substances, whichever is
the latest.
Article 1
Approval of active substance
Article 3
The active substance spiromesifen, as specified in Annex I, is
Amendments to Implementing Regulation (EU) No
approved subject to the conditions laid down in that Annex.
540/2011
( 1 ) OJ L 366, 15.12.1992, p. 10.
The Annex to Implementing Regulation (EU) No 540/2011 is
( 2 ) OJ L 153, 11.6.2011, p. 1.
amended in accordance with Annex II to this Regulation.

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EN
24.4.2013 Official
Journal
of
the
European
Union L
112/17
Article 4
Entry into force and date of application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official
Journal of the European Union.
It shall apply from 1 October 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 April 2013.
For the Commission
The President
José Manuel BARROSO

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L 112/18
ANNEX I
Common Name, Identification
Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Spiromesifen
3-mesityl-2-oxo-1-
≥ 965 g/kg (racemic)
1 October 2013 30
September
2023 For
the
implementation
of
the
uniform
CAS No 283594-90-1
oxaspiro[4.4]non-3-en-4-yl 3,3- The impurity N,N-dimethylacetamide
principles as referred to in Article 29(6) of
EN
dimethylbutyrate
Regulation (EC) No 1107/2009, the

CIPAC No 747
is of toxicological relevance and must
not exceed 4 g/kg in the technical
conclusions of the review report on
material.
spiromesifen, 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.
In this overall assessment Member States
shall pay particular attention to:
Off
— the long-term risk to aquatic invert
icial
ebrates,
Jour
— the risk to pollinating hymenoptera and
non-target arthropods if exposure is
nal
not negligible,
of
the
— the protection of workers and oper
ators.
European
Conditions of use shall include risk miti
gation measures, where appropriate.
Union
The applicant shall submit confirmatory
information as regards the recalculation of
the predicted concentration in groundwater
(PECGW) with a FOCUS GW scenario
adapted to the supported uses using a
Q10 value of 2,58.
The applicant shall submit to the
Commission, the Member States and the
Authority that information by 30 September
2015.
(1 ) Further details on identity and specification of active substance are provided in the review report.
24.4.2013

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24.4.2013 Off
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Common Name,
Number
Identification
IUPAC Name Purity
(*)
Date of
Numbers
approval
Expiration of approval Specific
provisions
EN

‘41 Spiromesifen 3-mesityl-2-oxo-1-
≥ 965 g/kg (racemic)
1 October
30 September
For the implementation of the uniform principles as referred to in
oxaspiro[4.4]non-3-en-4-yl
2013
2023
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the
CAS No
3,3-dimethylbutyrate
The impurity N,N-dimethyl
review report on spiromesifen, and in particular Appendices I and II
283594-90-1
acetamide is of toxicological
thereof, as finalised in the Standing Committee on the Food Chain and
relevance and must not
CIPAC No 747
Animal Health on 15 March 2013, shall be taken into account.
exceed 4
g/kg in the
technical material.
In this overall assessment Member States shall pay particular attention to:
— the long-term risk to aquatic invertebrates,
— the risk to pollinating hymenoptera and non-target arthropods if exposure
is not negligible,
icial
— the protection of workers and operators.
Jour
Conditions of use shall include risk mitigation measures, where appropriate.
nal
The applicant shall submit confirmatory information as regards the recalcu
of
lation of the predicted concentration in groundwater (PECGW) with a FOCUS
the
GW scenario adapted to the supported uses using a Q10 value of 2,58.
European
The applicant shall submit to the Commission, the Member States and the
Authority that information by 30 September 2015.’
(*) Further details on identity and specification of active substance are provided in the review report.
Union
L
112/19

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