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14.2.2014 Official
Journal
of
the
European
Union L
44/35
COMMISSION IMPLEMENTING REGULATION (EU) No 140/2014
of 13 February 2014
approving the active substance spinetoram, 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) The
draft
assessment
report
was
reviewed
by
the
Member
States and the European Food Safety Authority (here
inafter ‘the Authority’). The Authority presented to the
Having regard to the Treaty on the Functioning of the European
Commission its conclusion on the pesticide risk
Union,
assessment of the active substance spinetoram ( 4 ) on
6 May 2013. The draft assessment report and the
conclusion of the Authority were reviewed by the
Having regard to Regulation (EC) No 1107/2009 of the
Member States and the Commission within the
European Parliament and of the Council of 21 October 2009
Standing Committee on the Food Chain and Animal
concerning the placing of plant protection products on the
Health and finalised on 13 December 2013 in the
market and repealing Council Directives 79/117/EEC and
format of the Commission review report for spinetoram.
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
thereof,
(5)
It has appeared from the various examinations made that
Whereas:
plant protection products containing spinetoram may be
expected to satisfy, in general, the requirements laid
down in Article 5(1)(a) and (b) and Article 5(3) of
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
Directive 91/414/EEC, in particular with regard to the
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
uses which were examined and detailed in the
with respect to the procedure and the conditions for
Commission review report. It is therefore appropriate
approval, to active substances for which a decision has
to approve spinetoram.
been adopted in accordance with Article 6(3) of that
Directive before 14 June 2011. For spinetoram the
conditions of Article 80(1)(a) of Regulation (EC) No
1107/2009 are fulfilled by Commission Decision
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
2008/740/EC ( 3 ).
1107/2009 in conjunction with Article 6 thereof and in
the light of current scientific and technical knowledge, it
is, however, necessary to include certain conditions and
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
restrictions. It is, in particular, appropriate to require
the United Kingdom received on 17 October 2007 an
further confirmatory information.
application from Dow AgroSciences Ltd for the inclusion
of the active substance spinetoram in Annex I to
Directive 91/414/EEC. Decision 2008/740/EC
confirmed that the dossier was ‘complete’ in the sense
that it could be considered as satisfying, in principle, the
(7) A
reasonable
period
should
be
allowed
to
elapse
before
data and information requirements of Annexes II and III
approval in order to permit Member States and the
to Directive 91/414/EEC.
interested parties to prepare themselves to meet the
new requirements resulting from the approval.
(3) For
that
active
substance,
the
effects
on
human
and
animal health and the environment have been assessed,
in accordance with the provisions of Article 6(2) and (4)
(8) Without
prejudice
to
the
obligations
provided
for
in
of Directive 91/414/EEC, for the uses proposed by the
Regulation (EC) No 1107/2009 as a consequence of
applicant. The designated rapporteur Member State
approval, taking into account the specific situation
submitted a draft assessment report on 23 February
created by the transition from Directive 91/414/EEC to
2012.
Regulation (EC) No 1107/2009, the following should,
however, apply. Member States should be allowed a
period of six months after approval to review authori
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) Council Directive 91/414/EEC of 15 July 1991 concerning the
sations of plant protection products containing spine
placing of plant protection products on the market (OJ L 230,
toram. Member States should, as appropriate, vary,
19.8.1991, p. 1).
replace or withdraw authorisations. By way of derogation
( 3 ) Commission Decision 2008/740/EC of 12 September 2008 recog
from that deadline, a longer period should be provided
nising in principle the completeness of the dossier submitted for
detailed examination in view of the possible inclusion of spinetoram
in Annex I to Council Directive 91/414/EEC (OJ L 249, 18.9.2008,
( 4 ) EFSA Journal 2013; 11(5):3220. Available online: www.efsa.
p. 21).
europa.eu

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L 44/36
EN
Official Journal of the European Union
14.2.2014
for the submission and assessment of the complete
identified in the column on specific provisions of that Annex,
Annex III dossier, as set out in Directive 91/414/EEC,
and that the holder of the authorisation has, or has access to, a
of each plant protection product for each intended use
dossier satisfying the requirements of Annex II to Directive
in accordance with the uniform principles.
91/414/EEC in accordance with the conditions of Article 13(1)
to (4) of that Directive and Article 62 of Regulation (EC) No
1107/2009.
(9) 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
3600/92 ( 1 ) has shown that difficulties can arise in inter
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
preting the duties of holders of existing authorisations in
orised plant protection product containing spinetoram as either
relation to access to data. In order to avoid further
the only active substance or as one of several active substances,
difficulties it therefore appears necessary to clarify the
all of which were listed in the Annex to Implementing Regu
duties of the Member States, especially the duty to
lation (EU) No 540/2011 by 30 June 2014 at the latest,
verify that the holder of an authorisation demonstrates
Member States shall re-evaluate the product in accordance
access to a dossier satisfying the requirements of Annex
with the uniform principles, as referred to in Article 29(6) of
II to that Directive. However, this clarification does not
Regulation (EC) No 1107/2009, on the basis of a dossier
impose any new obligations on Member States or holders
satisfying the requirements of Annex III to Directive
of authorisations compared to the Directives which have
91/414/EEC and taking into account the column on specific
been adopted until now amending Annex I to that
provisions of Annex I to this Regulation. On the basis of that
Directive or the Regulations approving active substances.
evaluation, they shall determine whether the product satisfies
the conditions set out in Article 29(1) of Regulation (EC) No
1107/2009.
(10) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
1107/2009, the Annex to Commission Implementing
Regulation (EU) No 540/2011 ( 2 ) should be amended
accordingly.
Following that determination Member States shall:
(11) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(a) in the case of a product containing spinetoram as the only
Committee on the Food Chain and Animal Health,
active substance, where necessary, amend or withdraw the
authorisation by 31 December 2015 at the latest; or
HAS ADOPTED THIS REGULATION:
(b) in the case of a product containing spinetoram as one of
several active substances, where necessary, amend or
Article 1
withdraw the authorisation by 31 December 2015 or by
Approval of active substance
the date fixed for such an amendment or withdrawal in the
respective act or acts which added the relevant substance or
The active substance spinetoram, as specified in Annex I, is
substances to Annex I to Directive 91/414/EEC or approved
approved subject to the conditions laid down in that Annex.
that substance or those substances, whichever is the latest.
Article 2
Article 3
Re-evaluation of plant protection products
Amendments to Implementing Regulation (EU) No
1. Member
States
shall
in
accordance
with
Regulation
(EC)
540/2011
No 1107/2009, where necessary, amend or withdraw existing
authorisations for plant protection products containing
The Annex to Implementing Regulation (EU) No 540/2011 is
spinetoram as an active substance by 31 December 2014.
amended in accordance with Annex II to this Regulation.
By that date they shall in particular verify that the conditions in
Annex I to this Regulation are met, with the exception of those
Article 4
Entry into force and date of application
( 1 ) Commission Regulation (EEC) No 3600/92 of 11 December 1992
laying down the detailed rules for the implementation of the first
This Regulation shall enter into force on the twentieth day
stage of the programme of work referred to in Article 8(2) of
following that of its publication in the Official Journal of the
Council Directive 91/414/EEC concerning the placing of plant
European Union.
protection products on the market (OJ L 366, 15.12.1992, p. 10).
( 2 ) Commission Implementing Regulation (EU) No 540/2011 of
25 May 2011 implementing Regulation (EC) No 1107/2009 of
the European Parliament and of the Council as regards the list of
approved active substances (OJ L 153, 11.6.2011, p. 1).
It shall apply from 1 July 2014.

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EN
14.2.2014 Official
Journal
of
the
European
Union L
44/37
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 February 2014.
For the Commission
The President
José Manuel BARROSO

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L 44/38
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Spinetoram
XDE-175-J (Major factor)
≥ 830 g/kg
1 July 2014 30
June
2024
For the implementation of the uniform principles
as referred to in Article 29(6) of Regulation (EC)
EN
CAS No 935545-74-7 (2R,3aR,5aR,5bS,9S,13S,14R,16aS, 16bR)-2-(6- 50-90 % XDE-175-J; and
No 1107/2009, the conclusions of the review

CIPAC No 802
deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyr
report on spinetoram, and in particular
anosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tet
50-10 % XDE-175-L
Appendices I and II thereof, as finalised in the
rahydro-6-methylpyran-2-yloxy]-9-ethyl-
Standing Committee on the Food Chain and
2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-
Tolerance limits (g/kg):
Animal Health on 13 December 2013 shall be
hexadecahydro-14-methyl-1H-as-indaceno[3,2-
taken into account.
d]oxacyclododecine-7,15-dione
XDE-175-J = 581-810
In this overall assessment Member States shall pay
XDE_175-L (Minor factor)
XDE-175-L = 83-270
particular attention to:
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-
(a) the risk to aquatic and soil organisms;
Off
deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyr
icial
anosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tet
(b) the risk to non-target arthropods in-field;
rahydro-6-methylpyran-2-yloxy]-9-ethyl-
Jour
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetra
(c) the risk to bees during the application (over
decahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]ox
spray) and subsequently.
nal
acyclododecine-7,15-dione
Conditions of use shall include risk mitigation
of
measures, where appropriate.
the
European
The applicant shall submit confirmatory
information as regards the equivalence between
the stereochemistry of metabolites identified in
the metabolism/degradation studies and in the
Union
testing material used for the toxicity and ecot
oxicity studies.
The applicant shall submit to the Commission, the
Member States and the Authority the relevant
information within 6 months after the adoption
of pertinent guidance on the assessment of
isomers.
(1 ) Further details on identity and specification of active substance are provided in the review report.
14.2.2014

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14.2.2014 Off
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
EN
‘67 Spinetoram
XDE-175-J (Major factor)
≥ 830 g/kg
1 July 2014 30
June
2024 For the implementation of the uniform principles as referred

to in Article 29(6) of Regulation (EC) No 1107/2009, the
CAS No 935545-74-7 (2R,3aR,5aR,5bS,9S,13S,14R,16aS, 16bR)-2-(6- 50-90 % XDE-175-J;
conclusions of the review report on spinetoram, and in
deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyr
particular Appendices I and II thereof, as finalised in the
CIPAC No 802
anosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tet
and
Standing Committee on the Food Chain and Animal Health
rahydro-6-methylpyran-2-yloxy]-9-ethyl-
on 13 December 2013 shall be taken into account.
2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-
50-10 % XDE-175-L
hexadecahydro-14-methyl-1H-as-indaceno[3,2-
Tolerance limits (g/kg):
In this overall assessment Member States shall pay particular
d]oxacyclododecine-7,15-dione
attention to:
XDE-175-J = 581-810
XDE_175-L (Minor factor)
(a) the risk to aquatic and soil organisms;
XDE-175-L = 83-270
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-
(b) the risk to non-target arthropods in-field;
icial
deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyr
anosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tet
(c) the risk to bees during the application (overspray) and
Jour
rahydro-6-methylpyran-2-yloxy]-9-ethyl-
subsequently.
nal
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetra
decahydro-4,14-dimethyl-1H-as-indaceno[3,2-
Conditions of use shall include risk mitigation measures,
of
d]oxacyclododecine-7,15-dione
where appropriate.
the
The applicant shall submit confirmatory information as
European
regards the equivalence between the stereochemistry of
metabolites identified in the metabolism/degradation studies
and in the testing material used for the toxicity and ecot
oxicity studies.
Union
The applicant shall submit to the Commission, the Member
States and the Authority the relevant information by
31 December 2014.’
(*) Further details on identity and specification of active substance are provided in the review report.
L
44/39

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