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26.11.2013 Official
Journal
of
the
European
Union L
315/69
COMMISSION IMPLEMENTING REGULATION (EU) No 1199/2013
of 25 November 2013
approving the active substance chlorantraniliprole, 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,
of Directive 91/414/EEC, for the uses proposed by the
applicant. The designated rapporteur Member State
submitted a draft assessment report on 17 February
Having regard to the Treaty on the Functioning of the European
2010. In accordance with Article 11(6) of Commission
Union,
Regulation (EU) No 188/2011 ( 4 ) additional information
was requested from the applicant on 11 July 2011. The
evaluation of the additional data by Ireland was
submitted in the format of an updated draft assessment
Having regard to Regulation (EC) No 1107/2009 of the
report in December 2011.
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
91/414/EEC (
(4) The
draft
assessment
report
was
reviewed
by
the
Member

1 ), and in particular Article 13(2) and Article 78(2)
thereof,
States and the European Food Safety Authority (here
inafter ‘the Authority’). The Authority presented to the
Commission its conclusion on the pesticide risk
assessment of the active substance chlorantraniliprole ( 5 )
Whereas:
on 14 March 2013. The draft assessment report and the
conclusion of the Authority were reviewed by the
Member States and the Commission within the
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
Standing Committee on the Food Chain and Animal
1107/2009, Council Directive 91/414/EEC (
Health and finalised on 3 October 2013 in the format

2 ) is to apply,
with respect to the procedure and the conditions for
of the Commission review report for chlorantraniliprole.
approval, to active substances for which a decision has
been adopted in accordance with Article 6(3) of that
Directive before 14 June 2011. For chlorantraniliprole
(5)
It has appeared from the various examinations made that
the conditions of Article 80(1)(a) of Regulation (EC) No
plant protection products containing chlorantraniliprole
1107/2009 are fulfilled by Commission Decision
may be expected to satisfy, in general, the requirements
2007/560/EC ( 3 ).
laid down in Article 5(1)(a) and (b) and Article 5(3) of
Directive 91/414/EEC, in particular with regard to the
uses which were examined and detailed in the
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
Commission review report. It is therefore appropriate
Ireland received on 2 February 2007 an application from
to approve chlorantraniliprole.
DuPont de Nemours for the inclusion of the active
substance chlorantraniliprole in Annex I to Directive
91/414/EEC. Decision 2007/560/EC confirmed that the
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
dossier was ‘complete’ in the sense that it could be
1107/2009 in conjunction with Article 6 thereof and in
considered as satisfying, in principle, the data and
the light of current scientific and technical knowledge, it
information requirements of Annexes II and III to
is, however, necessary to include certain conditions and
Directive 91/414/EEC.
restrictions. It is, in particular, appropriate to require
further confirmatory information.
(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)
(7) A
reasonable
period
should
be
allowed
to
elapse
before
approval in order to permit Member States and the
interested parties to prepare themselves to meet the
( 1 ) OJ L 309, 24.11.2009, p. 1.
new requirements resulting from the approval.
( 2 ) Council Directive 91/414/EEC of 15 July 1991 concerning the
placing of plant protection products on the market (OJ L 230,
19.8.1991, p. 1).
( 4 ) Commission Regulation (EU) No 188/2011 of 25 February 2011
( 3 ) Commission Decision 2007/560/EC of 2 August 2007 recognising
laying down detailed rules for the implementation of Council
in principle the completeness of the dossiers submitted for detailed
Directive 91/414/EEC as regards the procedure for the assessment
examination in view of the possible inclusion of chlorantraniliprole,
of active substances which were not on the market 2 years after the
heptamaloxyglucan, spirotetramat and Helicoverpa armigera nucleo
date of notification of that Directive (OJ L 53, 26.2.2011, p. 51).
polyhedrovirus in Annex I to Council Directive 91/414/EEC
( 5 ) EFSA Journal 2013; 11(4):3143. Available online: www.efsa.europa.
(OJ L 213, 15.8.2007, p. 29).
eu

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L 315/70
EN
Official Journal of the European Union
26.11.2013
(8) Without
prejudice
to
the
obligations
provided
for
in
Article 2
Regulation (EC) No 1107/2009 as a consequence of
approval, taking into account the specific situation
Re-evaluation of plant protection products
created by the transition from Directive 91/414/EEC to
1. Member
States
shall
in
accordance
with
Regulation
(EC)
Regulation (EC) No 1107/2009, the following should,
No 1107/2009, where necessary, amend or withdraw existing
however, apply. Member States should be allowed a
authorisations for plant protection products containing chlor
period of six months after approval to review authori
antraniliprole as an active substance by 31 October 2014.
sations of plant protection products containing chlor
antraniliprole. Member States should, as appropriate,
vary, replace or withdraw authorisations. By way of dero
gation from that deadline, a longer period should be
By that date they shall in particular verify that the conditions in
provided for the submission and assessment of the
Annex I to this Regulation are met, with the exception of those
complete Annex III dossier, as set out in Directive
identified in the column on specific provisions of that Annex,
91/414/EEC, of each plant protection product for each
and that the holder of the authorisation has, or has access to, a
intended use in accordance with the uniform principles.
dossier satisfying the requirements of Annex II to Directive
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 chlorantraniliprole as
relation to access to data. In order to avoid further
either the only active substance or as one of several active
difficulties it therefore appears necessary to clarify the
substances, all of which were listed in the Annex to Imple
duties of the Member States, especially the duty to
menting Regulation (EU) No 540/2011 by 30 April 2014 at
verify that the holder of an authorisation demonstrates
the latest, Member States shall re-evaluate the product in
access to a dossier satisfying the requirements of Annex
accordance with the uniform principles, as referred to in
II to that Directive. However, this clarification does not
Article 29(6) of Regulation (EC) No 1107/2009, on the basis
impose any new obligations on Member States or holders
of a dossier 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
(a) in the case of a product containing chlorantraniliprole as
accordance with the opinion of the Standing
the only active substance, where necessary, amend or
Committee on the Food Chain and Animal Health,
withdraw the authorisation by 31 October 2015 at the
latest; or
HAS ADOPTED THIS REGULATION:
(b) in the case of a product containing chlorantraniliprole as
one of several active substances, where necessary, amend or
withdraw the authorisation by 31 October 2015 or by the
Article 1
date fixed for such an amendment or withdrawal in the
respective act or acts which added the relevant substance
Approval of active substance
or substances to Annex I to Directive 91/414/EEC or
The active substance chlorantraniliprole, as specified in Annex I,
approved that substance or those substances, whichever is
is approved subject to the conditions laid down in that Annex.
the latest.
( 1 ) Commission Regulation (EEC) No 3600/92 of 11 December 1992
laying down the detailed rules for the implementation of the first
stage of the programme of work referred to in Article 8(2) of
Article 3
Council Directive 91/414/EEC concerning the placing of plant
protection products on the market (OJ L 366, 15.12.1992, p. 10).
Amendments to Implementing Regulation (EU) No
( 2 ) Commission Implementing Regulation (EU) No 540/2011 of
540/2011
25 May 2011 implementing Regulation (EC) No 1107/2009 of
the European Parliament and of the Council as regards the list of
The Annex to Implementing Regulation (EU) No 540/2011 is
approved active substances (OJ L 153, 11.6.2011, p. 1).
amended in accordance with Annex II to this Regulation.

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EN
26.11.2013 Official
Journal
of
the
European
Union L
315/71
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 May 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 November 2013.
For the Commission
The President
José Manuel BARROSO

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L 315/72
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Chlorantraniliprole
3-bromo-4'-chloro-1-
≥ 950 g/kg
1 May 2014 30
April
2024
For the implementation of the uniform principles as referred to in Article 29(6) of
(3-chloro-2-pyridyl)-
Regulation (EC) No 1107/2009, the conclusions of the review report on chlorantranili
EN
CAS No 500008-45-7 2'-methyl-6'-(methyl
The following relevant
prole, and in particular Appendices I and II thereof, as finalised in the Standing

carbamoyl) pyrazole-
impurities must not
Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into
CIPAC No 794
5-carboxanilide
exceed a certain
account.
threshold in the
technical material:
In this overall assessment Member States shall pay particular attention to the risk to
aquatic organisms and to soil macroorganisms.
Acetonitrile: ≤ 3 g/kg
Conditions of use shall include risk mitigation measures, where appropriate.
3-picoline: ≤ 3 g/kg
The applicant shall submit confirmatory information as regards:
Methanesulfonic acid:
Off
≤ 2 g/kg
(1) the risk to groundwater from the active substance and its metabolites IN-EQW78 (2-
[3-bromo-1-(3-chloropyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-3,8-dimethylquinazolin-
icial
4(3H)-one), IN-ECD73 (2,6-dichloro-4-methyl-11H-pyrido[2,1-b]quinazolin-11-one),
Jour
IN-F6L99 (3-bromo-N-methyl-1H-pyrazole-5-carboxamide), IN-GAZ70 (2-[3-bromo-
1-(3-chloropyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-8-methylquinazolin-4(1H)-one) and
nal
IN-F9N04 (3-bromo-N-(2-carbamoyl-4-chloro-6-methylphenyl)-1-(3-chloropyridin-2-
of
yl)-1H-pyrazole-5-carboxamide);
the
(2) the risk to aquatic organisms from the photolysis metabolites IN-LBA22 (2-{[(4Z)-2-
European
bromo-4H-pyrazolo[1,5-d]pyrido[3,2-b][1,4]oxazin-4-ylidene] amino}-5-chloro-N,3-
dimethylbenzamide), IN-LBA23 (2-[3-bromo-1-(3-hydroxypyridin-2-yl)-1H-pyrazol-5-
yl]-6-chloro-3,8-dimethylquinazolin-4(3H)-one) and IN-LBA24 (2-(3-bromo-1H-
pyrazol-5-yl)-6-chloro-3,8-dimethylquinazolin-4(3H)-one).
Union
The applicant shall submit to the Commission, Member States and the Authority that
information by 30 April 2016.
(1 ) Further details on identity and specification of active substance are provided in the review report.
26.11.2013

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26.11.2013 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
‘62 Chlorantraniliprole
3-bromo-4'-chloro-1-(3-chloro-
≥ 950 g/kg
1 May 2014 30
April
2024
For the implementation of the uniform principles as referred to

2-pyridyl)-2'-methyl-6'-(methyl
in Article 29(6) of Regulation (EC) No 1107/2009, the
CAS No 500008-45-7
carbamoyl) pyrazole-5-carbox The following relevant
conclusions of the review report on chlorantraniliprole, and in
anilide
impurities must not exceed
particular Appendices I and II thereof, as finalised in the Standing
CIPAC No 794
a certain threshold in the
Committee on the Food Chain and Animal Health on 3 October
technical material:
2013 shall be taken into account.
Acetonitrile: ≤ 3 g/kg
In this overall assessment Member States shall pay particular
attention to the risk to aquatic organisms and to soil macro
3-picoline: ≤ 3 g/kg
organisms.
Methanesulfonic acid:
Conditions of use shall include risk mitigation measures, where
≤ 2 g/kg
icial
appropriate.
Jour
The applicant shall submit confirmatory information as regards:
nal
(1) the risk to groundwater from the active substance and its
of
metabolites IN-EQW78 (2-[3-bromo-1-(3-chloropyridin-2-
the
yl)-1H-pyrazol-5-yl]-6-chloro-3,8-dimethylquinazolin-4(3H)-
one), IN-ECD73 (2,6-dichloro-4-methyl-11H-pyrido[2,1-
European
b]quinazolin-11-one), IN-F6L99 (3-bromo-N-methyl-1H-
pyrazole-5-carboxamide), IN-GAZ70 (2-[3-bromo-1-(3-
chloropyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-8-methylquina
zolin-4(1H)-one) and IN-F9N04 (3-bromo-N-(2-carbamoyl-4-
Union
chloro-6-methylphenyl)-1-(3-chloropyridin-2-yl)-1H-
pyrazole-5-carboxamide);
(2) the risk to aquatic organisms from the photolysis metabolites
IN-LBA22 (2-{[(4Z)-2-bromo-4H-pyrazolo[1,5-d]pyrido[3,2-
b][1,4]oxazin-4-ylidene] amino}-5-chloro-N,3-dimethylben
zamide), IN-LBA23 (2-[3-bromo-1-(3-hydroxypyridin-2-yl)-
1H-pyrazol-5-yl]-6-chloro-3,8-dimethylquinazolin-4(3H)-one)
and IN-LBA24 (2-(3-bromo-1H-pyrazol-5-yl)-6-chloro-3,8-
dimethylquinazolin-4(3H)-one).
The applicant shall submit to the Commission, Member States
and the Authority that information by 30 April 2016.’
(*) Further details on identity and specification of active substance are provided in the review report.
L
315/73

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