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21.11.2013 Official
Journal
of
the
European
Union L
312/23
COMMISSION IMPLEMENTING REGULATION (EU) No 1176/2013
of 20 November 2013
approving the active substance pyroxsulam, 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 20 March
2008. In accordance with Article 11(6) of Commission
Having regard to the Treaty on the Functioning of the European
Regulation (EU) No 188/2011 ( 4 ) additional information
Union,
was requested from the applicant on 5 July 2012. The
evaluation of the additional data by the United Kingdom
was submitted in the format of an updated draft
assessment report in November 2012.
Having regard to Regulation (EC) No 1107/2009 of the
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
(4) The
draft
assessment
report
was
reviewed
by
the
Member
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
States and the European Food Safety Authority (here
thereof,
inafter ‘the Authority’). The Authority presented to the
Commission its conclusion on the pesticide risk
assessment of the active substance pyroxsulam ( 5 ) on
3 April 2013. The draft assessment report and the
Whereas:
conclusion of the Authority were reviewed by the
Member States and the Commission within the
Standing Committee on the Food Chain and Animal
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
Health and finalised on 3 October 2013 in the format
1107/2009, Council Directive 91/414/EEC (
of the Commission review report for pyroxsulam.

2 ) is to apply,
with respect to the procedure and the conditions for
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 pyroxsulam the
(5)
It has appeared from the various examinations made that
conditions of Article 80(1)(a) of Regulation (EC) No
plant protection products containing pyroxsulam may be
1107/2009 are fulfilled by Commission Decision
expected to satisfy, in general, the requirements laid
2007/277/EC (
down in Article 5(1)(a) and (b) and Article 5(3) of

3 ).
Directive 91/414/EEC, in particular with regard to the
uses which were examined and detailed in the
Commission review report. It is therefore appropriate
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
to approve pyroxsulam.
the United Kingdom received on 28 February 2006 an
application from Dow AgroSciences GmbH for the
inclusion of the active substance pyroxsulam in Annex
I to Directive 91/414/EEC. Decision 2007/277/EC
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
confirmed that the dossier was ‘complete’ in the sense
1107/2009 in conjunction with Article 6 thereof and in
that it could be considered as satisfying, in principle, the
the light of current scientific and technical knowledge, it
data and information requirements of Annexes II and III
is, however, necessary to include certain conditions and
to 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,
(7) A
reasonable
period
should
be
allowed
to
elapse
before
in accordance with the provisions of Article 6(2) and (4)
approval in order to permit Member States and the
interested parties to prepare themselves to meet the
new requirements resulting from the approval.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) Council Directive 91/414/EEC of 15 July 1991 concerning the
placing of plant protection products on the market (OJ L 230,
( 4 ) Commission Regulation (EU) No 188/2011 of 25 February 2011
19.8.1991, p. 1).
laying down detailed rules for the implementation of Council
( 3 ) Commission Decision 2007/277/EC of 20 April 2007 recognising
Directive 91/414/EEC as regards the procedure for the assessment
in principle the completeness of the dossier submitted for detailed
of active substances which were not on the market 2 years after the
examination in view of the possible inclusion of pyroxsulam in
date of notification of that Directive (OJ L 53, 26.2.2011, p. 51).
Annex I to Council Directive 91/414/EEC (OJ L 116, 4.5.2007,
( 5 ) EFSA Journal 2013; 11(4):3182. Available online: www.efsa.europa.
p. 59).
eu

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L 312/24
EN
Official Journal of the European Union
21.11.2013
(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
period of six months after approval to review authori
pyroxsulam as an active substance by 31 October 2014.
sations of plant protection products containing
pyroxsulam. 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
preting the duties of holders of existing authorisations in
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
relation to access to data. In order to avoid further
orised plant protection product containing pyroxsulam as either
difficulties it therefore appears necessary to clarify the
the only active substance or as one of several active substances,
duties of the Member States, especially the duty to
all of which were listed in the Annex to Implementing Regu
verify that the holder of an authorisation demonstrates
lation (EU) No 540/2011 by 30 April 2014 at the latest,
access to a dossier satisfying the requirements of Annex
Member States shall re-evaluate the product in accordance
II to that Directive. However, this clarification does not
with the uniform principles, as referred to in Article 29(6) of
impose any new obligations on Member States or holders
Regulation (EC) No 1107/2009, on the basis of a dossier
of authorisations compared to the Directives which have
satisfying the requirements of Annex III to Directive
been adopted until now amending Annex I to that
91/414/EEC and taking into account the column on specific
Directive or the Regulations approving active substances.
provisions of Annex I to this Regulation. On the basis of that
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 pyroxsulam as the only
accordance with the opinion of the Standing
active substance, where necessary, amend or withdraw the
Committee on the Food Chain and Animal Health,
authorisation by 31 October 2015 at the latest; or
HAS ADOPTED THIS REGULATION:
(b) in the case of a product containing pyroxsulam as one of
several active substances, where necessary, amend or
withdraw the authorisation by 31 October 2015 or by
Article 1
the date fixed for such an amendment or withdrawal in
the respective act or acts which added the relevant
Approval of active substance
substance or substances to Annex I to Directive 91/414/EEC
The active substance pyroxsulam, as specified in Annex I, is
or approved that substance or those substances, whichever
approved subject to the conditions laid down in that Annex.
is 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
21.11.2013 Official
Journal
of
the
European
Union L
312/25
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, 20 November 2013.
For the Commission
The President
José Manuel BARROSO

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L 312/26
ANNEX I
Common Name, Identification
Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Pyroxsulam
N-(5,7-dimethoxy[1,2,4]tria
≥ 965 g/kg 1
May
2014 30
April
2024
For the implementation of the uniform principles as referred to in
zolo[1,5-a]pyrimidin-2-yl)-2-
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
EN
CAS No 422556-08-9
methoxy-4-(trifluor
the review report on pyroxsulam, and in particular Appendices I

CIPAC No 793
omethyl)pyridine-3-sulfonamide
and II thereof, as finalised in the Standing Committee on the Food
Chain and Animal Health on 3 October 2013 shall be taken into
account.
In this overall assessment Member States shall pay particular
attention to:
(a) the risk to groundwater, when the active substance is applied in
regions with vulnerable soil or climatic conditions;
(b) the risk to aquatic organisms.
Off
Conditions of use shall include risk mitigation measures, where
icial
appropriate.
Jour
The applicant shall submit confirmatory information as regards:
nal
(1) the toxicological relevance of impurity number 3 (as referred to
in the review report);
of
the
(2) the acute toxicity of the metabolite PSA;
European
(3) the toxicological relevance of metabolite 6-Cl-7-OH-XDE-742.
The applicant shall submit to the Commission, Member States and
the Authority that information by 30 April 2016.
Union
(1 ) Further details on identity and specification of active substance are provided in the review report.
21.11.2013

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21.11.2013 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
‘61 Pyroxsulam
N-(5,7-dime
≥ 965 g/kg 1
May
2014 30
April
2024
For the implementation of the uniform principles as referred to in

thoxy[1,2,4]tria
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
CAS No 422556-08-9
zolo[1,5-a]pyrimidin-2-
the review report on pyroxsulam, and in particular Appendices I and
CIPAC No 793
yl)-2-methoxy-4-(triflu
II thereof, as finalised in the Standing Committee on the Food Chain
oromethyl)pyridine-3-
and Animal Health on 3 October 2013 shall be taken into account.
sulfonamide
In this overall assessment Member States shall pay particular attention
to:
(a) the risk to groundwater, when the active substance is applied in
regions with vulnerable soil or climatic conditions;
(b) the risk to aquatic organisms.
icial
Conditions of use shall include risk mitigation measures, where
Jour
appropriate.
nal
The applicant shall submit confirmatory information as regards:
of
the
(1) the toxicological relevance of impurity number 3 (as referred to in
the review report);
European
(2) the acute toxicity of the metabolite PSA;
(3) the toxicological relevance of metabolite 6-Cl-7-OH-XDE-742.
Union
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
312/27

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