HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 313/42
EN
Official Journal of the European Union
22.11.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 1187/2013
of 21 November 2013
approving the active substance penthiopyrad, 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 penthiopyrad ( 4 ) on
7 February 2013. The draft assessment report and the
conclusion of the Authority were reviewed by the
Member States and the Commission within the
Having regard to Regulation (EC) No 1107/2009 of the
Standing Committee on the Food Chain and Animal
European Parliament and of the Council of 21 October 2009
Health and finalised on 3 October 2013 in the format
concerning the placing of plant protection products on the
of the Commission review report for penthiopyrad.
market and repealing Council Directives 79/117/EEC and
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
plant protection products containing penthiopyrad may
Whereas:
be expected to satisfy, in general, the requirements 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
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
Commission review report. It is therefore appropriate
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
to approve penthiopyrad.
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 penthiopyrad the
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
conditions of Article 80(1)(a) of Regulation (EC) No
1107/2009 in conjunction with Article 6 thereof and in
1107/2009 are fulfilled by Commission Decision
the light of current scientific and technical knowledge, it
2010/466/EU (
is, however, necessary to include certain conditions and

3 ).
restrictions. It is, in particular, appropriate to require
further confirmatory information.
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
the United Kingdom received on 10 December 2009 an
application from LKC UK Ltd for the inclusion of the
(7) A
reasonable
period
should
be
allowed
to
elapse
before
active substance penthiopyrad in Annex I to Directive
approval in order to permit Member States and the
91/414/EEC. Decision 2010/466/EU confirmed that the
interested parties to prepare themselves to meet the
dossier was ‘complete’ in the sense that it could be
new requirements resulting from the approval.
considered as satisfying, in principle, the data and
information requirements of Annexes II and III to
Directive 91/414/EEC.
(8) Without
prejudice
to
the
obligations
provided
for
in
Regulation (EC) No 1107/2009 as a consequence of
approval, taking into account the specific situation
(3) For
that
active
substance,
the
effects
on
human
and
created by the transition from Directive 91/414/EEC to
animal health and the environment have been assessed,
Regulation (EC) No 1107/2009, the following should,
in accordance with the provisions of Article 6(2) and (4)
however, apply. Member States should be allowed a
of Directive 91/414/EEC, for the uses proposed by the
period of six months after approval to review authori
applicant. The designated rapporteur Member State
sations of plant protection products containing
submitted a draft assessment report on 31 January 2012.
penthiopyrad. Member States should, as appropriate,
vary, replace or withdraw authorisations. By way of dero
gation from that deadline, a longer period should be
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) Council Directive 91/414/EEC of 15 July 1991 concerning the
provided for the submission and assessment of the
placing of plant protection products on the market (OJ L 230,
complete Annex III dossier, as set out in Directive
19.8.1991, p. 1).
91/414/EEC, of each plant protection product for each
( 3 ) Commission Decision 2010/466/EU of 24 August 2010 recognising
intended use in accordance with the uniform principles.
in principle the completeness of the dossier submitted for detailed
examination in view of the possible inclusion of penthiopyrad in
Annex I to Council Directive 91/414/EEC (OJ L 224, 26.8.2010,
( 4 ) EFSA Journal 2013; 11(2):3111. Available online: www.efsa.
p. 6).
europa.eu

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EN
22.11.2013 Official
Journal
of
the
European
Union L
313/43
(9) 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 ( 1 ) has shown that difficulties can arise in inter
1107/2009.
preting the duties of holders of existing authorisations in
relation to access to data. In order to avoid further
difficulties it therefore appears necessary to clarify the
duties of the Member States, especially the duty to
2. By way of derogation from paragraph 1, for each auth
verify that the holder of an authorisation demonstrates
orised plant protection product containing penthiopyrad as
access to a dossier satisfying the requirements of Annex
either the only active substance or as one of several active
II to that Directive. However, this clarification does not
substances, all of which were listed in the Annex to Imple
impose any new obligations on Member States or holders
menting Regulation (EU) No 540/2011 by 30 April 2014 at
of authorisations compared to the Directives which have
the latest, Member States shall re-evaluate the product in
been adopted until now amending Annex I to that
accordance with the uniform principles, as referred to in
Directive or the Regulations approving active substances.
Article 29(6) of Regulation (EC) No 1107/2009, on the basis
of a dossier satisfying the requirements of Annex III to Directive
91/414/EEC and taking into account the column on specific
provisions of Annex I to this Regulation. On the basis of that
(10) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
evaluation, they shall determine whether the product satisfies
1107/2009, the Annex to Commission Implementing
the conditions set out in Article 29(1) of Regulation (EC) No
Regulation (EU) No 540/2011 ( 2 ) should be amended
1107/2009.
accordingly.
Following that determination Member States shall:
(11) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(a) in the case of a product containing penthiopyrad as the
only active substance, where necessary, amend or
withdraw the authorisation by 31 October 2015 at the
HAS ADOPTED THIS REGULATION:
latest; or
Article 1
(b) in the case of a product containing penthiopyrad as one of
Approval of active substance
several active substances, where necessary, amend or
withdraw the authorisation by 31 October 2015 or by
The active substance penthiopyrad, as specified in Annex I, is
the date fixed for such an amendment or withdrawal in
approved subject to the conditions laid down in that Annex.
the respective act or acts which added the relevant
substance or substances to Annex I to Directive 91/414/EEC
or approved that substance or those substances, whichever
is the latest.
Article 2
Re-evaluation of plant protection products
1. Member
States
shall
in
accordance
with
Regulation
(EC)
Article 3
No 1107/2009, where necessary, amend or withdraw existing
authorisations for plant protection products containing
Amendments to Implementing Regulation (EU) No
penthiopyrad as an active substance by 31 October 2014.
540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is
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
identified in the column on specific provisions of that Annex,
and that the holder of the authorisation has, or has access to, a
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 May 2014.

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L 313/44
EN
Official Journal of the European Union
22.11.2013
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 21 November 2013.
For the Commission
The President
José Manuel BARROSO

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22.11.2013 Off
ANNEX I
Common name,
identification numbers
IUPAC name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Penthiopyrad
(RS)-N-[2-(1,3-
≥ 980 g/kg
1 May 2014 30
April
2024
For the implementation of the uniform principles as referred to in
dimethylbutyl)-3-thienyl]-1-
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the
EN
CAS No 183675-82-3 methyl-3-
(50:50 racemic
review report on penthiopyrad, and in particular Appendices I and II

mixture)
CIPAC No 824
(trifluoromethyl)pyrazole-4-
thereof, as finalised in the Standing Committee on the Food Chain and
carboxamide
Animal Health on 3 October 2013 shall be taken into account.
In this overall assessment Member States shall pay particular attention
to:
(a) the protection of operators and workers;
(b) the risk to aquatic and soil organisms;
(c) the protection of groundwater, when the substance is applied in
regions with vulnerable soil and/or climatic conditions;
icial
(d) the level of residues in rotational crops following consecutive
application of the active substance over several years.
Jour
Conditions of use shall include risk mitigation measures, where
nal
appropriate.
of
The applicant shall submit confirmatory information as regards:
the
(1) the non-relevance of metabolite M11 (3-methyl-1-{3-[(1-methyl-3-
European
trifluoromethyl-1H-pyrazole-4-carbonyl)amino]thiophen-2-
yl}pentanoic acid) for groundwater with the exception of evidence
related to the risk of carcinogenicity, which is dependent on the
classification of the parent and specified separately at (3) below;
Union
(2) the toxicological profile and the reference values of the metabolite
PAM;
(3) the relevance of the metabolites M11 (3-methyl-1-{3-[(1-methyl-3-
trifluoromethyl-1H-pyrazole-4-carbonyl)amino]thiophen-2-
yl}pentanoic acid), DM-PCA (3-trifluoromethyl-1H-pyrazole-4-
carboxylic acid), PAM (1-methyl-3-trifluoromethyl-1H-pyrazole-4-
carboxamide) and PCA (1-methyl-3-trifluoromethyl-1H-pyrazole-4-
carboxylic acid) and their risk to contaminate groundwater, if
penthiopyrad is classified under Regulation (EC) No 1272/2008 as
carcinogenic cat. 2.
The applicant shall submit to the Commission, the Member States and
the Authority the relevant information set out in points (1) and (2) by
30 April 2016 and the information set out in point (3) within six
months from the notification of the classification decision concerning
penthiopyrad.
L
(1 ) Further details on identity and specification of active substance are provided in the review report.
313/45

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L 313/46
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
‘57 Penthiopyrad
(RS)-N-[2-(1,3-dimethyl
≥ 980 g/kg
1 May 2014 30
April
2024
For the implementation of the uniform principles as referred to in Article 29(6)

butyl)-3-thienyl]-1-methyl-
of Regulation (EC) No 1107/2009, the conclusions of the review report on
CAS No 183675-82-3 3-(trifluoromethyl)py
(50:50 racemic
penthiopyrad, and in particular Appendices I and II thereof, as finalised in the
mixture)
CIPAC No 824
razole-4-carboxamide
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 protection of operators and workers;
(b) the risk to aquatic and soil organisms;
(c) the protection of groundwater, when the substance is applied in regions
Off
with vulnerable soil and/or climatic conditions;
icial
(d) the level of residues in rotational crops following consecutive application
of the active substance over several years.
Jour
Conditions of use shall include risk mitigation measures, where appropriate.
nal
The applicant shall submit confirmatory information as regards:
of
the
(1) the non-relevance of metabolite M11 (3-methyl-1-{3-[(1-methyl-3-trifluor
European
omethyl-1H-pyrazole-4-carbonyl)amino]thiophen-2-yl}pentanoic acid) for
groundwater with the exception of evidence related to the risk of carcino
genicity, which is dependent on the classificationof the parent and specified
separately at (3) below;
Union
(2) the toxicological profile and the reference values of the metabolite PAM;
(3) the relevance of the metabolites M11 (3-methyl-1-{3-[(1-methyl-3-trifluor
omethyl-1H-pyrazole-4-carbonyl)amino]thiophen-2-yl}pentanoic acid), DM-
PCA (3-trifluoromethyl-1H-pyrazole-4- carboxylic acid), PAM (1-methyl-3-
trifluoromethyl-1H-pyrazole-4-carboxamide) and PCA (1-methyl-3-trifluor
omethyl-1H-pyrazole-4-carboxylic acid) and their risk to contaminate
groundwater, if penthiopyrad is classified under Regulation (EC) No
1272/2008 as carcinogenic cat. 2.
The applicant shall submit to the Commission, the Member States and the
Authority the relevant information set out in points (1) and (2) by 30 April
2016 and the information set out in point (3) within six months from the
notification of the classification decision concerning penthiopyrad.’
(*) Further details on identity and specification of active substance are provided in the review report.
22.11.2013

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