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25.10.2013 Official
Journal
of
the
European
Union L
283/17
COMMISSION IMPLEMENTING REGULATION (EU) No 1031/2013
of 24 October 2013
approving the active substance penflufen, 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,
(hereinafter ‘the Authority’). The Authority presented to
the Commission its conclusion on the review of the
pesticide risk assessment of the active substance
Having regard to the Treaty on the Functioning of the European
penflufen ( 4 ) on 30 July 2012. The draft assessment
Union,
report and the conclusion of the Authority were
reviewed by the Member States and the Commission
within the Standing Committee on the Food Chain and
Animal Health and the draft assessment report was
Having regard to Regulation (EC) No 1107/2009 of the
finalised on 15 March 2013 in the format of the
European Parliament and of the Council of 21 October 2009
Commission review report for penflufen.
concerning the placing of plant protection products on the
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 penflufen may be
expected to satisfy, in general, the requirements laid
down in Article 5(1)(a) and (b) and Article 5(3) of
Whereas:
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
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
to approve penflufen.
1107/2009, Council Directive 91/414/EEC ( 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
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
Directive before 14 June 2011. For penflufen the
1107/2009 in conjunction with Article 6 thereof and in
conditions of Article 80(1)(a) of Regulation (EC) No
the light of current scientific and technical knowledge, it
1107/2009 are fulfilled by Commission Decision
is, however, necessary to include certain conditions and
2010/672/EU (
restrictions. It is, in particular, appropriate to require

3 ).
further confirmatory information.
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
the United Kingdom received on 9 December 2009 an
(7) A
reasonable
period
should
be
allowed
to
elapse
before
application from Bayer CropScience AG for the inclusion
approval in order to permit Member States and the
of the active substance penflufen in Annex I to Directive
interested parties to prepare themselves to meet the
91/414/EEC. Decision 2010/672/EU confirmed that the
new requirements resulting from the approval.
dossier was ‘complete’ in the sense that it could be
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
created by the transition from Directive 91/414/EEC to
(3) For
that
active
substance,
the
effects
on
human
and
Regulation (EC) No 1107/2009, the following should,
animal health and the environment have been assessed,
however, apply. Member States should be allowed a
in accordance with the provisions of Article 6(2) and (4)
period of six months after approval to review authori
of Directive 91/414/EEC, for the uses proposed by the
sations of plant protection products containing
applicant. The designated rapporteur Member State
penflufen. Member States should, as appropriate, vary,
submitted a draft assessment report on 4 August 2011.
replace or withdraw authorisations. By way of derogation
from that deadline, a longer period should be provided
for the submission and assessment of the update of the
(4) The
draft
assessment
report
was
reviewed
by
the
complete Annex III dossier, as set out in Directive
Member States and the European Food Safety Authority
91/414/EEC, of each plant protection product for each
intended use in accordance with the uniform principles.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 4 ) EFSA Journal 2012; 10(8):2860. Available online: www.efsa.europa.
( 3 ) OJ L 290, 6.11.2010, p. 51.
eu

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L 283/18
EN
Official Journal of the European Union
25.10.2013
(9) The
experience
gained
from
inclusions
in
Annex
I
to authorisations for plant protection products containing
Directive 91/414/EEC of active substances assessed in
penflufen as an active substance by 31 July 2014.
the framework of 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
Council Directive 91/414/EEC concerning the placing of
By that date they shall in particular verify that the conditions in
plant protection products on the market ( 1 ) has shown
Annex I to this Regulation are met, with the exception of those
that difficulties can arise in interpreting the duties of
identified in part B of the column on specific provisions of that
holders of existing authorisations in relation to access
Annex, and that the holder of the authorisation has, or has
to data. In order to avoid further difficulties it therefore
access to, a dossier satisfying the requirements of Annex II to
appears necessary to clarify the duties of the Member
Directive 91/414/EEC in accordance with the conditions of
States, especially the duty to verify that the holder of
Article 13(1) to (4) of that Directive and Article 62 of Regu
an authorisation demonstrates access to a dossier
lation (EC) No 1107/2009.
satisfying the requirements of Annex II to that Directive.
However, this clarification does not impose any new
obligations on Member States or holders of authori
sations compared to the Directives which have been
adopted until now amending Annex I to that Directive
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
or the Regulations approving active substances.
orised plant protection product containing penflufen as either
the only active substance or as one of several active substances,
all of which were listed in the Annex to Implementing Regu
lation (EU) No 540/2011 by 31 January 2014 at the latest,
Member States shall re-evaluate the product in accordance
(10) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
with the uniform principles, as referred to in Article 29(6) of
1107/2009, the Annex to Commission Implementing
Regulation (EC) No 1107/2009, on the basis of a dossier
Regulation (EU) No 540/2011 of 25 May 2011 imple
satisfying the requirements of Annex III to Directive
menting Regulation (EC) No 1107/2009 of the European
91/414/EEC and taking into account part B of the column on
Parliament and of the Council as regards the list of
specific provisions of Annex I to this Regulation. On the basis
approved active substances
( 2 ) should be amended
of that evaluation, they shall determine whether the product
accordingly.
satisfies the conditions set out in Article 29(1) of Regulation
(EC) No 1107/2009.
(11) The
Standing
Committee
on
the
Food
chain
and
Animal
Health did not deliver an opinion. An implementing act
was deemed to be necessary and the chair submitted the
Following that determination Member States shall:
draft implementing act to the appeal committee for
further deliberation. The appeal committee did not
deliver an opinion,
(a) in the case of a product containing penflufen as the only
active substance, where necessary, amend or withdraw the
authorisation by 31 July 2015 at the latest; or
HAS ADOPTED THIS REGULATION:
(b) in the case of a product containing penflufen as one of
Article 1
several active substances, where necessary, amend or
withdraw the authorisation by 31 July 2015 or by the
Approval of active substance
date fixed for such an amendment or withdrawal in the
The active substance penflufen, as specified in Annex I, is
respective act or acts which added the relevant substance
approved subject to the conditions laid down in that Annex.
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
Article 3
1. Member
States
shall
in
accordance
with
Regulation
(EC)
Amendments to Implementing Regulation (EU) No
No 1107/2009, where necessary, amend or withdraw existing
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
25.10.2013 Official
Journal
of
the
European
Union L
283/19
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 February 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 October 2013.
For the Commission
The President
José Manuel BARROSO

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L 283/20
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Penflufen
2’-[(RS)-1,3-dimethylbutyl]-5-
≥ 950 g/kg
1 February 2014 31
January
2024 PART
A
fluoro-1,3-dimethylpyrazole-4-
EN

CAS No 494793-67-8 carboxanilide
1:1 (R:S) ratio of
Only uses to treat seed potato tubers before or during planting, may be auth
enantiomers
orised, limited to one application every third year on the same field.
CIPAC No 826
PART B
For the implementation of the uniform principles as referred to in Article 29(6)
of Regulation (EC) No 1107/2009, the conclusions of the review report on
penflufen, 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.
Off
icial
In this overall assessment Member States shall pay particular attention to:
Jour
(a) the protection of operators;
nal
(b) the protection of groundwater, when the substance is applied in regions
of
with vulnerable soil and/or climatic conditions.
the
European
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit confirmatory information as regards:
Union
(1) the long term risk to birds;
(2) the relevance of the metabolite M01 (penflufen-3-hydroxy-butyl) for
groundwater if penflufen is classified under Regulation (EC) No
1272/2008 of the European Parliament and of the Council (2 ) as ‘car
cinogen category 2’.
The applicant shall submit to the Commission, the Member States and the
Authority the information set out in point (1) by 30 September 2015 and the
information set out in point (2) within six months from the notification of the
classification decision concerning that substance.
The purity given in this entry is based on a pilot plant production. The
examining Member State shall inform the Commission in accordance with
Article 38 of Regulation (EC) No 1107/2009 on the specification of the
technical material as commercially manufactured.
25.10.2013
(1 ) Further details on identity and specification of active substance are provided in the review report.
(2 ) OJ L 353, 31.12.2008, p. 1.

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25.10.2013 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
‘55 Penflufen
2’-[(RS)-1,3-dimethylbutyl]- ≥ 950 g/kg
1 February 2014 31
January
2024 PART
A

5-fluoro-1,3-dimethyl
Only uses to treat seed potato tubers before or during planting, may be
CAS No 494793-67-8
pyrazole-4-carboxanilide
1:1 (R:S) ratio of
authorised, limited to one application every third year on the same field.
enantiomers
PART B
CIPAC No 826
For the implementation of the uniform principles as referred to in
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the
review report on penflufen, 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:
icial
(a) the protection of operators;
(b) the protection of groundwater, when the substance is applied in
Jour
regions with vulnerable soil and/or climatic conditions.
nal
Conditions of use shall include risk mitigation measures, where appro
priate.
of
the
The applicant shall submit confirmatory information as regards:
European
(1) the long term risk to birds;
(2) the relevance of the metabolite M01 (penflufen-3-hydroxy-butyl) for
groundwater if penflufen is classified under Regulation (EC) No
1272/2008 as ‘carcinogen category 2’.
Union
The applicant shall submit to the Commission, the Member States and the
Authority the information set out in point (1) by 30 September 2015 and
the information set out in point (2) within six months from the notifi
cation of the classification decision concerning that substance.
The purity given in this entry is based on a pilot plant production. The
examining Member State shall inform the Commission in accordance with
Article 38 of Regulation (EC) No 1107/2009 on the specification of the
technical material as commercially manufactured.’
(*) Further details on identity and specification of active substance are provided in the review report.
L
283/21

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