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23.8.2013 Official
Journal
of
the
European
Union L
225/13
COMMISSION IMPLEMENTING REGULATION (EU) No 802/2013
of 22 August 2013
approving the active substance fluopyram, 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,
(5)
It has appeared from the various examinations made that
plant protection products containing fluopyram may be
Having regard to the Treaty on the Functioning of the European
expected to satisfy, in general, the requirements laid
Union,
down in Article 5(1)(a) and (b) and Article 5(3) of
Directive 91/414/EEC, in particular with regard to the
Having regard to Regulation (EC) No 1107/2009 of the
uses which were examined and detailed in the
European Parliament and of the Council of 21 October 2009
Commission review report. It is therefore appropriate
concerning the placing of plant protection products on the
to approve fluopyram.
market and repealing Council Directives 79/117/EEC and
91/414/EEC ( 1 ), and in particular Articles 13(2) and 78(2)
thereof,
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
1107/2009 in conjunction with Article 6 thereof and in
Whereas:
the light of current scientific and technical knowledge, it
is, however, necessary to include certain conditions and
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
restrictions. It is, in particular, appropriate to require
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
further confirmatory information.
with respect to the procedure and the conditions for
approval, to active substances for which a decision has
(7) A
reasonable
period
should
be
allowed
to
elapse
before
been adopted in accordance with Article 6(3) of that
approval in order to permit Member States and the
Directive before 14 June 2011. For fluopyram the
interested parties to prepare themselves to meet the
conditions of Article 80(1)(a) of Regulation (EC) No
new requirements resulting from the approval.
1107/2009 are fulfilled by Commission Decision
2009/464/EC ( 3 ).
(8) Without
prejudice
to
the
obligations
provided
for
in
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
Regulation (EC) No 1107/2009 as a consequence of
Germany received on 30 June 2008 an application from
approval, taking into account the specific situation
Bayer CropScience AG for the inclusion of the active
created by the transition from Directive 91/414/EEC to
substance fluopyram in Annex I to Directive
Regulation (EC) No 1107/2009, the following should,
91/414/EEC. Decision 2009/464/EC confirmed that the
however, apply. Member States should be allowed a
dossier was ‘complete’ in the sense that it could be
period of six months after approval to review authori
considered as satisfying, in principle, the data and
sations of plant protection products containing
information requirements of Annexes II and III to
fluopyram. Member States should, as appropriate, vary,
Directive 91/414/EEC.
replace or withdraw authorisations. By way of derogation
from that deadline, a longer period should be provided
(3) For
that
active
substance,
the
effects
on
human
and
for the submission and assessment of the complete
animal health and the environment have been assessed,
Annex III dossier, as set out in Directive 91/414/EEC,
in accordance with the provisions of Article 6(2) and (4)
of each plant protection product for each intended use
of Directive 91/414/EEC, for the uses proposed by the
in accordance with the uniform principles.
applicant. The designated rapporteur Member State
submitted a draft assessment report on 30 August 2011.
(9) The
experience
gained
from
inclusions
in
Annex
I
to
Directive 91/414/EEC of active substances assessed in
(4) The
draft
assessment
report
was
reviewed
by
the
Member
the framework of Commission Regulation (EEC) No
States and the European Food Safety Authority (here
3600/92 of 11 December 1992 laying down the
inafter ‘the Authority’). The Authority presented to the
detailed rules for the implementation of the first stage
Commission its conclusion ( 4 ) on the pesticide risk
of the programme of work referred to in Article 8(2) of
assessment of the active substance fluopyram on
Council Directive 91/414/EEC concerning the placing of
17 December 2012. The draft assessment report and
plant protection products on the market (
the conclusion of the Authority were reviewed by the

5 ) has shown
that difficulties can arise in interpreting the duties of
Member States and the Commission within the
holders of existing authorisations in relation to access
Standing Committee on the Food Chain and Animal
to data. In order to avoid further difficulties it therefore
Health and finalised on 16 July 2013 in the format of
appears necessary to clarify the duties of the Member
the Commission review report for fluopyram.
States, especially the duty to verify that the holder of
an authorisation demonstrates access to a dossier
( 1 ) OJ L 309, 24.11.2009, p. 1.
satisfying the requirements of Annex II to that Directive.
( 2 ) OJ L 230, 19.8.1991, p. 1.
However, this clarification does not impose any new
( 3 ) OJ L 151, 16.6.2009, p. 37.
( 4 ) EFSA Journal 2013; 11(1):3052. Available online: www.efsa.europa.
eu
( 5 ) OJ L 366, 15.12.1992, p. 10.

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L 225/14
EN
Official Journal of the European Union
23.8.2013
obligations on Member States or holders of authori
the only active substance or as one of several active substances,
sations compared to the Directives which have been
all of which were listed in the Annex to Implementing Regu
adopted until now amending Annex I to that Directive
lation (EU) No 540/2011 by 31 January 2014 at the latest,
or the Regulations approving active substances.
Member States shall re-evaluate the product in accordance
with the uniform principles, as referred to in Article 29(6) of
(10) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
Regulation (EC) No 1107/2009, on the basis of a dossier
1107/2009, the Annex to Commission Implementing
satisfying the requirements of Annex III to Directive
Regulation (EU) No 540/2011 of 25 May 2011 imple
91/414/EEC and taking into account the column on specific
menting Regulation (EC) No 1107/2009 of the European
provisions of Annex I to this Regulation. On the basis of that
Parliament and of the Council as regards the list of
evaluation, they shall determine whether the product satisfies
approved active substances
( 1 ) should be amended
the conditions set out in Article 29(1) of Regulation (EC) No
accordingly.
1107/2009.
(11) The
measures
provided
for
in
this
Regulation
are
in
Following that determination Member States shall:
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(a) in the case of a product containing fluopyram as the only
active substance, where necessary, amend or withdraw the
HAS ADOPTED THIS REGULATION:
authorisation by 31 July 2015 at the latest; or
Article 1
(b) in the case of a product containing fluopyram as one of
Approval of active substance
several active substances, where necessary, amend or
withdraw the authorisation by 31 July 2015 or by the
The active substance fluopyram, as specified in Annex I, is
date fixed for such an amendment or withdrawal in the
approved subject to the conditions laid down in that Annex.
respective act or acts which added the relevant substance
or substances to Annex I to Directive 91/414/EEC or
Article 2
approved that substance or those substances, whichever is
Re-evaluation of plant protection products
the latest.
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
fluopyram as an active substance by 31 July 2014.
540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is
By that date they shall in particular verify that the conditions in
amended in accordance with Annex II to this Regulation.
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
dossier satisfying the requirements of Annex II to Directive
Entry into force and date of application
91/414/EEC in accordance with the conditions of Article 13(1)
to (4) of that Directive and Article 62 of Regulation (EC) No
This Regulation shall enter into force on the twentieth day
1107/2009.
following that of its publication in the Official Journal of the
European Union.
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
orised plant protection product containing fluopyram as either
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, 22 August 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

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23.8.2013 Off
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Fluopyram
N-{2-[3-chloro-5-
≥ 960 g/kg 1
February
2014 31
January
2024
For the implementation of the uniform principles as referred to in Article 29(6)
(trifluoromethyl)-2-
of Regulation (EC) No 1107/2009, the conclusions of the review report on
EN
CAS No 658066-35-4
pyridyl]ethyl}-α,α,α-
fluopyram, and in particular Appendices I and II thereof, as finalised in the

trifluoro-o-toluamide
Standing Committee on the Food Chain and Animal Health on 16 July 2013,
CIPAC No 807
shall be taken into account.
In this overall assessment Member States shall pay particular attention to the risk
to birds and aquatic organisms.
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit confirmatory information as regards:
(1) the long-term risk to insectivorous birds;
icial
Jour
(2) the potential for causing endocrine disrupting effects in non-target verte
brates other than mammals.
nal
of
The applicant shall submit to the Commission, Member States and the Authority
the
the information set out in point 1 by 1 February 2016 and the information set
out in point 2 within two years after adoption of the corresponding OECD test
European
guidelines on endocrine disruption.
(1 ) Further details on identity and specification of active substance are provided in the review report.
Union
L
225/15

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L 225/16
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

‘51 Fluopyram
N-{2-[3-chloro-5-(trifluor
≥ 960 g/kg 1
February
2014 31
January
2024 For the implementation of the uniform principles as referred to
omethyl)-2-pyridyl]ethyl}-
in Article 29(6) of Regulation (EC) No 1107/2009, the
CAS No 658066-35-4
α,α,α-trifluoro-o-toluamide
conclusions of the review report on fluopyram, and in
CIPAC No 807
particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health
on 16 July 2013, shall be taken into account.
In this overall assessment Member States shall pay particular
attention to the risk to birds and aquatic organisms.
Conditions of use shall include risk mitigation measures, where
Off
appropriate.
icial
The applicant shall submit confirmatory information as
Jour
regards:
nal
(1) the long-term risk to insectivorous birds;
of
the
(2) the potential for causing endocrine disrupting effects in
non-target vertebrates other than mammals.
European
The applicant shall submit to the Commission, Member States
and the Authority the information set out in point 1 by
1 February 2016 and the information set out in point 2
Union
within two years after adoption of the corresponding OECD
test guidelines on endocrine disruption.’
(*) Further details on identity and specification of active substance are provided in the review report.
23.8.2013

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