HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
31.8.2013 Official
Journal
of
the
European
Union L
233/7
COMMISSION IMPLEMENTING REGULATION (EU) No 833/2013
of 30 August 2013
approving the active substance pyriofenone, 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 Implementing Regulation (EU) No 540/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Health and the draft assessment report was finalised on
16 July 2013 in the format of the Commission review
Having regard to the Treaty on the Functioning of the European
report for pyriofenone.
Union,
(5)
It has appeared from the various examinations made that
Having regard to Regulation (EC) No 1107/2009 of the
plant protection products containing pyriofenone may be
European Parliament and of the Council of 21 October 2009
expected to satisfy, in general, the requirements laid
concerning the placing of plant protection products on the
down in Article 5(1)(a) and (b) and Article 5(3) of
market and repealing Council Directives 79/117/EEC and
Directive 91/414/EEC, in particular with regard to the
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
uses which were examined and detailed in the
thereof,
Commission review report. It is therefore appropriate
to approve pyriofenone.
Whereas:
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
1107/2009 in conjunction with Article 6 thereof and in
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
1107/2009, Directive 91/414/EEC (
the light of current scientific and technical knowledge, it

2 ) is to apply, with
respect to the procedure and the conditions for
is, however, necessary to include certain conditions and
approval, to active substances for which a decision has
restrictions. It is, in particular, appropriate to require
been adopted in accordance with Article 6(3) of that
further confirmatory information.
Directive before 14 June 2011. For pyriofenone the
conditions of Article 80(1)(a) of Regulation (EC) No
(7) A
reasonable
period
should
be
allowed
to
elapse
before
1107/2009 are fulfilled by Commission Decision
approval in order to permit Member States and the
2010/785/EU (
interested parties to prepare themselves to meet the

3 ).
new requirements resulting from the approval.
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
the United Kingdom received on 31 March 2010 an
(8) Without
prejudice
to
the
obligations
provided
for
in
application from ISK BioSciences Europe N.V. for the
Regulation (EC) No 1107/2009 as a consequence of
inclusion of the active substance pyriofenone in Annex
approval, taking into account the specific situation
I to Directive 91/414/EEC. Decision 2010/785/EU
created by the transition from Directive 91/414/EEC to
confirmed that the dossier was ‘complete’ in the sense
Regulation (EC) No 1107/2009, the following should,
that it could be considered as satisfying, in principle, the
however, apply. Member States should be allowed a
data and information requirements of Annexes II and III
period of six months after approval to review authori
to Directive 91/414/EEC.
sations of plant protection products containing
pyriofenone. Member States should, as appropriate,
vary, replace or withdraw authorisations. By way of dero
(3) For
that
active
substance,
the
effects
on
human
and
gation from that deadline, a longer period should be
animal health and the environment have been assessed,
provided for the submission and assessment of the
in accordance with the provisions of Article 6(2) and (4)
update of the complete Annex III dossier, as set out in
of Directive 91/414/EEC, for the uses proposed by the
Directive 91/414/EEC, of each plant protection product
applicant. The designated rapporteur Member State
for each intended use in accordance with the uniform
submitted a draft assessment report on 30 January 2012.
principles.
(4) The
draft
assessment
report
was
reviewed
by
the
Member (9) The
experience
gained
from
inclusions
in
Annex
I
to
States and the European Food Safety Authority (here
Directive 91/414/EEC of active substances assessed in
inafter 'the Authority'). The Authority presented to the
the framework of Commission Regulation (EEC) No
Commission its conclusion on the review of the pesticide
3600/92 of 11 December 1992 laying down the
risk assessment of the active substance pyriofenone ( 4 ) on
detailed rules for the implementation of the first stage
18 March 2013. The draft assessment report and the
of the programme of work referred to in Article 8(2) of
conclusion of the Authority were reviewed by the
Council Directive 91/414/EEC concerning the placing of
Member States and the Commission within the
plant protection products on the market (
Standing Committee on the Food Chain and Animal

5 ) has shown
that difficulties can arise in interpreting the duties of
holders of existing authorisations in relation to access
( 1 ) OJ L 309, 24.11.2009, p. 1.
to data. In order to avoid further difficulties it therefore
( 2 ) OJ L 230, 19.8.1991, p. 1.
appears necessary to clarify the duties of the Member
( 3 ) OJ L 335, 18.12.2010, p. 64.
( 4 ) EFSA Journal (2013) 11(4):3147. Available online: www.efsa.europa.
eu.
( 5 ) OJ L 366, 15.12.1992, p. 10.

---

L 233/8
EN
Official Journal of the European Union
31.8.2013
States, especially the duty to verify that the holder of an
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
authorisation demonstrates access to a dossier satisfying
orised plant protection product containing pyriofenone as either
the requirements of Annex II to that Directive. However,
the only active substance or as one of several active substances,
this clarification does not impose any new obligations on
all of which were listed in the Annex to Implementing Regu
Member States or holders of authorisations compared to
lation (EU) No 540/2011 by 31 January 2014 at the latest,
the Directives which have been adopted until now
Member States shall re-evaluate the product in accordance
amending Annex I to that Directive or the Regulations
with the uniform principles, as referred to in Article 29(6) of
approving active substances.
Regulation (EC) No 1107/2009, on the basis of a dossier
satisfying the requirements of Annex III to Directive
(10) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
91/414/EEC and taking into account the column on specific
1107/2009, the Annex to Commission Implementing
provisions of Annex I to this Regulation. On the basis of that
Regulation (EU) No 540/2011 of 25 May 2011 imple
evaluation, they shall determine whether the product satisfies
menting Regulation (EC) No 1107/2009 of the European
the conditions set out in Article 29(1) of Regulation (EC) No
Parliament and of the Council as regards the list of
1107/2009.
approved active substances
( 1 ) 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 pyriofenone 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 July 2015 at the latest; or
HAS ADOPTED THIS REGULATION:
(b) in the case of a product containing pyriofenone as one of
several active substances, where necessary, amend or
Article 1
withdraw the authorisation by 31 July 2015 or by the
Approval of active substance
date fixed for such an amendment or withdrawal in the
respective act or acts which added the relevant substance
The active substance pyriofenone, as specified in Annex I, is
or substances to Annex I to Directive 91/414/EEC or
approved subject to the conditions laid down in that Annex.
approved that substance or those substances, whichever is
Article 2
the latest.
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
authorisations for plant protection products containing
The Annex to Implementing Regulation (EU) No 540/2011 is
pyriofenone as an active substance by 31 July 2014.
amended in accordance with Annex II to this Regulation.
By that date they shall in particular verify that the conditions in
Article 4
Annex I to this Regulation are met, with the exception of those
identified in the column on specific provisions of that Annex,
Entry into force and date of application
and that the holder of the authorisation has, or has access to, a
This Regulation shall enter into force on the twentieth day
dossier satisfying the requirements of Annex II to Directive
following that of its publication in the Official Journal of the
91/414/EEC in accordance with the conditions of Article 13(1)
European Union.
to (4) of that Directive and Article 62 of Regulation (EC) No
1107/2009.
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, 30 August 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

---

31.8.2013 Off
ANNEX I
Common Name, Identification
Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Pyriofenone:
(5-chloro-2-methoxy-4-methyl-
≥ 965g/kg 1
February
2014 31
January
2024
For the implementation of the uniform principles as
3-pyridyl)(4,5,6-trimethoxy-o-
referred to in Article 29(6) of Regulation (EC) No
EN
CAS No 688046-61-9
tolyl)methanone
1107/2009, the conclusions of the review report on

CIPAC No 827
pyriofenone, and in 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.
Conditions of use shall include risk mitigation measures,
where appropriate.
The applicant shall submit confirmatory information as
regards
(a) the identity of two impurities to fully support the
icial
provisional specification;
(b) the toxicological relevance of the impurities present in
Jour
the proposed technical specification except for the one
nal
impurity for which an acute oral study and an Ames
test were provided.
of
the
The applicant shall submit to the Commission, the Member
States and the Authority that information by 31 January
European
2016.
(1 ) Further details on identity and specification of active substance are provided in the review report.
Union
L
233/9

---

L 233/10
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
‘53 Pyriofenone:
(5-chloro-2-methoxy-4-
≥ 965 g/kg 1
February
2014 31
January
2024
For the implementation of the uniform principles as referred

methyl-3-pyridyl)(4,5,6-
to in Article 29(6) of Regulation (EC) No 1107/2009, the
CAS No 688046-61-9
trimethoxy-o-tolyl)me
conclusions of the review report on pyriofenone, and in
CIPAC No 827
thanone
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.
Conditions of use shall include risk mitigation measures,
where appropriate.
The applicant shall submit confirmatory information as
regards
Off
(a) the identity of two impurities to fully support the
icial
provisional specification;
Jour
(b) the toxicological relevance of the impurities present in the
proposed technical specification except for the one
nal
impurity for which an acute oral study and an Ames
of
test were provided.
the
The applicant shall submit to the Commission, the Member
European
States and the Authority that information by 31 January
2016.’
(*) Further details on identity and specification of active substance are provided in the review report.
Union
31.8.2013

---

Document Outline

• �

---