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22.8.2013 Official
Journal
of
the
European
Union L
224/9
COMMISSION IMPLEMENTING REGULATION (EU) No 798/2013
of 21 August 2013
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the
active substance pyrethrins
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Committee on the Food Chain and Animal Health and
finalised on 16 July 2013 in the format of the
Commission review report for pyrethrins.
Having regard to the Treaty on the Functioning of the European
Union,
(3)
It is confirmed that the active substance pyrethrins is to
be deemed to have been approved under Regulation (EC)
No 1107/2009.
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) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
91/414/EEC (
1107/2009 in conjunction with Article 6 thereof and in

1 ), and in particular Article 13(2)(c) thereof,
the light of current scientific and technical knowledge, it
is necessary to amend the conditions of approval of
pyrethrins. In particular, it is appropriate to require
Whereas:
further confirmatory information.
(1) The
active
substance
pyrethrins
was
included
in
Annex
I (5) The
Annex
to
Implementing
Regulation
(EU)
No
to Council Directive 91/414/EEC ( 2 ) by Commission
540/2011 should therefore be amended accordingly.
Directive 2008/127/EC
( 3 ) in accordance with the
procedure provided for in Article 24b of Commission
Regulation (EC) No 2229/2004 of 3 December 2004
(6) A
reasonable
period
of
time
should
be
allowed
before
the
laying down further detailed rules for the implementation
application of this Regulation in order to allow Member
of the fourth stage of the programme of work referred to
States, notifiers and holders of authorisations for plant
in Article 8(2) of Council Directive 91/414/EEC ( 4 ). Since
protection products containing pyrethrins to meet the
the replacement of Directive 91/414/EEC by Regulation
requirements resulting from amendment to the
(EC) No 1107/2009, this substance is deemed to have
conditions of the approval.
been approved under that Regulation and is listed in Part
A of the Annex to Commission Implementing Regulation
(EU) No 540/2011 of 25 May 2011 implementing Regu
lation (EC) No 1107/2009 of the European Parliament
(7) The
measures
provided
for
in
this
Regulation
are
in
and of the Council as regards the list of approved active
accordance with the opinion of the Standing
substances ( 5 ).
Committee on the Food Chain and Animal Health,
(2) In
accordance
with
Article
25a
of
Regulation
(EC)
No HAS ADOPTED THIS REGULATION:
2229/2004, the European Food Safety Authority, here
inafter ‘the Authority’, presented to the Commission its
view on the draft review report for pyrethrins ( 6 ) on
12 December 2012. The Authority communicated its
Article 1
view on pyrethrins to the notifier. The Commission
Part A of the Annex to Implementing Regulation (EU) No
invited it to submit comments on the draft review
540/2011 is amended in accordance with the Annex to this
report for pyrethrins. The draft review report and the
Regulation.
view of the Authority were reviewed by the Member
States and the Commission within the Standing
Article 2
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) OJ L 230, 19.8.1991, p. 1.
This Regulation shall enter into force on the twentieth day
( 3 ) OJ L 344, 20.12.2008, p. 89.
following that of its publication in the Official Journal of the
( 4 ) OJ L 379, 24.12.2004, p. 13.
European Union.
( 5 ) OJ L 153, 11.6.2011, p. 1.
( 6 ) European Food Safety Authority; Conclusion on the peer review of
the pesticide risk assessment of the active substance pyrethrins. EFSA
Journal 2013;11(1):3032 [76 pp.] doi:10.2903/j.efsa.2013.3032.
Available online: www.efsa.europa.eu/efsajournal
It shall apply from 1 January 2014.

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L 224/10
EN
Official Journal of the European Union
22.8.2013
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 21 August 2013.
For the Commission
The President
José Manuel BARROSO

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22.8.2013 Off
ANNEX
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 246 on the active substance pyrethrins is replaced by the following:
Number
Common Name,
Identification Numbers
IUPAC Name Purity Date
of
approval Expiration
of
approval Specific
provisions
EN
‘246 Pyrethrins:
8003-34-7
Pyrethrins are a complex
Extract A: ≥ 500 g/kg
1 September 2009 31
August
2019 PART
A

mixture of chemical
Pyrethrins
CIPAC No 32
substances.
Extract B: ≥ 480 g/kg
Only uses as insecticide may be authorised.
Extract A: extractives of
Pyrethrins
PART B
Chrysanthemum
cinerariaefolium:
For the implementation of the uniform principles as
89997- 63-7
referred to in Article 29(6) of Regulation (EC) No
1107/2009, the conclusions of the review report on
Pyrethrin 1:
pyrethrins (SANCO/2627/2008) and in particular
CAS 121- 21-1
Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health shall be
Pyrethrin 2:
taken into account.
CAS 121- 29-9
icial
In this overall assessment Member States shall pay
Cinerin 1:
particular attention to:
CAS 25402- 06-6
Jour
(a) the risk to operators and workers;
Cinerin 2:
nal
CAS 121- 20-0
(b) the risk to non-target organisms.
of
Jasmolin 1:
Conditions of use shall, where appropriate, include the
the
CAS 4466- 14-2
application of adequate personal protective equipment
European
and other risk mitigation measures.
Jasmolin 2:
CAS 1172- 63-0
The applicant shall submit confirmatory information as
regards:
Extract B:
Union
Pyrethrin 1:
(1) the specification of the technical material, as commer
CAS 121-21-1
cially manufactured including information on any
relevant impurities and its equivalence with the specifi
Pyrethrin 2:
cations of the test material used in the toxicity studies;
CAS 121- 29-9
(2) the risk from inhalation;
Cinerin 1:
CAS 25402- 06-6
(3) the residue definition;
Cinerin 2:
(4) the representativeness of the major component
CAS 121- 20-0
“pyrethrin 1” as regards the fate and behaviour in soil
and water.
Jasmolin 1:
CAS 4466- 14-2
The applicant shall submit to the Commission, the Member
States and the Authority the information set out in points
Jasmolin 2:
(1) by 31 March 2014 and the information set out in
CAS 1172- 63-0
points (2), (3) and (4) by 31 December 2015.’
L
224/11

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Document Outline

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