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5.11.2013 Official
Journal
of
the
European
Union L
293/31
COMMISSION IMPLEMENTING REGULATION (EU) No 1089/2013
of 4 November 2013
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the
active substance kieselgur (diatomaceous earth)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(3)
It is confirmed that the active substance kieselgur (diato
maceous earth) is to be deemed to have been approved
under Regulation (EC) No 1107/2009.
Having regard to the Treaty on the Functioning of the European
Union,
(4) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
Having regard to Regulation (EC) No 1107/2009 of the
1107/2009 in conjunction with Article 6 thereof and in
European Parliament and of the Council of 21 October 2009
the light of current scientific and technical knowledge, it
concerning the placing of plant protection products on the
is necessary to amend the conditions of approval. It is, in
market and repealing Council Directives 79/117/EEC and
particular, appropriate to require further confirmatory
91/414/EEC (
information.

1 ), and in particular Article 13(2)(c) and
Article 78(2) thereof,
(5) The
Annex
to
Implementing
Regulation
(EU)
No
Whereas:
540/2011 should therefore be amended accordingly.
(1) The
active
substance
kieselgur
(diatomaceous
earth)
was
included in Annex I to Council Directive 91/414/EEC (
(6) Member
States
should
be
provided
with
time
to
amend

2 )
by Commission Directive 2008/127/EC (
or withdraw authorisations for plant protection products

3 ) in accordance
with the procedure provided for in Article 24b of
containing kieselgur (diatomaceous earth).
Commission Regulation (EC) No 2229/2004 ( 4 ). Since
the replacement of Directive 91/414/EEC by Regulation
(EC) No 1107/2009, this substance is deemed to have
(7) For
plant
protection
products
containing
kieselgur
(dia
been approved under that Regulation and is listed in Part
tomaceous earth), where Member States grant any grace
A of the Annex to Commission Implementing Regulation
period in accordance with Article 46 of Regulation (EC)
(EU) No 540/2011 ( 5 ).
No 1107/2009, this period should expire at the latest
eighteen months after the date of entry into force of the
Regulation.
(2) In
accordance
with
Article
25a
of
Regulation
(EC)
No
2229/2004, the European Food Safety Authority, here
inafter ‘the Authority’, presented to the Commission its
view on the draft review report for kieselgur (diato
(8) The
measures
provided
for
in
this
Regulation
are
in
maceous earth) on 22 June 2012. The Authority
accordance with the opinion of the Standing
communicated its view on kieselgur (diatomaceous
Committee on the Food Chain and Animal Health,
earth) to the notifier. The Commission invited it to
submit comments on the draft review report for
kieselgur (diatomaceous earth). The draft review report
HAS ADOPTED THIS REGULATION:
and the view of the Authority were reviewed by the
Member States and the Commission within the
Standing Committee on the Food Chain and Animal
Article 1
Health and the draft review report was finalised on
3 October 2013 in the format of the Commission
Amendment to Implementing Regulation (EU)
review report for kieselgur (diatomaceous earth).
No 540/2011
Part A of the Annex to Implementing Regulation (EU) No
( 1 ) OJ L 309, 24.11.2009, p. 1.
540/2011 is amended in accordance with the Annex to this
( 2 ) Council Directive 91/414/EEC of 15 July 1991 on the placing on
Regulation.
the market of plant protection products (OJ L 230, 19.8.1991, p. 1).
( 3 ) Commission Directive 2008/127/EC of 18 December 2008
amending Council Directive 91/414/EEC to include several active
substances (OJ L 344, 20.12.2008, p. 89).
Article 2
( 4 ) Commission Regulation (EC) No 2229/2004 of 3 December 2004
laying down further detailed rules for the implementation of the
Transitional measures
fourth stage of the programme of work referred to in Article 8(2)
of Council Directive 91/414/EEC (OJ L 379, 24.12.2004, p. 13).
Member States shall in accordance with Regulation (EC) No
( 5 ) Commission Implementing Regulation (EU) No 540/2011 of
1107/2009, where necessary, amend or withdraw existing auth
25 May 2011 implementing Regulation (EC) No 1107/2009 of
the European Parliament and of the Council as regards the list of
orisations for plant protection products containing kieselgur
approved active substances (OJ L 153, 11.6.2011, p. 1).
(diatomaceous earth) as active substance by 25 May 2014.

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L 293/32
EN
Official Journal of the European Union
5.11.2013
Article 3
Grace period
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No
1107/2009 shall be as short as possible and shall expire by 25 May 2015 at the latest.
Article 4
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official
Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 November 2013.
For the Commission
The President
José Manuel BARROSO

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5.11.2013 Off
ANNEX
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 236 on the active substance kieselgur (diatomaceous earth) is replaced by the following:
Number
Common name,
Identification numbers
IUPAC name Purity Date
of
approval Expiration
of
approval Specific
provisions
EN
‘236 Kieselgur
(diatomaceous Kieselgur (no IUPAC
The product consists of
1 September 2009 31
August
2019 PART
A

earth)
name)
100 % diatomaceous earth.
Only indoor uses as insecticide and acaricide by professional
CAS No 61790-53-2
Diatomaceous earth
Maximum 0,1 % of
users may be authorised.
CIPAC No 647
Amorphous silicon dioxide particles of crystalline silica
with diameter below
PART B
Silica
50 μm
For the implementation of the uniform principles as referred to
Diatomite
in Article 29(6) of Regulation (EC) No 1107/2009, the
conclusions of the review report on kieselgur (diatomaceous
earth) (SANCO/2617/2008) and in particular Appendices I and
II thereof, as finalised in the Standing Committee on the Food
Chain and Animal Health on 3 October 2013 shall be taken
icial
into account.
In this overall assessment Member States shall pay particular
Jour
attention to the safety of operators and workers. Conditions of
nal
use shall include the application of adequate personal and
respiratory protective equipment. Where necessary, conditions
of
of use shall prohibit the presence of workers after application
the
of the product concerned for a period appropriate in view of
European
the risks caused by that product.
The Member States concerned shall ensure that the notifiers
submit, by 25 November 2015, to the Commission, the
Member States and the Authority information concerning the
Union
inhalation toxicity to confirm the occupational limits of
kieselgur (diatomaceous earth).’
L
293/33

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Document Outline

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