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25.10.2013 Official
Journal
of
the
European
Union L
283/35
COMMISSION IMPLEMENTING REGULATION (EU) No 1036/2013
of 24 October 2013
approving etofenprox as an existing active substance for use in biocidal products for product-
type 18
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
expected to satisfy the requirements laid down in
Article 5 of Directive 98/8/EC.
Having regard to the Treaty on the Functioning of the European
Union,
(6) It
also
appears
from
the
reports
that
the
characteristics
of
etofenprox render it liable to bioaccumulate (B) and toxic
(T), in accordance with the criteria laid down in Annex
Having regard to Regulation (EU) No 528/2012 of the
XIII to Regulation (EC) No 1907/2006 of the European
European Parliament and of the Council of 22 May 2012
Parliament and of the Council ( 4 ). The period of approval
concerning the making available on the market and use of
should be 10 years in consistency with the current
biocidal products ( 1 ), and in particular the third subparagraph
practice under Directive 98/8/EC, since the conditions
of Article 89(1) thereof,
of Article 90(2) of Regulation (EU) No 528/2012 are
not met. However, for the purpose of authorising
products in accordance with Article 23 of Regulation
Whereas:
(EU) No 528/2012, etofenprox shall be considered as a
candidate for substitution pursuant to Article 10(1)(d) of
that Regulation.
(1) Commission
Regulation
(EC)
No
1451/2007
( 2 ) estab
lishes a list of active substances to be assessed, with a
view to their possible inclusion in Annex I, IA or IB to
(7) It
is
therefore
appropriate
to
approve
etofenprox
for
use
Directive 98/8/EC of the European Parliament and of the
in biocidal products for product-type 18.
Council ( 3 ). That list includes etofenprox.
(2) Etofenprox
has
been
evaluated
in
accordance
with (8) Since
the
evaluation
did
not
address
nanomaterials,
the
Article 11(2) of Directive 98/8/EC for use in product-
approval should not cover such materials pursuant to
type 18, insecticides, acaricides and products to control
Article 4(4) of Regulation (EU) No 528/2012.
other arthropods, as defined in Annex V to that
Directive, which corresponds to product-type 18 as
defined in Annex V to Regulation (EU) No 528/2012.
(9) A
reasonable
period
should
be
allowed
to
elapse
before
an active substance is approved, in order to permit
Member States, interested parties, and the Commission
(3) Austria
was
designated
as
Rapporteur
Member
State
and
where appropriate, to prepare themselves to meet the
submitted the competent authority report, together with
new requirements entailed.
a recommendation, to the Commission on 9 August
2011 in accordance with Article 14(4) and (6) of Regu
lation (EC) No 1451/2007.
(10) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Committee on Biocidal Products,
(4) The
competent
authority
report
was
reviewed
by
the
Member States and the Commission. In accordance
with Article 15(4) of Regulation (EC) No 1451/2007,
HAS ADOPTED THIS REGULATION:
the findings of the review were incorporated, within
the Standing Committee on Biocidal Products on
27 September 2013, in an assessment report.
Article 1
Etofenprox shall be approved as an active substance for use in
(5)
It appears from that report that biocidal products used
biocidal products for product-type 18, subject to the specifi
for product-type 18 and containing etofenprox may be
cations and conditions set out in the Annex.
( 1 ) OJ L 167, 27.6.2012, p. 1.
( 4 ) Regulation (EC) No 1907/2006 of the European Parliament and of
( 2 ) Commission Regulation (EC) No 1451/2007 of 4 December 2007
the Council of 18 December 2006 concerning the Registration,
on the second phase of the 10-year work programme referred to in
Evaluation, Authorisation and Restriction of Chemicals (REACH),
Article 16(2) of Directive 98/8/EC of the European Parliament and
establishing a European Chemicals Agency, amending Directive
of the Council concerning the placing of biocidal products on the
1999/45/EC and repealing Council Regulation (EEC) No 793/93
market (OJ L 325, 11.12.2007, p. 3).
and Commission Regulation (EC) No 1488/94 as well as Council
( 3 ) Directive 98/8/EC of the European Parliament and of the Council of
Directive 76/769/EEC and Commission Directives 91/155/EEC,
16 February 1998 concerning the placing of biocidal products on
93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006,
the market (OJ L 123, 24.4.1998, p. 1).
p. 1).

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L 283/36
EN
Official Journal of the European Union
25.10.2013
Article 2
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, 24 October 2013.
For the Commission
The President
José Manuel BARROSO

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25.10.2013 Off
ANNEX
Common Name
IUPAC Name
Minimum degree of purity of
Identification Numbers
the active substance (1 )
Date of approval
Expiry date of
approval
Product type Specific
conditions
(2 )
Etofenprox IUPAC
Name:
970 g/kg 1
July
2015 30
June
2025 18 Etofenprox
is
considered
a
candidate
for
substitution
in accordance with article 10(1)(d) of Regulation
EN
3-phenoxybenzyl-2-(4-ethoxyp
(EU) No 528/2012.

henyl)-2-methylpropylether
The product assessment shall pay particular
EC No: 407-980-2
attention to the exposures, the risks and the
efficacy linked to any uses covered by an application
CAS No: 80844-07-1
for authorisation, but not addressed in the Union
level risk assessment of the active substance.
Authorisations are subject to the following
conditions:
(1) For industrial or professional users, safe oper
ational procedures and appropriate organiz
icial
ational measures shall be established. Where
Jour
exposure cannot be reduced to an acceptable
level by other means, products shall be used
nal
with appropriate personal protective equipment.
of
(2) For products that may lead to residues in food
the
or feed, the need to set new or to amend
European
existing maximum residue levels (MRLs) in
accordance with Regulation (EC) No 470/2009
of the European Parliament and of the Coun
cil (3 ) or Regulation (EC) No 396/2005 of the
Union
European Parliament and of the Council (4 ) shall
be verified, and any appropriate risk mitigation
measures shall be taken to ensure that the
applicable MRLs are not exceeded.
(1 ) The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on
the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.
(2 ) For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/
biocides/index.htm
(3 ) Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal
origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152,
16.6.2009, p. 11).
(4 ) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC
(OJ L 70, 16.3.2005, p. 1).
L
283/37

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Document Outline

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