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EN
Official Journal of the European Union
25.10.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 1037/2013
of 24 October 2013
approving IPBC as an existing active substance for use in biocidal products for product-type 6
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5)
It appears from that report that biocidal products used
for product-type 6 and containing IPBC may be expected
Having regard to the Treaty on the Functioning of the European
to satisfy the requirements laid down in Article 5 of
Union,
Directive 98/8/EC.
Having regard to Regulation (EU) No 528/2012 of the
European Parliament and of the Council of 22 May 2012
(6) It
is
therefore
appropriate
to
approve
IPBC
for
use
in
concerning the making available on the market and use of
biocidal products for product-type 6.
biocidal products ( 1 ), and in particular the third subparagraph
of Article 89(1) thereof,
(7) Since
the
evaluation
did
not
address
nanomaterials,
the
approval should not cover such materials pursuant to
Whereas:
Article 4(4) of Regulation (EU) No 528/2012.
(1) Commission
Regulation
(EC)
No
1451/2007
( 2 ) estab
lishes a list of active substances to be assessed, with a
(8) A
reasonable
period
should
be
allowed
to
elapse
before
view to their possible inclusion in Annex I, IA or IB to
an active substance is approved, in order to permit
Directive 98/8/EC of the European Parliament and of the
Member States, interested parties, and the Commission
Council (
where appropriate, to prepare themselves to meet the

3 ). That list includes IPBC.
new requirements entailed.
(2) IPBC
has
been
evaluated
in
accordance
with
Article
11(2)
of Directive 98/8/EC for use in product-type 6, in-can
(9) The
measures
provided
for
in
this
Regulation
are
in
preservatives, as defined in Annex V to that Directive,
accordance with the opinion of the Standing
which corresponds to product-type 6 as defined in
Committee on Biocidal Products,
Annex V to Regulation (EU) No 528/2012.
HAS ADOPTED THIS REGULATION:
(3) Denmark
was
designated
as
Rapporteur
Member
State
and submitted the competent authority report, together
Article 1
with a recommendation, to the Commission on 27 June
2011 in accordance with Article 14(4) and (6) of Regu
IPBC shall be approved as an active substance for use in biocidal
lation (EC) No 1451/2007.
products for product-type 6, subject to the specifications and
conditions set out in the Annex.
(4) The
competent
authority
report
was
reviewed
by
the
Member States and the Commission. In accordance
Article 2
with Article 15(4) of Regulation (EC) No 1451/2007,
the findings of the review were incorporated, within
This Regulation shall enter into force on the twentieth day
the Standing Committee on Biocidal Products on
following that of its publication in the Official Journal of the
27 September 2013, in an assessment report.
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
( 1 ) OJ L 167, 27.6.2012, p. 1.
( 2 ) Commission Regulation (EC) No 1451/2007 of 4 December 2007
on the second phase of the 10-year work programme referred to in
Article 16(2) of Directive 98/8/EC of the European Parliament and
of the Council concerning the placing of biocidal products on the
market (OJ L 325, 11.12.2007, p. 3).
( 3 ) Directive 98/8/EC of the European Parliament and of the Council of
16 February 1998 concerning the placing of biocidal products on
the market (OJ L 123, 24.4.1998, p. 1).

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25.10.2013 Off
ANNEX
Common Name
IUPAC Name
Minimum degree of purity
Identification Numbers
of the active substance (1 )
Date of approval Expiry
date
of
approval Product
type Specific
conditions
(2 )
IPBC IUPAC
Name:
980 g/kg 1
July
2015 30
June
2025
6
The product assessment shall pay particular
attention to the exposures, the risks and the
EN
3-iodo-2-propynyl butylcarbamate
efficacy linked to any uses covered by an

application for authorisation, but not
EC No: 259-627-5
addressed in the Union level risk assessment
CAS No: 55406-53-6
of the active substance.
Authorisations are subject to the following
condition:
For industrial or professional users, safe
operational procedures and appropriate
organisational measures shall be established.
Where exposure cannot be reduced to an
icial
acceptable level by other means, products
shall be used with appropriate personal
Jour
protective equipment.
nal
Where a treated article has been treated
with or intentionally incorporates IPBC, and
of
where necessary due to the possibility of
the
skin contact as well as the release of IPBC
European
under normal conditions of use, the person
responsible for placing the treated article on
the market shall ensure that the label
provides information on the risk of skin
Union
sensitisation, as well as the information
referred to in the second subparagraph of
Article 58(3) of Regulation (EU) No
528/2012.
(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
L
283/39

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