HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 283/40
EN
Official Journal of the European Union
25.10.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 1038/2013
of 24 October 2013
approving tebuconazole as an existing active substance for use in biocidal products for product-
types 7 and 10
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
may be 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
tebuconazole render it very persistent (vP) and toxic (T)
in accordance with the criteria laid down in Annex XIII
Having regard to Regulation (EU) No 528/2012 of the
to Regulation (EC) No 1907/2006 of the European
European Parliament and of the Council of 22 May 2012
Parliament and of the Council
(
concerning the making available on the market and use of

4 ). The period of
approval should be 10 years in consistency with the
biocidal products ( 1 ), and in particular the third subparagraph
current practice under Directive 98/8/EC, since the
of Article 89(1) thereof,
conditions of Article 90(2) of Regulation (EU)
No 528/2012 are not met. However, for the purpose
Whereas:
of authorising products in accordance with Article 23
of Regulation (EU) No 528/2012, tebuconazole shall be
considered as a candidate for substitution pursuant to
(1) Commission
Regulation
(EC)
No
1451/2007
(
Article 10(1)(d) of that Regulation.

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
Directive 98/8/EC of the European Parliament and of the
(7) It
is
therefore
appropriate
to
approve
tebuconazole
for
Council ( 3 ). That list includes tebuconazole.
use in biocidal products for product-types 7 and 10.
(2) Tebuconazole
has
been
evaluated
in
accordance
with (8) Since
the
evaluations
did
not
address
nanomaterials,
the
Article 11(2) of Directive 98/8/EC for use in product-
approvals should not cover such materials pursuant to
type 7, film preservatives, and product-type 10,
Article 4(4) of Regulation (EU) No 528/2012.
masonry preservatives, as defined in Annex V to that
Directive, which correspond respectively to product-
types 7 and 10 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) Denmark
was
designated
as
rapporteur
Member
State
where appropriate, to prepare themselves to meet the
and submitted the competent authority reports,
new requirements entailed.
together with recommendations, to the Commission on
16 April 2012 in accordance with Article 14(4) and (6)
of Regulation (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
reports
were
reviewed
by
the
Member States and the Commission. In accordance with
Article 15(4) of Regulation (EC) No 1451/2007, the
HAS ADOPTED THIS REGULATION:
findings of the review were incorporated, within the
Standing Committee on Biocidal Products on
27 September 2013, in two assessment reports.
Article 1
Tebuconazole shall be approved as an active substance for use
(5) It
appears
from
those
reports
that
biocidal
products
used in biocidal products for product-types 7 and 10, subject to the
for product-types 7 and 10 and containing tebuconazole
specifications 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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EN
25.10.2013 Official
Journal
of
the
European
Union L
283/41
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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L 283/42
ANNEX
Minimum degree of
Common Name
IUPAC Name
Identification Numbers
purity of the active
Date of approval Expiry
date
of
approval Product
type Specific
conditions
(2 )
substance (1 )
Tebuconazole IUPAC
Name:
950 g/kg 1
July
2015 30
June
2025
7 Tebuconazole
is
considered
a
candidate
for
substitution
in
accordance EN
with Article 10(1)(d) of Regulation (EU) No 528/2012.

1-(4-chlorophenyl)-4,4-
dimethyl-3-(1,2,4-triazol-1-
The product assessment shall pay particular attention to the
ylmethyl)pentan-3-ol
exposures, the risks and the efficacy linked to any uses covered by
an application for authorisation, but not addressed in the Union level
EC No: 403-640-2
risk assessment of the active substance.
CAS No: 107534-96-3
Authorisations are subject to the following condition:
For industrial users, safe operational procedures and appropriate
organisational measures shall be established. Where exposure
cannot be reduced to an acceptable level by other means, products
Off
shall be used with appropriate personal protective equipment.
icial
10 Tebuconazole
is
considered
a
candidate
for
substitution
in
accordance Jour
with Article 10(1)(d) of Regulation (EU) No 528/2012.
nal
The product assessment shall pay particular attention to the
exposures, the risks and the efficacy linked to any uses covered by
of
an application for authorisation, but not addressed in the Union level
the
risk assessment of the active substance.
European
Authorisations are subject to the following conditions:
(1) For industrial or professional users, safe operational procedures
and appropriate organisational measures shall be established.
Union
Where exposure cannot be reduced to an acceptable level by
other means, products shall be used with appropriate personal
protective equipment.
(2) In the view of the risk for the soil compartment, tebuconazole
shall not be used in a sealant that will be used to seal vertical
joints outside residential facades (e.g. between two houses), unless
it can be demonstrated in the application for product authori
sation that risks can be reduced to an acceptable level by other
means.
(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
25.10.2013

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Document Outline

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