委员会实施条例(EU) No 1039/2013 ,修改批准壬酸用于生物杀灭剂产品类型2中活性物质的申请(1)?

技术法规类型:欧盟Eurlex法规 来源:tbtmap

EURLEX ID:32013R1039

OJ编号:OJ L 283, 25.10.2013, p. 43-45

中文标题:委员会实施条例(EU) No 1039/2013 ,修改批准壬酸用于生物杀灭剂产品类型2中活性物质的申请(1)?

原文标题:Commission Implementing Regulation (EU) No 1039/2013 of 24 October 2013 modifying the approval of nonanoic acid as an existing active substance for use in biocidal products for product-type 2 (1)

分类:03.50.20_植物健康

文件类型:二级立法 Regulation|条例

生效日期:2013-11-14

废止日期:2058-12-31

法规全文:查看欧盟官方文件

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25.10.2013 Official
Journal
of
the
European
Union L
283/43
COMMISSION IMPLEMENTING REGULATION (EU) No 1039/2013
of 24 October 2013
modifying the approval of nonanoic acid as an existing active substance for use in biocidal products
for product-type 2
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
a recommendation, to the Commission on 3 April 2012
in accordance with Article 14(4) and (6) of Regulation
(EC) No 1451/2007.
Having regard to the Treaty on the Functioning of the European
Union,
(5) The
competent
authority
report
was
reviewed
by
the
Member States and the Commission. In accordance
Having regard to Regulation (EU) No 528/2012 of the
with Article 15(4) of Regulation (EC) No 1451/2007,
European Parliament and of the Council of 22 May 2012
the findings of the review were incorporated, within
concerning the making available on the market and use of
the Standing Committee on Biocidal Products on
biocidal products ( 1 ), and in particular the third subparagraph
27 September 2013, in an assessment report.
of Article 89(1) thereof,
Whereas:
(6)
It appears from that report that biocidal products used as
an algaecide for the curative treatment of construction
materials and containing nonanoic acid may be expected
(1) Commission
Regulation
(EC)
No
1451/2007
( 2 ) estab
to satisfy the requirements laid down in Article 5 of
lishes a list of active substances to be assessed, with a
Directive 98/8/EC.
view to their possible inclusion in Annex I, IA or IB to
Directive 98/8/EC of the European Parliament and of the
Council ( 3 ). That list includes nonanoic acid.
(7) The
existing
approval
of
nonanoic
acid
for
product-type
2 does not cover the conditions resulting from the
evaluation of products used as an algaecide for the
(2) Nonanoic
acid
has
been
included
into
Annex
I
to
Directive 98/8/EC for use in product-type 2 through
curative treatment of construction materials. It is
Commission Directive 2012/41/EU (
therefore appropriate to complement that existing

4 ), and is therefore
considered as approved for that product-type by virtue
approval with those conditions. For the purpose of
of Article 86 of Regulation (EU) No 528/2012.
allowing all interested parties to prepare themselves to

meet the new requirements following from the recent
redefinition of biocidal product-types, it is furthermore
appropriate to modify the date of approval originally
(3) Furthermore,
nonanoic
acid
has
been
evaluated
in
provided for by Directive 2012/41/EU.
accordance with Article 11(2) of Directive 98/8/EC for
use in product-type 10, masonry preservatives, as defined
in Annex V to that Directive. The evaluation covered use
as an algaecide for the curative treatment of construction
(8) Since
the
evaluation
did
not
address
nanomaterials,
the
materials. That specific use is now covered by product-
approval should not cover such materials pursuant to
type 2 as defined in Annex V to Regulation (EU) No
Article 4(4) of Regulation (EU) No 528/2012.
528/2012.
(4) Austria
was
designated
as
Rapporteur
Member
State
and (9) The
measures
provided
for
in
this
Regulation
are
in
submitted the competent authority report, together with
accordance with the opinion of the Standing
Committee on Biocidal Products,
( 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
HAS ADOPTED THIS REGULATION:
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
Article 1
the market (OJ L 123, 24.4.1998, p. 1).
( 4 ) Commission Directive No 2012/41/EU of 26 November 2012
Nonanoic acid shall be approved as an active substance for use
amending Directive 98/8/EC of the European Parliament and of
in biocidal products for product-type 2, subject to the specifi
the Council to extend the inclusion in Annex I thereto of the
active substance nonanoic acid to product type 2 (OJ L 327,
cations, the new conditions and the new date of approval set
27.11.2012, p. 28).
out in the Annex.

L 283/44
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

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 )
Nonanoic acid, Pelargonic acid IUPAC
Name:
Nonanoic
acid
896 g/kg 1
October
2015 30
September
2025
2
The product assessment shall pay particular
attention to the exposures, the risks and the
EN
EC No: 203-931-2
efficacy linked to any uses covered by an

application for authorisation, but not
CAS No: 112-05-0
addressed in the Union level risk assessment
of the active substance.
Authorisations are subject to the following
conditions:
1. Unless it can be demonstrated in the
application for product authorisation
that risks for human health can be
reduced to acceptable levels by other
icial
means, authorisation shall be subject to
the following conditions:
Jour
(a) Instructions for use informing on
nal
how to minimize aerosol exposure.
of
(b) Authorisation of products for non-
the
professional users are subject to the
European
packaging being designed to
minimise user exposure.
2. Authorisation of products used as
Union
algaecide for outdoor remedial
treatment of construction materials shall
be subject to safe operating procedures
and risk mitigation measures in order to
protect the environment.
(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
283/45

Document Outline


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