委员会实施条例(EU) No 955/2013 ,批准丙环唑用于生物杀灭剂产品类型9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:32013R0955
OJ编号:OJ L 263, 5.10.2013, p. 7-8
中文标题:委员会实施条例(EU) No 955/2013 ,批准丙环唑用于生物杀灭剂产品类型9中活性物质的申请(1)
原文标题:Commission Implementing Regulation (EU) No 955/2013 of 4 October 2013 to approve propiconazole as an existing active substance for use in biocidal products for product-type 9 (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:2013-10-25
废止日期:2058-12-31
法规全文:查看欧盟官方文件
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5.10.2013 Official
Journal
of
the
European
Union L
263/7
COMMISSION IMPLEMENTING REGULATION (EU) No 955/2013
of 4 October 2013
to approve propiconazole as an existing active substance for use in biocidal products for product-
type 9
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
with Article 15(4) of Regulation (EC) No 1451/2007, the
findings of the review were incorporated, within the
Having regard to the Treaty on the Functioning of the European
Standing Committee on Biocidal Products on 12 July
Union,
2013, in an assessment report.
Having regard to Regulation (EU) No 528/2012 of the
European Parliament and of the Council of 22 May 2012
(5) It
appears
from
the
assessment
report
that
biocidal
concerning the making available on the market and use of
products used for product-type 9 and containing propi
biocidal products (
conazole may be expected to satisfy the requirements laid
1 ), and in particular the third subparagraph
of Article 89(1) thereof,
down in Article 5 of Directive 98/8/EC.
Whereas:
(6) It
is
therefore
appropriate
to
approve
propiconazole
for
use in biocidal products for product-type 9.
(1) Commission
Regulation
(EC)
No
1451/2007 of
4 December 2007 on the second phase of the 10-year
(7) Since
the
evaluation
did
not
address
nanomaterials,
the
work programme referred to in Article 16(2) of Directive
approval should not cover such materials pursuant to
98/8/EC of the European Parliament and of the Council
Article 4(4) of Regulation (EU) No 528/2012.
concerning the placing of biocidal products on the
market (
(8) A
reasonable
period
should
be
allowed
to
elapse
before
2 ) establishes a list of active substances to be
assessed, with a view to their possible inclusion in
an active substance is approved, in order to permit
Annex I, IA or IB to Directive 98/8/EC of the
Member States, interested parties, and the Commission
European Parliament and of the Council (
where appropriate, to prepare themselves to meet the
3 ). That list
includes propiconazole.
new requirements entailed.
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
propi
(9) The
measures
provided
for
in
this
Regulation
are
in
conazole has been evaluated in accordance with
accordance with the opinion of the Standing
Article 11(2) of Directive 98/8/EC for use in product-
Committee on Biocidal Products,
type 9, fibre, leather, rubber and polymerised materials
preservatives, as defined in Annex V to that Directive,
HAS ADOPTED THIS REGULATION:
which corresponds to product-type 9 as defined in
Article 1
Annex V to Regulation (EU) No 528/2012.
Propiconazole shall be approved as an active substance for use
(3) Finland
was
designated
as
Rapporteur
Member
State
and in biocidal products for product-type 9, subject to the specifi
submitted the competent authority report, together with
cations and conditions set out in the Annex to this Regulation.
a recommendation, to the Commission on 11 February
2011 in accordance with Article 14(4) and (6) of Regu
Article 2
lation (EC) No 1451/2007.
This Regulation shall enter into force on the twentieth day
(4) The
competent
authority
report
was
reviewed
by
the following that of its publication in the Official Journal of the
Member States and the Commission. In accordance
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 October 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 167, 27.6.2012, p. 1.
( 2 ) OJ L 325, 11.12.2007, p. 3.
( 3 ) OJ L 123, 24.4.1998, p. 1.
L 263/8
ANNEX
Minimum
Common Name
IUPAC Name
degree of purity
Identification Numbers
of the active
Date of approval
Expiry date of
approval
Product type Specific
conditions
(2 )
substance (1 )
EN
Propiconazole 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-
930 g/kg 1
June
2015 31
May
2025
9 The
product
assessment
shall
pay
particular
attention
to
the
dioxolan-2-yl]methyl]-1H-1,2,4-triazole
exposures, the risks and the efficacy linked to any uses
covered by an application for authorisation, but not
EC No: 262-104-4
addressed in the Union level risk assessment of the active
substance.
CAS No: 60207-90-1
Authorisations are subject to the following condition:
For industrial or professional users, safe operational
procedures and appropriate organizational measures shall be
established. Where exposure cannot be reduced to an
Off
acceptable level by other means, products shall be used
with appropriate personal protective equipment.
icial
Where a treated article has been treated with or intentionally
Jour
incorporates propiconazole, and where necessary due to the
nal
possibility of skin contact as well as the release of propi
conazole under normal conditions of use, the person
of
responsible for placing the treated article on the market
the
shall ensure that the label provides information on the risk
European
of skin sensitisation, as well as the information referred to in
the second subparagraph of Article 58(3) of Regulation (EU)
No 528/2012.
Union
(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
5.10.2013
5.10.2013 Official
Journal
of
the
European
Union L
263/7
COMMISSION IMPLEMENTING REGULATION (EU) No 955/2013
of 4 October 2013
to approve propiconazole as an existing active substance for use in biocidal products for product-
type 9
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
with Article 15(4) of Regulation (EC) No 1451/2007, the
findings of the review were incorporated, within the
Having regard to the Treaty on the Functioning of the European
Standing Committee on Biocidal Products on 12 July
Union,
2013, in an assessment report.
Having regard to Regulation (EU) No 528/2012 of the
European Parliament and of the Council of 22 May 2012
(5) It
appears
from
the
assessment
report
that
biocidal
concerning the making available on the market and use of
products used for product-type 9 and containing propi
biocidal products (
conazole may be expected to satisfy the requirements laid
1 ), and in particular the third subparagraph
of Article 89(1) thereof,
down in Article 5 of Directive 98/8/EC.
Whereas:
(6) It
is
therefore
appropriate
to
approve
propiconazole
for
use in biocidal products for product-type 9.
(1) Commission
Regulation
(EC)
No
1451/2007 of
4 December 2007 on the second phase of the 10-year
(7) Since
the
evaluation
did
not
address
nanomaterials,
the
work programme referred to in Article 16(2) of Directive
approval should not cover such materials pursuant to
98/8/EC of the European Parliament and of the Council
Article 4(4) of Regulation (EU) No 528/2012.
concerning the placing of biocidal products on the
market (
(8) A
reasonable
period
should
be
allowed
to
elapse
before
2 ) establishes a list of active substances to be
assessed, with a view to their possible inclusion in
an active substance is approved, in order to permit
Annex I, IA or IB to Directive 98/8/EC of the
Member States, interested parties, and the Commission
European Parliament and of the Council (
where appropriate, to prepare themselves to meet the
3 ). That list
includes propiconazole.
new requirements entailed.
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
propi
(9) The
measures
provided
for
in
this
Regulation
are
in
conazole has been evaluated in accordance with
accordance with the opinion of the Standing
Article 11(2) of Directive 98/8/EC for use in product-
Committee on Biocidal Products,
type 9, fibre, leather, rubber and polymerised materials
preservatives, as defined in Annex V to that Directive,
HAS ADOPTED THIS REGULATION:
which corresponds to product-type 9 as defined in
Article 1
Annex V to Regulation (EU) No 528/2012.
Propiconazole shall be approved as an active substance for use
(3) Finland
was
designated
as
Rapporteur
Member
State
and in biocidal products for product-type 9, subject to the specifi
submitted the competent authority report, together with
cations and conditions set out in the Annex to this Regulation.
a recommendation, to the Commission on 11 February
2011 in accordance with Article 14(4) and (6) of Regu
Article 2
lation (EC) No 1451/2007.
This Regulation shall enter into force on the twentieth day
(4) The
competent
authority
report
was
reviewed
by
the following that of its publication in the Official Journal of the
Member States and the Commission. In accordance
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 October 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 167, 27.6.2012, p. 1.
( 2 ) OJ L 325, 11.12.2007, p. 3.
( 3 ) OJ L 123, 24.4.1998, p. 1.
L 263/8
ANNEX
Minimum
Common Name
IUPAC Name
degree of purity
Identification Numbers
of the active
Date of approval
Expiry date of
approval
Product type Specific
conditions
(2 )
substance (1 )
EN
Propiconazole 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-
930 g/kg 1
June
2015 31
May
2025
9 The
product
assessment
shall
pay
particular
attention
to
the
dioxolan-2-yl]methyl]-1H-1,2,4-triazole
exposures, the risks and the efficacy linked to any uses
covered by an application for authorisation, but not
EC No: 262-104-4
addressed in the Union level risk assessment of the active
substance.
CAS No: 60207-90-1
Authorisations are subject to the following condition:
For industrial or professional users, safe operational
procedures and appropriate organizational measures shall be
established. Where exposure cannot be reduced to an
Off
acceptable level by other means, products shall be used
with appropriate personal protective equipment.
icial
Where a treated article has been treated with or intentionally
Jour
incorporates propiconazole, and where necessary due to the
nal
possibility of skin contact as well as the release of propi
conazole under normal conditions of use, the person
of
responsible for placing the treated article on the market
the
shall ensure that the label provides information on the risk
European
of skin sensitisation, as well as the information referred to in
the second subparagraph of Article 58(3) of Regulation (EU)
No 528/2012.
Union
(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
5.10.2013
Document Outline
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