委员会实施条例(EU) No 91/2014,批准S-烯虫酯用于生物杀灭剂产品类型18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:32014R0091
OJ编号:OJ L 32, 1.2.2014, p. 13-15
中文标题:委员会实施条例(EU) No 91/2014,批准S-烯虫酯用于生物杀灭剂产品类型18中活性物质的申请 (1)
原文标题:Commission Implementing Regulation (EU) No 91/2014 of 31 January 2014 approving S-methoprene as an existing active substance for use in biocidal products for product-type 18 (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:2014-02-21
废止日期:2058-12-31
法规全文:查看欧盟官方文件
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1.2.2014 Official
Journal
of
the
European
Union L
32/13
COMMISSION IMPLEMENTING REGULATION (EU) No 91/2014
of 31 January 2014
approving S-methoprene as an existing active substance for use in biocidal products for product-
type 18
(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
Standing Committee on Biocidal Products on
13 December 2013, in an assessment report.
Having regard to the Treaty on the Functioning of the European
Union,
(5)
It appears from that report that biocidal products used
for product-type 18 and containing S-methoprene may
Having regard to Regulation (EU) No 528/2012 of the
be expected to satisfy the requirements laid down in
European Parliament and of the Council of 22 May 2012
Article 5 of Directive 98/8/EC.
concerning the making available on the market and use of
biocidal products ( 1 ), and in particular the third subparagraph
of Article 89(1) thereof,
(6) It
is
therefore
appropriate
to
approve
S-methoprene
for
use in biocidal products for product-type 18.
Whereas:
(7) Since
the
evaluation
did
not
address
nanomaterials,
the
approval should not cover such materials pursuant to
(1) Commission
Regulation
(EC)
No
1451/2007
( 2 ) estab
lishes a list of active substances to be assessed, with a
Article 4(4) of Regulation (EU) No 528/2012.
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 S-methoprene.
(8) 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
(2) S-methoprene
has
been
evaluated
in
accordance
with
where appropriate, to prepare themselves to meet the
Article 11(2) of Directive 98/8/EC for use in product-
new requirements entailed.
type 18, insecticides, acaricides and products to control
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) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Committee on Biocidal Products,
(3) Ireland
was
designated
as
Rapporteur
Member
State
and
submitted the competent authority report, together with
a recommendation, to the Commission on 29 October
HAS ADOPTED THIS REGULATION:
2010 in accordance with Article 14(4) and (6) of Regu
lation (EC) No 1451/2007.
Article 1
(4) The
competent
authority
report
was
reviewed
by
the S-methoprene shall be approved as an active substance for use
Member States and the Commission. In accordance
in biocidal products for product-type 18, subject to the specifi
cations and conditions set out in the Annex.
( 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
Article 2
market (OJ L 325, 11.12.2007, p. 3).
This Regulation shall enter into force on the twentieth day
( 3 ) Directive 98/8/EC of the European Parliament and of the Council of
16 February 1998 concerning the placing of biocidal products on
following that of its publication in the Official Journal of the
the market (OJ L 123, 24.4.1998, p. 1).
European Union.
L 32/14
EN
Official Journal of the European Union
1.2.2014
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 31 January 2014.
For the Commission
The President
José Manuel BARROSO
1.2.2014 Off
ANNEX
IUPAC Name
Minimum degree of
Common Name
purity of the active
Date of approval Expiry
date
of
approval Product
type Specific
conditions
(2 )
Identification Numbers
substance (1 )
S-methoprene IUPAC
Name:
950 g/kg 1
September
2015 31
August
2025 18 The
product
assessment
shall
pay
particular
attention
to
the EN
exposures, the risks and the efficacy linked to any uses covered by
Isopropyl-(2E,4E,7S)-11-
an application for authorisation, but not addressed in the Union level
methoxy-3,7,11-trimethyl-
risk assessment of the active substance.
2,4-dodecadienoate
Authorisations are subject to the following condition:
EC No: N/A
For products that may lead to residues in food or feed, the need to
CAS No: 65733-16-6
set new or to amend existing maximum residue levels (MRLs) in
accordance with Regulation (EC) No 470/2009 of the European
Parliament and of the Council (3 ) or Regulation (EC) No 396/2005
of the European Parliament and of the Council (4 ) shall be verified,
and any appropriate risk mitigation measures shall be taken to ensure
icial
that the applicable MRLs are not exceeded.
Jour
(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.
nal
(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/
of
biocides/index.htm
(
the
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,
European
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).
Union
L
32/15
1.2.2014 Official
Journal
of
the
European
Union L
32/13
COMMISSION IMPLEMENTING REGULATION (EU) No 91/2014
of 31 January 2014
approving S-methoprene as an existing active substance for use in biocidal products for product-
type 18
(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
Standing Committee on Biocidal Products on
13 December 2013, in an assessment report.
Having regard to the Treaty on the Functioning of the European
Union,
(5)
It appears from that report that biocidal products used
for product-type 18 and containing S-methoprene may
Having regard to Regulation (EU) No 528/2012 of the
be expected to satisfy the requirements laid down in
European Parliament and of the Council of 22 May 2012
Article 5 of Directive 98/8/EC.
concerning the making available on the market and use of
biocidal products ( 1 ), and in particular the third subparagraph
of Article 89(1) thereof,
(6) It
is
therefore
appropriate
to
approve
S-methoprene
for
use in biocidal products for product-type 18.
Whereas:
(7) Since
the
evaluation
did
not
address
nanomaterials,
the
approval should not cover such materials pursuant to
(1) Commission
Regulation
(EC)
No
1451/2007
( 2 ) estab
lishes a list of active substances to be assessed, with a
Article 4(4) of Regulation (EU) No 528/2012.
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 S-methoprene.
(8) 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
(2) S-methoprene
has
been
evaluated
in
accordance
with
where appropriate, to prepare themselves to meet the
Article 11(2) of Directive 98/8/EC for use in product-
new requirements entailed.
type 18, insecticides, acaricides and products to control
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) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Committee on Biocidal Products,
(3) Ireland
was
designated
as
Rapporteur
Member
State
and
submitted the competent authority report, together with
a recommendation, to the Commission on 29 October
HAS ADOPTED THIS REGULATION:
2010 in accordance with Article 14(4) and (6) of Regu
lation (EC) No 1451/2007.
Article 1
(4) The
competent
authority
report
was
reviewed
by
the S-methoprene shall be approved as an active substance for use
Member States and the Commission. In accordance
in biocidal products for product-type 18, subject to the specifi
cations and conditions set out in the Annex.
( 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
Article 2
market (OJ L 325, 11.12.2007, p. 3).
This Regulation shall enter into force on the twentieth day
( 3 ) Directive 98/8/EC of the European Parliament and of the Council of
16 February 1998 concerning the placing of biocidal products on
following that of its publication in the Official Journal of the
the market (OJ L 123, 24.4.1998, p. 1).
European Union.
L 32/14
EN
Official Journal of the European Union
1.2.2014
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 31 January 2014.
For the Commission
The President
José Manuel BARROSO
1.2.2014 Off
ANNEX
IUPAC Name
Minimum degree of
Common Name
purity of the active
Date of approval Expiry
date
of
approval Product
type Specific
conditions
(2 )
Identification Numbers
substance (1 )
S-methoprene IUPAC
Name:
950 g/kg 1
September
2015 31
August
2025 18 The
product
assessment
shall
pay
particular
attention
to
the EN
exposures, the risks and the efficacy linked to any uses covered by
Isopropyl-(2E,4E,7S)-11-
an application for authorisation, but not addressed in the Union level
methoxy-3,7,11-trimethyl-
risk assessment of the active substance.
2,4-dodecadienoate
Authorisations are subject to the following condition:
EC No: N/A
For products that may lead to residues in food or feed, the need to
CAS No: 65733-16-6
set new or to amend existing maximum residue levels (MRLs) in
accordance with Regulation (EC) No 470/2009 of the European
Parliament and of the Council (3 ) or Regulation (EC) No 396/2005
of the European Parliament and of the Council (4 ) shall be verified,
and any appropriate risk mitigation measures shall be taken to ensure
icial
that the applicable MRLs are not exceeded.
Jour
(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.
nal
(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/
of
biocides/index.htm
(
the
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,
European
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).
Union
L
32/15
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