欧盟Eurlex法规详细信息

EURLEX ID:32012D0316

OJ编号:OJ L 160, 21.6.2012, p. 19-21

中文标题:2012年6月18日委员会实施决定,根据欧洲议会和理事会指令98/8/EC条款4(4),批准丹麦通报的包含噻鼠酮的生物农药产品的限制授权(通报文件C(2012) 4025)

原文标题:2012/316/EU: Commission Implementing Decision of 18 June 2012 approving restrictions of authorisations of biocidal products containing difethialone notified by Denmark in accordance with Article 4(4) of Directive 98/8/EC of the European Parliament and of the Council (notified under document C(2012) 4025)

分类:177,51,140

文件类型:二级立法 Decision|决定

废止日期:2058-12-31

法规全文:查看欧盟官方文件

EN
21.6.2012 Official
Journal
of
the
European
Union L
160/19
DECISIONS
COMMISSION IMPLEMENTING DECISION
of 18 June 2012
approving restrictions of authorisations of biocidal products containing difethialone notified by
Denmark in accordance with Article 4(4) of Directive 98/8/EC of the European Parliament and
of the Council
(notified under document C(2012) 4025)
(Only the Danish text is authentic)
(2012/316/EU)
THE EUROPEAN COMMISSION,
(4) The
scientific
evaluation
leading
to
the
adoption
of
Directive 2007/69/EC concluded that the most significant
reductions in exposure to and risks posed by difethialone
Having regard to the Treaty on the Functioning of the European
are achieved by restricting its use to treatment campaigns
Union,
of limited duration, limiting access of non-target animals
to the bait and removing unused bait and dead and
moribund rodents during a baiting campaign in order
Having regard to Directive 98/8/EC of the European Parliament
to minimise the opportunity of primary or secondary
and of the Council of 16 February 1998 concerning the placing
exposure of non-target animals. The evaluation also
of biocidal products on the market ( 1 ), and in particular
concluded that only professional users are expected to
Article 4(4) thereof,
follow such instructions. The risk mitigation measures
mentioned in Directive 2007/69/EC therefore include
restriction to professional use only.
Whereas:
(1) Annex
I
to
Directive
98/8/EC
contains
the
list
of
active
substances approved at Union level for inclusion in
(5) The
company
LiphaTech
S.A.S.
(‘the
applicant’)
has,
in
biocidal products. The active substance difethialone was
accordance with Article 8 of Directive 98/8/EC,
approved for inclusion in products belonging to product-
submitted an application to the United Kingdom for
type 14, rodenticides, as defined in Annex V to Directive
authorisation of nine rodenticides containing difethialone
98/8/EC, by Commission Directive 2007/69/EC of
(‘the products’). The products’ names and reference
29 November 2007 amending Directive 98/8/EC of the
numbers in the Register for Biocidal Products (‘R4BP’)
European Parliament and of the Council to include dife
are indicated in the Annex to this decision.
thialone as an active substance in Annex I thereto. ( 2 )
(2) Difethialone
is
an
anticoagulant
rodenticide
known
to (6) The
United
Kingdom
granted
the
authorisations
on
pose risks of accidental incidents with children, as well
20 April 2011 (Generation Pat’), on 26 April 2011 (Gen
as risks for animals and the environment. It has been
eration Block) and on 27 April 2011 (Generation
identified as potentially persistent, liable to bioac
Grain’Tech and Rodilon Trio) (‘the first authorisations’).
cumulate and toxic (‘PBT’), or very persistent and very
The products were authorised with restrictions to ensure
liable to bioaccumulate (‘vPvB’).
that the conditions of Article 5 of Directive 98/8/EC
were met in the United Kingdom. Those restrictions
did not include a restriction to trained professional
(3) For
reasons
of
public
health
and
hygiene,
it
was
never
theless found to be justified to include difethialone and
users with a license.
other anticoagulant rodenticides in Annex I to Directive
98/8/EC, thus allowing Member States to authorise dife
thialone-based products. However, Directive 2007/69/EC
obliges Member States to ensure, when granting auth
(7) The
applicant
submitted
a
complete
application
to
orisation of products containing difethialone, that
Denmark for mutual recognition of the first authori
primary as well as secondary exposure of humans,
sations in respect of seven of the products (Rodilon
non-target animals and the environment is minimised,
Paste, Kvit Muse-Pasta, Rodilon Block, Generation
by considering and applying all appropriate and
Korn’Tech, Rodilon Trio and Kvit Rde Musekorn, and
available risk mitigation measures.
the product now referred to as Generation Blok) on
9 June 2011, and in respect of two of the products
( 1 ) OJ L 123, 24.4.1998, p. 1.
(Generation Museblok and Generation Musekorn) on
( 2 ) OJ L 312, 30.11.2007, p. 23.
14 October 2011.

L 160/20
EN
Official Journal of the European Union
21.6.2012
(8) On
2 November
2011,
Denmark
notified
the
gation measure. The arguments put forward by the
Commission, the other Member States and the
applicant do not undermine that conclusion.
applicant of its proposal to restrict the first authori
sations in accordance with Article 4(4) of Directive
(13) In the absence of any indication to the contrary, the
98/8/EC. Denmark proposed to impose a restriction on
Commission therefore considers that a restriction to
the products to use by trained professionals with a
professional users is an appropriate and available risk
license.
mitigation measure for the authorisation of products
containing difethialone in Denmark. The fact that the
(9) The
Commission
invited
the
other
Member
States
and
United Kingdom did not consider such a restriction to
the applicant to submit comments to the notification
be appropriate and available for an authorisation in its
in writing within 90 days in accordance with
territory is immaterial for that conclusion. The decision
Article 27(1) of Directive 98/8/EC.
of the United Kingdom to authorise non-professional use
was based in particular on the risk of a delay in
treatment of household infestations due to the costs
(10) Only
the applicant submitted comments within that
involved in hiring trained professionals, and the
deadline. The notification was also discussed between
associated risks to public hygiene. Denmark, however,
Commission representatives, representatives of Member
has explained that that risk is less prevalent in
States’ Competent Authorities for biocidal products and
Denmark, thanks to a system of mandatory rat infes
the applicant in the meeting of the Product Authorisation
tation reporting and tax financed controlling by trained
and Mutual Recognition Facilitation Group of 6-
professionals, together with the general public’s access to
7 December 2011 and in the meeting of the
alternative methods for control of minor mice infes
Competent Authorities for Biocidal Products of
tations.
29 February to 2 March 2012.
(14) The
measures provided for in this Decision are in
(11) The
applicant
has
argued
that
the
restriction
to
use
by
accordance with the opinion of the Standing
trained professionals with a license is unjustified and
Committee on Biocidal Products,
should not be accepted, since its products are also
suitable for rodent control by non-trained professionals
and non-professionals. Furthermore, the applicant has
HAS ADOPTED THIS DECISION:
put forward the arguments that the products are ready-
to-use products; that the active ingredient content in the
Article 1
products is low; that an antidote exists; that the products
can easily be kept out of the reach of children and non-
Denmark may restrict the authorisations granted in accordance
target animals; that non-professional users are likely to
with Article 4 of Directive 98/8/EC for the products mentioned
remove dead rodents and that non-professional users can
in the Annex to this Decision to use by trained professionals
be trained.
with a license.
(12) The
Commission
notes
that,
in
accordance
with
Directive
Article 2
2007/69/EC, authorisations of biocidal products
This Decision is addressed to the Kingdom of Denmark.
containing difethialone are to be subject to all appro
priate and available risk mitigation measures, including
the restriction to professional use only. The scientific
evaluation leading to the adoption of Directive
Done at Brussels, 18 June 2012.
2007/69/EC concluded that only professional users
could be expected to follow the instructions leading to
For the Commission
the most significant reductions in exposure and risk. A
restriction to professional users should therefore in
Janez POTONIK
principle be considered to be an appropriate risk miti
Member of the Commission

EN
21.6.2012 Official
Journal
of
the
European
Union L
160/21
ANNEX
Products for which Denmark may restrict the authorisations granted in accordance with Article 4 of Directive
98/8/EC to use by trained professionals with a license
Product name in the
United Kingdom application reference
Product name in
Danish application reference number in
United Kingdom
number in R4BP
Denmark
R4BP
Generation Block 2009/4329/3928/UK/AA/4786 Generation
Blok 2011/4329/3928/DK/MA/18746
Generation Block 2009/4329/3928/UK/AA/4786 Rodilon
Block 2009/4329/3928/DK/MA/5109
Generation Block 2009/4329/3928/UK/AA/4786 Generation
Museblok 2009/4329/3928/DK/MA/5089
Generation Pat’ 2009/4329/3926/UK/AA/4788 Rodilon
Paste 2009/4329/3926/DK/MA/5111
Generation Pat’ 2009/4329/3926/UK/AA/4788 Kvit
Muse
Pasta 2010/4329/3926/DK/MA/16305
Generation Grain’Tech 2009/4329/3929/UK/AA/4785 Generation
Korn’Tech 2011/4329/3929/DK/MA/18745
Generation Grain’Tech 2009/4329/3929/UK/AA/4785 Generation
Musekorn 2009/4329/3929/DK/MA/5125
Rodilon Trio 2009/4329/3930/UK/AA/4792 Rodilon
Trio 2010/4329/3930/DK/MA/5108
Rodilon Trio 2009/4329/3930/UK/AA/4792 Kvit
Rde
Musekorn 2010/4329/3930/DK/MA/16306

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