EN
21.6.2012 Official
Journal
of
the
European
Union L
160/25
COMMISSION IMPLEMENTING DECISION
of 18 June 2012
approving restrictions of authorisations of biocidal products containing difethialone notified by
Sweden in accordance with Article 4(4) of Directive 98/8/EC of the European Parliament and of
the Council
(notified under document C(2012) 4027)
(Only the Swedish text is authentic)
(2012/318/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
are achieved by restricting its use to treatment campaigns
Having regard to the Treaty on the Functioning of the European
of limited duration, limiting access of non-target animals
Union,
to the bait and removing unused bait and dead and
moribund rodents during a baiting campaign in order
to minimise the opportunity of primary or secondary
exposure of non-target animals. The evaluation also
Having regard to Directive 98/8/EC of the European Parliament
concluded that only professional users are expected to
and of the Council of 16 February 1998 concerning the placing
follow such instructions. The risk mitigation measures
of biocidal products on the market ( 1 ), and in particular
mentioned in Directive 2007/69/EC therefore include
Article 4(4) thereof,
restriction to professional use only.
Whereas:
(5) The
company
LiphaTech
S.A.S.
(‘the
applicant’)
has,
in
accordance with Article 8 of Directive 98/8/EC,
submitted an application to the United Kingdom for
(1) Annex
I
to
Directive
98/8/EC
contains
the
list
of
active
authorisation of eight rodenticides containing dife
substances approved at Union level for inclusion in
thialone (‘the products’). The products’ names and
biocidal products. The active substance difethialone was
reference numbers in the Register for Biocidal Products
approved for inclusion in products belonging to product-
(‘R4BP’) are indicated in the Annex to this Decision.
type 14, rodenticides, as defined in Annex V to Directive
98/8/EC, by Commission Directive 2007/69/EC of
29 November 2007 amending Directive 98/8/EC of the
European Parliament and of the Council to include dife
(6) The
United
Kingdom
granted
the
authorisations
on
thialone as an active substance in Annex I thereto ( 2 ).
20 April 2011 (Generation Pat’), on 26 April 2011
(Generation Block) and on 27 April 2011 (Generation
Grain’Tech and Rodilon Trio) (‘the first authorisations’).
The products were authorised with restrictions to ensure
(2) Difethialone
is
an
anticoagulant
rodenticide
known
to
pose risks of accidental incidents with children, as well
that the conditions of Article 5 of Directive 98/8/EC
as risks for animals and the environment. It has been
were met in the United Kingdom. Those restrictions
identified as potentially persistent, liable to bioac
did not include a restriction to trained professional
cumulate and toxic (‘PBT’), or very persistent and very
users with a license.
liable to bioaccumulate (‘vPvB’).
(7) On
9
June
2011,
the
applicant
submitted
a
complete
(3) For
reasons
of
public
health
and
hygiene,
it
was
never
application to Sweden for mutual recognition of the
theless found to be justified to include difethialone and
first authorisations of the products. For the products
other anticoagulant rodenticides in Annex I to Directive
with the Swedish product names Rodilon Block,
98/8/EC, thus allowing Member States to authorise dife
Rodilon Trio and Rodilon Paste, the applications were
thialone-based products. However, Directive 2007/69/EC
restricted to authorisation for professional use only.
obliges Member States to ensure, when granting auth
orisation of products containing difethialone, that
primary as well as secondary exposure of humans,
non-target animals and the environment is minimised,
(8) On
11
October
2011,
Sweden
notified
the
Commission,
by considering and applying all appropriate and
the other Member States and the applicant of its proposal
available risk mitigation measures.
to restrict the first authorisations in accordance with
Article 4(4) of Directive 98/8/EC. Sweden proposed to
( 1 ) OJ L 123, 24.4.1998, p. 1.
impose a restriction on the products to use by trained
( 2 ) OJ L 312, 30.11.2007, p. 23.
professionals with a license.

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L 160/26
EN
Official Journal of the European Union
21.6.2012
(9) The
Commission
invited
the
other
Member
States
and (12) In the absence of any indication to the contrary, the
the applicant to submit comments to the notification
Commission therefore considers that restriction to
in writing within 90 days in accordance with
professional users is an appropriate and available risk
Article 27(1) of Directive 98/8/EC. Only the applicant
mitigation measure for the authorisation of products
submitted comments within that deadline. The notifi
containing difethialone in Sweden. The fact that the
cation was also discussed between Commission represen
United Kingdom did not consider such a restriction to
tatives, representatives of Member States’ Competent
be appropriate and available for authorisation in its
Authorities for biocidal products, and the applicant in
territory is immaterial for that conclusion. The decision
the meeting of the Product Authorisation and Mutual
of the United Kingdom to authorise non-professional use
Recognition Facilitation Group of 6-7 December 2011
was based in particular on the risk of a delay in
and in the meeting of the Competent Authorities for
treatment of household infestations due to the costs
Biocidal Products of 29 February to 2 March 2012.
involved in hiring trained professionals, and the
associated risks to public hygiene. Sweden, however,
has explained that that risk is less prevalent in Sweden
(10) The
applicant
has
argued
that
the
restriction
to
use
by
trained professionals with a license is unjustified and
thanks to the Swedish insurance system, in which house
should not be accepted, since its products are also
holder insurances typically cover the cost of professional
suitable for rodent control by non-trained professionals
pest control in case of an infestation.
and non-professionals. Furthermore, the applicant has
put forward the arguments that the products are ready-
(13) The
measures provided for in this Decision are in
to-use products; that the active ingredient content in the
accordance with the opinion of the Standing
products is low; that an antidote exists; that the products
Committee on Biocidal Products,
can easily be kept out of the reach of children and non-
target animals; that non-professional users are likely to
HAS ADOPTED THIS DECISION:
remove dead rodents; that non-professional users can be
trained and that the proposed restriction to use by
Article 1
trained professionals is likely to increases the cost of
Sweden may restrict the authorisations granted in accordance
householder’s insurances in Sweden in the long term.
with Article 4 of Directive 98/8/EC for the products mentioned
in the Annex to this Decision to use by trained professionals
(11) The
Commission
notes
that,
in
accordance
with
Directive
with a license.
2007/69/EC, authorisations of biocidal products
containing difethialone are to be subject to all appro
Article 2
priate and available risk mitigation measures, including
This Decision is addressed to the Kingdom of Sweden.
the restriction to professional use only. The scientific
evaluation leading to the adoption of Directive
2007/69/EC concluded that only professional users
could be expected to follow the instructions leading to
Done at Brussels, 18 June 2012.
the most significant reductions in exposure and risk. A
restriction to professional users should therefore in
For the Commission
principle be considered as an appropriate risk mitigation
measure. The arguments put forward by the applicant do
Janez POTONIK
not undermine that conclusion.
Member of the Commission

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EN
21.6.2012 Official
Journal
of
the
European
Union L
160/27
ANNEX
Products for which Sweden 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 United Kingdom application reference
Kingdom
number in R4BP
Product name in Sweden Swedish application reference number
in R4BP
Rodilon Trio 2009/4329/3930/UK/AA/4792 Radar
mus
och
rtta 2009/4329/3930/SE/MA/5034
korn
Generation Pat’ 2009/4329/3926/UK/AA/4788 Rodilon
Paste 2009/4329/3926/SE/MA/5036
Generation Pat’ 2009/4329/3926/UK/AA/4788 Radar
mus
och
rtta 2009/4329/3926/SE/MA/5037
pasta
Generation Grain’Tech 2009/4329/3929/UK/AA/4785 Generation
Grain’Tech 2009/4329/3929/SE/MA/5038
Generation Pat’ 2009/4329/3926/UK/AA/4788 Generation
Pat’ 2009/4329/3926/SE/MA/5039
Rodilon Trio 2009/4329/3930/UK/AA/4792 Rodilon
Trio 2009/4329/3930/SE/MA/5040
Generation Block 2009/4329/3928/UK/AA/4786 Rodilon
Block 2009/4329/3928/SE/MA/5041
Generation Block 2009/4329/3928/UK/AA/4786 Generation
Block 2009/4329/3928/SE/MA/5042

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Document Outline

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