L 160/22
EN
Official Journal of the European Union
21.6.2012
COMMISSION IMPLEMENTING DECISION
of 18 June 2012
approving restrictions of authorisations of biocidal products containing difethialone notified by
Germany in accordance with Article 4(4) of Directive 98/8/EC of the European Parliament and
of the Council
(notified under document C(2012) 4026)
(Only the German text is authentic)
(2012/317/EU)
THE EUROPEAN COMMISSION,
are achieved by restricting its use to treatment campaigns
of limited duration, limiting access of non-target animals
to the bait and removing unused bait and dead and
Having regard to the Treaty on the Functioning of the European
moribund rodents during a baiting campaign in order
Union,
to minimise the opportunity of primary or secondary
exposure of non-target animals. The evaluation also
concluded that only professional users are expected to
Having regard to Directive 98/8/EC of the European Parliament
follow such instructions. The risk mitigation measures
and of the Council of 16 February 1998 concerning the placing
mentioned in Directive 2007/69/EC therefore include
of biocidal products on the market ( 1 ), and in particular
restriction to professional use only.
Article 4(4) thereof,
(5) The
company
LiphaTech
S.A.S.
(‘the
applicant’)
has,
in
Whereas:
accordance with Article 8 of Directive 98/8/EC,
submitted an application to the United Kingdom for
authorisation of six rodenticides containing difethialone
(1) Annex
I
to
Directive
98/8/EC
contains
the
list
of
active
(‘the products’). The products’ names and reference
substances approved at Union level for inclusion in
numbers in the Register for Biocidal Products (‘R4BP’)
biocidal products. The active substance difethialone was
are indicated in the Annex to this Decision.
approved for inclusion in products belonging to product-
type 14, rodenticides, as defined in Annex V to Directive
98/8/EC, by Commission Directive 2007/69/EC of
(6) The
United
Kingdom
granted
the
authorisations
on
29 November 2007 amending Directive 98/8/EC of the
20 April 2011 (Generation Pat’), on 26 April 2011 (Gen
European Parliament and of the Council to include dife
eration Block, Generation B’Block and Generation
thialone as an active substance in Annex I thereto ( 2 ).
S’Block) and on 27 April 2011 (Generation Grain’Tech
and Rodilon Trio) (‘the first authorisations’). The products
were authorised with restrictions to ensure the conditions
(2) Difethialone
is
an
anticoagulant
rodenticide
known
to
of Article 5 of Directive 98/8/EC were met in the United
pose risks of accidental incidents with children, as well
Kingdom. Those restrictions did not include restriction to
as risks for animals and the environment. It has been
trained or licensed professional users.
identified as potentially persistent, liable to bioac
cumulate and toxic (‘PBT’), or very persistent and very
liable to bioaccumulate (‘vPvB’).
(7) On
6
November
2009,
the
applicant
submitted
a
complete application to Germany for mutual recognition
of the first authorisations in respect of the products.
(3) For
reasons
of
public
health
and
hygiene,
it
was
never
theless found to be justified to include difethialone and
other anticoagulant rodenticides in Annex I to Directive
(8) On
22
November
2011,
Germany
notified
the
98/8/EC, thus allowing Member States to authorise dife
Commission, the other Member States and the
thialone-based products. However, Directive 2007/69/EC
applicant of its proposal to restrict the first authori
obliges Member States to ensure, when granting auth
sations in accordance with Article 4(4) of Directive
orisation of products containing difethialone, that
98/8/EC. Germany proposed to impose a restriction on
primary as well as secondary exposure of humans,
the products to use by trained or licensed professionals.
non-target animals and the environment is minimised,
by considering and applying all appropriate and
available risk mitigation measures.
(9) The
Commission
invited
the
other
Member
States
and
the applicant to submit comments to the notification
in writing within 90 days in accordance with
(4) The
scientific
evaluation
leading
to
the
adoption
of
Article 27(1) of Directive 98/8/EC. Only the applicant
Directive 2007/69/EC concluded that the most significant
submitted comments within that deadline. The notifi
reductions in exposure to and risks posed by difethialone
cation was also discussed between Commission represen
tatives, representatives of Member States’ Competent
( 1 ) OJ L 123, 24.4.1998, p. 1.
Authorities for biocidal products and the applicant in
( 2 ) OJ L 312, 30.11.2007, p. 23.
the meeting of the Product Authorisation and Mutual

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EN
21.6.2012 Official
Journal
of
the
European
Union L
160/23
Recognition Facilitation Group of 6-7 December 2011,
territory is immaterial for that conclusion. The decision
in which the applicant participated, and in the meeting of
of the United Kingdom to authorise non-professional use
the Competent Authorities for Biocidal Products of
was based in particular on the risk of a delay in
29 February to 2 March 2012.
treatment of household infestations due to the costs
involved in hiring trained professionals, and the
(10) The
applicant
has
argued
that
the
restriction
to
use
by
associated risks to public hygiene. Germany, however,
trained or licensed professionals is unjustified and should
has explained that that risk is less prevalent in
not be accepted, since its products are also suitable for
Germany thanks to Germany’s well functioning infra
rodent control by non-trained professionals and non-
structure of trained pest control operators and licensed
professionals. Furthermore, the applicant has put
professionals, such as farmers, gardeners and foresters,
forward the arguments that the products are ready-to-
together with the availability of alternative methods for
use products; that the active ingredient content in the
pest control within buildings, especially for control of
products is low; that an antidote exists; that the
mice.
products can easily be kept out of the reach of
children and non-target animals; that non-professional
(13) The
measures provided for in this Decision are in
users are likely to remove dead rodents; and that non-
accordance with the opinion of the Standing
professional users can be trained.
Committee on Biocidal Products,
(11) The
Commission
notes
that,
in
accordance
with
Directive
HAS ADOPTED THIS DECISION:
2007/69/EC, authorisations of biocidal products
containing difethialone are to be subject to all appro
priate and available risk mitigation measures, including
Article 1
the restriction to professional use only. The scientific
Germany may restrict the authorisations granted in accordance
evaluation leading to the adoption of Directive
with Article 4 of Directive 98/8/EC for the products mentioned
2007/69/EC concluded that only professional users
in the Annex to this Decision to use by trained or licensed
could be expected to follow the instructions leading to
professionals.
the most significant reductions in exposure and risk. A
restriction to professional users should therefore in
principle be considered to be an appropriate risk miti
Article 2
gation measure. The arguments put forward by the
This Decision is addressed to the Federal Republic of Germany.
applicant do not undermine that conclusion.
(12) In the absence of any indication to the contrary, the
Commission therefore considers that restriction to
Done at Brussels, 18 June 2012.
professional users is an appropriate and available risk
mitigation measure for the authorisation of products
For the Commission
containing difethialone in Germany. The fact that the
United Kingdom did not consider such a restriction to
Janez POTONIK
be appropriate and available for an authorisation in its
Member of the Commission

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L 160/24
EN
Official Journal of the European Union
21.6.2012
ANNEX
Products for which Germany may restrict the authorisations granted in accordance with Article 4 of Directive
98/8/EC to use by licensed or trained professionals
Product name in the United United Kingdom application reference
Kingdom
number in R4BP
Product name in Germany German application reference number
in R4BP
Rodilon Trio 2009/4329/3930/UK/AA/4792 Brumolin
Forte 2009/4329/3930/DE/MA/5214
Generation B’Block 2009/4329/3927/UK/AA/4789 Generation
B’Block 2009/4329/3927/DE/MA/5169
Generation Block 2009/4329/3928/UK/AA/4786 Generation
Block 2009/4329/3928/DE/MA/5170
Generation Pat’ 2009/4329/3926/UK/AA/4788 Generation
Pat’ 2009/4329/3926/DE/MA/5171
Generation Grain’Tech 2009/4329/3929/UK/AA/4785 Generation
Grain’Tech 2009/4329/3929/DE/MA/5172
Generation S’Block 2009/4329/3927/UK/AA/4790 Generation
S’Block 2009/4329/3927/DE/MA/5173

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Document Outline

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