HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 306/26
EN
Official Journal of the European Union
6.11.2012
COMMISSION IMPLEMENTING DECISION
of 31 October 2012
approving restrictions of authorisations of biocidal products containing difenacoum 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) 7568)
(Only the German text is authentic)
(2012/679/EU)
THE EUROPEAN COMMISSION,
submitted an application to Ireland for authorisation of
two rodenticides containing difenacoum (‘the products’).
The products’ names and reference numbers in the
Having regard to the Treaty on the Functioning of the European
Register for Biocidal Products (‘R4BP’) are indicated in
Union,
the Annex to this Decision.
Having regard to Directive 98/8/EC of the European Parliament
and of the Council of 16 February 1998 concerning the placing
(5) Ireland
granted
the
authorisations
on
1
July
2011.
The
of biocidal products on the market (
products were authorised with restrictions to ensure the

1 ), and in particular
Article 4(4) thereof,
conditions of Article 5 of Directive 98/8/EC were met in
Ireland. Those restrictions did not include restriction to
trained or licensed professional users.
Whereas:
(6) On
30
March
2010,
the
applicant
submitted
a
complete
(1) Annex
I
to
Directive
98/8/EC
contains
the
list
of
active
application to Germany for mutual recognition of the
substances approved at Union level for inclusion in
first authorisations in respect of the products.
biocidal products. The active substance difenacoum was
approved for inclusion in products belonging to product-
type 14, rodenticides, as defined in Annex V to Directive
(7) On
7
February
2012,
Germany
notified
the
Commission,
98/8/EC, by Commission Directive 2008/81/EC of
the other Member States and the applicant of its proposal
29 July 2008 amending Directive 98/8/EC of the
to restrict the first authorisations in accordance with
European Parliament and of the Council to include
Article 4(4) of Directive 98/8/EC. Germany proposed to
difenacoum as an active substance in Annex I thereto ( 2 ).
impose a restriction on the products to use by trained or
licensed professionals.
(2) Difenacoum
is
an
anticoagulant
rodenticide
known
to
pose risks of accidental incidents with children, as well
(8) The
Commission
invited
the
other
Member
States
and
as risks for animals and the environment. It has been
the applicant to submit comments to the notification
identified as potentially persistent, liable to bioac
in writing within 90 days in accordance with
cumulate and toxic (‘PBT’), or very persistent and very
Article 27(1) of Directive 98/8/EC. No comments were
liable to bioaccumulate (‘vPvB’).
submitted within that deadline. The notification was also
discussed between Commission representatives, represen
(3) For
reasons
of
public
health
and
hygiene,
it
was
never
tatives of Member States’ Competent Authorities for
theless found to be justified to include difenacoum and
biocidal products in the meeting of the Product Auth
other anticoagulant rodenticides in Annex I to Directive
orisation and Mutual Recognition Facilitation Group of
98/8/EC, thus allowing Member States to authorise difen
22-23 May 2012.
acoum-based products. However, Directive 2008/81/EC
obliges Member States to ensure, when granting auth
orisation of products containing difenacoum, that
(9) The
Commission
notes
that,
in
accordance
with
Directive
primary as well as secondary exposure of humans,
2008/81/EC, authorisations of biocidal products
non-target animals and the environment is minimised,
containing difenacoum are to be subject to all appro
by considering and applying all appropriate and
priate and available risk mitigation measures, including
available risk mitigation measures. The risk mitigation
the restriction to professional use only. The scientific
measures mentioned in Directive 2008/81/EC therefore
evaluation leading to the adoption of Directive
include, amongst others, restriction to professional use
2008/81/EC concluded that only professional users
only.
could be expected to follow the instructions minimising
the risk of secondary poisoning of non-target animals,
and to use products in a way that prevents the devel
(4) The
company
Lodi
S.A.S.
(‘the
applicant’)
has,
in
opment and spreading of resistance. A restriction to
accordance with Article 8 of Directive 98/8/EC,
professional users should therefore in principle be
considered to be an appropriate risk mitigation
( 1 ) OJ L 123, 24.4.1998, p. 1.
measure, in particular in Member States where resistance
( 2 ) OJ L 201, 30.7.2008, p. 46.
to difenacoum occurs.

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EN
6.11.2012 Official
Journal
of
the
European
Union L
306/27
(10) In the absence of any indication to the contrary, the Commission therefore considers that restriction
to professional users is an appropriate and available risk mitigation measure for the authorisation of
products containing difenacoum in Germany. This conclusion is reinforced by the arguments put
forward by Germany that resistance against difenacoum in rats has been found and is thought to be
developing in the country, and that the country has a well-functioning infrastructure of trained pest
control operators and licensed professionals, such as farmers, gardeners and foresters who received
professional training, which means that the proposed restriction does not hinder infection prevention.
(11) The measures provided for in this Decision are in accordance with the opinion of the Standing
Committee on Biocidal Products,
HAS ADOPTED THIS DECISION:
Article 1
Germany may restrict the authorisations granted in accordance with Article 4 of Directive 98/8/EC for the
products mentioned in the Annex to this Decision to use by trained or licensed professionals.
Article 2
This Decision is addressed to the Federal Republic of Germany.
Done at Brussels, 31 October 2012.
For the Commission
Janez POTONIK
Member of the Commission

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L 306/28
ANNEX
Products for which Germany may restrict the authorisations granted in accordance with Article 4 of Directive 98/8/EC to use by trained or licensed professionals:
Product name in Ireland Irish
application
reference
number
in
R4PB Product
name
in
Germany German
application
reference
number
in
R4PB
EN
Ruby Block 2010/6249/5607/IE/AA/6647 Rubis
Bloc 2010/6249/5607/DE/MA/6893

Ruby Paste 2010/6249/5586/IE/AA/6645 Rubis
Pasta 2010/6249/5586/DE/MA/6765
Off
icial
Jour
nal
of
the
European
Union
6.11.2012

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Document Outline

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