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21.2.2013 Official
Journal
of
the
European
Union L
48/17
COMMISSION IMPLEMENTING DECISION
of 19 February 2013
regarding restrictions of authorisations of biocidal products containing difenacoum notified by
Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council
(notified under document C(2013) 780)
(Only the German text is authentic)
(2013/96/EU)
THE EUROPEAN COMMISSION,
submitted an application to the United Kingdom for
authorisation for six rodenticides containing difenacoum
(‘the products’).
Having regard to the Treaty on the Functioning of the European
Union,
Having regard to Directive 98/8/EC of the European Parliament
(5) The
United
Kingdom
granted
the
authorisations
to
five
and of the Council of 16 February 1998 concerning the placing
products on 3 November 2011 and to another one on
of biocidal products on the market (
14 November 2011. The products were authorised for

1 ), and in particular
Article 4(4) thereof,
general use against rats and mice for the protection of
stored products, food, health and material. The
restrictions to ensure that the conditions of Article 5
Whereas:
of Directive 98/8/EC were met in the United Kingdom
included a requirement to indicate ‘Keep away from food,
drink and animal feedingstuffs’ on the label, but did not
(1) Annex
I
to
Directive
98/8/EC
contains
the
list
of
active
include restriction to trained or licensed professional
substances approved at Union level for inclusion in
users.
biocidal products. Commission Directive 2008/81/EC of
29 July 2008 amending Directive 98/8/EC of the
European Parliament and of the Council to include
difenacoum as an active substance in Annex I thereto ( 2 )
(6) On
31
March
2010,
the
applicant
submitted
a
complete
added the active substance difenacoum to belonging to
application to Germany for mutual recognition of the
product type 14, rodenticides, as defined in Annex V to
first authorisations in respect of the products.
Directive 98/8/EC.
(2) Difenacoum
is
an
anticoagulant
rodenticide
known
to (7) On
8
June
2012,
Germany
notified
the
Commission,
the
pose risks of accidental incidents with children, as well
other Member States and the applicant of its proposal to
as risks for animals and the environment. It has been
restrict the first authorisations in accordance with
identified as potentially persistent, liable to bioac
Article 4(4) of Directive 98/8/EC. Germany proposed to
cumulate and toxic (‘PBT’), or very persistent and very
impose a restriction on the products to use by trained or
liable to bioaccumulate (‘vPvB’).
licensed professionals, as well as by excluding food
protection from the authorised intended uses of the
contested products if the food consists of plants or
(3) For
reasons
of
public
health
and
hygiene,
it
was
never
theless found to be justified to include difenacoum and
plant products within the meaning of Article 3 points
other anticoagulant rodenticides in Annex I to Directive
5 and 6 of Regulation (EC) No 1107/2009 of the
98/8/EC, thus allowing Member States to authorise difen
European Parliament and of the Council of 21 October
acoum-based products. However, Directive 2008/81/EC
2009 concerning the placing of plant protection
obliges Member States to ensure, when granting auth
products on the market and repealing Council Directives
orisation of products containing difenacoum, that
79/117/EEC and 91/414/EEC ( 3 ).
primary as well as secondary exposure of humans,
non-target animals and the environment is minimised,
by considering and applying all appropriate and
available risk mitigation measures. The risk mitigation
(8) The
Commission
invited
the
other
Member
States
and
measures mentioned in Directive 2008/81/EC therefore
the applicant to submit comments to the notification
include, amongst others, restriction to professional use
in writing within 90 days in accordance with
only.
Article 27(1) of Directive 98/8/EC. No comments were
submitted within that deadline. The notification was also
discussed between the Commission and Member States’
(4) The
company
Kwizda
France
S.A.S.
(‘the
applicant’)
has,
Competent Authorities for biocidal products in the
in accordance with Article 8 of Directive 98/8/EC,
meeting of the Product Authorisation and Mutual Recog
nition Facilitation Group of 3-4 July 2012.
( 1 ) OJ L 123, 24.4.1998, p. 1.
( 2 ) OJ L 201, 30.7.2008, p. 46.
( 3 ) OJ L 309, 24.11.2009, p. 1.

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L 48/18
EN
Official Journal of the European Union
21.2.2013
(9) Concerning
the
restriction
on
the
products
to
use
by
products whose main purpose is considered to be
trained or licensed professionals, in accordance with
hygiene rather than the protection of plants or plant
Directive 2008/81/EC, authorisations of biocidal
products.
products containing difenacoum are to be subject to all
appropriate and available risk mitigation measures,
including the restriction to professional use only. The
scientific evaluation leading to the adoption of
(14) The contested products are, inter alia, intended for use as
Directive 2008/81/EC concluded that only professional
rodenticides against mice and rats to protect food, and
users could be expected to follow the instructions mini
food can constitute plants or plant products as defined
mising the risk of secondary poisoning of non-target
in Article 3 points 5 and 6 of Regulation (EC) No
animals, and to use products in a way that prevents
1107/2009.
the development and spreading of resistance. A
restriction to professional users should therefore in
principle be considered to be an appropriate risk miti
gation measure, in particular in Member States where
(15) However,
the
contested
products
are
also
intended
for
a
resistance to difenacoum occurs.
number of other purposes than food protection, and
most food does not constitute plants or plant products.
Furthermore, the labelling requirements in the authori
sations of the contested products ensure that the
products are not directly applied on food ( 1 ). The appli
cation of the products referred to as ‘food protection’ in
(10) In the absence of any indication to the contrary,
restriction to professional users is therefore an appro
the authorisation should be seen as primarily intended to
priate and available risk mitigation measure for the auth
avoid food contamination from rodents and the
orisation of products containing difenacoum in Germany.
consequent danger for transmission of zoonotic
This conclusion is reinforced by the arguments put
diseases, in line with the general hygiene requirements
forward by Germany that resistance against difenacoum
for all stages of production, processing and distribution
in rats has been found and is thought to be developing in
according to Annex II to Regulation (EC) No 852/2004
the country. Furthermore, Germany has a well-func
of the European Parliament and of the Council of
tioning infrastructure of trained pest control operators
29 April 2004 on the hygiene of foodstuffs ( 2 ).
and licensed professionals, such as farmers, gardeners
and foresters who received professional training, which
means that the proposed restriction does not hinder
(16) As the main purpose of the contested products is hygiene
infection prevention.
rather than the protection of plants or plant products,
the products are not excluded from the scope of
Directive 98/8/EC by virtue of Article 1(2)(r) of that
Directive for the purpose of its use. The restriction
requested by Germany in this respect cannot be
(11) Regarding
the
exclusion
of
food
protection
from
the
justified on the grounds put forward.
authorised intended uses, Germany argued that
products used for food of plant origin protection are
covered, for this purpose, by Regulation (EC) No
1107/2009 and hence excluded from the scope of
(17) The
measures provided for in this Decision are in
Directive 98/8/EC if the protected food consists of
accordance with the opinion of the Standing
plants or plant products within the meaning of
Committee on Biocidal Products,
Article 3 points 5 and 6 of Regulation (EC) No
1107/2009.
HAS ADOPTED THIS DECISION:
(12) The
Commission
notes
that
it
is
undisputed
that
the
contested products are covered by the definition of a
Article 1
biocidal product in Article 2(1)(a) of Directive 98/8/EC.
Germany may restrict the authorisations granted in accordance
It therefore merely should be examined whether the
with Article 4 of Directive 98/8/EC for the products mentioned
products are nevertheless excluded from the scope of
in the Annex to this Decision to use by trained or licensed
Directive 98/8/EC by virtue of Article 1(2)(r) of that
professionals, without excluding food protection from the auth
Directive for the purpose of certain uses, in which case
orised intended uses of the products.
those particular uses would require additional authori
sations in accordance with Regulation (EC) No
( 1 ) See, in this respect, a published guidance document agreed between
1107/2009.
the Commission services and the competent authorities of Member
States for the biocidal products Directive 98/8/EC and for the plant
protection products Directive 91/414/EEC entitled ‘Borderline between
Directive 98/8/EC concerning the placing on the market of Biocidal product
and Directive 91/414/EEC concerning the placing on the market of plant
protection products’, available on the website http://ec.europa.eu/food/
(13) It
follows
from
Article
2(1)(a)
of
Regulation
(EC)
No
plant/protection/evaluation/borderline_en.htm
1107/2009 that that Regulation does not apply to
( 2 ) OJ L 139, 30.4.2004, p. 1.

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EN
21.2.2013 Official
Journal
of
the
European
Union L
48/19
Article 2
This Decision is addressed to the Federal Republic of Germany.
Done at Brussels, 19 February 2013.
For the Commission
Janez POTONIK
Member of the Commission

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L 48/20
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 UK
UK application reference number in the Register for Biocidal
Products
Product name in Germany
German application reference number in the Register for Biocidal
Products
EN
Murabloc LM 2010/1329/5686/UK/AA/7269 Murablock 2010/1329/5686/DE/MA/8105

Souribloc 2010/1329/5706/UK/AA/7465 Souriblock 2010/1329/5706/DE/MA/8109
Raticide VK 2010/1329/5726/UK/AA/7468 MUSCIDAN
Haferkder 2010/1329/5726/DE/MA/8113
Le Souriquois 2010/1329/5728/UK/AA/7470 MUSCIDAN
Weizenkder 2010/1329/5728/DE/MA/8120
Ratigum 2010/1329/5707/UK/AA/7466 Ratigum 2010/1329/5707/DE/MA/8110
Off
icial
Super Pellets 2010/1329/5708/UK/AA/7467 Super
Pellets 2010/1329/5708/DE/MA/8112
Jour
nal
of
the
European
Union
21.2.2013

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Document Outline

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