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15.3.2013 Official
Journal
of
the
European
Union L
72/13
COMMISSION IMPLEMENTING DECISION
of 13 March 2013
rejecting a restriction of the authorisation of a biocidal product containing indoxacarb notified by
Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council
(notified under document C(2013) 1366)
(Only the German text is authentic)
(2013/130/EU)
THE EUROPEAN COMMISSION,
lishments may be made only as a crack and crevice
treatment. The authorisation set out that the product
had to be labelled with the following instruction: ‘Do
Having regard to the Treaty on the Functioning of the European
not apply to areas where food/feed, food utensils or
Union,
food processing surfaces may come into contact with,
or be contaminated by the product’.
Having regard to Directive 98/8/EC of the European Parliament
and of the Council of 16 February 1998 concerning the placing
(5) On
21
December
2011,
the
applicant
submitted
a
of biocidal products on the market ( 1 ), and in particular
complete application to Germany for mutual recognition
Article 4(4) thereof,
of the first authorisation in respect of the contested
product.
Whereas:
(6) On
23
April
2012,
Germany
notified
the
Commission,
(1) Annex
I
to
Directive
98/8/EC
contains
the
list
of
active
the other Member States and the applicant of its proposal
substances approved at Union level for inclusion in
to restrict the first authorisation in accordance with
biocidal products. Commission Directive 2009/87/EC of
Article 4(4) of Directive 98/8/EC by excluding food
29 July 2009 amending Directive 98/8/EC of the
protection from the authorised intended uses of the
European Parliament and of the Council to include
contested product.
indoxacarb as an active substance in Annex I thereto ( 2 )
added the active substance indoxacarb to products
belonging to product-type 18: Insecticides, acaricides
(7) As
justification
for
the
notification,
Germany
submitted
and products to control other arthropods, as defined in
that products used for food protection are covered, for
Annex V to Directive 98/8/EC.
this purpose, by Regulation (EC) No 1107/2009 of the

European Parliament and of the Council of 21 October
2009 concerning the placing of plant protection
(2) Directive
2009/87/EC
requires
Member
States
to
assess,
products on the market and repealing Council Directives
for the purpose of granting product authorisation, any
79/117/EEC and 91/414/EEC ( 3 ), and are hence excluded
relevant use scenarios that have not been representatively
from the scope of Directive 98/8/EC if the protected food
addressed at the Union level risk assessment.
consists of plants or plant products within the meaning
of Article 3(5) and (6) of Regulation (EC) No 1107/2009.
(3) The
company
DuPont
de
Nemours
(Deutschland)
GmbH
(‘the applicant’) submitted an application to the United
(8) The
Commission
invited
the
other
Member
States
and
Kingdom for authorisation of a product containing
the applicant to submit comments to the notification
indoxacarb (‘the contested product’) in accordance with
in writing within 90 days in accordance with
Article 8 of Directive 98/8/EC. The names and reference
Article 27(1) of Directive 98/8/EC. Comments were
numbers of the contested product in the Register for
submitted within that deadline by the United Kingdom,
Biocidal Products (‘R4BP’) are indicated in the Annex to
France and Spain. The notification was also discussed
this Decision.
between Commission representatives, representatives of
Member States’ Competent Authorities for biocidal
products in the meeting of the Product Authorisation
(4) On
28
October
2011,
the
United
Kingdom
authorised
and Mutual Recognition Facilitation Group of 22-
the contested product for the control of ants. According
23 May 2012, where the applicant was present.
to that authorisation, the product may be applied only in
and around residential homes, industrial facilities, offices,
warehouses, commercial kitchens, hospitals, schools,
(9)
As it is undisputed that the contested product is covered
nursing homes, hotels, buses, trains, aircraft, retail and
by the definition of a biocidal product in Article 2(1)(a)
commercial establishments. That authorisation further
of Directive 98/8/EC, it merely should be examined
provides that the application of the contested product
whether the product is nevertheless excluded from the
to food or feed areas of food or feed handling estab
scope of Directive 98/8/EC by virtue of Article 1(2)(r) of
that Directive for the purpose of certain uses, in which
( 1 ) OJ L 123, 24.4.1998, p. 1.
( 2 ) OJ L 198, 30.7.2009, p. 35.
( 3 ) OJ L 309, 24.11.2009, p. 1.

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L 72/14
EN
Official Journal of the European Union
15.3.2013
case those particular uses would require an additional
(13) As the main purpose of the contested product is hygiene
authorisation in accordance with Regulation (EC) No
rather than the protection of plants or plant products,
1107/2009.
the product is not excluded from the scope of Directive
98/8/EC by virtue of Article 1(2)(r) of that Directive for
(10) It
follows
from
Article
2(1)(a)
of
Regulation
(EC)
No
the purpose of its use in commercial kitchens. The
1107/2009 that that Regulation does not apply to
Commission therefore considers that the restriction
products whose main purpose is considered to be
requested by Germany cannot be justified on the
hygiene rather than the protection of plants or plant
grounds put forward.
products.
(14) The
measures provided for in this Decision are in
(11) The contested product is, inter alia, intended for use as
accordance with the opinion of the Standing
an insecticide against ants in commercial kitchens. One
Committee on Biocidal Products,
of the intentions of such use can be the protection of
plant products as defined in Article 3(6) of Regulation
HAS ADOPTED THIS DECISION:
(EC) No 1107/2009, which can include food.
Article 1
(12) The
contested product is also intended for a large
The proposal by Germany to restrict the authorisation granted
number of other use areas, where it will not serve the
by the United Kingdom on 28 October 2011 of the product
purpose of protecting food consisting of plants or plant
mentioned in the Annex, by excluding food protection from the
products. Furthermore, even the application in
authorised intended uses of the product, is rejected.
commercial kitchens cannot be considered as primarily
intended for plant product protection: First, the contested
product must not be directly applied on food or indi
Article 2
rectly come into contact with food through application
This Decision is addressed to the Federal Republic of Germany.
on empty structures. Second, most products handled in a
commercial kitchen are not plant products ( 1 ). Third,
Member States other than Germany have informed the
Commission that the contested product is used in
Done at Brussels, 13 March 2013.
kitchens to comply with the general hygiene
requirements according to Annex II to Regulation (EC)
For the Commission
No 852/2004 of the European Parliament and of the
Council of 29 April 2004 on the hygiene of foodstuffs (
Janez POTONIK

2 )
for all stages of production, processing and distribution.
Member of the Commission
( 1 ) See, in this respect, a published guidance document agreed between
the Commission services and the competent authorities of Member
States for the biocidal products Directive 98/8/EC and for the plant
protection products Council Directive 91/414/EEC (OJ L 230,
19.8.1991, p. 1) 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/plant/
protection/evaluation/borderline_en.htm
( 2 ) OJ L 139, 30.4.2004, p. 1.

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EN
15.3.2013 Official
Journal
of
the
European
Union L
72/15
ANNEX
Product for which the proposal by Germany, to restrict the authorisation granted in accordance with Article 4 of
Directive 98/8/EC, is rejected:
Product name in the United
United Kingdom application
German application reference
Kingdom
reference number in the Register
Product name in Germany
number in the Register for
for Biocidal Products
Biocidal Products
DuPont Advion Ant Gel 2010/1949/4987/UK/
Advion Ameisen Gel 2011/1949/4987/DE/
0,05 %
AA/5945
MA/28005

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Document Outline

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