HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 48/10
EN
Official Journal of the European Union
21.2.2013
DIRECTIVES
COMMISSION DIRECTIVE 2013/6/EU
of 20 February 2013
amending Directive 98/8/EC of the European Parliament and of the Council to include
diflubenzuron as an active substance in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
the Standing Committee on Biocidal Products on
21 September 2012, in an assessment report.
Having regard to the Treaty on the Functioning of the European
Union,
(5) It
appears
from
the
evaluations
that
biocidal
products
used as insecticides, acaricides and products to control
Having regard to Directive 98/8/EC of the European Parliament
other arthropods and containing diflubenzuron may be
and of the Council of 16 February 1998 concerning the placing
expected to satisfy the requirements laid down in
of biocidal products on the market ( 1 ), and in particular the
Article 5 of Directive 98/8/EC. It is therefore appropriate
second subparagraph of Article 16(2) thereof,
to include diflubenzuron for use in product-type 18 in
Annex I to that Directive.
Whereas:
(1) Commission
Regulation
(EC)
No
1451/2007 of (6)
Not all potential uses and exposure scenarios have been
4 December 2007 on the second phase of the 10-year
evaluated at Union level. For example, outdoor use, use
work programme referred to in Article 16(2) of Directive
by non-professionals, and exposure of livestock were not
98/8/EC of the European Parliament and of the Council
assessed. It is therefore appropriate to require that
concerning the placing of biocidal products on the
Member States assess those uses or exposure scenarios
market ( 2 ) establishes a list of active substances to be
and those risks to human populations and to environ
assessed, with a view to their possible inclusion in
mental compartments that have not been representatively
Annex I, IA or IB to Directive 98/8/EC. That list
addressed in the Union level risk assessment and, when
includes N-[[(4-chlorophenyl)amino]carbonyl]-2,6-diflu
granting product authorisations, ensure that appropriate
orobenzamide, which is a synonym for diflubenzuron.
measures are taken or specific conditions imposed in
order to reduce the identified risks to acceptable levels.
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
diflu
benzuron has been evaluated in accordance with
Article 11(2) of Directive 98/8/EC for use in product-
(7)
In the light of the findings in the assessment report that
type 18, insecticides, acaricides and products to control
there is a possible indirect human exposure via
other arthropods, as defined in Annex V to that
consumption of food as a result of those uses repre
Directive.
sented in the assessment, it is appropriate to require,
where relevant, verification of the need to set new or
to amend existing maximum residue levels in accordance
(3) Sweden
was
designated
as
rapporteur
Member
State
and
with Regulation (EC) No 470/2009 of the European
submitted the competent authority report, together with
Parliament and of the Council of 6 May 2009 laying
a recommendation, to the Commission on 19 November
down Community procedures for the establishment of
2007 in accordance with Article 10(5) and (7) of
residue limits of pharmacologically active substances in
Commission Regulation (EC) No 2032/2003 of
foodstuffs of animal origin, repealing Council Regulation
4 November 2003 on the second phase of the 10-year
(EEC) No 2377/90 and amending Directive 2001/82/EC
work programme referred to in Article 16(2) of Directive
of the European Parliament and of the Council and Regu
98/8/EC of the European Parliament and of the Council
lation (EC) No 726/2004 of the European Parliament and
concerning the placing of biocidal products on the
of the Council ( 4 ) or with Regulation (EC) No 396/2005
market, and amending Regulation (EC) No
of the European Parliament and of the Council of
1896/2000 ( 3 ).
23 February 2005 on maximum residue levels of
pesticides in or on food and feed of plant and animal
(4) The
competent
authority
report
was
reviewed
by
the
origin and amending Council Directive 91/414/EEC ( 5 ).
Member States and the Commission. In accordance
Special consideration should be given to the in vivo
with Article 15(4) of Regulation (EC) No 1451/2007,
genotoxic metabolite PCA. Measures should be adopted
the findings of the review were incorporated, within
ensuring that the applicable maximum residue levels are
not exceeded.
( 1 ) OJ L 123, 24.4.1998, p. 1.
( 2 ) OJ L 325, 11.12.2007, p. 3.
( 4 ) OJ L 152, 16.6.2009, p. 11.
( 3 ) OJ L 307, 24.11.2003, p. 1.
( 5 ) OJ L 70, 16.3.2005, p. 1.

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EN
21.2.2013 Official
Journal
of
the
European
Union L
48/11
(8) In view of the assumptions made during the risk
the components of a directive and the corresponding
assessment, it is appropriate to require that professional
parts of national transposition instruments.
users of products containing diflubenzuron wear appro
priate personal protective equipment, unless it can be
(15) The
measures provided for in this Directive are in
demonstrated in the application for product authori
accordance with the opinion of the Standing
sation that risks to workers and operators can be
Committee on Biocidal Products,
reduced to an acceptable level.
HAS ADOPTED THIS DIRECTIVE:
(9)
In view of the risks identified for the environment, it is
appropriate to require, unless it can be demonstrated in
Article 1
the application for product authorisation that risks to the
aquatic and terrestrial ecosystems can be reduced to an
Annex I to Directive 98/8/EC is amended in accordance with
acceptable level, that products are not authorised in
the Annex to this Directive.
water systems, and that products authorised for use on
manure are only used on dry manure, which has to
Article 2
undergo complete aerobic composting prior to appli
cation of the manure on arable land.
1. Member
States
shall
adopt
and
publish,
by
31
January

2014 at the latest, the laws, regulations and administrative
provisions necessary to comply with this Directive.
(10) The
provisions
of
this
Directive
should
be
applied
simul
taneously in all Member States in order to ensure equal
treatment on the Union market of biocidal products of
They shall apply those provisions from 1 February 2015.
product-type 18 containing the active substance diflu
benzuron and also to facilitate the proper operation of
When Member States adopt those provisions, they shall contain
the biocidal products market in general.
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
(11) A
reasonable
period
should
be
allowed
to
elapse
before
States shall determine how such reference is to be made.
an active substance is included in Annex I to Directive
98/8/EC, in order to permit Member States and interested
2. Member
States
shall
communicate
to
the
Commission
the
parties to prepare themselves to meet the new
text of the main provisions of national law which they adopt in
requirements entailed and to ensure that applicants
the field covered by this Directive.
who have prepared dossiers can benefit fully from the
10-year period of data protection, which, in accordance
Article 3
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from
This Directive shall enter into force on the twentieth day
the date of inclusion.
following that of its publication in the Official Journal of the
European Union.
(12) After
inclusion,
Member States should
be allowed
a
reasonable period to implement Article 16(3) of
Article 4
Directive 98/8/EC.
This Directive is addressed to the Member States.
(13) Directive
98/8/EC
should
therefore
be
amended
accord
ingly.
Done at Brussels, 20 February 2013.
(14) In
accordance
with
the
Joint
Political
Declaration
of
28 September 2011 of Member States and the
Commission on explanatory documents
( 1 ), Member
For the Commission
States have undertaken to accompany, in justified cases,
the notification of their transposition measures with one
The President
or more documents explaining the relationship between
José Manuel BARROSO
( 1 ) OJ C 369, 17.12.2011, p. 14.

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L 48/12
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
Minimum
Deadline for compliance with
degree of
Article 16(3), unless one of the
EN
No Common
Name
IUPAC Name
Identification Numbers
purity of the
Date of inclusion
exceptions indicated in the
Expiry date of inclusion Product
type Specific
provisions
(***)

active
footnote to this heading
substance (*)
applies (**)
‘63 diflubenzuron 1-(4-chlorophenyl)-3-(2,6- 960 g/kg 1
February
2015 31
January
2017 31
January
2025 18 The
Union
level
risk
assessment
did
not
difluorobenzoyl)urea
address all potential uses and exposure
scenarios; certain uses and exposure scen
EC No: 252-529-3
arios, such as outdoor use, use by non-
professionals, and exposure of livestock
CAS No: 35367-38-5
were excluded. When assessing the appli
cation for authorisation of a product in
Off
accordance with Article 5 and Annex VI,
Member States shall assess, where relevant
icial
for the particular product, those uses or
Jour
exposure scenarios and those risks to
human populations and to environmental
nal
compartments that have not been repre
of
sentatively addressed in the Union level
the
risk assessment.
European
For products containing diflubenzuron
that may lead to residues in food or
feed, Member States shall verify the need
Union
to set new or to amend existing maximum
residue levels (MRLs) in accordance with
Regulation (EC) No 470/2009 or Regu
lation (EC) No 396/2005, with special
consideration to the in vivo genotoxic
metabolite PCA, and take any appropriate
risk mitigation measures ensuring that the
applicable MRLs are not exceeded.
Member States shall ensure that authori
sations are subject to the following
conditions unless it can be demonstrated
in the application for product authori
sation that the risks can be reduced to
an acceptable level:
21.2.2013
(1) Professional users shall wear appro
priate personal protective equipment.

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21.2.2013 Off
Minimum
Deadline for compliance with
degree of
Article 16(3), unless one of the
No Common
Name
IUPAC Name
Identification Numbers
purity of the
Date of inclusion
exceptions indicated in the
Expiry date of inclusion Product
type Specific
provisions
(***)
active
footnote to this heading
substance (*)
applies (**)
(2) Product information shall include the
requirement that products shall only
be used on dry manure, and that the
EN

manure must undergo complete
aerobic composting by professionals
prior to application on arable land.
(3) Products shall not be used in water
systems.’
(*) The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 11. The active substance in the product placed on the market can be of equal or
different purity if it has been proven technically equivalent with the evaluated substance.
(**) For products containing more than one active substance covered by Article 16(2), the deadline for compliance with Article 16(3) is that of the last of its active substances to be included in this Annex. For products for which the first
authorisation has been granted later than 120 days before the deadline for compliance with Article 16(3) and a complete application has been submitted for mutual recognition in accordance with Article 4(1) within 60 days of the
granting of the first authorisation, the deadline for compliance with Article 16(3) in relation to that application is extended to 120 days after the date of reception of the complete application for mutual recognition. For products for
icial
which a Member State has proposed to derogate from mutual recognition in accordance with Article 4(4), the deadline for compliance with Article 16(3) is extended to 30 days after the date of the Commission Decision adopted in
accordance with the second subparagraph of Article 4(4).
Jour
(***) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm
nal
of
the
European
Union
L
48/13

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