HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 44/14
EN
Official Journal of the European Union
15.2.2013
COMMISSION DIRECTIVE 2013/5/EU
of 14 February 2013
amending Directive 98/8/EC of the European Parliament and of the Council to include pyriproxyfen
as an active substance in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(6)
Not all potential uses and exposure scenarios have been
evaluated at Union level, which, in particular, included
only professional use. It is therefore appropriate to
Having regard to the Treaty on the Functioning of the European
require that Member States assess those uses or
Union,
exposure scenarios and those risks to human populations
and to environmental compartments that have not been
representatively addressed in the Union level risk
Having regard to Directive 98/8/EC of the European Parliament
assessment and, when granting product authorisations,
and of the Council of 16 February 1998 concerning the placing
ensure that appropriate measures are taken or specific
of biocidal products on the market ( 1 ), and in particular the
conditions imposed in order to reduce the identified
second subparagraph of Article 16(2) thereof,
risks to acceptable levels.
Whereas:
(7)
In the light of the findings in the assessment report that
there is a possible indirect human exposure via
consumption of food as a result of those uses repre
(1) Commission
Regulation
(EC)
No
1451/2007 of
4 December 2007 on the second phase of the 10-year
sented in the assessment, it is appropriate to require,
work programme referred to in Article 16(2) of Directive
where relevant, verification of the need to set new or
98/8/EC of the European Parliament and of the Council
to amend existing maximum residue levels in accordance
concerning the placing of biocidal products on the
with Regulation (EC) No 470/2009 of the European
market (
Parliament and of the Council of 6 May 2009 laying

2 ) establishes a list of active substances to be
assessed, with a view to their possible inclusion in
down Community procedures for the establishment of
Annex I, IA or IB to Directive 98/8/EC. That list
residue limits of pharmacologically active substances in
includes pyriproxyfen.
foodstuffs of animal origin, repealing Council Regulation

(EEC) No 2377/90 and amending Directive 2001/82/EC
of the European Parliament and of the Council and Regu
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
pyriproxyfen
lation (EC) No 726/2004 of the European Parliament and
has been evaluated in accordance with Article 11(2) of
of the Council ( 3 ) or with Regulation (EC) No 396/2005
Directive 98/8/EC for use in product-type 18, insec
of the European Parliament and of the Council of
ticides, acaricides and products to control other arth
23 February 2005 on maximum residue levels of
ropods, as defined in Annex V to that Directive.
pesticides in or on food and feed of plant and animal
origin and amending Council Directive 91/414/EEC ( 4 ).
Measures should be adopted ensuring that the applicable
(3) The
Netherlands
were
designated
as
Rapporteur
Member
maximum residue levels are not exceeded.
State and submitted the competent authority report,
together with a recommendation, to the Commission
on 2 October 2009 in accordance with Article 10(5)
(8) In view of the assumptions made during the risk
and (7) of Regulation (EC) No 1451/2007.
assessment, it is appropriate to require that products
authorised for professionals are used with appropriate
personal protective equipment, unless it can be demon
(4) The
competent
authority
report
was
reviewed
by
the
strated in the application for product authorisation that
Member States and the Commission. In accordance
risks to workers and operators can be reduced to an
with Article 15(4) of Regulation (EC) No 1451/2007,
acceptable level.
the findings of the review were incorporated, within
the Standing Committee on Biocidal Products on
21 September 2012, in an assessment report.
(9)
In view of the risks identified for the environment, it is
appropriate to require that products are not authorised
for direct use on surface water, unless it can be demon
(5) It
appears
from
the
evaluations
that
biocidal
products
strated in the application for product authorisation that
used as insecticides, acaricides and products to control
risks to the aquatic and terrestrial ecosystems and
other arthropods and containing pyriproxyfen may be
groundwater can be reduced to an acceptable level, and
expected to satisfy the requirements laid down in
that any authorisation of products intended to be used in
Article 5 of Directive 98/8/EC. It is therefore appropriate
waste treatment facilities is subject to appropriate risk
to include pyriproxyfen for use in product type 18 in
mitigation measures to avoid contamination of the area
Annex I to that Directive.
outside the waste treatment site.
( 1 ) OJ L 123, 24.4.1998, p. 1.
( 3 ) OJ L 152, 16.6.2009, p. 11.
( 2 ) OJ L 325, 11.12.2007, p. 3.
( 4 ) OJ L 70, 16.3.2005, p. 1.

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EN
15.2.2013 Official
Journal
of
the
European
Union L
44/15
(10) The
provisions
of
this
Directive
should
be
applied
simul
HAS ADOPTED THIS DIRECTIVE:
taneously in all Member States in order to ensure equal
treatment on the Union market of biocidal products of
Article 1
product-type 18 containing the active substance pyri
proxyfen and also to facilitate the proper operation of
Annex I to Directive 98/8/EC is amended in accordance with
the biocidal products market in general.
the Annex to this Directive.

Article 2
(11) A
reasonable
period
should
be
allowed
to
elapse
before
1. Member
States
shall
adopt
and
publish,
by
31
January
an active substance is included in Annex I to Directive
2014 at the latest, the laws, regulations and administrative
98/8/EC, in order to permit Member States and interested
provisions necessary to comply with this Directive.
parties to prepare themselves to meet the new
requirements entailed and to ensure that applicants
They shall apply those provisions from 1 February 2015.
who have prepared dossiers can benefit fully from the
10-year period of data protection, which, in accordance
When Member States adopt those provisions, they shall contain
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from
a reference to this Directive or be accompanied by such a
the date of inclusion.
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.
(12) After
inclusion,
Member States should
be allowed
a
2. Member
States
shall
communicate
to
the
Commission
the
reasonable period to implement Article 16(3) of
text of the main provisions of national law which they adopt in
Directive 98/8/EC.
the field covered by this Directive.
Article 3
(13) Directive
98/8/EC
should
therefore
be
amended
accord
ingly.
This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
European Union.
(14) In
accordance
with
the
Joint
Political
Declaration
of
28 September 2011 of Member States and the
Article 4
Commission on explanatory documents
( 1 ), Member
States have undertaken to accompany, in justified cases,
This Directive is addressed to the Member States.
the notification of their transposition measures with one
or more documents explaining the relationship between
the components of a directive and the corresponding
Done at Brussels, 14 February 2013.
parts of national transposition instruments.
For the Commission
(15) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
The President
Committee on Biocidal Products,
José Manuel BARROSO
( 1 ) OJ C 369, 17.12.2011, p. 14.

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L 44/16
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
EN
No Common
Name
IUPAC Name
Identification Numbers
purity of the
Date of inclusion
the exceptions indicated in Expiry date of inclusion Product
type Specific
provisions
(***)

active
the footnote to this heading
substance (*)
applies (**)
‘62 pyriproxyfen 4-phenoxyphenyl
(RS)-2-(2-
970 g/kg 1
February
2015 31
January
2017 31
January
2025 18 The
Union
level
risk
assessment
did
not
address
all
pyridyloxy)propyl ether
potential uses and exposure scenarios; certain uses
and exposure scenarios, such as use by non-profes
sionals, were excluded. When assessing the appli
EC No: 429-800-1
cation for authorisation of a product in accordance
with Article 5 and Annex VI, Member States shall
assess, where relevant for the particular product,
Off
CAS No: 95737-68-1
those uses or exposure scenarios and those risks to
icial
human populations and to environmental
compartments that have not been representatively
Jour
addressed in the Union level risk assessment.
nal
of
For products containing pyriproxyfen that may
the
lead to residues in food or feed, Member States
shall verify the need to set new or to amend
European
existing maximum residue levels (MRLs) in
accordance with Regulation (EC) No 470/2009
or Regulation (EC) No 396/2005, and take any
appropriate risk mitigation measures ensuring
Union
that the applicable MRLs are not exceeded.
Member States shall ensure that authorisations are
subject to the following conditions:
(1) Products authorised for professionals shall be
used with appropriate personal protective
equipment, unless it can be demonstrated in
the application for product authorisation that
risks can be reduced to an acceptable level by
other means.
(2) Products shall not be authorised for direct use
on surface water, unless it can be demon
15.2.2013
strated in the application for product authori
sation that risks can be reduced to an
acceptable level.

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15.2.2013 Off
Minimum
Deadline for compliance with
degree of
Article 16(3), unless one of
No Common
Name
IUPAC Name
Identification Numbers
purity of the
Date of inclusion
the exceptions indicated in Expiry date of inclusion Product
type Specific
provisions
(***)
active
the footnote to this heading
substance (*)
applies (**)
(3) Products intended to be used in waste
treatment facilities shall be subject to appro
EN
priate risk mitigation measures to avoid

contamination of the area outside the waste
treatment site.’
(*) 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
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).
(***) 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
icial
Jour
nal
of
the
European
Union
L
44/17

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Document Outline

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