HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 44/6
EN
Official Journal of the European Union
15.2.2013
DIRECTIVES
COMMISSION DIRECTIVE 2013/3/EU
of 14 February 2013
amending Directive 98/8/EC of the European Parliament and of the Council to extend the inclusion
in Annex I thereto of the active substance thiamethoxam to product-type 18
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) The
competent
authority
report
was
reviewed
by
the
Member States and the Commission. In accordance
with Article 15(4) of Regulation (EC) No 1451/2007,
Having regard to the Treaty on the Functioning of the European
the findings of the review were incorporated, within
Union,
the Standing Committee on Biocidal Products on
21 September 2012, in an assessment report.
Having regard to Directive 98/8/EC of the European Parliament
and of the Council of 16 February 1998 concerning the placing
of biocidal products on the market ( 1 ), and in particular the
(6) It
appears
from
the
evaluations
that
biocidal
products
second subparagraph of Article 16(2) thereof,
used as insecticides, acaricides and products to control
other arthropods and containing thiamethoxam may be
expected to satisfy the requirements laid down in
Whereas:
Article 5 of Directive 98/8/EC. It is therefore appropriate
to extend the inclusion of thiamethoxam in Annex I to
that Directive to product-type 18.
(1) Commission
Regulation
(EC)
No
1451/2007 of
4 December 2007 on the second phase of the 10-year
work programme referred to in Article 16(2) of Directive
98/8/EC of the European Parliament and of the Council
concerning the placing of biocidal products on the
(7) Not
all
potential
uses
have
been
evaluated
at
Union
level.
For example, neither outdoor use, nor use by non-profes
market ( 2 ) establishes a list of active substances to be
sional users were assessed. It is therefore appropriate that
assessed, with a view to their possible inclusion in
Member States assess those uses or exposure scenarios
Annex I, IA or IB to Directive 98/8/EC. That list
and those risks to human populations and to environ
includes thiamethoxam.
mental compartments that have not been representatively
addressed in the Union level risk assessment and, when
granting product authorisations, ensure that appropriate
(2) Commission
Directive
2008/77/EC
of
25
July
2008
measures are taken or specific conditions imposed in
amending Directive 98/8/EC of the European Parliament
order to reduce the identified risks to acceptable levels.
and of the Council to include thiamethoxam as an active

substance in Annex I thereto ( 3 ) included thiamethoxam
as an active substance in Annex I to Directive 98/8/EC
for use in product-type 8, wood preservatives, as defined
in Annex V to Directive 98/8/EC.
(8)
In the light of the unacceptable risks identified for profes
sional users in the brushing application scenario, it is
appropriate to require that products are not authorised
(3) Pursuant
to
Regulation
(EC)
No
1451/2007,
thiame
for such uses, unless data are submitted demonstrating
thoxam has now been evaluated in accordance with
that the product will meet the requirements of both
Article 11(2) of Directive 98/8/EC for use in product-
Article 5 of and Annex VI to Directive 98/8/EC, if
type 18, insecticides, acaricides and products to control
necessary by the application of appropriate risk miti
other arthropods, as defined in Annex V to that
gation measures.
Directive.
(4) Spain
was
designated
as
Rapporteur
Member
State
and (9)
In the light of the risks identified for the aquatic and
submitted the competent authority report, together with
terrestrial ecosystems when products were emitted via a
a recommendation, to the Commission on 2 March
sewage treatment plant or directly to surface water, it is
2009 in accordance with Article 14(4) and (6) of Regu
appropriate to require that products are not authorised
lation (EC) No 1451/2007.
for such uses, unless data are submitted demonstrating
that the product will meet the requirements of both
Article 5 of and Annex VI to Directive 98/8/EC, if
( 1 ) OJ L 123, 24.4.1998, p. 1.
( 2 ) OJ L 325, 11.12.2007, p. 3.
necessary by the application of appropriate risk miti
( 3 ) OJ L 198, 26.7.2008, p. 41.
gation measures.

---

EN
15.2.2013 Official
Journal
of
the
European
Union
L
44/7
(10) In the light of the risks identified in several scenarios of
(17) In
accordance
with
the
Joint
Political
Declaration
of
use without personal protective equipment, it is appro
28 September 2011 of Member States and the
priate to require that products authorised for professional
Commission on explanatory documents
( 3 ), Member
use be used with such equipment, unless it can be
States have undertaken to accompany, in justified cases,
demonstrated in the application for product authori
the notification of their transposition measures with one
sation that risks to professional users can be reduced
or more documents explaining the relationship between
to an acceptable level by other means.
the components of a directive and the corresponding
parts of national transposition instruments.
(11) In the light of the possible indirect human exposure via
consumption of food as a result of those uses presented
(18) The
measures provided for in this Directive are in
in the assessment report, it is appropriate to require,
accordance with the opinion of the Standing
where relevant, verification of the need to set new or
Committee on Biocidal Products,
to amend existing maximum residue levels in accordance
with Regulation (EC) No 470/2009 of the European
Parliament and of the Council of 6 May 2009 laying
HAS ADOPTED THIS DIRECTIVE:
down Community procedures for the establishment of
residue limits of pharmacologically active substances in
foodstuffs of animal origin, repealing Council Regulation
Article 1
(EEC) No 2377/90 and amending Directive 2001/82/EC
Annex I to Directive 98/8/EC is amended in accordance with
of the European Parliament and of the Council and Regu
the Annex to this Directive.
lation (EC) No 726/2004 of the European Parliament and
of the Council ( 1 ) or with Regulation (EC) No 396/2005
of the European Parliament and of the Council of
Article 2
23 February 2005 on maximum residue levels of
pesticides in or on food and feed of plant and animal
1. Member
States
shall
adopt
and
publish,
by
31
January
origin and amending Council Directive 91/414/EEC (
2014 at the latest, the laws, regulations and administrative

2 ).
Measures should be adopted ensuring that the applicable
provisions necessary to comply with this Directive.
maximum residue levels are not exceeded.
They shall apply those provisions from 1 February 2015.
(12) In view of the risks identified for the environment, it is
appropriate to require that product authorisations are
When Member States adopt those provisions, they shall contain
subject to appropriate risk mitigation measures for the
a reference to this Directive or be accompanied by such a
protection of honey bees.
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.
(13) 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
2. Member
States
shall
communicate
to
the
Commission
the
containing the active substance thiamethoxam and also
text of the main provisions of national law which they adopt in
to facilitate the proper operation of the biocidal products
the field covered by this Directive.
market in general.
Article 3
(14) A
reasonable
period
should
be
allowed
to
elapse
before
an active substance is included in Annex I to Directive
This Directive shall enter into force on the twentieth day
98/8/EC, in order to permit Member States and interested
following that of its publication in the Official Journal of the
parties to prepare themselves to meet the new
European Union.
requirements entailed and to ensure that applicants
who have prepared dossiers can benefit fully from the
Article 4
10-year period of data protection, which, in accordance
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from
This Directive is addressed to the Member States.
the date of inclusion.
(15) After
inclusion,
Member States should
be allowed
a
Done at Brussels, 14 February 2013.
reasonable period to implement Article 16(3) of
Directive 98/8/EC.
For the Commission
(16) Directive
98/8/EC
should
therefore
be
amended
accord
The President
ingly.
José Manuel BARROSO
( 1 ) OJ L 152, 16.6.2009, p. 11.
( 2 ) OJ L 70, 16.3.2005, p. 1.
( 3 ) OJ C 369, 17.12.2011, p. 14.

---

L 44/8
ANNEX
In Annex I to Directive 98/8/EC, the following is added to entry No 14:
Deadline for compliance with
Minimum degree of
Article 16(3), unless one of the
No Common
Name
IUPAC Name
Identification Numbers
purity of the active
Date of inclusion
exceptions indicated in the
Expiry date of inclusion Product
type Specific
provisions
(***)
EN
substance (*)
footnote to this heading

applies (**)
‘980 g/kg 1
February
2015 31
January
2017 31
January
2025 18 The
Union
level
risk
assessment
did
not
address all potential uses; certain uses, such
as outdoor application and use by non-
professionals, were excluded. When
assessing the application for authorisation
of a product in accordance with Article 5
and Annex VI, Member States shall assess,
where relevant for the particular product,
Off
those uses or exposure scenarios and those
icial
risks to human populations and to environ
mental compartments that have not been
Jour
representatively addressed in the Union
level risk assessment.
nal
of
Products shall not be authorised for appli
the
cation by brushing, unless data are
European
submitted demonstrating that the product
will meet the requirements of Article 5 and
Annex VI, if necessary by the application of
appropriate risk mitigation measures.
Union
For products containing thiamethoxam that
may lead to residues in food or feed,
Member States shall verify the need to set
new or to amend 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 that the
applicable MRLs are not exceeded.
Products applied in such a way that emission
via a sewage treatment plant or directly to
surface water cannot be prevented shall not
be authorised, unless data are submitted
demonstrating that the product will meet
15.2.2013
the requirements of Article 5 and Annex
VI, if necessary by the application of appro
priate risk mitigation measures.

---

15.2.2013 Off
Deadline for compliance with
Minimum degree of
Article 16(3), unless one of the
No Common
Name
IUPAC Name
Identification Numbers
purity of the active
Date of inclusion
exceptions indicated in the
Expiry date of inclusion Product
type Specific
provisions
(***)
substance (*)
footnote to this heading
applies (**)
Member States shall ensure that authori
sations are subject to the following
EN
conditions:

(1) Products authorised for professional use
shall be used with appropriate personal
protective equipment, unless it can be
demonstrated in the application for
product authorisation that risks to
professional users can be reduced to an
acceptable level by other means.
(2) Where appropriate, measures shall be
icial
taken to protect honey bees.’
Jour
(*) 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
nal
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
of
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
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
European
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
Union
L
44/9

---

Document Outline

• �

---