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2.7.2011 Official
Journal
of
the
European
Union L
175/13
COMMISSION DIRECTIVE 2011/67/EU
of 1 July 2011
amending Directive 98/8/EC of the European Parliament and of the Council to include abamectin as
an active substance in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(6) Not
all
potential
uses
have
been
evaluated
at
Union
level.
It is therefore appropriate that Member States assess
those uses or exposure scenarios and those risks to
Having regard to the Treaty on the Functioning of the European
human populations and to environmental compartments
Union,
that have not been representatively addressed in the
Union level risk assessment and, when granting
product authorisations, ensure that appropriate
Having regard to Directive 98/8/EC of the European Parliament
measures are taken or specific conditions imposed in
and of the Council of 16 February 1998 concerning the placing
order to reduce the identified risks to acceptable levels.
of biocidal products on the market ( 1 ), and in particular the
second subparagraph of Article 16(2) thereof,
Whereas:
(7)
In the light of the risks identified for sediment when

products are used with a certain application rate and
emitted to a sewage treatment plant, it is appropriate
to require that products are not authorised for such
(1) Commission
Regulation
(EC)
No
1451/2007 of
uses, unless data are submitted demonstrating that the
4 December 2007 on the second phase of the 10-year
product will meet the requirements of both Article 5 of
work programme referred to in Article 16(2) of Directive
and Annex VI to Directive 98/8/EC, if necessary by the
98/8/EC of the European Parliament and of the Council
application of appropriate risk mitigation measures.
concerning the placing of biocidal products on the

market ( 2 ) establishes a list of active substances to be
assessed, with a view to their possible inclusion in
Annex I, IA or IB to Directive 98/8/EC. That list
includes abamectin.
(8)
In the light of the findings of the assessment report, it is
appropriate to require that risk mitigation measures are
applied at product authorisation level. In particular, in
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
abamectin
the light of the possible risks for infants and children,
has been evaluated in accordance with Article 11(2) of
appropriate risk mitigation measures should be taken to
Directive 98/8/EC for use in product-type 18, insec
minimise the potential exposure of infants and children.
ticides, acaricides and products to control other
arthropods, as defined in Annex V to that Directive.
(9)
It is important that the provisions of this Directive be
(3) The
Netherlands
was
designated
as
rapporteur
Member
applied simultaneously in all Member States in order to
State and submitted the competent authority report,
ensure equal treatment of biocidal products on the
together with a recommendation, to the Commission
market containing the active substance abamectin and
on 19 June 2009 in accordance with Article 14(4) and
also to facilitate the proper operation of the biocidal
(6) of Regulation (EC) No 1451/2007.
products market in general.
(4) 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,
(10) A
reasonable
period
should
be
allowed
to
elapse
before
the findings of the review were incorporated, within
an active substance is included in Annex I to Directive
the Standing Committee on Biocidal Products on
98/8/EC in order to permit Member States and interested
18 February 2011, in an assessment report.
parties to prepare themselves to meet the new
requirements entailed and to ensure that applicants
who have prepared dossiers can benefit fully from the
(5) It
appears
from
the
evaluations
that
biocidal
products
10-year period of data protection, which, in accordance
used as insecticides, acaricides and products to control
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from
other arthropods and containing abamectin may be
the date of inclusion.
expected to satisfy the requirements laid down in
Article 5 of Directive 98/8/EC. It is therefore appropriate
to include abamectin in Annex I to that Directive.
(11) After
inclusion,
Member States should
be allowed
a
( 1 ) OJ L 123, 24.4.1998, p. 1.
reasonable period to implement Article 16(3) of
( 2 ) OJ L 325, 11.12.2007, p. 3.
Directive 98/8/EC.

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L 175/14
EN
Official Journal of the European Union
2.7.2011
(12) Directive 98/8/EC should therefore be amended
When Member States adopt those provisions, they shall contain
accordingly.
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.
(13) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
Committee on Biocidal Products,
2. Member
States
shall
communicate
to
the
Commission
the
text of the main provisions of national law which they adopt in
the field covered by this Directive.
HAS ADOPTED THIS DIRECTIVE:
Article 3
Article 1
This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.
Annex I to Directive 98/8/EC is amended in accordance with
the Annex to this Directive.
Article 4
This Directive is addressed to the Member States.
Article 2
Transposition
1. Member
States
shall
adopt
and
publish,
by
30
June
2012
Done at Brussels, 1 July 2011.
at the latest, the laws, regulations and administrative provisions
necessary to comply with this Directive.
For the Commission
The President
They shall apply those provisions from 1 July 2013.
José Manuel BARROSO

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2.7.2011 Off
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
Deadline for compliance with
Article 16(3) (except for
Minimum purity of the
products containing more
EN
than one active substance, for

No
Common
IUPAC Name
active substance in the
Date of
Expiry date of
Product
Name
Identification Numbers
biocidal product as
inclusion
which the deadline to comply
inclusion
type
Specific provisions (*)
placed on the market
with Article 16(3) shall be the
one set out in the last of the
inclusion decisions relating to
its active substances)
‘43 Abamectin Abamectin
is
a
mixture
of
avermectin
B 1a
The active
1 July 2013 30
June
2015 30
June
2023 18 When
assessing
the
application
for
authori
and avermectin B 1b
substance shall
sation of a product in accordance with
comply with all the
Article 5 and Annex VI, Member States shall
Abamectin:
following purities:
assess, when relevant for the particular
product, those uses or exposure scenarios
IUPAC name: n.a.
Abamectin:
and those risks to human populations and
icial
to environmental compartments that have
EC No: n.a.
minimum 900 g/kg
not been representatively addressed in the
Jour
Union level risk assessment.
nal
CAS No: 71751-41-2
Avermectin B 1a:
Products applied in such a way that emission
of
the
Avermectin B
to a sewage treatment plant cannot be

1a:
minimum 830 g/kg
prevented shall not be authorised for those
European
application rates for which the Union level
IUPAC name: (10E,14E,16E,22Z)-
Avermectin B 1b:
risk assessment showed unacceptable risks,
(1R,4S,5'S,6S,6'R,8R,12S,13S,20R,21R,24S)-
unless data are submitted demonstrating that
6'-[(S)-secbutyl]-21,24-dihydroxy-
maximum 80 g/kg
the product will meet the requirements of
5',11,13,22-tetramethyl-2-oxo-3,7,19-trioxa
Union
Article 5 and Annex VI, if necessary by the
tetracyclo[15.6.1.14,8 .020,24 ]pentacosa-
application of appropriate risk mitigation
10,14,16,22-tetraene-6-spiro-2'-(5',6'-
measures.
dihydro-2'H-pyran)-12-yl 2,6-dideoxy-4-O-
(2,6-dideoxy-3-O-methyl-α-L-arabino-
hexopyranosyl)-3-O-methyl-α-L-arabinohex
Authorisations shall be subject to appropriate
opyranoside
risk mitigation measures. In particular, appro
priate risk mitigation measures shall be taken
to minimise the potential exposure of infants
EC No: 265-610-3
and children.’
CAS No: 65195-55-3
Avermectin B 1b:
IUPAC name: (10E,14E,16E,22Z)-
(1R,4S,5'S,6S,6'R,8R,12S,13S,20R,21R,24S)-
21,24-dihydroxy-6'-isopropyl-5',11,13,22-
tetramethyl-2-oxo-3,7,19-trioxatet
L
racyclo[15.6.1.14,8 .020,24 ]pentacosa-
175/15
10,14,16,22-tetraene-6-spiro-2'-(5',6'-
dihydro-2'H-pyran)-12-yl

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L 175/16
Deadline for compliance with
Article 16(3) (except for
Minimum purity of the
products containing more
than one active substance, for
No
Common
IUPAC Name
active substance in the
Date of
Expiry date of
Product
Name
Identification Numbers
biocidal product as
inclusion
which the deadline to comply
inclusion
type
Specific provisions (*)
placed on the market
with Article 16(3) shall be the
one set out in the last of the
inclusion decisions relating to
its active substances)
EN

2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-
L-arabino-hexopyranosyl)-3-O-methyl-α-L-
arabinohexopyranoside
EC No: 265-611-9
CAS No: 65195-56-4
Off
icial
(*) 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
Jour
nal
of
the
European
Union
2.7.2011

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