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21.9.2011 Official
Journal
of
the
European
Union L
243/7
DIRECTIVES
COMMISSION DIRECTIVE 2011/78/EU
of 20 September 2011
amending Directive 98/8/EC of the European Parliament and of the Council to include Bacillus
thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 as an active substance in Annex I
thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(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,
the findings of the review were incorporated, within
Having regard to the Treaty on the Functioning of the European
the Standing Committee on Biocidal Products on
Union,
6 May 2011, 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
(5) It
appears
from
the
evaluations
that
biocidal
products
of biocidal products on the market ( 1 ), and in particular the
used as insecticides, acaricides and products to control
second subparagraph of Article 16(2) thereof,
other arthropods and containing Bacillus thuringiensis
subsp. israelensis Serotype H14, Strain AM65-52, may
be expected to satisfy the requirements laid down in
Article 5 of Directive 98/8/EC. It is therefore appropriate
Whereas:
to include Bacillus thuringiensis subsp. israelensis Serotype
H14, Strain AM65-52 in Annex I to that Directive.
(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
(6) Not
all
potential
uses
have
been
evaluated
at
Union
level.
98/8/EC of the European Parliament and of the Council
It is therefore appropriate that Member States assess
concerning the placing of biocidal products on the
those uses or exposure scenarios and those risks to
market (
human populations and to environmental compartments

2 ) establishes a list of active substances to be
assessed, with a view to their possible inclusion in
that have not been representatively addressed in the
Annex I, IA or IB to Directive 98/8/EC. That list
Union level risk assessment and, when granting
includes Bacillus thuringiensis subsp. israelensis Serotype
product authorisations, ensure that appropriate
H14.
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,
Strain
AM65-52 of Bacillus thuringiensis subsp. israelensis
(7)
In the light of the potential risks identified for profes
Serotype H14, has been evaluated in accordance with
sional use without personal protective equipment, it is
Article 11(2) of Directive 98/8/EC for use in product-
appropriate to require that product authorisations for
type 18, insecticides, acaricides and products to control
professional use are granted only for use with appro
other arthropods, as defined in Annex V to that
priate personal protective equipment, unless it can be
Directive. Strain SA3A of Bacillus thuringiensis subsp.
demonstrated in the application for product authori
israelensis Serotype H14 is still under evaluation for use
sation that risks to professional users can be reduced
in that product-type.
to an acceptable level by others means.
(3) Italy
was
designated
as
Rapporteur
Member
State
and
submitted the competent authority report, together
(8) In
the
light
of
the
possible
indirect
human
exposure
via
with a recommendation, to the Commission on 11 July
consumption of food as a result of those uses repre
2008 in accordance with Article 14(4) and (6) of Regu
sented in the assessment, it is appropriate to require,
lation (EC) No 1451/2007.
where relevant, verification of the need to set new or
to amend existing maximum residue levels according to
( 1 ) OJ L 123, 24.4.1998, p. 1.
Regulation (EC) No 470/2009 of the European
( 2 ) OJ L 325, 11.12.2007, p. 3.
Parliament and of the Council of 6 May 2009 laying

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L 243/8
EN
Official Journal of the European Union
21.9.2011
down Community procedures for the establishment of
HAS ADOPTED THIS DIRECTIVE:
residue limits of pharmacologically active substances in
foodstuffs of animal origin, repealing Council Regulation
(EEC) No 2377/90 and amending Directive 2001/82/EC
Article 1
of the European Parliament and of the Council and Regu
lation (EC) No 726/2004 of the European Parliament and
Annex I to Directive 98/8/EC is amended in accordance with
of the Council ( 1 ) or Regulation (EC) No 396/2005 of the
the Annex to this Directive.
European Parliament and of the Council of 23 February
2005 on maximum residue levels of pesticides in or on
food and feed of plant and animal origin and amending
Article 2
Council Directive 91/414/EEC ( 2 ). Measures should be
adopted ensuring that the applicable maximum residue
1. Member
States
shall
adopt
and
publish,
by
30
September
levels are not exceeded.
2012 at the latest, the laws, regulations and administrative
provisions necessary to comply with this Directive.
(9) The
provisions
of
this
Directive
should
be
applied
at
the
same time in all Member States in order to ensure equal
They shall apply those provisions from 1 October 2013.
treatment on the Union market of biocidal products
containing the active substance Bacillus thuringiensis
subsp. israelensis Serotype H14, Strain AM65-52 and
When Member States adopt those provisions, they shall contain
also to facilitate the proper operation of the market for
a reference to this Directive or be accompanied by such a
biocidal products in general.
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.
(10) A
reasonable
period
should
be
allowed
to
elapse
before
an active substance is included in Annex I to Directive
2. Member
States
shall
communicate
to
the
Commission
the
98/8/EC, in order to permit Member States and interested
text of the main provisions of national law which they adopt in
parties to prepare themselves to meet the new
the field covered by this Directive.
requirements entailed and to ensure that applicants
who have prepared dossiers can benefit fully from the
10-year period of data protection, which, in accordance
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from
Article 3
the date of inclusion.
This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.
(11) 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.
(12) Directive 98/8/EC should therefore be amended
accordingly.
Done at Brussels, 20 September 2011.
For the Commission
(13) 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 L 152, 16.6.2009, p. 11.
( 2 ) OJ L 70, 16.3.2005, p. 1.

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21.9.2011 Off
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
Deadline for compliance
with Article 16(3) (except
EN
Minimum purity
for products containing

of the active
more than one active
substance, for which the
No Common
Name
IUPAC Name
substance in the
Expiry date of Product-
Identification Numbers
biocidal product Date of inclusion
deadline to comply with
inclusion
type
Specific provisions (*)
as placed on the
Article 16(3) shall be the
market
one set out in the last of
the inclusion decisions
relating to its active
substances)
‘46 Bacillus
Not applicable No
relevant
1 October 2013 30
September
2015 30
September 18 When
assessing
the
application
for
authorisation
of
a
thuringiensis
impurities
2023
product in accordance with Article 5 and Annex VI,
subsp.
Member States shall assess, where relevant for the particular
israelensis
product, those uses or exposure scenarios and those risks to
icial
Serotype
human populations and to environmental compartments
H14, Strain
that have not been representatively addressed in the Union
Jour
AM65-52
level risk assessment.
nal
Products authorised for professional use shall be used with
of
appropriate personal protective equipment, unless it can be
the
demonstrated in the application for product authorisation
European
that risks to professional users can be reduced to an
acceptable level by other means.
For products containing Bacillus thuringiensis subsp. israelensis
Union
Serotype H14, Strain AM65-52 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)
according to 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.’
(*) 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
L
243/9

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