HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 102/28
EN
Official Journal of the European Union
16.4.2011
COMMISSION IMPLEMENTING DIRECTIVE 2011/48/EU
of 15 April 2011
amending Council Directive 91/414/EEC to include bromadiolone as active substance and amending
Commission Decision 2008/941/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
accelerated procedure for the assessment of active
substances which were part of the programme of work
referred to in Article 8(2) of that Directive but have not
been included into its Annex I ( 5 ).
Having regard to the Treaty on the Functioning of the European
Union,
(4) The
application
was
submitted
to
Sweden,
which
had
been designated rapporteur Member State by Regulation
(EC) No 2229/2004. The time period for the accelerated
Having regard to Council Directive 91/414/EEC of 15 July
procedure was respected. The specification of the active
1991 concerning the placing of plant protection products on
substance and the supported uses are the same as were
the market ( 1 ), and in particular Article 6(1) thereof,
the subject of Decision 2008/941/EC. That application
also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation
(EC) No 33/2008.
Whereas:
(5) Sweden
evaluated
the
additional
data
submitted
by
the
(1) Commission
Regulations
(EC)
No
1112/2002
( 2 ) and (EC)
applicant and prepared an additional report. It
No 2229/2004 ( 3 ) lay down the detailed rules for the
communicated that report to the European Food Safety
implementation of the fourth stage of the programme
Authority (hereinafter ‘the Authority’) and to the
of work referred to in Article 8(2) of Directive
Commission on 4 December 2009. The Authority
91/414/EEC and establish a list of active substances to
communicated the additional report to the other
be assessed, with a view to their possible inclusion in
Member States and the applicant for comments and
Annex I to Directive 91/414/EEC. That list included
forwarded the comments it had received to the
bromadiolone.
Commission. In accordance with Article 20(1) of Regu
lation (EC) No 33/2008 and at the request of the
Commission, the Authority presented its conclusion on
bromadiolone to the Commission on 15 September
2010 ( 6 ). The draft assessment report, the additional
(2) In
accordance
with
Article
24e
of
Regulation
(EC)
report and the conclusion of the Authority were
No 2229/2004 the notifier withdrew its support of the
reviewed by the Member States and the Commission
inclusion of that active substance in Annex I to Directive
within the Standing Committee on the Food Chain and
91/414/EEC within 2 months from receipt of the draft
Animal Health and finalised on 11 March 2011 in the
assessment report. Consequently, Commission Decision
format of the Commission review report for bromad
2008/941/EC of 8 December 2008 concerning the
iolone.
non-inclusion of certain active substances in Annex I
to Council Directive 91/414/EEC and the withdrawal of
authorisations for plant protection products containing
these substances ( 4 ) was adopted on the non-inclusion
of bromadiolone.
(6)
It has appeared from the various examinations made that

plant protection products containing bromadiolone may
be expected to satisfy, in general, the requirements laid
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
in particular with regard to the uses which have been
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
examined and detailed in the Commission review report.
original notifier (hereinafter ‘the applicant’) submitted a
It is therefore appropriate to include bromadiolone in
new application requesting the application of the accel
Annex I, in order to ensure that in all Member States
erated procedure provided for in Articles 14 to 19 of
the authorisations of plant protection products
Commission Regulation (EC) No 33/2008 of 17 January
containing this active substance can be granted in
2008 laying down detailed rules for the application of
accordance with the provisions of that Directive.
Council Directive 91/414/EEC as regards a regular and an
( 5 ) OJ L 15, 18.1.2008, p. 5.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 6 ) European Food Safety Authority; Conclusion on the peer review of
( 2 ) OJ L 168, 27.6.2002, p. 14.
the pesticide risk assessment of the active substance bromadiolone.
( 3 ) OJ L 379, 24.12.2004, p. 13.
EFSA Journal 2010;8(10):1783. [44 pp.] doi:10.2903/j.efsa.2010.
( 4 ) OJ L 335, 13.12.2008, p. 91.
1783. Available online: www.efsa.europa.eu/efsajournal.htm

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EN
16.4.2011 Official
Journal
of
the
European
Union L
102/29
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to (11) It is therefore appropriate to amend Directive
obtain further information on certain specific points.
91/414/EEC accordingly.
Article 6(1) of Directive 91/414/EC provides that
inclusion of a substance in Annex I may be subject to
conditions. Therefore, it is appropriate to require that the
applicant submit confirmatory information as regards:
(12) Decision
2008/941/EC
provides
for
the
non-inclusion
of
the specification of the technical material as
bromadiolone and the withdrawal of authorisation of
commercially manufactured, in the form of appropriate
plant protection products containing that substance by
analytical data, the relevance of the impurities, the deter
31 December 2011. It is necessary to delete the line
mination of bromadiolone in water, the effectiveness of
concerning bromadiolone in the Annex to that Decision.
proposed mitigation measures to reduce the risk to birds
and non-target mammals and the groundwater exposure
assessment in respect of metabolites.
(13) It is therefore appropriate to amend Decision
2008/941/EC accordingly.
(8) A
reasonable
period
should
be
allowed
to
elapse
before
an active substance is included in Annex I in order to
(14) The
measures provided for in this Directive are in
permit Member States and the interested parties to
accordance with the opinion of the Standing
prepare themselves to meet the new requirements
Committee on the Food Chain and Animal Health,
which will result from the inclusion.
HAS ADOPTED THIS DIRECTIVE:
(9) Without
prejudice
to
the
obligations
defined
by
Directive
91/414/EEC as a consequence of including an active
substance in Annex I, Member States should be
Article 1
allowed a period of 6 months after inclusion to review
existing authorisations of plant protection products
Annex I to Directive 91/414/EEC is amended as set out in the
containing bromadiolone to ensure that the requirements
Annex to this Directive.
laid down by Directive 91/414/EEC, in particular in its
Article 13 and the relevant conditions set out in Annex I,
are satisfied. Member States should vary, replace or
withdraw, as appropriate, existing authorisations, in
Article 2
accordance with the provisions of Directive
The line concerning bromadiolone in the Annex to Decision
91/414/EEC. By derogation from the above deadline, a
2008/941/EC is deleted.
longer period should be provided for the submission and
assessment of the complete Annex III dossier of each
plant protection product for each intended use in
accordance with the uniform principles laid down in
Article 3
Directive 91/414/EEC.
Member States shall adopt and publish by 30 November 2011
at the latest the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
communicate to the Commission the text of those provisions
(10) The
experience
gained
from
previous
inclusions
in
Annex
and a correlation table between those provisions and this
I to Directive 91/414/EEC of active substances assessed
Directive.
in the framework of Commission Regulation (EEC)
No 3600/92 of 11 December 1992 laying down the
detailed rules for the implementation of the first stage
of the programme of work referred to in Article 8(2) of
They shall apply those provisions from 1 December 2011.
Council Directive 91/414/EEC concerning the placing of
plant protection products on the market ( 1 ) has shown
that difficulties can arise in interpreting the duties of
holders of existing authorisations in relation to access
When Member States adopt those provisions, they shall contain
to data. In order to avoid further difficulties it therefore
a reference to this Directive or be accompanied by such a
appears necessary to clarify the duties of the Member
reference on the occasion of their official publication. Member
States, especially the duty to verify that the holder of
States shall determine how such reference is to be made.
an authorisation demonstrates access to a dossier
satisfying the requirements of Annex II to that Directive.
However, this clarification does not impose any new
obligations on Member States or holders of authori
Article 4
sations compared to the Directives which have been
1. Member States shall in accordance with Directive
adopted until now amending Annex I.
91/414/EEC, where necessary, amend or withdraw existing
authorisations for plant protection products containing bromad
( 1 ) OJ L 366, 15.12.1992, p. 10.
iolone as an active substance by 30 November 2011.

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L 102/30
EN
Official Journal of the European Union
16.4.2011
By that date they shall in particular verify that the conditions in
(b) in the case of a product containing bromadiolone as one of
Annex I to that Directive relating to bromadiolone are met,
several active substances, where necessary, amend or
with the exception of those identified in Part B of the entry
withdraw the authorisation by 31 May 2015 or by the
concerning that active substance, and that the holder of the
date fixed for such an amendment or withdrawal in the
authorisation has, or has access to, a dossier satisfying the
respective Directive or Directives which added the relevant
requirements of Annex II to that Directive in accordance with
substance or substances to Annex I to Directive
the conditions of Article 13 of that Directive.
91/414/EEC, whichever is the latest.
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
orised plant protection product containing bromadiolone as
Article 5
either the only active substance or as one of several active
substances all of which were listed in Annex I to Directive
This Directive shall enter into force on 1 June 2011.
91/414/EEC by 31 May 2011 at the latest, Member States
shall re-evaluate the product in accordance with the uniform
principles provided for in Annex VI to Directive 91/414/EEC,
on the basis of a dossier satisfying the requirements of Annex
Article 6
III to that Directive and taking into account Part B of the entry
in Annex I to that Directive concerning bromadiolone. On the
This Directive is addressed to the Member States.
basis of that evaluation, they shall determine whether the
product satisfies the conditions set out in Article 4(1)(b), (c),
(d) and (e) of Directive 91/414/EEC.
Done at Brussels, 15 April 2011.
Following that determination Member States shall:
For the Commission
(a) in the case of a product containing bromadiolone as the
only active substance, where necessary, amend or withdraw
The President
the authorisation by 31 May 2015 at the latest; or
José Manuel BARROSO

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16.4.2011 Off
ANNEX
The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:
No
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Entry
into
force
Expiration of
inclusion
Specific provisions
EN
‘352 bromadiolone
3-[(1RS,3RS;1RS,3SR)-
≥ 970 g/kg 1
June
2011 31
May
2021 PART
A

CAS No: 28772-56-7
3-(4′-bromobiphenyl-4-
Only uses as rodenticide in the form of pre-prepared baits placed into the rodent tunnels
CIPAC No: 371
yl)-3-hydroxy-1-
phenylpropyl]-4-hydroxy
may be authorised.
coumarin
The nominal concentration of the active substance in the plant protection products shall
not exceed 50 mg/kg.
Authorisations shall be granted for uses by professional users only.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the
review report on bromadiolone, and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health on
icial
11 March 2011 shall be taken into account.
Jour
In this overall assessment Member States shall:
nal
— pay particular attention to the risk to professional operators and ensure that
conditions of use include the application of adequate personal protective
of
equipment where appropriate,
the
— pay particular attention to the risk to birds and non-target mammals from primary
European
and secondary poisoning.
Conditions of authorisation shall include risk mitigation measures, where appropriate.
Union
The Member States concerned shall request the submission of confirmatory information
as regards:
(a) the specification of the technical material, as commercially manufactured, in the
form of appropriate analytical data;
(b) the relevance of the impurities;
(c) the determination of bromadiolone in water with a limit of quantification of
0,01 μg/l;
(d) the effectiveness of proposed mitigation measures to reduce risk to birds and non-
target mammals;
(e) the groundwater exposure assessment in respect of metabolites.
The Member States concerned shall ensure that the applicant submits to the
Commission the information set out in points (a), (b) and (c) by 30 November 2011
and the information set out in points (d) and (e) by 31 May 2013.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
L
102/31

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