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9.12.2011 Official
Journal
of
the
European
Union L
327/49
COMMISSION IMPLEMENTING REGULATION (EU) No 1278/2011
of 8 December 2011
approving the active substance bitertanol, in accordance with Regulation (EC) No 1107/2009 of the
European Parliament and of the Council concerning the placing of plant protection products on the
market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and
Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
rules for the implementation of the fourth stage of the
programme of work referred to in Article 8(2) of Council
Directive 91/414/EEC
( 6 ) the notifier withdrew its
Having regard to the Treaty on the Functioning of the European
support of the inclusion of that active substance in
Union,
Annex I to Directive 91/414/EEC within two months
from entry into force of that Regulation. Consequently,
Commission Decision 2008/934/EC of 5 December
Having regard to Regulation (EC) No 1107/2009 of the
2008 concerning the non-inclusion of certain active
European Parliament and of the Council of 21 October 2009
substances in Annex I to Council Directive 91/414/EEC
concerning the placing of plant protection products on the
and the withdrawal of authorisations for plant protection
market and repealing Council Directives 79/117/EEC and
products containing these substances ( 7 ) was adopted on
91/414/EEC ( 1 ), and in particular Article 13(2) and
the non-inclusion of bitertanol.
Article 78(2) thereof,
(4) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
Whereas:
original notifier (hereinafter ‘the applicant’) submitted a
new application requesting the accelerated procedure to
be applied, as provided for in Articles 14 to 19 of Regu
(1) In
accordance
with
Article
80(1)(c)
of
Regulation
(EC)
lation (EC) No 33/2008.
No 1107/2009, Council Directive 91/414/EEC ( 2 ) is to
apply to active substances for which completeness has
been established in accordance with Article 16 of
(5) The
application
was
submitted
to
the
United
Kingdom,
Commission Regulation (EC) No 33/2008 of
which had been designated rapporteur Member State by
17 January 2008 laying down detailed rules for the
Regulation (EC) No 1490/2002. The time period for the
application of Council Directive 91/414/EEC as regards
accelerated procedure was respected. The specification of
a regular and an accelerated procedure for the assessment
the active substance and the supported uses are the same
of active substances which were part of the programme
as were the subject of Decision 2008/934/EC. That appli
of work referred to in Article 8(2) of that Directive but
cation also complies with the remaining substantive and
have not been included into its Annex I ( 3 ), with respect
procedural requirements of Article 15 of Regulation (EC)
to the procedure and the conditions for approval.
No 33/2008.
Bitertanol is an active substance for which completeness
has been established in accordance with that Regulation.
(6) The
United
Kingdom
evaluated
the
additional
data
submitted by the applicant and prepared an additional
(2) Commission
Regulations
(EC)
No
451/2000
( 4 ) and (EC)
report. It communicated that report to the European
No 1490/2002 ( 5 ) lay down the detailed rules for the
Food Safety Authority (hereinafter ‘the Authority’) and
implementation of the second and third stages of the
to the Commission on 29 November 2009. The
programme of work referred to in Article 8(2) of
Authority communicated the additional report to the
Directive 91/414/EEC and establish a list of active
other Member States and the applicant for comments
substances to be assessed, with a view to their possible
and forwarded the comments it had received to the
inclusion in Annex I to Directive 91/414/EEC. That list
Commission. In accordance with Article 20(1) of Regu
included bitertanol.
lation (EC) No 33/2008 and at the request of the
Commission, the Authority presented its conclusion on
bitertanol to the Commission on 6 October 2010 ( 8 ).
(3) In
accordance
with
Article
3(2)
of
Commission
Regu
The draft assessment report, the additional report and
lation (EC) No 1095/2007 of 20 September 2007
the conclusion of the Authority were reviewed by the
amending Regulation (EC) No 1490/2002 laying down
Member States and the Commission within the
further detailed rules for the implementation of the third
Standing Committee on the Food Chain and Animal
stage of the programme of work referred to in
Health and finalised on 11 October 2011 in the
Article 8(2) of Council Directive 91/414/EEC and Regu
format of the Commission review report for bitertanol.
lation (EC) No 2229/2004 laying down further detailed
( 6 ) OJ L 246, 21.9.2007, p. 19.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 7 ) OJ L 333, 11.12.2008, p. 11.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 8 ) European Food Safety Authority, ‘Conclusion on the peer review of
( 3 ) OJ L 15, 18.1.2008, p. 5.
the pesticide risk assessment of the active substance bitertanol’. EFSA
( 4 ) OJ L 55, 29.2.2000, p. 25.
Journal 2010; 8(10):1850. [63 pp.]. doi:10.2903/j.efsa.2010.1850.
( 5 ) OJ L 224, 21.8.2002, p. 23.
Available online: www.efsa.europa.eu

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L 327/50
EN
Official Journal of the European Union
9.12.2011
(7)
It has appeared from the various examinations made that
the provisions of Article 29(6) of Regulation (EC)
plant protection products containing bitertanol may be
No 1107/2009 should not exceed two and a half years.
expected to satisfy, in general, the requirements laid
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
in particular as regards the uses which were examined
(13) The
experience
gained
from
inclusions
in
Annex
I
to
and detailed in the Commission review report. It is
Directive 91/414/EEC of active substances assessed
therefore appropriate to approve bitertanol in accordance
in the framework of Commission Regulation (EEC)
with Regulation (EC) No 1107/2009.
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
(8) In
accordance
with
Article
13(2)
of
Regulation
(EC)
Council Directive 91/414/EEC concerning the placing of
No 1107/2009 in conjunction with Article 6 thereof
plant protection products on the market ( 2 ) has shown
and in the light of current scientific and technical
that difficulties can arise in interpreting the duties of
knowledge, it is, however, necessary to include certain
holders of existing authorisations in relation to access
conditions and restrictions.
to data. In order to avoid further difficulties it therefore
appears necessary to clarify the duties of the Member
States, especially the duty to verify that the holder of
(9) Without
prejudice
to
the
conclusion
that
bitertanol
an authorisation demonstrates access to a dossier
should be approved, it is, in particular, appropriate to
satisfying the requirements of Annex II to that Directive.
require further confirmatory information.
However, this clarification does not impose any new
obligations on Member States or holders of authori
sations compared to the directives which have been
(10) Concerns were expressed as regards the hazard profile of
adopted until now amending Annex I to that Directive
the active substance due to the proposed classification for
or the Regulations approving active substances.
this active substance as ‘reproductive toxicant category
1B’ in accordance with Regulation (EC) No 1272/2008
of the European Parliament and of the Council (
(14) In
accordance
with
Article
13(4) of Regulation
(EC)

1 ). Data
and information related to the hazard profile of the
No 1107/2009 the Annex to Commission Implementing
active substance will need to be reassessed. Account
Regulation (EU) No 540/2011 ( 3 ) should be amended
should also be taken on the progressive understanding
accordingly.
of the need to ensure a high level of protection of human
health and the sustainable environment. Therefore it is
(15) Decision
2008/934/EC
provides
for
the
non-inclusion
of
considered appropriate to limit the approval period to
bitertanol and the withdrawal of authorisations for plants
three and half years. This period is considered the
protection products containing that substance by
shortest period possible to allow the applicant to
31 December 2011. It is necessary to delete the line
submit an application for renewal under the provisions
concerning bitertanol in the Annex to that Decision. It
of Regulation (EC) No 1107/2009.
is therefore appropriate to amend Decision 2008/934/EC
accordingly.
(11) A
reasonable
period
should
be
allowed
to
elapse
before
approval in order to permit Member States and the
(16) The
Standing
Committee
on
the
Food
Chain
and
Animal
interested parties to prepare themselves to meet the
Health did not deliver an opinion. An implementing act
new requirements resulting from the approval.
was deemed to be necessary and the chair submitted the
draft implementing act to the appeal committee for
further deliberation. The appeal committee did not
(12) Without
prejudice
to
the
obligations
defined
by
Regu
deliver an opinion,
lation (EC) No 1107/2009 as a consequence of the
approval, taking into account the specific situation
created by the transition from Directive 91/414/EEC to
HAS ADOPTED THIS REGULATION:
Regulation (EC) No 1107/2009 the following should,
however, apply. Member States should be allowed a
Article 1
period of six months after approval to review authori
sations of plant protection products containing
Approval of active substance
bitertanol. Member States should, as appropriate, vary,
The active substance bitertanol, as specified in Annex I, is
replace or withdraw existing authorisations. By way of
approved subject to the conditions laid down in that Annex.
derogation from the above deadline, a longer period
should be provided for the submission and assessment
of the update of the complete Annex III dossier, as set
Article 2
out in Directive 91/414/EEC, of each plant protection
product for each intended use in accordance with the
Re-evaluation of plant protection products
uniform principles. Given the hazardous properties of
1. Member
States
shall
in
accordance
with
Regulation
(EC)
bitertanol, the period for Member States to verify
No 1107/2009, where necessary, amend or withdraw existing
whether the plant protection products, which contain
authorisations for plant protection products containing
bitertanol as the only active substance or in combination
bitertanol as an active substance by 30 June 2012.
with other approved active substances, comply with
( 2 ) OJ L 366, 15.12.1992, p. 10.
( 1 ) OJ L 353, 31.12.2008, p. 1.
( 3 ) OJ L 153, 11.6.2011, p. 1.

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EN
9.12.2011 Official
Journal
of
the
European
Union L
327/51
By that date they shall in particular verify that the conditions in
Article 3
Annex I to this Regulation are met, with the exception of those
identified in Part B of the column on specific provisions of that
Amendments to Implementing Regulation (EU)
Annex, and that the holder of the authorisation has, or has
No 540/2011
access to, a dossier satisfying the requirements of Annex II to
The Annex to Implementing Regulation (EU) No 540/2011 is
Directive 91/414/EEC in accordance with the conditions
amended in accordance with Annex II to this Regulation.
of Article 13(1) to (4) of that Directive and Article 62 of
Regulation (EC) No 1107/2009.
Article 4
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
orised plant protection product containing bitertanol as either
Amendments to Decision 2008/934/EC
the only active substance or as one of several active substances,
The line concerning bitertanol in the Annex to Decision
Member States shall re-evaluate the product in accordance with
2008/934/EC is deleted.
the uniform principles, as referred to in Article 29(6) of Regu
lation (EC) No 1107/2009, on the basis of a dossier satisfying
the requirements of Annex III to Directive 91/414/EEC and
taking into account Part B of the column on specific provisions
Article 5
of Annex I to this Regulation. On the basis of that evaluation,
Entry into force and date of application
they shall determine whether the product satisfies the conditions
set out in Article 29(1) of Regulation (EC) No 1107/2009.
This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.
Following that determination Member States shall,
where necessary, amend or withdraw the authorisation by
30 June 2014.
It shall apply from 1 January 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 December 2011.
For the Commission
The President
José Manuel BARROSO

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L 327/52
ANNEX I
Common name,
identification numbers
IUPAC name Purity
(1 ) Date
of
approval
Expiration of
approval
Specific provisions
Bitertanol
(1RS,2RS;1RS,2SR)-1-
≥ 970 g/kg (A≥ 80, 1 January 2012 30
June
2015 PART
A
(biphenyl-4-yloxy)-3,3-
B≤ 20)
EN
CAS No: 55179-31-2 dimethyl-1-(1H-1,2,4-

Only uses as fungicide for seed treatment may be authorised.
triazol-1-yl)butan-2-ol
RS + SR 80 – 90 %
CIPAC No: 386
(20:80 ratio of (1RS,2RS)-
and (1RS,2SR)-isomers)
RR + SS 10 – 20 %
Member States shall ensure that authorisations provide that seed coating be performed
exclusively in professional seed treatment facilities and that these facilities apply the best
available techniques to exclude the release of dust clouds during storage, transport and
application.
PART B
Off
For the implementation of the uniform principles as referred to in Article 29(6) of
icial
Regulation (EC) No 1107/2009, the conclusions of the review report on bitertanol, and
in particular Appendices I and II thereof, as finalised in the Standing Committee on the
Jour
Food Chain and Animal Health on 11 October 2011 shall be taken into account.
nal
In this overall assessment Member States:
of
the
(a) shall pay particular attention to the risk to operators and workers and shall ensure that
European
conditions of use include the application of adequate personal protective equipment,
where appropriate;
Union
(b) shall pay particular attention to the dietary exposure of consumers to the residues of
triazole derivative metabolites (TDMs);
(c) shall pay particular attention to the risk to birds and mammals.
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit confirmatory information as regards:
(1) the toxicological relevance of the impurities BUE 1662, thus referred to for confi
dentiality reasons, and 3-chlorophenoxy compound;
(2) the acute and short-term risk to granivorous birds;
(3) the long-term risk to granivorous mammals;
9.12.2011
(4) residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops
and products of animal origin;

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9.12.2011 Off
Common name,
identification numbers
IUPAC name Purity
(1 ) Date
of
approval
Expiration of
approval
Specific provisions
(5) the possible impact of the variable isomer-ratio in the technical material and of the
preferential degradation and/or conversion of the mixture of isomers on the worker
risk assessment, the consumer risk assessment and the environmental risk assessment.
The applicant shall submit to the Commission, the Member States and the Authority the
EN
information set out in point (1) by 30 June 2012, the information set out in points (2),

(3) and (4) by 31 December 2013 and the information set out in point (5) two years after
the adoption of specific guidance.
(1 ) Further details on identity and specification of active substance are provided in the review report.
icial
Jour
nal
of
the
European
Union
L
327/53

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L 327/54
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number
Common name,
identification numbers
IUPAC name Purity
(*) Date
of
approval
Expiration of
approval
Specific provisions
EN
‘21 Bitertanol
(1RS,2RS;1RS,2SR)-1-
≥ 970 g/kg (A ≥ 80,
1 January 2012 30
June
2015 PART
A

(biphenyl-4-yloxy)-3,3-
B ≤ 20)
CAS No: 55179-31-2 dimethyl-1-(1H-1,2,4-
Only uses as fungicide for seed treatment may be authorised.
triazol-1-yl)butan-2-ol
RS + SR 80 – 90 %
CIPAC No: 386
(20:80 ratio of (1RS,2RS)-
Member States shall ensure that authorisations provide that seed coating be
and (1RS,2SR)-isomers)
RR + SS 10 – 20 %
performed exclusively in professional seed treatment facilities and that these
facilities apply the best available techniques to exclude the release of dust
clouds during storage, transport and application.
PART B
Off
icial
For the implementation of the uniform principles as referred to in Article 29(6)
of Regulation (EC) No 1107/2009, the conclusions of the review report on
Jour
bitertanol, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 11 October
nal
2011 shall be taken into account.
of
the
In this overall assessment Member States:
European
(a) shall pay particular attention to the risk to operators and workers and shall
ensure that conditions of use include the application of adequate personal
protective equipment, where appropriate;
Union
(b) shall pay particular attention to the dietary exposure of consumers to the
residues of triazole derivative metabolites (TDMs);
(c) shall pay particular attention to the risk to birds and mammals.
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit confirmatory information as regards:
(1) the toxicological relevance of the impurities BUE 1662, thus referred to for
confidentiality reasons, and 3-chlorophenoxy compound;
(2) the acute and short-term risk to granivorous birds;
(3) the long-term risk to granivorous mammals;
9.12.2011
(4) residues of triazole derivative metabolites (TDMs) in primary crops,
rotational crops and products of animal origin;

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9.12.2011 Off
Number
Common name,
identification numbers
IUPAC name Purity
(*) Date
of
approval
Expiration of
approval
Specific provisions
(5) the possible impact of the variable isomer-ratio in the technical material
and of the preferential degradation and/or conversion of the mixture of
isomers on the worker risk assessment, the consumer risk assessment and
the environmental risk assessment.
EN
The applicant shall submit to the Commission, the Member States and the

Authority the information set out in point (1) by 30 June 2012, the
information set out in points (2), (3) and (4) by 31 December 2013 and the
information set out in point (5) two years after the adoption of specific
guidance.’
(*) Further details on identity and specification of active substance are provided in the review report.
icial
Jour
nal
of
the
European
Union
L
327/55

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