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EN
Official Journal of the European Union
21.1.2011
COMMISSION DIRECTIVE 2011/6/EU
of 20 January 2011
amending Council Directive 91/414/EEC to include buprofezin as active substance
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
tional report in August 2009. It communicated that
report to the European Food Safety Authority (hereinafter
‘the Authority’) and to the Commission on 21 August
Having regard to the Treaty on the Functioning of the European
2009.
Union,
(5) The
Authority
communicated
the
additional
report
to
the
Having regard to Council Directive 91/414/EEC of 15 July
other Member States and the applicant for comments
1991 concerning the placing of plant protection products on
and forwarded the comments it had received to the
the market ( 1 ), and in particular Article 6(1) thereof,
Commission. In accordance with Article 20(1) of Regu
lation (EC) No 33/2008 and at the request of the
Commission, the additional report was peer reviewed
Whereas:
by the Member States and the Authority. The Authority
then presented its conclusion on buprofezin to the
Commission on 21 May 2010 ( 6 ). The draft assessment
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
report, the additional report and the conclusion of the
No 1490/2002 ( 3 ) lay down the detailed rules for the
Authority were reviewed by the Member States and the
implementation of the third stage of the programme of
Commission within the Standing Committee on the Food
work referred to in Article 8(2) of Directive 91/414/EEC
Chain and Animal Health and finalised on 23 November
and establish a list of active substances to be assessed,
2010 in the format of the Commission review report for
with a view to their possible inclusion in Annex I to
buprofezin.
Directive 91/414/EEC. That list included buprofezin. By
Commission Decision 2008/771/EC ( 4 ) it was decided
not to include buprofezin in Annex I to Directive
(6) The
additional
report
by
the
rapporteur
Member
State
91/414/EEC.
and the new conclusion by the Authority concentrate
on the concerns that lead to the non-inclusion. Those
concerns were, in particular, the impossibility to perform
(2)
Pursuant to Article 6(2) of Directive 91/414/EEC the
a reliable consumer exposure assessment because of lack
original notifier (hereinafter ‘the applicant’) submitted a
of data to determine an appropriate residue definition.
new application requesting the accelerated procedure to
be applied, as provided for in Articles 14 to 19 of
Commission Regulation (EC) No 33/2008 of
(7) The
new
information
submitted
by
the
applicant
enabled
17 January 2008 laying down detailed rules for the
a consumer exposure assessment. The information
application of Council Directive 91/414/EEC as regards
currently available indicates that the risk to consumers
a regular and an accelerated procedure for the assessment
is acceptable.
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 ).
(8) Consequently,
the
additional
data
and
information
provided by the applicant permit to eliminate the
specific concerns that led to the non-inclusion. No
(3) The
application
was
submitted
to
the
United
Kingdom,
other open scientific questions have arisen.
which had been designated rapporteur Member State by
Regulation (EC) No 33/2008. The time period for the
accelerated procedure was respected. The specification
(9)
It has appeared from the various examinations made that
of the active substance and the supported uses are the
plant protection products containing buprofezin may be
same as those that were the subject of Decision
expected to satisfy, in general, the requirements laid
2008/771/EC. That application also complies with the
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
remaining substantive and procedural requirements of
in particular with regard to the uses which were
Article 15 of Regulation (EC) No 33/2008.
examined and detailed in the Commission review
report. It is therefore appropriate to include buprofezin
in Annex I, in order to ensure that in all Member States
(4) The
United
Kingdom
evaluated
the
new
information
and
the authorisations of plant protection products
data submitted by the applicant and prepared an addi
containing this active substance may be granted in
accordance with the provisions of that Directive.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 2 ) OJ L 55, 29.2.2000, p. 25.
( 6 ) European Food Safety Authority: Conclusion on the peer review of
( 3 ) OJ L 224, 21.8.2002, p. 23.
the pesticide risk assessment of the active substance buprofezin
( 4 ) OJ L 263, 2.10.2008, p. 18.
EFSA Journal 2010; 8(6):1624. [77 pp.]. doi:10.2903/j.efsa.2010.
( 5 ) OJ L 15, 18.1.2008, p. 5.
1624. Available online: www.efsa.europa.eu

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EN
21.1.2011 Official
Journal
of
the
European
Union L
18/39
(10) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
Directive by 31 July 2011 at the latest. They shall forthwith
obtain confirmatory information on certain specific
communicate to the Commission the text of those provisions
points. Article 6(1) of Directive 91/414/EEC provides
and a correlation table between those provisions and this
that the inclusion of a substance in Annex I may be
Directive.
subject to conditions. Therefore, it is appropriate to
require that the applicant submit further information to
confirm the processing and conversion factors in the
When Member States adopt those provisions, they shall contain
consumer risk assessment.
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.
(11) It is therefore appropriate to amend Directive
91/414/EEC accordingly.
Article 3
(12) The
measures provided for in this Directive are in
This Directive shall enter into force on 1 February 2011.
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
Article 4
HAS ADOPTED THIS DIRECTIVE:
This Directive is addressed to the Member States.
Article 1
Annex I to Directive 91/414/EEC is amended as set out in the
Done at Brussels, 20 January 2011.
Annex to this Directive.
Article 2
For the Commission
Member States shall bring into force the laws, regulations and
The President
administrative provisions necessary to comply with this
José Manuel BARROSO

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L 18/40
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
‘325 Buprofezin
(Z)-2-tert-butylimino-3-
≥ 985 g/kg 1
February
2011 31
January
2021 PART
A

CAS No: 953030-84-7 isopropyl-5-phenyl-1,3,5-
Only uses as insecticide and acaricide may be authorised.
CIPAC No: 681
thiadiazinan-4-one
PART B
For the implementation of the uniform principles of Annex VI the
conclusions of the review report on buprofezin, and in particular
Appendices I and II thereof, as finalised in the Standing Committee on
the Food Chain and Animal Health on 23 November 2010, shall be taken
into account.
Off
In this overall assessment Member States shall pay particular attention to:
icial
(a) the operators’ and workers’ safety and ensure that conditions of use
impose adequate personal protective equipment where appropriate;
Jour
(b) the dietary exposure of consumers to the buprofezin (aniline) metab-
olites in processed food;
nal
(c) the application of an appropriate waiting period for rotational crops
of
in greenhouses;
the
(d) the risk to aquatic organisms and ensure that conditions of use
European
impose adequate risk mitigation measures, where appropriate.
The Member States concerned shall request the submission of
confirmatory information as regards the processing and conversion
factors for consumer risk assessment.
Union
The Member States concerned shall ensure that the applicant submits
such confirmatory information to the Commission by 31 January 2013.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
21.1.2011

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