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7.10.2011 Official
Journal
of
the
European
Union L
263/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 993/2011
of 6 October 2011
approving the active substance 8-hydroxyquinoline, 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
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Directive 91/414/EEC and establish lists of active
substances to be assessed, with a view to their possible
inclusion in Annex I to Directive 91/414/EEC. These lists
Having regard to the Treaty on the Functioning of the European
included 8-hydroxyquinoline.
Union,
Having regard to Regulation (EC) No 1107/2009 of the
(3) For
8-hydroxyquinoline
no
complete
dossier
was
European Parliament and of the Council of 21 October 2009
submitted within the prescribed time limit. Consequently,
concerning the placing of plant protection products on the
Commission Decision 2006/797/EC of 22 November
market and repealing Council Directives 79/117/EEC and
2006 concerning the non-inclusion of certain active
91/414/EEC ( 1 ), and in particular Article 13(2) and
substances in Annex I to Council Directive 91/414/EEC
Article 78(2) thereof,
and the withdrawal of authorisations for plant protection
products containing these substances ( 6 ) was adopted on
the non-inclusion of 8-hydroxyquinoline.
Whereas:
(1) In
accordance
with
Article
80(1)(c)
of
Regulation
(EC)
No (4) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
original notifier (hereinafter ‘the applicant’) submitted a
with respect to the procedure and the conditions for
new application requesting the regular procedure to be
approval, to active substances for which completeness
applied, as provided for in Articles 3 to 12 of Regulation
has been established in accordance with Article 6 of
(EC) No 33/2008.
Commission Regulation (EC) No 33/2008 of
17 January 2008 laying down detailed rules for the
application of Council Directive 91/414/EEC as regards
a regular and an accelerated procedure for the assessment
(5) The
application
was
submitted
to
Spain,
which
had
been
of active substances which were part of the programme
designated rapporteur Member State by Regulation (EC)
of work referred to in Article 8(2) of that Directive but
No 1490/2002. That application complies with the
have not been included into its Annex I ( 3 ). 8-hydroxy
substantive and procedural requirements of Articles 3
quinoline is an active substance for which completeness
and 4 of Regulation (EC) No 33/2008.
has been established in accordance with that Regulation.
(2) Commission
Regulations
(EC)
No
451/2000
( 4 ) and (EC)
(6) Spain
evaluated
the
information
submitted
and
prepared
No 1490/2002 ( 5 ) lay down the detailed rules for the
a draft assessment report. It communicated that report to
implementation of the second and third stages of the
the European Food Safety Authority (hereinafter ‘the
programme of work referred to in Article 8(2) of
Authority’) and to the Commission on 3 August 2009.
The Authority communicated the draft assessment report
( 1 ) OJ L 309, 24.11.2009, p. 1.
to the other Member States and the applicant for
( 2 ) OJ L 230, 19.8.1991, p. 1.
comments and forwarded the comments received to the
( 3 ) OJ L 15, 18.1.2008, p. 5.
( 4 ) OJ L 55, 29.2.2000, p. 25.
( 5 ) OJ L 224, 21.8.2002, p. 23.
( 6 ) OJ L 324, 23.11.2006, p. 8.

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L 263/2
EN
Official Journal of the European Union
7.10.2011
Commission. The Authority also made the draft
Regulation (EU) No 540/2011 of 25 May 2011 imple
assessment report available to the public. In accordance
menting Regulation (EC) No 1107/2009 of the European
with Article 10 of Regulation (EC) No 33/2008 and at
Parliament and of the Council as regards the list of
the request of the Commission, the Authority presented
approved active substances
( 2 ) should be amended
its conclusion on the risk assessment of 8-hydroxyqui
accordingly.
noline to the Commission on 17 December 2010 ( 1 ). The
draft assessment report and the conclusion of the
Authority were reviewed by the Member States and the
(11) The
measures
provided
for
in
this
Regulation
are
in
Commission within the Standing Committee on the Food
accordance with the opinion of the Standing
Chain and Animal Health and finalised on 15 July 2011
Committee on the Food Chain and Animal Health,
in the format of the Commission review report for 8-
hydroxyquinoline.
HAS ADOPTED THIS REGULATION:
(7)
It has appeared from the various examinations made that
Article 1
plant protection products containing 8-hydroxyquinoline
may be expected to satisfy, in general, the requirements
Approval of active substance
laid down in Article 5(1)(a) and (b) of Directive
The active substance 8-hydroxyquinoline, as specified in Annex
91/414/EEC, in particular as regards the uses which
I, is approved subject to the conditions laid down in that
were examined and detailed in the Commission review
Annex.
report. It is therefore appropriate to approve 8-hydroxy
quinoline in accordance with Regulation (EC) No
1107/2009.
Article 2
Amendments to Implementing Regulation (EU) No
(8) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
540/2011
1107/2009 in conjunction with Article 6 thereof and in
the light of current scientific and technical knowledge, it
The Annex to Implementing Regulation (EU) No 540/2011 is
is, however, necessary to include certain conditions and
amended in accordance with Annex II to this Regulation.
restrictions.
Article 3
(9) Without
prejudice
to
the
conclusion
that
8-hydroxyqui
Entry into force and date of application
noline should be approved, it is, in particular, appropriate
to require further confirmatory information.
This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.
(10) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
1107/2009 the Annex to Commission Implementing
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, 6 October 2011.
For the Commission
The President
José Manuel BARROSO
( 1 ) European Food Safety Authority; Conclusion on the peer review of
the pesticide risk assessment of the active substance 8-hydroxyqui
noline. EFSA Journal 2011;9(1):1964 [49pp.] doi:10.2903/
j.efsa.2011.1964. Available online: www.efsa.europa.eu/efsajournal.
htm
( 2 ) OJ L 153, 11.6.2011, p. 1.

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7.10.2011 Off
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
8-hydroxyquinoline
8-quinolinol
≥ 990 g/kg 1
January
2012 31
December
2021 PART
A
Only uses as fungicide and bactericide in greenhouses may be
EN
CAS No
authorised.

148-24-3 (8-hydroxyquinoline)
PART B
CIPAC No 677
For the implementation of the uniform principles, as referred to in
(8-hydroxyquinoline)
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
the review report on 8-hydroxyquinoline, and in particular Appendices
I and II thereof, as finalised in the Standing Committee on the Food
Chain and Animal Health on 15 July 2011 shall be taken into account.
In this overall assessment Member States shall pay particular attention to
the operator safety and shall ensure that conditions of use include the
application of adequate personal protective equipment, where appro
priate.
The applicant shall submit confirmatory information on 8-hydroxyqui
icial
noline and its salts as regards:
(1) the method of analysis for air;
Jour
(2) a new storage stability covering the storage time periods of samples
nal
from both the metabolism study and from the supervised reidue
trials.
of
The applicant shall submit to the Commission, the Member States and
the
the Authority such information by 31 December 2013.
European
(1 ) Further details on identity and specification of active substance are provided in the review report.
Union
L
263/3

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L 263/4
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
‘18 8-hydroxyquinoline
8-quinolinol
≥ 990 g/kg 1
January
2012 31 December 2021 PART
A

CAS No
Only uses as fungicide and bactericide in greenhouses may be authorised.
148-24-3 (8-hydroxy
quinoline)
PART B
CIPAC No 677
For the implementation of the uniform principles, as referred to in Article 29(6) of
(8-hydroxyquinoline)
Regulation (EC) No 1107/2009, the conclusions of the review report on 8-hydroxyqui
noline, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 15 July 2011 shall be taken into
account.
In this overall assessment Member States shall pay particular attention to the operator
Off
safety and shall ensure that conditions of use include the application of adequate personal
icial
protective equipment, where appropriate.
Jour
The applicant shall submit confirmatory information on 8-hydroxyquinoline and its salts
as regards:
nal
(1) the method of analysis for air;
of
the
(2) a new storage stability covering the storage time periods of samples from both the
metabolism study and from the supervised reidue trials.
European
The applicant shall submit to the Commission, the Member States and the Authority such
information by 31 December 2013.’
Union
7.10.2011

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