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19.11.2013 Official
Journal
of
the
European
Union L
309/17
COMMISSION IMPLEMENTING REGULATION (EU) No 1165/2013
of 18 November 2013
approving the active substance orange oil, 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,
applicant. The designated rapporteur Member State
submitted a draft assessment report on 12 August
2009. In accordance with Article 11(6) of Commission
Regulation (EU) No 188/2011 ( 4 ) additional information
Having regard to the Treaty on the Functioning of the European
was requested from the applicant on 13 June 2012. The
Union,
evaluation of the additional data by France was submitted
in the format of an updated draft assessment report in
November 2012.
Having regard to Regulation (EC) No 1107/2009 of the
European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the
market and repealing Council Directives 79/117/EEC and
(4) The
draft
assessment
report
was
reviewed
by
the
Member
91/414/EEC (
States and the European Food Safety Authority (here

1 ), and in particular Article 13(2) and Article 78(2)
thereof,
inafter ‘the Authority’). The Authority presented to the
Commission its conclusion ( 5 ) on the pesticide risk
assessment of the active substance orange oil on
1 March 2013. The draft assessment report and the
Whereas:
conclusion of the Authority were reviewed by the
Member States and the Commission within the
Standing Committee on the Food Chain and Animal
Health and finalised on 3 October 2013 in the format
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
of the Commission review report for orange oil.
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
with respect to the procedure and the conditions for
approval, to active substances for which a decision has
been adopted in accordance with Article 6(3) of that
(5)
It has appeared from the various examinations made that
Directive before 14 June 2011. For orange oil the
plant protection products containing orange oil may be
conditions of Article 80(1)(a) of Regulation (EC) No
expected to satisfy, in general, the requirements laid
1107/2009 are fulfilled by Commission Decision
down in Article 5(1)(a) and (b) and Article 5(3) of
2009/438/EC ( 3 ).
Directive 91/414/EEC, in particular with regard to the
uses which were examined and detailed in the
Commission review report. It is therefore appropriate
to approve orange oil.
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
France received on 22 February 2008 an application
from Oro Agri for the inclusion of the active substance
orange oil in Annex I to Directive 91/414/EEC. Decision
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
2009/438/EC confirmed that the dossier was ‘complete’
1107/2009 in conjunction with Article 6 thereof and in
in the sense that it could be considered as satisfying, in
the light of current scientific and technical knowledge, it
principle, the data and information requirements of
is, however, necessary to include certain conditions and
Annexes II and III to Directive 91/414/EEC.
restrictions. It is, in particular, appropriate to require
further confirmatory information.
(3) For
that
active
substance,
the
effects
on
human
and
animal health and the environment have been assessed,
in accordance with the provisions of Article 6(2) and (4)
(7) A
reasonable
period
should
be
allowed
to
elapse
before
of Directive 91/414/EEC, for the uses proposed by the
approval in order to permit Member States and the
interested parties to prepare themselves to meet the
new requirements resulting from the approval.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) Council Directive 91/414/EEC of 15 July 1991 concerning the
placing of plant protection products on the market (OJ L 230,
( 4 ) Commission Regulation (EU) No 188/2011 of 25 February 2011
19.8.1991, p. 1).
laying down detailed rules for the implementation of Council
( 3 ) Commission Decision 2009/438/EC of 8 June 2009 recognising in
Directive 91/414/EEC as regards the procedure for the assessment
principle the completeness of the dossier submitted for detailed
of active substances which were not on the market 2 years after the
examination in view of the possible inclusion of orange oil in
date of notification of that Directive (OJ L 53, 26.2.2011, p. 51).
Annex I to Council Directive 91/414/EEC (OJ L 145, 10.6.2009,
( 5 ) EFSA Journal 2013; 11(2):3090. Available online: www.efsa.
p. 47).
europa.eu

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L 309/18
EN
Official Journal of the European Union
19.11.2013
(8) Without
prejudice
to
the
obligations
provided
for
in
Article 2
Regulation (EC) No 1107/2009 as a consequence of
approval, taking into account the specific situation
Re-evaluation of plant protection products
created by the transition from Directive 91/414/EEC to
1. Member
States
shall
in
accordance
with
Regulation
(EC)
Regulation (EC) No 1107/2009, the following should,
No 1107/2009, where necessary, amend or withdraw existing
however, apply. Member States should be allowed a
authorisations for plant protection products containing orange
period of six months after approval to review authori
oil as an active substance by 31 October 2014.
sations of plant protection products containing orange
oil. Member States should, as appropriate, vary, replace
or withdraw authorisations. By way of derogation from
that deadline, a longer period should be provided for the
By that date they shall in particular verify that the conditions in
submission and assessment of the complete Annex III
Annex I to this Regulation are met, with the exception of those
dossier, as set out in Directive 91/414/EEC, of each
identified in the column on specific provisions of that Annex,
plant protection product for each intended use in
and that the holder of the authorisation has, or has access to, a
accordance with the uniform principles.
dossier satisfying the requirements of Annex II to Directive
91/414/EEC in accordance with the conditions of Article 13(1)
to (4) of that Directive and Article 62 of Regulation (EC) No
1107/2009.
(9) The
experience
gained
from
inclusions
in
Annex
I
to
Directive 91/414/EEC of active substances assessed in
the framework of Commission Regulation (EEC) No
3600/92 ( 1 ) has shown that difficulties can arise in inter
preting the duties of holders of existing authorisations in
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
relation to access to data. In order to avoid further
orised plant protection product containing orange oil as either
difficulties it therefore appears necessary to clarify the
the only active substance or as one of several active substances,
duties of the Member States, especially the duty to
all of which were listed in the Annex to Implementing Regu
verify that the holder of an authorisation demonstrates
lation (EU) No 540/2011 by 30 April 2014 at the latest,
access to a dossier satisfying the requirements of Annex
Member States shall re-evaluate the product in accordance
II to that Directive. However, this clarification does not
with the uniform principles, as referred to in Article 29(6) of
impose any new obligations on Member States or holders
Regulation (EC) No 1107/2009, on the basis of a dossier
of authorisations compared to the Directives which have
satisfying the requirements of Annex III to Directive
been adopted until now amending Annex I to that
91/414/EEC and taking into account the column on specific
Directive or the Regulations approving active substances.
provisions of Annex I to this Regulation. On the basis of that
evaluation, they shall determine whether the product satisfies
the conditions set out in Article 29(1) of Regulation (EC) No
1107/2009.
(10) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
1107/2009, the Annex to Commission Implementing
Regulation (EU) No 540/2011 ( 2 ) should be amended
accordingly.
Following that determination Member States shall:
(11) The
measures
provided
for
in
this
Regulation
are
in
(a) in the case of a product containing orange oil as the only
accordance with the opinion of the Standing
active substance, where necessary, amend or withdraw the
Committee on the Food Chain and Animal Health,
authorisation by 31 October 2015 at the latest; or
HAS ADOPTED THIS REGULATION:
(b) in the case of a product containing orange oil as one of
several active substances, where necessary, amend or
withdraw the authorisation by 31 October 2015 or by
Article 1
the date fixed for such an amendment or withdrawal in
the respective act or acts which added the relevant
Approval of active substance
substance or substances to Annex I to Directive 91/414/EEC
The active substance orange oil, as specified in Annex I, is
or approved that substance or those substances, whichever
approved subject to the conditions laid down in that Annex.
is the latest.
( 1 ) 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
Article 3
Council Directive 91/414/EEC concerning the placing of plant
protection products on the market (OJ L 366, 15.12.1992, p. 10).
Amendments to Implementing Regulation (EU) No
( 2 ) Commission Implementing Regulation (EU) No 540/2011 of
540/2011
25 May 2011 implementing Regulation (EC) No 1107/2009 of
the European Parliament and of the Council as regards the list of
The Annex to Implementing Regulation (EU) No 540/2011 is
approved active substances (OJ L 153, 11.6.2011, p. 1).
amended in accordance with Annex II to this Regulation.

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EN
19.11.2013 Official
Journal
of
the
European
Union L
309/19
Article 4
Entry into force and date of application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official
Journal of the European Union.
It shall apply from 1 May 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 November 2013.
For the Commission
The President
José Manuel BARROSO

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L 309/20
ANNEX I
Common Name, Identification
Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Orange oil
(R)-4-isopropenyl-1-methyl
≥ 945 g/kg (of D-limonene)
1 May 2014 30
April
2024
For the implementation of the uniform principles as referred to in
cyclohexene or p-mentha-
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
EN
CAS No 8028-48-6 (Orange 1,8-diene
The active substance shall
the review report on orange oil, and in particular Appendices I and

extract)
comply with the specifications of
II thereof, as finalised in the Standing Committee on the Food Chain
Ph. Eur. (Pharmacopoeia
5989-27-5 (D-limonene)
and Animal Health on 3 October 2013 shall be taken into account.
Europea) 5.0 (Aurantii dulcis
CIPAC No 902
aetheroleum) and ISO
In this overall assessment Member States shall pay particular
3140:2011(E)
attention to:
(a) the protection of operators and workers;
(b) the risk to birds and mammals.
Conditions of use shall include risk mitigation measures, where
Off
appropriate.
icial
The applicant shall submit confirmatory information as regards
Jour
(1) the metabolite fate of orange oil and the route and rate of
degradation in soil;
nal
(2) the validation of endpoints used in the ecotoxicological risk
of
assessment.
the
The applicant shall submit that information to the Commission,
European
Member States and the Authority by 30 April 2016.
(1 ) Further details on identity and specification of active substance are provided in the review report.
Union
19.11.2013

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19.11.2013 Off
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
‘56 Orange
oil
(R)-4-isopropenyl-1-
≥ 945 g/kg (of D-limonene)
1 May 2014 30
April
2024 For the implementation of the uniform principles as referred to in

methylcyclohexene
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
CAS No 8028-48-6 or p-mentha-1,8-diene The active substance shall
the review report on orange oil, and in particular Appendices I and II
(Orange extract)
comply with the specifi
thereof, as finalised in the Standing Committee on the Food Chain and
cations of Ph. Eur. (Phar
5989-27-5
Animal Health on 3 October 2013 shall be taken into account.
macopoeia Europea) 5.0
(D-limonene)
(Aurantii dulcis aetheroleum)
In this overall assessment Member States shall pay particular attention
CIPAC No 902
and ISO 3140:2011(E)
to:
(a) the protection of operators and workers;
(b) the risk to birds and mammals.
icial
Conditions of use shall include risk mitigation measures, where appro
priate.
Jour
The applicant shall submit confirmatory information as regards the
nal
metabolite fate of orange oil and the route and rate of degradation in
of
soil and on the validation of endpoints used in the ecotoxicological risk
the
assessment.
European
The applicant shall submit that information to the Commission,
Member States and the Authority by 30 April 2016.’
(*) Further details on identity and specification of active substance are provided in the review report.
Union
L
309/21

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