HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 168/18
EN
Official Journal of the European Union
20.6.2013
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 570/2013
of 17 June 2013
approving the active substance geraniol, 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 Implementing Regulation (EU) No 540/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
in accordance with the provisions of Article 6(2) and (4)
of Directive 91/414/EEC, for the uses proposed by the
applicant. The designated rapporteur Member State
submitted a draft assessment report on 30 June 2011.
Having regard to the Treaty on the Functioning of the European
Union,
(4) The
draft
assessment
report
was
reviewed
by
the
Member
Having regard to Regulation (EC) No 1107/2009 of the
States and the European Food Safety Authority (here
European Parliament and of the Council of 21 October 2009
inafter ‘the Authority’). The Authority presented to the
concerning the placing of plant protection products on the
Commission its conclusion on the review of the pesticide
market and repealing Council Directives 79/117/EEC and
risk assessment of the active substance geraniol ( 4 ) on
91/414/EEC (
15 October 2012. The draft assessment report and the

1 ), and in particular Article 13(2) and Article 78(2)
thereof,
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 the draft assessment report was finalised on
Whereas:
17 May 2013 in the format of the Commission review
report for geraniol.
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
1107/2009, Directive 91/414/EEC ( 2 ) is to apply, with
(5)
It has appeared from the various examinations made that
respect to the procedure and the conditions for
plant protection products containing geraniol may be
approval, to active substances for which a decision has
expected to satisfy, in general, the requirements laid
been adopted in accordance with Article 6(3) of that
down in Article 5(1)(a) and (b) and Article 5(3) of
Directive before 14 June 2011. For geraniol the
Directive 91/414/EEC, in particular with regard to the
conditions of Article 80(1)(a) of Regulation (EC) No
use which was examined and detailed in the Commission
1107/2009 are fulfilled by Commission Decision
review report. It is therefore appropriate to approve
2011/266/EU ( 3 ).
geraniol.
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
the United Kingdom received on 7 March 2008 an appli
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
cation from Eden Research PLC for the inclusion of the
1107/2009 in conjunction with Article 6 thereof and in
active substance geraniol in Annex I to Directive
the light of current scientific and technical knowledge, it
91/414/EEC. Decision 2011/266/EU confirmed that the
is, however, necessary to include certain conditions and
dossier was ‘complete’ in the sense that it could be
restrictions. It is, in particular, appropriate to require
considered as satisfying, in principle, the data and
further confirmatory information.
information requirements of Annexes II and III to
Directive 91/414/EEC.
(7) A
reasonable
period
should
be
allowed
to
elapse
before
(3) For
that
active
substance,
the
effects
on
human
and
approval in order to permit Member States and the
animal health and the environment have been assessed,
interested parties to prepare themselves to meet the
new requirements resulting from the approval.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 4 ) EFSA Journal (2012) 10(11):2915. Available online: www.efsa.
( 3 ) OJ L 114, 4.5.2011, p. 3.
europa.eu

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EN
20.6.2013 Official
Journal
of
the
European
Union L
168/19
(8) Without
prejudice
to
the
obligations
provided
for
in HAS ADOPTED THIS REGULATION:
Regulation (EC) No 1107/2009 as a consequence of
approval, taking into account the specific situation
created by the transition from Directive 91/414/EEC to
Regulation (EC) No 1107/2009, the following should,
Article 1
however, apply. Member States should be allowed a
Approval of active substance
period of six months after approval to review authori
sations of plant protection products containing geraniol.
The active substance geraniol, as specified in Annex I, is
Member States should, as appropriate, vary, replace or
approved subject to the conditions laid down in that Annex.
withdraw authorisations. By way of derogation from
that deadline, a longer period should be provided for
the submission and assessment of the update of the
complete Annex III dossier, as set out in Directive
Article 2
91/414/EEC, of each plant protection product for each
Re-evaluation of plant protection products
intended use in accordance with the uniform principles.
1. Member
States
shall
in
accordance
with
Regulation
(EC)
No 1107/2009, where necessary, amend or withdraw existing
authorisations for plant protection products containing geraniol
as an active substance by 31 May 2014.
(9) The
experience
gained
from
inclusions
in
Annex
I
to By that date they shall in particular verify that the conditions in
Directive 91/414/EEC of active substances assessed in
Annex I to this Regulation are met, with the exception of those
the framework of Commission Regulation (EEC) No
identified in the column on specific provisions of that Annex,
3600/92 of 11 December 1992 laying down the
and that the holder of the authorisation has, or has access to, a
detailed rules for the implementation of the first stage
dossier satisfying the requirements of Annex II to Directive
of the programme of work referred to in Article 8(2) of
91/414/EEC in accordance with the conditions of Article 13(1)
Council Directive 91/414/EEC concerning the placing of
to (4) of that Directive and Article 62 of Regulation (EC)
plant protection products on the market ( 1 ) has shown
No 1107/2009.
that difficulties can arise in interpreting the duties of
holders of existing authorisations in relation to access
to data. In order to avoid further difficulties it therefore
appears necessary to clarify the duties of the Member
2. By way of derogation from paragraph 1, for each auth
States, especially the duty to verify that the holder of
orised plant protection product containing geraniol as either the
an authorisation demonstrates access to a dossier
only active substance or as one of several active substances, all
satisfying the requirements of Annex II to that Directive.
of which were listed in the Annex to Implementing Regulation
However, this clarification does not impose any new
(EU) No 540/2011 by 30 November 2013 at the latest,
obligations on Member States or holders of authori
Member States shall re-evaluate the product in accordance
sations compared to the Directives which have been
with the uniform principles, as referred to in Article 29(6) of
adopted until now amending Annex I to that Directive
Regulation (EC) No 1107/2009, on the basis of a dossier
or the Regulations approving active substances.
satisfying the requirements of Annex III to Directive
91/414/EEC and taking into account the column on specific
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 of 25 May 2011 imple
Following that determination Member States shall:
menting Regulation (EC) No 1107/2009 of the European
Parliament and of the Council as regards the list of
approved active substances
( 2 ) should be amended
(a) in the case of a product containing geraniol as the only
accordingly.
active substance, where necessary, amend or withdraw the
authorisation by 31 May 2015 at the latest; or
(b) in the case of a product containing geraniol as one of
several active substances, where necessary, amend or
(11) The
measures
provided
for
in
this
Regulation
are
in
withdraw the authorisation by 31 May 2015 or by the
accordance with the opinion of the Standing
date fixed for such an amendment or withdrawal in the
Committee on the Food Chain and Animal Health,
respective act or acts which added the relevant substance
or substances to Annex I to Directive 91/414/EEC or
( 1 ) OJ L 366, 15.12.1992, p. 10.
approved that substance or those substances, whichever is
( 2 ) OJ L 153, 11.6.2011, p. 1.
the latest.

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L 168/20
EN
Official Journal of the European Union
20.6.2013
Article 3
Amendments to Implementing Regulation (EU) No 540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this
Regulation.
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 December 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 June 2013.
For the Commission
The President
José Manuel BARROSO

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20.6.2013 Off
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Geraniol CAS No 106-24-1 (E) 3,7-dimethyl-2,6-octadien-1-ol
≥ 980 g/kg 1
December
2013 30
November
2023
For the implementation of the uniform principles as referred to in
EN
CIPAC No 968
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
the review report on geraniol, and in particular Appendices I and II

thereof, as finalised in the Standing Committee on the Food Chain
and Animal Health on 17 May 2013 shall be taken into account.
In this overall assessment Member States shall pay particular attention
to
— the protection of operators, workers, bystanders and residents,
ensuring that conditions of use include the application of
adequate personal protective equipment, where appropriate;
— the protection of groundwater, when the substance is applied in
icial
regions with vulnerable soil and/or climatic conditions;
Jour
— the risk to aquatic organisms;
nal
of
— the risk to birds and mammals.
the
Conditions of use shall include risk mitigation measures, where
European
appropriate.
The applicant shall submit confirmatory information as regards
Union
(a) data comparing natural background exposure situations of
geraniol in relation to exposure from the use of geraniol as a
plant protection product. This data shall cover human exposure as
well as exposure of birds, mammals and aquatic organisms;
(b) the groundwater exposure.
The applicant shall submit to the Commission, the Member States
and the Authority that information by 30 November 2015.
(1 ) Further details on identity and specification of active substance are provided in the review report.
L
168/21

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L 168/22
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
‘46 Geraniol
CAS
No
106-24-1
(E) 3,7-dimethyl-2,6-octadien-1-ol
≥ 980 g/kg 1
December
2013 30
November
2023
For the implementation of the uniform principles

CIPAC No 968
as referred to in Article 29(6) of Regulation (EC)
No 1107/2009, the conclusions of the review
report on geraniol, and in particular Appendices
I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal
Health on 17 May 2013 shall be taken into
account.
In this overall assessment Member States shall
pay particular attention to
Off
— the protection of operators, workers,
icial
bystanders and residents, ensuring that
conditions of use include the application of
Jour
adequate personal protective equipment,
where appropriate;
nal
of
— the protection of groundwater, when the
the
substance is applied in regions with
vulnerable soil and/or climatic conditions;
European
— the risk to aquatic organisms;
— the risk to birds and mammals.
Union
Conditions of use shall include risk mitigation
measures, where appropriate.
The applicant shall submit confirmatory
information as regards
(a) data comparing natural background exposure
situations of geraniol in relation to exposure
from the use of geraniol as a plant protection
product. This data shall cover human
exposure as well as exposure of birds,
mammals and aquatic organisms;
(b) the groundwater exposure.
The applicant shall submit to the Commission,
the Member States and the Authority that
information by 30 November 2015.
20.6.2013
(*) Further details on identity and specification of active substance are provided in the review report.’

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