HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
15.6.2013 Official
Journal
of
the
European
Union L
163/17
COMMISSION IMPLEMENTING REGULATION (EU) No 546/2013
of 14 June 2013
approving the active substance eugenol, 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,
Standing Committee on the Food Chain and Animal
Health and the draft assessment report was finalised on
Having regard to the Treaty on the Functioning of the European
17 May 2013 in the format of the Commission review
Union,
report for eugenol.
Having regard to Regulation (EC) No 1107/2009 of the
(5)
It has appeared from the various examinations made that
European Parliament and of the Council of 21 October 2009
plant protection products containing eugenol may be
concerning the placing of plant protection products on the
expected to satisfy, in general, the requirements laid
market and repealing Council Directives 79/117/EEC and
down in Article 5(1)(a) and (b) and Article 5(3) of
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
Directive 91/414/EEC, in particular with regard to the
thereof,
use which was examined and detailed in the Commission
review report. It is therefore appropriate to approve
Whereas:
eugenol.


(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No (6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
1107/2009 in conjunction with Article 6 thereof and in
with respect to the procedure and the conditions for
the light of current scientific and technical knowledge, it
approval, to active substances for which a decision has
is, however, necessary to include certain conditions and
been adopted in accordance with Article 6(3) of that
restrictions. It is, in particular, appropriate to require
Directive before 14 June 2011. For eugenol the
further confirmatory information.
conditions of Article 80(1)(a) of Regulation (EC) No
1107/2009 are fulfilled by Commission Implementing
(7) A
reasonable
period
should
be
allowed
to
elapse
before
Decision 2011/266/EU ( 3 ).
approval in order to permit Member States and the
interested parties to prepare themselves to meet the
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
new requirements resulting from the approval.
the United Kingdom received on 7 March 2008 an appli
cation from Eden Research PLC for the inclusion of the
active substance eugenol in Annex I to Directive
(8) Without
prejudice
to
the
obligations
provided
for
in
91/414/EEC. Implementing Decision 2011/266/EU
Regulation (EC) No 1107/2009 as a consequence of
confirmed that the dossier was ‘complete’ in the sense
approval, taking into account the specific situation
that it could be considered as satisfying, in principle, the
created by the transition from Directive 91/414/EEC to
data and information requirements of Annexes II and III
Regulation (EC) No 1107/2009, the following should,
to Directive 91/414/EEC.
however, apply. Member States should be allowed a

period of six months after approval to review authori
sations of plant protection products containing eugenol.
(3) For
that
active
substance,
the
effects
on
human
and
Member States should, as appropriate, vary, replace or
animal health and the environment have been assessed,
withdraw authorisations. By way of derogation from
in accordance with the provisions of Article 6(2) and (4)
that deadline, a longer period should be provided for
of Directive 91/414/EEC, for the uses proposed by the
the submission and assessment of the update of the
applicant. The designated rapporteur Member State
complete Annex III dossier, as set out in Directive
submitted a draft assessment report on 30 June 2011.
91/414/EEC, of each plant protection product for each
intended use in accordance with the uniform principles.
(4) The
draft
assessment
report
was
reviewed
by
the
Member
States and the European Food Safety Authority (here
(9) The
experience
gained
from
inclusions
in
Annex
I
to
inafter ‘the Authority’). The Authority presented to the
Directive 91/414/EEC of active substances assessed in
Commission its conclusion on the review of the pesticide
the framework of Commission Regulation (EEC) No
risk assessment of the active substance eugenol ( 4 ) on
3600/92 of 11 December 1992 laying down the
15 October 2012. The draft assessment report and the
detailed rules for the implementation of the first stage
conclusion of the Authority were reviewed by the
of the programme of work referred to in Article 8(2) of
Member States and the Commission within the
Council Directive 91/414/EEC concerning the placing of
plant protection products on the market ( 5 ) has shown
( 1 ) OJ L 309, 24.11.2009, p. 1.
that difficulties can arise in interpreting the duties of
( 2 ) OJ L 230, 19.8.1991, p. 1.
holders of existing authorisations in relation to
( 3 ) OJ L 114, 4.5.2011, p. 3.
( 4 ) EFSA Journal 2012; 10(11):2914. Available online: www.efsa.
europa.eu
( 5 ) OJ L 366, 15.12.1992, p. 10.

---

L 163/18
EN
Official Journal of the European Union
15.6.2013
access to data. In order to avoid further difficulties it
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
therefore appears necessary to clarify the duties of the
orised plant protection product containing eugenol as either the
Member States, especially the duty to verify that the
only active substance or as one of several active substances, all
holder of an authorisation demonstrates access to a
of which were listed in the Annex to Implementing Regulation
dossier satisfying the requirements of Annex II to that
(EU) No 540/2011 by 30 November 2013 at the latest,
Directive. However, this clarification does not impose any
Member States shall re-evaluate the product in accordance
new obligations on Member States or holders of auth
with the uniform principles, as referred to in Article 29(6) of
orisations compared to the Directives which have been
Regulation (EC) No 1107/2009, on the basis of a dossier
adopted until now amending Annex I to that Directive or
satisfying the requirements of Annex III to Directive
the Regulations approving active substances.
91/414/EEC and taking into account the column on specific
provisions of Annex I to this Regulation. On the basis of that
(10) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
evaluation, they shall determine whether the product satisfies
1107/2009, the Annex to Commission Implementing
the conditions set out in Article 29(1) of Regulation (EC) No
Regulation (EU) No 540/2011 of 25 May 2011 imple
1107/2009.
menting Regulation (EC) No 1107/2009 of the European
Parliament and of the Council as regards the list of
Following that determination Member States shall:
approved active substances
( 1 ) should be amended
accordingly.
(a) in the case of a product containing eugenol as the only
(11) The
measures
provided
for
in
this
Regulation
are
in
active substance, where necessary, amend or withdraw the
accordance with the opinion of the Standing
authorisation by 31 May 2015 at the latest; or
Committee on the Food Chain and Animal Health,
(b) in the case of a product containing eugenol as one of
HAS ADOPTED THIS REGULATION:
several active substances, where necessary, amend or
withdraw the authorisation by 31 May 2015 or by the
Article 1
date fixed for such an amendment or withdrawal in the
respective act or acts which added the relevant substance
Approval of active substance
or substances to Annex I to Directive 91/414/EEC or
The active substance eugenol, as specified in Annex I, is
approved that substance or those substances, whichever is
approved subject to the conditions laid down in that Annex.
the latest.
Article 2
Article 3
Re-evaluation of plant protection products
Amendments to Implementing Regulation (EU) No
540/2011
1. Member
States
shall
in
accordance
with
Regulation
(EC)
No 1107/2009, where necessary, amend or withdraw existing
The Annex to Implementing Regulation (EU) No 540/2011 is
authorisations for plant protection products containing eugenol
amended in accordance with Annex II to this Regulation.
as an active substance by 31 May 2014.
Article 4
By that date they shall in particular verify that the conditions in
Annex I to this Regulation are met, with the exception of those
Entry into force and date of application
identified in the column on specific provisions of that Annex,
and that the holder of the authorisation has, or has access to, a
This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
dossier satisfying the requirements of Annex II to Directive
European Union.
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.
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, 14 June 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

---

15.6.2013 Off
ANNEX I
Common Name, Identification
Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Eugenol CAS No 97-53-0 4-allyl-2-methoxyphenol
≥ 990 g/kg
1 December 2013 30
November
2023
For the implementation of the uniform principles as referred to in
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions
EN
CIPAC No 967
Relevant impurity: methyl
of the review report on eugenol, and in particular Appendices I

eugenol maximum 0,1 %
and II thereof, as finalised in the Standing Committee on the Food
of the technical material
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,
icial
— the protection of groundwater, when the substance is applied
in regions with vulnerable soil and/or climatic conditions,
Jour
— the risk to aquatic organisms,
nal
— the risk to insectivorous birds.
of
the
Conditions of use shall include risk mitigation measures, where
European
appropriate.
The applicant shall submit confirmatory information as regards:
Union
(a) the storage stability (2 years) at ambient temperature on the
formulated product;
(b) data comparing natural background exposure situations of
eugenol and methyl eugenol in relation to exposure from
the use of eugenol as a plant protection product. This data
shall cover human exposure as well as exposure of birds and
aquatic organisms;
(c) the groundwater exposure assessment for potential meta
bolites of eugenol, in particular for methyl eugenol.
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
163/19

---

L 163/20
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Common Name,
Number
Identification
IUPAC Name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
Numbers
EN

‘45 Eugenol
CAS 4-allyl-2-metho ≥ 990 g/kg
1 December 2013 30
November
2023 For
the
implementation
of
the
uniform
principles
as
referred
to
in
Article
29(6)
of
No 97-53-0
xyphenol
Regulation (EC) No 1107/2009, the conclusions of the review report on eugenol,
Relevant impurity: methyl
and in particular Appendices I and II thereof, as finalised in the Standing Committee
CIPAC No 967
eugenol maximum 0,1 % of
on the Food Chain and Animal Health on 17 May 2013 shall be taken into
the technical material
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
Off
equipment, where appropriate,
icial
— the protection of groundwater, when the substance is applied in regions with
vulnerable soil and/or climatic conditions,
Jour
nal
— the risk to aquatic organisms,
of
— the risk to insectivorous birds.
the
Conditions of use shall include risk mitigation measures, where appropriate.
European
The applicant shall submit confirmatory information as regards:
(a) the storage stability (2 years) at ambient temperature on the formulated product;
Union
(b) data comparing natural background exposure situations of eugenol and methyl
eugenol in relation to exposure from the use of eugenol as a plant protection
product. This data shall cover human exposure as well as exposure of birds and
aquatic organisms;
(c) the groundwater exposure assessment for potential metabolites of eugenol, in
particular for methyl eugenol.
The applicant shall submit to the Commission, the Member States and the Authority
that information by 30 November 2015.’
(*) Further details on identity and specification of active substance are provided in the review report.
15.6.2013

---

Document Outline

• �

---