HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
19.6.2013 Official
Journal
of
the
European
Union L
167/33
COMMISSION IMPLEMENTING REGULATION (EU) No 568/2013
of 18 June 2013
approving the active substance thymol, 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,
Member States and the Commission within the Standing
Committee on the Food Chain and Animal Health and
Having regard to the Treaty on the Functioning of the European
the draft assessment report was finalised on 17 May
Union,
2013 in the format of the Commission review report
for thymol.
Having regard to Regulation (EC) No 1107/2009 of the
European Parliament and of the Council of 21 October 2009
(5)
It has appeared from the various examinations made that
concerning the placing of plant protection products on the
plant protection products containing thymol may be
market and repealing Council Directives 79/117/EEC and
expected to satisfy, in general, the requirements laid
91/414/EEC (
down in Article 5(1)(a) and (b) and Article 5(3) of

1 ), and in particular Articles 13(2) and 78(2)
thereof,
Directive 91/414/EEC, in particular with regard to the
use which was examined and detailed in the Commission
review report. It is therefore appropriate to approve
Whereas:
thymol.
(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 thymol the
further confirmatory information.
conditions of Article 80(1)(a) of Regulation (EC) No
1107/2009 are fulfilled by Commission Implementing
Decision 2011/266/EU ( 3 ).
(7) A
reasonable
period
should
be
allowed
to
elapse
before
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 thymol 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 thymol.
(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 thymol ( 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
Council Directive 91/414/EEC concerning the placing of
( 1 ) OJ L 309, 24.11.2009, p. 1.
plant protection products on the market ( 5 ) has shown
( 2 ) OJ L 230, 19.8.1991, p. 1.
that difficulties can arise in interpreting the duties of
( 3 ) OJ L 114, 4.5.2011, p. 3.
( 4 ) EFSA Journal (2012) 10(11):2916. Available online: www.efsa.
europa.eu
( 5 ) OJ L 366, 15.12.1992, p. 10.

---

L 167/34
EN
Official Journal of the European Union
19.6.2013
holders of existing authorisations in relation to access to
91/414/EEC in accordance with the conditions of Article 13(1)
data. In order to avoid further difficulties it therefore
to (4) of that Directive and Article 62 of Regulation (EC) No
appears necessary to clarify the duties of the Member
1107/2009.
States, especially the duty to verify that the holder of
an authorisation demonstrates access to a dossier
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
satisfying the requirements of Annex II to that Directive.
orised plant protection product containing thymol as either the
However, this clarification does not impose any new
only active substance or as one of several active substances, all
obligations on Member States or holders of authori
of which were listed in the Annex to Implementing Regulation
sations compared to the Directives which have been
(EU) No 540/2011 by 30 November 2013 at the latest,
adopted until now amending Annex I to that Directive
Member States shall re-evaluate the product in accordance
or the Regulations approving active substances.
with the uniform principles, as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, on the basis of a dossier
(10) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
satisfying the requirements of Annex III to Directive
1107/2009, the Annex to Commission Implementing
91/414/EEC and taking into account the column on specific
Regulation (EU) No 540/2011 of 25 May 2011 imple
provisions of Annex I to this Regulation. On the basis of that
menting Regulation (EC) No 1107/2009 of the European
evaluation, they shall determine whether the product satisfies
Parliament and of the Council as regards the list of
the conditions set out in Article 29(1) of Regulation (EC) No
approved active substances
(
1107/2009.

1 ) 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 thymol 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 May 2015 at the latest; or
(b) in the case of a product containing thymol as one of several
HAS ADOPTED THIS REGULATION:
active substances, where necessary, amend or withdraw the
authorisation by 31 May 2015 or by the date fixed for such
Article 1
an amendment or withdrawal in the respective act or acts
Approval of active substance
which added the relevant substance or substances to Annex
I to Directive 91/414/EEC or approved that substance or
The active substance thymol, as specified in Annex I, is
those substances, whichever is the latest.
approved subject to the conditions laid down in that Annex.
Article 3
Article 2
Amendments to Implementing Regulation (EU) No
Re-evaluation of plant protection products
540/2011
1. Member
States
shall
in
accordance
with
Regulation
(EC)
The Annex to Implementing Regulation (EU) No 540/2011 is
No 1107/2009, where necessary, amend or withdraw existing
amended in accordance with Annex II to this Regulation.
authorisations for plant protection products containing thymol
Article 4
as an active substance by 31 May 2014.
Entry into force and date of application
By that date they shall in particular verify that the conditions in
This Regulation shall enter into force on the twentieth day
Annex I to this Regulation are met, with the exception of those
following that of its publication in the Official Journal of the
identified in the column on specific provisions of that Annex,
European Union.
and that the holder of the authorisation has, or has access to, a
dossier satisfying the requirements of Annex II to Directive
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, 18 June 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

---

19.6.2013 Off
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Thymol
5-methyl-2-propan-2-yl-phenol ≥ 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 of the review report on thymol, and
EN
CAS No 89-83-8
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.
CIPAC No 969
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 regions with
vulnerable soil and/or climatic conditions;
— the risk to aquatic organisms;
icial
— the risk to birds and mammals.
Jour
nal
Conditions of use shall include risk mitigation measures, where appropriate.
of
The applicant shall submit confirmatory information as regards
the
European
(a) data comparing natural background exposure situations of thymol in relation to
exposure from the use of thymol as a plant protection product. This data shall
cover human exposure as well as exposure of birds, mammals and aquatic
organisms;
Union
(b) the long-term and reproductive toxicity, in a form of a full report (in English) of
the Combined Test of Repeated Oral-Administration Toxicity and Reproductive
Toxicity of Thymol;
(c) 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
167/35

---

L 167/36
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number
Common Name,
Expiration of
Identification Numbers
IUPAC Name Purity
(*)
Date of
approval
approval
Specific provisions
EN
‘47 Thymol
5-methyl-2-
≥ 990 g/kg 1
December 30 November For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No

CAS No
propan-2-yl-phenol
2013
2023
1107/2009, the conclusions of the review report on thymol, and in particular Appendices I and II
89-83-8
thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May
2013, shall be taken into account.
CIPAC No
969
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 regions with vulnerable soil and/or
climatic conditions;
Off
— the risk to aquatic organisms;
icial
— the risk to birds and mammals.
Jour
Conditions of use shall include risk mitigation measures, where appropriate.
nal
The applicant shall submit confirmatory information as regards
of
(a) data comparing natural background exposure situations of thymol in relation to exposure from the
the
use of thymol as a plant protection product. This data shall cover human exposure as well as
European
exposure of birds, mammals and aquatic organisms;
(b) the long-term and reproductive toxicity, in a form of a full report (in English) of the Combined
Test of Repeated Oral-Administration Toxicity and Reproductive Toxicity of Thymol;
Union
(c) the groundwater exposure.
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.
19.6.2013

---

Document Outline

• �

---