HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 101/20
EN
Official Journal of the European Union
15.4.2011
DIRECTIVES
COMMISSION IMPLEMENTING DIRECTIVE 2011/46/EU
of 14 April 2011
amending Council Directive 91/414/EEC to include hexythiazox as active substance and amending
Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
new application requesting the accelerated procedure to
be applied, as provided for in Articles 14 to 19 of
Commission Regulation (EC) No 33/2008 of
17 January 2008 laying down detailed rules for the
Having regard to the Treaty on the Functioning of the European
application of Council Directive 91/414/EEC as regards
Union,
a regular and an accelerated procedure for the assessment
of active substances which were part of the programme
of work referred to in Article 8(2) of that Directive but
have not been included into its Annex I ( 5 ).
Having regard to Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant protection products on
the market ( 1 ), and in particular Article 6(1) thereof,
(4) The
application
was
submitted
to
Finland,
which
had
been designated rapporteur Member State by Regulation
Whereas:
(EC) No 1490/2002. The time period for the accelerated
procedure was respected. The specification of the active
substance and the supported uses are the same as were
the subject of Decision 2008/934/EC. That application
also complies with the remaining substantive and
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
No 1490/2002 (
procedural requirements of Article 15 of Regulation

3 ) lay down the detailed rules for the
implementation of the third stage of the programme of
(EC) No 33/2008.
work referred to in Article 8(2) of Directive 91/414/EEC
and establish a list of active substances to be assessed,
with a view to their possible inclusion in Annex I to
Directive 91/414/EEC. That list included hexythiazox.
(5) Finland
evaluated
the
additional
data
submitted
by
the
applicant and prepared an additional report. It
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
communicated that report to the European Food Safety
1490/2002 the notifier withdrew its support of the
Authority (hereinafter ‘the Authority’) and to the
inclusion of that active substance in Annex I to
Commission on 20 October 2009. The Authority
Directive 91/414/EEC within 2 months from receipt of
communicated the additional report to the other
the draft assessment report. Consequently, Commission
Member States and the applicant for comments and
Decision 2008/934/EC of 5 December 2008 concerning
forwarded the comments it had received to the
the non-inclusion of certain active substances in Annex I
Commission. In accordance with Article 20(1) of Regu
to Council Directive 91/414/EEC and the withdrawal of
lation (EC) No 33/2008 and at the request of the
authorisations for plant protection products containing
Commission, the Authority presented its conclusion on
these substances (
hexythiazox to the Commission on 7 September

4 ) was adopted on the non-inclusion
of hexythiazox.
2010 ( 6 ). The draft assessment report, the additional
report and the 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 11 March 2011 in the
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
format of the Commission review report for hexythiazox.
original notifier (hereinafter ‘the applicant’) submitted a
( 5 ) OJ L 15, 18.1.2008, p. 5.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 6 ) European Food Safety Authority; Conclusion on the peer review of
( 2 ) OJ L 55, 29.2.2000, p. 25.
the pesticide risk assessment of the active substance hexythiazox.
( 3 ) OJ L 224, 21.8.2002, p. 23.
EFSA Journal 2010; 8(9):1722. [78 pp.]. doi:10.2903/
( 4 ) OJ L 333, 11.12.2008, p. 11.
j.efsa.2010.1722. Available online: www.efsa.europa.eu

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EN
15.4.2011 Official
Journal
of
the
European
Union L
101/21
(6)
It has appeared from the various examinations made that
rules for the implementation of the first stage of the
plant protection products containing hexythiazox may be
programme of work referred to in Article 8(2) of
expected to satisfy, in general, the requirements laid
Council Directive 91/414/EEC concerning the placing
down in Article 5(1)(a) and (b) of Directive
of plant protection products on the market ( 2 ) has
91/414/EEC, in particular with regard to the uses
shown that difficulties can arise in interpreting the
which have been examined and detailed in the
duties of holders of existing authorisations in relation
Commission review report. It is therefore appropriate
to access to data. In order to avoid further difficulties
to include hexythiazox in Annex I, in order to ensure
it therefore appears necessary to clarify the duties of
that in all Member States the authorisations of plant
the Member States, especially the duty to verify that
protection products containing this active substance can
the holder of an authorisation demonstrates access to a
be granted in accordance with the provisions of that
dossier satisfying the requirements of Annex II to that
Directive.
Directive. However, this clarification does not impose any
new obligations on Member States or holders of auth
orisations compared to the Directives which have been
adopted until now amending Annex I.
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
obtain further information on certain specific points.
Article 6(1) of Directive 91/414/EC provides that
(11) It is therefore appropriate to amend Directive
inclusion of a substance in Annex I may be subject to
91/414/EEC accordingly.
conditions. Therefore, it is appropriate to require that the
applicant submit information confirming the risk
assessment for the toxicological relevance and the
potential occurrence of the metabolite PT-1-3 ( 1 ) in
(12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
processed commodities, the potential adverse effects of
hexythiazox and the withdrawal of authorisations for
hexythiazox on bee brood and the possible impact of the
plant protection products containing that substance by
preferential degradation and/or conversion of the mixture
31 December 2011. It is necessary to delete the line
of isomers on the worker risk assessment, the consumer
concerning hexythiazox in the Annex to that Decision.
risk assessment and the environment.
(13) It is therefore appropriate to amend Decision
2008/934/EC accordingly.
(8) A
reasonable
period
should
be
allowed
to
elapse
before
an active substance is included in Annex I in order to
permit Member States and the interested parties to
prepare themselves to meet the new requirements
(14) The
measures provided for in this Directive are in
which will result from the inclusion.
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(9) Without
prejudice
to
the
obligations
defined
by
Directive HAS ADOPTED THIS DIRECTIVE:
91/414/EEC as a consequence of including an active
substance in Annex I, Member States should be
allowed a period of 6 months after inclusion to review
existing authorisations of plant protection products
Article 1
containing hexythiazox to ensure that the requirements
laid down by Directive 91/414/EEC, in particular in its
Annex I to Directive 91/414/EEC is amended as set out in the
Article 13 and the relevant conditions set out in Annex I,
Annex to this Directive.
are satisfied. Member States should vary, replace or
withdraw, as appropriate, existing authorisations, in
accordance with the provisions of Directive 91/414/EEC.
Article 2
By derogation from the above deadline, a longer period
should be provided for the submission and assessment of
The line concerning hexythiazox in the Annex to Decision
the complete Annex III dossier of each plant protection
2008/934/EC is deleted.
product for each intended use in accordance with the
uniform principles laid down in Directive 91/414/EEC.
Article 3
Member States shall adopt and publish by 30 November 2011
(10) The
experience
gained
from
previous
inclusions
in
Annex
at the latest the laws, regulations and administrative provisions
I to Directive 91/414/EEC of active substances assessed
necessary to comply with this Directive. They shall forthwith
in the framework of Commission Regulation (EEC) No
communicate to the Commission the text of those provisions
3600/92 of 11 December 1992 laying down the detailed
and a correlation table between those provisions and this
Directive.
( 1 ) (4S,5S)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4R,
5R)-5-(4-chlorophenyl)-4-methyl- 1,3-thiazolidin-2-one.
( 2 ) OJ L 366, 15.12.1992, p. 10.

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L 101/22
EN
Official Journal of the European Union
15.4.2011
They shall apply those provisions from 1 December 2011.
evaluation, they shall determine whether the product satisfies
the conditions set out in Article 4(1)(b), (c), (d) and (e) of
Directive 91/414/EEC.
When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
Following that determination Member States shall:
States shall determine how such reference is to be made.
(a) in the case of a product containing hexythiazox as the only
active substance, where necessary, amend or withdraw the
Article 4
authorisation by 31 May 2015 at the latest; or
1. Member States shall in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
(b) in the case of a product containing hexythiazox as one of
authorisations for plant protection products containing hexy
several active substances, where necessary, amend or
thiazox as an active substance by 30 November 2011.
withdraw the authorisation by 31 May 2015 or by the
date fixed for such an amendment or withdrawal in the
respective Directive or Directives which added the relevant
By that date they shall in particular verify that the conditions in
substance or substances to Annex I to Directive
Annex I to that Directive relating to hexythiazox are met, with
91/414/EEC, whichever is the latest.
the exception of those identified in part B of the entry
concerning that active substance, and that the holder of the
authorisation has, or has access to, a dossier satisfying the
Article 5
requirements of Annex II to that Directive in accordance with
the conditions of Article 13 of that Directive.
This Directive shall enter into force on 1 June 2011.
Article 6
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
orised plant protection product containing hexythiazox as either
This Directive is addressed to the Member States.
the only active substance or as one of several active substances
all of which were listed in Annex I to Directive 91/414/EEC by
31 May 2011 at the latest, Member States shall re-evaluate the
Done at Brussels, 14 April 2011.
product in accordance with the uniform principles provided for
in Annex VI to Directive 91/414/EEC, on the basis of a dossier
For the Commission
satisfying the requirements of Annex III to that Directive and
taking into account part B of the entry in Annex I to that
The President
Directive concerning hexythiazox. On the basis of that
José Manuel BARROSO

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15.4.2011 Off
ANNEX
The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:
No
Common name,
identification numbers
IUPAC name Purity
(1 ) Entry
into
force Expiration
of
inclusion Specific
provisions
EN
‘343 Hexythiazox
(4RS,5RS)-5-(4-chloro
≥ 976 g/kg
1 June 2011 31
May
2021 PART
A

phenyl)-N-cyclohexyl-4-
CAS No 78587-05-0
methyl-2-oxo-1,3-thia
(1:1 mixture of
Only uses as acaricide may be authorised.
(4R, 5R) and
CIPAC No 439
zolidine-3-carboxamide
(4S, 5S))
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of
the review report on hexythiazox, and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health on
11 March 2011 shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
icial
— the protection of aquatic organisms. Conditions of use shall include risk
mitigation measures, where appropriate,
Jour
— the operators and workers safety. Conditions of use shall include protective
nal
measures, where appropriate.
of
the
The Member States concerned shall request the submission of confirmatory
information as regards:
European
(a) the toxicological relevance of the metabolite PT-1-3 (*);
(b) the potential occurrence of the metabolite PT-1-3 in processed commodities;
Union
(c) the potential adverse effects of hexythiazox on bee brood;
(d) the possible impact of the preferential degradation and/or conversion of the
mixture of isomers on the worker risk assessment, the consumer risk
assessment and the environment.
The Member States concerned shall ensure that the applicant submits to the
Commission the information set out in points (a), (b) and (c) by 31 May 2013
and the information set out in point (d) 2 years after the adoption of specific
guidance.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
(*) (4S,5S)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4R,5R)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one.
L
101/23

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