HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 18/34
EN
Official Journal of the European Union
21.1.2011
COMMISSION DIRECTIVE 2011/5/EU
of 20 January 2011
amending Council Directive 91/414/EEC to include hymexazol as active substance and amending
Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) The
application
was
submitted
to
Finland,
which
had
been designated rapporteur Member State by Regulation
(EC) No 451/2000. The time period for the accelerated
procedure was respected. The specification of the active
Having regard to the Treaty on the Functioning of the European
substance and the supported uses are the same as were
Union,
the subject of Decision 2008/934/EC. That application
also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation
Having regard to Council Directive 91/414/EEC of 15 July
(EC) No 33/2008.
1991 concerning the placing of plant protection products on
the market ( 1 ), and in particular Article 6(1) thereof,
(5) Finland
evaluated
the
additional
data
submitted
by
the
applicant and prepared an additional report. It
communicated that report to the European Food Safety
Whereas:
Authority (hereinafter ‘the Authority’) and to the
Commission on 17 September 2009. The Authority
communicated the additional report to the other
Member States and the applicant for comments and
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
No 1490/2002 (
forwarded the comments it had received to the

3 ) lay down the detailed rules for the
implementation of the third stage of the programme of
Commission. In accordance with Article 20(1) of Regu
work referred to in Article 8(2) of Directive 91/414/EEC
lation (EC) No 33/2008 and at the request of the
and establish a list of active substances to be assessed,
Commission, the Authority presented its conclusion on
with a view to their possible inclusion in Annex I to
hymexazol to the Commission on 4 November 2010 ( 6 ).
Directive 91/414/EEC. That list included hymexazol.
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
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
Health and finalised on 23 November 2010 in the
1490/2002 the applicant withdrew its support of the
format of the Commission review report for hymexazol.
inclusion of that active substance in Annex I to
Directive 91/414/EEC within two months from receipt
of the draft assessment report. Consequently,
(6)
It has appeared from the various examinations made that
Commission Decision 2008/934/EC of 5 December
plant protection products containing hymexazol may be
2008 concerning the non-inclusion of certain active
expected to satisfy, in general, the requirements laid
substances in Annex I to Council Directive 91/414/EEC
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
and the withdrawal of authorisations for plant protection
in particular with regard to the uses which have been
products containing these substances ( 4 ) was adopted on
examined and detailed in the Commission review report.
the non-inclusion of hymexazol.
It is therefore appropriate to include hymexazol in Annex
I, in order to ensure that in all Member States the au-
thorisations of plant protection products containing this
active substance can be granted in accordance with the
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
original notifier (hereinafter ‘the applicant’) submitted a
provisions of that Directive.
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
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
17 January 2008 laying down detailed rules for the
obtain further information on certain specific points.
application of Council Directive 91/414/EEC as regards
Article 6(1) of Directive 91/414/EC provides that
a regular and an accelerated procedure for the assessment
inclusion of a substance in Annex I may be subject to
of active substances which were part of the programme
conditions. Therefore, it is appropriate to require that the
of work referred to in Article 8(2) of that Directive but
applicant submit further information confirming the
have not been included into its Annex I ( 5 ).
nature of residues in root crops and to confirm the
risk for granivorous birds and mammals.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 2 ) OJ L 55, 29.2.2000, p. 25.
( 6 ) European Food Safety Authority; Conclusion on the peer review
( 3 ) OJ L 224, 21.8.2002, p. 23.
of the pesticide risk assessment of the active substance
( 4 ) OJ L 333, 11.12.2008, p. 11.
hymexazol. EFSA Journal 2010; 8(11):1653. [63 pp.].
( 5 ) OJ L 15, 18.1.2008, p. 5.
doi:10.2903/j.efsa.2010.1653. Available online: www.efsa.europa.eu

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EN
21.1.2011 Official
Journal
of
the
European
Union L
18/35
(8) A
reasonable
period
should
be
allowed
to
elapse
before HAS ADOPTED THIS DIRECTIVE:
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
which will result from the inclusion.
Article 1

Annex I to Directive 91/414/EEC is amended as set out in the
Annex to this Directive.
(9) Without
prejudice
to
the
obligations
defined
by
Directive
91/414/EEC as a consequence of including an active
substance in Annex I, Member States should be
allowed a period of six months after inclusion to
Article 2
review existing authorisations of plant protection
The line concerning hymexazol in the Annex to Decision
products containing hymexazol to ensure that the
2008/934/EC is deleted.
requirements laid down by Directive 91/414/EEC, in
particular in its Article 13 and the relevant conditions
set out in Annex I, are satisfied. Member States should
vary, replace or withdraw, as appropriate, existing au-
Article 3
thorisations, in accordance with the provisions of
Member States shall adopt and publish by 30 November 2011
Directive 91/414/EEC. By derogation from the above
at the latest the laws, regulations and administrative provisions
deadline, a longer period should be provided for the
necessary to comply with this Directive. They shall forthwith
submission and assessment of the complete Annex III
communicate to the Commission the text of those provisions
dossier of each plant protection product for each
and a correlation table between those provisions and this
intended use in accordance with the uniform principles
Directive.
laid down in Directive 91/414/EEC.
(10) The
experience
gained
from
previous
inclusions
in
Annex
They shall apply those provisions from 1 December 2011.
I to Directive 91/414/EEC of active substances assessed
in the framework of Commission Regulation (EEC) No
3600/92 of 11 December 1992 laying down the detailed
rules for the implementation of the first stage of the
When Member States adopt those provisions, they shall contain
programme of work referred to in Article 8(2) of
a reference to this Directive or be accompanied by such a
Council Directive 91/414/EEC concerning the placing
reference on the occasion of their official publication. Member
of plant protection products on the market (
States shall determine how such reference is to be made.

1 ) has
shown 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
Article 4
it therefore appears necessary to clarify the duties of
the Member States, especially the duty to verify that
1. Member States shall in accordance with Directive
the holder of an authorisation demonstrates access to a
91/414/EEC, where necessary, amend or withdraw existing
dossier satisfying the requirements of Annex II to that
authorisations for plant protection products containing
Directive. However, this clarification does not impose any
hymexazol as an active substance by 1 December 2011.
new obligations on Member States or holders of au-
thorisations compared to the directives which have
been adopted until now amending Annex I.
By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to hymexazol are met, with
the exception of those identified in part B of the entry
(11) It is therefore appropriate to amend Directive
concerning that active substance, and that the holder of the
91/414/EEC accordingly.
authorisation has, or has access to, a dossier satisfying the
requirements of Annex II to that Directive in accordance with
the conditions of Article 13 of that Directive.
(12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
hymexazol and the withdrawal of authorisations for plant
protection products containing that substance by
31 December 2011. It is necessary to delete the line
2. By way of derogation from paragraph 1, for each au-
concerning hymexazol in the Annex to that Decision.
thorised plant protection product containing hymexazol as
either the only active substance or as one of several active
substances all of which were listed in Annex I to Directive
(13) It is therefore appropriate to amend Decision
91/414/EEC by 31 May 2011 at the latest, Member States
2008/934/EC accordingly.
shall re-evaluate the product in accordance with the uniform
principles provided for in Annex VI to Directive 91/414/EEC,
on the basis of a dossier satisfying the requirements of Annex
(14) The
measures provided for in this Directive are in
III to that Directive and taking into account part B of the entry
accordance with the opinion of the Standing
in Annex I to that Directive concerning hymexazol. On the
Committee on the Food Chain and Animal Health,
basis of that evaluation, they shall determine whether the
product satisfies the conditions set out in Article 4(1)(b), (c),
( 1 ) OJ L 366, 15.12.1992, p. 10.
(d) and (e) of Directive 91/414/EEC.

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L 18/36
EN
Official Journal of the European Union
21.1.2011
Following that determination Member States shall:
Article 5
This Directive shall enter into force on 1 June 2011.
(a) in the case of a product containing hymexazol as the only
active substance, where necessary, amend or withdraw the
Article 6
authorisation by 31 May 2015 at the latest; or
This Directive is addressed to the Member States.
(b) in the case of a product containing hymexazol as one of
several active substances, where necessary, amend or
Done at Brussels, 20 January 2011.
withdraw the authorisation by 31 May 2015 or by the
date fixed for such an amendment or withdrawal in the
For the Commission
respective Directive or Directives which added the relevant
substance or substances to Annex I to Directive
The President
91/414/EEC, whichever is the latest.
José Manuel BARROSO

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21.1.2011 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
‘318 Hymexazol
5-methylisoxazol-3-ol (or
≥ 985 g/kg 1
June
2011 31
May
2021 PART
A

CAS No:
5-methyl-1,2-oxazol-3-ol)
10004-44-1
Only uses as fungicide for seed pelleting of sugar beets in professional seed
CIPAC No: 528
treatment facilities may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions
of the review report on hymexazol, and in particular Appendices I and II thereof,
as finalised in the Standing Committee on the Food Chain and Animal Health on
23 November 2010 shall be taken into account.
icial
In this overall assessment Member States shall pay particular attention to:
Jour
— the operators and workers safety. Conditions of authorisation shall include
protective measures, where appropriate,
nal
— the risk to granivorous birds and mammals.
of
Conditions of use shall include risk mitigation measures, where appropriate.
the
The Member States concerned shall request the submission of confirmatory
European
information as regards the nature of residues in root crops and the risk for
granivorous birds and mammals.
The Member States concerned shall ensure that the applicant submits such
Union
confirmatory information to the Commission by 31 May 2013.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
L
18/37

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