HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 60/12
EN
Official Journal of the European Union
5.3.2011
DIRECTIVES
COMMISSION DIRECTIVE 2011/27/EU
of 4 March 2011
amending Council Directive 91/414/EEC to include oryzalin as active substance and amending
Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(3) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
original notifier (hereinafter ‘the applicant’) submitted a
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
France,
which
had
been
designated rapporteur Member State by Regulation (EC)
No 1490/2002. The time period for the accelerated
procedure was respected. The specification of the active
Whereas:
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
procedural requirements of Article 15 of Regulation
(EC) No 33/2008.
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
No 1490/2002 ( 3 ) lay down the detailed rules for the
implementation of the third stage of the programme of
work referred to in Article 8(2) of Directive 91/414/EEC
and establish a list of active substances to be assessed,
(5)
France evaluated the additional data submitted by the
with a view to their possible inclusion in Annex I to
applicant and prepared an additional report. It
Directive 91/414/EEC. That list included oryzalin.
communicated that report to the European Food Safety
Authority (hereinafter ‘the Authority’) and to the
Commission on 17 August 2009. The Authority
communicated the additional report to the other
Member States and the applicant for comments and
forwarded the comments it had received to the
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
Commission. In accordance with Article 20(1) of Regu
1490/2002 the notifier withdrew its support of the
lation (EC) No 33/2008 and at the request of the
inclusion of that active substance in Annex I to
Commission, the Authority presented its conclusion on
Directive 91/414/EEC within 2 months from receipt of
oryzalin to the Commission on 6 August 2010 ( 6 ). The
the draft assessment report. Consequently, Commission
draft assessment report, the additional report and the
Decision 2008/934/EC of 5 December 2008 concerning
conclusion of the Authority were reviewed by the
the non-inclusion of certain active substances in Annex I
Member States and the Commission within the
to Council Directive 91/414/EEC and the withdrawal of
Standing Committee on the Food Chain and Animal
authorisations for plant protection products containing
Health and finalised on 28 January 2011 in the format
these substances ( 4 ) was adopted on the non-inclusion
of the Commission review report for oryzalin.
of oryzalin.
( 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 oryzalin. EFSA
( 3 ) OJ L 224, 21.8.2002, p. 23.
Journal 2010; 8(9):1707. [59 pp.]. doi:10.2903/j.efsa.2010.1707.
( 4 ) OJ L 333, 11.12.2008, p. 11.
Available online: www.efsa.europa.eu

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EN
5.3.2011 Official
Journal
of
the
European
Union L
60/13
(6)
It has appeared from the various examinations made that
assessment of the complete Annex III dossier of each
plant protection products containing oryzalin may be
plant protection product for each intended use in
expected to satisfy, in general, the requirements laid
accordance with the uniform principles laid down in
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
Directive 91/414/EEC.
in particular with regard to the uses which have been
examined and detailed in the Commission review report.
It is therefore appropriate to include oryzalin in Annex I,
in order to ensure that in all Member States the auth
(10) The
experience
gained
from
previous
inclusions
in
Annex
orisations of plant protection products containing this
I to Directive 91/414/EEC of active substances assessed
active substance can be granted in accordance with the
in the framework of Commission Regulation (EEC) No
provisions of that Directive.
3600/92 of 11 December 1992 laying down the detailed
rules for the implementation of the first stage of the
programme of work referred to in Article 8(2) of
Council Directive 91/414/EEC concerning the placing
of plant protection products on the market ( 4 ) has
shown that difficulties can arise in interpreting the
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
duties of holders of existing authorisations in relation
obtain further information on certain specific points.
to access to data. In order to avoid further difficulties
Article 6(1) of Directive 91/414/EEC provides that
it therefore appears necessary to clarify the duties of
inclusion of a substance in Annex I may be subject to
the Member States, especially the duty to verify that
conditions. Therefore, it is necessary that the specification
the holder of an authorisation demonstrates access to a
of the technical material, as commercially manufactured,
dossier satisfying the requirements of Annex II to that
be confirmed by appropriate analytical data, including
Directive. However, this clarification does not impose any
information on the relevance of the impurities, which
new obligations on Member States or holders of auth
for confidentiality reasons are referred to as impurities
orisations compared to the directives which have been
2, 6, 7, 9, 10, 11, 12. The relevance of the test material
adopted until now amending Annex I.
used in the toxicity dossiers should be confirmed in view

of the specification of the technical material and
information confirming the risk assessment for aquatic
organisms should be requested. Provided that oryzalin
(11) It is therefore appropriate to amend Directive
becomes classified under Regulation (EC) No
91/414/EEC accordingly.
1272/2008 of the European Parliament and of the
Council ( 1 ) as ‘suspected of causing cancer’, the Member
States concerned shall request the submission of further
information confirming the relevance of the metabolites
(12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
OR13 (
oryzalin and the withdrawal of authorisations for plant

2 ) and OR15
( 3 ), and the corresponding
groundwater risk assessment.
protection products containing that substance by
31 December 2011. It is necessary to delete the line
concerning oryzalin in the Annex to that Decision.
(8) A
reasonable
period
should
be
allowed
to
elapse
before (13) It is therefore appropriate to amend Decision
an active substance is included in Annex I in order to
2008/934/EC accordingly.
permit Member States and the interested parties to
prepare themselves to meet the new requirements
which will result from the inclusion.
(14) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(9) Without
prejudice
to
the
obligations
defined
by
Directive
91/414/EEC as a consequence of including an active
HAS ADOPTED THIS DIRECTIVE:
substance in Annex I, Member States should be
allowed a period of 6 months after inclusion to review
existing authorisations of plant protection products
containing oryzalin to ensure that the requirements laid
Article 1
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 to this Directive.
Annex I, are satisfied. Member States should vary,
replace or withdraw, as appropriate, existing authori
sations, in accordance with the provisions of Directive
91/414/EEC. By derogation from the above deadline, a
Article 2
longer period should be provided for the submission and
The line concerning oryzalin in the Annex to Decision
2008/934/EC is deleted.
( 1 ) OJ L 353, 31.12.2008, p. 1.
( 2 ) 2-ethyl-7-nitro-1-propyl-1H-benzimidazole-5-sulfonamide.
( 3 ) 2-ethyl-7-nitro-1H-benzimidazole-5-sulfonamide.
( 4 ) OJ L 366, 15.12.1992, p. 10.

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L 60/14
EN
Official Journal of the European Union
5.3.2011
Article 3
satisfying the requirements of Annex III to that Directive and
taking into account part B of the entry in Annex I to that
Member States shall adopt and publish by 30 November 2011
Directive concerning oryzalin. On the basis of that evaluation,
at the latest the laws, regulations and administrative provisions
they shall determine whether the product satisfies the conditions
necessary to comply with this Directive. They shall forthwith
set out in Article 4(1)(b), (c), (d) and (e) of Directive
communicate to the Commission the text of those provisions
91/414/EEC.
and a correlation table between those provisions and this
Directive.
Following that determination Member States shall:
They shall apply those provisions from 1 December 2011.
(a) in the case of a product containing oryzalin as the only
When Member States adopt those provisions, they shall contain
active substance, where necessary, amend or withdraw the
a reference to this Directive or be accompanied by such a
authorisation by 31 May 2015 at the latest; or
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.
(b) in the case of a product containing oryzalin as one of
several active substances, where necessary, amend or
Article 4
withdraw the authorisation by 31 May 2015 or by the
1. Member States shall in accordance with Directive
date fixed for such an amendment or withdrawal in the
91/414/EEC, where necessary, amend or withdraw existing
respective Directive or Directives which added the relevant
authorisations for plant protection products containing
substance or substances to Annex I to Directive
oryzalin as an active substance by 30 November 2011.
91/414/EEC, whichever is the latest.
By that date they shall in particular verify that the conditions in
Article 5
Annex I to that Directive relating to oryzalin are met, with the
This Directive shall enter into force on 1 June 2011.
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 requirements of
Annex II to that Directive in accordance with the conditions of
Article 6
Article 13 of that Directive.
This Directive is addressed to the Member States.
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
Done at Brussels, 4 March 2011.
orised plant protection product containing oryzalin as either 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
For the Commission
31 May 2011 at the latest, Member States shall re-evaluate the
product in accordance with the uniform principles provided for
The President
in Annex VI to Directive 91/414/EEC, on the basis of a dossier
José Manuel BARROSO

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5.3.2011 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, Identifi
cation Numbers
IUPAC Name Purity
(*) Entry
into
force Expiration
of
inclusion Specific
provisions
EN

‘334 Oryzalin
3,5-dinitro-N4,N4-dipropylsulfanilamide ≥ 960 g/kg
1 June 2011 31
May
2021 PART
A
CAS No: 19044-88-3
N-nitrosodipropylamine:
Only uses as herbicide may be authorised.
CIPAC No: 537
≤ 0,1 mg/kg
Toluene: ≤ 4 g/kg
PART B
For the implementation of the uniform principles of Annex
VI the conclusions of the review report on oryzalin, and in
particular Appendices I and II thereof, as finalised in the
icial
Standing Committee on the Food Chain and Animal
Health on 28 January 2011, shall be taken into account.
Jour
In this overall assessment Member States shall pay particular
nal
attention to:
of
the
1. the operator safety and ensure that conditions of use
include the application of adequate personal protective
European
equipment;
2. the protection of aquatic organisms and non-target
plants;
Union
3. the protection of groundwater, where the active
substance is applied in regions with vulnerable soil
and/or climatic conditions;
4. the risk to herbivorous birds and mammals;
5. the risk to bees, in the flowering season.
Conditions of authorisation shall include risk mitigation
measures, where appropriate.
The Member States concerned shall carry out monitoring
programmes to verify potential groundwater contamination
from the metabolites OR13 (2-ethyl-7-nitro-1-propyl-1H-
benzimidazole-5-sulfonamide) and OR15 (2-ethyl-7-nitro-
1H-benzimidazole-5-sulfonamide) in vulnerable zones,
where appropriate. The Member States concerned shall
request the submission of confirmatory information as
L
regards:
60/15

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L 60/16
No
Common Name, Identifi
cation Numbers
IUPAC Name Purity
(*) Entry
into
force Expiration
of
inclusion Specific
provisions
1. the specification of the technical material, as
commercially manufactured, by appropriate analytical
data, including information on the relevance of the
impurities which for confidentiality reasons are referred
EN
to as impurities 2, 6, 7, 9, 10, 11, 12;

2. the relevance of the test material used in the toxicity
dossiers in view of the specification of the technical
material;
3. the risk assessment for aquatic organisms;
4. the relevance of the metabolites OR13 and OR15, and
the corresponding groundwater risk assessment, provided
that oryzalin becomes classified under Regulation (EC)
Off
No 1272/2008 of the European Parliament and of the
Council (OJ L 353, 31.12.2008, p. 1) as “suspected of
icial
causing cancer”.
Jour
The Member States concerned shall ensure that the
nal
applicant submits to the Commission the information set
out in points 1 and 2 by 1 December 2011, and the
of
information set out in point 3 by 31 May 2013. The
the
information set out in point 4 shall be submitted within
European
6 months of notification of a decision classifying oryzalin.’
(*) Further details on identity and specification of active substance are provided in the review report.
Union
5.3.2011

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