HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 97/34
EN
Official Journal of the European Union
12.4.2011
COMMISSION IMPLEMENTING DIRECTIVE 2011/40/EU
of 11 April 2011
amending Council Directive 91/414/EEC to include sintofen as active substance and amending
Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation
Having regard to the Treaty on the Functioning of the European
(EC) No 33/2008.
Union,
(5)
France evaluated the additional data submitted by the
applicant and prepared an additional report. It
Having regard to Council Directive 91/414/EEC of 15 July
communicated that report to the European Food Safety
1991 concerning the placing of plant protection products on
Authority (hereinafter ‘the Authority’) and to the
the market ( 1 ), and in particular Article 6(1) thereof,
Commission on 14 January 2010. The Authority
communicated the additional report to the other
Whereas:
Member States and the applicant for comments and
forwarded the comments it had received to the
Commission. In accordance with Article 20(1) of Regu
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
lation (EC) No 33/2008 and at the request of the
No 1490/2002 ( 3 ) lay down the detailed rules for the
Commission, the Authority presented its conclusion on
implementation of the third stage of the programme of
sintofen to the Commission on 26 November 2010 (
work referred to in Article 8(2) of Directive 91/414/EEC

6 ).
The draft assessment report, the additional report and the
and establish a list of active substances to be assessed,
conclusion of the Authority were reviewed by the
with a view to their possible inclusion in Annex I to
Member States and the Commission within the
Directive 91/414/EEC. That list included sintofen.
Standing Committee on the Food Chain and Animal
Health and finalised on 11 March 2011 in the format
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
of the Commission review report for sintofen.
1490/2002 the notifier withdrew its support of the
inclusion of that active substance in Annex I to
(6)
It has appeared from the various examinations made that
Directive 91/414/EEC within 2 months from receipt of
plant protection products containing sintofen may be
the draft assessment report. Consequently, Commission
expected to satisfy, in general, the requirements laid
Decision 2008/934/EC of 5 December 2008 concerning
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
the non-inclusion of certain active substances in Annex I
in particular with regard to the uses which have been
to Council Directive 91/414/EEC and the withdrawal of
examined and detailed in the Commission review report.
authorisations for plant protection products containing
It is therefore appropriate to include sintofen in Annex I,
these substances ( 4 ) was adopted on the non-inclusion
in order to ensure that in all Member States the au-
of sintofen.
thorisations of plant protection products containing
this active substance can be granted in accordance with
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
the provisions of that Directive.
original notifier (hereinafter ‘the applicant’) submitted a
new application requesting the accelerated procedure to
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
be applied, as provided for in Articles 14 to 19 of
obtain further information on certain specific points.
Commission Regulation (EC) No 33/2008 of
Article 6(1) of Directive 91/414/EEC provides that
17 January 2008 laying down detailed rules for the
inclusion of a substance in Annex I may be subject to
application of Council Directive 91/414/EEC as regards
conditions. Therefore, it is appropriate to require that the
a regular and an accelerated procedure for the assessment
applicant submit further information confirming: the
of active substances which were part of the programme
specification of the technical material, the relevance of
of work referred to in Article 8(2) of that Directive but
the impurities present in the technical specifications, the
have not been included into its Annex I ( 5 ).
relevance of the test material used in the toxicity and
ecotoxicity dossiers and the metabolic profile of
(4) The
application
was
submitted
to
France,
which
had
been
sintofen in rotational crops.
designated rapporteur Member State by Regulation (EC)
No 1490/2002. The time period for the accelerated
(8) A
reasonable
period
should
be
allowed
to
elapse
before
procedure was respected. The specification of the active
an active substance is included in Annex I in order to
substance and the supported uses are the same as were
permit Member States and the interested parties to
the subject of Decision 2008/934/EC. That application
prepare themselves to meet the new requirements
which will result from the inclusion.
( 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 of
( 3 ) OJ L 224, 21.8.2002, p. 23.
the pesticide risk assessment of the active substance sintofen. EFSA
( 4 ) OJ L 333, 11.12.2008, p. 11.
Journal 2010;8(12): [49 pp.]. doi:10.2903/j.efsa.2010.1931.
( 5 ) OJ L 15, 18.1.2008, p. 5.
Available online: www.efsa.europa.eu/efsajournal.htm

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EN
12.4.2011 Official
Journal
of
the
European
Union L
97/35
(9) Without
prejudice
to
the
obligations
defined
by
Directive
Article 2
91/414/EEC as a consequence of including an active
substance in Annex I, Member States should be
The line concerning sintofen in the Annex to Decision
allowed a period of 6 months after inclusion to review
2008/934/EC is deleted.
existing authorisations of plant protection products
containing sintofen to ensure that the requirements laid
Article 3
down by Directive 91/414/EEC, in particular in its
Article 13 and the relevant conditions set out in
Member States shall adopt and publish by 30 November 2011
Annex I, are satisfied. Member States should vary,
at the latest the laws, regulations and administrative provisions
replace or withdraw, as appropriate, existing authori
necessary to comply with this Directive. They shall forthwith
sations, in accordance with the provisions of Directive
communicate to the Commission the text of those provisions
91/414/EEC. By derogation from the above deadline, a
and a correlation table between those provisions and this
longer period should be provided for the submission and
Directive.
assessment of the complete Annex III dossier of each
plant protection product for each intended use in
They shall apply those provisions from 1 December 2011.
accordance with the uniform principles laid down in
Directive 91/414/EEC.
When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
(10) The
experience
gained
from
previous
inclusions
in
Annex
reference on the occasion of their official publication. Member
I to Directive 91/414/EEC of active substances assessed
States shall determine how such reference is to be made.
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
Article 4
programme of work referred to in Article 8(2) of
1. Member States shall in accordance with Directive
Council Directive 91/414/EEC concerning the placing
91/414/EEC, where necessary, amend or withdraw existing
of plant protection products on the market ( 1 ) has
authorisations for plant protection products containing
shown that difficulties can arise in interpreting the
sintofen as an active substance by 30 November 2011.
duties of holders of existing authorisations in relation
to access to data. In order to avoid further difficulties
it therefore appears necessary to clarify the duties of
By that date they shall in particular verify that the conditions in
the Member States, especially the duty to verify that
Annex I to that Directive relating to sintofen are met, with the
the holder of an authorisation demonstrates access to a
exception of those identified in part B of the entry concerning
dossier satisfying the requirements of Annex II to that
that active substance, and that the holder of the authorisation
Directive. However, this clarification does not impose any
has, or has access to, a dossier satisfying the requirements of
new obligations on Member States or holders of au-
Annex II to that Directive in accordance with the conditions of
thorisations compared to the Directives which have
Article 13 of that Directive.
been adopted until now amending Annex I.
2. By way of derogation from paragraph 1, for each au-
(11) It is therefore appropriate to amend Directive
thorised plant protection product containing sintofen as either
91/414/EEC accordingly.
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
(12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
product in accordance with the uniform principles provided for
sintofen and the withdrawal of authorisations for plant
in Annex VI to Directive 91/414/EEC, on the basis of a dossier
protection products containing that substance by
satisfying the requirements of Annex III to that Directive and
31 December 2011. It is necessary to delete the line
taking into account part B of the entry in Annex I to that
concerning sintofen in the Annex to that Decision.
Directive concerning sintofen. On the basis of that evaluation,
they shall determine whether the product satisfies the conditions
set out in Article 4(1)(b), (c), (d) and (e) of Directive
(13) It is therefore appropriate to amend Decision
91/414/EEC.
2008/934/EC accordingly.
Following that determination Member States shall:
(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,
(a) in the case of a product containing sintofen as the only
active substance, where necessary, amend or withdraw the
authorisation by 31 May 2015 at the latest; or
HAS ADOPTED THIS DIRECTIVE:
(b) in the case of a product containing sintofen as one of
Article 1
several active substances, where necessary, amend or
withdraw the authorisation by 31 May 2015 or by the
Annex I to Directive 91/414/EEC is amended as set out in the
date fixed for such an amendment or withdrawal in the
Annex to this Directive.
respective Directive or Directives which added the relevant
substance or substances to Annex I to Directive
( 1 ) OJ L 366, 15.12.1992, p. 10.
91/414/EEC, whichever is the latest.

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L 97/36
EN
Official Journal of the European Union
12.4.2011
Article 5
This Directive shall enter into force on 1 June 2011.
Article 6
This Directive is addressed to the Member States.
Done at Brussels, 11 April 2011.
For the Commission
The President
José Manuel BARROSO

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12.4.2011 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
‘347 Sintofen
1-(4-chlorophenyl)-1,4-dihydro-
≥ 980 g/kg
1 June 2011 31
May
2021 PART
A

CAS No 130561-48-7
5-(2-methoxyethoxy)-4-
Impurities:
Only uses as a plant growth regulator on wheat for hybrid seed
oxocinnoline-3-carboxylic acid
CIPAC No 717
2-methoxyethanol, not more
production not intended for human consumption may be authorised.
than 0,25 g/kg
PART B
N,N-dimethylformamide, not
For the implementation of the uniform principles of Annex VI, the
more than 1,5 g/kg
conclusions of the review report on sintofen, and in particular
Appendices I and II thereto, 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
icial
to the risk to operators and workers and shall ensure that conditions
of use include the application of adequate risk mitigation measures.
Jour
They shall ensure that wheat treated with sintofen does not enter the
food and feed chain.
nal
The Member States concerned shall request the submission of
of
confirmatory information as regards:
the
(1) the specification of the technical material, as commercially manu
European
factured, supported by appropriate analytical data;
(2) the relevance of the impurities present in the technical
specifications, except of the impurities 2-methoxyethanol and
Union
N,N-dimethylformamide;
(3) the relevance of the test material used in the toxicity and
ecotoxicity dossiers in view of the specification of the technical
material;
(4) the metabolic profile of sintofen in rotational crops.
The Member States concerned shall ensure that the applicant submits
to the Commission: the information set out in points (1) (2) and (3) by
1 December 2011 and the information set out in point (4) by
31 May 2013.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
L
97/37

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