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14.4.2011 Official
Journal
of
the
European
Union L
100/39
DIRECTIVES
COMMISSION IMPLEMENTING DIRECTIVE 2011/43/EU
of 13 April 2011
amending Council Directive 91/414/EEC to include lime sulphur as active substance and amending
Commission Decision 2008/941/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Council Directive 91/414/EEC as regards 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
Having regard to the Treaty on the Functioning of the European
been included into its Annex I ( 5 ).
Union,
Having regard to Council Directive 91/414/EEC of 15 July
(4) The
application
was
submitted
to
Spain,
which
had
been
1991 concerning the placing of plant protection products on
designated rapporteur Member State by Regulation (EC)
the market (
No 2229/2004. The time period for the accelerated

1 ), and in particular Article 6(1) thereof,
procedure was respected. The specification of the active
substance and the supported uses are the same as were
the subject of Decision 2008/941/EC. That application
Whereas:
also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation
(EC) No 33/2008.
(1) Commission
Regulations
(EC)
No
1112/2002
( 2 ) and (EC)
No 2229/2004 ( 3 ) lay down the detailed rules for the
implementation of the fourth stage of the programme
of work referred to in Article 8(2) of Directive
(5) Spain
evaluated
the
additional
data
submitted
by
the
applicant and prepared an additional report. It
91/414/EEC and establish a list of active substances to
communicated that report to the European Food Safety
be assessed, with a view to their possible inclusion in
Authority (hereinafter ‘the Authority’) and to the
Annex I to Directive 91/414/EEC. That list included
Commission on 14 February 2010. The Authority
lime sulphur.
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
24e
of
Regulation
(EC)
Commission. In accordance with Article 20(1) of Regu
No 2229/2004 the applicant withdrew its support of
lation (EC) No 33/2008 and at the request of the
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
lime sulphur to the Commission on 28 October 2010 ( 6 ).
the draft assessment report. Consequently, Commission
The draft assessment report, the additional report and the
Decision 2008/941/EC of 8 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 11 March 2011 in the format
these substances (
of the Commission review report for lime sulphur.

4 ) was adopted on the non-inclusion

of lime sulphur.
(6)
It has appeared from the various examinations made that
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
plant protection products containing lime sulphur may
original notifier (hereinafter ‘the applicant’) submitted a
be expected to satisfy, in general, the requirements laid
new application requesting the application of the accel
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
erated procedure provided for in Articles 14 to 19 of
in particular with regard to the uses which have been
Commission Regulation (EC) No 33/2008 of 17 January
examined and detailed in the Commission review report.
2008 laying down detailed rules for the application of
( 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 the
( 2 ) OJ L 168, 27.6.2002, p. 14.
pesticide risk assessment of the active substance lime sulphur. EFSA
( 3 ) OJ L 379, 24.12.2004, p. 13.
Journal 2010; 8(11):1890. [45pp].doi:10.2903/j.efsa.2010.1890.
( 4 ) OJ L 335, 13.12.2008, p. 91.
Available online: www.efsa.europa.eu

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L 100/40
EN
Official Journal of the European Union
14.4.2011
It is therefore appropriate to include lime sulphur in
(12) It is therefore appropriate to amend Decision
Annex I, in order to ensure that in all Member States
2008/941/EC accordingly.
the authorisations of plant protection products
containing this active substance can be granted in
accordance with the provisions of that Directive.
(13) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
(7) A
reasonable
period
should
be
allowed
to
elapse
before
Committee on the Food Chain and Animal Health,
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.
HAS ADOPTED THIS DIRECTIVE:
(8) Without
prejudice
to
the
obligations
defined
by
Directive
Article 1
91/414/EEC as a consequence of including an active
substance in Annex I, Member States should be
Annex I to Directive 91/414/EEC is amended as set out in the
allowed a period of 6 months after inclusion to review
Annex to this Directive.
existing authorisations of plant protection products
containing lime sulphur to ensure that the requirements
laid down by Directive 91/414/EEC, in particular in its
Article 13 and the relevant conditions set out in Annex I,
Article 2
are satisfied. Member States should vary, replace or
withdraw, as appropriate, existing authorisations, in
The line concerning lime sulphur in the Annex to Decision
accordance with the provisions of Directive 91/414/EEC.
2008/941/EC is deleted.
By derogation from the above deadline, a longer period
should be provided for the submission and assessment of
the complete Annex III dossier of each plant protection
product for each intended use in accordance with the
Article 3
uniform principles laid down in Directive 91/414/EEC.
Member States shall adopt and publish by 30 November 2011
at the latest the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
(9) The
experience
gained
from
previous
inclusions
in
Annex communicate to the Commission the text of those provisions
I to Directive 91/414/EEC of active substances assessed
and a correlation table between those provisions and this
in the framework of Commission Regulation (EEC)
Directive.
No 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
They shall apply those provisions from 1 December 2011.
plant protection products on the market ( 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 it therefore
When Member States adopt those provisions, they shall contain
appears necessary to clarify the duties of the Member
a reference to this Directive or be accompanied by such a
States, especially the duty to verify that the holder of
reference on the occasion of their official publication. Member
an authorisation demonstrates access to a dossier
States shall determine how such reference is to be made.
satisfying the requirements of Annex II to that Directive.
However, this clarification does not impose any new
obligations on Member States or holders of authori
sations compared to the directives which have been
Article 4
adopted until now amending Annex I.
1. Member States shall in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations for plant protection products containing lime
(10) It is therefore appropriate to amend Directive
91/414/EEC accordingly.
sulphur as an active substance by 30 November 2011.

(11) Decision
2008/941/EC
provides
for
the
non-inclusion
of
By that date they shall in particular verify that the conditions in
lime sulphur and the withdrawal of authorisation of plant
Annex I to that Directive relating to lime sulphur are met, with
protection products containing that substance by
the exception of those identified in Part B of the entry
31 December 2011. It is necessary to delete the line
concerning that active substance, and that the holder of the
concerning lime sulphur in the Annex to that Decision.
authorisation has, or has access to, a dossier satisfying the
requirements of Annex II to that Directive in accordance with
( 1 ) OJ L 366, 15.12.1992, p. 10.
the conditions of Article 13 of that Directive.

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EN
14.4.2011 Official
Journal
of
the
European
Union L
100/41
2. By
way
of
derogation
from
paragraph
1,
for
each
au-
withdraw the authorisation by 31 May 2015 or by the
thorised plant protection product containing lime sulphur as
date fixed for such an amendment or withdrawal in the
either the only active substance or as one of several active
respective Directive or Directives which added the relevant
substances all of which were listed in Annex I to Directive
substance or substances to Annex I to Directive
91/414/EEC by 30 April 2011 at the latest, Member States
91/414/EEC, whichever is the latest.
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
Article 5
III to that Directive and taking into account Part B of the entry
in Annex I to that Directive concerning lime sulphur. On the
This Directive shall enter into force on 1 June 2011.
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 91/414/EEC.
Article 6
This Directive is addressed to the Member States.
Following that determination Member States shall:
(a) in the case of a product containing lime sulphur as the only
Done at Brussels, 13 April 2011.
active substance, where necessary, amend or withdraw the
authorisation by 31 May 2015 at the latest; or
For the Commission
(b) in the case of a product containing lime sulphur as one of
The President
several active substances, where necessary, amend or
José Manuel BARROSO

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L 100/42
ANNEX
The following entry shall be added at the end of the table in Annex I to Directive 91/414/EC:
No
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Entry
into
force Expiration
of
inclusion Specific
provisions
EN
‘349 Lime
sulphur
Calcium polysulfide
≥ 290 g/Kg. 1
June
2011 31
May
2021 PART
A

CAS No: 1344 – 81 – 6
Only uses as fungicide may be authorised.
CIPAC No: 17
PART B
For the implementation of the uniform principles of Annex VI the conclusions
of the review report on lime sulphur, 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:
Off
icial
— operator safety and shall ensure that the conditions of authorisation include
appropriate protective measures,
Jour
— to the protection of aquatic organisms and non-target arthropods and shall
nal
ensure that the conditions of use include risk mitigation measures as appro
of
priate.’
the
European
(1 ) Further details on identity and specification of active substance are provided in the review report.
Union
14.4.2011

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