HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 102/24
EN
Official Journal of the European Union
16.4.2011
DIRECTIVES
COMMISSION IMPLEMENTING DIRECTIVE 2011/47/EU
of 15 April 2011
amending Council Directive 91/414/EEC to include aluminium sulphate as active substance and
amending Commission Decision 2008/941/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
new application requesting the application of the accel
erated procedure provided for in Articles 14 to 19 of
Commission Regulation (EC) No 33/2008 of 17 January
2008 laying down detailed rules for the application of
Having regard to the Treaty on the Functioning of the European
Council Directive 91/414/EEC as regards a regular and an
Union,
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
the
Netherlands,
which
had been designated rapporteur Member State by Regu
Whereas:
lation (EC) No 2229/2004. The time period for the accel
erated 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 appli
cation also complies with the remaining substantive and
(1) Commission
Regulations
(EC)
No
1112/2002
( 2 ) and (EC)
procedural requirements of Article 15 of Regulation (EC)
No 2229/2004 ( 3 ) lay down the detailed rules for the
No 33/2008.
implementation of the fourth 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, with a view to their possible inclusion in
Annex I to Directive 91/414/EEC. That list included
aluminium sulphate.
(5) The
Netherlands
evaluated
the
additional
data
submitted
by the applicant and prepared an additional report. It
communicated that report to the European Food Safety
Authority (hereinafter ‘the Authority’) and to the
(2) In
accordance
with
Article
24e
of
Regulation
(EC)
Commission on 9 March 2010. The Authority
No 2229/2004 the notifier withdrew its support of the
communicated the additional report to the other
inclusion of that active substance in Annex I to Directive
Member States and the applicant for comments and
91/414/EEC within two months from receipt of the draft
forwarded the comments it had received to the
assessment report. Consequently, Commission Decision
Commission. In accordance with Article 20(1) of Regu
2008/941/EC of 8 December 2008 concerning the
lation (EC) No 33/2008 and at the request of the
non-inclusion of certain active substances in Annex I
Commission, the Authority presented its conclusion on
to Council Directive 91/414/EEC and the withdrawal of
aluminium sulphate to the Commission on 28 October
authorisations for plant protection products containing
2010 ( 6 ). The draft assessment report, the additional
these substances (
report and the conclusion of the Authority were

4 ) was adopted on the non-inclusion
of aluminium sulphate.
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
format of the Commission review report for aluminium
sulphate.
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
original notifier (hereinafter the ‘applicant’) submitted a
( 5 ) OJ L 15, 18.1.2008, p. 5.
( 6 ) European Food Safety Authority; Conclusion on the peer review of
( 1 ) OJ L 230, 19.8.1991, p. 1.
the pesticide risk assessment of the active substance aluminium
( 2 ) OJ L 168, 27.6.2002, p. 14.
sulfate. EFSA Journal 2010;8(11):1889. [32 pp.] doi:10.2903/
( 3 ) OJ L 379, 24.12.2004, p. 13.
j.efsa.2010.1889. Available online: www.efsa.europa.eu/efsajournal.
( 4 ) OJ L 335, 13.12.2008, p. 91.
htm

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EN
16.4.2011 Official
Journal
of
the
European
Union L
102/25
(6)
It has appeared from the various examinations made that
satisfying the requirements of Annex II to that Directive.
plant protection products containing aluminium sulphate
However, this clarification does not impose any new
may be expected to satisfy, in general, the requirements
obligations on Member States or holders of authori
laid down in Article 5(1)(a) and (b) of Directive
sations compared to the Directives which have been
91/414/EEC, in particular with regard to the uses
adopted until now amending Annex I.
which have been examined and detailed in the
Commission review report. It is therefore appropriate
to include aluminium sulphate in Annex I, in order to
(11) It is therefore appropriate to amend Directive
ensure that in all Member States the authorisations of
91/414/EEC accordingly.
plant protection products containing this active
substance can be granted in accordance with the
provisions of that Directive.
(12) Decision
2008/941/EC
provides
for
the
non-inclusion
of
aluminium sulphate and the withdrawal of authorisation
of plant protection products containing that substance by
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
31 December 2011. It is necessary to delete the line
obtain further information on certain specific points.
concerning aluminium sulphate in the Annex to that
Article 6(1) of Directive 91/414/EC provides that
Decision.
inclusion of a substance in Annex I may be subject to
conditions. Therefore, it is appropriate to require that the
applicant submit confirmatory information as regards the
(13) It is therefore appropriate to amend Decision
specification of the technical material, as commercially
2008/941/EC accordingly.
manufactured, in the form of appropriate analytical data.
(14) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
(8) A
reasonable
period
should
be
allowed
to
elapse
before
an active substance is included in Annex I in order to
Committee on the Food Chain and Animal Health,
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:

Article 1
(9) Without
prejudice
to
the
obligations
defined
by
Directive
91/414/EEC as a consequence of including an active
Annex I to Directive 91/414/EEC is amended as set out in the
substance in Annex I, Member States should be
Annex to this Directive.
allowed a period of six months after inclusion to
review existing authorisations of plant protection
products containing aluminium sulphate to ensure that
Article 2
the requirements laid down by Directive 91/414/EEC, in
The line concerning aluminium sulphate in the Annex to
particular in its Article 13 and the relevant conditions set
Decision 2008/941/EC is deleted.
out in Annex I, are satisfied. Member States should vary,
replace or withdraw, as appropriate, existing authori
sations, in accordance with the provisions of Directive
Article 3
91/414/EEC. By derogation from the above deadline, a
longer period should be provided for the submission and
Member States shall adopt and publish by 30 November 2011
assessment of the complete Annex III dossier of each
at the latest the laws, regulations and administrative provisions
plant protection product for each intended use in
necessary to comply with this Directive. They shall forthwith
accordance with the uniform principles laid down in
communicate to the Commission the text of those provisions
Directive 91/414/EEC.
and a correlation table between those provisions and this
Directive.
(10) The
experience
gained
from
previous
inclusions
in
Annex
I to Directive 91/414/EEC of active substances assessed
They shall apply those provisions from 1 December 2011.
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
When Member States adopt those provisions, they shall contain
of the 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 of
reference on the occasion of their official publication. Member
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 it therefore
Article 4
appears necessary to clarify the duties of the Member
1. Member States shall in accordance with Directive
States, especially the duty to verify that the holder of
91/414/EEC, where necessary, amend or withdraw existing
an authorisation demonstrates access to a dossier
authorisations for plant protection products containing
aluminium sulphate as an active substance by 30 November
( 1 ) OJ L 366, 15.12.1992, p. 10.
2011.

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L 102/26
EN
Official Journal of the European Union
16.4.2011
By that date they shall in particular verify that the conditions in
(b) in the case of a product containing aluminium sulphate as
Annex I to that Directive relating to aluminium sulphate are
one of several active substances, where necessary, amend or
met, with the exception of those identified in part B of the entry
withdraw the authorisation by 31 May 2015 or by the date
concerning that active substance, and that the holder of the
fixed for such an amendment or withdrawal in the
authorisation has, or has access to, a dossier satisfying the
respective Directive or Directives which added the relevant
requirements of Annex II to that Directive in accordance with
substance or substances to Annex I to Directive
the conditions of Article 13 of that Directive.
91/414/EEC, whichever is the latest.
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
orised plant protection product containing aluminium sulphate
Article 5
as either the only active substance or as one of several active
substances all of which were listed in Annex I to Directive
This Directive shall enter into force on 1 June 2011.
91/414/EEC by 31 May 2011 at the latest, Member States
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 6
III to that Directive and taking into account part B of the entry
in Annex I to that Directive concerning aluminium sulphate. On
This Directive is addressed to the Member States.
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 91/414/EEC.
Done at Brussels, 15 April 2011.
Following that determination Member States shall:
For the Commission
(a) in the case of a product containing aluminium sulphate as
the only active substance, where necessary, amend or
The President
withdraw the authorisation by 31 May 2015 at the latest; or
José Manuel BARROSO

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16.4.2011 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
‘351 Aluminium
sulphate Aluminium sulphate 970
g/kg 1
June
2011 31
May
2021 PART
A

CAS No: 10043-01-3
Only indoor uses as post-harvest bactericide for ornamental plants may be auth
CIPAC not available
orised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of
the review report on aluminium sulphate, 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.
The Member States concerned shall request the submission of confirmatory
icial
information as regards the specification of the technical material, as commercially
manufactured, in the form of appropriate analytical data.
Jour
nal
The Member States concerned shall ensure that the applicant submits such
information to the Commission by 1 December 2011.’
of
the
(1 ) Further details on identity and specification of active substance are provided in the review report.
European
Union
L
102/27

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