HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 310/24
EN
Official Journal of the European Union
9.11.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 1043/2012
of 8 November 2012
approving the active substance phosphane, in accordance with Regulation (EC) No 1107/2009 of the
European Parliament and of the Council concerning the placing of plant protection products on the
market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
reviewed by the Member States and the Commission
within the Standing Committee on the Food Chain and
Having regard to the Treaty on the Functioning of the European
Animal Health and was finalised on 28 September 2012
Union,
in the format of the Commission review report for phos
phane.
Having regard to Regulation (EC) No 1107/2009 of the
European Parliament and of the Council of 21 October 2009
(5)
It has appeared from the various examinations made that
concerning the placing of plant protection products on the
plant protection products containing phosphane may be
market and repealing Council Directives 79/117/EEC and
expected to satisfy, in general, the requirements laid
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
down in Article 5(1)(a) and (b) and Article 5(3) of
thereof,
Directive 91/414/EEC, in particular with regard to the
uses which were examined and detailed in the
Whereas:
Commission review report. It is therefore appropriate

to approve phosphane.
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
with respect to the procedure and the conditions for
1107/2009 in conjunction with Article 6 thereof and in
approval, to active substances for which a decision has
the light of current scientific and technical knowledge, it
been adopted in accordance with Article 6(3) of that
is, however, necessary to include certain conditions and
Directive before 14 June 2011. For phosphane the
restrictions.
conditions of Article 80(1)(a) of Regulation (EC) No
1107/2009 are fulfilled by Commission Decision
2008/566/EC ( 3 ).
(7) Without
prejudice
to
the
obligations
provided
for
in
Regulation (EC) No 1107/2009 as a consequence of
approval, taking into account the specific situation
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
created by the transition from Directive 91/414/EEC to
Germany received on 11 November 2007 an application
Regulation (EC) No 1107/2009, the following should,
from S&A Service- und Anwendungstechnik GmbH for
however, apply. Member States should be allowed a
the inclusion of the active substance phosphane in Annex
period of six months after approval to review authori
I to Directive 91/414/EEC. Decision 2008/566/EC
sations of plant protection products containing phos
confirmed that the dossier was ‘complete’ in the sense
phane. Member States should, as appropriate, vary,
that it could be considered as satisfying, in principle, the
replace or withdraw authorisations. By way of derogation
data and information requirements of Annexes II and III
from that deadline, a longer period should be provided
to Directive 91/414/EEC.
for the submission and assessment of the update of the
complete Annex III dossier, as set out in Directive
(3) For
that
active
substance,
the
effects
on
human
and
91/414/EEC, of each plant protection product for each
animal health and the environment have been assessed,
intended use in accordance with the uniform principles.
in accordance with the provisions of Article 6(2) and (4)
of Directive 91/414/EEC, for the uses proposed by the
applicant. The designated rapporteur Member State
(8) The
experience
gained
from
inclusions
in
Annex
I
to
submitted a draft assessment report on 24 February
Directive 91/414/EEC of active substances assessed in
2010.
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
(4) The
draft
assessment
report
was
reviewed
by
the
Member
of the programme of work referred to in Article 8(2) of
States and the European Food Safety Authority (here
Council Directive 91/414/EEC concerning the placing of
inafter ‘the Authority’). The Authority presented to the
plant protection products on the market (
Commission its conclusion on the review of the pesticide

5 ) has shown
that difficulties can arise in interpreting the duties of
risk assessment of the active substance phosphane ( 4 ) on
holders of existing authorisations in relation to access
22 February 2012. The draft assessment report was
to data. In order to avoid further difficulties it therefore
appears necessary to clarify the duties of the Member
( 1 ) OJ L 309, 24.11.2009, p. 1.
States, especially the duty to verify that the holder of
( 2 ) OJ L 230, 19.8.1991, p. 1.
an authorisation demonstrates access to a dossier
( 3 ) OJ L 181, 10.7.2008, p. 52.
( 4 ) EFSA Journal 2012; 10(3):2595. Available online: http://www.efsa.
europa.eu
( 5 ) OJ L 366, 15.12.1992, p. 10.

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EN
9.11.2012 Official
Journal
of
the
European
Union L
310/25
satisfying the requirements of Annex II to that Directive.
2. By way of derogation from paragraph 1, for each auth
However, this clarification does not impose any new
orised plant protection product containing phosphane as either
obligations on Member States or holders of authori
the only active substance or as one of several active substances,
sations compared to the Directives which have been
all of which were listed in the Annex to Implementing Regu
adopted until now amending Annex I to that Directive
lation (EU) No 540/2011 by 31 March 2013 at the latest,
or the Regulations approving active substances.
Member States shall re-evaluate the product in accordance
with the uniform principles, as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, on the basis of a dossier
(9) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No satisfying the requirements of Annex III to Directive
1107/2009, the Annex to Commission Implementing
91/414/EEC and taking into account the column on specific
Regulation (EU) No 540/2011 of 25 May 2011 imple
provisions of Annex I to this Regulation. On the basis of that
menting Regulation (EC) No 1107/2009 of the European
evaluation, they shall determine whether the product satisfies
Parliament and of the Council as regards the list of
the conditions set out in Article 29(1) of Regulation (EC) No
approved active substances
( 1 ) should be amended
1107/2009.
accordingly.
Following that determination Member States shall:
(10) The
measures
provided
for
in
this
Regulation
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 phosphane as the only
active substance, where necessary, amend or withdraw the
authorisation by 30 September 2014 at the latest; or
HAS ADOPTED THIS REGULATION:
(b) in the case of a product containing phosphane as one of
Article 1
several active substances, where necessary, amend or
withdraw the authorisation by 30 September 2014 or by
Approval of active substance
the date fixed for such an amendment or withdrawal in the
The active substance phosphane, as specified in Annex I, is
respective act or acts which added the relevant substance or
approved subject to the conditions laid down in that Annex.
substances to Annex I to Directive 91/414/EEC or approved
that substance or substances, whichever is the latest.
Article 2
Article 3
Re-evaluation of plant protection products
Amendments to Implementing Regulation (EU) No
1. Member
States
shall
in
accordance
with
Regulation
(EC)
540/2011
No 1107/2009, where necessary, amend or withdraw existing
authorisations for plant protection products containing
The Annex to Implementing Regulation (EU) No 540/2011 is
phosphane as an active substance by 30 September 2013.
amended in accordance with Annex II to this Regulation.
Article 4
By that date they shall in particular verify that the conditions in
Annex I to this Regulation are met, with the exception of those
Entry into force and date of application
identified in the column on specific provisions of that Annex,
and that the holder of the authorisation has, or has access to, a
This Regulation shall enter into force on the twentieth day
dossier satisfying the requirements of Annex II to Directive
following that of its publication in the Official Journal of the
91/414/EEC in accordance with the conditions of Article 13(1)
European Union.
to (4) of that Directive and Article 62 of Regulation (EC) No
1107/2009.
It shall apply from 1 April 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 November 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

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L 310/26
ANNEX I
Common name, identification
numbers
IUPAC name Purity
(1 ) Date
of
approval
Expiration of
approval
Specific provisions
Phosphane
Phosphane
≥ 994 g/kg
1 April 2013 31
March
2023 Authorisations
shall
be
limited
to
professional
users.
EN
CAS No 7803-51-2
The relevant impurity arsane must
For the implementation of the uniform principles as referred to in Article 29(6) of

not exceed 0,023 g/kg in the
Regulation (EC) No 1107/2009, the conclusions of the review report on phosphane,
CIPAC No 127
technical material
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 28 September 2012 shall be taken into
account.
In this overall assessment Member States shall pay particular attention to:
— the protection of operators in and around the treated premises during the
treatment as well as during and after the aeration;
Off
— the protection of workers in and around the treated premises during the
treatment as well as during and after the aeration;
icial
Jour
— the protection of bystanders around the treated premises during the treatment as
well as during and after the aeration.
nal
Conditions of use shall include risk mitigation measures, like permanent monitoring
of
of the phosphane concentration by automatic devices, the use of personal
the
protection equipment and setting-up an area around the treated premise where
European
bystanders are denied, where appropriate.
(1 ) Further details on identity and specification of active substance are provided in the review report.
Union
9.11.2012

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9.11.2012 Off
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number Common name, identi
fication numbers
IUPAC name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
EN
‘28 Phosphane
Phosphane
≥ 994 g/kg
1 April 2013 31
March
2023 Authorisations
shall
be
limited
to
professional
users.

CAS No 7803-51-2
The relevant impurity arsane
For the implementation of the uniform principles as referred to in
must not exceed 0,023 g/kg
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the
CIPAC No 127
in the technical material
review report on phosphane, and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain and
Animal Health on 28 September 2012 shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
— the protection of operators in and around the treated premises during
the treatment as well as during and after the aeration;
icial
— the protection of workers in and around the treated premises during
the treatment as well as during and after the aeration;
Jour
nal
— the protection of bystanders around the treated premises during the
treatment as well as during and after the aeration.
of
the
Conditions of use shall include risk mitigation measures, like permanent
European
monitoring of the phosphane concentration by automatic devices, the
use of personal protection equipment and setting-up an area around the
treated premise where bystanders are denied, where appropriate.’
Union
(1 ) Further details on identity and specification of active substance are provided in the review report.
L
310/27

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