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31.8.2013 Official
Journal
of
the
European
Union L
233/3
COMMISSION IMPLEMENTING REGULATION (EU) No 832/2013
of 30 August 2013
approving the active substance disodium phosphonate, 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 Implementing Regulation (EU)
No 540/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Standing Committee on the Food Chain and Animal
Health and finalised on 16 July 2013 in the format of
Having regard to the Treaty on the Functioning of the European
the Commission review report for disodium phos
Union,
phonate.
Having regard to Regulation (EC) No 1107/2009 of the
(5)
It has appeared from the various examinations made that
European Parliament and of the Council of 21 October 2009
plant protection products containing disodium phos
concerning the placing of plant protection products on the
phonate may be expected to satisfy, in general, the
market and repealing Council Directives 79/117/EEC and
requirements laid down in Article 5(1)(a) and (b) and
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
Article 5(3) of Directive 91/414/EEC, in particular with
thereof,
regard to the use which was examined and detailed in the
Commission review report. It is therefore appropriate to
Whereas:
approve disodium phosphonate.
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No (6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
1107/2009, Directive 91/414/EEC (
1107/2009 in conjunction with Article 6 thereof and in

2 ) is to apply, with
respect to the procedure and the conditions for
the light of current scientific and technical knowledge, it
approval, to active substances for which a decision has
is, however, necessary to include certain conditions and
been adopted in accordance with Article 6(3) of that
restrictions. It is, in particular, appropriate to require
Directive before 14 June 2011. For disodium phos
further confirmatory information.
phonate the conditions of Article 80(1)(a) of Regulation
(EC) No 1107/2009 are fulfilled by Commission Decision
(7) A
reasonable
period
should
be
allowed
to
elapse
before
2008/953/EC (
approval in order to permit Member States and the

3 ).
interested parties to prepare themselves to meet the
new requirements resulting from the approval.
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
France received on 11 February 2008 an application
from ISK BioSciences Europe N.V. for the inclusion of
(8) Without
prejudice
to
the
obligations
provided
for
in
the active substance disodium phosphonate in Annex I to
Regulation (EC) No 1107/2009 as a consequence of
Directive 91/414/EEC. Decision 2008/953/EC confirmed
approval, taking into account the specific situation
that the dossier was ‘complete’ in the sense that it could
created by the transition from Directive 91/414/EEC to
be considered as satisfying, in principle, the data and
Regulation (EC) No 1107/2009, the following should,
information requirements of Annexes II and III to
however, apply. Member States should be allowed a
Directive 91/414/EEC.
period of six months after approval to review authori
sations of plant protection products containing disodium
phosphonate. Member States should, as appropriate, vary,
(3) For
that
active
substance,
the
effects
on
human
and
replace or withdraw authorisations. By way of derogation
animal health and the environment have been assessed,
from that deadline, a longer period should be provided
in accordance with the provisions of Article 6(2) and (4)
for the submission and assessment of the complete
of Directive 91/414/EEC, for the uses proposed by the
Annex III dossier, as set out in Directive 91/414/EEC,
applicant. The designated rapporteur Member State
of each plant protection product for each intended use
submitted a draft assessment report on 27 August 2009.
in accordance with the uniform principles.
(4) The
draft
assessment
report
was
reviewed
by
the
Member (9) The
experience
gained
from
inclusions
in
Annex
I
to
States and the European Food Safety Authority (here
Directive 91/414/EEC of active substances assessed in
inafter 'the Authority'). The Authority presented to the
the framework of Commission Regulation (EEC) No
Commission its conclusion on the pesticide risk
3600/92 of 11 December 1992 laying down the
assessment of the active substance disodium phospho
detailed rules for the implementation of the first stage
nate ( 4 ) on 22 April 2013. The draft assessment report
of the programme of work referred to in Article 8(2) of
and the conclusion of the Authority were reviewed by
Council Directive 91/414/EEC concerning the placing of
the Member States and the Commission within the
plant protection products on the market ( 5 ) has shown
that difficulties can arise in interpreting the duties of
( 1 ) OJ L 309, 24.11.2009, p. 1.
holders of existing authorisations in relation to access
( 2 ) OJ L 230, 19.8.1991, p. 1.
to data. In order to avoid further difficulties it therefore
( 3 ) OJ L 338, 17.12.2008, p. 62.
( 4 ) EFSA Journal (2013) 11(5):3213. Available online: www.efsa.europa.
eu.
( 5 ) OJ L 366, 15.12.1992, p. 10.

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L 233/4
EN
Official Journal of the European Union
31.8.2013
appears necessary to clarify the duties of the Member
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
States, especially the duty to verify that the holder of
orised plant protection product containing disodium phos
an authorisation demonstrates access to a dossier
phonate as either the only active substance or as one of
satisfying the requirements of Annex II to that Directive.
several active substances, all of which were listed in the
However, this clarification does not impose any new
Annex to Implementing Regulation (EU) No 540/2011 by
obligations on Member States or holders of authori
31 January 2014 at the latest, Member States shall re-evaluate
sations compared to the Directives which have been
the product in accordance with the uniform principles, as
adopted until now amending Annex I to that Directive
referred to in Article 29(6) of Regulation (EC) No 1107/2009,
or the Regulations approving active substances.
on the basis of a dossier satisfying the requirements of Annex
III to Directive 91/414/EEC and taking into account the column
(10) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
on specific provisions of Annex I to this Regulation. On the
1107/2009, the Annex to Commission Implementing
basis of that evaluation, they shall determine whether the
Regulation (EU) No 540/2011 of 25 May 2011 imple
product satisfies the conditions set out in Article 29(1) of Regu
menting Regulation (EC) No 1107/2009 of the European
lation (EC) No 1107/2009.
Parliament and of the Council as regards the list of
approved active substances
( 1 ) should be amended
Following that determination Member States shall:
accordingly.
(11) The
measures
provided
for
in
this
Regulation
are
in
(a) in the case of a product containing disodium phosphonate
accordance with the opinion of the Standing
as the only active substance, where necessary, amend or
Committee on the Food Chain and Animal Health,
withdraw the authorisation by 31 July 2015 at the latest; or
HAS ADOPTED THIS REGULATION:
(b) in the case of a product containing disodium phosphonate
as one of several active substances, where necessary, amend
Article 1
or withdraw the authorisation by 31 July 2015 or by the
date fixed for such an amendment or withdrawal in the
Approval of active substance
respective act or acts which added the relevant substance
The active substance disodium phosphonate, as specified in
or substances to Annex I to Directive 91/414/EEC or
Annex I, is approved subject to the conditions laid down in
approved that substance or those substances, whichever is
that Annex.
the latest.
Article 2
Article 3
Re-evaluation of plant protection products
Amendments to Implementing Regulation (EU) No
540/2011
1. Member
States
shall
in
accordance
with
Regulation
(EC)
No 1107/2009, where necessary, amend or withdraw existing
The Annex to Implementing Regulation (EU) No 540/2011 is
authorisations for plant protection products containing
amended in accordance with Annex II to this Regulation.
disodium phosphonate as an active substance by 31 July 2014.
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
following that of its publication in the Official Journal of the
dossier satisfying the requirements of Annex II to Directive
European Union.
91/414/EEC in accordance with the conditions of Article 13(1)
to (4) of that Directive and Article 62 of Regulation (EC) No
1107/2009.
It shall apply from 1 February 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 30 August 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

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31.8.2013 Off
ANNEX I
Common Name, Identification
Numbers
IUPAC Name Purity
(1 ) Date
of
approval
Expiration of
approval
Specific provisions
Disodium phosphonate
disodium phosphonate 281-337
g/kg
(TK) 1 February 2014 31
January
2024 For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on disodium
EN
CAS No 13708-85-5
≥ 917 g/kg (TC)
phosphonate, and in particular Appendices I and II thereof, as finalised in the

CIPAC No 808
Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be
taken into account.
In this overall assessment Member States shall pay particular attention to the risk of
eutrophication of surface water.
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit confirmatory information as regards
(a) the chronic risk to fish;
(b) the long term risk to earthworms and soil macro-organisms.
icial
The applicant shall submit to the Commission, the Member States and the Authority that
Jour
information by 31 January 2016.
nal
(1 ) Further details on identity and specification of active substance are provided in the review report.
of
the
European
Union
L
233/5

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L 233/6
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number
Common Name,
Identification Numbers
IUPAC Name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
EN
‘54 Disodium
phosphonate
disodium phos 281-337 g/kg
1 February 2014 31
January
2024
For the implementation of the uniform principles as referred to in

phonate
(TK)
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
CAS No 13708-85-5
the review report on disodium phosphonate, and in particular
≥ 917 g/kg (TC)
Appendices I and II thereof, as finalised in the Standing Committee
CIPAC No 808
on the Food Chain and Animal Health on 16 July 2013 shall be taken
into account.
In this overall assessment Member States shall pay particular attention
to the risk to eutrophication of surface water.
Conditions of use shall include risk mitigation measures, where appro
Off
priate.
icial
The applicant shall submit confirmatory information as regards
Jour
(a) the chronic risk to fish;
nal
(b) the long term risk to earthworms and soil macro-organisms.
of
the
The applicant shall submit to the Commission, the Member States and
European
the Authority that information by 31 January 2016.’
(*) Further details on identity and specification of active substance are provided in the review report.
Union
31.8.2013

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