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26.11.2013 Official
Journal
of
the
European
Union L
315/27
COMMISSION IMPLEMENTING REGULATION (EU) No 1195/2013
of 22 November 2013
approving the active substance sodium silver thiosulfate, 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,
submitted a draft assessment report on 4 July 2005. In
accordance with Article 11(6) of Commission Regulation
(EU) No 188/2011
( 4 ) additional information was
Having regard to the Treaty on the Functioning of the European
requested from the applicant on 1 February 2012. The
Union,
evaluation of the additional data by the Netherlands was
submitted in the format of an updated draft assessment
report in November 2012.
Having regard to Regulation (EC) No 1107/2009 of the
European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the
(4) The
draft
assessment
report
was
reviewed
by
the
Member
market and repealing Council Directives 79/117/EEC and
States and the European Food Safety Authority (here
91/414/EEC ( 1 ), and in particular Article 13(2) and Article 78(2)
inafter ‘the Authority’). The Authority presented to the
thereof,
Commission its conclusion on the pesticide risk
assessment of the active substance sodium silver thiosul
fate ( 5 ) on 1 March 2013. The draft assessment report
Whereas:
and the conclusion of the Authority were reviewed by
the Member States and the Commission within the
Standing Committee on the Food Chain and Animal
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
Health and finalised on 3 October 2013 in the format
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
of the Commission review report for sodium silver thio
with respect to the procedure and the conditions for
sulfate.
approval, to active substances for which a decision has
been adopted in accordance with Article 6(3) of that
Directive before 14 June 2011. For sodium silver thio
(5)
It has appeared from the various examinations made that
sulfate, referred to in Commission Decision
plant protection products containing sodium silver thio
2003/850/EC ( 3 ) as silver thiosulfate, the conditions of
sulfate may be expected to satisfy, in general, the
Article 80(1)(a) of Regulation (EC) No 1107/2009 are
requirements laid down in Article 5(1)(a) and (b) and
fulfilled by that Decision.
Article 5(3) of Directive 91/414/EEC, in particular with
regard to the uses which were examined and detailed in
the Commission review report. It is therefore appropriate
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
to approve sodium silver thiosulfate.
the Netherlands received on 27 January 2003 an appli
cation from Enhold B.V for the inclusion of the active
substance sodium silver thiosulfate in Annex I to
(6) A
reasonable
period
should
be
allowed
to
elapse
before
Directive 91/414/EEC. Decision 2003/850/EC
approval in order to permit Member States and the
confirmed that the dossier was ‘complete’ in the sense
interested parties to prepare themselves to meet the
that it could be considered as satisfying, in principle, the
new requirements resulting from the approval.
data and information requirements of Annexes II and III
to Directive 91/414/EEC.
(7) Without
prejudice
to
the
obligations
provided
for
in
Regulation (EC) No 1107/2009 as a consequence of
(3) For
that
active
substance,
the
effects
on
human
and
animal health and the environment have been assessed,
approval, taking into account the specific situation
in accordance with the provisions of Article 6(2) and (4)
created by the transition from Directive 91/414/EEC to
of Directive 91/414/EEC, for the uses proposed by the
Regulation (EC) No 1107/2009, the following should,
applicant. The designated rapporteur Member State
however, apply. Member States should be allowed a
period of six months after approval to review authori
sations of plant protection products containing sodium
( 1 ) OJ L 309, 24.11.2009, p. 1.
silver thiosulfate. Member States should, as appropriate,
( 2 ) Council Directive 91/414/EEC of 15 July 1991 concerning the
placing of plant protection products on the market (OJ L 230,
19.8.1991, p. 1).
( 4 ) Commission Regulation (EU) No 188/2011 of 25 February 2011
( 3 ) Commission Decision 2003/850/EC of 4 December 2003 recog
laying down detailed rules for the implementation of Council
nising in principle the completeness of the dossiers submitted for
Directive 91/414/EEC as regards the procedure for the assessment
detailed examination in view of the possible inclusion of BAS 670H
of active substances which were not on the market 2 years after the
and silver thiosulphate in Annex I to Council Directive 91/414/EEC
date of notification of that Directive (OJ L 53, 26.2.2011, p. 51).
concerning the placing of plant protection products on the market
( 5 ) EFSA Journal 2013; 11(3):3136. Available online: www.efsa.europa.
(OJ L 322, 9.12.2003, p. 28).
eu

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L 315/28
EN
Official Journal of the European Union
26.11.2013
vary, replace or withdraw authorisations. By way of dero
identified in part B of the column on specific provisions of that
gation from that deadline, a longer period should be
Annex, and that the holder of the authorisation has, or has
provided for the submission and assessment of the
access to, a dossier satisfying the requirements of Annex II to
complete Annex III dossier, as set out in Directive
Directive 91/414/EEC in accordance with the conditions of
91/414/EEC, of each plant protection product for each
Article 13(1) to (4) of that Directive and Article 62 of Regu
intended use in accordance with the uniform principles.
lation (EC) No 1107/2009.
(8) The
experience
gained
from
inclusions
in
Annex
I
to
Directive 91/414/EEC of active substances assessed in
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
the framework of Commission Regulation (EEC) No
orised plant protection product containing sodium silver thio
3600/92 ( 1 ) has shown that difficulties can arise in inter
sulfate as either the only active substance or as one of several
preting the duties of holders of existing authorisations in
active substances, all of which were listed in the Annex to
relation to access to data. In order to avoid further
Implementing Regulation (EU) No 540/2011 by 30 April
difficulties it therefore appears necessary to clarify the
2014 at the latest, Member States shall re-evaluate the
duties of the Member States, especially the duty to
product in accordance with the uniform principles, as referred
verify that the holder of an authorisation demonstrates
to in Article 29(6) of Regulation (EC) No 1107/2009, on the
access to a dossier satisfying the requirements of Annex
basis of a dossier satisfying the requirements of Annex III to
II to that Directive. However, this clarification does not
Directive 91/414/EEC and taking into account part B of the
impose any new obligations on Member States or holders
column on specific provisions of Annex I to this Regulation.
of authorisations compared to the Directives which have
On the basis of that evaluation, they shall determine whether
been adopted until now amending Annex I to that
the product satisfies the conditions set out in Article 29(1) of
Directive or the Regulations approving active substances.
Regulation (EC) No 1107/2009.
(9) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
1107/2009, the Annex to Commission Implementing
Following that determination Member States shall:
Regulation (EU) No 540/2011 ( 2 ) should be amended
accordingly.
(a) in the case of a product containing sodium silver thiosulfate
(10) The
measures
provided
for
in
this
Regulation
are
in
as the only active substance, where necessary, amend or
accordance with the opinion of the Standing
withdraw the authorisation by 31 October 2015 at the
Committee on the Food Chain and Animal Health,
latest; or
HAS ADOPTED THIS REGULATION:
(b) in the case of a product containing sodium silver thiosulfate
Article 1
as one of several active substances, where necessary, amend
or withdraw the authorisation by 31 October 2015 or by
Approval of active substance
the date fixed for such an amendment or withdrawal in the
The active substance sodium silver thiosulfate, as specified in
respective act or acts which added the relevant substance or
Annex I, is approved subject to the conditions laid down in that
substances to Annex I to Directive 91/414/EEC or approved
Annex.
that substance or those 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 sodium
The Annex to Implementing Regulation (EU) No 540/2011 is
silver thiosulfate as an active substance by 31 October 2014.
amended in accordance with Annex II to this Regulation.
By that date they shall in particular verify that the conditions in
Annex I to this Regulation are met, with the exception of those
Article 4
Entry into force and date of application
( 1 ) Commission Regulation (EEC) No 3600/92 of 11 December 1992
laying down the detailed rules for the implementation of the first
This Regulation shall enter into force on the twentieth day
stage of the programme of work referred to in Article 8(2) of
following that of its publication in the Official Journal of the
Council Directive 91/414/EEC concerning the placing of plant
European Union.
protection products on the market (OJ L 366, 15.12.1992, p. 10).
( 2 ) Commission Implementing Regulation (EU) No 540/2011 of
25 May 2011 implementing Regulation (EC) No 1107/2009 of
the European Parliament and of the Council as regards the list of
approved active substances (OJ L 153, 11.6.2011, p. 1).
It shall apply from 1 May 2014.

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EN
26.11.2013 Official
Journal
of
the
European
Union L
315/29
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 November 2013.
For the Commission
The President
José Manuel BARROSO

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L 315/30
ANNEX I
Common Name, Identification
Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Sodium silver thiosulfate
Not applicable
≥ 10,0 g Ag/kg
1 May 2014 30
April
2024 PART
A
CAS No not allocated
Expressed as silver (Ag)
EN
Only indoor uses in non-edible crops shall be authorised.
CIPAC No 762

PART B
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 sodium silver thiosulfate, and in particular Appendices I
and II thereof, as finalised in the Standing Committee on the Food Chain and
Animal Health on 3 October 2013 shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
Off
(a) the protection of operators and workers;
icial
(b) limiting the possible release of silver ions through disposal of used
Jour
solutions;
nal
(c) the risk to terrestric vertebrates and soil invertebrates from the use of
sewage sludge in agriculture.
of
the
Conditions of use shall include risk mitigation measures, where appropriate.
European
(1 ) Further details on identity and specification of active substance are provided in the review report.
Union
26.11.2013

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26.11.2013 Off
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
‘63 Sodium
silver
thiosulfate
Not applicable
≥ 10,0 g Ag/kg
1 May 2014 30
April
2024 PART
A

CAS No not allocated
Expressed as silver (Ag)
Only indoor uses in non-edible crops shall be authorised.
CIPAC No 762
PART B
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 sodium
silver thiosulfate, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall
be taken into account.
In this overall assessment Member States shall pay particular attention to
icial
(a) the protection of operators and workers;
Jour
nal
(b) limiting the possible release of silver ions through disposal of used solutions;
of
(c) the risk to terrestric vertebrates and soil invertebrates from the use of sewage
the
sludge in agriculture.
European
Conditions of use shall include risk mitigation measures, where appropriate.’
(*) Further details on identity and specification of active substance are provided in the review report.
Union
L
315/31

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