HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 38/26
EN
Official Journal of the European Union
7.2.2014
COMMISSION IMPLEMENTING REGULATION (EU) No 116/2014
of 6 February 2014
concerning the non-approval of the active substance potassium iodide, 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
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
applicant. The designated rapporteur Member State
submitted a draft assessment report on 27 July 2007.
In accordance with Article 11(6) of Commission Regu
lation (EU) No 188/2011 ( 4 ) additional information was
Having regard to the Treaty on the Functioning of the European
requested from the applicant. The applicant informed on
Union,
30 May 2011 that no additional information was
available.
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) thereof,
inafter ‘the Authority’). The Authority presented to the
Commission its conclusion on the pesticide risk
assessment of the active substance potassium iodide ( 5 )
Whereas:
on 22 October 2012. The Authority identified several

data gaps that would have required further contributions
from the applicant. By letter of 27 September 2013
Koppert BV withdrew its application for the approval
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
of potassium iodide.
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
with respect to the procedure and the conditions for
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 potassium iodide
(5) In
accordance
with
Article
8(1)(b)
of
Directive
the conditions of Article 80(1)(a) of Regulation (EC) No
91/414/EEC, Member States were given the possibility
1107/2009 are fulfilled by Commission Decision
to grant provisional authorisations for plant protection
2005/751/EC (
products containing potassium iodide for an initial

3 ).
period of 3 years. Commission Decision 2010/457/EU ( 6 )
allowed Member States to extend provisional authori
sations for potassium iodide for a period ending on
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
31 August 2012 at the latest. Commission Implementing
the Netherlands received on 6 September 2004 an appli
Decision 2012/363/EU ( 7 ) allowed Member States to
cation from Koppert Beheer BV for the inclusion of the
extend provisional authorisations for potassium iodide
active substance potassium iodide in Annex I to Directive
for a period ending on 31 July 2014 at the latest.
91/414/EEC. Decision 2005/751/EC confirmed that the
dossier was ‘complete’ in the sense that it could be
considered as satisfying, in principle, the data and
information requirements of Annexes II and III to
Directive 91/414/EEC.
(6)
Due to the withdrawal of the application, potassium
iodide should therefore not be approved pursuant to
Article 13(2) of Regulation (EC) No 1107/2009.
(3) For
that
active
substance,
the
effects
on
human
and ( 4 ) Commission Regulation (EU) No 188/2011 of 25 February 2011
animal health and the environment have been assessed,
laying down detailed rules for the implementation of Council
in accordance with the provisions of Article 6(2) and (4)
Directive 91/414/EEC as regards the procedure for the assessment
of Directive 91/414/EEC, for the uses proposed by the
of active substances which were not on the market 2 years after the
date of notification of that Directive (OJ L 53, 26.2.2011, p. 51).
( 5 ) EFSA Journal 2013;11(6):2923. Available online: www.efsa.europa.eu
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 6 ) Commission Decision 2010/457/EU of 17 August 2010 allowing
( 2 ) Council Directive 91/414/EEC of 15 July 1991 concerning the
Member States to extend provisional authorisations granted for the
placing of plant protection products on the market (OJ L 230,
new active substances Candida oleophila strain O, potassium iodide
19.8.1991, p. 1).
and potassium thiocyanate (OJ L 218, 19.8.2010, p. 24).
( 3 ) Commission Decision 2005/751/EC of 21 October 2005 recog
( 7 ) Commission Implementing Decision 2012/363/EU of 4 July 2012
nising in principle the completeness of the dossiers submitted for
allowing Member States to extend provisional authorisations granted
detailed examination in view of the possible inclusion of ascorbic
for the new active substances bixafen, Candida oleophila strain O,
acid, potassium iodide and potassium thiocyanate in Annex I to
fluopyram, halosulfuron, potassium iodide and potassium thio
Council Directive 91/414/EEC (OJ L 282, 26.10.2005, p. 18).
cyanate and spirotetramat (OJ L 176, 6.7.2012, p. 70).

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EN
7.2.2014 Official
Journal
of
the
European
Union L
38/27
(7) Existing
provisional
authorisations
should,
consequently, HAS ADOPTED THIS REGULATION:
be withdrawn and no new authorisations be granted.
Article 1
Non-approval of active substance
(8) Member States should be provided with time to
The active substance potassium iodide is not approved.
withdraw authorisations for plant protection products
containing potassium iodide.
Article 2
Transitional measures
Member States shall withdraw existing authorisations for plant
(9) For
plant
protection
products
containing
potassium
iodide, where Member States grant any grace period in
protection products containing potassium iodide as active
accordance with Article 46 of Regulation (EC) No
substance by 27 August 2014 at the latest.
1107/2009, this period should expire at the latest 18
months after the entry into force of this Regulation.
Article 3

Grace period
Any grace period granted by Member States in accordance with
(10) This
Regulation
does
not
prejudice
the
submission
of
a
Article 46 of Regulation (EC) No 1107/2009 shall be as short
further application for potassium iodide pursuant to
as possible and shall expire by 27 August 2015 at the latest.
Article 7 of Regulation (EC) No 1107/2009.
Article 4
Entry into force
(11) The
measures
provided
for
in
this
Regulation
are
in
This Regulation shall enter into force on the twentieth day
accordance with the opinion of the Standing
following that of its publication in the Official Journal of the
Committee on the Food Chain and Animal Health,
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 6 February 2014.
For the Commission
The President
José Manuel BARROSO

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