HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 246/16
EN
Official Journal of the European Union
23.9.2011
COMMISSION IMPLEMENTING REGULATION (EU) No 943/2011
of 22 September 2011
concerning the non-approval of the active substance propargite, 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 Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
lation (EC) No 2229/2004 laying down further detailed
rules for the implementation of the fourth stage of the
programme of work referred to in Article 8(2) of Council
Having regard to the Treaty on the Functioning of the European
Directive 91/414/EEC
( 6 ) the notifier withdrew its
Union,
support for the inclusion of that active substance in
Annex I to Directive 91/414/EEC within 2 months
from entry into force of Regulation (EC) No 1095/2007.
Having regard to Regulation (EC) No 1107/2009 of the
Consequently, Commission Decision 2008/934/EC of
European Parliament and of the Council of 21 October 2009
5 December 2008 concerning the non-inclusion of
concerning the placing of plant protection products on the
certain active substances in Annex I to Council
market and repealing Council Directives 79/117/EEC and
Directive 91/414/EEC and the withdrawal of author
91/414/EEC (
isations for plant protection products containing these

1 ), and in particular Article 13(2) and
Article 78(2) thereof,
substances ( 7 ) was adopted on the non-inclusion of
propargite.
Whereas:
(4) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
original notifier (hereinafter ′the applicant ′) submitted a
new application requesting the accelerated procedure to
(1) In
accordance
with
Article
80(1)(c)
of
Regulation
(EC)
No
be applied, as provided for in Articles 14 to 19 of Regu
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
lation (EC) No 33/2008.
with respect to the procedure and the conditions for
approval, to active substances for which completeness
has been established in accordance with Article 16 of
Commission Regulation (EC) No 33/2008 of
(5) The
application
was
submitted
to
Italy
which
carried
out
the evaluation in agreement with France which had been
17 January 2008 laying down detailed rules for the
designated rapporteur Member State by Regulation (EC)
application of Council Directive 91/414/EEC as regards
No 1490/2002. The time period for the accelerated
a regular and an accelerated procedure for the assessment
procedure was respected. The specification of the active
of active substances which were part of the programme
substance and the supported uses are the same as were
of work referred to in Article 8(2) of that Directive but
the subject of Decision 2008/934/EC. That application
have not been included into its Annex I ( 3 ). Propargite is
also complies with the remaining substantive and
an active substance for which completeness has been
procedural requirements of Article 15 of Regulation
established in accordance with that Regulation.
(EC) No 33/2008.
(2) Commission
Regulations
(EC)
No
451/2000
( 4 ) and (EC)
(6) Italy evaluated the additional data submitted by the
No 1490/2002 ( 5 ) lay down the detailed rules for the
applicant and prepared an additional report. It
implementation of the second and third stages of the
communicated that report to the European Food Safety
programme of work referred to in Article 8(2) of
Authority (hereinafter ′the Authority ′) and to the
Directive 91/414/EEC and establish lists of active
Commission on 4 March 2010. The Authority
substances to be assessed, with a view to their possible
communicated the additional report to the other
inclusion in Annex I to Directive 91/414/EEC. These lists
Member States and the applicant for comments and
included propargite.
forwarded the comments it had received to the
Commission. In accordance with Article 20(1) of Regu
lation (EC) No 33/2008 and at the request of the
(3) In
accordance
with
Article
3(2)
of
Commission
Regu
Commission, the Authority presented its conclusion on
lation (EC) No 1095/2007 of 20 September 2007
the risk assessment of propargite to the Commission on
amending Regulation (EC) No 1490/2002 laying down
23 February 2011 ( 8 ). The draft assessment report, the
further detailed rules for the implementation of the third
additional report and the conclusion of the Authority
stage of the programme of work referred to in
were reviewed by the Member States and the
Article 8(2) of Council Directive 91/414/EEC and Regu
( 6 ) OJ L 246, 21.9.2007, p. 19.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 7 ) OJ L 333, 11.12.2008, p. 11.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 8 ) European Food Safety Authority; Conclusion on the peer review of
( 3 ) OJ L 15, 18.1.2008, p. 5.
the pesticide risk assessment of the active substance propargite. EFSA
( 4 ) OJ L 55, 29.2.2000, p. 25.
Journal 2011; 9(3):2087. [71 pp.]. doi:10.2903/j.efsa.2011.2087.
( 5 ) OJ L 224, 21.8.2002, p. 23.
Available online: www.efsa.europa.eu/efsajournal.htm

---

EN
23.9.2011 Official
Journal
of
the
European
Union L
246/17
Commission within the Standing Committee on the Food
(13) In
the
interest
of
clarity,
the
entry
for
propargite
in
the
Chain and Animal Health and finalised on 15 July 2011
Annex to Decision 2008/934/EC should be deleted.
in the format of the Commission review report for
propargite.
(14) It is therefore appropriate to amend Decision
2008/934/EC accordingly.
(7) During
the
evaluation
of
this
active
substance,
concerns
were identified. Those concerns were, in particular, the
(15) The
measures
provided
for
in
this
Regulation
are
in
following. It was not possible to perform reliable risk
accordance with the opinion of the Standing
assessments for consumers, operators, workers and
Committee on the Food Chain and Animal Health,
bystanders. In addition, it was not possible to finalise
the ecotoxicological risk assessment. In particular, a
high long term risk to mammals, a risk of secondary
HAS ADOPTED THIS REGULATION:
poisoning to birds and a high risk to aquatic
organisms were identified.
Article 1
Non-approval of active substance
(8) The
Commission
invited
the
applicant
to
submit
its
comments on the conclusion of the Authority.
The active substance propargite is not approved.
Furthermore, in accordance with Article 21(1) to Regu
lation (EC) No 33/2008, the Commission invited the
Article 2
applicant to submit comments on the draft review
report. The applicant submitted its comments, which
Transitional measures
have been carefully examined.
Member States shall ensure that authorisations for plant
protection products containing propargite are withdrawn by
(9) However,
despite
the
arguments
put
forward
by
the 31 December 2011.
applicant, the concerns referred to in recital 7 could
not be eliminated. Consequently, it has not been demon
Article 3
strated that it may be expected that, under the proposed
conditions of use, plant protection products containing
Period of grace
propargite satisfy in general the requirements laid down
in Article 5(1)(a) and (b) of Directive 91/414/EEC.
Any period of grace granted by Member States in accordance
with Article 46 of Regulation (EC) No 1107/2009 shall be as
short as possible and shall expire on 31 December 2012 at the
(10) Propargite
should
therefore
not
be
approved
pursuant
to
latest.
Article 13(2) of Regulation (EC) No 1107/2009.
Article 4
(11) For plant protection products containing propargite,
Amendments to Decision 2008/934/EC
where Member States grant any period of grace in
accordance with Article 46 of Regulation (EC) No
In the Annex to Decision 2008/934/EC, the entry for
1107/2009, this period should expire on 31 December
‘propargite’ is deleted.
2012 at the latest as laid down in the second paragraph
of Article 3 of Decision 2008/934/EC.
Article 5
Entry into force and date of application
(12) This
Regulation
does
not
prejudice
the
submission
of
a
further application for propargite pursuant to Article 7 of
This Regulation shall enter into force on the 20th day following
Regulation (EC) No 1107/2009.
its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 September 2011.
For the Commission
The President
José Manuel BARROSO

---