HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
26.10.2011 Official
Journal
of
the
European
Union
L
279/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 1078/2011
of 25 October 2011
concerning the non-approval of the active substance propanil, 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,
programme of work referred to in Article 8(2) of
Directive 91/414/EEC and establish lists of active
substances to be assessed, with a view to their possible
inclusion in Annex I to Directive 91/414/EEC. These lists
Having regard to the Treaty on the Functioning of the European
included propanil.
Union,
(3) In
accordance
with
Article
11f
of
Regulation
(EC)
No
Having regard to Regulation (EC) No 1107/2009 of the
1490/2002 and Article 12(1)(a) and (2)(b) of that
European Parliament and of the Council of 21 October 2009
Regulation, Commission Decision 2008/769/EC of
concerning the placing of plant protection products on the
30 September 2008 concerning the non-inclusion of
market and repealing Council Directives 79/117/EEC and
propanil in Annex I to Council Directive 91/414/EEC
91/414/EEC ( 1 ), and in particular Article 13(2) thereof,
and the withdrawal of authorisations for plant protection
products containing that substance ( 6 ) was adopted.
Whereas:
(4) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
original notifier (hereinafter ‘the applicant’) submitted a
(1) In
accordance
with
Article
80(1)(c)
of
Regulation
(EC)
No
new application requesting the accelerated procedure to
1107/2009, Council Directive 91/414/EEC (
be applied, as provided for in Articles 14 to 19 of Regu

2 ) is to apply,
with respect to the procedure and the conditions for
lation (EC) No 33/2008.
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
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 2008/769/EC. That application
have not been included into its Annex I ( 3 ). Propanil is an
also complies with the remaining substantive and
active substance for which completeness has been estab
procedural requirements of Article 15 of Regulation
lished 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 detailed rules for the imple
applicant and prepared an additional report. It
mentation of the second and third stages of the
communicated that report to the European Food Safety
Authority (hereinafter ‘the Authority’) and to the
( 1 ) OJ L 309, 24.11.2009, p. 1.
Commission on 26 February 2010. The Authority
( 2 ) OJ L 230, 19.8.1991, p. 1.
communicated the additional report to the other
( 3 ) OJ L 15, 18.1.2008, p. 5.
( 4 ) OJ L 55, 29.2.2000, p. 25.
( 5 ) OJ L 224, 21.8.2002, p. 23.
( 6 ) OJ L 263, 2.10.2008, p. 14.

---

L 279/2
EN
Official Journal of the European Union
26.10.2011
Member States and the applicant for comments and
not be eliminated. Consequently, it has not been demon
forwarded the comments it had received to the
strated that it may be expected that, under the proposed
Commission. In accordance with Article 20(1) of Regu
conditions of use, plant protection products containing
lation (EC) No 33/2008 and at the request of the
propanil satisfy in general the requirements laid down in
Commission, the Authority presented its conclusion on
Article 5(1)(a) and (b) of Directive 91/414/EEC.
the risk assessment of propanil to the Commission on
23 February 2011 ( 1 ). The draft assessment report, the
additional report and the conclusion of the Authority
(10) Propanil
should
therefore
not
be
approved
pursuant
to
were reviewed by the Member States and the
Article 13(2) of Regulation (EC) No 1107/2009.
Commission within the Standing Committee on the
Food Chain and Animal Health and finalised on
27 September 2011 in the format of the Commission
(11) In
the
interest
of
clarity,
Decision
2008/769/EC
should
review report for propanil.
be repealed.
(7)
Based on the new data submitted by the applicant and
(12) This
Regulation
does
not
prejudice
the
submission
of
a
included in the additional report an acceptable operator
further application for propanil pursuant to Article 7 of
exposure level could be set. However, during the
Regulation (EC) No 1107/2009.
evaluation of this active substance, a number of other
concerns have been identified. In particular, it was not
possible to perform a reliable consumer exposure
(13) The
measures
provided
for
in
this
Regulation
are
in
assessment as data were missing on the toxicity of meta
accordance with the opinion of the Standing
bolite 3,4-DCA which may be higher than the parent
Committee on the Food Chain and Animal Health,
compound. Moreover, no maximum residue levels
could be proposed for the supported use on rice as the
submitted trials have not been conducted according to
HAS ADOPTED THIS REGULATION:
the critical good agricultural practices. A high risk to
birds and mammals has been identified while a high
risk for aquatic organisms and non-target arthropods
Article 1
cannot be excluded on the basis of the data made
available by the applicant. In addition, a potential for
Non-approval of active substance
long-range transport through the atmosphere cannot be
excluded.
The active substance propanil is not approved.

Article 2
(8) The
Commission
invited
the
applicant
to
submit
its
comments on the conclusion of the Authority.
Repeal
Furthermore, in accordance with Article 21(1) of Regu
lation (EC) No 33/2008, the Commission invited the
Decision 2008/769/EC is repealed.
applicant to submit comments on the draft review
report. The applicant submitted its comments, which
have been carefully examined.
Article 3
Entry into force
(9) However,
despite
the
arguments
put
forward
by
the This Regulation shall enter into force on the 20th day following
applicant, the concerns referred to in recital 7 could
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, 25 October 2011.
For the Commission
The President
José Manuel BARROSO
( 1 ) European Food Safety Authority; Conclusion on the peer review of
the pesticide risk assessment of the active substance propanil. EFSA
Journal 2011; 9(3):2085 [63 pp.]. doi:10.2903/j.efsa.2011.2085.
Available online: www.efsa.europa.eu/efsajournal.htm

---