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30.4.2011 Official
Journal
of
the
European
Union L
111/19
COMMISSION IMPLEMENTING DECISION
of 27 April 2011
concerning the non-inclusion of propisochlor in Annex I to Council Directive 91/414/EEC and
amending Commission Decision 2008/941/EC
(notified under document C(2011) 2726)
(Text with EEA relevance)
(2011/262/EU)
THE EUROPEAN COMMISSION,
Commission Regulation (EC) No 33/2008 of 17 January
2008 laying down detailed rules for the application of
Council Directive 91/414/EEC as regards a regular and an
accelerated procedure for the assessment of active
Having regard to the Treaty on the Functioning of the European
substances which were part of the programme of work
Union,
referred to in Article 8(2) of that Directive but have not
been included into its Annex I ( 5 ).
Having regard to Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant protection products on
(4) The
application
was
submitted
to
Hungary,
which
had
the market (
been designated rapporteur Member State by Regulation

1 ), and in particular Article 6(1) thereof,
(EC) No 2229/2004. The time period for the accelerated
procedure was respected. The specification of the active
substance and the supported uses are the same as were
the subject of Decision 2008/941/EC. That application
Whereas:
also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation
(EC) No 33/2008.
(1) Commission
Regulations
(EC)
No
1112/2002
( 2 ) and (EC)
No 2229/2004 ( 3 ) lay down the detailed rules for the
implementation of the fourth stage of the programme
of work referred to in Article 8(2) of Directive
(5) Hungary
evaluated
the
additional
data
submitted
by
the
applicant and prepared an additional report. It
91/414/EEC and establish a list of active substances to
communicated that report to the European Food Safety
be assessed, with a view to their possible inclusion in
Authority (hereinafter ‘the Authority’) and to the
Annex I to Directive 91/414/EEC. That list included
Commission on 30 November 2009. The Authority
propisochlor.
communicated the additional report to the other
Member States and the applicant for comments and
forwarded the comments it had received to the
Commission. In accordance with Article 20(1) of Regu
(2) In
accordance
with
Article
24e
of
Regulation
(EC)
lation (EC) No 33/2008 and at the request of the
No 2229/2004 the notifier withdrew its support of the
Commission, the Authority presented its conclusion on
inclusion of that active substance in Annex I to Directive
propisochlor to the Commission on 9 September
91/414/EEC within 2 months from receipt of the draft
2010 ( 6 ) based on data submitted in accordance with
assessment report. Consequently, Commission Decision
Regulation (EC) No 33/2008. The draft assessment
2008/941/EC of 8 December 2008 concerning the
report, the additional report and the conclusion of the
non-inclusion of certain active substances in Annex I
Authority were reviewed by the Member States and the
to Council Directive 91/414/EEC and the withdrawal of
Commission within the Standing Committee on the Food
authorisations for plant protection products containing
Chain and Animal Health and finalised on 24 March
these substances ( 4 ) was adopted which provides for the
2011 in the format of the Commission review report
non-inclusion of propisochlor.
for propisochlor.
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
(6) During
the
evaluation
of
this
active
substance,
a
number
original notifier (hereinafter ‘the applicant’) submitted a
of concerns have been identified. In particular, it was not
new application requesting the accelerated procedure to
possible to perform a reliable consumer risk assessment
be applied, as provided for in Articles 14 to 19 of
( 5 ) OJ L 15, 18.1.2008, p. 5.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 6 ) ‘European Food Safety Authority; Conclusion on the peer review of
( 2 ) OJ L 168, 27.6.2002, p. 14.
the pesticide risk assessment of the active substance propisochlor’,
( 3 ) OJ L 379, 24.12.2004, p. 13.
EFSA Journal 2010; 8(9):1769. [60pp].doi:10.2903/j.efsa.2010.1769.
( 4 ) OJ L 335, 13.12.2008, p. 91.
Available online: www.efsa.europa.eu

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L 111/20
EN
Official Journal of the European Union
30.4.2011
and to conclude on a residue definition for propisochlor
(10) This
Decision
does
not
prejudice
the
submission
of
a
and its metabolites due to a lack of data on the toxico
further application for propisochlor pursuant to
logical relevance of several metabolites (M2 ( 1 ), M7 ( 2 ),
Article 6(2) of Directive 91/414/EEC and Chapter II of
M12 ( 3 ), M14 ( 4 ), M17 ( 5 ), M20 ( 6 ), M22 ( 7 ) and M35 ( 8 ).
Regulation (EC) No 33/2008.
In addition, harmful effects on groundwater cannot be
excluded for several metabolites (M1 ( 9 ), M2, M5 ( 10 ), M7
and M9 ( 11 ) of unknown toxicological and ecotoxico
logical relevance whose levels exceeded the maximum
(11) In the interest of clarity, the entry for propisochlor in the
permissible concentration of 0,1 μg/l as laid down by
Annex to Decision 2008/941/EC should be deleted.
Council Directive 98/83/EC of 3 November 1998
on the quality of water intended for human
consumption ( 12 ) in several model scenarios for
groundwater leaching. Finally, the data available were
not sufficient to conclude on the soil, sediment and
(12) It is therefore appropriate to amend Decision
groundwater exposure for the major soil metabolite M9
2008/941/EC accordingly.
and to finalise the risk assessment for aquatic organisms.
(13) The
measures provided for in this Decision are in
accordance with the opinion of the Standing
(7) The
Commission
invited
the
applicant
to
submit
its
Committee on the Food Chain and Animal Health,
comments on the results of the focused peer review.
Furthermore, in accordance with Article 21(1) of Regu
lation (EC) No 33/2008, the Commission invited the
applicant to submit comments on the draft review
HAS ADOPTED THIS DECISION:
report. The applicant submitted its comments, which
have been carefully examined.
Article 1
Propisochlor shall not be included as active substance in Annex
(8) However,
despite
the
arguments
put
forward
by
the I to Directive 91/414/EEC.
applicant, the concerns identified could not be elim
inated, and assessments made on the basis of the
information submitted in accordance with Regulation
(EC) No 33/2008 and evaluated during the meetings of
Article 2
the Authority have not demonstrated that it may be
expected that, under the proposed conditions of use,
Member States shall ensure that:
plant protection products containing propisochlor
satisfy in general the requirements laid down in
Article 5(1)(a) and (b) of Directive 91/414/EEC.
(a) authorisations for plant protection products containing
propisochlor are withdrawn by 27 October 2011;
(9) Propisochlor
should
therefore
not
be
included
in
Annex
I
to Directive 91/414/EEC.
(b) no authorisations for plant protection products containing
propisochlor are granted or renewed from the date of publi
( 1 ) 2-[(2-ethyl-6-methylphenyl) (isopropoxymethyl)amino]-2-oxoethane
cation of this Decision.
sulfonic acid.
( 2 ) ({2-[(2-ethyl-6-methylphenyl)
(isopropoxymethyl)amino]-2-oxoet
hyl}sulfinyl) acetic acid.
( 3 ) Unidentified compound in maize forage and sunflower seeds.
( 4 ) 3-({2-[(2-ethyl-6-methylphenyl)amino]-2-oxoethyl}sulfinyl)-2-
Article 3
hydroxypropanoic acid.
( 5 ) N-(2-ethyl-6-methylphenyl)-2-(hexopyranosyloxy)-N-[(propan-2-
Any period of grace granted by Member States in accordance
yloxy)methyl]acetamide.
with the provisions of Article 4(6) of Directive 91/414/EEC,
( 6 ) methyl3-[(2-{(2-ethyl-6-methylphenyl)[(propan-2-yloxy)methyl]
shall be as short as possible and shall expire on 27 October
amino}-2-oxoethyl)sulfinyl]-2-hydroxypropanoate.
( 7 ) Unidentified compound in maize grains, sugar beet roots and
2012 at the latest.
sunflower seeds.
( 8 ) unidentified compound in sunflower seeds.
( 9 ) 2-[(2-ethyl-6-methylphenyl) amino]-2-oxoethane sulfonic acid.
( 10 ) N-(2-ethyl-6-methylphenyl)-2-hydroxy-N-(isopropoxymethyl)
acetamide.
Article 4
( 11 ) dimer of N-(2-ethyl-6-methyl phenyl)-N-(isopropoxymethyl)-2-
(mercapto) acetamide.
In the Annex to Decision 2008/941/EC, the entry for ‘propi
( 12 ) OJ L 330, 5.12.1998, p. 32.
sochlor’ is deleted.

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EN
30.4.2011 Official
Journal
of
the
European
Union L
111/21
Article 5
This Decision is addressed to the Member States.
Done at Brussels, 27 April 2011.
For the Commission
John DALLI
Member of the Commission

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