HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 293/26
EN
Official Journal of the European Union
11.11.2011
COMMISSION IMPLEMENTING REGULATION (EU) No 1143/2011
of 10 November 2011
approving the active substance prochloraz, 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
and 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 of the inclusion of that active substance in
Annex I to Directive 91/414/EEC within 2 months
from entry into force of that Regulation. Consequently,
Having regard to Regulation (EC) No 1107/2009 of the
Commission Decision 2008/934/EC of 5 December
European Parliament and of the Council of 21 October 2009
2008 concerning the non-inclusion of certain active
concerning the placing of plant protection products on the
substances in Annex I to Council Directive 91/414/EEC
market and repealing Council Directives 79/117/EEC and
and the withdrawal of authorisations for plant protection
91/414/EEC ( 1 ), and in particular Articles 13(2) and 78(2)
products containing these substances ( 7 ) was adopted on
thereof,
the non-inclusion of prochloraz.
(4) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
Whereas:
original notifier (hereinafter ‘the applicant’) submitted a
new application requesting the accelerated procedure to
be applied, as provided for in Articles 14 to 19 of Regu
(1) In
accordance
with
Article
80(1)(c)
of
Regulation
(EC)
No
lation (EC) No 33/2008.
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply
to active substances for which completeness has been
established in accordance with Article 16 of Commission
(5) The
application
was
submitted
to
Ireland,
which
had
Regulation (EC) No 33/2008 of 17 January 2008 laying
been designated rapporteur Member State by Regulation
down detailed rules for the application of Council
(EC) No 1490/2002. The time period for the accelerated
Directive 91/414/EEC as regards a regular and an accel
procedure was respected. The specification of the active
erated procedure for the assessment of active substances
substance and the supported uses are the same as were
which were part of the programme of work referred to in
the subject of Decision 2008/934/EC. That application
Article 8(2) of that Directive but have not been included
also complies with the remaining substantive and
into its Annex I ( 3 ), with respect to the procedure and the
procedural requirements of Article 15 of Regulation
conditions for approval. Prochloraz is an active substance
(EC) No 33/2008.
for which completeness has been established in
accordance with that Regulation.
(6)
Ireland evaluated the additional data submitted by the
applicant and prepared an additional report. It
communicated that report to the European Food Safety
(2) Commission
Regulations
(EC)
No
451/2000
( 4 ) and (EC)
Authority (hereinafter ‘the Authority’) and to the
No 1490/2002 ( 5 ) lay down the detailed rules for the
Commission on 3 August 2010. The Authority
implementation of the second and third stages of the
communicated the additional report to the other
programme of work referred to in Article 8(2) of
Member States and the applicant for comments and
Directive 91/414/EEC and establish a list of active
forwarded the comments it had received to the
substances to be assessed, with a view to their possible
Commission. In accordance with Article 20(1) of Regu
inclusion in Annex I to Directive 91/414/EEC. That list
lation (EC) No 33/2008 and at the request of the
included prochloraz.
Commission, the Authority presented its conclusion on
prochloraz to the Commission on 13 July 2011 ( 8 ). The
draft assessment report, the additional report and the
(3) In
accordance
with
Article
3(2)
of
Commission
Regu
conclusion of the Authority were reviewed by the
lation (EC) No 1095/2007 of 20 September 2007
Member States and the Commission within the
amending Regulation (EC) No 1490/2002 laying down
Standing Committee on the Food Chain and Animal
further detailed rules for the implementation of the third
Health and finalised on 27 September 2011 in the
stage of the programme of work referred to in
format of the Commission review report for prochloraz.
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 prochloraz.
( 4 ) OJ L 55, 29.2.2000, p. 25.
EFSA Journal 2011, 9(7):2323 [120 pp.]. doi:10.2903/j.efsa.
( 5 ) OJ L 224, 21.8.2002, p. 23.
2011.2323. Available online: www.efsa.europa.eu

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EN
11.11.2011 Official
Journal
of
the
European
Union L
293/27
(7)
It has appeared from the various examinations made that
However, this clarification does not impose any new
plant protection products containing prochloraz may be
obligations on Member States or holders of authori
expected to satisfy, in general, the requirements laid
sations compared to the directives which have been
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
adopted until now amending Annex I to that Directive
in particular as regards the uses which were examined
or the Regulations approving active substances.
and detailed in the Commission review report. It is
therefore appropriate to approve prochloraz in
accordance with Regulation (EC) No 1107/2009.
(13) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
1107/2009 the Annex to Commission Implementing
Regulation (EU) No 540/2011 ( 2 ) should be amended
accordingly.
(8) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
1107/2009 in conjunction with Article 6 thereof and in
the light of current scientific and technical knowledge, it
(14) Decision
2008/934/EC
provides
for
the
non-inclusion
of
is, however, necessary to include certain conditions and
prochloraz and the withdrawal of authorisations for
restrictions.
plants protection products containing that substance by
31 December 2011. It is necessary to delete the line
concerning prochloraz in the Annex to that Decision.
It is therefore appropriate to amend Decision
(9) Without
prejudice
to
the
conclusion
that
prochloraz
2008/934/EC accordingly.
should be approved, it is, in particular, appropriate to
require further confirmatory information.
(15) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(10) A
reasonable
period
should
be
allowed
to
elapse
before
Committee on the Food Chain and Animal Health,
approval in order to permit Member States and the
interested parties to prepare themselves to meet the
new requirements resulting from the approval.
HAS ADOPTED THIS REGULATION:

Article 1
(11) Without
prejudice
to
the
obligations
defined
by
Regu
Approval of active substance
lation (EC) No 1107/2009 as a consequence of the
approval, taking into account the specific situation
The active substance prochloraz, as specified in Annex I, is
created by the transition from Directive 91/414/EEC to
approved subject to the conditions laid down in that Annex.
Regulation (EC) No 1107/2009, the following should,
however, apply. Member States should be allowed a
period of 6 months after approval to review authori
Article 2
sations of plant protection products containing
Re-evaluation of plant protection products
prochloraz. Member States should, as appropriate, vary,
replace or withdraw existing authorisations. By way of
1. Member
States
shall
in
accordance
with
Regulation
(EC)
derogation from the above deadline, a longer period
No 1107/2009, where necessary, amend or withdraw existing
should be provided for the submission and assessment
authorisations for plant protection products containing
of the update of the complete Annex III dossier, as set
prochloraz as an active substance by 30 June 2012.
out in Directive 91/414/EEC, of each plant protection
product for each intended use in accordance with the
uniform principles.
By that date they shall in particular verify that the conditions in
Annex I to this Regulation are met, with the exception of those
identified in Part B of the column on specific provisions of that
Annex, and that the holder of the authorisation has, or has
(12) The
experience
gained
from
inclusions
in
Annex
I
to
access to, a dossier satisfying the requirements of Annex II to
Directive 91/414/EEC of active substances assessed in
Directive 91/414/EEC in accordance with the conditions of
the framework of Commission Regulation (EEC) No
Article 13(1) to (4) of that Directive and Article 62 of Regu
3600/92 of 11 December 1992 laying down the
lation (EC) No 1107/2009.
detailed rules for the implementation of the first stage
of the programme of work referred to in Article 8(2) of
Council Directive 91/414/EEC concerning the placing of
2. By way of derogation from paragraph 1, for each auth
plant protection products on the market ( 1 ) has shown
orised plant protection product containing prochloraz as either
that difficulties can arise in interpreting the duties of
the only active substance or as one of several active substances
holders of existing authorisations in relation to access
all of which were listed in the Annex to Implementing Regu
to data. In order to avoid further difficulties it therefore
lation (EU) No 540/2011 by 31 December 2011 at the latest,
appears necessary to clarify the duties of the Member
Member States shall re-evaluate the product in accordance with
States, especially the duty to verify that the holder of
the uniform principles, as referred to in Article 29(6) of Regu
an authorisation demonstrates access to a dossier
lation (EC) No 1107/2009, on the basis of a dossier satisfying
satisfying the requirements of Annex II to that Directive.
the requirements of Annex III to Directive 91/414/EEC and
( 1 ) OJ L 366, 15.12.1992, p. 10.
( 2 ) OJ L 153, 11.6.2011, p. 1.

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L 293/28
EN
Official Journal of the European Union
11.11.2011
taking into account Part B of the column on specific provisions
Article 3
of Annex I to this Regulation. On the basis of that evaluation,
they shall determine whether the product satisfies the conditions
Amendments to Implementing Regulation (EU) No
set out in Article 29(1) of Regulation (EC) No 1107/2009.
540/2011
Following that determination Member States shall:
The Annex to Implementing Regulation (EU) No 540/2011 is
amended in accordance with Annex II to this Regulation.
(a) in the case of a product containing prochloraz as the only
Article 4
active substance, where necessary, amend or withdraw the
Amendments to Decision 2008/934/EC
authorisation by 31 December 2015 at the latest; or
The line concerning prochloraz in the Annex to Decision
2008/934/EC is deleted.
(b) in the case of a product containing prochloraz as one of
Article 5
several active substances, where necessary, amend or
withdraw the authorisation by 31 December 2015 or by
Entry into force and date of application
the date fixed for such an amendment or withdrawal in the
This Regulation shall enter into force on the 20th day following
respective act or acts which added the relevant substance or
its publication in the Official Journal of the European Union.
substances to Annex I to Directive 91/414/EEC or approved
that substance or substances, whichever is the latest.
It shall apply from 1 January 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 November 2011.
For the Commission
The President
José Manuel BARROSO

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11.11.2011 Off
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Prochloraz
N-propyl-N-[2-(2,4,6-
≥ 970 g/kg
1 January 2012 31
December
2021 PART
A
trichlorophenoxy)
EN
CAS No 67747-09-5
ethyl]imidazole-1-
Impurities:
Only uses as fungicide may be authorised. In the case of outdoor uses, rates shall

not exceed 450 g/ha per application.
CIPAC No 407
carboxamide
Sum of dioxins and
furans (WHO-PCDD/T
PART B
TEQ) (2 ): not more than
0,01 mg/kg
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
prochloraz, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 27 September
2011, shall be taken into account.
In this overall assessment Member States:
(a) shall pay particular attention to the protection of operators and workers and
icial
shall ensure that conditions of use include the application of adequate personal
protective equipment, where appropriate;
Jour
(b) shall pay particular attention to the risk to aquatic organisms, and shall ensure
nal
that conditions of authorisation include risk mitigation measures, where
appropriate;
of
the
(c) shall pay particular attention to the long-term risk to mammals and shall
ensure that conditions of authorisation include risk mitigation measures,
European
where appropriate.
The applicants shall submit confirmatory information as regards:
Union
(1) comparison and verification of the test material used in the mammalian
toxicity and ecotoxicity dossiers against the specification of the technical
material;
(2) the environmental risk assessment for the metal complexes of prochloraz;
(3) the potential endocrine disrupting properties of prochloraz on birds.
The notifier shall submit to the Commission, the Member States and the Authority
the information set out in points 1 and 2 by 31 December 2013 and the
information set out in point 3 within 2 years after the adoption of the
pertinent OECD test guidelines on endocrine disruption.
(1 ) Further details on identity and specification of active substance are provided in the review report.
(2 ) Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent (TEQ) using the WHO-toxic equivalency factors (WHO-TEFs)).
L
293/29

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L 293/30
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
‘20 Prochloraz
N-propyl-N-[2-(2,4,6-
≥ 970 g/kg
1 January 2012 31
December
2021 PART
A
trichlorophenoxy)
CAS No 67747-09-5 ethyl]imidazole-1-
Impurities:
Only uses as fungicide may be authorised. In the case of outdoor
EN
uses, rates shall not exceed 450 g/ha per application.
CIPAC No 407
carboxamide
Sum of dioxins and furans

(WHO-PCDD/T TEQ) (*): not
PART B
more than 0,01 mg/kg
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 prochloraz, and in particular
Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on
27 September 2011, shall be taken into account.
In this overall assessment Member States:
Off
(a) shall pay particular attention to the protection of operators
icial
and workers and shall ensure that conditions of use include
the application of adequate personal protective equipment,
Jour
where appropriate;
nal
(b) shall pay particular attention to the risk to aquatic
of
organisms, and shall ensure that conditions of authorisation
the
include risk mitigation measures, where appropriate;
European
(c) shall pay particular attention to the long-term risk to
mammals and shall ensure that conditions of authorisation
include risk mitigation measures, where appropriate.
Union
The applicants shall submit confirmatory information as regards:
(1) comparison and verification of the test material used in the
mammalian toxicity and ecotoxicity dossiers against the
specification of the technical material;
(2) the environmental risk assessment for the metal complexes
of prochloraz;
(3) the potential endocrine disrupting properties of prochloraz
on birds.
The notifier shall submit to the Commission, the Member States
and the Authority the information set out in points 1 and 2 by
31 December 2013 and the information set out in point 3
within 2 years after the adoption of the pertinent OECD test
guidelines on endocrine disruption.
11.11.2011
(*) Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent (TEQ) using the WHO-toxic equivalency factors (WHO-TEFs)).’

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