European and Mediterranean Plant Protection Organization
Organisation Europe
´enne et Me
´diterrane
´enne pour la Protection des Plantes
PP 1/241 (2)
Efficacy evaluation of plant protection products
Evaluation biologique des produits phytosanitaires
PP 1/241 (2) Guidance on comparable climates
Specific scope
This Standard provides guidance to regulatory authorities
and
applicants
in
determining
comparability
of
climatic
conditions between geographical areas where efficacy eval-
uation trials on plant protection products are performed. It
describes in particular four climatic zones in the EPPO
region, within each of which climatic conditions may be
considered comparable.
Specific approval and amendment
Proposed for approval in 2005
–
09.
Revision to reflect changes due to the new Regulation EC
1107/2009 approved in 2014
–
09.
Introduction
The
main
purpose
of
EPPO
Standards
on
the
efficacy
evaluation of plant protection products is
to harmonize
the
process
of
efficacy
evaluation
within
the
registration
procedures
of
EPPO
member
countries
by
describing how field trials should be conducted. Recently,
these standards have taken on formal importance within
the registration process of the European Union, through
their
adoption
under
EC
Regulation
1107/2009
(EC,
2009) and Commission Regulation (EU) 284/2013. This
includes
the
requirement
that
organizations
conducting,
developing
and
carrying
out
efficacy
and
phytotoxicity
trials
in
EU
member
states
are
official
or
officially
recognized.
The published EPPO Standards have also facilitated an
important secondary aim, which is to use data generated
in one country to support registration in another country.
Since the introduction of EC Regulation 1107/2009 (EC,
2009), applicants in the EU and EPPO generally are now
beginning
to
generate
data
for
the
efficacy
dossier
on
products on a Europe-wide basis. In addition, there is a
specific provision under Article 40 of the Regulation for
the mutual recognition of authorizations from other Mem-
ber States. In establishing a Europe-wide
dossier or in
mutual recognition, not only should trials be conducted
according
to
harmonized
procedures,
but
the
applicant
and the registration authority should be able to establish
the
relevance
of
the
data
under
local
conditions,
i.e.
whether the appropriate conditions (see below) are com-
parable in the countries concerned, particularly in relation
to climate.
This Standard aims to assist both regulatory authorities
and applicants in determining the comparability of condi-
tions
between
given
areas.
It
specifically
addresses
the
issue of climate and presents agreed defined zones in the
EPPO region within which conditions are considered cli-
matically
comparable.
Applicants
can
use
this
Standard
by referring to these defined zones rather than making a
detailed case involving the submission of meteorological
data. Resources are saved for all parties, as such cases
will not have to be re-submitted with each application.
Further
information
on
how
the
zones
were
defined
is
provided by Bouma (2005).
Climate is only one factor that may affect the efficacy
and crop safety of a product. The applicant still needs to
address any other relevant factors (agronomic, edaphic, tar-
get-related) when establishing the relevance of data gener-
ated within different countries. The relative importance of
each condition will depend on various factors including
mode of action of the active substance, formulation type
and intended use.
Finally,
it
is
very
important
to
remember
that,
even
when climatic conditions are not comparable, use of the
data may still be acceptable, as it may be possible to
argue
that
the
identified
differences
represent
a
more
challenging
situation,
and
the
data
can
therefore
be
accepted for evaluation.
ª
2014 OEPP/EPPO,
Bulletin OEPP/EPPO Bulletin
44
, 281–283
281
Bulletin OEPP/EPPO Bulletin
(2014)
44
(3), 281–283
ISSN 0250-8052. DOI: 10.1111/epp.12137