European and Mediterranean Plant Protection Organization
Organisation Europe
´enne et Me
´diterrane
´enne pour la Protection des Plantes
PP 1/257 (2)
Efficacy evaluation of plant protection products
Evaluation biologique des produits phytosanitaires
PP 1/257 (2) Efficacy and crop safety extrapolations for minor uses
Specific scope
This Standard describes the principles of extrapolation regard-
ing the efficacy and crop safety of plant protection products
intended for minor uses. It provides guidance for regulatory
authorities and applicants in the context of the registration of
plant protection products for minor uses. It also provides
detailed lists of acceptable extrapolations organized by crop
groups, and these will be added as they are developed.
Specific approval and amendment
First approved in 2007
–
09.
Revision to reflect changes due to the new Regulation
EC 1107/2009 approved in 2014
–
09.
1. Introduction
The aim of this Standard is to provide guidance on princi-
ples of extrapolation regarding the efficacy and crop safety
of plant protection products intended for minor uses. The
text includes extrapolation tables which provide guidance
for applicants and regulatory authorities to seek and grant
authorizations
in
the
absence
of
specific
data
(or
with
reduced data), whilst ensuring efficacy and crop safety of
the extrapolated use. Extrapolation tables are developed and
available
on
the
EPPO
website
(www.eppo.int).
More
extrapolation tables are in preparation. Once agreed, they
are maintained and updated separately from this Standard
by the EPPO Panels on Efficacy Evaluation and the Expert
Working Group on Extrapolation Tables and are published
as
‘Extrapolation
tables
for
effectiveness/crop
safety
of
plant protection products (insecticides/fungicides/herbicides)
to accompany EPPO Standard PP 1/257’.
These principles and examples of extrapolations (given
in the extrapolation tables) provide a harmonized frame-
work to support regulators, but it is important to ensure that
expert judgement and regulatory experience are employed
when using these documents.
2. Background
Minor
uses
are
those
uses
of
plant
protection
products
(defined in relation to crops and pests) in which either the crop
is considered to be of low economic importance at a national
level (minor crop), or the pest is of limited importance on a
major crop (minor pest). It should be noted that a minor use in
one country may be a major use in another country, and it is
for each country to define what its minor uses are.
The availability of plant protection products to growers
of minor crops is becoming increasingly limited. Given the
low quantity of a plant protection product that would be
used for a certain minor crop, agrochemical companies find
it difficult to justify the registration costs. The requirement
to generate a considerable amount of data makes the autho-
rization process very expensive. However, minor crops are
of substantial economic importance in many countries. For
minor use authorization, it is therefore preferable to explore
other possibilities for determining the efficacy and crop
safety of a plant protection product than those based on the
amount of data normally required.
3. Efficacy requirements
1
Efficacy is defined as the direct effect (effectiveness) on the
pest or on the modification of plant growth (growth regula-
tors) together with other indirect effects such as those on the
crop being protected, on succeeding or adjacent crops, on
natural enemies, or on the development of resistance (see
EPPO Standard PP 1/214
Principles of acceptable efficacy
).
1
EC (2009) Regulation (EC) No 1107/2009 regulates the placing of
plant protection products on the market and contains special provisions
for the application and authorisation of so called minor uses. According
to Article 51 no data on efficacy for minor uses are required. However,
EPPO Standard PP 1/224
Principles of efficacy evaluation for minor
uses
recommends registering and using a product which has an accept-
able level of efficacy.
ª
2014 OEPP/EPPO,
Bulletin OEPP/EPPO Bulletin
44
, 299–305
299
Bulletin OEPP/EPPO Bulletin
(2014)
44
(3), 299–305
ISSN 0250-8052. DOI: 10.1111/epp.12141