European and Mediterranean Plant Protection Organization
PP 1/276(1)
Organisation Europe
´enne et Me
´diterrane
´enne pour la Protection des Plantes
Efficacy evaluation of plant protection products
Evaluation biologique des produits phytosanitaires
Principles of efficacy evaluation for microbial plant protection
products
Specific scope
This standard describes the principles for determining the
requirements for an efficacy evaluation (effectiveness and
crop safety) of plant protection products containing micro-
organisms in a registration procedure.
Specific approval and amendment
First approved in 2012
–
09.
1. Introduction
This standard describes the principles for determining the
requirements for an efficacy evaluation (effectiveness and
crop safety) of plant protection products containing micro-
organisms
in
a
registration
procedure.
It
is
based
on
addressing the data requirements as specified by the EC
Regulation 1107/2009 (EC, 2009) and refers extensively to
relevant EPPO Standards. In particular, this standard draws
together the various aspects considered particularly relevant
to this type of product.
Microbial plant protection products are those plant pro-
tection products in which the active substance is a living
micro-organism. Micro-organisms are defined by EC Regu-
lation 1107/2009 (EC, 2009) as ‘any microbiological entity,
including lower fungi and viruses, cellular or non-cellular,
capable of replication or of transferring genetic material’.
1
For microbial products, a similar approach should be used
as for chemical products. However, by their nature, prod-
ucts based on micro-organisms may be highly specific in
the pests that they affect, or require specific environmental
conditions to reach optimal effectiveness, and many such
products may therefore be more appropriately used as part
of control measures in minor use situations. EPPO Standard
1/224
Principles of efficacy evaluation for minor uses
sets
out the principles for evaluating plant protection products
for minor uses.
It should be noted that, although there are various areas
to be addressed, for some aspects e.g. succeeding crops,
it may be possible to use reasoned cases in lieu of actual
data (e.g. based on mode of action, natural occurrence
etc.) in practice. In so doing, reference may be made to
laboratory studies and any relevant published data. Both of
these are important sources of information to describe and
explain the mode of action and properties of the product.
The objective of this document is to provide a frame-
work for the minimum efficacy data requirements required
to demonstrate that a microbial plant protection product is
sufficiently effective (and crop safe) for registration pur-
poses.
EPPO Standard 1/214
Principles of acceptable efficacy
;
states that because of the ‘risk attached to the use of plant
protection products, it is thus necessary to decide if the
benefits from the use of the plant protection product out-
weigh any disadvantages. The net result of the positive and
negative effects should be a sufficient overall agricultural
benefit in order to justify the use of the plant protection
product. Data should demonstrate a benefit in use, and this
may relate directly to pest control or aspects of yield qual-
ity/quantity.
2. General principles of efficacy assessment
of microbial plant protection products
EPPO Standard PP1/214
Principles of acceptable efficacy
considers that efficacy can be considered to be a balance
between the following points:
1
See Directive 2001/36/EC for further information on defining the iden-
tity of the micro-organism.
348
ª
2012 OEPP/EPPO,
Bulletin OEPP/EPPO Bulletin
42
, 348–352
Bulletin OEPP/EPPO Bulletin
(2012)
42
(3), 348–352
ISSN 0250-8052. DOI: 10.1111/epp.2607