European and Mediterranean Plant Protection Organization
Organisation Europe
´enne et Me
´diterrane
´enne pour la Protection des Plantes
PP 1/307(2)
Efficacy Evaluation
PP 1/307(2) Efficacy considerations and data generation when making
changes to the chemical composition or formulation type of plant
protection products
Specific approval and amendment
First approved in 2018-09.
First revision approved in 2020-09.
Specific scope
This Standard considers the possible impacts of biologi-
cally significant changes in the chemical composition of
plant protection products and the requirements to support
such
changes.
1
A
change
in
chemical
composition
is
defined within this Standard as a change in the chemical
composition
but
where
the
content
of
active
substance
remains
unchanged
and
the
formulation
type
remains
unchanged.
2
The Standard also covers the circumstances
in
which
a
change
in
formulation
type
(automatically
defined as a new product) may be supported by a more
limited data package. Also discussed within the Standard
is
the
development
of
a
new
product
which
is
to
be
based on the principle of comparing with, and ‘bridging’
to, an existing formulation. The existing authorized for-
mulation should have a full underlying supporting data
package.
3
Introduction
Part I of this Standard describes general considerations
when a change in chemical composition within a formula-
tion type is proposed. It provides detailed criteria relevant
to efficacy of the key components and the types of changes
which may have an impact on efficacy (both effectiveness
and crop safety). Whether a change is considered biologi-
cally significant or not will determine the requirements for
support,
through
reasoned
cases
and/or
further
data,
as
described in the second part of this Standard. Finally, a sec-
tion on new products also covers changes in formulation
type; the steps and principles that should be followed in
considering the possible impact of changes in chemical
composition are applicable.
Part II of this Standard describes the type of supporting
data required where proposed changes are considered bio-
logically significant. The objective is to generate a limited
amount of data in challenging conditions to demonstrate
comparable effectiveness and crop safety properties with
the existing formulation. It may be sufficient in many cir-
cumstances to conduct this testing using glasshouse studies.
However, if there are significant differences relative to the
1
Other areas of the risk assessment will have different criteria and
requirements, which are outside the scope of this Standard. For exam-
ple, a change in technical material resulting in differences in impurities
may be of toxicological significance but would not require efficacy con-
sideration or supporting data.
2
Definition
is
broadly
in
accordance
with
EU
Guidance
document
SANCO/12638/2011 Guidance document on significant and non-signifi-
cant changes of the chemical composition of authorised plant protection
products under Regulation (EC) No 1107/2009 (EC, 2012). However
minor changes in the content of active substance and changes of formu-
lation type are also considered within this EPPO Standard. Details on
agreed definitions of formulation types can be found in Manual on
development and use of FAO and WHO specifications for pesticides
(FAO and WHO, 2016).
3
In this circumstance, the guidance provided within this Standard is
based on the premise that there is appropriate data access to the exist-
ing formulation. Any consideration of the regulatory basis and proce-
dures in individual member countries concerning data protection and
access to unprotected data is outside its scope. Within the European
Union, for zonal authorizations involving more than one Member State,
the zonal rapporteur Member State will assess the relevance of the data
and whether comparability to an authorized product has been demon-
strated. However, only individual concerned Member States can deter-
mine the data protection status and data access to that authorized
product and are able to make a detailed comparison of the relevant for-
mulation details.
ª
2020 OEPP/EPPO,
Bulletin OEPP/EPPO Bulletin
0
, 1–7
1
Bulletin OEPP/EPPO Bulletin
(2020)
0
(0), 1–7
ISSN 0250-8052. DOI: 10.1111/epp.12693