Part B – Section 7
Core Assessment or
National Addenda – insert
Member State
Micro-organisms
Registration Report –
Northern/Central/ Southern Zone
Member State: xxx
Page 1 of 9
,5
REGISTRATION REPORT
Part B
Section 7: Efficacy Data and Information
Detailed summary
Product code:
xxxxxxx
Active Substance:
xx g/L or g/kg
Northern/Central/Southern Zone
Zonal Rapporteur Member State: xxxx
NATIONAL ADDENDA – insert Member State
Applicant:
Insert company name
Date:
xx/xx/xxxx
This revision will apply to applications submitted from 1 July 2013 onwards.
Applicant
Evaluator
Applicant Author
Date
Part B – Section 7
Core Assessment or
National Addenda – insert
Member State
Micro-organisms
Registration Report –
Northern/Central/ Southern Zone
Member State: xxx
Page 2 of 9
Table of Contents
IIIM 6
Efficacy Data and Information (including Value Data) on the Plant
Protection Product ................................................................................................ 4
IIIM 6.1
Efficacy data .......................................................................................................... 4
IIIM 6.1.1
Preliminary range-finding tests ........................................................................... 4
IIIM 6.1.2
Minimum effective dose tests ............................................................................... 4
IIIM 6.1.3
Efficacy tests .......................................................................................................... 4
IIIM 6.1.4
Effects on yield and quality .................................................................................. 4
IIIM 6.1.4.1 Impact on the quality of plants and plant products ........................................... 4
IIIM 6.1.4.2 Effects on the processing procedure. ................................................................... 4
IIIM 6.1.4.3 Effects on the yield of treated plants and plant products .................................. 4
IIIM 6.2
Adverse effects ....................................................................................................... 5
IIIM 6.2.1
Phytotoxicity to host crop ..................................................................................... 5
IIIM 6.2.2
Adverse effects on beneficial organisms (other than bees) ................................ 5
IIIM 6.2.3
Adverse effects on parts of plant used for propagating purposes..................... 5
IIIM 6.2.4
Impact on succeeding crops .................................................................................. 5
IIIM 6.2.5
Impact on other plants including adjacent crops ............................................... 5
IIIM 6.2.6
Possible development of resistance or cross-resistance ..................................... 5
IIIM 6.3
Toxic or pathogenic effects on the crop or host which is to be protected ........ 5
IIIM 6.4
Compatibility with products in authorized tank mixes and with other
products that are applied under expected conditions of use ............................. 5
IIIM 6.4.1
Physical compatibility ........................................................................................... 5
IIIM 6.4.2
Chemical compatibility ......................................................................................... 5
IIIM 6.4.3
Biological compatibility ........................................................................................ 5
IIIM 6.4.4
Recommended interval between application of MPCP and chemical
pesticide, to avoid loss of efficacy
Applicant
Evaluator
Applicant Author
Date
6
Part B – Section 7
Core Assessment or
National Addenda – insert
Member State
Micro-organisms
Registration Report –
Northern/Central/ Southern Zone
Member State: xxx
Page 3 of 9
IIIM 6.5
Contribution to risk reduction and integrated pest management
strategies for the targeted crop or resource ........................................................ 6
IIIM 6.6
Summary and assessment of data according to points 6.1 to 6.5 ...................... 6
IIIM 6.7
List of test facilities including the corresponding certificates ........................... 6
Appendix 1: List of data submitted in support of the evaluation ........................................... 7
Appendix 2: GAP tables ............................................................................................................. 8
Appendix 3: Additional information provided by the applicant (e.g. detailed
modelling data) ...................................................................................................... 9
Appendix 4: Summary of data on trials site and application details per use (EPPO
code). ....................................................................................................................... 9
Appendix 5: Summary of data on effectiveness trials per use (crop/harmful
organism); (EPPO code) ....................................................................................... 9
Appendix 6: Summary of detailed data on herbicide effectiveness trials. ............................. 9
Appendix 7: Summary of phytotoxicity trials data in summary form ................................... 9
Appendix 8: Summary of available studies: Adverse effects on beneficial
(arthropods other than bees) organisms. ............................................................ 9
Appendix 9: Summary of data on succeeding crop .................................................................. 9
Applicant
Evaluator
Applicant Author
Date
Part B – Section 7
Core Assessment or
National Addenda – insert
Member State
IIIM 6
Micro-organisms
Registration Report –
Northern/Central/ Southern Zone
Member State: xxx
Page 4 of 9
Efficacy Data and Information (including Value Data) on the Plant
Protection Product
This introductory section should include the following info:
 Reference to Approval Regulation
o include any specific provisions to be addressed as listed in the Annex to Implementing
Regulation (EU) No 540/2011
IIIM 6.1
Efficacy data
IIIM 6.1.1
Preliminary range-finding tests



Details of the evaluation (could be provided in tabular form Appendix 4, 5 and 6)
Conclusions
Does the product comply with the Uniform Principles?
IIIM 6.1.2



Details of the evaluation (could be provided in tabular form Appendix 4, 5 and 6)
Conclusions
Does the product comply with the Uniform Principles?
IIIM 6.1.3



Minimum effective dose tests
Efficacy tests
Details of the evaluation (could be provided in tabular form Appendix 4, 5 and 6)
Conclusions
Does the product comply with the Uniform Principles?
IIIM 6.1.4
Effects on yield and quality
IIIM 6.1.4.1 Impact on the quality of plants and plant products



Details of the evaluation
Conclusions
Does the product comply with the Uniform Principles?
IIIM 6.1.4.2 Effects on the processing procedure.



Details of the evaluation
Conclusions
Does the product comply with the Uniform Principles?
IIIM 6.1.4.3 Effects on the yield of treated plants and plant products



Details of the evaluation
Conclusions
Does the product comply with the Uniform Principles?
Applicant
Evaluator
Applicant Author
Date
Part B – Section 7
Core Assessment or
National Addenda – insert
Member State
Micro-organisms
IIIM 6.2
Adverse effects
IIIM 6.2.1
Phytotoxicity to host crop



Impact on other plants including adjacent crops
Details of the evaluation
Conclusions
Does the product comply with the Uniform Principles?
IIIM 6.2.6



Impact on succeeding crops
Details of the evaluation (could be provided in tabular form Appendix 9)
Conclusions
Does the product comply with the Uniform Principles?
IIIM 6.2.5



Adverse effects on parts of plant used for propagating purposes
Details of the evaluation
Conclusions
Does the product comply with the Uniform Principles?
IIIM 6.2.4



Adverse effects on beneficial organisms (other than bees)
Details of the evaluation (could be provided in tabular form Appendix 8)
Conclusions
Does the product comply with the Uniform Principles?
IIIM 6.2.3



Page 5 of 9
Details of the evaluation (could be provided in tabular form Appendix 7)
Conclusions
Does the product comply with the Uniform Principles?
IIIM 6.2.2



Registration Report –
Northern/Central/ Southern Zone
Member State: xxx
Possible development of resistance or cross-resistance
Details of the evaluation
Conclusions
Does the product comply with the Uniform Principles?
IIIM 6.3
Toxic or pathogenic effects on the crop or host which is to be protected
IIIM 6.4
Compatibility with products in authorized tank mixes and with other
products that are applied under expected conditions of use
IIIM 6.4.1
Physical compatibility

Provide any additional information that is considered relevant
IIIM 6.4.2

Chemical compatibility
Provide any additional information that is considered relevant
IIIM 6.4.3
Biological compatibility
Applicant
Evaluator
Applicant Author
Date
Part B – Section 7
Core Assessment or
National Addenda – insert
Member State

Micro-organisms
Registration Report –
Northern/Central/ Southern Zone
Member State: xxx
Page 6 of 9
Provide any additional information that is considered relevant
IIIM 6.4.4
Recommended interval between application of MPCP and chemical
pesticide, to avoid loss of efficacy

Provide any additional information that is considered relevant
IIIM 6.5

Provide any additional information that is considered relevant
IIIM 6.6

Summary and assessment of data according to points 6.1 to 6.5
Provide table of recommended uses for registration, uses conditions and restrictions
IIIM 6.7

Contribution to risk reduction and integrated pest management strategies
for the targeted crop or resource
List of test facilities including the corresponding certificates
Provide table of test facilities and corresponding certificates
Applicant
Evaluator
Applicant Author
Date
Part B – Section 7
Core Assessment or
National Addenda – insert
Member State
Micro-organisms
Registration Report –
Northern/Central/ Southern Zone
Member State: xxx
Page 7 of 9
Appendix 1: List of data submitted in support of the evaluation
Annex
point
Author
Year
Title
Source (where different from
company)
Data
protection
claimed
Y/N
Owner
Company, Report No.
GLP or GEP status (where
relevant)
Published or Unpublished
Applicant
Evaluator
Applicant Author
Date
Part B – Section 7
Core Assessment or
National Addenda – insert country
Registration Report –
Northern/Central/Southern Zone
Micro-organisms
Page 8 of 9
Appendix 2: GAP tables
GAP rev.
PPP (product name/code)
active substance 1
active substance 2
active substance
product name / code
active substance 1
active substance 2
active substance ...
Formulation type:
Conc. of as 1:
Conc. of as 2:
Conc. of as:
type
conc.
conc.
conc.
safener
synergist
safener
synergist
Conc. of safener:
Conc. of synergist:
conc.
conc.
Applicant:
company
Zone(s): northern/central/southern/EU
, date: year-month-day
professional use
non professional use
Verified by MS: j/n
1
UseNo.
2
Member
state(s)
3
Crop and/
or situation
(crop destination /
purpose of crop)
4
F
G
or
I
5
Pests or Group of pests
controlled
(additionally:
developmental stages of
the pest or pest group)
6
7
8
10
Application
Method /
Kind
Timing / Growth
stage of crop &
season
11
12
Application rate
Max. number
(min. interval
between
applications)
a) per use
b) per crop/
season
kg, L product /
ha
g, kg as/ha
Water L/ha
a) max. rate per
appl.
a) max. rate
per appl.
min / max
13
PHI
(days)
b) max. total rate b) max. total
per crop/season rate per
crop/season
1
2
3
Applicant (insert company name)
Applicant Document ID (insert company doc ID)
Applicant Author (applicant author)
Evaluator
Date
14
Remarks:
e.g. safener/synergist per ha
e.g. recommended or mandatory tank
mixtures
Part B – Section 7
Core Assessment or
National Addenda – insert country
Registration Report –
Northern/Central/Southern Zone
Micro-organisms
Page 9 of 9
Appendix 3: Additional information provided by the applicant (e.g. detailed modelling data)
Appendix 4: Summary of data on trials site and application details per use (EPPO code).
Appendix 5: Summary of data on effectiveness trials per use (crop/harmful organism); (EPPO code)
Appendix 6: Summary of detailed data on herbicide effectiveness trials.
Appendix 7: Summary of phytotoxicity trials data in summary form
Appendix 8 - Summary of available studies: Adverse effects on beneficial (arthropods other than bees) organisms.
Appendix 9: Summary of data on succeeding crop
Applicant (insert company name)
Applicant Document ID (insert company doc ID)
Applicant Author (applicant author)
Evaluator
Date