Product File Note ModelProduct File Note Model

3. Biology3. Biology

3.1 Efficacy and selectivity3.1 Efficacy and selectivity

F. Cors & B. Weickmans October 23, 2006 1

The product file note should be in line with The product file note should be in line with the proposed labelthe proposed label !

All uses and conditions of use should be at All uses and conditions of use should be at least presented in Dutch and Frenchleast presented in Dutch and French

F. Cors & B. Weickmans October 23, 2006 2

To be treated (crop)

Example : Winter wheat

If special crop, eg chou frisé boerekool (krulkool) Curly kale

Use latin name :Brassica oleracea var sabellica Crop names are described on Fytoweb

and Bayer Code : BRSOCManaged by EPPO

F. Cors & B. Weickmans October 23, 2006 3

StageFirst node – second node (BBCH 21-22)

Remark

- Max (number) applications per crop, season, year, production cycle

Waiting period

… days Not relevant if application at a well defined crop stage

Precautions for following crops

/

If risk identified

F. Cors & B. Weickmans October 23, 2006 4

And Max product amount

Enemy

Mould… (mention only more enemies in this cell if stage, remark, rate, number of applications and application method are identical)

Should be identified by Latin name and Bayer Code

Stage Preventively

RemarkSecondary effect against…(enemy) Only if some efficacy Only if some efficacy

but not enough but not enough to grant full approvalto grant full approval

F. Cors & B. Weickmans October 23, 2006 5

And consult

Number of applications

1-3 applications, with an interval of 21 days

Rate 1.5 L/haby ha Leaf-wall areaby ha Leaf-wall area for vertical cropfor vertical crop

Method of application

Field sprayer, at 200-500 l water/ha

Buffer zone20 m with classical technique

F. Cors & B. Weickmans October 23, 2006 6

EPPO PP 1/239EPPO PP 1/239

Herbicides : Splitting Herbicides : Splitting of the full dose !of the full dose !

F. Cors & B. Weickmans October 23, 2006 7

Submitted studies:

Crop Studies Form. Effi./selec.GEP Arg. or study reference

Crop 1 2 (code) Efficacy Yes (reference)

(code) Selectivity Yes (reference)

Crop 2 1 NoGEP not required due to …

Crop 3 0Extr. from crop 2 (ornementals, medicinals)

Mutual recognitionMutual recognition

The applicant should verify that the GAP are The applicant should verify that the GAP are comparable in the 2 countries for : comparable in the 2 countries for :

•crop husbandrycrop husbandry• enemyenemy• materialmaterial .. .. ..

and justify all differenceand justify all difference

The Registration Report of the reference MS should be The Registration Report of the reference MS should be added as well as updated Doc C and Dadded as well as updated Doc C and D

F. Cors & B. Weickmans October 23, 2006 8

Biological dossierBiological dossier

Trial 1 Trial 2 …Untreated - -Reference 88 62Product 1 95 88…

Efficacy All original full trial reports should be added

F. Cors & B. Weickmans October 23, 2006 9

Trial 1 Trial 2 …Annex 1 a Annex 5c

Untreated - -Reference 88 a 62 aProduct 1 95 bc 88 c…

Efficacy %Trials should be clearly identified and referenced

Biological dossierBiological dossier

F. Cors & B. Weickmans October 23, 2006 10

Max min Mean TrialsUntreated - - 10Reference 90 58 80 10T1 1 L/ha 82 45 70 3T1 2 L/ha 100 75 90 8…

Efficacy %

Max min Mean AssessmentsUntreated - - 18 (n=6)Reference 90 58 80 18 (n=6)T1 1 L/ha 82 45 70 18 (n=3)T1 2 L/ha 100 75 90 18 (n=2)…

Efficacy %Different assessments should be compared in different tables e.g. for efficacy duration

Means should be compared for the same number of trials

Biological dossierBiological dossier

Data on CD in .doc (Word) or .pdf (Acrobat) files

Organization of files : the same as the paper versionOrganization of files : the same as the paper versionAccess to trial reports should be quick and easyAccess to trial reports should be quick and easy

F. Cors & B. Weickmans October 23, 2006 11