Application presentation model for submission to the Authorization Committee of Pesticides for Agricultural use. This application presentation will be copied into the agenda
of the Authorization Committee.
Non-relevant parts can be removed by the applicant in TRACK CHANGES, for example the part residues in the case of no new use or the part analyse in the case that no new
analytical data have been generated (Word menu “Tools” – “track changes” “highlight changes” – “track changes while editing” – “highlight changes on screen”.
N(dossier number) – NAME PRODUCT (registration number/B)
Type (herbicide, fungicide, insecticide,…), formulation type (EC, WG, …), concentration of active substances (100 g/l imidastrobin, 25% cymidazool)
Formulation code: (development code)
Application for registration/renewal/prolongation/extension/modification of the composition
Expiry date of current authorization:
Intended users: private (home and garden) /professional growers / private and professional
Reference product : dossier number (if known), product name, authorization number, formulation type, content of active substances of:
- the original product, or otherwise the most comparable currently authorized product in the case of an application for authorization of a generic product;
- the product on which the application is based, in the case of a back-to-back authorisation (same or different registration holder ? letter of access ?)
Conditions for the prolongation (only for applications for prolongation) :
1. Physical-chemical analysis and analysis methods
1.1 Active substance
Name of the active substance:
Origin : name of the producer (letter of supply: yes/no)
Minimum degree of purity:
Nominal degree of purity (if relevant):
FAO specification : number of the specification + imposed minimum purity
If specification (declaration of producer concerning purity and content of impurities) already submitted : see dossier NXXX – Name (n° authorisation)
Analysis report of 5 production batches of the technical active substance furnished for the dossier: NXXX – Product (n° authorisation)
Or
Declaration of the producer concerning the degree of minimum purity of the a.s. and of the maximum concentrations of impurities to be furnished in annex to the application.
GLP analysis bulletin of 5 production batches of the technical active substance to be furnished in annex to the application.
Submitted studies (mention all studies) :
Study reference (title, author, year, reference number applicant, reference number lab). GLP : Y/N
+ if modification of the specification or new origin with new impurities or higher content of existing impurities: technical equivalence to be demonstrated by means of
document Sanco/10597/2003-rev. 7 (the applicant fills out the data known to him, see instructions on www.phytoweb.fgov.be ).
Remarks of the secretariat:
1.2 Formulation
Parameter
Formulation type
Method of analysis
used
Content of a.s.
Appearance
(odour, colour,
physical state)
Explosive
properties
All
All
To specify
Description
All (except when
thermodynamic data
exclude the
possibility of an
exothermic reaction)
All (except when
thermodynamic data
exclude the
possibility of an
exothermic reaction
with combustible
materials)
Liquids containing
flammable solvents
EEC A14
Oxidising
properties
Flash point
EEC A17 (or other
to be justified)
EEC A9 (or
CIPAC MT 12)
Before storage
After storage for
14 days at 54°C
After storage for 7
days at 0°C
After storage for 2
years at room
temperature
Argumentation or
study reference (title,
author, year, ref n°
lab)
GLP: Y/N
Parameter
Formulation type
Method of analysis
used
Flammability
Solids and gasses
Solids : EEC A10
or A12
Gas : EEC A11
Liquids and gas :
EEC A15
Solids : EEC A16
CIPAC MT 75
CIPAC MT 75
Autoflammability
All
pH
pH of a 1%
dilution,
emulsion or
dispersion
Acidity/Alcalini
ty
Kinematic
viscosity
Viscosity
All aqueous liquids
All applied as
aqueous dilutions
Surface tension
Relative density
Bulk (tap)
density
All acids or alcalins
CIPAC MT 31
Liquids for
application at ULV
Not Newtonian
liquids
Liquids
Liquids
Powders and granules
OECD 114 (or
CIPAC MT 22)
OECD 114
EEC A5
EEC A3
Powders : CIPAC
MT 33
Granules : CIPAC
MT 159
WG : CIPAC MT
169
Before storage
After storage for
14 days at 54°C
After storage for 7
days at 0°C
After storage for 2
years at room
temperature
Argumentation or
study reference (title,
author, year, ref n°
lab)
GLP: Y/N
Parameter
Formulation type
Method of analysis
used
Before storage
After storage for
14 days at 54°C
Stability at low
temperature
Liquids
Derived oil :
CIPAC MT48, 51
or 54
SL aqueous, SC
and SE : CIPAC
MT 39.2
CS : after cycles
frost/melt
Other liquids :
CIPAC MT 39.1
CIPAC MT 53.3
Wettability
Persistant
foaming
Solids used in
dilution
All to be diluted in
water
All
CIPAC MT 47.2
All
All except WS,
WG and SG
EW, SP, SG, WP,
WG if formulated
in WSB
Suspensibility
Hydrodispersibles
Spontaneity of
dispersion
Hydrodispersibles
Stability of
dilution
Water soluble
products
Dry sieve test
Dustable powders
WP : CIPAC MT
15
WG : CIPAC MT
168
Liquids: CIPAC
MT 161
Solids : CIPAC
MT 174
Liquids : CIPAC
MT 160
LS, SL : CIPAC
MT 41
SS, ST, SG, SP :
CIPAC MT 179
WSB: CIPAC MT
176
CIPAC MT 59.1
After storage for 7
days at 0°C
After storage for 2
years at room
temperature
All
All except SL, LS,
EC
Argumentation or
study reference (title,
author, year, ref n°
lab)
GLP: Y/N
Parameter
Formulation type
Method of analysis
used
Wet sieve test
Water dispersible
products
Particle size
distribution
Powders, granules for
direct application,
water dispersible
granules
Dust content
Particle size
distribution of
dust (if relevant
for exposure
risk)
Friability and
attrition
Emulsion
stability
Granules
Granules
WG, WT : CIPAC
MT 167
WP, WS, SC, CS,
FS, SE, DC:
CIPAC MT 59.3
Powders : OECD
110
Ready to use
granules : CIPAC
MT 58.3
Water dispersible
granules : CIPAC
MT 170
CIPAC MT 171
OECD 110
Granules
CIPAC MT 178
Preparations which
form emulsions
CIPAC MT 36
If concentration of
use < 2% : CIPAC
MT 173 or 173’
SE : CIPAC MT
173’
CIPAC MT 172
CIPAC MT 148.1
Flowability
Pourability
(including
rinsed
residue)
Dustability
Granules
Suspensions (SC, SE,
FS)
Dustable powders
CIPAC MT 34
Before storage
After storage for
14 days at 54°C
After storage for 7
days at 0°C
After storage for 2
years at room
temperature
All
granules for direct
application
Granules ready to
use
All
GR and CG
GR and CG
Argumentation or
study reference (title,
author, year, ref n°
lab)
GLP: Y/N
Parameter
Formulation type
Method of analysis
used
Physical
compatibility of
tank mixes
All (depending on
label claim)
Chemical
compatibility of
tank mixes
Adherence and
repartition on
seed
All (depending on
label claim)
Internal method or
practical studies
(result of mixes in
different order of
introduction of the
products)
Essais pratiques
Products for seed
treatment
Repartition :
CIPAC MT 175
Adherence :
CIPAC MT 83
Before storage
After storage for
14 days at 54°C
All
DS
After storage for 7
days at 0°C
After storage for 2
years at room
temperature
Argumentation or
study reference (title,
author, year, ref n°
lab)
GLP: Y/N
DS
Remarks of the secretariat:
1.3 Adjuvants
Does the product contain one of following adjuvants : Yes/No. If yes, an additional analysis will be required (see confidential part at the end)
calcium sulphate (E516), kaolinitic clays (E559), vermiculite (E561), natrolite-phonolite (E566), calcium aluminates (E598) and clinoptilotite of sedimentary origin.
1.4 Data Protection
For following data protection is claimed by the applicant. Due to the fact that the data concerning the technical a.s. are covered by the letter of supply of the producer
(condition for each authorisation) and the data concerning analysis of the formulation are only valid for this very product and also have to be submitted for each authorisation,
only following specific data are mentioned :
Dossier
Data
Protection for : Expiry date of
Holder of
Confirmation of Study reference (title, author, year, ref n° of applicant, ref n°
protection
protection
the protection
of lab)
(Active
substance
active, ev.
formulation
type)
(parameter,
aspect of the
aspect)
(deleting R10)
Authorisation
date + 5 years
(applicant)
By letter while
granting the
authorisation
with N° …. of
…
Author
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
Remarks of the secretariat:
Advice of the expert concerning physical-chemical analysis and analysis methods: (not to be filled out by the applicant)
Analysis : acceptable results both for active substances and formulation. The GLP declarations are correct, both for analysis and lab. The data protection claims of the applicant
are justified.
Conditions for prolongation : the parameter emulsion stability should be determined again, according to the appropriate method (MT 173’)
Conditions for authorisation : the impurity profile should be adapted to the results of the analysis of the a.s. The parameter suspensability still has to be determined.
2. Toxicology
2.1 Labelling
Submitted studies (mention all studies) :
Test
Acute oral
Tested species:
TG 401, 423 (ATC), 425 (up &
down): specify
Acute dermal
Tested species:
Acut inhalation
Tested species:
Duration of exposure:
Performed on
Endpoint
Results
Name active substance: xxx ;
or code formulation: xxx
LD50 (mg/kg)
Male:
Female:
Name active substance: xxx ;
or code formulation: xxx
Name active substance: xxx ;
or code formulation: xxx +
Formulation type (aerosol,
LD50 (mg/kg)
Male:
Female:
Male:
Female:
powder, ...) :
LC50 (mg/l)
Argumentation or study
reference (tile, author, year,
ref n° applicant, ref n° lab).
GLP: Y/N
Name active substance: xxx ;
or code formulation: xxx
Irritation skin
Name active substance: xxx ;
or code formulation: xxx
Irritation eyes
Score erythema at
24(a)/48(b)/72(c)h:
If 3 rabbits: <Se> = a/b/c
If 6 rabbits: <<Se>>= x (mean of a, b and
c)
Score oedema at
24/48/72h
Reversibility
If 3 rabbits: <So> = a/b/c
If 6 rabbits: <<So>>= x
Yes (day …) / No
Score corneal opacity
at 24/48/72h:
Score iris at 24/48/72h:
If 3 rabbits: <Sco> = a/b/c
If 6 rabbits: <<Sco>>= x
If 3 rabbits: <Si> = a/b/c
If 6 rabbits: <<Si>>= x
If 3 rabbits: <Se> = a/b/c
If 6 rabbits: <<Se>>= x
If 3 rabbits: <Sc> = a/b/c
If 6 rabbits: <<Sc>>= x
Yes (day …) / No
Neovascularisation of the cornea…
% sensibilisation treated:
% sensibilisation not treated:
Score erythema at
24/48/72h:
Score chemosis at
24/48/72h:
Reversibility
Other observations
Sensibilisation
Tested species:
Method : Bühler / Magnussen
& Kligman /LLNA/ other (to
be specified)
Name active substance: xxx ;
or code formulation: xxx
Summary of data on the active substance(s) and pertinent non active substances:
Substance
Classification
Symbol
Reference (origin of the mentioned results)
R phrases
Note: According to Dir. 98/98/EU all preparations containing more than 10% aromatic solvent have to be labelled with R65. Such a labelling is not necessary
if the kinematic viscosity at 40°C is higher than 7 x 10-6 m2/sec or if the surface tension at 25°C is higher than 33 mN/m. See point 1.2 demonstrating that
these requirements are fulfilled for this formulation…
Material Safety Data Sheets :
-
Active substance : available/not available; established in accordance to 91/155/EEC: yes/no
formulation : available/not available; established in accordance to 91/155/EEC: yes/no
all adjuvants : available/not available; established in accordance to 91/155/EEC: yes/no
Applicant proposal for labelling in accordance to 99/45/EC:
- Classified as (toxic, harmful, … inflammable, ,…)
- Hazard symbol : Xn, N, …
- Risk phrases : R10-20-…
- Safety phrases : S2-13-20/21-…
Labelling reference (take over of the above mentioned reference product)
- Classified as (toxic, harmful, … inflammable,…)
- Hazard symbol : Xn, N, …
- Risk phrases : R10-20-…
- Safety phrases : S2-13-20/21-…
- Base : (to be filled out by the secretariat of the Authorisation committee)
2.2 Operator exposure (in case of new uses for new active substances)
Summary of data on the active substance(s) and safener(s):
Substance
AOEL(s)
(mg/kg bw/d)
Parameters used for the calculation of the operator exposure:
Use:
Type formulation (EC, SC, WG, WP, …):
Container: volume:
size opening:
Application rate L or kg formulation/ha:
kg a.s./ha:
Concentration of a.s.:
Spray volume (L):
Area treated (ha): German:
UK
Personal protective equipment (PPE):
BW: 60 kg (German), 70 kg (UK)
Dermal absorption
- Conc.
- Spray
Reference (origin of mentioned results)
Models used:
- German:
- UK POEM:
- Other:
Summary of the evaluation of operator exposure risk
Active substance
Model
German
PPE
POE
AOEL
%
(mg/kg bw/ d)
(mg/kg bw/ d)
of AOEL
none
PPE
UK
none
PPE
2.3 Data Protection
For following data protection is claimed by the applicant. Due to the fact that the toxicological data concerning the formulation are specific to this product and hence cannot
be used to support other authorisations, only following specific data are mentioned :
Dossier
Data
Protection for:
Expiry date of Holder of
Confirmation
Study reference (title, author, year, ref n° of applicant, ref n° of
protection
protection
of the
lab)
protection
(Active
(aspect dossier,
(extension at a
Authorisation
(applicant)
By letter while
substance
e.g. point of
higher dose)
date + 5 years
granting the
active, ev.
annex II,
authorisation
formulation
calculation of
with N° …. of
type)
operator
exposure, …)
…
Remarks of the secretariat:
Advice of the expert concerning toxicology (not to be filled out by the applicant) :
Toxicology : based on the flashpoint of the formulation, the studies performed on the formulation (oral, dermal, irritation eyes/skin, sensibilisation), the active substance
properties, the formulation will be classified as (toxic, harmful, ... flammable, …) with hazard symbol Xn,…, danger sentences R… and safety sentences S2-13-20/21…
Based on the calculation of the operator exposure (AOEL : …, AF : …, adsorption : …) following sentences are added : S36/37…
The declarations of the applicant concerning GLP (of both report and lab) are correct and the claim for data protection is justified. The study of the acute oral toxicity does not
comply to GLP (validity of the certificate expired).
Conditions for prolongation : a new calculation of the operator exposure, taking into account the correct endpoints of the a.s.
Conditions for authorisation : a new study of the acute oral toxicity, this time according to GLP.
3. Biology
3.1 Efficacy and selectivity
Use proposal of the applicant (for presentation, see authorisation document or www.phytoweb.fgov.be)
Uses to be presented in Dutch and French, as will be mentioned on the Authorization Document and on the website www.phytoweb.fgov.be. More than one crop and/or
enemy can be mentioned in the concerned cells of the table but only if all cells related to the application conditions are completely identical for the mentioned crops and
enemies; in the other case, the crops and/or enemies have to be mentioned separately, in different cells. Not every cell does necessarily have to be filled out, e.g. if the last
application stage is well determined, the PHI does not need to be filled out.
Te behandelen
Stadium
Opmerking
(gewas)
A traiter
Eerste knoop – tweede knoop
Stade
(BBCH 21-22)
- max. (aantal) toepassingen Remarque
per teelt, seizoen, jaar,
productiecyclus
- secundaire werking tegen
….
(culture)
To be treated
Premier noeud – deuxième
Stage
noeud (BBCH 21-22)
- max (nombre)
Remark
applications par
culture, saison, an,
cycle de production
- effet secondaire
contre …
(crop)
First node – second node
(BBCH 21-22)
- Max (number)
applications per
crop, season, year,
production cycle
- Secondary effect
against…(enemy)
Wachttijd
MRL
Voorzorgen voor
volggewassen
Vijand
… dagen
… mg/kg
/
Stadium
Opmerking
Dosis
Aantal toepassingen
Toepassingsmethode
Vijand
Stadium
Opmerking
Dosis
Aantal toepassingen
Toepassingsmethode
Bufferzone
Délais
LMR
Précautions pour les
cultures suivantes
Ennemis
… jours
… mg/kg
/
Preventief of bij het verschijnen
van de eerste symptomen
Stade
/
1 l/ha
1-3 toepassingen, met een interval
van 21 dagen
Veldspuittoestel, à 200-500 l
water/ha
Witziekte
Preventief of bij het verschijnen
van de eerste symptomen
Remarque
Dose
Nombre de traitements
/
1,5 l/ha
1-3 toepassingen, met een interval
van 21 dagen
Veldspuittoestel, à 200-500 l
water/ha
20 m met klassieke techniek
Remarque
Dose
Nombre de traitements
Préventivement ou à
l’apparition des premiers
symptômes
/
1 l/ha
1-3 applications, à intervalle
de 21 jours
Pulvérisateur de champ, à
200-500 l d’eau/ha
Oïdium
Préventivement ou à
l’apparition des premiers
symptômes
/
1,5 l/ha
1-3 applications, à intervalle
de 21 jours
Pulvérisateur de champ, à
200-500 l d’eau/ha
20 m à technique classique
Roest, Papiervlekkenziekte, …
Méthode d’application
Ennemis
Stade
Méthode d’application
Zône tampon
Rouille, Mildiou, …
Waiting period
MRL
Precautions for following
crops
Enemy
Stage
Remark
Rate
Number of applications
Method of application
Enemy
Stage
Remark
Rate
Number of applications
Method of application
Buffer zone
… days
… mg/kg
/
Mould… (mention only
more enemies in this cell if
stage, remark, rate, number
of applications and
application method are
identical)
Preventively
/
1 L/ha
1-3 applications, with an
interval of 21 days
Field sprayer, at 200-500 L
water/ha
Oïdium
Preventively or when first
symptoms appear
/
1.5 L/ha
1-3 applications, with an
interval of 21 days
Field sprayer, at 200-500 l
water/ha
20 m with classical technique
Uses authorised for the reference product: (indicate differences with the table above in colour)
Te behandelen
Stadium
(gewas)
Eerste knoop – tweede knoop
(BBCH 21-22)
A traiter
Stade
(culture)
Premier noeud – deuxième
noeud (BBCH 21-22)
To be treated
Stage
(crop)
First node – second node
(BBCH 21-22)
Opmerking
-
-
max. (aantal) toepassingen Remarque
per teelt, seizoen, jaar,
productiecyclus
secundaire werking tegen
….
Wachttijd
MRL
Voorzorgen voor
volggewassen
Vijand
… dagen
… mg/kg
/
Stadium
Preventief of bij het verschijnen
van de eerste symptomen
Stade
Opmerking
Dosis
Aantal toepassingen
/
1 l/ha
1-3 toepassingen, met een interval
van 21 dagen
Veldspuittoestel, à 200-500 l
water/ha
Witziekte
Preventief of bij het verschijnen
van de eerste symptomen
Remarque
Dose
Nombre de traitements
/
1,5 l/ha
1-3 toepassingen, met een interval
van 21 dagen
Veldspuittoestel, à 200-500 l
water/ha
20 m met klassieke techniek
Remarque
Dose
Nombre de traitements
Toepassingsmethode
Vijand
Stadium
Opmerking
Dosis
Aantal toepassingen
Toepassingsmethode
Bufferzone
Roest, Papiervlekkenziekte, …
Délais
LMR
Précautions pour les
cultures suivantes
Ennemis
Méthode d’application
Ennemis
Stade
Méthode d’application
Zone tampon
-
max (nombre)
Remark
applications par
culture, saison, an,
cycle de production
- effet secondaire
contre …
… jours
Waiting period
… mg/kg
MRL
/
Precautions for following
crops
Rouille, Mildiou, …
Enemy
Préventivement ou à
l’apparition des premiers
symptômes
/
1 l/ha
1-3 applications, à intervalle
de 21 jours
Pulvérisateur de champ, à
200-500 l d’eau/ha
Oïdium
Préventivement ou à
l’apparition des premiers
symptômes
/
1,5 l/ha
1-3 applications, à intervalle
de 21 jours
Pulvérisateur de champ, à
200-500 l d’eau/ha
20 m à technique classique
Stage
Remark
Rate
Number of applications
Method of application
Enemy
Stage
Remark
Rate
Number of applications
Method of application
Buffer zone
-
-
Max (number)
applications per
crop, season, year,
production cycle
Secondary effect
against…(enemy)
… days
… mg/kg
/
Mould… (mention only
more enemies in this cell if
stage, remark, rate, number
of applications and
application method are
identical)
Preventively
/
1 L/ha
1-3 applications, with an
interval of 21 days
Field sprayer, at 200-500 L
water/ha
Oïdium
Preventively or when first
symptoms appear
/
1.5 L/ha
1-3 applications, with an
interval of 21 days
Field sprayer, at 200-500 l
water/ha
20 m with classical technique
Submitted studies:
Crop
Crop 1
Number
of studies
2
Crop 2
Crop 3
1
0
Tested
formulation
(code)
(code)
Efficacy/selectivity
GEP ?
Argumentation or study reference (tile, author, year, ref n° applicant, ref n° lab).
Efficacy
Selectivity
Yes
Yes
No
(reference)
(reference)
GEP not required due to …
Extrapolation from crop 2
3.2 Data Protection
For following data protection is claimed by the applicant. Due to the fact that the selectivity data are specific to this product and hence cannot be used to support other
authorisations, only following specific data are mentioned :
Dossier
Data
Protection for:
Expiry date of Holder of
Confirmation
Study reference (title, author, year, ref n° of applicant, ref n° of
protection
protection
of the
lab)
protection
(Active
Efficacy studies
Extension in
Authorisation
(applicant)
By letter while
substance
in (crop)
(crop)
date + 5 years
granting the
active, ev.
authorisation
formulation
with N° …. of
type)
…
Remarks of the secretariat:
Advice of the expert concerning biology ( Not to be filled out by the applicant) :
Biology : The submitted studies comply with GEP and with OECD specification N°…
The requested uses can be granted, taking into account the modifications in the table above… The data protection claim of the applicant is justified.
Conditions for prolongation:
Conditions for authorisation:
4. Residues (To be filled out only in the case of new uses or modification of the use patterns, like higher dose or number of applications, shorter PHI,…)
Active substance
ADI (mg/kg bw/d) + source (Review report or JMPR*)
ARfD (mg/kg bw) + source (Review report or JMPR*)
Residue definition for products of plant origin + tested crop
category
Residue definition for products of animal origin + tested
animals
*see doc. 3010 at the following internet address: http://europa.eu.int/comm/food/plant/protection/evaluation/index_en.htm
4. 1 MRL setting
Products of plant origin
Crop
Existing EU
MRL
(mg/kg) +
Directive EC
Existing
Belgian
MRL
(mg/kg)
Proposed
MRL
(mg/kg)
Proposed critical GAP
(application rate s.a. kg/ha,
application number, PHI or
crop growth stage)
Products of animal origin
Product
Existing EU
MRL
(mg/kg) +
Directive EC
Existing
Belgian
MRL
(mg/kg)
Proposed
MRL
(mg/kg)
Tested
animal
Residue trials complying with
the critical GAP (number,
north/south/indoor) or
extrapolation (guideline
reference)
Argumentation or study reference (tile, author, year, ref n° applicant, ref n°
lab).
GLP: Y/N
4.2 Consumer exposure assessment
Chronic exposure
TMDI
NEDI
Acute exposure
NESTI
Argumentation or
study reference (tile,
author, year, ref n°
applicant, ref n° lab).
GLP: Y/N
% ADI and used model
% ARfD/crop or product of animal origin and
used model
4.3 Other information provided (Stability of residues during storage, metabolism in plants or livestock, livestock feeding study, effects of industrial processing
and/or household preparations, residues in succeeding crops)
Study type
Study reference (tile, author, year, ref n° applicant, ref n° lab).
GLP: Y/N
4.4 Data Protection
For following data protection is claimed by the applicant:
Dossier
Data
Protection for:
Expiry date of
protection
(Active
substance
active, ev.
formulation
type)
Residue studies
in (crop)
Extension at a
higher rate in
(crop)
Authorisation
date + 5 years
Holder of
protection
(applicant)
Confirmation
of the
protection
By letter while
granting the
authorisation
with N° …. of
…
Study reference (title, author, year, ref n° of applicant, ref n° of
lab)
Remarks of the secretariat:
Advice of the expert concerning residues (not to be filled out by the applicant ):
Residues : the MRL for (a.s.) in (crop) was fixed at … g/kg for a PHI of … days and a maximum number of … applications of … kg/ha. The declarations of the applicant
concerning GLP (of both report and lab) are correct and the claim for data protection is justified. Two of the submitted studies in tomatoes do not comply with GLP
(certificate expired). For peas, only three studies were submitted so authorisation in this crop is for the moment not possible.
Conditions for prolongation : Two additional studies in tomatoes.
Conditions for authorisation/extension : Five additional residue studies in peas.
5. Ecotoxicology
5.1 Ecotoxicological labelling
Submitted studies (mention all studies) :
Test
Carried out with
Endpoint
Results (mg a.s./l
Argumentation or study reference (tile, author, year,
a.s.
acute toxicity on
Algae
acute toxicity on
Daphnia
acute toxicity on
Fish
Lemna
Other aquatic
organisms (e.g.
chironomus…)
Formulation
Comparable
formulation
(formulation code)
or mg formul./l)
e.g. EC50…
x
ref n° applicant, ref n° lab).
GLP: Y/N
e.g. 10 mg
formulation/l
X
X
The applicant's label proposal:
- Classified as (dangerous for the environment)
- Hazard symbol : N, /
- Risk phrases : R50/53, R51/53, R52/53 (the phrase R53 is assigned by default unless a biodegradable study reveals that this phrase is not necessary)
- Safety phrases : professionals : S35-61 (by default in case of R50 or R51) or S61 (by default in case of R52 or R53), non-professionals : S29-56 (by default in case of
R50, R51, R52 or R53)
- The product has no unacceptable effects on … (Poecilus sp., Aphidius rhopalosiphi,…) (in case of submission of relevant studies)
5.2 Exposure of water organisms
In order to determine the PEC for surface water, the applicant has to use the excel sheets available on the website
http://www.fytoweb.fgov.be (under 'infos pour l'industrie' and 'Ecotoxicologie'). The excel sheet files with the calculation have to be attached to this application presentation.
As a worst case scenario, DT50-value of 1000 days is used in the excell sheet unless other data on the degradation is available.
Possible crop categories (not to be changed by the applicant):
Horizontal crops
Vegetables, cereals, herbicides, grassland, ornamentals < 50 cm height, …
Vertical crops
Small fruit, grapes, ornamentals > 50 cm height, tomatoes, cucumbers, …
Orchards
Apple, Pears, Prunes, …
Hops
Hops
Drift mitigation measures as proposed by the applicant, for each possible scenario regarding crop category, dose and number of applications:
Crop category
Crops applied for
Horizontal crops
Horizontal crops
Vertical crops
Orchards
Dose (kg
product/ha)
1
0,3-0,5
0,5
0,75
Number of
applications
1-2
2-3
1
2
Drift mitigation measures as proposed by the applicant
Buffer zone of
Buffer zone of
Buffer zone of
Buffer zone of
… meter with classic technique/with … % drift reduction
… meter with classic technique/with … % drift reduction
… meter with classic technique/with … % drift reduction
… meter with classic technique/with … % drift reduction
5.3 Data Protection
For following data protection is claimed by the applicant. Due to the fact that the ecotoxicological data concerning the formulation are specific to this product and hence
cannot be used to support other authorisations, only following specific data are mentioned:
Dossier
Data
Protection for:
Expiry date of Holder of
Confirmation
Study reference (title, author, year, ref n° of applicant, ref n° of
protection
protection
of the
lab)
protection
(Active
Mesocosmos
(extension at a
Authorisation
(applicant)
By letter while
substance
study…
higher dose)
date + 5 years
granting the
active, ev.
authorisation
formulation
with N° …. of
type)
…
Remarks of the secretariat:
Advice of the expert concerning ecotoxicology (not to be filled out by the applicant ):
Ecotoxicology : based on the submitted studies with the formulation on algae, daphnia and fish, the formulation has to be classified as …(dangerous for the environment),
with hazard symbol: N, …, risk phrases: R50/53-… (the phrase R53 is automatically assigned unless a biodegradable study reveals that this phrase is not necessary) and safety
phrases: S35-61-… Based on the risk evaluation for water organisms, a buffer zone of … meter with … % drift reduction has to be imposed for (crop category) (dose, number
of applications) and a buffer zone of … meter with … % risk reduction for (crop category) (dose, number of applications) ...
The declarations of the applicant concerning GLP (of both report and lab) are correct and the claim for data protection is justified.
6. Fate and behaviour
Only for in annex I included active substances or in case of specific problems (e.g. ground water contamination).
Submitted studies (mention all studies):
Study type
Study reference (tile, author, year, ref n° applicant, ref n° lab).
GLP: Y/N
For following data protection is claimed by the applicant. Due to the fact that the ecotoxicological data concerning the formulation are specific to this product and hence
cannot be used to support other authorisations, only following specific data are mentioned:
Dossier
Data
Protection for: Expiry date
Holder of
Confirmation Study reference (title, author, year, ref n° of applicant, ref n°
of protection
protection
of the
of lab)
protection
(Active
Biodegradability Authorisatioin
Authorisation
(applicant)
By letter while
substance
study…
date + 5 years
granting the
active)
Pertinence of a
authorisation
metabolite…
with N° …. of
…
Remarks of the secretariat:
Advice of the expert concerning fate and behaviour (not to be filled out by the applicant) :
7. Other useful information:
Packaging:
1 – 20 L bottles; 1000 L drums
Material
Size
Capacity
Size of opening
Closure
Seal
high density polyethylene (HDPE)
20 x 20 x 50 cm, ….
Bottles : 1-20 L; drums : 1000 L
20 mm
Safety closure….
Guaranteed conservation of the product in the packaging: … year
8. Administrative matters:
- Retribution of the application paid: Yes/No
- Instructions for first aid measures submitted: Yes/No
- Non confidential dossier submitted: Yes/No
- Additional contribution: not required/required if no biological studies : …. EUR.
- Label : the following has to be mentioned on the label. If the product is already authorised, also the remarks on the authorisation certificate have to be mentioned on
the label (or the draft label) :
1. Name and address of the natural or juridical person who has obtained or requested the authorization, and of the person responsible for the packaging and the
final labelling of the product : Yes/No
2. The commercial name of the product : Yes/No
3. The formulation type : Yes/No
4. The nature of the product (e.g. “insecticide”) : Yes/No
5. The name of each active substance (including synergists and safeners) and their guaranteed concentration in the product expressed in
a)
percentage, for solid products, aerosols and viscose or volatile liquids : Yes/No
b) g/l and in w/w percentage for all other liquids : Yes/ Non
c)
volumetric percentage for gasses : Yes/No
6. The authorization number : Yes/No
7. The batch number: Yes/No
8. The weight of the content of the packaging for solid products and viscous or volatile liquids ; the volume of the content of the packaging for other liquids ;
the weight and the volume of the content of the packaging for aerosols : Yes/No
9. The expiry date for use (month + year) for products with a conservation period of less than 2 year (remark : for rodenticides, the expiry dat will always be
imposed by the authorization certificate, even with a conservation period of 2 years) : Yes/No
10. The interdiction to re-use the packaging in case of a very toxic, toxic or harmful product (unless if the packaging is specifically meant for this by the holder
of the authorisation) : Yes/No
11. The recommendations concerning an effective method to destroy empty packaging and spraying rests : Yes/No
12. The use of the product, as well as :
a) The use recommendations : Yes/No
b) The application rate : Yes/No
c) The waiting period between the application and sowing or planting of the crop to be protected or the following crop, entry to the treated crop, harvest or
slaughtering, and use or consumption : Yes/No
13.
14.
16.
17.
18.
d) The agricultural, phytosanitary and agri-environmental conditions under which the product can (or cannot) be used : Yes/No
The recommendations concerning first aid and the phone number of the Antipoisons Centre: Yes/No
Danger symbols and corresponding risk indications, as well as the R and S phrases: Yes/No
The name of all components of the product (other than the active substances) that, according to the Royal Decree of 11/01/93 (regulating the classification,
the packaging and the identification of dangerous preparations, in view of their marketing or use), are considered to be dangerous and that exceed the
threshold limit of the foreseen concentrations : Yes/No
For aerosols (under pressure), the recommendations foreseen by the Royal Decree of 17 April 1978 concerning aerosols, modified by the Royal Decree of 7
April 1995 : Yes/No
For fertilizers containing plant protection products, the label has to comply with the recommendations of the Royal Decree of 07/01/98 concerning the
marketing of fertilizers, soil amendments and cultivation substrates, modified by the Royal Decree of 18/05/98 : Yes/No