A-form: Information on active substance
A-form: Information on active substance
All the points in the form should be filled with information. In cases where the data requirement is not covered by a
study/report, a detailed justification should be given.
Data requirements marked with an asterisk (*) are core data requirements that always should be provided to the
application, independent of product type and intended use of the product.
Further information can be found in the Technical Notes for Guidance (TNsG) on Data Requirements. Consider in
particular chapter 2 and 3 (Common core data set for active substances and biocidal products), Part A (Active
substances).
For guidance on exposure estimates for livestock, see the guidance document "Guidance on Estimating Livestock
Exposure to Active Substances used in Biocidal Products" which is available via the European Commission's website
for biocidal products (DG Environment). For guidance on the assessment of MRLs (Maximum Residue Limits) please
refer to the guidance document "Risk characterisation and assessment of Maximum Residue Limits (MRLs) for
Biocides" at the European Medicines Agency’s (EMA) website.
If you have questions, please contact the Swedish Chemicals Agency at: kemi@kemi.se
Point
Data requirement
Information/value
A1. Information about identity of the active substance
A1.1
Common name
Reference to the application
Reference in
the TNsG on
Data
Requirements
Chapter 2, part A
2.1
State the ISO-name
A1.2
Chemical name according to CAor IUPAC nomenclature
2.2
A1.3
Manufacturer’s development
code
2.3
A1.4
CAS and EC numbers, if available
2.4
A1.5
Molecular formula
2.5
A1.6
Structural formula
2.5
State e.g. optical isomers
A1.7
Molecular weight
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2.5
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A-form: Information on active substance
Point
Data requirement
Information/value
Reference to the application
A2. Information on the active substance in the technical product
A2.1
Purity
Reference in
the TNsG on
Data
Requirements
Chapter 2, part A
2.7
State in weight % (w/w)
A2.2
Chemical name and content of
impurities
2.8
State optical isomers, by-products from
the synthesis, decomposition products
etc. In % (w/w) with the largest
contributor first with an unambiguous
chemical name according to CA or IUPAC
nomenclature as well as the CAS No., the
method of analysis as well as its accuracy
A2.3
Additives
2.8
State the name and the type of the
additive, e.g. stabilisators, inhibitors etc
as well as the content in % (w/w) or ppm.
A3. Information about analysis of the active substance
A3.1
Methods of analysis for
qualitative and quantitative
analysis of the active substance
Chapter 2, part A
4.1 and 4.2
State analytical method for the active
substance in soil, water, air and
biological material.
A4. Information about production and origin of the active substance
A4.1
Manufacturer
Chapter 2, part A
1.2
State name or company
A4.2
Production plant(s)
State address(es) of all production
plant(s)
A4.3
Description of the production of
the active substance
A5. Physical- chemical properties of the active substance
A5.1
Appearance, physical state,
colour, odour etc.
May 2012
2.6
Chapter 2, part A
3.3
2 (11)
A-form: Information on active substance
Information/value
Reference to the application
Reference in
the TNsG on
Data
Requirements
Point
Data requirement
A5.2
Aggregation state at ambient
temperature
3.3
A5.3
Melting point or temperature for
sublimation, decomposition
3.1
A5.4
Boiling point
3.1
A5.5
Density
3.1
If the substance is a gas, state the density
at 0oC and 760 mm Hg
A5.6
Vapour pressure
3.2
State the vapour pressure (Pa) for at
least 2 temperatures in degree Celsius, or
in a vapour pressure diagram
A5.7
Surface tension
3.13
A5.8
Water solubility
3.5
A5.9
Fat solubility
A5.10
Partition coefficient
n-octanol/ water
3.9
A5.11
Solubility in organic solvents
3.7
A5.12
Thermal stability
3.10
State solvent and concentrations in
mg/100 ml
A5.13
Flash-point
3.12
A5.14
Flammability
3.11
State the classification of flammability
A5.15
Oxidising properties
3.16
A5.16
Decomposition or other reaction
during incineration
3.11
State whether or not the substance can
entertain, speed up or catalyse the
incineration
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3 (11)
A-form: Information on active substance
Point
Data requirement
A5.17
Dissociation constant
Information/value
Reference to the application
Reference in
the TNsG on
Data
Requirements
3.6
State the lowest temperature for
complete incineration
A5.18
Other physical-chemical
properties
3.6
State the pKa-value
A6. Toxicological properties of the active substance
A6.1
Acute oral toxicity
Chapter 2, part A
6.1.1
Should be stated if the information is missing for the formulation
Animal species
LD50 (mg/kg)
Observed effects, organ injuries
etc.
A6.2
Acute dermal toxicity
6.1.2
Should be stated if the information is missing for the formulation
Animal species
LD50 (mg/kg)
Observed effects, organ injuries
etc.
A6.3
Acute inhalation toxicity
6.1.3
Should be stated if the information is missing for the formulation
Animal species
LC50 (mg/L)
Observed effects, organ injuries
etc.
A6.4
Skin irritation
6.1.4
Should be stated if the information is
missing for the formulation
A6.5
Eye irritation
6.1.4
Should be stated if the information is
missing for the formulation
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A-form: Information on active substance
Point
Data requirement
A6.6
Skin sensitisation
Information/value
Reference to the application
Reference in
the TNsG on
Data
Requirements
6.1.5
Should be stated if the information is
missing for the formulation
A6.7
Kinetics
These studies should be performed on laboratory animals and also on (all) other animals when the intention is to use
the active substance for treatment of food-producing animals
A6.7.1
Oral absorption (%)*
6.2*
A6.7.2
Distribution
6.2
A6.7.3
Excretion
6.2
A6.7.4
Metabolism
6.2
A6.8
Dermal absorption (%)
6.2
Should be stated if the information is
missing for the formulation
A6.9
Mechanistic studies
6.10
Should be stated if documentation is
available
A6.10
Oral 90-day study*
6.4.1*
Animal species
LOAEL/NOAEL (mg/kg/day)
Observed effects, organ injuries
etc.
A6.11
Other administration-routes or
time intervals
6.11
Should be stated if documentation is
available
A6.12
Chronic toxicity
6.5
Can often be combined with carcinogenicity. The study must be performed with oral administration for active
substances that demands an ADI (Acceptable Daily Intake)
Animal species
LOAEL/NOAEL (mg/kg/day)
Observed effects, organ injuries
etc.
May 2012
5 (11)
A-form: Information on active substance
Point
Data requirement
A6.13
Carcinogenicity
Information/value
Reference to the application
Reference in
the TNsG on
Data
Requirements
6.7
The study must be performed with oral
administration for active substances that
demands an ADI (Acceptable Daily
Intake).
A6.14
A6.15
Genotoxicity*
In vitro
6.6.1 6.6.3*
In vivo
6.6.4 6.6.6
Reproductive toxicity
The studies must be performed with oral administration for active substances that demands an ADI (Acceptable Daily
Intake)
Multigenerational study *
6.8.2*
Animal species
LOAEL/NOAEL (mg/kg/day)
Observed effects, organ injuries
etc.
Teratogenicity*
6.8.1*
Animal species
LOAEL/NOAEL (mg/kg/day)
Observed effects, organ injuries
etc.
A6.16
Neurotoxicity
6.9
The study must be performed with oral
administration for active substances that
demands an ADI (Acceptable Daily
Intake)
A6.17
Effects on humans
6.12
State experiences acquired during the
professional manufacturing process or in
relation with a case of poisoning. Antidotes and therapeutic regimes should be
stated when available.
Enclose epidemiological studies if these
are available
A6.18
Toxicity of metabolites
May 2012
6.14
6 (11)
A-form: Information on active substance
Point
Data requirement
Information/value
Reference to the application
Reference in
the TNsG on
Data
Requirements
A7. Residue data of the active substance in exposed food,
Charter 3, part A
feeding stuffs or livestock that will be used for food manufacturing industry
For products that will be used in e.g. storage spaces for food and feeding stuffs, for treatment of food,
feeding stuffs and drinking water, or nearby or directly on livestock that will be used for food manufacturing industry
A7.1
Identification of the residues
(identity and concentrations),
degradation and reaction
products and of metabolites of
the active substance on livestock
that will be used for food
manufacturing industry and in
contaminated foods or feeding
stuffs
6.15.1
A7.2
Behaviour of the residues of the
active substance, its degradation
and reaction products and,
where relevant, its metabolites
on livestock that will be used for
food manufacturing industry and
in contaminated foods or
feeding stuffs, including the
kinetics of disappearance
6.15.2
A7.3
Data of residue levels
Studies of residue levels should be
performed both with and without
radioactive labelled substance. These
studies must be performed for all animals
that are comprised in the application.
Residues should be measured in liver,
kidney, fat, muscle and also in milk, egg
and honey when needed
Guidance
on
Estimating
Livestock
Exposure
to Active
Substances
used in
Biocidal
Products1
Risk
characteris
ation and
assessment
of
Maximum
Residue
Limits
(MRL) for
biocides2
1
http://ec.europa.eu/environment/biocides/consultation.htm
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000512.jsp&mid&jsen
abled=true
2
May 2012
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A-form: Information on active substance
Point
Data requirement
A7.4
Estimation of potential or actual
exposure of the active substance
to humans or animals through
livestock, animal stables, food
and feeding stuffs or other
means.
Information/value
Reference to the application
A8. Fate and behaviour of the active substance in water
Reference in
the TNsG on
Data
Requirements
6.15.3
Chapter 2, part A
A8.1
Abiotic degradation
A8.1.1
Hydrolysis in water as a function
of pH*
7.1.1.1.1*
A8.1.2
Photolysis in water*
7.1.1.1.2*
A8.2
Biotic degradation
A8.2.1
Ready biodegradability *
7.1.1.2.1*
A8.2.2
Inherent biodegradability*
7.1.1.2.2*
A8.2.3
Aerobic biodegradation in water
7.1.2.2.1
A8.2.4
Water/sediment degradation
study
7.1.2.2.2
A8.3
Adsorption to organic material
A8.3.1
Screening test of
adsorption/desorption*
7.1.3*
A8.3.2
Field study on accumulation in
the sediment
7.1.4.1
A9. Fate and behaviour of the active substance in soil
Chapter 3 part A
A9.1
Abiotic degradation
A9.1.1
Photolysis on soil
A9.2
Biotic degradation
A9.2.1
Aerobic degradation in soil
A9.2.2
Adsorption and desorption to
soil particles
7.2.3.1
A9.2.3
Accumulation in soil
7.2.2.2
A10. Fate and behaviour of the active substance in air
A10.1
Photolysis in air
May 2012
7.2.2.4
7.2.1 and
7.2.2
Chapter 3 part A
7.3.1
8 (11)
A-form: Information on active substance
Point
Data requirement
Information/value
A11. Toxicity to aquatic organisms
Reference to the application
Reference in
the TNsG on
Data
Requirements
Chapter 2 part A
A11.1
Acute toxicity to fish*
7.4.1.1*
A11.2
Acute toxicity to invertebrates
(Daphnia)*
7.4.1.2*
A11.3
Growth inhibition test on algae*
7.4.1.3*
A11.4
Inhibition to microbiological
activity*
7.4.1.4*
A11.5
Effects on reproduction and
growth of fish
7.4.3.2
A11.6
Reproduction study with
Daphnia
7.4.3.4
A11.7
Bioconcentration (calculated
value)*
7.4.2*
A11.8
Bioaccumulation study
A11.9
Tests with simulated ecosystems
7.4.3.3.1
and
7.4.3.3.2
For example mesocosmstudies
A12. Toxicity to terrestrial organisms
Chapter 3 part A
A12.1
Inhibition to microbial activity
7.5.1.1
A12.2
Acute toxicity to earthworms or
other soil non-target macroorganisms
7.5.1.2
A12.3
Acute toxicity to plants
7.5.1.3
A12.4
Reproduction study with
earthworms or other soil nontarget macro-organisms
7.5.2.1
A12.5
Long-term test with terrestrial
plants
7.5.2.2
A12.6
Bioconcentration (calculated
value)
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7.5.5
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A-form: Information on active substance
Point
Data requirement
A12.7
Bioconcentration study
Information/value
Reference to the application
A13. Toxicity to birds and mammals including bioaccumulation
Reference in
the TNsG on
Data
Requirements
7.5.5.1
Chapter 3 part A
A13.1
Acute toxicity to bird
7.5.3.1.1
A13.2
Short-term dietary test with bird
7.5.3.1.2
A13.3
Reproduction study with bird
7.5.3.1.3
A13.4
Other environmental toxicological studies (e.g.
bioaccumulation,
biomagnification)
A14. Acute toxicity to honeybees and other beneficial arthropods
7.5.5
Chapter 3 part A
A14.1
Acute toxicity for bees and other
beneficial arthropods
7.5.4.1
A14.2
Effects on other terrestrial nontarget organism
7.5.6
State e.g. experiences from field tests or
investigations with other arthropods of
importance
A15. Measurements in the environment
A15.1
Measurements in the
environment
State measured concentrations of active
substance and its degradation products
A16. Resistance creating properties
A16.1
Resistance creating properties
A17. Classification
A17.1
Classification of the active
substance
State classification according to Directive
67/548/EEC, or proposed classification
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A-form: Information on active substance
Point
Data requirement
Information/value
Reference to the application
Reference in
the TNsG on
Data
Requirements
A18. Recommended risk and protection information in relation to:
A18.1
Handling
Enclose proposed safety data sheet
A18.2
Storage
A18.3
Transport
A18.4
Danger of fire
A19. Destruction methods
A19.1
Destruction methods
State method, appropriate chemicals,
final product etc
A20. Reference list
A20.1
Reference list
State title, author, lab, and other
information that can facilitate the
identification of each annex
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