A-form: Information on active substance

A-form: Information on active substance

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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: /
Point / Data requirement / Information/value / Reference to the application / Reference in the TNsG on Data Requirements /

A1. Information about identity of the active substance Chapter 2, part A

A1.1 / Common name
State the ISO-name / 2.1
A1.2 / Chemical name according to CA- or 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
State e.g. optical isomers / 2.5
A1.7 / Molecular weight / 2.5

A2. Information on the active substance in the technical product Chapter 2, part A

A2.1 / Purity
State in weight % (w/w) / 2.7
A2.2 / Chemical name and content of impurities
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 / 2.8
A2.3 / Additives
State the name and the type of the additive, e.g. stabilisators, inhibitors etc as well as the content in % (w/w) or ppm. / 2.8

A3. Information about analysis of the active substance Chapter 2, part A

A3.1 / Methods of analysis for qualitative and quantitative analysis of the active substance
State analytical method for the active substance in soil, water, air and biological material. / 4.1 and 4.2

A4. Information about production and origin of the active substance Chapter 2, part A

A4.1 / Manufacturer
State name or company / 1.2
A4.2 / Production plant(s)
State address(es) of all production plant(s)
A4.3 / Description of the production of the active substance / 2.6

A5. Physical- chemical properties of the active substance Chapter 2, part A

A5.1 / Appearance, physical state, colour, odour etc. / 3.3
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
If the substance is a gas, state the density at 0oC and 760 mm Hg / 3.1
A5.6 / Vapour pressure
State the vapour pressure (Pa) for at least 2 temperatures in degree Celsius, or in a vapour pressure diagram / 3.2
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
State solvent and concentrations in mg/100 ml / 3.10
A5.13 / Flash-point / 3.12
A5.14 / Flammability
State the classification of flammability / 3.11
A5.15 / Oxidising properties / 3.16
A5.16 / Decomposition or other reaction during incineration
State whether or not the substance can entertain, speed up or catalyse the incineration / 3.11
A5.17 / Dissociation constant
State the lowest temperature for complete incineration / 3.6
A5.18 / Other physical-chemical properties
State the pKa-value / 3.6

A6. Toxicological properties of the active substance Chapter 2, part A

A6.1 / Acute oral toxicity
Should be stated if the information is missing for the formulation / 6.1.1
Animal species
LD50 (mg/kg)
Observed effects, organ injuries etc.
A6.2 / Acute dermal toxicity
Should be stated if the information is missing for the formulation / 6.1.2
Animal species
LD50 (mg/kg)
Observed effects, organ injuries etc.
A6.3 / Acute inhalation toxicity
Should be stated if the information is missing for the formulation / 6.1.3
Animal species
LC50 (mg/L)
Observed effects, organ injuries etc.
A6.4 / Skin irritation
Should be stated if the information is missing for the formulation / 6.1.4
A6.5 / Eye irritation
Should be stated if the information is missing for the formulation / 6.1.4
A6.6 / Skin sensitisation
Should be stated if the information is missing for the formulation / 6.1.5
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 (%)
Should be stated if the information is missing for the formulation / 6.2
A6.9 / Mechanistic studies
Should be stated if documentation is available / 6.10
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
Should be stated if documentation is available / 6.11
A6.12 / Chronic toxicity
Can often be combined with carcinogenicity. The study must be performed with oral administration for active substances that demands an ADI (Acceptable Daily Intake) / 6.5
Animal species
LOAEL/NOAEL (mg/kg/day)
Observed effects, organ injuries etc.
A6.13 / Carcinogenicity
The study must be performed with oral administration for active substances that demands an ADI (Acceptable Daily Intake). / 6.7
A6.14 / Genotoxicity*
In vitro / 6.6.1 - 6.6.3*
In vivo / 6.6.4 - 6.6.6
A6.15 / 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
The study must be performed with oral administration for active substances that demands an ADI (Acceptable Daily Intake) / 6.9
A6.17 / Effects on humans
State experiences acquired during the professional manufacturing process or in relation with a case of poisoning. Anti-dotes and therapeutic regimes should be stated when available.
Enclose epidemiological studies if these are available / 6.12
A6.18 / Toxicity of metabolites / 6.14

A7. Residue data of the active substance in exposed food, Charter 3, part Afeeding 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 Products[1]
Risk characterisation and assessment of Maximum Residue Limits (MRL) for biocides[2]
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. / 6.15.3

A8. Fate and behaviour of the active substance in water 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 / 7.2.2.4
A9.2 / Biotic degradation
A9.2.1 / Aerobic degradation in soil / 7.2.1 and 7.2.2
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 Chapter 3 part A

A10.1 / Photolysis in air / 7.3.1

A11. Toxicity to aquatic organisms 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 / 7.4.3.3.1 and 7.4.3.3.2
A11.9 / Tests with simulated eco-systems
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 macro-organisms / 7.5.1.2
A12.3 / Acute toxicity to plants / 7.5.1.3
A12.4 / Reproduction study with earthworms or other soil non-target macro-organisms / 7.5.2.1
A12.5 / Long-term test with terrestrial plants / 7.5.2.2
A12.6 / Bioconcentration (calculated value) / 7.5.5
A12.7 / Bioconcentration study / 7.5.5.1

A13. Toxicity to birds and mammals including bioaccumulation 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) / 7.5.5

A14. Acute toxicity to honeybees and other beneficial arthropods Chapter 3 part A

A14.1 / Acute toxicity for bees and other beneficial arthropods / 7.5.4.1
A14.2 / Effects on other terrestrial non-target organism
State e.g. experiences from field tests or investigations with other arthropods of importance / 7.5.6

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

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

May 2012 1 (11)

[1]http://ec.europa.eu/environment/biocides/consultation.htm

[2]http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000512.jsp&mid&jsenabled=true