C-form: Risk assessment and summary of the chemical biocidal product
C-form: Risk assessment and summary
of the chemical biocidal product

From December 1, 2008, all applications for approval of a biocidal product in Sweden must contain a
quantitative risk assessment of human health and of the environment.

From September 1, 2011, applications for products intended to be applied directly on animals or in the
vicinity of animals must also contain a consideration of the risk posed to animals from the biocidal
product. When considering the risk posed to animals the same relevant principles as for dealing with effects
on humans might be used.

A quantitative risk assessment means that a calculated exposure is related to the reference value that is not
expected to produce any negative effects on humans, animals and the environment. An estimate of the
exposure and concentration in the environment is made using measured data or mathematical models. The
predicted exposure levels are then compared with the reference values , i.e. acceptable exposure levels
due to health risks (AEL, Acceptable Exposure Level) and the product’s distribution in the environment
(PNEC, Predicted No Effect Concentration). The reference values are calculated from the toxicological and
ecotoxicological data deemed as most relevant for the product based on the envisaged pattern of use
applied for. If the ratio between the calculated exposure and the reference value is more than 1, there is a
risk of negative effects on the health and/or the environment.

For a more detailed description of how to do a quantitative risk assessment, refer to the guidance
documents on the European Commission Joint Research Centre website on biocides, for example TNsG
(Technical Notes for Guidance) on Data Requirements, TNsG on Human Exposure, TNsG on Product
Evaluation, TGD (Technical Guidance Document) and the relevant ESD (Emission Scenario Document) for
different product types.

This application form states all the data that should be included in the risk assessment. The risk
assessment can be presented in a separate report. If any point in the form is not met with information, a
detailed and scientific justification should be presented. If the risk assessment is summarised in the C-form,
all calculations and assumptions should be enclosed as annex(es).
If you have questions, please contact the Swedish Chemicals Agency at: kemi@kemi.se
December 2011
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C-form: Risk assessment and summary of the chemical biocidal product
Point
Data requirements
Information/value
Reference to
guidance document
C1. Product included in the risk assessment
C1.1
Product name
C2. Toxicological risk assessment
C2.1
State the exposed groups
that are included in the risk
assessment
Note that for products intended to
be used directly on animals, or in
the vicinity of animals, also a
consideration of the potential
exposure for the animal must be
included
C2.2
State the exposure model
for the risk assessment
C2.3
Exposure (mg/kg/day)
C2.4
Risk mitigation measures
C2.5
Body weight (kg)
Adult 60 kg
Children 15 kg
Infant 10 kg
C2.6
Dermal absorption (%)
C2.7
Oral absorption (%)
C2.8
Assessment factors
“Guidance
Document on
Dermal Absorption”
Lowest difference between animal
species (10) and difference between
individuals (10)
C2.9
State the NOAEL on which
the risk assessment is based
(mg/kg/day)
C2.10
Calculated AOEL(s)
(mg/kg/day)
C2.11
Margin of Exposure (MOE)
December 2011
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C-form: Risk assessment and summary of the chemical biocidal product
Point
Data requirements
C2.12
Exposure/AOEL
Information/value
Reference to
guidance document
If the ratio is <1 the risk for
negative effects is expected to be
low and the use of the substance
considered to be acceptable
considering the circumstances
C2.13
Risk assessment –
conclusion
C3. Environmental risk assessment
C3.1
Summary of the
biodegradation and
behaviour of the substance
in water
TNsG on Data
Requirements, Chap
2 Part A 7.6
C3.2
Summary of degradation
and behaviour of the
substance in soil
TNsG on Data
Requirements, Chap
2 Part A 7.6
C3.3
Summary of the toxicity of
the substance to aquatic
and sediment living
organisms and calculation of
PNEC
TNsG on Data
Requirements, Chap
2 Part A 7.6
See TGD for
guidance in the
choice of
appropriate study
and assessment
factors
C3.4
Summary of the toxicity of
the substance to terrestrial
organisms and calculation of
PNEC
TNsG on Data
Requirements, Chap
2 Part A 7.6
See TGD for
guidance in the
choice of
appropriate study
and assessment
factors
C3.5
Summary of the toxicity of
the substance to birds and
mammals and calculation of
PNEC
TNsG on Data
Requirements, Chap
2 Part A 7.6
See TGD for
guidance in the
choice of
appropriate study
and assessment
factors
December 2011
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C-form: Risk assessment and summary of the chemical biocidal product
Point
Data requirements
Information/value
Reference to
guidance document
C3.6
Summary of the substance’s
toxicity to bees and other
beneficial arthropods and
calculation of PNEC
C3.7
State the areas that are
expected to be exposed
during use and that will be
included in the risk
assessment.
See the ESDs for
each use and
product type
C3.8
State relevant steps in the
lifecycle of the active
substance that will be part
of the risk assessment
See the ESDs for
each use and
product type
C3.9
State scenario/model that
has been used in the
calculation of predicted
concentration (PEC) of the
active substance in each
recipient
For a correct
calculation method
see the ESDs for
each use and
product type or use
recommended
models
C3.10
State predicted
concentration of the active
substance (PEC) in each
recipient
For a correct
calculation method
see the ESDs for
each use and
product type or use
recommended
models
C3.11
State calculated risk ratio
(PEC/PNEC) for each active
substance and recipient that
has been assessed
TNsG on Data
Requirements, Chap
2 Part A 7.6
See TGD for
guidance in the
choice of
appropriate study
and assessment
factors
If the ratio is <1 the risk for
negative effects is expected to be
low and the use of the substance
considered to be acceptable
considering the circumstances
C3.12
Risk mitigation measures
If the ratio is >1 the risk for
negative effects is expected to be
high and the use of the substance is
in general considered to be
unacceptable unless acceptable risk
reducing measures can be applied
C3.13
Risk assessment –
conclusion
December 2011
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