C-form: Risk assessment and summary of the biological biocidal product
C-form: Risk assessment and summary
of the characteristics of the biological 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 micro-organisms
there is a guidance document to the data requirements, TNsG on data requirements for micro-organisms
including viruses and fungi (in the following TNsG mo). In the first part of that guidance document the data
requirements for the active micro-organism are met and in the second part are the data requirements for
the micro-biological biocidal product. As there is otherwise few guidance documents, reference is given to
other guidance documents, like 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. These documents are not adapted to microorganisms however the basic principles are the same as for chemicals and micro-organisms for use as
biocidal products.

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 any 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 biological biocidal product
Point
Data requirements
Information/value
Reference to the application
Reference to
guidance
C1. Product included in the risk assessment
C1.1
Product name
C2. Risk assessment of effects on human health
C2.1
Specify which groups are
included in the risk assessment
All groups that can be exposed for the
active micro-organism and/or
metabolites/toxins during all phases of
preparation, application, cleaning and
destruction as well as secondary
exposure via treated material or via the
environment.
C2.2
Risk mitigation measures
Recommended protective clothing as well
as other risk mitigation measures.
C2.3
Exposure for the active microorganisms
A risk assessment must always be done
for the active micro-organism. In case
there is a NOAEL value a quantitative risk
assessment shall be done based on the
derived AOEL value. In case there is no
threshold value a risk assessment shall be
done based on other properties of the
active micro-organism, especially with
regard to inhalatory exposure.
C2.3.1
Specify which exposure model
that has been used for the risk
assessment
Field trials, mathematic models or other
theoretical calculation model that has
been used for the risk assessment, if
applicable.
C2.3.2
Exposure (CFU/kg/day)
Detailed quantitative exposure
assessment based on field trials,
mathematic models or other theoretical
calculation model. Argumentation can be
conducted on minimal exposure for
humans as a consequence of the
proposed field of use.
December 2011
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C-form: Risk assessment and summary of the biological biocidal product
Point
Data requirements
C2.4
Exposure to metabolites/toxins
Information/value
Reference to the application
Reference to
guidance
Only relevant in case such are produced
by the active micro-organism and can be
expected to have detrimental effects on
human and animal health under the
proposed conditions of use. Specify which
substance(s) that are produced and also
in which phase of the manufacturing
process and/or the use of the active
micro-organism. If applicable, specify the
amount of the metabolite/toxin that is
produced at every occasion and how this
has been calculated or approximated, or
which concentration that is part of the
quality control. In case a high enough
amount is produced of the
metabolite/toxin to be assumed to be a
reasonable risk for humans a risk
assessment of the substance must be
performed.
C2.4.1
Specify which exposure model
that has been used for the risk
assessment
Field trials, mathematic models or other
theoretical calculation model that has
been used for the risk assessment, if
applicable.
C2.4.2
Exposure (mg/kg/day)
Detailed quantitative exposure
assessment based on field trials,
mathematic models or other theoretical
calculation model, if applicable.
C2.5
Body weight (kg)
Only relevant if a systemic dose is
calculated and compared with an AOEL
value. Adult 60 kg, child 15 kg, infant 10
kg.
C2.6
Dermal exposure
For metabolites/toxins give dermal
absorption (%). For micro-organisms a
discussion can be done on other effects
of dermal exposure (e.g. growth on the
skin, uptake via wounds).
C2.7
“Guidance
Document
on Dermal
Absorption”
Oral absorption (%)
Only relevant for setting an AOEL value.
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C-form: Risk assessment and summary of the biological biocidal product
Point
Data requirements
C2.8
Safety factor(s)
Only relevant for setting an AOEL value.
At least 10 x 10 for difference between
animal species and difference between
individuals, respectively.
C2.9
Information/value
Reference to the application
Reference to
guidance
For
information,
see TNsG on
Annex I
inclusion.
Specify the NOAEL(s) which the
risk assessment is based on
(CFU/kg/day or mg/kg/day)
Specify NOAEL for the active microorganism and/or for all relevant
metabolites/toxins at suitable exposure
time(s) (acute, subacute, subchronic
and/or chronic), if applicable.
C2.10
Calculated AOEL(s)
(CFU/kg/day or mg/kg/day)
Specify AOEL for the active microorganism and/or for all relevant
metabolites/toxins at suitable exposure
time(s) (acute, subacute, subchronic
and/or chronic), if applicable.
C2.11.1
Margin of Exposure (MOE)
NOAEL (NOAEC)/exposure if applicable. If
a NOAEL has been established a
discussion on whether MOE is acceptable
and why must be submitted.
C2.11.2
Exposure/AOEL
This quotient should be ≤1 for the
exposure to be acceptable.
C2.12
Information on pathogenicity
and infectivity
C2.13
Summary of toxicity,
pathogenicity and infectivity for
mammals and overall evaluation
(from form B)
For
information,
see TNsG on
Annex I
inclusion.
For
information,
see TNsG on
Annex I
inclusion.
Summary of data from B8.1-8.5 including
a detailed qualitative overall assessment
of expected health effects on humans
and animals for the proposed use(s).
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C-form: Risk assessment and summary of the biological biocidal product
Point
Data requirements
Information/value
Reference to the application
Reference to
guidance
C3. Risk assessment of effects in the environment
C3.1
Specify the areas that are
expected to be exposed at use
and which will be included in the
risk assessment
See relevant
ESD
See respective ESD for every use and
product type or a discussion on why there
is no exposure to the environment.
C3.2
Specify the relevant phases in
the life cycle of the microorganism that are taken into
account in the risk assessment
Specify which phase that is taken into
account in the risk assessment, e.g.
spore, as well as in which phase relevant
toxins/metabolites are produced.
Specify which toxins/metabolites that are
taken into account in the risk
assessment.
C3.3
Specify the scenario/model that
has been used for the calculation
of nominal amount of the active
micro-organism and/or relevant
metabolite/toxin in the
respective recipient
See relevant
ESD
For the correct calculation method see
respective ESD for every use and product
type or use recommended models. Also
field trials for the proposed use during
representative environmental conditions
or other relevant mathematical
model/theoretical discussion can be
applied.
C3.4
Specify nominal amount of the
active micro-organism and/or
relevant metabolite/toxin in the
respective recipient.
Quantitative approximation of the
nominal amount in all relevant
compartments of the environment.
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C-form: Risk assessment and summary of the biological biocidal product
Point
Data requirements
C3.5
Specify the studies that have
been used for calculation of
predicted no effect
concentration and where
relevant together with
respective safety factor.
Information/value
Reference to the application
Reference to
guidance
See TGD for
guidance in
selection of
applicable
test and
safety factor
Give the lowest NOEC for the active
micro-organism and/or relevant
metabolites/toxins and applicable safety
factor for relevant metabolites/toxins.
C3.6
Specify the obtained nominal
risk quotient (predicted
environmental concentration/
predicted no effect
concentration) for every active
micro-organism and/or relevant
metabolite/toxin for all
recipients that have been risk
assessed.
C3.7
Summary of effects, fate and
behaviour in the environment
and overall evaluation
A discussion on the risks with the
proposed use based mainly on the
quantitative risk assessment (3.6 above).
C3.8
Risk reduction mitigations
overall
C3.9
Risk assessment – overall
conclusions and
recommendations
December 2011
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