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 approvalof a biocidal product in Swedenmust 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 micro-organisms 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:
Point / Data requirements / Information/value / Reference to the application / Referencetoguidance

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 micro-organisms
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.
C2.4 / Exposure to metabolites/toxins
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). / “Guidance Document on Dermal Absorption”
C2.7 / Oral absorption (%)
Only relevant for setting an AOEL value.
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. / For information, see TNsG on Annex I inclusion.
C2.9 / Specify the NOAEL(s) which the risk assessment is based on (CFU/kg/day or mg/kg/day)
Specify NOAEL for the active micro-organism 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 micro-organism 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. / For information, see TNsG on Annex I inclusion.
C2.11.2 / Exposure/AOEL
This quotient should be ≤1 for the exposure to be acceptable. / For information, see TNsG on Annex I inclusion.
C2.12 / Information on pathogenicity and infectivity
C2.13 / Summary of toxicity, pathogenicity and infectivity for mammals and overall evaluation (from form B)
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).

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 respective ESD for every use and product type or a discussion on why there is no exposure to the environment. / See relevant ESD
C3.2 / Specify the relevant phases in the life cycle of the micro-organism 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
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. / See relevant ESD
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.
C3.5 / Specify the studies that have been used for calculation of predicted no effect concentration and where relevant together with respective safety factor.
Give the lowest NOEC for the active micro-organism and/or relevant metabolites/toxins and applicable safety factor for relevant metabolites/toxins. / See TGD for guidance in selection of applicable test and safety factor
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

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