Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products
DRAFT RISK ASSESSMENT OF A BIOCIDAL PRODUCT (FAMILY) FOR NATIONAL AUTHORISATION APPLICATIONS
(submitted by the applicant)
[or]
PRODUCT ASSESSMENT REPORT OF A BIOCIDAL PRODUCT (FAMILY) FOR NATIONAL AUTHORISATION APPLICATIONS
(submitted by the evaluating Competent Authority)
[Product name(s)]
Product type(s) [X]
[Active substance name as included in the Union list of approved active substances]
Case Number in R4BP: [xxx]
Evaluating Competent Authority: [eCA]
Date: [day/month/year]
In this template:
· Explanatory notes are marked as follows:
[Times New Roman – Italics – brackets]
· Examples provided for some areas are marked as follows:
Times New Roman – Italics – red writing
· Other text that should be deleted is marked as follows:
[Times New Roman – Italics – brackets]
The eCA should delete all these texts when providing the PAR.
Explanatory note for the use of this template:
The PAR (i.e. “DRAFT RISK ASSESSMENT OF A BIOCIDAL PRODUCT (FAMILY) FOR NATIONAL AUTHORISATION APPLICATIONS (submitted by the applicant)”) together with the IUCLID file and the SPC replaces the formerly valid formats of Document I, II and III which were in use under Directive 98/8/EC according the former Guidance document “TNsG on Preparation of Dossiers and Study Evaluation”.
The PAR template should allow for a certain flexibility. Free text may be added, where necessary, and the content of the section may be adapted to the specific needs required for the different product types. Also tables can be added or deleted, when needed.
The PAR template is suitable for both a single biocidal product and a biocidal product family. The content of the template can be adapted accordingly.
Table of Contents
1 CONCLUSION 5
2 ASSESSMENT REPORT 6
2.1 Summary of the product assessment 6
2.1.1 Administrative information 6
2.1.1.1 Identifier of the product / product family 6
2.1.1.2 Authorisation holder 6
2.1.1.3 Manufacturer(s) of the products of the family 6
2.1.1.4 Manufacturer(s) of the active substance(s) 6
2.1.2 Product (family) composition and formulation 7
2.1.2.1 Identity of the active substance 7
2.1.2.2 Candidate(s) for substitution 7
2.1.2.3 Qualitative and quantitative information on the composition of the biocidal product 8
2.1.2.4 Qualitative and quantitative information on the composition of the biocidal product family 8
2.1.2.5 Information on technical equivalence 8
2.1.2.6 Information on the substance(s) of concern 8
2.1.2.7 Type of formulation 8
2.1.3 Hazard and precautionary statements 9
2.1.4 Authorised use(s) 9
2.1.4.1 Use description 9
2.1.4.2 Use-specific instructions for use 10
2.1.4.3 Use-specific risk mitigation measures 10
2.1.4.4 Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment 10
2.1.4.5 Where specific to the use, the instructions for safe disposal of the product and its packaging 10
2.1.4.6 Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage 10
2.1.5 General directions for use 11
2.1.5.1 Instructions for use 11
2.1.5.2 Risk mitigation measures 11
2.1.5.3 Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment 11
2.1.5.4 Instructions for safe disposal of the product and its packaging 11
2.1.5.5 Conditions of storage and shelf-life of the product under normal conditions of storage 11
2.1.6 Other information 11
2.1.7 Packaging of the biocidal product 11
2.1.8 Documentation 12
2.1.8.1 Data submitted in relation to product application 12
2.1.8.2 Access to documentation 12
2.2 Assessment of the biocidal product (family) 13
2.2.1 Intended use(s) as applied for by the applicant 13
2.2.2 Physical, chemical and technical properties 13
2.2.3 Physical hazards and respective characteristics 15
2.2.4 Methods for detection and identification 16
2.2.5 Efficacy against target organisms 18
2.2.5.1 Function and field of use 18
2.2.5.2 Organisms to be controlled and products, organisms or objects to be protected 18
2.2.5.3 Effects on target organisms, including unacceptable suffering 19
2.2.5.4 Mode of action, including time delay 19
2.2.5.5 Efficacy data 19
2.2.5.6 Occurrence of resistance and resistance management 19
2.2.5.7 Known limitations 19
2.2.5.8 Evaluation of the label claims 19
2.2.5.9 Relevant information if the product is intended to be authorised for use with other biocidal product(s) 19
2.2.6 Risk assessment for human health 20
2.2.6.1 Assessment of effects on Human Health 20
2.2.6.2 Exposure assessment 30
2.2.6.3 Risk characterisation for human health 42
2.2.7 Risk assessment for animal health 46
2.2.8 Risk assessment for the environment 46
2.2.8.1 Effects assessment on the environment 46
2.2.8.2 Exposure assessment 59
2.2.8.3 Risk characterisation 63
2.2.9 Measures to protect man, animals and the environment 68
2.2.10 Assessment of a combination of biocidal products 68
2.2.11 Comparative assessment 68
2.2.11.1 Screening phase 68
2.2.11.2 Tier IA 68
2.2.11.3 Tier IB 68
2.2.11.4 Tier II 69
2.2.11.5 Overall conclusion 69
3 Annexes 70
3.1 List of studies for the biocidal product (FAMILY) 70
3.2 Output tables from exposure assessment tools 70
3.3 New information on the active substance 70
3.4 Residue behaviour 70
3.5 Summaries of the efficacy studies (B.5.10.1-xx) 70
3.6 Confidential annex 70
3.7 Other 70
1 CONCLUSION
The CA should provide a general conclusion on the application.
2 ASSESSMENT REPORT
2.1 Summary of the product assessment
2.1.1 Administrative information
2.1.1.1 Identifier of the product / product family
Identifier[1] / Country (if relevant) /2.1.1.2 Authorisation holder
Name and address of the authorisation holder / NameAddress
Authorisation number
Date of the authorisation
Expiry date of the authorisation
2.1.1.3 Manufacturer(s) of the products of the family
Name of manufacturerAddress of manufacturer
Location of manufacturing sites
2.1.1.4 Manufacturer(s) of the active substance(s)
Active substanceName of manufacturer
Address of manufacturer
Location of manufacturing sites
72
<eCA> / Product name / PT2.1.2 Product (family) composition and formulation
NB: the full composition of the product according to Annex III Title 1 should be provided in the confidential annex.
Does the product have the same identity and composition as the product evaluated in connection with the approval for listing of the active substance(s) on the Union list of approved active substances under Regulation No. 528/2012?
Yes
No
2.1.2.1 Identity of the active substance
Main constituent(s)ISO name
IUPAC or EC name
EC number
CAS number
Index number in Annex VI of CLP
Minimum purity / content
Structural formula
2.1.2.2 Candidate(s) for substitution
[If the active substance(s) contained in the biocidal products is/are candidate(s) for substitution in accordance with Article 10 of BPR, please indicate here which criteria for substitution are met and the outcome of the public consultation.]
2.1.2.3 Qualitative and quantitative information on the composition of the biocidal product[2]
Common name / IUPAC name / Function / CAS number / EC number / Content (%) /Active substance
Non-active substance[3]
2.1.2.4 Qualitative and quantitative information on the composition of the biocidal product family2
Common name / IUPAC name / Function / CAS number / EC number / Content (%) /Min / Max
Active substance
Non-active substance3
2.1.2.5 Information on technical equivalence
[Please indicate here the results of the assessment of technical equivalence of the active substance(s) contained in the product and the active substance(s) listed in the Union list of approved active substances under Regulation No. 528/2012.]
2.1.2.6 Information on the substance(s) of concern
Please see the confidential annex for further details.
2.1.2.7 Type of formulation
2.1.3 Hazard and precautionary statements[4]
Classification and labelling of the products of the family according to the Regulation (EC) 1272/2008
[It should also be stated if some P statements triggered by the criteria in CLP has been excluded due to the risk assessment.]
Classification /Hazard category /
Hazard statement /
Labelling /
Signal words /
Hazard statements /
Precautionary statements /
Note /
2.1.4 Authorised use(s)
2.1.4.1 Use description[5]
Table 1. Use # 1 – name of the use
Product TypeWhere relevant, an exact description of the authorised use
Target organism (including development stage)
Field of use
Application method(s)
Application rate(s) and frequency
Category(ies) of users
Pack sizes and packaging material / Please see the relevant section.
2.1.4.2 Use-specific instructions for use[6]
2.1.4.3 Use-specific risk mitigation measures
2.1.4.4 Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
2.1.4.5 Where specific to the use, the instructions for safe disposal of the product and its packaging
2.1.4.6 Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
2.1.5 General directions for use
2.1.5.1 Instructions for use[7]
2.1.5.2 Risk mitigation measures
2.1.5.3 Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
2.1.5.4 Instructions for safe disposal of the product and its packaging
2.1.5.5 Conditions of storage and shelf-life of the product under normal conditions of storage
2.1.6 Other information
Application codes2.1.7 Packaging of the biocidal product
Type of packaging / Size/volume of the packaging / Material of the packaging / Type and material of closure(s) / Intended user (e.g. professional, non-professional) / Compatibility of the product with the proposed packaging materials (Yes/No)2.1.8 Documentation
2.1.8.1 Data submitted in relation to product application
[Please indicate here whether any new data on the product or on the active substace(s) and substance(s) of concern contained in the product have been submitted. A reference to a reference list can be made.]
2.1.8.2 Access to documentation
[Please indicate here whether the applicant has submitted a letter of acces. It must be clear to which data access is granted.]
2.2 Assessment of the biocidal product (family)
2.2.1 Intended use(s) as applied for by the applicant
Table 1. Intended use # 1 – name of the use[8]
Product Type(s)Where relevant, an exact description of the authorised use
Target organism (including development stage)
Field of use
Application method(s)
Application rate(s) and frequency
Category(ies) of user(s)
Pack sizes and packaging material
2.2.2 Physical, chemical and technical properties
Property / Guideline and Method / Purity of the test substance (% (w/w) / Results / Reference /Physical state at 20 °C and 101.3 kPa
Colour at 20 °C and 101.3 kPa
Odour at 20 °C and 101.3 kPa
Acidity / alkalinity
Relative density / bulk density
Storage stability test – accelerated storage
Storage stability test – long term storage at ambient temperature
Storage stability test – low temperature stability test for liquids
Effects on content of the active substance and technical characteristics of the biocidal product - light
Effects on content of the active substance and technical characteristics of the biocidal product – temperature and humidity
Effects on content of the active substance and technical characteristics of the biocidal product - reactivity towards container material
Wettability
Suspensibility, spontaneity and dispersion stability
Wet sieve analysis and dry sieve test
Emulsifiability, re-emulsifiability and emulsion stability
Disintegration time
Particle size distribution, content of dust/fines, attrition, friability
Persistent foaming
Flowability/Pourability/Dustability
Burning rate — smoke generators
Burning completeness — smoke generators
Composition of smoke — smoke generators
Spraying pattern — aerosols
Physical compatibility
Chemical compatibility
Degree of dissolution and dilution stability
Surface tension
Viscosity
Conclusion on the physical, chemical and technical properties of the product
2.2.3 Physical hazards and respective characteristics
Property / Guideline and Method / Purity of the test substance (% (w/w) / Results / Reference /Explosives
Flammable gases
Flammable aerosols
Oxidising gases
Gases under pressure
Flammable liquids
Flammable solids
Self-reactive substances and mixtures
Pyrophoric liquids
Pyrophoric solids
Self-heating substances and mixtures
Substances and mixtures which in contact with water emit flammable gases
Oxidising liquids
Oxidising solids
Organic peroxides
Corrosive to metals
Auto-ignition temperatures of products (liquids and gases)
Relative self-ignition temperature for solids
Dust explosion hazard
Conclusion on the physical hazards and respective characteristics of the product
2.2.4 Methods for detection and identification
[Description of analytical methods used for the analysis of the active substance(s), residues, relevant impurities and substances of concern in the biocidal product]
Analytical methods for the analysis of the product as such including the active substance, impurities and residuesAnalyte (type of analyte e.g. active substance) / Analytical method / Fortification range / Number of measurements / Linearity / Specificity / Recovery rate (%) / Limit of quantification (LOQ) or other limits / Reference
Range / Mean / RSD
Analytical methods for monitoring
Analyte (type of analyte e.g. active substance) / Analytical method / Fortification range / Number of measurements / Linearity / Specificity / Recovery rate (%) / Limit of quantification (LOQ) or other limits / Reference
Range / Mean / RSD
Analytical methods for soil
Analyte (type of analyte e.g. active substance) / Analytical method / Fortification range / Number of measurements / Linearity / Specificity / Recovery rate (%) / Limit of quantification (LOQ) or other limits / Reference
Range / Mean / RSD
Analytical methods for air
Analyte (type of analyte e.g. active substance) / Analytical method / Fortification range / Number of measurements / Linearity / Specificity / Recovery rate (%) / Limit of quantification (LOQ) or other limits / Reference
Range / Mean / RSD
Analytical methods for water
Analyte (type of analyte e.g. active substance) / Analytical method / Fortification range / Number of measurements / Linearity / Specificity / Recovery rate (%) / Limit of quantification (LOQ) or other limits / Reference
Range / Mean / RSD
Analytical methods for animal and human body fluids and tisues
Analyte (type of analyte e.g. active substance) / Analytical method / Fortification range / Number of measurements / Linearity / Specificity / Recovery rate (%) / Limit of quantification (LOQ) or other limits / Reference
Range / Mean / RSD
Analytical methods for monitoring of active substances and residues in food and feeding stuff
Analyte (type of analyte e.g. active substance) / Analytical method / Fortification range / Number of measurements / Linearity / Specificity / Recovery rate (%) / Limit of quantification (LOQ) or other limits / Reference
Range / Mean / RSD
Conclusion on the methods for detection and identificationof the product
2.2.5 Efficacy against target organisms
2.2.5.1 Function and field of use