CA-May15-Doc.4.7.rev1

<eCA> / Product name / PT

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 textswhen providing the PAR.

Explanatory note for the use of this template:

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

2.ASSESSMENT REPORT

2.1. summary of the product assessment

2.1.1. Administrative information

A.trade name of the product / Trade name(s) of the products of the family

B.Authorisation holder

C.Manufacturer(s) of the products of the family

D.Manufacturer(s) of the active substance(s)

2.1.2. Product (family) composition and formulation

A.Identity of the active substance

B.Candidate(s) for substitution

C.Qualitative and quantitative information on the composition of the biocidal product

D.Qualitative and quantitative information on the composition of the biocidal product family2

E.Information on technical equivalence

F.Information on the substance(s) of concern

G.Type of formulation

2.1.3. Authorised use(s)

2.1.4. Hazard and precautionary statements

2.1.5 Packaging of the biocidal product

2.1.6. Directions for use

A.Instructions for use

B.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

C.Instructions for safe disposal of the product and its packaging

D.Conditions of storage and shelf-life of the product under normal conditions of storage

2.1.7 Other information

2.2 Assessment of the biocidal product (family)

2.2.1 Physical, chemical and technical properties

2.2.2 Physical hazards and respective characteristics

2.2.3 Methods for detection and identification

2.2.4 Efficacy against target organisms

A.Function and field of use

B.Organisms to be controlled and products, organisms or objects to be protected

C.Effects on target organisms, including unacceptable suffering

D.Mode of action, including time delay

E.Efficacy data

F.Occurrence of resistance and resistance management

G.Known limitations

H.Evaluation of the label claims

I.Relevant information if the product is intended to be authorised for use with other biocidal product(s)

2.2.5 Risk assessment for human health

A.Assessment of effects on Human Health

B.Exposure assessment

C.Risk characterisation for human health

2.2.6 Risk assessment for animal health

2.2.7 Risk assessment for the environment

A.Effects assessment on the environment

B.Exposure assessment

C.Risk characterisation

2.2.8 Measures to protect man, animals and the environment

2.2.9 Assessment of a combination of biocidal products

2.2.10 Comparative assessment

A.Screening phase

B.Tier IA

C.Tier IB

D.Tier II

E.Overall conclusion

3.Annexes

3.1 List of studies for the biocidal product (FAMILY)

3.2 Output tables from exposure assessment tools

3.3 New information on the active substance

3.4 Residue behaviour

3.5 Summaries of the efficacy studies (B.5.10.1-xx)

3.6 Confidential annex

3.7 Other

3.6 Confidential annex

3.6.1 Product (FAMILY) composition and formulation

A.Qualitative and quantitative information on the composition of the biocidal product

B.Qualitative and quantitative information on the composition of the biocidal product family24

C.Qualitative and quantitative information on the composition of the coformulant xy [if relevant]

3.6.2 Information on the substance(s) of concern

1.CONCLUSION

  • [For national authorisation, 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

A.trade nameof the product name / Trade name(s) of the products of the family name
Product (family) nTrade name[1] / Country (if relevant)
B.Authorisation holder
Name and address of the authorisation holder / Name
Address
Authorisation number
Date of the authorisation
Expiry date of the authorisation
C.Manufacturer(s) of the products of the family
Name of manufacturer
Address of manufacturer
Location of manufacturing sites
D.Manufacturer(s) of the active substance(s)
Active substance
Name of manufacturer
Address of manufacturer
Location of manufacturing sites

CA-May15-Doc.4.7.rev1

<eCA> / Product name / PT

2.1.2. 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

A.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
B.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.]

C.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]
D.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
E.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

F.Information on the substance(s) of concern

Please see the confidential annex for further details.

G.Type of formulation

2.1.3. Authorised use(s)

Table 1. Use # 1 – name of the use[4]

Product Type
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 users
Pack sizes and packaging material / Please see the relevant section.

2.1.4. Hazard and precautionary statements[5]

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

2.1.5 Packaging of the biocidal product

Type of packaging / Size/volumeof 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)

2.1.6. Directions for use[LHA(1]

A.Instructions for use[6]

Use # 1 - name of the use[7]

B.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
C.Instructions for safe disposal of the product and its packaging
D.Conditions of storage and shelf-life of the product under normal conditions of storage

2.1.7Other information

Application codes

2.2 Assessment of the biocidal product(family)

2.2.1 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

2.2.2 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

2.2.3 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 residues
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
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

2.2.4 Efficacy against target organisms

  1. Function and field of use

[Please include here the description of the function and the field of use of the biocidal product.]

  1. Organisms to be controlled and products, organisms or objects to be protected

[Please include here the description of the organisms to be controlled and products, organisms or objects to be protected.]

  1. Effects on target organisms, including unacceptable suffering

[Please describe here the effects of the biocidal product on target organism(s).]

  1. Mode of action, including time delay

[Please describe here the mode of action, including time delay.]

  1. Efficacy data

[Please include here any experimental data on the efficacy of the active substance against target organism(s).]

Experimental data on the efficacy of the biocidal product against target organism(s)
Function / Field of use envisaged / Test substance / Test organism(s) / Test method / Test system / concentrations applied / exposure time / Test results: effects / Reference

[Please insert/delete rows according to the number of studies.]

Conclusion on the efficacy of the product
  1. Occurrence of resistance and resistance management

[Please describe here the occurrence or possible occurrence of the development of resistance and appropriate management strategies.]

  1. Known limitations

[Please describe here any known limitations on efficacy, including observations on undesirable or unintended side effects.]

  1. Evaluation of the label claims

[Please include here the assessment on how efficacy of the product is reflected in the label claim.]

  1. Relevant information if the product is intended to be authorised for use with other biocidal product(s)

2.2.5 Risk assessment for human health

[Please indicate in the following sections whether new data/information on human health and exposure is for the product or for the active substance(s) due to differences in product composition and/or intended use (compared to representative product(s) for the active substance(s)listed in the Union list of approved active substances under Regulation No. 528/2012.

If no new data/information is required and if the product applied for authorisation is identical to the example product in the CAR, a very short summary of the human health risk assessment can be presented here which could be copied from the assessment report or from the CAR.]

  1. Assessment of effects on Human Health

Skin corrosion and irritation

[If no data is provided, please delete the table and indicate the justification for the adaptation/waiving of the data requirement(s), including a reference to the IUCLID data point.]

Summary table of in vitro studies on skin corrosion/irritation
Method,
Guideline,
GLP status, Reliability / Test substance, Doses / Relevant information about the study / Results / Remarks (e.g. major deviations) / Reference

[Please insert/delete rows according to the number of studies.]

Summary table of animal studies on skin corrosion /irritation
Method,
Guideline,
GLP status, Reliability / Species,
Strain,
Sex,
No/group / Test substance, Vehicle, Dose levels,
Duration of exposure / Results
Average score(24, 48, 72h)/
observations and time point of onset, reversibility; other adverse local / systemic effects, histopathological
findings / Remarks (e.g. major deviations) / Reference

[Please insert/delete rows according to the number of studies.]

Summary table of human data on skin corrosion irritation
Type of data/ report, Reliability / Test substance / Relevant information about the study / Observations / Reference

[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]

Conclusion used in Risk Assessment – Skin corrosion and irritation
Value/conclusion
Justification for the value/conclusion
Classification of the product according to CLP and DSD / [Please include a proposal if relevant]
Data waiving
Information requirement
Justification

[If not relevant, delete the table.]

Eye irritation

[If no data is provided, please delete the table and indicate the justification for the adaptation/waiving of the data requirement(s), including a reference to the IUCLID data point.]

Summary table of in vitro studies on serious eye damage and eye irritation
Method,
Guideline,
GLP status, Reliability / Test substance, Doses / Relevant information about the study / Results / Remarks (e.g. major deviations) / Reference

[Please insert/delete rows according to the number of studies.]

Summary table of animal studies on serious eye damage and eye irritation
Method,
Guideline,
GLP status, Reliability / Species,
Strain,
Sex,
No/group / Test substance,Dose levels, Duration of exposure / Results
Average score (24, 48, 72h)/
observations and time point of onset, reversibility / Remarks (e.g. major deviations) / Reference

[Please insert/delete rows according to the number of studies.]

Summary table of human data on serious eye damage and eye irritation
Type of data/ report, Reliability / Test substance / Relevant information about the study / Observations / Reference

[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]

Conclusion used in Risk Assessment – Eye irritation
Value/conclusion
Justification for the value/conclusion
Classification of the product according to CLP and DSD / [Please include a proposal if relevant]
Data waiving
Information requirement
Justification

[If not relevant, delete the table.]

Respiratory tract irritation

[If no data is provided, please delete the table and indicate the justification for the adaptation/waiving of the data requirement(s), including a reference to the IUCLID data point.]

Summary table of animal studies on respiratory tract irritation
Method,
Guideline,
GLP status, Reliability / Species,
Strain,
Sex,
No/group / Test substance
Dose levels,
Duration of exposure / Results
Clinical signs, histopathology, reversibility / Remarks
(e.g. major deviations) / Reference

[Please insert/delete rows according to the number of studies.]

Summary table of human data on respiratory tract irritation
Type of data/ report, Reliability / Test substance / Relevant information about the study / Observations / Reference

[Please insert/delete rows according to the number of studies. If not relevant, delete the table and include a statement that no human data is available.]

Conclusion used in the Risk Assessment – Respiratory tract irritation
Justification for the conclusion
Classification of the product according to CLP and DSD / [Please include a proposal if relevant]
Data waiving
Information requirement
Justification

[If not relevant, delete the table.]