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Great Britain

Regulation (EU) No 528/2012 as it applies in Great Britain (theGB Biocidal Products Regulation (GB BPR))

Evaluation of a biocidal product (family)

(Draft)Simplified authorisation (Product) Assessment Report

Great Britain

27

Guidance

For further guidance visit https://www.hse.gov.uk/biocides/product-authorisation-overview.htm.

Where there is no GB-specific guidance, reference is made to relevant technical guidance for the EU Biocidal Products Regulation (EU BPR), as the two sets of legislation are very similar.

Sections 1 is to be completed by the Competent Authority only.

Applicants should complete all other sections from Section 2 onwards.

Explanatory notes and other text that should be deleted is marked as follows:

[Italics – green writing]

Examples and indications of the text that should be provided for some areas are marked as follows:

Great Britain

Table of contents

1.Conclusion5

1.1.Summary of decisions and restrictions5

1.1.1.Usage area5

1.1.2.Pest and application rate5

1.1.3.Active substance details5

1.1.4.Eligibility for the simplified authorisation procedure5

1.1.5.Comparative assessment and authorisation6

1.2.Necessary issues accounted for in the product label6

1.3.Requirement for further information6

2.Assessment report7

2.1.Summary of the product assessment7

2.1.1.Administrative information7

2.1.2.Product (family) composition and formulation8

2.1.3.Hazard and precautionary statements11

2.1.4.Authorised use(s)12

2.1.5.General directions for use13

2.1.6.Other information14

2.1.7.Packaging of the biocidal product14

2.1.8.Documentation14

2.2.Assessment of the biocidal product (family)15

2.2.1.Intended use(s) as applied for by the applicant15

2.2.2.Physical, chemical and technical properties16

2.2.3.Physical hazards and respective characteristics19

2.2.4.Methods for detection and identification19

2.2.5.Efficacy against target organisms21

2.2.6.Risk assessment for human health24

2.2.7.Risk assessment for the environment24

3.Annexes25

3.1.List of studies for the biocidal product (family)25

3.2.Output tables from exposure assessment tools26

3.3.New information on the active substance26

3.4.Residue behaviour26

3.5.Summaries of the efficacy studies26

3.6.Confidential annex26

3.6.1.Product (family) composition and formulation26

3.6.2.Information on the substance(s) of concern27

3.7.Other27

1. Conclusion

[To be completed by the Competent Authority only.]

1.1. Summary of decisions and restrictions

It is concluded after evaluation, that sufficient data have been provided to verify the outcome and conclusions, and permit authorisation of the biocidal product (family) in accordance with Article 25 of Regulation (EU) No. 528/2012 as it applies in Great Britain (the GB Biocidal Products Regulation (GB BPR)), subject to the following conditions:

1.1.1. Usage area

User

Usage area

1.1.2. Pest and application rate1.1.3. Active substance details

The concentration of the active substance in the biocidal product is w/w.

[If relevant]The source of is the same as that considered at active substance approval.

[If relevant]The applicant has a letter of access to the list of endpoints and active substance dossier agreed at active substance approval ().

is included on the GB Simplified Active Substance List under Category .

1.1.4. Eligibility for the simplified authorisation procedure

Following evaluation, the product (family) has been shown to meet the conditions required for simplified authorisation as defined in Article 25 of GB BPR i.e.:

1. The active substance appears on the GB Simplified Active Substance List with no restrictions applied.

2. The biocidal product contains no substances of concern.

3. The biocidal product does not contain any nanomaterials.

4. The use pattern and associated label claims of the biocidal product have been judged sufficiently effective.

5. The handling of the biocidal product as part of its intended use does not require any PPE.

1.1.5. Comparative assessment and authorisation

does not meet the conditions laid down in Article 10 of GB BPR, and therefore is not considered as a candidate for substitution.

1.1.6. Endocrine disruption assessment

1.2. Necessary issues accounted for in the product label1.3. Requirement for further information

2. Assessment report2.1. Summary of the product assessment2.1.1. Administrative information2.1.1.1. Identifier of the product (family)

2.1.1.2. Authorisation holder

Authorisation holder name

Authorisation holder address

Authorisation number

Date of the authorisation

Expiry date of the authorisation

2.1.1.3. Manufacturer(s) of the product (products of the family)

Manufacturer name

Manufacturer address

Location of manufacturing sites

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

Active substance

Manufacturer name

Manufacturer address

Location of manufacturing sites

2.1.2. Product (family) composition and formulation

[The full composition of the product according to GB BPR 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 listing of the active substance on the GB Simplified Active Substance List?[Delete if not relevant.]

Yes|_|

No|_|

2.1.2.1. Identity of the active substanceMain constituents

ISO name

IUPAC name

CAS number

EC number

Index number in Annex VI of GB CLP

Minimum purity / content

Structural formula

2.1.2.2. Candidate(s) for substitution

does not meet the conditions laid down in Article 10 of GB BPR, and therefore is not considered as a candidate for substitution.

is included on the GB Simplified Active Substance List under Category .

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

[Delete this heading and table if the assessment is of a product family.]

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

[Formulation details in this section are non-confidential and must include the active substance(s).

Other non-confidential co-formulants, such as Substances of Concern (SoCs) and other substances that users of the product need to be aware of in order to properly use the product, must also be included. (Substances that users of the product need to be aware of in order to properly use the product should be assessed on a case-by-case basis and may depend on their properties and function.)

Where the active substance(s) are the only non-confidential components, the last row of the table should state the total contents of non-active substances in the formulation.]

The full formulation composition details are contained within the confidential annex 3.6.1. The biocidal product does not contain nanomaterials.

2.1.2.4. Qualitative and quantitative information on the composition of the biocidal product family

[Delete this heading and table if the assessment is not of a product family.]

Common name

IUPAC name

Function

CAS number

EC number

Minimum Content (%)

Maximum Content (%)

[Formulation details in this section are non-confidential and must include the active substance(s).

Other non-confidential co-formulants, such as Substances of Concern (SoCs) and other substances that users of the product need to be aware of in order to properly use the product, must also be included. (Substances that users of the product need to be aware of in order to properly use the product should be assessed on a case-by-case basis and may depend on their properties and function.)

Where the active substance(s) are the only non-confidential components, the last row of the table should state the total contents of non-active substances in the formulation.]

The full formulation composition details are contained within the confidential annex 3.6.1. The biocidal product family does not contain nanomaterials.

2.1.2.5. Information on technical equivalence

The active substance is included on the GB Simplified Active Substance List and therefore technical equivalence is not required at this time.

2.1.2.6. Information on the substance(s) of concern2.1.2.7. Type of formulation

2.1.3. 2.1.4. Hazard and precautionary statementsClassification and labelling of the product (products of the family) according to Regulation (EC) No 1272/2008 as it applies in Great Britain (GB) (GB Classification, Labelling and Packaging of substances and mixtures Regulation (GB CLP))

[For microorganism-based products, this section must address any need for the biocidal product to carry the biohazard sign specified in Part IV of Schedule 3 of the Control of Substances Hazardous to Health Regulations 2002 (COSHH).]

Classification according to GB CLP

Hazard category

Hazard statement

Labelling

Signal Words

Hazard Statements

Precautionary statements

Note

2.1.5. 2.1.6. Authorised use(s)

[Please provide details of the different uses of the product. Uses should be defined as appropriate based on shared characteristics, such as application methods, pack sizes, instructions for use, risk mitigation measures etc.

Each section should describe one single use of the product. This section can be copied as many times as required for the number of uses, for example you may have one use for general public users and a separate use for professional users. The information provided in each section should be specific for the use indicated. Other general instructions for use that are shared across all uses should be included in section 2.1.5.]

2.1.6.1. Use descriptionTable 1. Use #1 -

Product type

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Field(s) of use

Application method(s)

Application rate(s) and frequency

Category(ies) of users

Pack sizes and packaging material

2.1.6.2. Use-specific instructions for use – Use #1 -

2.1.6.3. Use-specific risk mitigation measures – Use #1 -

2.1.6.4. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment – Use #1 -

2.1.6.5. Where specific to the use, the instructions for safe disposal of the product and its packaging – Use #1 -

2.1.6.6. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage – Use #1 -

2.1.7. General directions for use

[The information provided in this section should be common to all the uses indicated in section 2.1.4. Instructions for use that are specific to a particular use and not another e.g. professional use not general public use, should be included in the appropriate use-section within section 2.1.4.]

2.1.7.1. Instructions for use

2.1.7.2. Risk mitigation measures

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

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

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

2.1.8. Other information

2.1.9. 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, general public)

Compatibility of the product with the proposed packaging materials (Yes/No)

2.1.10. Documentation2.1.10.1. Data submitted in relation to product application

2.1.10.2. Access to documentation

2.2. Assessment of the biocidal product (family)2.2.1. Intended use(s) as applied for by the applicant

[Please provide details of the different uses of the product. Uses should be defined as appropriate based on shared characteristics, such as application methods, pack sizes, instructions for use, risk mitigation measures etc.

Each section should describe one single use of the product. This section can be copied as many times as required for the number of uses, for example you may have one use for general public users and a separate use for professional users. The information provided in each section should be specific for the use indicated.]

Table 1. Intended use #1 -

Product type

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Field(s) of use

Application method(s)

Application rate(s) and frequency

Category(ies) of users

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

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 characteristicsConclusion on the physical hazards and respective characteristics of the product

2.2.4. Methods for detection and identification

Analytical methods for the analysis of the product as such including the active substance, impurities and residues

The active substance is included on the GB Simplified Active Substance List and therefore no further consideration is required.

Analytical methods for monitoring

Conclusion on the methods for detection and identification of the product

Great Britain

2.2.5. Efficacy against target organisms2.2.5.1. Function and field of use

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

2.2.5.3. Effects on target organisms, including unacceptable suffering

2.2.5.4. Mode of action

Great Britain

2.2.5.5. 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

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

Great Britain

Conclusion on the efficacy of the product

2.2.5.6. Occurrence of resistance and resistance management

2.2.5.7. Known limitations

2.2.5.8. Evaluation of the label claims

Great Britain

2.2.5.9. Relevant information if the product is intended to be authorised for use with other biocidal products2.2.6. Risk assessment for human health2.2.6.1. Assessment of effects on human health

[Please provide a summary of the effects of the biocidal product (family) on human health, considering the criteria for simplified authorisation.]

2.2.6.2. Exposure assessment

[Please provide a summary of the assessment of exposureto the biocidal product (family), considering the criteria for simplified authorisation.]

2.2.6.3. Risk characterisation for human health

[Please provide a summary of the risk characterisation for human health, considering the criteria for simplified authorisation.]

2.2.7. Risk assessment for the environment

[Please provide a summary of the risk assessment for the environment, considering the criteria for simplified authorisation.]

3. Annexes3.1. List of studies for the biocidal product (family)

Section No. / Reference No.

Author(s)

Year

Title, Source (where different from company), Company, Report No., GLP (where relevant) / (Un)Published

Vertebrate study(Yes/No)

Data protection claimed(Yes/No)

Data protection expiry date

Owner

Great Britain

3.2. Output tables from exposure assessment tools

[Indicate if not relevant.]

3.3. New information on the active substance


3.4. Residue behaviour


3.5. Summaries of the efficacy studies

[If an IUCLID file is not available, please indicate here the summaries of the efficacy studies.]


3.6. Confidential annex

N.B. This information is confidential and should not be disclosed to third parties.

3.6.1. Product (family) composition and formulation3.6.1.1. Qualitative and quantitative information on the composition of the biocidal product

[Delete this heading and table if the assessment is of a product family.]

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

[Formulation details in this section are confidential and must include all co-formulants.]

[Add / delete rows as required.]

3.6.1.2. Qualitative and quantitative information on the composition of the biocidal product family

[Delete this heading and table if the assessment is not of a product family.]

Common name

IUPAC name

Function

CAS number

EC number

Minimum Content (%)

Maximum Content (%)

[Formulation details in this section are confidential and must include all co-formulants.]

[Add / delete rows as required.]

[Please include in the table only the range of composition of the biocidal product family. The full composition of the individual members of the family should be reported in the separate excel file embedded below.]

3.6.1.3. Qualitative and quantitative information on the composition of the co-formulant [If relevant.]

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

[Please insert one line for each co-formulant.]

3.6.2. Information on the substance(s) of concern

No substances of concern identified.

3.6.3. Endocrine disruption assessment

3.7. Other


Full

composition_Members.xlsx

Sheet1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Active substanceNon-active substance

Please insert/delete rows accordingly

Sheet2

Sheet3

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