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Application form for biocidal product / biocidal product family authorisation, amendment or renewal under the GB Biocidal Products Regulation (GB BPR)

This form is for companies who are:

making a new application

resubmitting a pending application, in accordance with the EU Exit transitional provisions

resubmitting data to support an existing authorisation in Great Britain (GB), in accordance with the EU Exit transitional provisions

1

Introduction

Introduction

Please send completed application forms by email to: [email protected]

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

Form sectionsSection 1 – Application details..............................................................................3Section 2 – New application...................................................................................5Section 2a – New same biocidal products............................................................9Section 2b – New changes...................................................................................10Section 2c – New renewals...................................................................................12Section 3 – Resubmission of a pending application.........................................13Section 3a – Resubmission of same biocidal products....................................20Section 3b – Resubmission of changes..............................................................21Section 3c – Resubmission of renewals.............................................................23Section 4 – Resubmission of data to support an existing authorisation in GB................................................................................................................................24Section 5 – Company details................................................................................28Section 6 – Checklist............................................................................................30Section 7 – Declaration.........................................................................................39

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https://www.hse.gov.uk/biocides/product-authorisation-overview.htm

mailto:[email protected]

Section 4 – Resubmission of data to support an existing authorisation in GBProduct types

Section 1 – Application details

Complete this section for all applications.

Application type

Please mark the relevant box for the type of application you wish to make.

New application

New applications can be made for:

national authorisation of a biocidal product or biocidal product family

simplified authorisation of a biocidal product or biocidal product family

a same biocidal product or biocidal product family

an administrative, minor or major change to a national or simplified authorisation of a biocidal product or biocidal product family

an administrative change to a national or simplified authorisation of a biocidal product / biocidal product family as a direct result of EU Exit e.g. change to UK authorisation holder or supplier on the GB Article 95 List

renewal of a national authorisation of a biocidal product or biocidal product family

Resubmission of a pending application, in accordance with the EU Exit transitional provisions

Pending applications are those that were submitted to and accepted by the UK or ECHA under EU BPR prior to 01 January 2021 and no decision was taken for the UK market by 31 December 2020.

This includes applications for:

national authorisation of a biocidal product or biocidal product family, as well as those originally made through the EU mutual recognition process or through the EU Union authorisation process

simplified authorisation of a biocidal product or biocidal product family

any type of same biocidal product or biocidal product family

an administrative, minor or major change to a national or simplified authorisation of a biocidal product or biocidal product family, as well as those originally made through the EU mutual recognition process or through the EU Union authorisation process

renewal of a national authorisation of a biocidal product or biocidal product family, as well as those originally made through the EU mutual recognition process or through the EU Union authorisation process

3


Resubmission of data to support an existing authorisation in GB, in accordance with the EU Exit transitional provisions

All existing product authorisations that are valid in Great Britain (GB) will continue to be valid in GB after 31 December 2020. If requested by HSE, you may need to resubmit the data that supports an existing authorisation, including:

national authorisations, as well as those originally granted via mutual recognition and the same biocidal product route

simplified authorisations, as well as those originally granted via the same biocidal product route

Union authorisations, as well as those originally granted via the same biocidal product route

☐ New application

☐ Resubmission of a pending application, in accordance with the EU Exit transitional provisions

☐ Resubmission of data to support an existing authorisation in GB, in accordance with the EU Exit transitional provisions

Now go to:

Section 2 - New application

Section 3 - Resubmission of a pending application

Section 4 - Resubmission of data to support an existing authorisation in GB

4


Section 2 – New application

Complete this section if you are making a new application.

Application type

Please mark the relevant box for the type of application you wish to make.

An overview of the types of application can be found at: https://www.hse.gov.uk/biocides/product-authorisation-overview.htm

☐ National authorisation

☐ Simplified authorisation

☐ Same biocidal product (authorised)

☐ Same biocidal product (pending)

☐ Administrative change

☐ Administrative change as a direct result of EU Exit e.g. change to UK authorisation holder or supplier on the GB Article 95 List

☐ Minor change

☐ Major change

☐ Renewal

Authorisation type

Please mark the relevant box to indicate the type of authorisation you wish to apply for i.e. a single biocidal product or a biocidal product family.

An overview of the types of authorisation can be found at: https://www.hse.gov.uk/biocides/product-authorisation-overview.htm

☐ Single biocidal product

☐ Biocidal product family

Product / product family name

This is the primary name of your single biocidal product or the name of your biocidal product family.

Product names must be unique. Check the list of GB authorised biocidal products (https://www.hse.gov.uk/biocides/uk-authorised-biocidal-products.htm) to determine if your proposed product name has already been used.

5

https://www.hse.gov.uk/biocides/uk-authorised-biocidal-products.htm




Click or tap here to enter primary product or family name.

Trade names

Authorisations under GB BPR can cover multiple trade names. Any additional names for the product, or the names of any products included in your biocidal product family should be stated here.

Click or tap here to enter additional product trade names.

Active substance details

Please provide the following details of the active substances in the product or product family – at least one active substance needs to be listed.

Name

For each active substance, please give the name as it appears on the GB List of Active Substances (https://www.hse.gov.uk/biocides/uk-list-active-substances.htm).

CAS / EC number

For each active substance, please provide the unique numeric identifiers assigned by the Chemical Abstracts System (CAS) and / or European Community (EC) as they appear on the GB List of Active Substances (https://www.hse.gov.uk/biocides/uk-list-active-substances.htm).

Active substance name CAS number EC number

Click or tap here to enter active substance name.

Click or tap here to enter active substance CAS number.

Click or tap here to enter active substance EC number.







If you need to enter more active substances, first click or tap anywhere in the last row of the table and a plus sign will appear at the bottom right-hand corner – click or tap on this to add a new row.

Product types

6

https://www.hse.gov.uk/biocides/uk-list-active-substances.htm




Please mark the relevant boxes. Descriptions for each product type are available at: https://www.hse.gov.uk/biocides/basics.htm.If you are not sure which product type(s) your product or product family fits into, please contact us at [email protected] before you submit your application.

☐ PT1 – Human hygiene

☐ PT2 – Disinfectants and algaecides not intended for direct application to humans or animals

☐ PT3 – Veterinary hygiene

☐ PT4 – Food and feed area

☐ PT5 – Drinking water

☐ PT6 – Preservatives for products during storage

☐ PT7 – Film preservatives

☐ PT8 – Wood preservatives

☐ PT9 – Fibre, leather, rubber and polymerised materials preservatives

☐ PT10 – Construction material preservatives

☐ PT11 – Preservatives for liquid-cooling and processing systems

☐ PT12 – Slimicides

☐ PT13 – Working or cutting fluid preservatives

☐ PT14 – Rodenticides

☐ PT15 – Avicides

☐ PT16 – Molluscicides, vermicides and products to control other invertebrates

☐ PT17 – Piscicides

☐ PT18 – Insecticides, acaricides and products to control other arthropods

☐ PT19 – Repellents and attractants

☐ PT20 – Control of other vertebrates

☐ PT21 – Antifouling products

☐ PT22 – Embalming and taxidermist fluids

Now go to:

Section 2a - New same biocidal products

7

https://www.hse.gov.uk/biocides/basics.htm


Section 2b - New changes

Section 2c - New renewals

Section 5 - Company details

8


Section 2a – New same biocidal products

Complete this section if you are applying for any type of new same biocidal product or product family of:

an already authorised product or product family

a pending product or product family authorisation (i.e. where an application has been made but an authorisation has not yet been granted)

Reference product name

Please provide the name of the already authorised or pending product or product family that your application is identical to.

Click or tap here to enter reference product name.

Reference product authorisation number

If the reference product or product family is already authorised, please provide its GB authorisation number. The authorisation number may be prefixed with either UK or GB.

Click or tap here to enter reference product GB authorisation number.

Reference product application reference number

If the reference product or product family is not yet authorised, please provide the reference number for its GB application.

Click or tap here to enter reference product GB application reference number.

Now go to:


9


Section 2b – New changes

Complete this section if you are applying for a new administrative, minor or major change to an already authorised product.

Authorisation number

Please provide the GB authorisation number of the authorisation you wish to change in GB. The authorisation number may be prefixed with either UK or GB.

Click or tap here to enter GB authorisation number.

Summary of the changes requested

You should provide details of any authorisation conditions you would like to add, remove or change. For changes to existing conditions, the current condition as well as the new condition should be given e.g. current name and proposed new name.

For some changes, additional documentation may need to be provided – more information can be found in Section 6.

Click or tap here to enter summary of the changes requested.

Previous changes

Please provide details of any previous changes to the GB authorisation, either under GB BPR or EU BPR, including:

those that are already completed

those that are ongoing

You should include:

the previous change application reference number (either under GB BPR or EU BPR) – this should be the reference number given to you by HSE where possible but may also be the R4BP3 case number (where applicable)

the type of change i.e. administrative, minor, or major

brief details of the change

the date the change was completed or indicate it is ongoing

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Change number

Previous application reference number

Application type

Brief details of the change

Date completed

Ongoing

Click or tap here to enter change number.

Click or tap here to enter application reference number.

Choose an item.

Click or tap here to enter brief details of the change.

Click or tap to enter the date the change was completed.

☐



Choose an item.



☐



Choose an item.



☐



Choose an item.



☐



Choose an item.



☐

If you need to enter more previous changes, first click or tap anywhere in the last row of the table and a plus sign will appear at the bottom right-hand corner – click or tap on this to add a new row.

Now go to:


11


Section 2c – New renewals

Complete this section if you are applying for new renewal of an authorisation.


Please provide the GB authorisation number of the authorisation you wish to renew in GB. The authorisation number may be prefixed with either UK or GB.

Click or tap here to enter GB authorisation number.

Now go to:


12


Section 3 – Resubmission of a pending application

Complete this section if you are resubmitting a pending application in accordance with the EU Exit transitional provisions.

Original application reference number

Please provide the reference number for the original application submitted under EU BPR – this should be the reference number given to you by HSE where possible but may also be the R4BP3 case number.


Stage reached under EU BPR

Please indicate the stage that your original application reached under EU BPR.

Choose an item or enter free text.

Previous reference Member State (rMS) or evaluating Competent Authority (eCA) under EU BPR

Please indicate the reference Member State (rMS) or evaluating Competent Authority (eCA) that was evaluating the original application under EU BPR.

Choose an rMS or eCA.

Application type

Please mark the relevant box for the type of application you are resubmitting.

National authorisation

You are resubmitting a national authorisation in GB if your original application under EU BPR was for:

national authorisation in the UK, including those with related mutual recognitions in another Member State(s)

mutual recognition in the UK, either in sequence or in parallel

Union authorisation

Simplified authorisation

You are resubmitting a simplified authorisation in GB if your original application under EU BPR was for simplified authorisation. This does not include simplified notifications that were made to the UK.

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Same biocidal product (authorised)

You are resubmitting a same biocidal product (authorised) in GB if your original application under EU BPR was for a:

same biocidal product of any existing national authorisation in the UK, including those originally granted via mutual recognition or the same biocidal product route

same biocidal product of any existing simplified authorisation in the EU

same biocidal product of any existing Union authorisation, including those originally applied for as a Union authorisation or national authorisation in the UK

This includes same biocidal products of:

a single product

a whole product family

part of a product family

a single product of a product family

Same biocidal product (pending)

You are resubmitting a same biocidal product (pending) in GB if your original application under EU BPR was for a:

same biocidal product of any pending national authorisation in the UK, including those originally granted via mutual recognition or the same biocidal product route

same biocidal product of any pending simplified authorisation in the EU

same biocidal product of any pending Union authorisation, including those originally applied for as a Union authorisation or national authorisation in the UK

This includes same biocidal products of:

a single product

a whole product family

part of a product family

a single product of a product family

Administrative change

You are resubmitting an administrative change in GB if your original application under EU BPR was for an administrative change to any:

national authorisation in the UK, including those granted via mutual recognition and the same biocidal product route

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simplified authorisation, including those granted via the same biocidal product route

Union authorisation, including those granted via the same biocidal product route

Minor change

You are resubmitting a minor change in GB if your original application under EU BPR was for a minor change to any:




Major change

You are resubmitting a major change in GB if your original application under EU BPR was for a major change to any:




Renewal

You are resubmitting a renewal in GB if your original application under EU BPR was for renewal of any valid:

national authorisation in the UK, including those applied for via mutual recognition and those originally granted via the same biocidal product route

Union authorisation, including those originally granted via the same biocidal product route

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☐ National authorisation

☐ Simplified authorisation

☐ Same biocidal product (authorised)

☐ Same biocidal product (pending)

☐ Administrative change

☐ Minor change

☐ Major change

☐ Renewal

Authorisation type

Please mark the relevant box to indicate the type of authorisation you wish to apply for i.e. a single biocidal product or a biocidal product family.

An overview of the types of authorisation can be found at: https://www.hse.gov.uk/biocides/product-authorisation-overview.htm




This is the primary name of your single biocidal product or the name of your biocidal product family.

Product names must be unique. Check the list of GB authorised biocidal products (https://www.hse.gov.uk/biocides/uk-authorised-biocidal-products.htm) to determine if your proposed product name has already been used.


Trade names

Authorisations under GB BPR can cover multiple trade names. Any additional names for the product, or the names of any products included in your biocidal product family should be stated here.

16

https://www.hse.gov.uk/biocides/uk-authorised-biocidal-products.htm






Name


CAS / EC number












If you need to enter more active substances, first click or tap anywhere in the last row of the table and a plus sign will appear at the bottom right-hand corner – click or tap on this to add a new row.

Product types

Please mark the relevant boxes. Descriptions for each product type are available at: https://www.hse.gov.uk/biocides/basics.htm. If you are not sure which product type(s) your product or product family fits into, please contact us at [email protected] before you submit your application.

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mailto:[email protected]

https://www.hse.gov.uk/biocides/basics.htm



























Now go to:

Section 3a - Resubmission of same biocidal products

Section 3b - Resubmission of changes

18


Section 3c - Resubmission of renewals


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Section 3a – Resubmission of same biocidal products

Complete this section if you are resubmitting a same biocidal product (authorised) or same biocidal product (pending).

Reference product name

Please provide the name of the already authorised or pending product or product family that your application is identical to.

Click or tap here to enter reference product name.

Reference product authorisation number

If the reference product or product family is already authorised, please provide its authorisation number. The authorisation number may be prefixed with either UK or EU depending on whether it was granted as a UK national authorisation, simplified authorisation or Union authorisation.

Click or tap here to enter reference product authorisation number.

Reference product original application reference number

If the reference product or product family is not yet authorised, please provide the reference number for the original application submitted under EU BPR – this should be the reference number given to you by HSE where possible but may also be the R4BP3 case number.

Click or tap here to enter reference product application reference number.

Now go to:


20


Section 3b – Resubmission of changes

Complete this section if you are resubmitting an administrative, minor or major change to an already authorised product.


Please provide the authorisation number of the authorisation you wish to change in GB. The authorisation number may be prefixed with either UK or EU depending on whether it was granted as a UK national authorisation, simplified authorisation or Union authorisation.

Click or tap here to enter authorisation number.

Summary of the changes requested

You should provide details of any authorisation conditions you would like to add, remove or change. For changes to existing conditions, the current condition as well as the new condition should be given e.g. current name and proposed new name.

For some changes, additional documentation may need to be provided – more information can be found in Section 6.

Click or tap here to enter summary of the changes requested.

Previous changes

Please provide details of any previous changes to the authorisation under EU BPR, including:

those that are already completed

those that are ongoing

You should include:

the previous change application reference number – this should be the reference number given to you by HSE where possible but may also be the R4BP3 case number

the type of change i.e. administrative, minor, or major

brief details of the change

the date the change was completed or indicate it is ongoing

21


Change number

Previous application reference number

Application type

Brief details of the change

Date completed

Ongoing



Choose an item.



☐



Choose an item.



☐



Choose an item.



☐



Choose an item.



☐



Choose an item.



☐

If you need to enter more previous changes, first click or tap anywhere in the last row of the table and a plus sign will appear at the bottom right-hand corner – click or tap on this to add a new row.

Now go to:


22


Section 3c – Resubmission of renewals

Complete this section if you are resubmitting an application for renewal of an authorisation.


Please provide the authorisation number of the authorisation you wish to renew in GB. The authorisation number may be prefixed with either UK or EU depending on whether it was granted as a UK national authorisation, simplified authorisation or Union authorisation.


Now go to:


23


Section 4 – Resubmission of data to support an existing authorisation in GB

Complete this section if you are resubmitting data to support an existing authorisation in GB in accordance with the EU Exit transitional provisions.

Authorisation process

Please mark the relevant box for the process by which your authorisation was originally granted.

☐ National authorisation valid in GB granted by the UK as the reference Member State (rMS)

☐ National authorisation valid in GB granted via mutual recognition in sequence or parallel i.e. where the UK was a concerned Member State (cMS)

☐ National authorisation valid in GB granted via the same biocidal product route

☐ Union authorisation valid in GB prior to 01 January 2021 that was converted to a GB national authorisation by HSE

☐ Simplified authorisation valid in GB granted by the UK as the evaluating Competent Authority (eCA)

☐ Simplified notification valid in GB prior to 01 January 2021 that was converted to a GB simplified authorisation by HSE

Authorisation type

Please mark the relevant box to indicate the type of authorisation i.e. a single biocidal product or a biocidal product family.




Please provide the authorisation number of the authorisation you are submitting data for. The authorisation number may be prefixed with either UK or EU depending on whether it was granted as a UK national authorisation, simplified authorisation or Union authorisation.


24



This is the primary product or family name that appears on the authorisation.


Trade names

Any additional product names included in the authorisation should be stated here.




Name


CAS / EC number












If you need to enter more active substances, first click or tap anywhere in the last row

25





of the table and a plus sign will appear at the bottom right-hand corner – click or tap on this to add a new row.

Product types

Please mark the relevant boxes for the product type(s) that are included in your authorisation.

26
























Resubmission type

Please mark the relevant box to indicate whether your resubmission is voluntary or at 27


the request of HSE.

☐ Voluntary resubmission of data

☐ Resubmission of data at the request of HSE

If HSE has requested specific data, please provide details.

Click or tap here to enter details of the data requested by HSE.

Now go to:


28


Section 5 – Company details


Applicant

Please provide the applicant details. This part should only be completed if the applicant is a party other than the authorisation holder e.g. a consultant acting on behalf of a company.

Company name

Click or tap here to enter applicant company name.

Address

Click or tap here to enter applicant company address.

Postcode

Click or tap here to enter applicant company postcode.

29


Contact name

Click or tap here to enter applicant contact name.

Email address

Click or tap here to enter applicant contact email address.

Authorisation holder

Please provide the authorisation holder details. The authorisation holder is the eventual holder of the legal document signifying authorisation. They are responsible for the authorisation and must be based in the UK.

Company name

Click or tap here to enter authorisation holder company name.

30


Address

Click or tap here to enter authorisation holder company address.

Postcode

Click or tap here to enter authorisation holder company postcode.

Contact name

Click or tap here to enter authorisation holder contact name.

Email address

Click or tap here to enter authorisation holder contact email address.

Invoicing details

Please provide the details of the person or company that will pay the invoice for the 31


application.

Company name

Click or tap here to enter invoice company name.

Address

Click or tap here to enter invoice company address.

Postcode

Click or tap here to enter invoice company postcode.

Contact name

Click or tap here to enter invoice contact name.

32


Email address

Click or tap here to enter invoice contact email address.

Now go to:

Section 6 - Checklist

33


Section 6 – Checklist

You should complete the checklist relevant to the type of application you are making.

By completing the checklist, you are confirming that you understand and accept the requirement to submit the listed documentation.

Guidance on the different types of attachments and evidence you may need to submit is given below.

Data / supporting information / dossier

You can find out more about what data and supporting information you need to provide and / or put in a biocidal product or product family dossier for the various application types at: https://www.hse.gov.uk/biocides/product-authorisation-overview.htm

Any relevant letters of access

If any part of your application relies on data that are protected under GB BPR, you will need to provide a letter of access from the data owner that gives permission for HSE to use those data.

If HSE does not hold the data that your letter of access refers to your application may be delayed or rejected.

Proposed label(s)

Your proposed label(s) should accurately reflect the information provided as part of this application.

Your final label(s) must accurately reflect the authorisation conditions for the product.

You can find out more about labelling at: https://www.hse.gov.uk/biocides/packaging-labelling-requirements.htm.

Safety data sheets (SDSs)

SDSs should be provided for:

each active substance and co-formulant in the product or product family (your suppliers should provide you with these)

the product or each product in the family

SDSs should comply with GB REACH.

Draft Summary of Product Characteristics (SPC)

Your draft SPC should provide a summary of the important details of the product or product family that you are applying for.

For single products, use the template at: https://www.hse.gov.uk/biocides/template-single-biocidal-product-spc.docx.

34

https://www.hse.gov.uk/biocides/template-single-biocidal-product-spc.docx

https://www.hse.gov.uk/biocides/template-single-biocidal-product-spc.docx

https://www.hse.gov.uk/biocides/packaging-labelling-requirements.htm

https://www.hse.gov.uk/biocides/packaging-labelling-requirements.htm



For product families, use the templates at: https://www.hse.gov.uk/biocides/template-biocidal-product-family-spc.docx.

and: https://www.hse.gov.uk/biocides/template-biocidal-product-family-meta-spc.docx.

Draft Product Assessment Report (PAR)

Your draft PAR should provide an assessment of the data and risk assessments for the product or product family that you are applying for.

For national authorisation, use the template at: https://www.hse.gov.uk/biocides/template-national-authorisation-par.docx.

For simplified authorisation, use the template at: https://www.hse.gov.uk/biocides/template-simplified-authorisation-par.docx.

Reference list of studies

You should provide a list of the studies that your application relies on using the template at: https://www.hse.gov.uk/biocides/template-reference-list-of-studies.xlsx.

35

https://www.hse.gov.uk/biocides/template-reference-list-of-studies.xlsx

https://www.hse.gov.uk/biocides/template-simplified-authorisation-par.docx

https://www.hse.gov.uk/biocides/template-national-authorisation-par.docx

https://www.hse.gov.uk/biocides/template-biocidal-product-family-meta-spc.docx

https://www.hse.gov.uk/biocides/template-biocidal-product-family-spc.docx

https://www.hse.gov.uk/biocides/template-biocidal-product-family-spc.docx

Section 5 – Company detailsChecklist E – New applications for renewals

Checklist A – New applications for national authorisation

Complete this section if you completed Section 2 and you are making a new application for national authorisation.

More specific guidance on the data and documentation required can be found at: https://www.hse.gov.uk/biocides/national-authorisation.htm.

Please mark the boxes to confirm you understand and accept the requirement to submit the following documentation, as applicable:

☐ letter(s) of access to a dossier for each active substance

☐ a dossier for each active substance (satisfying the data requirements in Annex II of GB BPR)

☐ letter(s) of access to a dossier for the biocidal product / biocidal product family

☐ a dossier for the biocidal product / biocidal product family (satisfying the data requirements in Annex III of GB BPR)

☐ a copy of the proposed product label

☐ Safety Data Sheets (SDSs) for each active substance and co-formulant

☐ Safety Data Sheet (SDS) for the biocidal product / each product in the family

☐ a draft Summary of Product Characteristics (SPC) for the biocidal product / biocidal product family

☐ a draft Product Assessment Report (PAR) for the biocidal product / biocidal product family

☐ reference list of studies for the biocidal product / biocidal product family

☐ any pre-submission correspondence with HSE

Now go to:

Section 7 - Declaration

36

https://www.hse.gov.uk/biocides/national-authorisation.htm


Checklist B – New applications for simplified authorisation

Complete this section if you completed Section 2 and are making a new application for simplified authorisation.

More specific guidance on the data and documentation required can be found at: https://www.hse.gov.uk/biocides/simplified-product-authorisation.htm.


☐ information to show that the criteria for simplified authorisation are met

☐ letter(s) of access to a dossier for each active substance in Category B of the GB Simplified Active Substance List

☐ a copy of the proposed product label

☐ Safety Data Sheets (SDSs) for each active substance and co-formulant

☐ Safety Data Sheet (SDS) for the biocidal product / each product in the family


☐ a draft Product Assessment Report (PAR) for the biocidal product / biocidal product family

☐ reference list of studies for the biocidal product / biocidal product family

☐ any pre-submission correspondence with HSE

Now go to:


37

https://www.hse.gov.uk/biocides/simplified-product-authorisation.htm


Checklist C – New applications for same biocidal products

Complete this section if you completed Section 2 and 2a.

More specific guidance on the data and documentation required can be found at: https://www.hse.gov.uk/biocides/same-biocidal-product.htm.


☐ letter(s) of access to a dossier for each active substance

☐ letter(s) of access to a dossier for the reference biocidal product / biocidal product family


☐ details of the proposed differences between the same product / product family and the related reference product / product family

☐ evidence that the products are identical on all other aspects

Now go to:


38

https://www.hse.gov.uk/biocides/same-biocidal-product.htm


Checklist D – New applications for changes

Complete this section if you completed Section 2 and 2b.

More specific guidance on the data and documentation required can be found at: https://www.hse.gov.uk/biocides/change-cancel.htm.


☐ the full data package supporting your authorisation and any subsequent changes or renewals, where relevant

☐ any data or other documentation necessary to support the change, including where relevant:

to demonstrate that the proposed change would not adversely affect the conclusions previously reach concerning the compliance with the conditions set out in Article 19 or 25 (as appropriate) of GB BPR

where a change leads to, or is the consequence of, other changes of the terms of the authorisation, a description of the relation between these changes


☐ reference list of studies for the change

Now go to:


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https://www.hse.gov.uk/biocides/change-cancel.htm


Checklist E – New applications for renewals

Complete this section if you completed Section 2 and 2c.

More specific guidance on the data and documentation required can be found at: https://www.hse.gov.uk/biocides/renew.htm.


☐ the full data package supporting your authorisation and any subsequent changes or renewals, where relevant

☐ all relevant data that has been gathered or generated since the initial authorisation / previous renewal


☐ a draft Product Assessment Report (PAR) of whether the conclusions of the initial or previous assessment for the biocidal product / biocidal product family remain valid

☐ reference list of studies for the renewal

Now go to:


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https://www.hse.gov.uk/biocides/renew.htm


Checklist F – Resubmission of a pending application

Complete this section if you completed Section 3.

More specific guidance on the data and documentation required can be found at: https://www.hse.gov.uk/biocides/brexit.htm.


☐ your full original application – this includes the full original data package and any additional data gathered or generated since the original submission

☐ reference list of studies for the application

Now go to:


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https://www.hse.gov.uk/biocides/brexit.htm


Checklist G – Resubmission of data to support an existing authorisation in GB

Complete this section if you completed Section 4.

You should provide all data and documentation as requested by HSE.


☐ all data requested by HSE

☐ reference list of studies

Now go to:


42

Section 7 – Declaration

Section 7 – Declaration


Physical signing of the declaration is not necessary – providing your name, position / role in the company and the date in this section will validate the declaration.

Application forms without a completed declaration will not be accepted.

Declaration

By completing this declaration, I:

confirm that the information given in this application form is true to the best of my knowledge and belief.

acknowledge that any incomplete information may delay the processing of my application.

understand that HSE will send me a link to submit the documentation and data related to my application (as indicated in the relevant checklist and / or by HSE) via the HSE Secure File Sharing Service.

Name Click or tap here to enter your name.

Position / role in company

Click or tap here to enter your position / role in the company.

Date Click or tap to enter a date.

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