· web vieweu exit biocides resubmission form. this form is for companies who are resubmitting...

EU Exit biocides resubmission form

This form is for companies who are resubmitting data or pending applications due to EU Exit for:

biocidal products

biocidal active substances – including declarations of interest and notifications

GB Article 95

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Guidance

Guidance

Please use one form per resubmission e.g.

one active substance with five PTs in the Review Programme would be one form

one active substance with one PT in the Review Programme and one PT outside of the Review Programme would be two separate forms

two pending same biocidal products would be two separate forms

Article 95 resubmissions for four different active substances would be four separate forms

Please send completed resubmission forms by email to: [email protected].

If you have any questions about filling in this form, please email [email protected].

For further information on resubmissions due to EU Exit, including any relevant deadlines, please visit www.hse.gov.uk/biocides/resubmit.htm and read the fact sheets available at: www.hse.gov.uk/biocides/biocides-fact-sheet.pdf.

Formats

Data dossiers should be submitted in IUCLID format. If you are unable to submit in IUCLID format, you must provide a justification in Section 4 e.g. your pending active substance application consists of an old BPD dossier which is currently only available as a series of word documents etc in a structured file system.

Existing EU versions of documents such as CARs, PARs and SPCs will be accepted as part of a resubmission – it is not necessary to copy these into the GB templates.

If you are submitting data as part of your resubmission, it is essential that you complete and submit a reference list of studies using the template at: www.hse.gov.uk/biocides/template-reference-list-of-studies.xlsx. This is to enable HSE to build up an accurate record of the data we hold and must be submitted regardless of any reference list that exists as part of your original EU submission e.g. as part of the CAR or PAR template.

Specific resubmission guidance

Please read our fact sheets (www.hse.gov.uk/biocides/biocides-fact-sheet.pdf) for a breakdown of the action you need to take, when you need to do it, and the consequences if you don’t. Fact sheets relevant to the different resubmission types included in this form are listed below.

Pending applications - products

2B – Pending applications for changes to existing BPR product authorisations in GB

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http://www.hse.gov.uk/biocides/biocides-fact-sheet.pdf

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

http://www.hse.gov.uk/biocides/biocides-fact-sheet.pdf

http://www.hse.gov.uk/biocides/resubmit.htm

mailto:[email protected]


Guidance

3A – Pending product applications in GB – UK was rMS or eCA

3B – Pending product applications in GB – UK was not rMS or eCA

4 – Pending same biocidal product applications in GB

5A – Pending product renewals in GB – UK was rMS or eCA

5B – Pending product renewals in GB – UK was not rMS or eCA

Pending applications – active substances

9A – Pending Review Programme active substance applications in GB – UK was eCA

9B – Pending Review Programme active substance applications in GB – UK was not eCA

10A – Pending Article 93 active substance applications in GB – UK was eCA

10B – Pending Article 93 active substance applications in GB – UK was not eCA

11A – Pending new and non-Review Programme existing active substance applications in GB – UK was eCA

11B – Pending new and non-Review Programme existing active substance applications in GB – UK was not eCA

12A – Pending active substance renewals in GB – UK was eCA

12B – Pending active substance renewals in GB – UK was not eCA

Data resubmissions

1 – Existing BPR product authorisations in GB

14 – GB Article 95 List

Active substance – declarations of interest

For guidance about resubmitting active substance declarations of interest, please contact us at [email protected] with full details of your situation.

Active substance – notifications

For guidance about resubmitting active substance notifications, please contact us at [email protected] with full details of your situation.

Establishment – biocidal products

GB authorisation holders must be established in the UK.

Submission of this form is not sufficient to fulfil the requirement to be established in the UK. You must also complete the ‘EU Exit biocides establishment form’ to confirm your GB authorisation holder.

Please visit www.hse.gov.uk/biocides/confirm_established_UK.htm for guidance on confirming to HSE that you are established in the UK

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http://www.hse.gov.uk/biocides/confirm_established_UK.htm



Guidance

For pending applications, failure to submit an ‘EU Exit biocides establishment form’ may cause delays to the processing of your application.

For existing authorisations, failure to submit an ‘EU Exit biocides establishment form’ by 31 December 2021 will result in your authorisation being cancelled.

The ‘EU Exit biocides establishment form’ also allows you to tell us if you want to retain your pending application in NI and confirm your NI authorisation holder.

NI authorisation holders must be established in the EU.

Establishment – GB Article 95

Companies on the GB Article 95 List must be established in the UK or have a UK representative.

Submission of this form is not sufficient to fulfil the requirement to be established in the UK. You must also complete the ‘EU Exit biocides establishment form’ to confirm your UK address or UK representative. Failure to submit an ‘EU Exit biocides establishment form’ by 31 December 2022 will result in your entry being removed from the GB Article 95 List.

Form sections

Section 1 – Administrative details.........................................................................5Section 2 – Active substance details....................................................................7Section 3 – Product details....................................................................................9Section 4 – Data....................................................................................................11Section 5 – Company details...............................................................................13Section 6 – Checklist............................................................................................16Section 7 – Declaration........................................................................................24

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Section 3 – Product detailsApplication / authorisation type

Section 1 – Administrative details

Complete this section for all applications.

Resubmission type

Please mark one box only for the type of resubmission you are making.

Biocidal product – pending application

☐ National authorisation (including previous mutual recognitions and unions)

☐ Simplified authorisation

☐ Same biocidal product (authorised)

☐ Same biocidal product (pending)

☐ Administrative change

☐ Minor change

☐ Major change

☐ Renewal

Biocidal product – data resubmission

☐ voluntary resubmission of product data to support existing authorisation

☐ voluntary resubmission of active substance data to support existing product authorisations or pending product applications

☐ resubmission at the request of HSE

Active substance – Pending application

☐ Review Programme

☐ Renewal

☐ Article 93

☐ New active substance

☐ Non-Review Programme existing active substance

☐ Simplified active substance

Active substance – data resubmission to support GB Article 95 listing

☐ complete dossier

☐ Letter of Access to a complete dossier

☐ reference to a complete dossier for which all data protection periods have expired

Active substance – declaration of interest

☐ pending declaration

Active substance – notification

☐ pending notification

☐ compliant notification

Pending application details5


Complete this section if you are resubmitting a pending active substance or biocidal product application.

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.

Click or tap here to enter application reference 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.

Changes to original application

If you want to make changes to your original application e.g. removing trade names, changing from a family to a single product, or withdrawing support for one of your active substance product types, please provide details here.

Click or tap here to enter details of any changes to the original application.

Now go to:

Section 2 - Active substance details

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Section 2 – Active substance details


Active substance identifiers

If your resubmission relates to an active substance (pending application, GB Article 95, declaration of interest or notification), only one active substance should be listed per application form.

If your resubmission relates to a biocidal product (pending application or data resubmission), you should list all of the active substances in the product or product family.

Name

For each active substance, please give a name for the active substance according to the International Union of Pure and Applied Chemistry (IUPAC) system. IUPAC names allow for unambiguous identification of substances; however, a common name may be provided in addition. If applicable, this should match the relevant entry 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). If applicable, these should match the relevant entry 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

Please mark the relevant boxes. Descriptions for each product type are available at: https://www.hse.gov.uk/biocides/basics.htm.

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

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

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


☐ 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 3 - Product details

Section 4 - Data

Section 5 – Company details

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Section 3 – Product details

Complete this section if your resubmission relates to a biocidal product (pending application or data resubmission).

If you are resubmitting active substance data to support another company’s product authorisation or application, you can fill in this section with the relevant information you have. If you don’t know some of the information, you can leave the section blank. You only need to fill in this form once, even if your data supports multiple companies’ products.

Application / authorisation type

Please mark the relevant box for the type of application you are resubmitting or the type of authorisation your data supports.

☐ 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. If you are resubmitting a pending application, this should match the product / product family name of your original submission under EU BPR.

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

Trade names

Any additional names for the product, or the names of any products included in your biocidal product family should be stated here. If you are resubmitting a pending application, these should match the trade names of your original submission under EU BPR.

If you want to add more trade names than were included in your original EU submission, you should detail those in section 1.

Click or tap here to enter additional product trade names.

Authorisation number

If your resubmission relates to an existing authorisation (pending application for change or renewal, or data resubmission), please provide the authorisation number. The authorisation number may be prefixed with either UK or EU depending on whether it was granted as a UK national authorisation (including via mutual recognition or same biocidal product processes), simplified authorisation or Union authorisation.

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Click or tap here to enter authorisation number.

Same biocidal product – reference product details

If your resubmission relates to a pending application for a same biocidal product, please provide the name and authorisation number or original EU BPR application reference number of the product or product family that your application is identical to.

Reference product name Click or tap here to enter reference product name.

Reference product authorisation number

Click or tap here to enter reference product authorisation number.

Reference product application reference number

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

Original admin, minor or major change application details

If your resubmission relates to a pending application for any type of change (administrative, minor or major), please provide details of the changes requested in your original change application. 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.

Click or tap here to enter details of the original change application.

Now go to:

Section 4 - Data

Section 5 - Company details

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Section 4 – Data

Section 4 – Data

Please complete this section as applicable.

Data sharing / access issues

If you are having any issues with data sharing or data access that will affect your resubmission, please provide details e.g.

difficulty in reconfirming existing EU data sharing agreements

difficulty in reconfirming the applicability of previously obtained EU BPR letters of access

delays in your supplier submitting their active substance dossier

You should include a summary of the data missing from your resubmission and the anticipated timeline for resolution.

Click or tap here to enter details of any data sharing / access issues.

IUCLID dossier issues

If your resubmission contains a data dossier, this should be in IUCLID format. If you are unable to submit in IUCLID format, please provide a justification e.g. your pending active substance application consists of an old BPD dossier which is currently only available as a series of word documents etc in a structured file system.

Click or tap here to enter a justification for submitting a non-IUCLID dossier.

Product authorisation data resubmissions at the request of HSE

If you are resubmitting product authorisation data due to a specific request from HSE, please provide details.

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

Data to support another company

If you are submitting data in support of a product application or authorisation belonging to another company, where possible, please provide the name of that company e.g.

active substance data to support your customers’ product applications

product data to support another company’s same biocidal product application

If your data supports applications from multiple companies, you can list them all here. If you don’t have this information, you can leave this section blank.

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Section 4 – Data

Click or tap here to enter the name(s) of the company(ies) that have products supported by your data.

Now go to:

Section 5 - Company details

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Section 5 – Company detailsInvoicing details

Section 5 – Company details


Submission of this form is not sufficient to fulfil any requirement to be established in the UK. You must also complete the ‘EU Exit biocides establishment form’ to confirm your establishment status. Read our fact sheets (https://www.hse.gov.uk/biocides/biocides-fact-sheet.pdf) for more details.

Applicant

Please provide details of the person, company or consortium / task force whose application and / or data is being resubmitted.

Where the applicant is a consortium or task force, please provide the consortium / task force name in this section and details of each of the member companies in the section ‘Data owners / consortium members’.

If you are part of a consortium or task force and are submitting your data independently of the other members, please provide your details in this section and the name of the consortium / task force in the section ‘Data owners / consortium members’.

Company name Click or tap here to enter company name.

Address Click or tap here to enter company address.

Postcode Click or tap here to enter company postcode.

Contact name Click or tap here to enter contact name.

Email address Click or tap here to enter contact email address.

Entity acting on behalf of the applicant

If different from the applicant, please provide the details of the person / company that is completing this form and will be the main point of contact for this application / resubmission. For example, this could be a consultant acting on behalf of a company, the representative of a consortium / task force, or the UK representative of a non-UK-based Article 95 supplier.

Company type Choose a company type or enter free text.


13

Shelley Collins, 05/03/21,

Insert the link to this form

https://www.hse.gov.uk/biocides/biocides-fact-sheet.pdf

https://www.hse.gov.uk/biocides/biocides-fact-sheet.pdf






Data owners / consortium members

Where there are data owners in addition to the applicant or the applicant is a consortium / task force, please provide the details of the additional companies in this section.

Where the applicant is part of a consortium or task force and is submitting data independently of the other members, please provide the name of the consortium / task force in this section.

The table can be copied as many times as necessary for the number of data owners / consortium members. You can do this by first clicking or tapping anywhere in the table. A plus sign will appear at the bottom right-hand corner – click or tap on this to add a new data owner / consortium member table.

Data owner 1






Invoicing details

Please provide the details of the person or company that will pay the fees associated with the product or active substance evaluation.

If you are resubmitting data that does not require its own evaluation e.g. GB Article 95 or active substance data solely to support a product, you can leave this section blank.

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Now go to:

Section 6 - Checklist

15

Section 6 – ChecklistChecklist E – Pending declaration of interest

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.

Checklist A – Resubmission of a pending application.....................................17Checklist B – Product data resubmission in support of an existing product authorisation.........................................................................................................18Checklist C – Active substance data resubmission to support pending product applications or existing authorisations................................................19Checklist D – Active substance data resubmission to support GB Article 95 listing.....................................................................................................................20Checklist E – Pending declaration of interest....................................................21Checklist F – Pending notification......................................................................22Checklist G – Compliant notification..................................................................23

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Checklist A – Resubmission of a pending application

Complete this section if your resubmission relates to a pending application (active substance or biocidal product).

Please mark the boxes to confirm you understand and accept the requirement to submit the following:

☐ your full original EU submission – this should include:

☐ the full original data dossier(s) (this may include Letters of Access)

☐ any CAR / PAR / SPC or other templates that formed part of your original EU submission

☐ any additional data gathered or generated since the original EU submission e.g. data requested during the EU evaluation

☐ reference list of studies for the resubmission using the template at: https://www.hse.gov.uk/biocides/template-reference-list-of-studies.xlsx

Now go to:

Section 7 - Declaration

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


Checklist B – Product data resubmission in support of an existing product authorisation

Complete this section if you are resubmitting product data is support of either, your own existing product authorisation, or a pending product application belonging to another company e.g. same biocidal product.

If you are resubmitting product authorisation data due to a specific request from HSE, you should provide all data and documentation as requested by HSE and detailed in Section 4 of this form.

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

Either:

☐ all data requested by HSE

☐ voluntary resubmission of the data supporting the product authorisation


Now go to:


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Checklist C – Active substance data resubmission to support pending product applications or existing authorisations

Complete this section if you are resubmitting active substance data to support a product application or authorisation belonging to another company.


☐ voluntary resubmission of the data supporting the active substance approval


Now go to:


19



Checklist D – Active substance data resubmission to support GB Article 95 listing

Complete this section if your resubmission relates to a GB Article 95 listing.


☐ your full original EU Article 95 submission – this should include one of the following:

☐ a complete dossier for the active substance

☐ letter of access to a complete dossier for the active substance

☐ reference to a complete dossier for the active substance for which all data protection periods have expired


Now go to:


20



Checklist E – Pending declaration of interest

Complete this section if your resubmission relates to a pending active substance declaration of interest.


☐ your full original EU declaration of interest – this should include:

☐ evidence of the published guidance or written advice that you relied on

☐ evidence of the new published guidance or decision

☐ justification of how the guidance or advice you relied on has been reviewed by the new published guidance or decision

Now go to:


21


Checklist F – Pending notification

Complete this section if your resubmission relates to a pending active substance notification.


☐ your full original EU notification – this should include:

☐ evidence that the substance is an existing active substance as defined in Article 3 (1) (d) of BPR

☐ information on any studies that have been commissioned for the purpose of applying for approval or inclusion as a simplified active substance – this should include the expected completion date of each study

☐ for chemical substances – the information referred to in sections 1, 2 and 7.1 to 7.5 of the table in Title 1 of Annex II of BPR

☐ for micro-organisms – the information referred to in sections 1, 2 and 6.1 to 6.4 of the table in Title 2 of Annex II of BPR

☐ where your notification followed a compliant declaration of interest, evidence that the substance was on the market as an active substance in a biocidal product of the relevant product type on the date of publication of the new guidance or decision

Now go to:


22


Checklist G – Compliant notification

Complete this section if your resubmission relates to a compliant active substance notification.


☐ your full compliant EU notification – this should include:

☐ evidence that the substance is an existing active substance as defined in Article 3 (1) (d) of BPR

☐ information on any studies that have been commissioned for the purpose of applying for approval or inclusion as a simplified active substance – this should include the expected completion date of each study

☐ for chemical substances – the information referred to in sections 1, 2 and 7.1 to 7.5 of the table in Title 1 of Annex II of BPR

☐ for micro-organisms – the information referred to in sections 1, 2 and 6.1 to 6.4 of the table in Title 2 of Annex II of BPR

☐ where your notification followed a compliant declaration of interest, evidence that the substance was on the market as an active substance in a biocidal product of the relevant product type on the date of publication of the new guidance or decision

☐ evidence that the notification was considered compliant under EU BPR prior to 01 January 2021

☐ where your notification followed a compliant declaration of interest, your full compliant EU declaration of interest – this should include:

☐ evidence of the published guidance or written advice that you relied on

☐ evidence of the new published guidance or decision

☐ justification of how the guidance or advice you relied on has been reviewed by the new published guidance or decision

☐ evidence that the declaration of interest was considered compliant under EU BPR prior to 01 January 2021

Now go to:


23

Section 7 – Declaration

Section 7 – Declaration

Complete this section for all resubmissions.

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.

Resubmission forms without a completed declaration will not be accepted.

Declaration

By completing this declaration, I:

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

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

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

understand that there may be additional actions I need to take to comply with the EU Exit transitional arrangements and that I can take these actions separately from the submission of this form.

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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· web vieweu exit biocides resubmission form. this form is for companies who are resubmitting...

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