Simplified Authorisation

Contents

Criteria
How to apply
Things to note
What HSE will do
Product authorisation decision
Unsuccessful applications

To encourage the use of products with a more favourable environmental or human or animal health profile, the GB Biocidal Products Regulation (GB BPR) establishes a list of active substances that are eligible for simplified product authorisation in Great Britain (GB).

If you have received a simplified product authorisation in an EU-27 Member State, please note that the EU BPR simplified notification process is not applicable under GB BPR. You will need to make a separate GB application for simplified product authorisation under GB BPR as described on this page.

Criteria

A biocidal product / biocidal product family only qualifies for simplified product authorisation if all of the following conditions are met:

• all the active substances in the biocidal product / biocidal product family have GB approval as simplified active substances and are included in the GB Active Substance List
• any restrictions specified in the GB Active Substance List for the active substances are satisfied
• the biocidal product / biocidal product family does not contain any substances of concern
• the biocidal product / biocidal product family does not contain any nanomaterials
• the biocidal product / biocidal product family is sufficiently effective for the entire shelf life of the product
• the handling of the biocidal product / biocidal product family and its intended use does not require personal protective equipment

How to apply

The prospective simplified product authorisation holder or company acting on their behalf must submit, in English, a completed application form to [email protected] - companies may wish to mark emails as appropriate for example confidential. Please note that your application form may be returned if it is incomplete.

Only the application form should be submitted by email. All other relevant documentation / data must be submitted via the HSE Secure File Sharing Service, including:

• a dossier in IUCLID format, or letter of access to a dossier held by HSE, that contains information to show that the above criteria are met - this may include:
  • storage stability data (may be addressed with aged product efficacy data, see below for specific details)
  • analytical methods
  • efficacy data
  • intended uses
  • risk mitigation measures
  • classification, labelling and packaging
• a draft Product Assessment Report (PAR) for the biocidal product / biocidal product family
• a copy of the proposed label
• Safety Data Sheets (SDSs) for:
  • the proposed biocidal product / each biocidal product in the product family
  • all active substances and co-formulants in the proposed biocidal product / biocidal product family
• a draft Summary of Product Characteristics (SPC) for the biocidal product / biocidal product family using the following templates as appropriate:
  • single biocidal product SPC
  • biocidal product family SPC
  • biocidal product family meta SPC
• reference list of studies
• any pre-submission correspondence with HSE

All documents / attachments should be included within your IUCLID dossier.

The storage stability and efficacy data requirements can be met by providing either:

• unaged/fresh product efficacy data and chemistry storage stability data covering the shelf life of the product
• ambient aged product (covering the shelf life) efficacy data - aging the product through accelerated conditions (for example, 2 weeks at 54 °C) is not considered appropriate to meet this data requirement

Using the HSE Secure File Sharing Service

• Once we have received and processed your application form, you may be sent a link to upload the files associated with the relevant application - please do not use the link to upload files related to other applications.
• Links will be sent out Monday - Friday and are valid for 5 working days - if the link expires before you are able to upload your files, please email [email protected] to request a new link.
• Please ensure you comply with the terms and conditions of using the HSE Secure File Sharing Service - these will be included in the email alongside the link.
• Please check the spam settings on your email account to ensure our emails are not going to your junk folder.

Things to note

• The authorisation holder must be established in the UK.
• All biocidal product names must be unique - please check the list of GB authorised products to determine if your proposed product name has already been used.
• Letters of Access must relate to data held by HSE - for active substances listed as Category B simplified active substances in the GB Active Substance List, you should talk to your active substance supplier to ensure they have submitted the data to HSE.

What HSE will do

After receiving your application HSE will:

• conduct a brief initial check of the information to confirm that it meets the requirements for the application type
• estimate how much it may cost ("initial estimated fee") to process the application based on the information provided
• issue an invoice to the applicant which must be paid within 30 days of the date of the invoice - failure to pay the requested fees will result in your application being rejected
• accept the application once the initial estimated fee has been paid
• evaluate the application to assess the risks to health and the environment, intended use and efficacy of the biocidal product / biocidal product family. HSE will then make a decision as to whether the biocidal product / biocidal product family can be authorised in GB. Overall, this process will take approximately 90 days from accepting the application
• issue an invoice for a "top up" fee if the cost of evaluating the application has gone beyond the initial estimated fee which must be paid within 30 days of the date of the invoice - failure to pay the requested fees will result in your authorisation being cancelled

You may be asked to provide further information at any point during the 90-day evaluation period.

Following the submission of the requested information HSE will have an additional 90 days to complete its evaluation. Please note that this is a one-time only opportunity to provide further information - if you fail to provide the requested information within the deadline set by HSE or the information you provide is not satisfactory, your application may be rejected.

If the biocidal product / biocidal product family is supplied in the form of a bait station or other physical device then we may request a sample to inform the risk assessment.

Product authorisation decision

When the evaluation of an application is completed, a decision will be made as to whether the simplified biocidal product / biocidal product family can be authorised.

Successful applications

HSE will:

• send the applicant a copy of the draft authorisation conditions HSE intends to set for the product - these are set out in a draft Product Assessment Report (PAR) and draft Certificate of Authorisation
• take into account the applicant's comments, where relevant
• assign an authorisation number to the biocidal product / biocidal product family
• issue a signed Certificate of Authorisation

You should:

• examine the draft Product Assessment Report (PAR) and draft Certificate of Authorisation and return them to HSE (with comments if necessary) to indicate your agreement with the authorisation conditions
• wait until the signed Certificate of Authorisation has been issued and ensure you comply with the conditions and restrictions in the authorisation before making the product available on the market in GB
• ensure you remove from the distribution chain any existing stocks that do not meet the new conditions and restrictions of the authorisation within 180 days of the authorisation being issued - if you were previously allowed to supply the product under other national law in GB, for example COPR
• ensure you comply with any deadlines associated with the authorisation, such as for any post authorisation data requirements or your authorisation may be cancelled
• note your authorisation expiry date - GB BPR does not allow for the renewal of simplified product authorisations, but you may apply for a new authorisation for the biocidal product / biocidal product family
• manage the stocks of the biocidal product / biocidal product family to ensure none remains in the supply chain by the expiry date as no phase out will be given
• ensure you comply with other requirements of GB BPR which include (but are not limited to):
  • packaging and labelling requirements (Article 69)
  • advertising requirements (Article 72)
  • record keeping requirements (Article 68)
  • notification of unexpected or adverse effects (Article 47)
• ensure you comply with general chemical and product safety law which continues to operate such as:
  • GB Classification, Labelling and Packaging of Substances and Mixtures (GB CLP) Regulation
  • General Product Safety (GPS) Regulations
• Contact HSE if you intend to amend or cancel your authorisation

Unsuccessful applications

HSE will not issue an authorisation where an application does not meet the required standards.

Before your simplified authorisation expires

The GB BPR regulations do not allow for the renewal of a simplified product authorisation. Therefore, to prevent a break in the supply of your simplified biocidal product / biocidal product family HSE recommend that you submit a new simplified product authorisation application at least 550 days prior to your current simplified product authorisation expiring.

HSE will allow current simplified product authorisation holders to continue to use their current product names if they apply for a new simplified product authorisation.

The current simplified product authorisation holder or company acting on their behalf must submit, in English, a completed application form to [email protected] - companies may wish to mark emails as appropriate, for example confidential. Your application form may be returned if it is incomplete.

Only the application form should be submitted by email. All other relevant documentation / data must be submitted via the HSE Secure File Sharing Service, please include the relevant information as detailed above.