Active substance approvals may be renewed for up to 15 years in Great Britain (GB) and Northern Ireland (NI).
Biocide active substances that are approved under the Biocidal Products Regulation (BPR) can be found in the BPR active substance lists for GB and NI. The lists include details like the approval expiry dates and the renewal submission deadlines.
Supporter
Any person, company, task force or consortium can support an active substance/product type combination for renewal – it does not have to be the original supporter. However, if no-one supports the active substance/product type combination for renewal, the approval will expire on the existing expiry date. This would mean the active substance will no longer be able to be used in biocidal products of the relevant product type and articles treated with such products will no longer be able to be placed on the market.
Deadline
In GB, applicants that wish to renew the approval of an active substance must submit an application to HSE at least 550 days before the expiry date of the approval of that active substance for the relevant product type. If you wish to submit one application for the renewal of the active substance covering different product types, you should submit it at least 550 days before the earliest expiry date for the product types concerned. Alternatively, you may submit one application for each product type, submitted at different times depending on the expiry dates.
In NI, European Union (EU) decisions that relate to the renewal of active substance approvals continue to apply. Applicants wishing to renew an active substance for the NI/EU market should submit an application to ECHA.
Data requirements
If supporting the renewal of an active substance approval in GB, you should submit:
- all relevant data required under Article 20 of GB Biocidal Products Regulation (GB BPR) you have generated since the initial approval or previous renewal (as appropriate)
- your assessment whether the conclusions of the initial or previous assessment(s) of the active substance remain valid, and any supporting information
Guidance on data requirements and assessment of applications for renewal of approval
Expiry dates
Once a renewal application is made, if for reasons beyond the control of the applicant the approval of the active substance is likely to expire before a decision has been made on its renewal, the expiry date may be postponed. This decision will be communicated in an ebulletin, and the active substance list will be updated.
Note this does not generate a new renewal submission deadline. Only after a positive renewal decision is taken and an expiry date set, would a new 550-day renewal submission deadline be given for a subsequent renewal of the active substance.
Submitting an application
First, an application form should be emailed to [email protected].
Then you should submit:
- the full data dossier that currently supports the approval (or if you did not support the original approval, a full data dossier for the active substance). This should also include any post-approval data and data supporting previous renewals, where relevant. The requirements for the dossier are given in Annex II of GB BPR. You do not need to resend it when HSE already holds the dossier
- all relevant data that you have gathered or generated since the initial approval or previous renewal, as applicable
- a renewal risk assessment report (RAR) of whether the conclusions of the initial or previous assessments for the active substance remain valid
- a reference list of studies for the application
- 5-batch analysis and reference specifications of the active substance
- a renewal document that summarises the renewal application
Guidance on data requirements and assessment of applications for renewal of approval
Only the application form should be submitted by email. The date on which we receive the emailed application form will be recorded as the submission date. All other relevant documentation and data must be submitted via the HSE Secure File Sharing Service. Renewal applications should be in IUCLID format.
Using the HSE Secure File Sharing Service
Once we have received and processed your application form, you will be sent a link to upload the files associated with the relevant application. Do not use the link to upload files related to other applications.
Links will be sent out Monday to Friday and are valid for 5 working days. If the link expires before you are able to upload your files, email [email protected] to request a new link.
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.
Check the spam settings on your email account to ensure our emails are not going to your junk folder.
What HSE will do
After submitting your documents, HSE will conduct a brief initial check of the information to confirm that it meets the requirements for the application type and issue you an invoice for the non-refundable pre-evaluation assessment fee, which must be paid within 30 days of the date of the invoice.
Upon payment of the fee, HSE will perform an initial assessment of the submitted information and decide whether a full evaluation of the application for renewal is necessary or if the renewal can be carried out with a partial evaluation.
A full evaluation will be required when any of these conditions are met:
- the original or previous assessment report does not contain an assessment of the substitution and exclusion criteria including endocrine disruptor (ED) properties of the active substance
- the previous report contains an ED assessment but there are new data that could question the validity of its conclusions
- there are new data available that will impact either the key conclusions of the exclusion and substitution criteria, assessment on hazards, risks or efficacy or the conditions of the approval
- a re-assessment of data considered in previous assessments will impact either the key conclusions of the assessment on hazards, risks or efficacy or the conditions of the approval
We will then inform you of the fees for your renewal evaluation. Once you have received this information you may choose not to proceed with your renewal application. If this is the case, there will not be an opportunity for someone else to support the renewal. HSE will usually not work on the evaluation until the fees for renewal have been paid.
After completing the evaluation the applicant will be issued an invoice for the opinion development fee, and after payment HSE will make a recommendation to the Secretary of State and Devolved Authorities as to whether the active substance approval can be renewed, and whether such renewal will amend the conditions of the original approval or previous renewal. Such opinion will be submitted within 270 days of the completion of the evaluation conclusions, if a full evaluation was needed, and within 90 days otherwise.
If the approval of the active substance for the relevant product types is likely to expire before a decision has been taken on its renewal, the expiry date may be postponed. That will not affect the renewal submission deadline.
Renewal decision
Approval renewed
The approval for the active substance/product type combination will be renewed with either the original approval or previous renewal conditions or these conditions will be amended. Any change in the conditions will apply from the date of the renewal. We will communicate details via our ebulletin, subscribe to HSE biocides ebulletin.
Impact on the GB Article 95 list supplier
Once the active substance approval has been renewed, companies (other than the supporter of the renewal) may need to resubmit information to HSE to maintain their existing entry on the GB Article 95 list.
Impact on the products
If the approval of the active substance for one or more product types is not renewed or is amended, HSE will cancel or amend the authorisations of biocidal products that contain that active substance on the concerned product types. For example, the active substance approval may be amended to prohibit amateur use, allowed in previous evaluations. If that was the case all the concerned product authorisations would be amended to ensure that amateur use is removed from the authorisation.
When a product authorisation is cancelled due to the active substance approval not being renewed, usually there will be a period of grace for the supply and use of the product. The period of grace will not exceed 180 days for the supply and 360 days for the use of existing stocks. In cases where the supply and use of the product constitute an unacceptable risk to human health, animal health of the environment, there will not be a period of grace.
HSE will also cancel or amend Control of Pesticides Regulations (COPR) approvals accordingly for products that contain the active substance but have not undergone a product assessment under BPR, for example when they contain also active substances that are in the Review Programme.
Impact on treated articles
The supply of treated articles may also be affected if the approval of the active substance for one or more product types is not renewed or is amended. If the active substance approval is not renewed, the supply of treated articles in the concerned product type will only be permitted for 180 days after the decision not to renew the approval is issued by the Secretary of State.
Likewise, if the active substance approval is amended, there may be certain uses prohibited that will affect the treated articles that may be supplied. For example, an active substance approval in wood preservatives may be amended to prohibit its use for certain situations, like wood that will be used in furniture. In that case, wood treated with wood preservative products with that active substance will have to be clearly labelled so it is not used in furniture manufacturing.
No renewal application, renewal application withdrawn or non-renewal decision
The approval for the active substance/product type combination will not be extended beyond its expiry date where:
- no renewal application is received
- a renewal application is received but withdrawn
- a decision is taken not to renew the approval
This means the active substance can no longer be used in biocidal products of the relevant product types or used to treat articles.
We will communicate details of these active substance/product type combinations via our ebulletin, subscribe to HSE biocides ebulletin.
If you hold an affected GB BPR product authorisation or COPR product approval, we will contact you about cancelling or revoking your authorisation or approval. You will have an opportunity to submit comments or additional information, and we will take account of these when finalising our decision.
You can confirm the status of an active substance at any time by checking the BPR active substance lists for GB and NI.