Product Re-approval Process (Advice Sheet 11)
Version 1.6 November 2025
1. Introduction
Approval of products is granted on the basis of the information provided to the Drinking Water Inspectorate (DWI) by the applicant and data from any testing undertaken. In order to provide assurances that products included in the list have not changed and so continue to be suitable for contact with drinking water, all products are now subject to a re-approval process five years after the initial approval date.
2. Re-Approval Process
Applications for product re-approval are accepted 6 months before the expiry date of the product. If the re-approval application is submitted after the expiry date then the product will be removed from the Secretary of States’ list and a new product application will be required.
In all cases DWI will endeavour to contact the product holder by letter to inform them of the requirement to apply through the Reg31 portal 6 months before the expiry date of the product.
To apply for a product re-approval, the following information and actions will be needed:
a. Submit a re-approval application through the DWI Regulation 31 portal. Input full formulation and relevant associated Material Safety Data Sheets (MSDSs) and Technical Datasheets (TDS) for each component.
b. Details of the quality management system for the manufacture and supplier of the product;
c. The current Instructions for Use (IFU) document.
d. A statement from the company indicating that no changes to either the formulation, the place of manufacture have taken place or, if changes have been made, an outline of the changes that are being requested to take place during the re-approval of the product
e. Copy of the current approval letter
2.1 Changes Requests made to Products during the Re-approval Process
Whilst required changes made to the product during its approval period must be notified to the DWI through a Change Application and before the change is implemented, the DWI may accept a change application included within a product re-approval application. However, any changes submitted as part of the re-approval process may lead to testing and may delay the re-approval of the product.
Note: Changes made to a product without notification to DWI will break the conditions of the approval, and if picked up through the re-approval process, could result in the immediate revocation of the product and any water undertaker using the product could be in breach of the requirements set out in the relevant regulations.
2.2 Change Requests made within 6 months of the Re-approval Expiry Date
If a Change Application is received by the DWI within the 6-month period before the products expiry date, then the DWI will include the products re-approval application within this review. This may result in additional information being submitted in order to satisfy the information required above. In each case the DWI will contact the product holder to inform them of this process.
3. Charges
Where no changes have been made then a charge of £350 is required to assess the application and renew each product reapproval.
However, further charges may be incurred if significant changes have been made to the product, or place of manufacture, since the approval was granted. Any product changes made without prior notification to DWI will result in the revocation of the product and require a new product application to be made.
4. Timescale
The time taken to assess the information and issue a new approval letter will be dependent upon:
- the completeness and quality of the supporting information provided
- whether any changes have been made to the product and/or the place of manufacture
- the requirement for any additional testing
- payment of invoice
5. Expiry Dates of Approval
On receipt of the new approval letter the product will be valid for a further 5 years.
The five-year period of re-approval will begin on the issuance and receipt of a signed acknowledgment of the re-approval letter, not the original expiry date.
For those products where the expiry date lapses whilst the re-approval is still being reviewed then the product will be removed from the list and re-added once re-approval has been granted.
If DWI is not contacted by an approval holder about their re-approval by the products expiry date, the product will be removed from the Secretary of States’ List of Approved Products immediately after the expiry date has passed and added to Annex 1. Those products will then be subject to the full approval process if the approval holder wants to add the product to the list at a future date.