20 August 2020

Any company currently manufacturing hand sanitiser under the UK derogation, who wants to continue to manufacture after 30th March 2022 (assuming the UK extension to UKCSP-2020-01 is granted) will need to apply to the UK HSE for a full BPR authorisation by 3 December 2020.

The average cost of BPR product authorisation in the UK is in the region of £20,000 - £25,000. This is the fee payable to HSE and there will be other costs associated with the generation of the necessary data. Whilst these costs may seem prohibitive for small companies, there are options available to reduce these costs such as companies entering into data sharing agreements or purchasing access to trade names as part of another company’s application (one application for one product can include more than one trade name of that product).

BASA has been approached to ask whether any BASA Members would be interested in forming a task groups with other companies also wishing to gain BPR product authorisation for the WHO formulation 2. Under such task groups, a single data package can be generated to support multiple applications with the cost of generating these data shared amongst all parties. HSE would only evaluate a shared data package once, thereby also reducing the costs associated with the application itself. BASA is willing to facilitate the formation of any task groups.

Please could you email me, Lorna Williams, via secretary@basa.uk.com as soon as possible if you are interested in a discussion in relation to this

Please note that as the UK will simply be cutting and pasting this regulation into UK law on 1st January directly from the current EU regulation that the BPR does not provide phase out periods for Article 55(1) derogations. This means that there will be no opportunity to continue to supply or use existing stocks of WHO formulation 2 hand sanitisers under UKCSP-2020-01 beyond the expiry date. If you do not intend to apply for product authorisation for your hand sanitiser, you must take steps to manage your supply chain to ensure that existing stocks are not supplied or used beyond 30 March 2022.

Information regarding the data requirements for product authorisation can be found on the European Chemicals Agency (ECHA) website via the weblink on this posting and we expect to get further onformation from HSE regarding the process for submitting the application nearer to the 3^rd December 2020 deadline.

Any non- BASA member comopanies who are interested in joining this task group can also contact me as we may be able to widen the group if there is sufficient interest.

Written by: Lorna Williams