Over 20% of UK chemicals registrations to face revocation from April

The United Kingdom (UK) and the European Union (EU)’s chemical industries are currently heavily intertwined. Given the UK’s exit of the EU, measures are needed to ensure that the UK has a chemical framework that does not lower the safety standards of the EU and that does not disrupt supply chains in either market. The Brexit trade agreement includes considerations for a transition of the chemical industry, but there are concerns by the industry that enforcement of this transition will incur high costs to both the EU and the UK.

The UK government has stated that a UK database  will be implemented to replace the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the EUs’s chemical framework. In this database, registration will take place across a period of six years starting on 28 October 2021. These new registrations will require companies to review entire product portfolios, whichwill not only be time-consuming but will also incur huge costs for duplicated work. Furthermore, should UK companies fail to renegotiate data sharing agreements with EU companies, they will need to reconduct studies and can ultimately incur over £1 billion in “unnecessary duplication”.

UK-based companies that wish to market their chemicals in the EU were given a transition period until 31 December 2020 by which pending registrations had to be finalised. These registrations enable these companies to registrations to EU companies, which is required to continue marketing in the EU market. According to the European Chemicals Agency (ECHA), around 80% of the 2,140 UK-based REACH registrants have started or completed the transfer of their registration to EU companies by the designated deadline. However, this means that approximately 20% of UK chemicals registrations face revocation after Brexit as they have not been transferred to the EU. This number could increase as the ongoing transfers must still be accepted by the EU successors in order to be completed. Should completion by 31 March 2021 fail, or the transfer get cancelled, registrants will be unable to place the substance in question on the EU market. ECHA stated that over 2,900 UK registrations representing 1,830 substances have missed the transition period deadline and will be revoked. Around 60% of the revoked substances were only for intermediate use – in other words, they are used in the manufacture of other substances ECHA also commented on potential market impact, stating that.

There are also fears that this transition will lower the safety standards of chemicals. Although the agreement includes a non-regression clause – meaning that neither the UK or the EU can weaken environmental protection requirements – an initial assessment conducted by ChemTrust concluded that the UK system does not provide adequate protection against hazardous chemicals to human health and the environment.

BTA follows this process very closely as it will inevitably affect blood bag sets. The BTA is committed to ensuring the safe supply of blood and blood products and supporting policies that will enable blood bag manufacturers to meet public health needs. BTA is actively talking to the relevant stakeholders, including the Medicines and Healthcare products Regulatory Agency (MHRA), in order toensure proper supply of blood bag sets in the UK.

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