REACH Regulations (UK)

B. Braun is a global company which has a range of more than 5000 different products, of which 95% are manufactured by the company within a B. Braun site throughout the world. The UK B. Braun Group of companies (B. Braun UK) distributes many of these medical devices, disinfection & hygiene,  and medicinal products, some of which are manufactured here in the UK. The UK B. Braun Group of companies (B. Braun UK) consist of B. Braun Medical, B. Braun Avitum and B. Braun Sterilog companies.

Since the 1^st January 2021 (BREXIT) B. Braun UK ceased being a Downstream User and became a Producer/Importer of products containing substances. It has carried out its compliance duties by Grandfathering (via a DUINs) intended release substances, sold over a tonne pre-brexit, with the Health & Safety Executive (HSE). It continues to review these substances and amounts and where identified will register these substances with the HSE.

Safety Data Sheets (SDS) are supplied or are available upon request as per article 31 of (EU) REACH Regulation (1907/2006). These have been updated to the UK REACH Regulations requirements. The products should be used as intended.

Under EU and UK REACH regulations B. Braun UK has to inform customers which devices include a substance with a concentration of more than 0.1 % weight by weight (w/w), known as Substances of Very High Concern (SVHC).

Please see the B. Braun Group Reach Statement @ REACH Regulations - B. Braun (bbraun.com) and the list of affected products (by description or product code) and the associated SVHCs Reporting requirement according to paragraph 33 of the EU REACH regulation (EC no. 1907/2006).

In summary, B. Braun UK are a distributor/retailer/manufacturer/producer and supplies Safety Data Sheets with product/devices either with the product or upon request or at the website link above. Where customers inform B. Braun UK of an unintended use it will supply this information through the supply chain to its supplier. Where products contain substances according to paragraph 33 of the (EU) REACH regulation (EC no. 1907/2006) of over 0.1% (w/w), these products are clearly labelled or an additional letter will inform the customer.