These Regulations are made in exercise of the powers in section 8(1) of the European Union (Withdrawal) Act 2018 (c.16) in order to address failures of retained EU law to operate effectively and other deficiencies (in particular under section 8(2)(a) and (g) of that Act) arising from the withdrawal of the United Kingdom from the European Union.

They amend the Blood Safety and Quality Regulations 2005 (S.I. 2005/50) relating to the safety and quality of blood and blood components; both so as to make necessary amendments to enable those Regulations to continue to operate after the withdrawal of the United Kingdom from the European Union and to enable the appropriate authority to make regulations relating to the safety and quality of blood and blood components.

An impact assessment has not been produced for this instrument as no, or no significant, impact on the private or voluntary sector is foreseen.