Human Tissue Authority

The regulator for human tissue and organs

Consultation on two new EU Directives - the application of a Single European Code and the Import of Tissues and Cells

Issue date: 
13 March 2017

The Department of Health is consulting on draft Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2017. The draft Regulations transposes two new EU Directives on the application of a Single European Code to tissues and cells to support full traceability and the Import of tissues and cells into UK law.

On 23 June, the EU referendum took place and the United Kingdom voted to leave the European Union. Until exit negotiations are concluded, the UK remains a full member of the European Union and all the rights and obligations of EU membership remain in force. During this period the Government will continue to negotiate, implement and apply EU legislation. The outcome of these negotiations will determine what arrangements apply in relation to EU legislation in future once the UK has left the EU

About the consultation

  • The consultation will run for a 4-week period from 10 March - 7 April 2017.  The consultation provides an opportunity to contribute to the amendment Regulations.

The  Regulations will transpose two EU Directives into UK law:

  • Directive 2015/565/EC

This amends Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells.

  • Directive 2015/566/EC

This augments the implementation of Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells.

The Directives will primarily affect establishments who are licensed by the Human Tissue Authority (HTA) and the Human Fertilisation and Embryology Authority (HFEA). The HFEA will be consulting separately.

To support the consultation, the HTA is hosting webinars to discuss the impact of the Directives.  More details on the dates and times, and how to sign up to a webinar, can be found here.

Further information about the consultation, including how to respond is available here.

The Department of Health encourages everyone affected by the Directives to take this opportunity to respond

HTA Chief Executive, Allan Marriott-Smith said:

We want to take this opportunity to listen to those who will be affected by the implementation of the Directives. The purpose of the two Directives is to facilitate traceability and ensure equivalent standards for imported tissues and cells. These objectives support our aim to make sure human tissue is stored and used safely, ethically and with proper consent. However, we also want to minimise any unnecessary burdens. We are committed to working with the Department of Health and other stakeholders to ensure a proportionate approach to implementation. To do this effectively, we need your input into the amendment Regulations."

For more information, please visit the HTA website.



1.    The Human Tissue Authority (HTA) is an executive agency of the Department of Health, established by the Human Tissue Act 2004.

2.    The HTA is the regulator for human tissues, cells and organ. The HTA is also the Competent Authority for ensuring the quality and safety of organs intended for Transplantation, and tissues and cells for human application. 

3.    Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations), the HTA licences and inspects establishments that undertake the procurement, testing, processing, storage, distribution, import and export of tissues and cells for human


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