Human Tissue Authority

The regulator for human tissue and organs

Material covered by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended)

    The list below provides guidance on which types of tissues and cells are regulated under the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended) (the Regulations).

    It is not intended to be an exhaustive list of the tissues and cells covered by the Regulations; rather, it provides information about various tissues and cells that stakeholders have contacted the HTA about.

    The list below has not been affected by EU Exit.

    Material covered by the Regulations:

    • Acellular bone products - Yes
    • Acellular skin products - Yes
    • Adipose tissue - Yes
    • Amniotic membrane - Yes
    • Antibodies - No
    • Appendages (severed, for reattachment) - No
    • Blood (whole blood)* - No, unless being collected as a starting material for ATMP manufacture. See the HTA’s website for further information about the regulation of blood as a starting material for ATMP manufacture.
    • Blood vessels - Yes
    • Bone marrow - Yes
    • Bone (e.g. femoral heads, skull flaps) - Yes
    • Breast milk (for nutritional purposes) - No
    • Cartilage cells – Yes, may be collected as a starting material for an ATMP
    • Cell lines – Yes, when intended as a starting material/potential starting material for an ATMP
    • Dendritic cells - Yes, see the HTA’s website for further information about the regulation of dendritic cells and white blood cells.
    • Dental pulp – Yes, may be collected as potential starting material for an ATMP
    • Donor lymphocytes (for the purposes of haematopoietic stem cell transplantation) – Yes
    • Eggs (ova)** - No
    • Embryonic stem cells  - Yes
    • Embryos (outside the body)** - No
    • Faecal material - No, see the HTA’s website for further information about the regulation of microbiota transplant.
    • Fetal tissue - Yes
    • Fibroblasts – Yes, when intended as a starting material/potential starting material for an ATMP
    • Gametes** - No
    • Haematopoietic stem cells - Yes
    • Heart valves - Yes
    • Hepatocytes - Yes
    • Keratinocytes – Yes, when intended as a starting material/potential starting material for an ATMP
    • Ligaments - Yes
    • Limbal stem cells - Yes
    • Liver lobe*** - No
    • Meniscus - Yes
    • Musculoskeletal tissue - Yes
    • Non-blood derived stem cells - Yes
    • Ocular tissue (e.g. cornea, sclera) - Yes
    • Organs*** - No
    • Ovarian tissue (for transplantation) – Yes, see the HFEA and HTA joint statement on ovarian and testicular tissue storage for further information. 
    • Pancreatic islet cells - Yes
    • Placenta (for oral ingestion) - No
    • Plasma* - No
    • Platelets* - No
    • Primary cell cultures - Yes
    • Red blood cells* - No
    • Skin (allograft, autograft) - Yes
    • Sperm cells (spermatozoa)** - No
    • Tendons - Yes
    • Teeth - Yes
    • Testicular tissue (for transplantation) – Yes, see the HFEA and HTA joint statement on ovarian and testicular tissue storage for further information.
    • Tumour tissue – Yes 
    • Umbilical cord blood - Yes, see the HTA’s website for further information for establishments involved in cord blood collection.  
    • Umbilical cord tissue – Yes, may be collected as a potential starting material for an ATMP
    * While outside the definition of tissue and cells for the purposes of the Regulations, these materials fall under the Blood Safety and Quality Regulations 2005 and are regulated by the MHRA.
    ** While outside the definition of tissue and cells for the purposes of the Regulations, these materials fall under the Human Fertilisation and Embryology Act 1990 and are regulated by the HFEA.
    *** While outside the definition of tissue and cells for the purposes of the Regulations, these materials fall under the Quality and Safety of Organs Intended for Transplantation Regulations 2012.
     
    Audience: 
    Professional
    Sector: 
    Human application
    Tags: 
    EU tissue and cells directive
    Relevant material
    Last updated on: 15 Feb 2021