Engineering Biology Regulators Network
Network of regulators involved in regulating engineering biology products. The network shares knowledge and best practice for the benefit of the sector.
About the Network
The Engineering Biology Regulators Network was created in 2023 to bring together regulators, agencies and policy teams, from across government, to share best practice on pro-innovation regulation, identify common challenges and collaborate on solutions. The network will enable a joined-up system to support technology from discovery research to market.
There are currently 12 regulators/agencies involved in the network, which is convened by the Department for Science, Innovation and Technology (DSIT). If you are a UK regulator interested in joining the network, please contact engineeringbiology@dsit.gov.uk.
In October 2024, DSIT announced engineering biology as one of the priority areas for the new Regulatory Innovation Office. The Regulatory Innovation Office will work collaboratively with regulators including through the Engineering Biology Regulators Network to update regulation, speed up approvals, and ensure different regulatory bodies work together smoothly.
Network members
Animal & Plant Health Agency
The Animal & Plant Health Agency (APHA) is responsible for protecting the UK from threats to animal and plant health and zoonotic risk to human health. The agency’s challenge is to deliver a seamless border using the latest technology to enable efficient and low cost trade while maintaining the UK’s biosecurity. As part of the agency’s role in National Security, it seeks to understand and mitigate the evolving risk of zoonosis to the UK; which could impact human health, welfare and the economy. Ensuring the UK is at the forefront of engineering biology is crucial to the APHA.
Contact: apha.corporatecorrespondence@apha.gov.uk
Department for Environment, Food & Rural Affairs
Engineering biology encompasses a range of genetic technologies, which can result in genetically modified, and precision bred organisms. The Department for Environment, Food and Rural Affairs (Defra) is responsible for regulating the environmental release of these organisms in England. This includes regulating their use in research and development trials and in marketing applications.
Contact: gm-regulation@defra.gov.uk
Environment Agency
The Environment Agency has a duty to protect or enhance the environment and contribute towards sustainable development in England.
The Environment Agency has a broad regulatory remit that covers emissions to land, air and water, and sectors such as waste, oil, gas, food, and drink. Engineering biology products or processes could be used in activities that are permitted by the Environment Agency. Guidance on whether a permit is needed is available on GOV.UK (Check if you need an environmental permit - GOV.UK). The Environment Agency runs a free pre-application service to provide basic advice on permit applications (Get advice before you apply for an environmental permit - GOV.UK).
Contact: enquiries@environment-agency.gov.uk
Food Standards Agency
The Food Standards Agency’s (FSA) mission is ‘food you can trust’ and has responsibility for ensuring food safety. The FSA assesses the safety of new types of food and feed and provide advice to ministers on whether new foods should be authorised for sale in Great Britain. The FSA’s aim is to keep people safe, while providing an effective service to businesses and removing barriers to innovation.
The FSA recognises the potential of engineering biology for producing new types of food or creating existing foods in novel ways. It seeks to learn more about these technologies and regulate them in proportion to their potential risks.
Contact: RegulatedProductsEngagement@food.gov.uk
Health and Safety Executive
The Health and Safety Executive is the GB regulator for workplace health and safety, which includes work activities in connection with genetic modification in facilities such as laboratories.
Contact:bioagents@hse.gov.uk
Human Fertilisation and Embryology Authority
The Human Fertilisation and Embryology Authority (HFEA) is the UK’s independent regulator of fertility treatment and research using human embryos.
The HFEA has an active interest in the regulatory challenges associated with engineering biology technologies because scientific advances are now creating new ‘categories’ of cells, such as in vitro-derived gametes and stem-cell based embryo models, and research on these could offer significant benefits for healthcare and fertility treatment
Contact: enquiriesteam@hfea.gov.uk
Human Tissue Authority
The Human Tissue Authority (HTA) is an executive Non-Departmental Public Body that regulates organisations involved in the removal, storage and use of human tissue for research, medical treatment, post-mortem examination, education and training, and public display.
The HTA’s regulatory oversight extends to engineering biology where it involves the use of human tissue, recognising the field’s potential to advance medical treatments while ensuring compliance with established standards and consent requirements. The organisation works to enable innovation in this space through proportionate regulation that protects public interests without creating unnecessary barriers to scientific advancement.
Contact: policy@hta.gov.uk
Information Commissioner’s Office
The Information Commissioner’s Office (ICO) is an independent regulator whose role is to uphold information rights in the public interest.
The ICO has an interest in engineering biology as some forms of engineering biology pose important privacy and information rights issues. The ICO engages with organisations that are developing applications of engineering with implications for personal data through its Regulatory Sandbox and wider innovation services.
Contact: emergingtechnology@ico.org.uk
Medicines and Healthcare products Regulatory Agency
Medicines and Healthcare products Regulatory Agency recognises the significant potential of engineering biology to continue to shape the future of medicine, requiring adaptation to emerging challenges in production and regulatory environments.
Contact: info@mhra.gov.uk
Office for Product Safety and Standards
The Office for Product Safety and Standards (OPSS) is the UK product regulator. The OPSS maintains a keen interest in engineering biology as it has the ability to change how consumer goods are manufactured. The OPSS are interested in the toxicological and biological safety of materials produced, and in the use of metrology to improve the quality and safety of engineering biology-based production processes, reducing the risk of harms to enable this innovation. The OPSS are also interested in engineering biology research as the UK regulator responsible for ensuring compliance with Nagoya Protocol-related regulations.
Contact: OPSS.enquiries@businessandtrade.gov.uk
UK Civil Aviation Authority
The UK Civil Aviation Authority (CAA) provides regulatory oversight for the UK aviation sector. The UK CAA recognises the potential of future engineering biology applications and continues to monitor and prepare for emerging technologies that may impact aviation safety and operations.
Contact: enquiries@caa.co.uk
Veterinary Medicines Directorate
The Veterinary Medicines Directorate (VMD) is the UK’s veterinary medicines regulator. The VMD recognises the potential of engineering biology in influencing current and future veterinary medicines and animal health and welfare.
Contact: postmaster@vmd.gov.uk