Regulatory Requirements - Supply of restricted microbial pathogens
Handling and Containment
Within the UK, UKHSA products are regulated by the Control of Substances Hazardous to Health (COSHH) regulations. COSHH references the Approved List of Biological Agents which is a list that classifies biological agents into 4 hazard groups according to the risk of infection to a healthy worker.
HSE guidance to the Approved List of biological agents.
It is the End User’s responsibility to ensure that they can handle microbial strains according to their local and national guidance.
Anti-Terrorism, Crime and Security Act 2001, Schedule 5
This regulation is applicable to UK organisations. Specific pathogens and toxins are listed in Schedule 5 to the act. Obligations under this act include notifying appropriate authorities when a UK organisation intends to hold, keep or use stocks of Schedule 5 pathogens and or toxins. Adequate security arrangements must also be in place.
Please refer to the following legislation:
The Specified Animal Pathogens Order 2008
This act regulates the possession and use of specified animal pathogens in the UK to prevent release into the environment, protecting animal health and the agricultural industry. Obligations under the act covers possession, importation and specific responsibilities related to handling and storage of pathogens. UK organisations must hold a SAPO licence to be able to order specified animal pathogens.
UK Strategic Export Controls
Strategic export controls of dual-use goods are regulated by:
Specific bacterial and viral strains are defined to be ‘dual use’ and are listed in the Consolidated list of Strategic military and dual-use items that require export authorisation’ under control list category 1C351. This is applicable to all organisations outside of the UK. Any bacterial or viral strain listed will require an export licence for the product to be exported.
UKHSA submit export licence applications on behalf of the end user to the UK Export Control Joint Unit, Department for Business and Trade for review.
Regulations for shipping Infectious substances
All UKHSA products are packaged and distributed according to dangerous goods regulations governed by a combination of international and national law (IATA and ADR).
Additional regulatory requirements
Customers purchasing UKHSA products are strongly advised to check all regulatory requirements within their country prior to purchasing.
Ordering Restricted Products
Guidance on the procedures for ordering restricted products should be reviewed prior to placing an order. Find information on how to order restricted products from Culture Collections.
Export Licence Requirements
Some of our restricted products require a UK export licence. For more information, kinldy review our Export licence requirements.