Deuterated chemicals in R&D and drugs

About the author
Joe Bradley is a Biochemist with decades of experience in controlled drug regulations, drug discovery and cheminformatics. He has spent the last 12 years working to improve controlled drug and regulatory compliance within the chemicals and pharmaceuticals industry, through the development of software solutions which allows the rapid and accurate identification of controlled and regulated chemicals.

He founded Scitegrity in 2011 and the tools he helped create are now used by many of the worlds top chemical and pharmaceutical companies, specialist controlled drug suppliers and regulators.

He has consulted for regulators globally, helping to refine and assess the impact of proposed controlled drug regulations before final enactment.
When not absorbed in chemical regulations you'll find him on is skateboard, trials bike or with snooker cue in hand.

The International Atomic Energy Agency (IAEA) produces regulations designed to prevent the proliferation of nuclear weapons. These regulations have been incorporated into export control regulations in many countries, including the UK, EU and USA. Due to the way these have been written, they unfortunately control even milligram amounts of labelled R&D chemicals, meaning an export licences are often required to export them.

Below I have outlined why this is and what it means. The slides at the end of this page go into more detail

The IAEA regulations means any chemicals with more than 1:5000 deuterium to hydrogen atoms are considered "enriched" and require a degree of monitoring by national authorities. This limit has been transcribed into national export control regulations, usually requiring them to have an export licence.

The issue with this, for non-nuclear use, within life sciences and R&D, is that almost every deuterium labelled chemical is considered enriched by these regulations

In summary this means

• Export of deuterated chemicals for non-nuclear use from the EU or UK requires an export licence (usually a general licence)
• A licence is required for movements between the EU and UK (with Northern Ireland exemptions)
• Movement of those chemicals within the EU do not require a licence
• Movement of those chemicals within the UK do not require a licence (including Northern Ireland)
• Export from the USA to many countries (but excluding China or Israel) do not require licences, or have a lower licencing requirement. However, even in these cases, you should be careful about re-export to places such as China and Israel (amongst others)

• The USA have exempted most licencing requirements for non-nuclear use.
  

You can read more about this, regulators responses to this issue and the history of this in these slides.

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