(Document IV)

A Steering Group of the Scientific Committee, with the support of the staff of the EMCDDA,
prepared draft guidelines for risk assessment of new synthetic drugs. This draft was
submitted to the Scientific Committee at its plenary meeting of 17 April 1998 and sent also to
the institutional participants in the risk assessment. After taking account of their opinions and
amendments, the Scientific Committee adopted the draft guidelines at its meeting of 1–2
October 1998 (ST/SCO/9/98 (rev.1)).

In accepting the assignment of risk assessment, the Scientific Committee had adopted some
basic principles.

1. The concept of risk will be understood in its dual meaning, which includes both the
element of probability that some harm may occur (usually defined as ‘risk’) and the degree
of seriousness of such a harm (usually defined as ‘hazard’).

2. The first phase of the scientific risk assessment of a particular drug will be carried out
independently of its legal status.

3. Consideration of appropriate measures and of the possible consequences of control of
new synthetic drugs will cover a wide range of options and will not necessarily imply
prohibition and law enforcement.

4. Scientific evidence on new synthetic drugs will often be limited, so it will be necessary to
evaluate the possible risks with reference to similar, known drugs.

5. In the final evaluation the issues of reliability (quality) of information and relevance of the
specific risk issues that are involved (health, social risks and consequences of
prohibition) should be separately weighted. The final policy consequences of risk
assessment will have to be decided within the framework of national or local drug policy
priorities.

The meeting having considered the above documentation and comments made by participants
adopted the ‘Revised Guidelines for Risk Assessment’ ( Document IV A).