Research & Development Derogations
The Notification of New Substances regulations contains two derogations relating
to the use of chemicals in research. These are the Scientific Research and Development
derogation and the Process Orientated Research and Development (PORD) derogation.
It important to note that a derogation is not an exemption from the regulations,
it merely lessens the requirements.
The Scientific Research and Development derogation
The Scientific Research derogation applies to substances supplied at <100kg/year/manufacturer
for use in scientific research. In the regulations scientific research and development
is defined as "scientific experimentation, analysis or chemical research carried
out under controlled conditions including the determination of intrinsic properties,
performance and efficacy as well as scientific investigation relating to product
development".
This would include, for example:
- Screening tests for potential uses of compounds within a laboratory,
- formulation trials by customers (e.g. getting a stable preparation),
- efficacy testing (i.e. does the substance have the desired properties?).
- the supply and use of chemicals in university/company labs for experimental
synthetic work.
The precise text is given in
regulation 6(4)
(c) of the Notification Of New Substances regulations 1993. For information
on how you can use the Scientific R&D derogation and the approach of the UK
authority see the
Scientific R&D procedures
The Process Orientated Research and Development derogation
The Process Orientated Research and Development (PORD) derogation applies to
industrial processes. It starts at a supply level of 100Kg/year. In the regulations
Process Oriented Research and Development is defined as "the further development
of a substance in the course of which pilot plant or production trials are used
to test the fields of application of the substance".
This would include, for example:
- Transfer from bench-top to pilot plant
- Transfer from pilot plant to full scale production facility
- Production trials.
The precise text is given in
regulation 6(4)
(d) of the Notification Of New Substances regulations 1993. PORD's are the
most commonly used derogation, for further information and detailed guidance
see the
PORD Guide
