Product and process oriented research and development (PPORD) is defined as any scientific development related to product development or the further development of a substance, on its own, in preparations or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance.
Any scientific development on a substance consisting of, for example, campaign(s) for the scaling-up or improvement of a production process in a pilot plant or in the full-scale production, or the investigation of the fields of applications for that substance, falls under the definition of PPORD irrespective of the tonnage involved.
Examples of PPORD activities include:
Development and testing of a new process for the manufacture of a substance, as for instance when testing a new catalyst, when changing raw materials or when optimizing control or manufacturing parameters for improved quality, implying for instance innovative equipment or significant changes in the mass and heat transfer conditions;
Testing of a new intermediate for the synthesis of a substance for instance in the manufacturing of an active pharmaceutical ingredient (API);
Development and testing of a new application for a substance; for example the feasibility for use in a new preparation.
Considerations before making a PPORD notification
Prior to an eventual submission of a PPORD notification for a substance to the Agency, the potential PPORD notifier needs to figure out whether the activity he carries out alone or in cooperation with listed customers is within the scope of the definition of product and process oriented research and development .
In addition, it is important to figure out, based on the hazardous properties of the substance and the conditions of manufacture and use, whether the substance is effectively handled in reasonably controlled conditions for the protection of human health and the environment. In particular it is useful to take the following considerations into account:
⦁ Is the substance effectively manufactured and used for the purpose of PPORD?
⦁ What are the objectives of the research program?
⦁ What is the scale of the program: who will be exposed to the substance (workers, selected customers?)
⦁ What are the conditions for the manufacture, use and disposal of the substance?
⦁ What is the process (including batch sizes, identification of any potential losses (e.g. process emissions to waste water, reactor washings and residual material left in containers))
⦁ Information regarding any treatment of wastes and waste disposal practices for all potential waste streams.
⦁ What is the research program?
Description of the program including timelines and quantities used
The above considerations should make it easier for the PPORD notifier and his listed customers to comply.