The EU REACH Regulation (1907/2006, as amended) improves the safe use of chemicals with its simple requirement that suppliers must have data on the potential hazards of their products.
To demonstrate access to hazard data, manufacturers or importers (M/Is) of new chemical substances must compile a registration dossier that is submitted to the European Chemicals Agency (ECHA). The M/Is then pass on the information to downstream users via the safety data sheet (SDS).
The hazard data required to produce a registration dossier depends on the tonnage of substance manufactured or imported. Basic data is required above 1 tonne per year, with increasingly advanced information required at 10 tonnes, 100 tonnes, and 1000 tonnes. The costs of producing data, particularly through testing, can rise to hundreds of thousands of pounds at the higher tonnage bands.
The costs could be a barrier to innovation of new substances, but the REACH Regulation has provisions for Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD), which require a simpler notification process, rather than registration.
Scientific Research and Development (SR&D)
The SR&D provision has limited applicability, because use of the substance must be < 1 tonne/year per M/I, so normal REACH registration would not apply in any case.
The main benefit to SR&D is to side-step restrictions on use of particularly hazardous chemicals in the Authorisation List (REACH Annex XIV), or in the Restrictions List (REACH Annex XVII). A substance used for SR&D, once notified to ECHA, is exempt from the REACH provisions for restriction and authorisation.
The SR&D substance, once notified, can be used for research and analysis, under controlled conditions, ie with risk management measures in place proportionate to the hazard of the substance and the conditions of use.
Product and Process Orientated Research and Development (PPORD)
PPORDs allow manufacturers or importers (M/Is) to investigate uses and processes for a substance, including feasibility studies, pilot plant trials, or investigation of fields of application.
There is no limit on the tonnage, but the PPORD is limited to a specified duration (which may be extended) and customer list. It is recommended to include non-EU companies.
The substance must be handled in reasonably controlled conditions for the protection of workers and the environment. Only staff of the manufacturer and listed customers should be exposed to substance. It must not be made available to public at any time, even outside EU.
All quantities must be tracked, eg using documentation for shipping, disposal, and process losses. Remaining quantities should be collected for disposal.
Data on the identity of the M/I, the substance (composition and impurity details), hazard classification, and commercial information are compiled in a notification dossier in IUCLID format, and submitted to ECHA via the REACH IT portal. The supplier can start manufacture/import for purposes of the PPORD upon confirmation of the completeness check by ECHA.
1. Guidance on Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD).
2. How to prepare registration and PPORD dossiers.
Alchemy Compliance has 22 years of regulatory experience with industrial chemicals, in EU REACH Registration, safety data sheet compilation (EU, US, and beyond), and chemical hazard assessment. Contact us for more information.