EU Regulatory Update: Defining R&D in REACH

By: Annelie Struessman, PhD, CONUSBAT

Posted: November 16, 2009

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Substances in PPORD have to be to be carefully checked if they are included in Annex XVII, the list of substances subject to restriction, or Annex XIV, the list of substances subject to authorization. If not yet included in these lists, the substance should be investigated for properties of very high concern. If these properties of very high concern exist, the substance may be subject to a future authorization.

The manufacturer or importer of substances in PPORD must provide a safety data sheet (SDS) to downstream users for substances meeting the criteria for classification as dangerous, for PBT or vPvB substances and for substances included in the candidate list of substances which may be subject to authorization. If the SDS is not required, the supplier must still provide all available and relevant information about the substance that is necessary to enable the users to perform the appropriate risk management measures.

Similar to registration dossiers, a PPORD notification dossier has to be provided through REACH-IT. ECHA will perform a completeness check of the notification within two weeks of the submission. The completeness check verifies whether all the required information elements have been submitted and the payment of the applicable fee has been received.

Key summary:
• REACH distinguishes between SR&D and PPORD.
• SR&D applies to research under controlled conditions in quantities below 1 tonne/year.
• Substances undergoing SR&D are exempt from registration, authorization and restriction.
• A notification needs to be made to ECHA for substances in SR&D meeting the criteria for classification as dangerous.
• The definition PPORD applies to any development of a substance through scaling-up or process improvement research in a pilot plant or in a full-scale production, as well as to application research.
• REACH does not impose a limit on the quantity in PPORD.
• PPORD in quantities below 1 tonne per year requires the same provisions as for SR&D, except that authorization and restriction requirements may apply.
• Substances undergoing PPORD in volumes of more than 1 tonne/year can be exempt from registration for a period of five years.
• A company needs to submit a PPORD notification in order to be granted an exemption.
• Upon request, ECHA can further extend the exemption time line.

Further questions? Ask them at C&T magazine online's REACH Round Table.