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EU Regulatory Update: Defining R&D in REACH
By: Annelie Struessman, PhD, CONUSBAT
Posted: November 16, 2009
REACH legislation distinguishes between scientific research and development (SR&D) and product and process oriented research and development (PPORD). In Article 3/23, SR&D is defined as, "research carried out under controlled conditions in quantities of less than 1 tonne per year."
Under REACH, substances manufactured or imported in volumes less than 1 tonne per year do not need to be registered. Therefore, substances undergoing SR&D are exempt from registration. Additionally, according to Article 56(3) and Article 67(1), the provisions for authorization and restriction of substances do not apply. However, a notification to the European Chemicals Agency (ECHA) has to be made for substances meeting the criteria for classification as dangerous, per Article 113. This obligation goes into effect on Nov. 30, 2010. For substances placed on the market after that date, it applies as soon as the substance is launched, per Article 116.
In Article 3/22, 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." As such, 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 application research, falls under the definition of PPORD.
REACH does not impose a limit on the quantity in PPORD, neither to manufacture or import of the substance as such or in a preparation, nor to the incorporation or import in articles. Obligations for substances in PPORD in quantities below 1 tonne per year are the same as those for SR&D, except that authorization and restriction requirements may apply to PPORD.
Substances in volumes of more than 1 tonne/year undergoing PPORD can be exempt from registration for a period of five years, according to Article 9. In order to benefit from this provision, a company needs to submit a PPORD notification to ECHA. Upon request, the exemption can be extended for another five years. If substances have not launched to the market or if a company is developing medicinal products for human or veterinary use, an extension of up to 10 years can be granted. If a substance is also manufactured or imported for other purposes than PPORD, the quantity outside PPORD has to be registered as any other substance when exceeding the 1 tonne threshold.