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Denehurst Chemical Safety Ltd

Process Research Exemptions (PPORD)

One of the stated aims of REACH is to encourage innovation, and to help achieve this a reduced system of notification is available for new substances used in research and development

Substances manufactured or imported in quantities of less than 1 tonne per year.
Under REACH, registration is not required for substances manufactured or imported in less than one tonne per year. This is a change, and possibly an opportunity for some, from the requirements of the former NONS system, which required notification of new substances manufactured or imported in quantities of 10 kgs per year or more.

Although registration is not required, this does not mean that such substances are completely free from regulation. All substances, regardless of tonnage, must undergo a hazard assessment (classification), and if necessary be appropriately packaged and labeled. In addition, a Safety Data Sheet may be required. If the substance is classified as hazardous, then it must be notified to the new Classification ad Labelling Inventory, no later than 1 December 2010.

Substances manufacturer or imported in quantities of 1 tonne per year or more.
If manufactured or imported in quantities of 1 tonne per year or more, then a substance would normally be subject to the registration requirements of REACH. However, if the substance is used for the purposes of Product and Process Orientated Research and Development (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) then it is possible to obtain an exemption from this requirements for a period of 5 years through the submission of a reduced PPORD notification. This notification can be extended for a further 5 years subject to approval by ECHA, or in the case of medicinal and veterinary products, or substances not yet placed on the market, a further 10 years.

PPORDs can only be granted where the substance is to be used by the manufacturer or importer himself, or in cooperation with listed customers. There is no limit on the quantity of substance that can be covered under a PPORD notification, but any substance manufactured or imported for a use other than for research and development will be subject to the normal registration requirements.

Obtaining a PPORD exemption
To obtain a PPORD exemption, the manufacturer or importer must submit a dossier created using the IUCLID5 software to ECHA through the REACH-IT system.

The information required for a PPORD notification includes

(a) the identity of the manufacturer or importer or producer of articles
(b) the identity of the substance
(c) the classification of the substance
(d) the estimated quantity of the substance to be manufactured or imported for the purpose of PPORD for the calendar year of the notification
(e) the list of customers with which the PPORD cooperation is carried out, including their names and addresses.

The manufacturer or importer can also add additional information if they believe it will be helpful, such bas information on the R&D project. A fee is payable to ECHA for the processing of the PPORD dossier.

Substances used under a PPORD exemption will still be subject to any conditions placed on them through the Authorisation or Restrictions processes. PPORD substances are also still subject to legislation covering worker and environmental protection, and ECHA may demand more information, and impose conditions on use to ensure these objectives are met.