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.
