Guidance on registration - ECHA - Europa

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<strong>Guidance</strong> on registration
Version 2.0 May 2012
been registered by the supplier or another actor up their supply chain. For most polymer
manufacturers the situation will generally be that their monomers and other substances will be
registered by the suppliers of these substances. However, for an importer of a polymer
consisting of monomer(s) or other substance(s) fulfilling both the conditions (b) and (c) stated
above, the monomer(s) or other substance(s) must be registered unless:
an only representative has been appointed by the non-EU manufacturer to fulfil the
obligations of the importer. In this specific case, it is the duty of the only representative
to proceed with the registration of the monomer(s);
the monomer substances or any other substances used for the manufacture of the
polymer have already been registered up the supply chain, e.g. if they have been
manufactured within the EU and exported to a non-EU manufacturer.
More detailed information can be found in the <strong>Guidance</strong> for polymers. The guidance describes
the provisions for monomers and polymers under REACH and provides clarification on how to
deal with specific cases such as naturally occurring polymers and recycled polymers. The
reader is advised to consult the document if in need of further information on these topics.
Legal references: Article 2 (9), Article 6 (3)
2.2.3.8 Substances used for the purpose of research and development
Since one of the main objectives of REACH is to enhance innovation, the REACH Regulation
promotes research and development, inter alia, through a number of exemptions from the
registration obligations.
Scientific research and development
Scientific research and development means any scientific experimentation, analysis or
chemical research carried out under controlled conditions in a volume below 1 tonne per year
(Article 3 (23)).
A substance being used solely for scientific research and development does not need to be
registered since the registration obligation applies to volumes of one tonne or more per year.
Product and process orientated research and development (PPORD)
Product and process orientated research and development is defined as any scientific
development related to product development or the further development of a substance, on its
own, in mixtures 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 (Article
3 (22)).
Substances used for PPORD in quantities of one tonne or more per year will receive an
exemption from registration for five years if they are notified to ECHA. The notifier must pay a
fee to ECHA when submitting his notification dossier in addition to providing certain
information about the substances and the PPORD use. Substances used for PPORD in
quantities below one tonne per year do not need to be notified since they fall below the
registration threshold of one tonne per year.
The exemption applies only to the quantity of substance being used for PPORD by a
manufacturer, importer or producer of articles, himself or in cooperation with a limited number
of customers. The notifier must identify these customers in his notification dossier including
their names and addresses. These identified customers are referred under REACH as listed
customers.
ECHA may extend the exemption period for up to a further five years (or ten years in the case
of medicinal products or substances not placed on the market) upon request, as long as this
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