REACH requires the registration of all chemical substances that are imported,
produced or used in the EU at quantities above 1 ton per annum, unless subject
to exemption. It is estimated that in the EU more than 30,000
substances will require registration under REACH. The total number of
pre-registrations done in Europe exceeds the 2 million. Not all of them will
be followed by registration.
In order to provide for this large registration load, a phased approach has
been implemented. Registration priority is given to high-volume substances and
to substances of special concern, for example those that may cause cancer,
reproductive harm, or negative environmental effects.
Exemptions
For certain substances or specific applications of substances registration
under REACH is not required. These include waste, substances applied in food
and feed, active pharmaceutical ingredients and polymers
. The monomers of polymers do, however, need to be registered. It should be
mentioned that application exemptions are limited to the particular
application only!
Products that are supplied for product or process research and development
(PPORD) are subject to a registration exemption for a 5-year up to 15-year
research period.
Importers and manufacturer in the EU
Each legal entity that imports or
manufactures chemical substances in the EU is responsible for the
registration of these substances in accordance with the given schedule.
Authorisation
A subset of the most hazardous substances will require an additional
authorisation procedure. This may require the submission of a
Socio-Economic Impact analysis and documentation stating that potential
substitutes have been evaluated for their technical feasibility. Use of the
substance may be restricted to specified uses, or subject to an outright ban.
ECHA published the first candidate list of substances requiring authorisation
on October 28th, 2008. DSM will monitor and take action where necessary, and
communicate any negative impact to affected customers.
Downstream users in the EU
If you are a downstream user of chemical substances
in the EU you need to verify whether your use conforms to those listed on the
extended Safety Data Sheet for the specific substance. If this is the case you
must apply the appropriate Risk Management Measures (RMMs) to ensure safe use.
If the intended use is not listed you must inform the supplier and supply the
information that is needed for making the risk assessment for safe use.
Alternatively you may register the specific use of the substance yourself.
