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Which substances?

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.

REACH

What is REACH?
Planning
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