Life Sciences Pre-Registration
REACH regulation requires the registration of substances over one tonne per year, per manufacturer, or importer.
For substances that already exist in the European Community before REACH comes into force (i.e. phase-in substances), a longer preparation time may be allowed if a manufacturer or importer has pre-registered their substance.
The normal pre-registration period closed on 30 November, 2008. Companies that have missed the normal period but want to use the transitional arrangement and register at a later stage must check their eligibility for late pre-registration.
For a substance to be eligible for late pre-registration it must be what is known as a ‘phase-in’ substance. In addition, it must be the first time that you have manufactured or imported the substance in quantities greater than one tonne per year or more after 1 December, 2008. If both of these conditions are met, late pre-registration has to be submitted within six months of first manufacturing, importing or using the substance and no later than 12 months before the relevant tonnage band deadline.
Other chemical substances, that do not meet the above conditions, must be submitted for registration straight after submitting an inquiry dossier to the European Chemicals Agency (ECHA). For example, substances that are “non-phase-in” and/or have no pre-registration.
We can determine the total impact of REACH on your company by performing a REACH Impact Analysis, consisting of both a Simple Inventory and a Complex Inventory.
The Simple Inventory enables you to determine which substances to late pre-register. The Complex Inventory is an additional phase to prepare for entering the Substance Information Exchange Forum (SIEF) and for the registration of chemical substances. SGS can also enter SIEF on your behalf as your third-party representative and discuss with other SIEF members the exchange of data on substances and the cost of sharing these data.
Find out more about late pre-registration and REACH services from SGS.