Registration
Registration is the process under which chemical substance manufacturers and importers (into the EU) are obliged to send a registration dossier containing safety and other production data to the central European Chemicals Agency (ECHA) on substances produced or imported in quantities of one tonne per year or more.
Manufacturers and importers of 10 tonnes or more per year of a substance must also submit a chemical safety report (CSR), in which they must detail the hazard and risk assessment of the substance for specified (‘identified’) uses and how the risks posed by the chemical can be ‘adequately controlled’ for these uses. One of the outputs of the assessment is an ‘exposure scenario’; this is a summary of the use(s) and appropriate risk management measures which is communicated to downstream users as an Annex to the (material) safety data sheet (SDS). If the SDS contains an exposure scenario, it is called an eSDS.
Registration includes phase-in periods of 3, 6, and 11 years for compliance, according to the tonnage manufactured or imported in order to collect this information for ‘existing’substances.
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1 December 2010 |
Manufacturers and importers have to register phase-in substances produced or imported with volumes of over 1,000 tonnes/year, as well as CMR and toxic substances (R50/53) with volumes of over 1 tonne/year, according to the REACH regulation. |
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1 December 2013 |
Manufacturers and importers have to register phase-in substances with volumes of over 100 tonnes/year. |
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1 December 2018 |
Manufacturers and importers have to register phase-in substances with volumes of over 1 tonne/year. |
Pre-registration, which allows companies to continue manufacturing and importing their phase-in substances for several years until the registration deadline is reached, took place between June 7, and December 1, 2008. Expectations for pre-registration were substantially underestimated: authorities expected 185,000 pre-registration submissions but received 2.75 million.
In some specific cases companies can benefit from late pre-registration 6 months after beginning their process with the new chemical. There are two major factors the company has to comply with, (1) the company starts a new business process with a chemical was not used before by the company, (2) the date of the late pre-registration is 12 month in advance of the extended registration deadline for this chemical.
The new substances now coming to the market have to be registered immediately, before placing them on the market. The late pre-registration doesn’t apply for these substances. It is important to highlight too that late pre-registration does not apply to companies that failed to meet the pre-registration deadline of 1 December 2008 for their substances.
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