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Scientist checking test tubes in a lab

The registration of a product under REACH is a complex process, requiring significant effort on the part of manufacturers and importers.

The registration of products in line with REACH regulations follow a defined series of steps and take place in specific time bands. Here is a high level summary of those key steps.

Pre-registration

The pre-registration period opened on 1 June 2008 and closed on 1 December 2008. In this six month period, pre-registrations were made for existing chemicals being sold in Europe in quantities of more than one tonne per year, to benefit from extended registration periods.  Pre-registrations were made:

  • by individual substance
  • by each manufacturer or importer of that substance

The real effort on the part of manufacturers and importers in this phase came from ensuring that they had a complete inventory of all of their products, as well as a clear understanding of the legal entities that make them. The amount of information that needs to be submitted for pre-registration is relatively small.

Registration

Following pre-registration, manufacturers and importers move into the registration phase. This entire phase extends out to 2018, but the deadline for registering substances manufactured or imported in volumes of more than 1000 tonnes per year was the end of November 2010.

As part of the registration of each substance, registrants will have to demonstrate that they know the hazards of their products, how they are used and are ensuring that products are used safely. To do this, a comprehensive dossier of physicochemical, ecological and toxicological data will have to be submitted to the European Chemicals Agency. This will also need to include information on how products are used.

To reduce the overall amount of effort and testing this would require, fellow registrants will work together to share the underlying data they already have and devise follow-up test plans.

Managing all of this activity will require intensive effort over a multi-year period on the part of chemicals manufacturers and importers.

After submission, the European Chemicals Agency assesses each dossier for completeness.

Evaluation

While securing a registration ensures that a company can continue to manufacture or import a substance, the next step is for the registration dossier to be evaluated by the European Chemicals Agency. They will be:

  • Checking for compliance with the REACH regulation
  • Assessing any proposals for further testing

Test proposals will be scrutinised with a view to limiting the amount of animal testing.

The dossier will also be assessed by Member States to examine the risks to human health or the environment of chemicals of concern. This assessment may result in a recommendation that a substance moves into the authorisation phase.

Authorisation

Authorisation will only apply to substances deemed to be of very high concern to human health and the environment. This category will include substances that can cause cancer or can have other serious and irreversible effects on human health or the environment.

The authorisation process will be rigorous and, for each situation in which a substance is used, it will have to be shown that either the risks are adequately controlled, or the socio-economic benefits from their use outweigh the risks.

Manufacturers and importers of these substances will also have to investigate the possibility of substituting these substances with safer alternatives or technologies.