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REACH the key stages
The registration of a product under REACH is a complex process, requiring significant effort on the part of manufacturers and importers, and likely to stretch over at least three years.
The registration of products in line with REACH regulations will follow a defined series of steps and take place in specific time bands. Here is a high level summary of those key steps.
The pre-registration period was 1 June 2008 to 1 December 2008. In this six months, pre-registrations were made for existing chemicals being sold in Europe in quantities of more than one tonne per year, to ensure their continued manufacture or import.
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 in 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 needed to be submitted for pre-registration was relatively small.
Following pre-registration, manufacturers and importers move into the registration phase. This entire phase extends out to 2018, but the deadline for registering products sold in the larger volumes of more than 1000 tonnes per year is the end of November 2010.
As part of the registration of each chemical, 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 in the associated workplaces and, therefore, what the potential for exposure is that might impact human health or the environment.
To reduce the overall amount of effort and testing this would require, fellow producers 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 two-year period on the part of major chemicals manufacturers and importers.
After submission, the European Chemicals Agency has indicated that it will assess each dossier for completeness within three weeks.
While securing a registration ensures that a company can continue to manufacture or import a product, 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 product moves into the authorisation phase.
Authorisation will only apply to products deemed to be of very high concern to human health and the environment. This category will include products 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 product 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 products will also have to investigate the possibility of substituting these products with safer alternatives or technologies.