Registration, Evaluation, Authorization, and Restriction of Chemical Substances

The REACH Regulation (EC/1907/2006) of the European Union entered into force on June 1, 2007 and is based on the precautionary principle. REACH stands for the Registration, Evaluation, Authorization, and Restriction of Chemical Substances regulation. It represented a significant change in terms of a shift in the obligation for risk assessment, risk evaluation, and risk management to the manufacturer or importer with regard to chemical safety. These duties are affected through a process of information disclosure through registration followed by evaluation and authorization for chemicals with varying levels of risk thresholds.

There is no explicit reference to nanomaterials within the REACH. In principle, however, nanomaterials would be included within the definition of “substance” in the [Page 657]REACH. Thus under the REACH, manufacturers, importers, and downstream users have an obligation to ensure that nanomaterials do not adversely affect human health or the environment. The primary obligation of the manufacturer or importer is to submit a registration dossier in the case of substances manufactured or imported up to or over one ton per year. The registration dossier for any nanomaterial would include all relevant information covering its properties, uses, effects, and exposure related information and other information relating to classification, labeling, safety assessment and any exposure scenarios. Chemical safety reports are required to be submitted for substances imported or manufactured up to or above 10 tonnes per year. The European Chemicals Agency (ECA) is also empowered require any information on any substance from the manufacturer apart from the minimum informational requirements of REACH.

On the issue of phase-in and non-phase-in of substances, it was decided that the decisive criteria of whether a nanomaterial was new or an existing substance would be the same as the one applied in the case of other substances. The criterion is whether the substance is included in the European Inventory of Existing Commercial Chemical Substances (EINECS Manual of Decisions, or MOD) to Directive 67/548/EEC (see Annex II). If the substance is not included and is therefore “new,” they had to be notified in accordance with NONS (substances notified under Directive 67/548/EEC) for quantities of 10 kg, or more. Notification was considered equivalent to being registered under REACH. Since June 2008, nanoscale substances that fall under non-phase-in category and that are manufactured or imported in quantities at 1 ton per year or more have to be registered prior to manufacture or importation. Nanoscale substances falling under the phase-in category can benefit from extended registration deadlines, provided they have been preregistered. For substances that are not preregistered, registration could be more complicated. In these cases, intrinsic properties of not only the substance in the bulk form, but also, in cases where the properties of the substance in nanoform are different, assessment of the properties in its nanoform is required, along with other information relating to classification, labeling, identified use, and chemical safety assessment (see Annex VI.3 of REACH).

REACH enforces chemical information disclosure through registration, followed by evaluation and authorization.

One of the important amendments that have been made (keeping in the mind the applicability of REACH to nanoscale substances) have been in the context of the list of substances under Annex IV and V of the Regulation. Annex IV specifies a list of substances considered to be of minimum risk on the basis of their intrinsic qualities, and in cases where sufficient information exists to validate the inclusion of these substances in the list. Both Annex IV and Annex V (which contains a list of substances exempted from the registration requirements under REACH) were to be reviewed by the Commission by June 1, 2008.

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