The restrictions procedure is a safety net for substances posing an unacceptable risk to human health or the environment arising from its manufacture, use or placing on the market, which need to be addressed on a Community wide basis.

The basis of the demonstration of the unacceptable risk to human health or the environment on a Community wide basis, will be a risk assessment. This will be different from the CSR of the individual dossiers as they usually won’t deal with regional ‘exposure’, aggregate volumes, and multiple exposures.

A restriction of a substance is any condition for, or prohibition of, its manufacture, use or placing on the market. Restrictions enable risk management measures beyond those already implemented by manufacturers, importers and downstream users, to be introduced across the Community where they are shown to be necessary. Restrictions can also impose a harmonised level of risk management measures. Restrictions apply to all manufacturers, importers, downstream users and distributors of a substance if the manufacture, use or placing on the market (activity) of this substance is included in Annex XVII.

Annex XVII contains restrictions on the manufacture, placing on the market and use of certains dangerous substances, preparations and articles; a consolidation of the restrictions contained in Directive 76/769/EC.

Activities with the substances not included in Annex XVII are allowed, provided there is no restriction in other, sector specific Community legislation, and the substance is not subject to authorisation (Annex XIV).

All substances on their own, in preparations or in articles may be subject to restrictions, regardless of any duty to register the substance. Restrictions apply to activities regardless of the quantity, unless the annex specifies thresholds. However, use of a restricted substance in scientific research and development, as well as product and process oriented research and development activities in quantities below 1 tonne per year, is exempted.

The restrictions also do not apply to substances that are waste being treated in a waste treatment installation within the conditions of a permit.