The restriction procedure is used to limit the manufacturing, use or marketing of substances, mixtures and articles that pose an unacceptable risk to human health or to the environment. Few examples of the targeted substances: applications of mercury such as in thermometers, the use of asbestos, some phtalates in toys, etc.
Scope of application of the restriction procedure
Restriction is some type of "safety net" to combat risks not handled by other REACH procedures. Its scope is much wider than the REACH registration procedure: it is also applicable to substances that are manufactured and imported in quantities less than 1 tonne/year and to products that are managed by sectoral legislations (such as toys, building materials, etc.).
In addition, it compensates for the fact that the authorisation procedure does not allow acting on the import of substances, mixtures and articles.
However, it does not cover manufacturing, marketing and the use of substances as part of the research and development activities or the use of substances in cosmetic products.
A restriction may prohibit the use of a substance for a target public. For example, prohibition may affect articles meant for consumers whereas marketing for professionals would still be possible (possibly with personal protective equipment).
The list of substances subject to restriction is given in appendix XVII of REACH and includes the restrictions existing from the old directive 76/769/CE. As soon as a commercial player wants to market a substance included in this appendix, it must comply with the terms and conditions specified therein (for example, prohibition of manufacturing, marketing and/or using a substance, mixture or article).
ECHA, European Chemicals Agency, coordinates the REACH activities including the Restriction process. Here one can also find the list of public debates about restrictions that are in preparation phase.
A Member State or the European Commission may file a restriction dossier under REACH. This dossier must include an assessment of risks for various uses to be covered by the restriction as well as a socio-economic justification for the measure being planned to reduce the risk. These items are then assessed by the RAC (Risk Assessment Committee) and SEAC (Socio-Economic Assessment Committee) Committees of ECHA (European Chemicals Agency). Public debate is organised at various stages of the procedure. Finally, the substance may or may not be added to appendix XVII of REACH based on proposal by the Commission discussed within the REACH Committee representing the Member States.
A nearly automatic procedure ensures the inclusion of the CMR substances and mixtures (carcinogenic, mutagenic, and reprotoxic) meant for consumers in appendix XVII.
In addition, the REACH regulations propose to restrict the use of category 1 and 2 CMR substances in consumer articles based on a simplified procedure. This is solely based on the Commission's initiative and bypasses the opinions of the ECHA Committees.
A restriction dossier is receivable only if the need for action at the Community level is demonstrated.
Note: Each Member State may at any time take restriction measures at the national level. In this case it must demonstrate that its national situation is specific and justify the fact that the measure has not been proposed at the European level. The aim is to avoid any competitive distortion within the single market.