Restriction

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Restriction is one of the two mechanisms in REACH used to address substances of concern. A restriction can ban or place limits on any substance or substance type which poses an unacceptable risk to human health or the environment. A substance does not need to meet the SVHC criteria associated with the Authorisation process to be restricted.

Examples of Restriction

Restriction can apply to the manufacture, use and placing on the market of a substance or substance type. It can be specific to a particular application, product type, or intended recipient. Unlike Authorisation, it can also apply to the presence of substances in imported articles.

Many restrictions are in place to protect the consumer. For example, aerosol dispensers of “silly string” or stink bombs intended for supply to the general public must not contain flammable liquids.

Restriction is not necessarily an outright ban on a substance. The entry often includes an allowable threshold below which the substance is permitted to be present in a given product. An example is acrylamide in mixtures for grouting applications: the substance must not be present at 0.1% or more by weight.

In some cases a restriction considers a release rate of a substance from a product. An example is nickel: the migration rate of nickel from the post assemblies of earrings for pierced ears and other body piercings must be less than 0.2 μg/cm² /week.

Existing Restrictions

The list of restrictions is found in Annex XVII to REACH, which took effect from 1 June 2009. Many of these entries were incorporated into REACH from old legislation such as the Marketing and Use Directives.

There have been numerous amendments to Annex XVII since it came into effect; please consult our REACH Resource section for further information and to access the REACH consolidated text. ECHA also maintains a table of the restricted substances.

The Restriction process

Before a restriction can be introduced a Member State or ECHA (usually at the request of the European Commission) must first submit a proposal according to Annex XV to REACH. This dossier must be submitted within twelve months of the Member State notifying its intention to make the proposal. The restriction dossier should contain all available information on the hazards and risks of the substance, any information on alternatives, and justification of the proposed restriction from REACH registration and evaluation or from any other source. A six-month public consultation period then ensues, providing the opportunity for interested parties to comment on the proposal.

Restriction proposals currently under consideration can be found on the ECHA website.

Two scientific committees, the Risk Assessment Committee (RAC) and the Socio-Economic Assessment Committee (SEAC), consider the proposed restriction and must prepare draft opinions to be sent to the European Commission within nine months of the publication date. Given that each Committee meets three months after the proposal is published submitting comments in the first half of the public consultation may be more beneficial.

A second public consultation period lasting 60 days allows interested parties to comment on the SEAC’s draft opinion; there is no public consultation on the RAC’s draft opinion.

Within three months of receipt of the two Committees’ opinions, a draft amendment of the list of restrictions in Annex XVII to REACH will be provided by the Commission and a final decision will be made on the Restriction of a substance.

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