Evaluation, Authorisation and Restriction under REACH

Evaluation

ECHA and the Member States will evaluate the information submitted by companies to examine the quality of the registration dossiers and the testing proposals and to clarify if a given substance constitutes a risk to human health or the environment.

Evaluation under REACH focuses on three different areas:

  • Examination of testing proposals submitted by registrants
  • Compliance check of the dossiers submitted by registrants
  • Substance evaluation

Once the evaluation is done, registrants may be required to submit further information on the substance.

In line with Article 54 of the REACH Regulation, by 28 February of each year, ECHA has to publish a report on the progress it has made over the previous calendar year on its obligations in relation to evaluation. ECHA is specifically required to include recommendations to potential registrants to foster improvement in the quality of future registrations, in these reports.

Authorisation

The authorisation process aims to ensure that substances of very high concern (SVHCs) are progressively replaced by less dangerous substances or technologies where technically and economically feasible alternatives are available.

The route to authorisation starts when a Member State or ECHA, at the request of the Commission, proposes a substance to be identified as an SVHC.

Substances with the following hazard properties may be identified as SVHCs:

  • Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B in accordance with the CLP Regulation.
  • Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to REACH Annex XIII.
  • Substances on a case-by-case basis, that cause an equivalent level of concern as CMR or PBT/vPvB substances.

The SVHC identification process includes a 45-day public consultation. Once a substance is identified as an SVHC, it is included in the Candidate List. The inclusion in the Candidate List brings immediate obligations for suppliers of the substance, such as:

  • supplying a safety data sheet
  • communicating on safe use
  • responding to consumer requests within 45 days and
  • notifying ECHA if the article they produce contains an SVHC in quantities above one tonne per producer/importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w).

Restriction

Restrictions are an instrument to protect human health and the environment from unacceptable risks posed by chemicals. Restrictions are normally used to limit or ban the manufacture, placing on the market (including imports) or use of a substance, but can impose any relevant condition, such as requiring technical measures or specific labels.

A restriction may apply to any substance on its own, in a mixture or in an article, including those that do not require registration, for example, substances manufactured or imported below one tonne per year or certain polymers.

On-site isolated intermediates, substances used in scientific research and development, and substances only posing risks to human health from their use in cosmetics are exempted from those substances to which REACH restriction applies.