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REACH Authorisation and Restriction

REACH requires the communication of information in two directions in the supply chain:

Authorisation

For substances of very high concern (SVHC), an authorisation is required in order for them to be placed on the market or used. Such substances will gradually be entered into Annex XIV of the REACH Regulation. Once included in this annex, substances will not be allowed to be placed on the market or used after a set date (the “sunset date”) unless authorisation is granted.

Substances of very high concern include:

  • Carcinogenic, Mutagenic or reprotoxic (CMRs; category 1 or 2) substances;
  • Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) substances; and/or
  • Substances identified on a case-by-case basis for which there is scientific evidence of probable serious effects on humans or the environment of an equivalent level of concern as those above, such as endocrine disrupters

There is no tonnage threshold for a substance to meet the requirements for authorisation.

A list of candidate substances to be considered for authorisation has been published by ECHA, and prioritised according to their intrinsic properties, uses, releases.

Industry must apply for authorisation of substances of very high concern within the timescale of the set deadline. Applications must include:

  • a chemical safety report covering risks related to those properties that caused the substance to be included in authorisation system (unless already submitted as part of the registration dossier);
  • an analysis of possible alternative substances or technologies;

Where suitable alternatives have been identified, a substitution place should also be included which explains how the replacement will be achieved. If no suitable alternative exists or risks are not shown to be adequately controlled, a socio-economic analysis must be included.

Authorisations will be granted if the applicant can demonstrate that the risk from the use of the substance is adequately controlled. Downstream users may only use such chemical substances for authorised uses, achieved through obtaining the chemical from a company which has obtained authorisation for that specific use or by applying for authorisation themselves.

Restriction

Under REACH, certain substances of very high concern may be subject to restrictions to regulate their manufacture, placing on the market or use within the EU if they are deemed to pose an unacceptable level of risk to human health or the environment. Restrictions will take many forms, ranging from limitations on supply of the substance to the general public to a total ban, and may be applied to substances on their own, in a preparation or in an article. There is no tonnage threshold required for a substance to be subject to restriction. Decisions regarding restrictions will be made by ECHA, and are designed to act as a 'safety net' to ensure risks that may not be covered by other areas of the REACH Regulation are managed.

Annex XVII of REACH contains a list of all restricted substances, including which uses are restricted.

Need assistance preparing your chemical safety report, analysing alternatives or applying for authorisation? Our dedicated REACH team can assist through the provision of tailored and cost-effective services including: