Selecting substances to propose for authorisation, restriction, evaluation or harmonised classification and labelling

REACH provides the opportunity for national authorities to propose substances to be considered under REACH for authorisation (via adding to the Candidate List of Substances of Very High Concern, SVHC), restriction or (from 2011) evaluation. National authorities can also propose substances for harmonised classification and labelling, though usually only for carcinogenic, mutagenic and/or reproductive toxicity (CMR) and respiratory sensitisation properties unless there is strong justification for considering another endpoint(s).

The UK REACH CA Steering Committee confirms the annual work programme of the UK REACH CA that is then delivered by the CA. One component of this programme is the progression of work on individual substances for introduction into EU REACH processes. In this context, the Steering Committees has developed a process and criteria by which nationally the UK can develop a list of priority substances on which the UK REACH CA will work. The flow chart below outlines this process.

Notes

1. Stakeholders should approach the relevant UK Government Department, Agency or Devolved Administration to put forward suggestions on possible substances for consideration.  UK Government Departments, Agencies and the Devolved Administrations may also seek input from their relevant advisory bodies.
2. The UK REACH Competent Authority Steering Committee secretariat will maintain a log of proposed substances. Each proposal will have an associated explanation of the basis/justification for its entry into the log, which will also carry information on the EU-wide picture.
3. Preparation of a proposed priority list will be linked to REACH processes operating at EU level as well as taking account of the work planning cycles for the UK REACH CA.
4. The Steering Committee will consider the proposed priority list will agree a final list for taking forward including a consideration of the resources available within the REACH CA to deliver the overall package.
5. Ministerial consultation may be required in some circumstances where proposals for action need a higher level of approval.
6. The REACH CA will use the mechanisms operated at EU level by ECHA to put forward formal proposals for activity by the UK.

Substance selection criteria

In developing a proposal for any specific substance, it is important that clear criteria are available against which judgements can be made in relation to proposing any particular action. The Steering Committee has thus developed the following national criteria for identifying substances that could be deemed a priority for the UK REACH CA to work on in the context of authorisation, restriction or evaluation:

Authorisation:

• It meets one or more of the criteria for an SVHC as laid down in Article 57 of REACH
• It normally (but not necessarily) would meet at least one of the conditions:
  • PBT or vPvB
  • wide dispersive use
  • supplied in high volumes
• There should be regulatory coherence (e.g. not taking forward one or more members of a chemical family but leaving behind others with similar properties)
• There should be at least one situation of manufacture or use for which the UK government has concerns that current risk management does not secure the desirable degree of control
• There is an overriding UK government policy need for the UK to take the initiative on a substance

Restriction:

• The Article 57 criteria are met but the situation deemed to require regulatory intervention is not suitable for an authorisation approach (e.g. the presence of the substance in imported articles)
• The substance presents serious concerns for human health and/or the environment but does not meet the criteria of Article 57 of REACH
• There is concern that the chemical safety assessment and associated exposure scenarios developed by the registrant do not satisfy the regulatory authorities that the potential exposure of humans and/or the environment could be controlled to satisfactory levels
• There should be regulatory coherence (e.g. not taking forward one or more members of a chemical family but leaving behind others with similar properties)
• The substance is used in appreciable quantities, such that a significant number of humans are significantly exposed and/or there is significant exposure to the environment; or there is reason to believe that some humans are potentially at considerable risk of serious ill-health consequences
• There is knowledge that substitution to create a less threatening situation is possible or likely to become possible in the near future

Evaluation:

• The substance should be one that is of interest/relevance to the UK in some context and/or
• There are scientific/technical issues associated with the substance on which the UK wishes to exert the influence best expressed through leadership of the evaluation
• There is a reason to believe, from the information available at the time, that the substance might become a future candidate for authorisation or restriction activity