Potential substances of very high concern based on environmental protection criteria of the REACH regulation: Verification by substance properties and prioritisation by relevance criteria

The REACH Regulation No. 1907/2006 introduced the concept of substances of very high concern (SHVC; Art. 57) for the control of risks to human health and the environment. In this project, the focus was on environmental concerns according to Art. 57(d) to 57(f):

• Persistent, bioaccumulating and toxic substances (PBT; Art. 57(d))
• Very persistent and very bioaccumulating substances (vPvB; Art. 57(e))
• Endocrine disrupting substances (Art. 57(f))
• PBT-like and vPvB-like substances (Art. 57(f))
• Other properties of concern that are of environmental relevance (Art. 57(f))

A training set of 144 substances suspected to be substances of very high concern was used to develop methods to consolidate the suspicion and to prioritise the substances. Standardised assessment phrases were developed, which represent a certain likelihood that the assessment of a category for a specific substance might be supported by an extended and detailed evaluation. The level of certainty was termed ‘likelihood of categorisation’ (LoC) and visualised with a colour code.

The prioritisation is based on so-called relevance criteria that are independent of the SVHC criteria. The prioritisation method applied is a combination of a decision tree and a scoring system. The relevance criteria within this project were production volume, wide-dispersive use, monitoring, hazard to groundwater, long-range transport, allocation to more than one SVHC (sub)category, part of (inter)national legislation/conventions.

The large set of information was managed in a Microsoft Access database named ‘categorisation and prioritisation tool’. The categorisation and prioritisation tool is organised in several sections corresponding to the substance properties, the SVHC criteria and the relevance criteria. The system requires expert judgement, but also contains the functionality of automated assessments for certain steps due to standardised assessment phrases. The categorisation and prioritisation tool offers the possibility to prioritise the substances while being able to adjust the scores for the relevance criteria.