Which are the requirements for the identification of Substances of Very High Concern in accordance with Article 57 (f) of the REACH regulation?
The European Regulation on the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulates the safe use of chemicals in Europe. So-called "Substances of Very High Concern" (SVHC) are of particular interest under REACH. These include substances that are carcinogenic, mutagenic, or toxic to reproduction (CMR) and, according to Article 57 (f), also substances with other properties constituting an ‘equivalent level of concern’. However, REACH does not provide a definite description of such properties. For this reason, the Federal Institute for Occupational Safety and Health (BAuA) and the Federal Institute for Risk Assessment (BfR) held a one-day workshop in Berlin on 29 March 2012 to discuss possible requirements for SVHC of ‘equivalent level of concern’. Under the title "REACH Article 57 (f): Non-Endocrine Disrupting Human Health Hazards Leading to SVHC Identification", experts from both national and European authorities, the chemical industry and non-governmental organisations (NGOs) exchanged and discussed their opinions on how Article 57 (f) should be implemented in practice.
The experts agreed that a harmonised concept for dealing with Article 57(f) would be helpful. In their opinion respiratory sensitisers in principle meet the requirements of Article 57(f) and thus should be regarded as potential SVHC. In addition, the representatives of BAuA and BfR in their lectures recommended that under certain circumstances also substances able to cause severe organ damage should be considered as possible SVHC candidates. In contrast, chemicals which only cause minor health problems or which due to their nature require effective risk management in any case, such as strongly corrosive substances, would normally not be regarded as SVHC.
In the course of the discussions, it became clear that many issues require further discussions between authorities and stakeholders from industry and non-governmental organisations. The debate between different stakeholders as such already constitutes a first successful step towards a harmonised approach. BAuA and BfR conclude that agreeing on a harmonised concept will not only lead to more transparency in dealing with Article 57 (f) but will also enable effective risk management for hazardous substances not sufficiently regulated previously.
The results of the workshop, the summaries of the lectures and discussions as well as the lecture slides are published as a report under the title “REACH Article 57 (f): Non-Endocrine Disrupting Human Health Hazards Leading to SVHC Identification”. This report is available on the internet pages of BAuA and BfR.
About the BfR
The Federal Institute for Risk Assessment (BfR) is a scientific institution within the portfolio of the Federal Ministry of Food, Agriculture and Consumer Protection (BMELV). It advises the Federal Government and Federal Laender on questions of food, chemical and product safety. The BfR conducts its own research on topics that are closely linked to its assessment tasks.