Substances of Very High Concern (SVHC): No Authorisation = No Market

Substances of Very High Concern (SVHC) listed in the Candidate List or the Annex XIV of EU-REACH are subject to the process of Authorisation.

It does not come as a surprise that those companies finding themselves in the web of the provisions on Authorisation under REACH are trapped with a regulatory burden if they desire to keep their substance in the market. The combination of fulfilling an essential function in their products or processes and the perception of either no alternatives being available or developing one against disproportional cost leads to regulatory strategies to obtain a maximum review period of 12 years before a re-application is due.

Engaging experts early in the process may avoid disappointment and unnecessary delays and cost while running the risk of losing reputation and in the worst case the entire business.

For more information, our experts can answer any questions on tracking emerging issues and preparing Applications of Authorisation.

Working with global corporations since day 1 of REACH, those companies subjected to the process of Authorisation because their substance was listed as Substance of Very High Concern (SVHC) on the Candidate List or already included in Annex XIV proved to be the most challenging consulting scenarios. These substances fulfill essential functions in their EU-based manufacturing processes, or their clients’ processes or products. Despite compelling evidence to the contrary, some companies claimed their substance “being a strictly controlled intermediate” is exempt from Authorisation. Other companies prepared for the worst spending fortunes developing regrettable alternatives, or only after an expert review to find out their substance would hardly attract regulators’ attention. A notification in the EU SCIP database would suffice in the latter case.

Engaging experts early in the process may avoid disappointment. It does not come as a surprise that those companies finding themselves in the web of the provisions on Authorisation under REACH are trapped with a regulatory burden if they desire to keep their substance in the market. The combination of fulfilling an essential function in their products or processes and the perception of either no alternatives being available or developing one against disproportional cost leads to regulatory strategies to obtain a maximum review period of 12 years before a re-application is due. The Authorisation process aims to ensure that SVHC’s are progressively replaced by less hazardous substances or technologies, where technically and economically feasible alternatives are available. However, numerous examples showed that despite no feasible alternatives or technologies identified in the Analysis of Alternatives (AoA), regulators, non-governmental organizations, and end consumers increased regulatory pressure supported by increasing willingness to pay for safer technologies. Consumers’ concerns proved powerful drivers for the industry to innovate and take advantage of being the first one in the market with safer alternatives or lose the business.

Preparing an Application for Authorisation (AfA) is a process in which client and consultant are engaged over a long period evaluating all possible alternatives in the face of non-use scenario(s) describing the actions and consequences when the substance is not available any longer. Ideally, Exposure & Risk Assessments are prepared with data stretching long observation periods, while data gaps are closed with new data from optimized measurement campaigns. The resulting Chemical Safety Report (CSR) shows the risks of the substance’s use are either adequately controlled or minimized to the lowest possible value for non-threshold substances by applying a combination of viable technical solutions and Risk Management Measures.

Finally, Economic Cost & Profitability Analysis, investment plans, and research timelines flow into the Socio-Economic Analysis (SEA), showing the monetized benefit to society of continued use of the substance outweighs by several orders of magnitude the monetized risk. High-quality AoA, CSR, and SEA are the means to support the RAC and SEAC in recommending the maximum review period to the EU Commission. Clients keeping abreast of the rapidly changing global regulatory landscape using Decernis’ early warning systems and working with their experts with a proven track record in successfully preparing Applications for Authorisation (AfA), control the life cycle of their substances of concern well ahead of becoming an issue of concern.