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How dangerous are Substances of Very High Concern?

In Europe, the manufacture and use of chemical substances is regulated by REACH, the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals. It constitutes the framework legislation on chemicals in the EU. Some chemical substances could, based on their properties, have potential serious effects on human health and the environment. REACH therefore foresees a procedure to identify these substances, the so-called Substances of Very High Concern (SVHCs). But how does the framework go about it and how does it ensure that we are actually safe?

What is the difference between “risk” vs “hazard”?

In the discussion about chemical substances and their regulation, two words come up all the time: “risk” and “hazard.” While people often think that the two terms mean the same thing, and in many languages there is unfortunately only one word to describe both, there are fundamental differences between a risk and a hazard.

  • Hazards are everywhere. May they be man-made (like noise, a synthetic chemical substance, or tools) or natural (like a natural chemical substance, bacteria, animals, or radiation) they are around us and can cause adverse effects to our health. This is because their properties have the potential to cause harm to a person or the environment. The procedure for identifying Substances of Very High Concern is hazard based, i.e. it looks only at the intrinsic properties of a substance.
  • Risk is the actual probability that a person is harmed when exposed to a hazard under specific circumstances. Mere exposure does not necessarily mean that a person would experience adverse effects; specific exposure conditions and circumstances may trigger negative effects on human health or the environment. For example, a lion is intrinsically a hazard. However, when a lion is safely constrained in a zoo, it is not a risk since there is no exposure to it. Different pieces of EU legislation foresee risk assessments that are performed to investigate substance properties together with the actual exposure; they help determine safe levels and measures to ensure safe use.

What about BPA?

As a result of its classification as “reprotox 1B”, which entered into force in August 2016, BPA formally meets the criteria for identification as a Substance of Very High Concern. In December 2016, ECHA’s Member State Committee (MSC) agreed to identify BPA as SVHC, based on its harmonised classification. In addition, in June 2017 BPA was also identified as SVHC due to alleged endocrine disruptong properties for human health. These are a purely hazard based processes.

Coming back to the difference between “risk” vs “hazard”, regulators also looked at the real life uses and exposure scenarios for BPA to determine its safe use. On the use of BPA in food contact materials, the European Food Safety Authority’s (EFSA) latest risk assessment concluded that BPA poses no health risk to consumers of any age group at current exposure levels.


See also:

BPA Safety

Regulatory Framework

Article about (re)classification