The concepts of hazard and risk provide the entire foundation for regulating chemicals: only after the hazardous properties of a chemical are known can risk management measures be taken. Even though they are interlinked, in the debate around the EU’s chemicals legislation, such as REACH, hazard and risk are often juxtaposed.
The generic risk approach, on the one hand, seeks to regulate the most harmful chemicals based on their intrinsic hazards combined with concern about exposure. In doing so, it effectively eliminates the exposure risks. Specific risk assessments, on the other hand, rely on detailed calculations for specific uses. They seek to regulate hazardous chemicals only when the estimated exposure would lead to “safe levels” being exceeded.
Which approach should we use for regulating hazardous chemicals? Here opinions diverge. Is knowledge of the hazardous properties of a substance enough to restrict it? Or should we first assess the exposure in detail to see if there is a risk that can be limited by managing the exposure, and thus allow continued use of the most harmful substances?
Generic risk approach
This approach considers exposure to the most harmful chemicals in a pre-determined way. The substances targeted by GRA are, for example, cancer-causing, hormone-disrupting, toxic to reproductive or neurological systems, or persistent in the environment. Due to such hazardous properties, risks can be assumed as a default for widely used products. No resource-intensive specific risk assessment is required. By eliminating the hazard, you effectively eliminate the exposure and thus eliminate the risk. This is, for example, suitable for chemicals where the level of exposure is difficult to assess or control.
Specific risk assessment
This approach depends on elaborate probability calculations of risks based on estimated exposure levels compared to safe exposure levels. However, in many cases, it is not possible to scientifically establish safe exposure levels. This approach might be useful in a sealed-off environment where all the exposure routes are known, but it must account for uncertainties, including mixture effects, to be sufficiently protective of human health and the environment.
Specific is not more scientific
Advocates of the specific risk assessment approach argue that this method is the correct way to handle hazardous chemicals since it is thorough and specific to the use in question. However, the sealed-off and perfectly managed environment necessary for this method is often unachievable. In reality, it is extremely challenging to accurately estimate the exposures to a chemical throughout its lifecycle; from workers involved in production, consumers exposed to a product throughout its lifetime, all the way through to waste and recycling.
Moreover, persistent chemicals such as PFAS make things even more difficult since they easily spread in waterways, building up in the environment and the food chain. Generally, information on exposures to chemicals is scarce. In fact, we don’t even know where all hazardous chemicals are used. This makes exposure estimates impossible.
Even if it were possible to estimate the exact exposure to a chemical, for many of the most harmful substances there is no safe level of exposure. Cancer-causing substances can, for example, cause harm at any level, while hormone-disruptive chemicals can have the most severe effects at low concentrations.
On top of this, we are constantly exposed to multiple substances, causing a combined toxic effect where the combination of chemicals poses a larger risk. This is often called the “cocktail effect” and is not considered in legislation today.
In short, specific risk assessments:
❌ Are very complex and require a huge amount of data, which is rarely available
❌ Require significant resources from the authorities
❌ Have difficulties in estimating exposures from widespread uses
❌ Cannot establish scientifically safe levels of exposure for many hazardous chemicals
This means specific risk assessments are applicable only in very limited circumstances. They are not an effective regulatory approach to ensuring a high level of protection for people and the planet — not from the most harmful substances, and especially not for those with widespread uses.
A safer and more effective approach
The generic risk approach, on the other hand, does a better job of effectively protecting human health and the environment. It is a simpler and much more cost-efficient regulatory approach, which is why the EU’s Chemicals Strategy for Sustainability suggested that the use of the generic approach be extended to all most harmful substances.
The generic risk approach relies on well-established scientific reasoning, as well as a number of cautionary historical examples of wide dispersive uses of substances causing irreversible damage and high costs for society (the best known include leaded gasoline, asbestos, PCBs, DDT, as well as the ongoing PFAS crisis).
This approach is already used by responsible companies when evaluating substitution priorities as a way to future-proof their business. Such straightforward identification of substances and uses to phase out is a very efficient driver of innovation toward new and safer chemicals and products because anticipation of regulation creates a demand for safer alternatives that producers are eager to meet.
The call for extending the use of the generic risk approach in regulation is partly based on recent years’ lessons, which have clearly shown that it is not possible to scientifically define safe levels for many of the most harmful chemicals. Hormone-disrupting substances are one example of such “non-threshold chemicals”, which have no safe level of exposure at which they do not have a harmful effect. Yet, authorities still treat these chemicals as if it is possible to manage their risks with safe levels (see example below). In summary, the generic risk approach:
✅ Protects human health and the environment more effectively
✅ Is simpler and much more cost-efficient
✅ Drives innovation toward safer chemicals and products more effectively
✅ Is already used by responsible companies when evaluating substitution priorities
Example: Bisphenol A (BPA)
Late action from an early warning
The first evidence of BPA’s toxicity emerged in the 1930s. There followed an explosion of BPA use in plastics, from bicycle helmets to baby feeding bottles. In the 1990s, scientists found evidence of harm to the foetus at low doses, and that BPA could leach out of bottles.
The European Food Safety Authority (EFSA) established a Tolerable Daily Intake of 50 micrograms/kg body weight per day in 2006. After 800 more studies, in 2015 it lowered the limit by a factor of 10. In 2023, EFSA further lowered the limit by a factor of 20,000 (!). Its experts concluded that current exposure levels posed a risk to consumers of all ages.
If a generic risk approach had been adopted, concerns about toxicity and the widespread use of this chemical, including exposure of vulnerable population groups, should have been enough to introduce a ban decades ago. Waiting for new evidence has lowered the official threshold, while allowing exposure and pollution to go on and on.
In contrast, there is not one single example of the European Union acting too early or too forcefully on harmful chemicals.
Another obvious example of “too little, too late” is the global PFAS crisis we are facing as a consequence of insufficient regulatory action.
The demand for detailed risk assessments — even for the most harmful substances — has contributed to severe under-regulation of chemicals.
Policymakers must act when there is scientific suspicion of risk and apply the generic risk approach to avoid similar mistakes in the future. This is the only way to effectively prevent pollution at source.