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Explained: EU’s make-or-break debate on chemical risk management

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Explained: EU’s make-or-break debate on chemical risk management

When it comes to regulating hazardous chemicals, the EU has a choice: keep relying on slow, complex risk calculations that leave people exposed — or take a simpler, more protective route that removes toxic substances from the start. The debate between specific risk assessments and the generic risk approach will determine whether Europe can protect its citizens against the most harmful chemicals.

Published on 20 Nov 2025

Everyone has that one embarrassing story. 

That one time they used under-eye cream instead of toothpaste because they were sitting next to each other and look sort of similar. 

That one time they opened a bottle of medicine and half the pills went flying across the bathroom and into the toilet. 

That one time they forgot to turn the stove-top all the way off, burning their non-stick pan and ruining what was supposed to be tomorrow’s leftover lunch, and only remembered because the smoke alarm started going off in the kitchen (too specific to be just hypothetical?). 

It happens more often than you think. 

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But, according to the European Commission, companies don’t have to consider the chemical risk to you or the environment in ANY of these situations. This is thanks to the dominant approach to regulating hazardous chemicals in the EU: the specific risk assessment (SRA). 

This approach to risk management looks at a certain chemical in a product, considers how much you’re exposed to it, then compares that to so-called safe levels. In other words, what kind of risk this expected exposure presents to you, the consumer.  

The problem? In the real world, exposures are messy — no one ever expected you to swallow that under-eye cream or drop your pills down the toilet. And companies aren’t required to account for or even consider any of this with the SRA. 

We’re surrounded by countless chemicals at unexpected levels all the time, and it’s often impossible to say what’s truly safe. 

The pitfalls of specific risk assessments

❌ Too complex, too data-reliant 

Specific risk assessments need a huge amount of data to estimate exposures for each use of a chemical — from production to use to disposal. Can regulators account for every single scenario at every single level of a chemical’s life cycle? That seems unlikely. 

These assessments often demand a level of precision that nature simply doesn’t allow. This false sense of accuracy creates what experts call the “analysis placebo effect” — the illusion that a risk has been managed simply because it has been analysed. 

In practice, however, risk assessments are held back by four types of uncertainty: lack of information, measurement uncertainties, observation conditions and inadequate models. 

And those uncertainties are sure to be exacerbated. 

Just rewatch Jurassic Park for Christ’s sake! The whole premise of the movie is that chaos will eventually beat out predictive models of risk assessment, regardless of time and money (and also dinosaurs). 

But real life is also filled with examples of risk assessments gone wrong: underestimated toxic emissions, “acceptable” pollution levels that are outdated or don’t take account of the chemical cocktail effect, or disasters like the Deepwater Horizon spill where the predicted risk was far lower than the actual outcome. The list goes on and on. 

As Jeff Goldblum put it: “Life, uh, finds a way.” 

❌ Overly burdensome on authorities 

Some research suggests that 40 new chemicals are discovered every hour, with thousands of synthesised chemicals reaching the global market each year. Yet the process for restricting a single chemical can take years to prepare depending on the complexity, not to mention hundreds of thousands of euros. 

Between 2011 and 2022, only 2.5 restrictions per year were adopted using the SRA under REACH — far fewer than the 11 originally predicted. 

Meanwhile, hazardous chemicals continue to remain on the market, often lacking detailed data and information on the uses and exposure 

This also opens the door to lobbying. 

One lobbying watchdog has noted that chemical industry talking points have begun showing up in new European Commission policies. A result of not just direct lobbying, but also of the 5,000+ industry responses submitted in the public consultation phase of ECHA’s PFAS proposal. 

❌ Can’t estimate exposure from widespread uses

People are exposed to chemicals every day. They’re in our clothes, cosmetics, phones and even food — virtually inescapable. And that’s fine when the chemical makeup is something like H2O, but it gets a little uglier when it’s something more harmful.  

Companies may be able to assess how much exposure a person has to chemicals in their product alone, but it quickly becomes a staggering math problem to try and calculate exposure to that same chemical from all products on the market.  

Many harmful substances are used in a wide variety of different materials and applications across society. Substances like PFAS, for example, are used in countless sectors — from plastics and coatings to textiles — and leak into the environment at every stage of their life cycle.  

Someone eating PFAS-contaminated fish, drinking PFAS-contaminated water and using PFAS-contaminated products may very quickly reach concerning levels of PFAS in their blood, even if the PFAS level in the original products was considered “safe.”  

Another person might not drink the PFAS-contaminated water but might eat double the number of PFAS-contaminated fish and have a completely different, but equally concerning level of PFAS in their blood.  

The truth is it’s impossible to know the real exposure to people and the environment — life is often messy and people unpredictable. Even if every company predicted their chemical footprint exactly right, regulators do not (and simply cannot) accurately predict exposure from widespread uses.  

❌ Doesn’t establish true safe levels of exposure

Some substances act on a monotonic dose-response curve where the higher the dose of the substance, the stronger the effect — like the more coffee you drink, the more awake you feel.  

Others, however, do not. 

Take natural hormones, for example. Hormones control things like growth, mood and reproduction through very precise chemical signals in the body. So when endocrine disrupting chemicals (EDCs) are introduced, even at exceedingly low levels, they can still have huge effects that may not have been predicted at higher levels

Moreover, it’s estimated that nearly a quarter of all human diseases and disorders around the world are linked to environmental factors, playing a role in about 80% of the deadliest ones — including cancer and heart disease. 

Some substances, such as cancer-causing or hormone-disrupting chemicals, can cause harm at any dose, even at levels well below supposed “safe” thresholds. 

Part 2 coming soon: The advantages of the generic risk approach

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