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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. 

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The flip side of the coin

All this to say that while the specific risk assessment sounds technical and scientifically grounded, it is often anything but. Measuring specific risks will never be as efficient or effective as addressing the most harmful substances directly.

On the other hand, the generic risk approach (GRA) cuts through the noise by looking at the properties of the chemical itself. If, for example, it’s cancer-causing, hormone-disrupting or persistent, then it’s a risk — full stop.

This approach is far more protective — and equally science-based. Instead of gambling on exposure estimates, it removes the most dangerous substances from the start, keeping people and the environment safer.

The GRA is currently used in the EU for substances that are carcinogenic, mutagenic or reprotoxic (otherwise known as CMRs). Extending this approach to all the most harmful substances in the EU Chemicals Strategy for Sustainability (CSS) would have enormous benefits for Europe.

Advantages of the generic risk approach

✅ More effective protection

The generic risk approach assumes that if a chemical is cancer-causing then it is too hazardous for widespread use. By cutting out the most harmful substances from the start, GRA provides stronger protection for people and the environment.

Why take our word for it? The EU Commission said it best:

“One of the greatest health benefits of the EU chemicals legislation over recent decades has been the reduction in citizens’ exposure to carcinogenic substances. This has been achieved particularly through a preventative approach across legislation – the ‘generic approach to risk management.’ Such a preventative approach is simpler, generally quicker, and offers clear guidance to all stakeholders”.

“Such a preventative approach is simpler, generally quicker, and offers clear guidance to all stakeholders”

✅ Simpler and more cost-efficient

As mentioned, regulating hazardous chemicals one by one through specific risk assessments has proven slow, expensive and unsustainable. This case-by-case process eats up regulatory capacity and leaves thousands of hazardous substances on the market while authorities struggle to keep up.

The generic risk approach, however, solves this by applying faster safeguards to the most harmful substances (and at a fraction of the cost).

According to the EU Commission’s own estimates, continuing to rely on specific risk assessments as the main chemical restriction tool will cost public authorities and companies around €5-6.3 billion over the next 30 years.

In comparison, using the GRA to restrict CMRs will cost just €900 million over the same period — nearly seven times less.

And that says nothing about the money saved from avoiding harm to human health and the environment. It’s estimated that the current health-related societal costs from endocrine disrupting chemicals alone range from €46-288 billion per year.

So while extending the GRA beyond CMRs may increase the cost upfront, cutting down on the human health impacts would more than make up the difference.

✅ Better at driving innovation

The generic risk approach doesn’t just cut red tape — it also gives companies something they’ve been asking for: clarity and predictability.

When the rules clearly spell out which chemicals are too hazardous to use, businesses can plan ahead, invest in safer alternatives and stay ahead of the curve instead of reacting at the last minute.

Take the plastics industry, for example. If harmful plastic chemicals were identified based on their inherent dangers — like being toxic or building up in our bodies — regulators and companies could act much faster, without spending years waiting for exposure data or complex risk models.

Acting early on what we already know would mean less pollution, fewer health risks and more time spent developing real solutions.

Over time, this approach would push the entire plastics sector toward smarter, safer design — creating materials that can actually fit into a circular economy instead of contaminating it.

Not only that, but it would also help stop the cycle of “regrettable substitutions,” where one harmful chemical is swapped for another simply because the rules haven’t caught up yet.

✅ Already in use

Many responsible companies already apply the logic behind the generic risk approach when deciding which chemicals to substitute. Instead of waiting for a case-by-case risk assessment or official restriction, these companies act as soon as a substance is identified as hazardous — for example, when it appears on the REACH Candidate List (or maybe even the SIN List?!).

According to ECHA, this kind of hazard-driven trigger has proven to be one of the strongest drivers of substitution. The mere inclusion of a chemical on a regulatory list often prompted companies to start searching for safer alternatives, well before any exposure-based evaluation or legal deadline.

Companies also reported that early action based on hazard information improved their reputation, reduced long-term compliance costs and created innovation opportunities in safer product design.

This shows that industry understands what regulators are still debating: that eliminating a hazard at the source is more efficient and predictable than trying to manage risk after the fact.

So what does it all mean?

Let’s look at what this all means in practice with an example. Remember that non-stick frying pan from earlier that you may or may not have ruined?

The main manufacturers of non-stick cookware rely on Teflon, or PTFE — a type of PFAS “forever chemical” — to make them non-stick. And while these products may inadvertently shed some toxic PFAS substances during use, the worst PFAS emissions actually come from their production and disposal.

A specific risk assessment would try to calculate exactly how much PFAS is emitted during each phase of the pan’s lifespan (including disposal), and estimate how much risk it poses to people and the environment based on assumed exposure levels.

That’s a lot of assumption and math already. But then multiply that by every company making non-stick frying pans. And add in all the PFAS emissions from other wide spread uses, like companies using PFAS to make raincoats or phone screens. Seems a little unsustainable, doesn’t it?

On the other hand, the generic risk approach assumes the worst and goes from there. In this example, the generic risk approach sees that PFAS are highly problematic for people and the environment, so we should avoid using PTFE in cookware altogether.

Commercial alternatives to PTFE already exist — society won’t collapse without non-stick frying pans containing PFAS, and, aside from some grumbling from industry, the world would move on.

In this case, using the generic risk approach, we would see a ban on PTFE in cookware and a timed phase-out to let manufactures to switch to alternatives.

More straight-forward for manufacturers. Easier on regulators. Better for people and the environment.

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