In terms of chemicals legislation, there is high pressure on policy makers today to abandon the hazard-based approach. A number of stakeholders would like to go back to the “dark age of chemicals legislation” and reintroduce legislation based solely on risk assessments – a system that was deemed ineffective almost two decades ago, but is still practised outside Europe, for example in the USA. A change like this would be a fundamental deviation from how Europe protects its citizens from toxic chemicals today.
ChemSec has noticed the effects of this pressure from stakeholders. Small changes of wordings in texts and presentations as well as general comments in various forums paint a clear picture that something is going on. Examples of this include:
- The major aim of the REFIT process is to analyse the overall effectiveness of hazard- and risk-based regulations.
- The Commission’s draft criteria for endocrine disruptors clearly favour a risk-based approach.
- In discussions about the authorisation process, in which substances are assessed based on their hazard properties, both voices from the Commission and parts of industry advocate abandoning this approach and instead moving towards restriction, where authorities need to show risk.
- Inclusion of substances on the Candidate List should be based on hazard only. But by adding the process of RMOA (Risk Management Option Analysis), Candidate listing now introduces an element of risk and has been slowed down considerably.
- Hazard-based approaches are described as “non-scientific” in comparison to risk-based.
The concept of hazard and risk are central in chemicals legislation; it constitutes the whole foundation for how to approach regulation of chemicals. An example often used by advocates on both sides is the cosmetics industry. In the US, where chemical legislation is based on risk, about 20 cosmetic substances are regulated. In the EU, where legislation is a mix of hazard and risk, over 1,000 substances are regulated.
Risk advocates claim this is a perfect example of how legislation has gone nuts, banning substances left and right. Hazard advocates, on the other hand, say this is proof that the system is working, as there are clear reasons for protecting consumers and the environment from these toxic chemicals. We will let you decide for yourself who you think is right and what level of precaution and safety you prefer. But before you do, ask yourself if you think cosmetics are less available in the EU than in the USA? Do Europeans use less make-up? And if cosmetic legislation in the EU is so burdensome, why are many of the biggest producers based in Europe?
How to build a lion cage
The use of risk assessment has been compared to putting a lion in a cage. It builds upon the idea that we can limit the effects of a hazardous chemical by using the chemical only in situations where it cannot cause harm or in concentrations where it cannot cause harm. In other words: to build it a cage.
A cage sounds robust and solid. However, risk assessment builds upon assumptions. In practice, for most substances used in society and in consumer products, it is simply impossible to have full knowledge of how the substance is used, how it is spread, how people and the environment may be exposed and where the waste will end up, and so forth. Uncertainty factors are therefore built into the assessment to compensate for this. Risk assessment is a thorough scientific methodology, but even so, it cannot be any better than the information we put into it, and it will always include uncertainties. How the risk assessment will be used is also a policy decision: what level of risk are we willing to accept, what is the cut-off?
The reason parts of industry want REACH to abandon the hazard approach in favour of a more risk-based approach is simple: risk assessment needs loads of data and holds uncertainties. Decisions to regulate certain chemicals can therefore be postponed forever by referring to the need for more data. In addition, the outcome of the risk assessment can be altered depending on the data you put in. To call a risk-based approach more scientific than a hazard-based approach is therefore simply nonsense.
We believe it is crucial to keep the hazard-based approach, especially for those situations where we have the worst chemicals and the most vulnerable groups. SVHCs are the worst chemicals of all, and therefore they should be substituted wherever possible. When substitution is not possible and the chemical is important to society, a rigorous risk assessment should be done to show how the chemical could be safely used.
It is vital not to weaken protection from the worst chemicals. We must acknowledge that we cannot build a foolproof cage for these, and that we are not willing to put a lion in such a cage.