Chemicals are an indispensable part of our daily life; some are harmless, while many may have harmful effects. But how do we properly assess whether chemicals are harmful or not? We need to assess how toxic a chemical may be, but also what its behaviour is in the environment – does it accumulate in organisms, including in our bodies? Does it stick around in the environment? Could it damage development in the womb? Might it affect fish or insects – or marine mammals like whales?
Traditionally the main method of assessing toxicity has been to use tests on animals, though these days there are a range of other non-animal methods (NAMs), including computer-based methods, looking at similar substances, and in vitro non-animal tests.
No method is perfect, and there is a big difference between what a company might want to use in the development phase and what is accepted for legal controls on the production or use of a chemical. The latter is particularly relevant for substances already on the market, with ongoing (sometimes substantial) exposure to people and wildlife around the EU and the world.
One crucial issue in any testing system is to decide ‘what is the burden of evidence needed to take a decision?’. If the legal rules say you must prove an adverse effect in an intact organism in order to label a chemical as having a certain hazard, then you must use intact organisms to test for that effect or use data based on previous testing in animals, showing that it is highly probable that the substance will cause the adverse effect.
If you don’t understand the hazards of a chemical, then you may be exposing unborn babies, children or wildlife to chemicals that will cause them harm. We must therefore have a system that establishes these hazards to a sufficient extent to be able to control the use of chemicals.
A more precautionary approach to the identification and control of harmful chemicals
CHEM Trust has worked actively for many years to accelerate regulatory action to better protect human health and the environment from harmful chemicals. This week we have sent a joint NGO letter and position paper (led by EEB) to the European Commission calling for a more precautionary approach to regulation that enables faster and more effective identification of very harmful chemicals while reducing animal testing.
Here are five key improvements that are needed, according to our analysis:
1. An update of REACH information requirements for better prediction of harmful properties, e.g. endocrine disrupting properties
- The addition of more specific and appropriate methods to close data gaps in REACH are needed. The REACH review in 2018 found that the current requirements do not allow a sufficiently thorough hazard assessment, including for identifying substances of very high concern (SVHCs).
- Inclusion of in vitro tests and other non-animal methods, were available, as a minimum, plus a follow up for action or more information if these indicate potential harm. This could facilitate earlier decision making on exposure reduction (e.g. regulatory controls) based on NAMs.
2. Increased use of Non-Animal Methods (NAMs) for identification of harmful properties
- New NAMs should be implemented whenever they have been validated and accepted for regulatory use. REACH has a goal to promote alternative methods for hazard assessment and has introduced the (only) regulatory and internationally accepted in vitro methods to detect eye and skin irritation/sensitisation. This work needs to continue, so we therefore welcome (and will attend) the upcoming workshop by EU chemicals agency ECHA ´Towards an animal free regulatory system for industrial chemicals´.
- Data from NAMs, where available, should be used to support identification of hazardous properties, and the development of new NAMs must be promoted. The EU-funded research cluster EURION aims to establish new methods to improve identification by using new approaches, including in vitro assays, adverse outcome pathways (AOPs) and other, more predictive non-animal test methods. CHEM Trust is following the progress of this project, e.g. see our presentation at their workshop in December.
- It is important to realise the scientific challenges in developing reliable NAMs for use in a regulatory context, particularly for more complex endpoints such as carcinogenicity, reproductive toxicity and endocrine disruption, and also behavioural effects and effects on the next generations.
3. Better use of existing information and restrictions on groups of chemicals
- Better use of existing data: From our work in the ECHA ED expert group we see the great potential of an improved, integrated, approach for identification, e.g. using data from mammal studies to predict effects in the environment, even when studies were originally conducted to look at human health. The new CLP hazard classes for EDCs establish separate classes for human health and environment, and the upcoming ECHA guidance document on this should emphasise the use of all available evidence.
- Restrictions on groups of chemicals: One very important way of accelerating identification while reducing additional animal studies is to restrict chemicals as a group, including substances with less hazard data. For the current bisphenol restriction under discussion it would mean enlarging the group of restricted substances now, rather than waiting for further testing to agree an EU-wide EDC identification first.
4. Using NAMs to provide early prediction of adverse effects
- We need a regulatory system that predicts adverse effects much faster, and takes action based on early warnings rather than waiting for proven harm in multiple animal studies. NAMs could flag that a chemical has unwanted properties for sensitive uses, e.g. in consumer products, then action could be taken to restrict this use. This requires that companies accept the role of NAMs in restricting the use of their chemicals.
- Biological changes which are likely to lead to adverse effects should be used as an early warning of adverse effects. For example, changes in thyroid hormone levels can indicate neurodevelopmental effects and changes in vitellogenin levels in especially male fish can indicate adverse impacts on reproduction.
- The current official definition of ‘adverse effect’ should be wide enough to cover this approach as it includes ´physiology changes that result in impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in susceptibility to other influences´.
5. Revision of the regulatory system to accept identification of, and action on, harmful properties based on NAMs.
- Revisions are needed in the laws on chemicals in order to make it possible to take more protective regulatory action based on NAM data – the main EU chemicals law REACH is currently being revised, providing an important opportunity to do this.
- NAMs must be explicitly accepted as a basis for restrictions, risk reduction measures and improved chemical risk management, rather than requiring animal tests.
- A new precautionary approach for hazard identification and restriction should be implemented as part of the REACH revision, based on read-across, grouping of substances, in vitro data and other NAMs where possible. More efficient identification of EDCs and other harmful substances is needed. This should be based on methods, that are sensitive enough to adequately predict ED and other problematic properties to ensure a high level of protection for people and wildlife. Then it is possible to improve protection whilst also minimising animal testing.
Beware of an industry ‘agenda of inaction’!
Many companies and industry associations claim to support a move away from animal testing. However, this position is not necessarily matched by their actions within regulatory processes. Some tricks we have noticed are:
- Disputing the results from studies that have been used by regulators to justify hazard identifications or restrictions of a chemical.
- Not accepting expert and regulatory decisions, and instead challenging ECHA through legal processes, e.g. on the identification of SVHCs, like on bisphenol A and GenX.
- Conducting animal tests with inappropriate (e.g. too low) concentrations of chemicals, which are not sufficient to show an adverse effect. This is a waste of test animals, and creates meaningless results, as the studies cannot be used for classification nor to demonstrate that the chemicals are safe. (see e.g. this publication by Dutch Institute RIVM).
Luckily, there are also responsible companies that work for increased protection against hazardous substances (see e.g. Chemsec`s corporate #noPFAS movement).
It is now up to industry to take their responsibility seriously, to deliver the legally required information on their chemicals and to demonstrate that the concerns about animal welfare are also matched by their concern for people and wildlife. The sad fact is that many animal studies are currently carried out because of ongoing disputes between producers of chemicals and regulators. We need clear commitments from industry that regulatory measures to minimize exposures will be accepted based on read- across, grouping and NAMs, even if this creates higher uncertainty.
All existing information, including all types of NAMs, should be used for the prediction of substances’ hazardous properties, with action following based on results from NAMs, rather than requiring ever more animal tests before protective action is taken.
Change is needed, with these key components:
- The regulatory system must be amended to make it easier to identify hazards and control chemical use based on NAMS. This will involve increased use of grouping and a reduced burden of evidence for action. This must be part of the current revision of REACH.
- The chemical industry must accept the use of NAMs in this identification of hazards and regulatory controls on their chemicals, and stop pushing for further animal testing when NAMs have shown a problem.
- More funding is needed for developing and validating NAMs for regulatory use.
Unfortunately, time for transition is needed and testing on animals cannot be fully phased out immediately without undermining the protection of human health and wildlife.
- This week our colleagues at HEAL have published a very informative Q&A about animal testing and chemical safety assessments.
- And check out ChemSec`s interesting new story `No one likes animal testing. Here is how to reduce them.`
Update: on 3rd March the Commission adopted some 100 new and updated test methods for the regulatory safety testing of chemicals under REACH.