Abstract
Societal concern for animal welfare and scientific concerns about the predictive power of animal models for the human situation are driving forces for the development of animal-free approaches for the safety testing of chemicals. A paradigm shift towards an assessment of human health risks that is fully based on non-animal approaches is not foreseen within the next decades. To accelerate the use of non-animal innovations (e.g. in vitro experiments, in silico methods etc) in the EU, it has multiple advantages to simultaneously work towards a new risk assessment paradigm and to aim their development at better meeting the current regulatory needs. To achieve this, a multi-stakeholder collaboration is needed already in the development phase of animal-free innovations, where regulators can inform on the regulatory needs and the criteria for acceptance. As a first step, the present paper discusses what basic information is needed within the context of four areas of chemical safety assessment in the EU: 1) classification, labelling and packaging, 2) the derivation of health-based guidance values and product limits, 3) risk assessments of exposure situations of concern and 4) addressing specific topics of societal concern. Further agreements on the level of detail and uncertainty, robustness, predictive value, reproducibility and validation are a prerequisite to develop tools that can be trusted and that will be legally binding.
Highlights
Humans come into contact with a variety of chemicals that have a wide range of uses and applications, including food additives, food contact materials, industrial chemicals, plant protection products (PPP), biocides and cosmetics
A third scientific reason meets present societal concerns and more or less follows from the previous reason. It relates to the question: Can chemicals in our daily environment be responsible for human diseases such as Alzheimer’s disease, Parkinson’s disease, obesity or attention deficit hyperactivity disorder (ADHD), some of which are accompanied by high costs for human society?
We focus on the current regulatory needs, i.e., the current frameworks for which information on the effects of chemicals on human health needs to be generated to assure their safe production, application and use
Summary
Humans come into contact with a variety of chemicals that have a wide range of uses and applications, including food additives, food contact materials, industrial chemicals, plant protection products (PPP), biocides and cosmetics. Over the past few years, several stepwise or tiered approaches have been suggested to evaluate potential health risks or to perform a safety assessment for chemicals within specific regulatory frameworks (e.g., Adeleye et al, 2015; Berggren et al, 2017; Blaauboer et al, 2016; Dent et al, 2018; Desprez et al, 2018; Embry et al, 2014; Pastoor et al, 2014) These strategies serve different purposes and do not (always) focus on the derivation of HBGVs but are mentioned here to illustrate how animal-free strategies and methods can be combined in a tiered approach to generate answers to specific regulatory questions. From a societal and from a health-economic point of view, it is worthwhile to explore the possibilities of new methods and methodologies to include this information in human safety and risk assessment (Pistollato et al, 2016)
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