Essential use of chemicals. Opportunities or constrains

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Essential use, as initially proposed by scientists and later referred to in the EU 2020 Chemicals Strategy for Sustainability, is a radical departure from the current method of regulating hazardous substances.
The genesis of “essential use” can be traced back to the USA Carter administration’s amendments to the Toxic Substances Control Act (TSCA) in which banned non-essential aerosol sprays, thus affecting nearly USD 3 billion worth of sales in a wide range of products. Similar actions were taken by Canada, Sweden, Norway, Denmark, and Finland. Amendments to the TSCA were introduced at a time when both Congress and the US judiciary took a precautionary approach towards the regulation of novel, problematic substances.
Later, an essential use exemption was included in the Montreal Protocol.
The early, precautionary responses to the regulation of hazardous substances adopted a legal and qualitative approach to questions regarding the burden of proof, standards of proof and establishment of cause and effect, and were far more inclined to apply a “zero-tolerance” attitude towards setting safety standards than is currently the case, which applies a threshold dosage approach to apply safety standards. These early views on how to manage hazardous substances are arguably more in tune with incorporating concepts of essential and non-essential use in consumer products than the existing model of risk analysis. The precautionary approach, however, was challenged by producers and industry, particularly in the US. Opponents claimed that a ‘zero-tolerance’ approach to potentially hazardous substances amounted to “zero-risk”, which was arguably unachievable. This is a common principal in all risk assessment analysis were the concept of zero risk is never foreseen; it is commonly accepted that a risk can be mitigated or reduced by application of mitigation procedure or as much as technically reducible but zero risk is not a real situation.
The Risk regulation as applied in international laws, as well as in the US, the EU and other countries, is managing the control of particularly problematic substances by listing them in different types of annexes to the statutory instrument seeking to control them. The default position vis-à-vis these select groups of substances is to grant a producer market authorization only if its product features in a positive list – typically “Annex I” of the statutory instrument concerned. Market authorization is typically issued following a thorough risk analysis and control report, and is made subject to a number of conditions, most importantly threshold/dosage levels. The European Commission has identified substances subject to this regime as being “a priori hazardous”. In the case of a positive listing, the legislator has ‘clearly reversed the burden of proof by requiring that the substances be deemed hazardous until proven otherwise’. Products containing substances which are considered a priori hazardous include plastic materials coming into contact with food materials, biocides and plant protection products.