There are many thousands of chemicals on the market globally with over 12,000 reported to be available for use in food contact applications alone (see Food Contact Chemicals database (FCCdb)). In many regions, including the European Union and the United States, chemicals can enter the market with just a limited set of safety information made available to the public. If public health agencies later gather enough information to regulate or outright ban a single substance for newly discovered safety issues, manufacturers often switch to a chemically similar but less well studied substance. Such substitutions generally prevent a complex redesign of products or manufacturing processes that the chemicals are used in, but structurally similar substances often behave similarly and may have similar toxicological effects. Or sometimes a manufacturer switches to a completely different family of chemicals or a new material. Either way, as more information is gathered about the replacement, it may later be uncovered that it too is hazardous. This switching from one hazardous substance to another is called “regrettable substitution.”
One possible example of regrettable substitution of similar chemicals currently being discussed is the switch from bisphenol A (BPA, CAS 80-05-7) to bisphenol S (BPS, CAS 80-09-1) or bisphenol F (BPF, CAS 620-92-8) in plastic bottles and metal can coatings. For many years, BPA has been linked to various health outcomes, such as reduced semen quality (FPF reported) and other reproductive and immune system effects (FPF reported, also here). Due to growing consumer pressure and increased regulation, companies have been moving away from BPA and marketing their products as “BPA-free”. However, the BPA in products is often switched to another, structurally similar bisphenol such as BPS or BPF.
For example, a study of urinary bisphenol concentrations in Belgian adults published in July 2022 found that five BPA alternatives “were measured in higher concentrations in 2018 vs 2015 while BPA levels did not differ significantly” (FPF reported). And research in February 2022 found urinary BPS concentrations were positively associated with heart disease risk with the researchers concluding that “although BPA, BPS, and BPF share similar chemical properties, BPS and BPF are not safe alternatives for BPA.”
In recent years, per- and polyfluoroalkyl substances (PFAS) with known hazard properties have often been replaced by other PFAS, but also by chemically different alternatives. Both approaches are examples of regrettable substitution. In January 2022, the Organization for Economic Co-operation and Development (OECD) published a report on chemicals commonly used as replacements for long-chain PFAS in paper and board food packaging. They concluded that “the hazard profiles of the majority of alternatives to long-chain PFAS for paper and paperboard food packaging are poorly understood and/or not publicly available.” Many of the alternatives the OECD investigated were short-chain PFAS which have been shown to be similarly hazardous to humans (FPF reported, also here) but some replacements were from entirely different chemical families with incomplete hazard profiles (FPF reported).
In most instances, a chemical must be proven hazardous to be removed from the market – a process that can take years if not decades depending on the regulatory processes within a country. An analysis by the European Environmental Bureau (EEB) in July 2022 found that it takes the EU about 20 years to ban a hazardous chemical (FPF reported). One of the bottlenecks EEB identified in the EU regulatory process is that with the current way the REACH and CLP regulations work, “ECHA has no power to act decisively on a precautionary basis.”
There’s a growing call from many stakeholders, and especially from consumer health organizations, to look at chemicals such as bisphenols, phthalates, or PFAS as a group and apply the precautionary principle before allowing their structurally similar alternatives onto the market (FPF reported, also here and here). This means that if the government does not have comprehensive data to determine whether a chemical belonging to these groups is safe or is not safe, it should be assumed not safe. To be the most comprehensive, the precautionary principle would ideally apply to each new chemical as well. With this framework, regulators would err on the side of safety and not take unnecessary risks with chemicals they do not currently understand enough about.
As of August 2022, there is a group of five member countries in the EU that are developing a proposal to restrict or ban PFAS as an entire group from all uses without having to spend the time to look at each chemical (and use) individually (FPF reported). The US state of Washington is currently considering similar regulatory action with PFAS, bisphenols, and phthalates (FPF reported, also here). Washington’s Safer Products Initiative assesses subsets of consumer products to find safer alternatives for each case and then acts to mandate the use of those alternatives.
Reference
Huanjia Zhang (February 1, 2022). “BPA replacement linked to increased cardiovascular risk.” Environmental Health News
Read more
Thomas Backhaus (November 1, 2016). “Substitution of hazardous chemicals: Fundamental concepts, examples and challenges for FCMs.” YouTube
Stephen Klump (November 1, 2016). “Food producer challenges to eliminate chemicals of concern in food packaging.” YouTube
Greta Stieger (November 2016). “Modern science to inform regulation of food contact materials in the circular economy.” Food Packaging Forum
Joseph Allen (December 15, 2016). “Opinion: Stop playing whack-a-mole with hazardous chemicals.” Washington Post
Sherer, LD, et al. (2014). “The psychology of ‘regrettable substitutions’: Examining consumer judgements of Bisphenol A and its alternatives.” Health, Risk and Society DOI: 10.1080/13698575.2014.969687
Michelle Harvey (November 12, 2013). “Regrettable substitution: Swapping the devil you know for the devil you don’t.” Environmental Defense Fund
