Chemical Regulation: Risks, Replacements, and R&D Opportunities

Recently we highlighted on LinkedIn some developments occurring in the chemical industry, with the confirmed banning of dichloromethane (DCM) in most industries and commercial applications in the USA. We decided to start by looking at DCM, then explore broader changes in chemical regulations, and finally highlight some emerging areas to watch. 

Chemical regulation is undertaken at a national level and is driven by health and safety and environmental concerns. How different geographies approach this is varied, and you will see restrictions are not universal across every country. They will also depend on volumes used and even the sector where it is implemented. The level of control applied to a chemical can vary widely, from requiring specific labeling, to restricting its manufacture, or even banning its use entirely. 

 

Solving chemical regulation changes with sustainable chemicals? 

In the USA, DCM is used as a paint stripper and degreaser, two high-volume industries, while it is also used in caffeine extraction. But what will existing users do? We can look to Europe to get a sense of what consumers will do, with DCM banned in paint strippers over 10 years ago in the EU. The obvious answer is to use something else, with people resorting to other solvents, with N-Methyl-2-pyrrolidone (NMP) initially emerging as a safer alternative in paint strippers, but this is now also restricted in the EU, although still available in the USA (for now). 

Clearly, it’s a complex and dynamic space where changing chemicals without a clear strategy is not a sustainable approach. Some companies have provided alternatives which do not contain these ingredients, but they are specific to one application and use complex formulations. Both DCM and NMP are used in multiple applications, from pharmaceutical synthesis to polymer production, so having an alternative which can cover multiple applications is attractive. Some companies have gone even further, producing new, safe (even sustainable) solvents to act as replacements for these. One of NMP’s most exciting and innovative alternatives is Cyrene™, a green and safe solvent, with demonstrated success in paint stripping. Could this maybe be one of the answers to the paint stripping sector in the USA to replace DCM? Perhaps, but finding solutions which perform the same, cost the same (or ideally less) and are readily available is always going to be challenging. Indeed, the future of Cyrene™ is in question with the company announcing its bankruptcy last year, and although it appears to still be available online, it is unclear what the long term use of this solvent is. We have proposed a potentially game-changing chemical for paint strippers in the USA, if it can be found, but are there other developments on the horizon that could impact companies?  

 

Chemical regulations in the USA – a colourful space with new trends 

Earlier this year, colorants in the food sector came under attack in the USA, namely artificial, petroleum-derived colour dyes. They announced the banning of 8 compounds, with these largely expected to come into effect by the end of 2026. Similar to DCM use before, 3 of these are already banned within the EU, while 3 require clear labelling if used in products in the EU, and one has had its safe content continually lowered by the EU. The picture is complicated with the USA already banning some colorants which the EU approves, but the announcement of the 8 chemicals hints at a stricter stance emerging from the USA with other sectors potentially experiencing the rocky waves.  

To help this phase-out, the USA has approved several natural food colorants, making the use of naturally derived colours an obvious and accessible step away from artificial alternatives. These are generally extracted from plants, while the recent additions also include an algae-derived dye and even a natural mineral. Unfortunately, not all sectors can simply turn to nature to solve their problems with extracting these compounds often requiring expensive, complex processing while natural ingredients can introduce unwanted impurities. 

 

A persistent problem – regulations to tackle forever chemicals 

Last year, Strategic Allies Ltd (SAL) spoke with Yordas Group, a company that works alongside organisations, providing them with regulatory updates and importantly offering suppliers global regulatory insights using their bespoke platform. We asked the Yordas Group what they thought would be some of the biggest regulatory changes on the horizon, and they highlighted expected restrictions on PFAS (often referred to as ‘forever chemicals’). This prediction has indeed come true, with many different regulatory bodies introducing changes to their use.  

PFAS are a diverse class of chemical covering compounds which contain multiple carbon-fluorine bonds around a single carbon atom (-CF3 or -CF2-). They have been used in many sectors, due to their exceptional chemical stability, as they are resistant to water, heat, oil and other substances. But this stability comes at a price, and this is where the “forever” part comes into effect as they are very difficult to break down, persisting in the environment and potentially accumulating in our bodies. They have been linked to cancers and other diseases, hence the rise in regulation. PFAS are frequently discharged into the environment, and as they are used in many everyday products such as non-stick pans, firefighting equipment, cosmetics, food packaging etc, they can also enter our water and food supply this way.  

Regulation is ongoing for PFAS, which encompasses thousands of chemicals, though their impacts are not universal. In the USA, earlier this year, the FDA withdrew food contact status for a range of PFAS, restricting their use in the food packaging sector. In Canada, they announced a phased ban of PFAS being used in industrial and consumer applications, this is currently undergoing a public consultation. If approved, it would see PFAS removed from firefighting foams initially then removing PFAS in non-essential applications like cosmetics, before tackling addressing more challenging sectors. A similar phased ban was also announced in France, firstly targeting cosmetics containing them and clothing. Within the wider EU, a subset of PFAS have already faced some restrictions, while they are still considering the next steps for a larger ban of more PFAS. They have already announced the banning of food contact packaging containing PFAS by August 2026, and we can expect new restrictions soon. 

Given their widespread use, it is difficult to identify the best alternatives to PFAS, but academic studies have investigated different sectors and assessed the feasibility of replacement. One study categorised PFAS applications based on the importance of specific products. Those applications deemed non-essential should allow for easy PFAS replacement, and some already have a suitable replacement. The final category are applications which are essential to society and lack suitable replacement, these represent key areas for future investigation. Pharmaceuticals, protective clothing, and some medical devices have been recognised as priority areas requiring further research. Some progress into alternatives is ongoing with the Fraunhofer Institute producing a non-stick alternative to PFAS known as the PLASLON® coating. It is not only PFAS-free but also more durable than PFAS in non-stick applications, with their coating produced through a plasma process. 

 

Keeping your eyes open – potential regulations on the horizon? 

It is safe to say that the EU leads the regulatory space, with other countries generally following their actions. We took a brief look at what else is being tested and may impact your sector in the future. Within the EU, chemical regulation is controlled by the European Chemical Agency (ECHA) and categorised according to Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), with potentially toxic and dangerous chemicals facing restrictions classified as “substances of very high concern”.  

Part of the ECHA is a program known as the community rolling action plan (CoRAP) which is a program to investigate potentially harmful chemicals. These have been proposed by member states, and are chemicals which have concerns about their impact on human health or the environment. Chemicals which qualify are those which pose potential hazards and those which have wide exposure. The hazards include “potential persistency, bioaccumulation and toxicity, endocrine disruption, or carcinogenicity, mutagenicity and toxicity to reproduction”, while exposure includes chemicals used in many applications or produced in large volumes. EU Member States agree to test these and evaluate if the potential flagged concern is valid, and if so, actions may be taken to control this chemical. We decided to take a look at the CoRAP list of upcoming testing, with one standing out as very interesting due to its wide usage and current minimal restrictions. 

Carbon Black – a common material used in coatings, inks, an additive in rubber and plastics and even rechargeable batteries – currently has no hazard classifications, but this could change. Concerns have been raised due to its wide usage, with industrial and consumer applications, and some early studies suggest that it may be carcinogenic and reprotoxic. The study is aiming to clarify these toxicological concerns and better understand exposure, as it is still unclear whether the material leaches from current formulations or if blending it with polymers makes it completely safe. As a supplier or customer, there is no immediate cause for concern, with substance evaluation expected to begin in 2027, but it’s always good practice to start considering potential alternatives. For Carbon Black, most alternative measures revolve around using biochar, with this offering a more sustainable alternative as it is not fossil-derived. It is unclear if biochar will also satisfy toxicological benefits. One company, Living Ink Technologies, has produced an alternative product designed for printing inks known as Algae Black™ produced from algal waste, with this described as a safer and more sustainable Carbon Black replacement. This Carbon Black replacement might be a safe bet to bypass future regulatory headaches. 

 

Conclusion

 Here we have taken a quick look at changes currently occurring in chemical regulation and what might be on the horizon, but other drivers do exist which are also important to consider. These include internal factors such as cost reductions and external factors such as consumer pressures, with health and sustainability key for the latter. But whether you’re looking for drop-ins or functional equivalents, we are here to help, with SAL able to showcase potential new technologies or partners to help you tackle various pressures. If you are interested in learning more about how SAL can help or have questions about upcoming regulations in general please reach out to John Allies – john@strategicallies.co.uk!