The potential reclassification of ethanol by the European Chemicals Agency (ECHA) as a carcinogen is sending ripples through the food industry. Experts warn of significant consequences, while the industry itself is mounting a robust defense.
Ethanol-based sanitizers: Their absence would create challenges in markets.
Image source: Getty Images
A temporary reprieve for the food industry, but not much more: At its recent meeting, the ECHA’s Biocidal Products Committee (BPC) did not classify ethanol as a CMR substance (Carcinogenic, Mutagenic, or Reprotoxic) for use as a disinfectant – contrary to initial plans.
However, further discussion is scheduled for February. And the deliberations, likely concluding later this year, could result in a CMR classification. This status would effectively exclude ethanol as a disinfectant, while alcoholic beverages would remain unaffected. Experts predict that the impact on the food industry would be substantial.
“Ethanol would have to be labeled as a CMR substance,” explains Dr. Thomas Rauch, Managing Director of the German Association for Hygiene and Surface Protection (IHO). “This would prevent laypersons from using such products and discourage consumers from purchasing them. Anyone wishing to continue using ethanol would have to apply for exemptions, modify production processes, and, in some cases, rebuild facilities. Critically, “German occupational health and safety regulations would prohibit contact with ethanol for pregnant women, breastfeeding mothers, and women of childbearing age.”
Delay is a “Positive Sign”
Given the need for ethanol-based disinfectants in the sale and production of food, the German Food Retail Association (BVLH) is also taking a stand. Its representative, Frederic Wagner, tells Lebensmittel Praxis that the consequences for food safety in markets would be “not to be underestimated.” Ethanol, according to the BVLH, is virtually irreplaceable as a disinfectant due to its potent germicidal action.
Frederic Wagner, heads the BVLH office in Brussels. Wagner views the postponement of the decision as a “positive sign.” He attributes this to the broad coalition against an effective ethanol ban, which includes over 1,100 institutions, associations, companies, and scientists – including medical societies and university hospitals concerned about medical hygiene.
Industry Associations Mobilize
Alongside the BVLH and the German Food Federation, other associations within the food industry are supporting this coalition. These include: the German Association of the Confectionery Industry, the German Brewers’ Federation, the German Spice Industry Association, Kulinaria Deutschland, the German Dairy Industry Association, the Association of the German Grain, Milling and Starch Industry, the German Meat Industry Association, and the Association of German Master Bakers.
What prompted the ECHA’s attention to ethanol? The root cause lies in studies on the harmful effects of ethanol based on alcohol abuse. These are being applied by the EU bureaucracy to products containing ethanol but far removed from oral consumption.
Competence Ignored
Opinion by LP Editor Thomas Klaus
In theory, the European Chemicals Agency could have simply asked. Then, the users of ethanol in “disinfection” could have readily explained why its use is essential – and what dangers to public safety and food security its removal would entail. However, close collaboration with practitioners doesn’t seem to be standard procedure in bureaucratic decision-making – and this applies beyond the European level. Ultimately, this disregard for the expertise of professionals and practitioners repeatedly leads to regulations that become stumbling blocks for the economy and fuel political disillusionment.
Future Trends and Implications
The ethanol debate highlights a growing trend: increased scrutiny of common chemicals based on hazard identification, even when real-world exposure scenarios differ significantly from those used in risk assessment. This is likely to continue, impacting a wide range of industries beyond food.
The Rise of “Regrettable Substitutes”
If ethanol is restricted, companies will be forced to seek alternatives. However, many potential substitutes – such as quaternary ammonium compounds (quats) – have their own environmental and health concerns. This phenomenon, known as “regrettable substitution,” is a major challenge for sustainable chemistry. A 2021 study by the University of Gothenburg found that many alternatives to commonly used chemicals are often more toxic or persistent in the environment. Read more here.
Data-Driven Risk Assessment
The ethanol case underscores the need for more nuanced, data-driven risk assessments. Instead of relying solely on hazard identification, regulators should consider actual exposure levels and the specific conditions of use. The development of sophisticated modeling tools and the collection of real-world monitoring data will be crucial. The US EPA is increasingly using this approach in its chemical evaluations, as outlined in their Chemical Risk Assessment program.
Increased Industry Collaboration
The strong industry response to the ECHA proposal demonstrates the power of collective action. Expect to see more industry consortia and partnerships forming to proactively address regulatory challenges and advocate for science-based policies. The American Chemistry Council serves as a model for this type of collaborative effort.
Focus on Circular Economy Solutions
The debate around ethanol also highlights the importance of circular economy principles. Exploring ways to sustainably source ethanol – for example, from waste streams – could reduce reliance on virgin materials and minimize environmental impact. Companies like Novozymes are pioneering technologies for producing ethanol from agricultural residues.
FAQ
Q: Will the ECHA’s decision affect alcoholic beverages?
A: No. The proposed restrictions apply specifically to the use of ethanol as a disinfectant, not to its consumption in alcoholic beverages.
Q: What are “CMR substances”?
A: CMR stands for Carcinogenic, Mutagenic, or Reprotoxic. These are substances that are known or suspected to cause cancer, genetic mutations, or reproductive harm.
Q: What are “regrettable substitutes”?
A: These are alternative chemicals that replace a restricted substance but pose equal or greater risks to human health or the environment.
Q: How can food companies prepare for potential changes?
A: Companies should monitor the ECHA’s deliberations closely, explore alternative disinfectants, and assess the potential costs of compliance with new regulations.
Did you know? The global disinfectant market is projected to reach $54.8 billion by 2027, driven by increasing awareness of hygiene and infection control. (Source: Grand View Research)
Pro Tip: Stay informed about upcoming regulatory changes by subscribing to industry newsletters and participating in relevant trade associations.
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