FDA vs EFSA: How do the food regulatory agencies in the US and EU differ?
September 2, 2024
Is the EU’s EFSA better than the USA’s FDA?
Have you ever wondered why fruits and vegetables are in and out of season in Europe but available year-round in the US? Why does food spoil in Europe after a few days, but many in the US can last weeks in your refrigerator? Why do European NBA players say they gain weight and feel sluggish in the US then feel better when they go home during the off-season? Why do McDonald’s fries have 10+ ingredients in the US but only 3 in Europe? Why is Potassium Bromate, a suspected carcinogen banned in Europe, still allowed in bread and other products in the US (except CA)? Or why are there over 10,000 chemicals in the US food supply but only 410 in the EU?
When it comes to food safety, the US has a unique regulatory system compared to the EU due to historical policies and their approach in introducing chemicals in food, the players involved, and how the system was structured. Examining the differences between these two agencies provides insight into how we can improve our food system and urge our agencies to adopt the effective approaches adopted by the EU.
The Roles and Regulatory Approaches of the EFSA and the FDA
Established in 2002 based on the EU’s General Food Law Regulation, the European Food Safety Authority (EFSA) is often seen as the gold standard for food regulation and oversight of additives because they look at the entire food chain, including all the stages of food and feed production and distribution. It is solely focused on keeping food safe, favoring consumers over producers and erring on the side of caution. The EFSA takes a “guilty until proven innocent” stance, meaning that companies must prove an additive is safe before it can be used in food according to EFSA’s standards. They have stringent processes in place to (1) evaluate new food additives or proposed new uses of existing food additives before they can go to market and (2) periodically re-evaluate all the food additives permitted for use in the EU. They even have strict naming rules that assign every additive an “E-number,” thus making it easy for consumers to recognize what’s in their food.
In contrast, the US Food and Drug Administration (FDA) covers a much wider scope, from drugs and medical devices to food safety, but food doesn’t seem to be their top priority despite it being in the agency’s name. The FDA operates under an “innocent until proven guilty” system, where many food additives don’t need pre-market approval if they are considered ‘generally recognized as safe’ (GRAS) by industry experts. In fact, companies can add new additives to food without even notifying the FDA that the new additive exists, as long as they decide it’s safe. The GRAS loophole was originally set up for ingredients such as baking soda and vinegar, but it’s now how the majority of additives enter our food supply. This approach favors producers over consumers, resulting in addictive foods and an American epidemic of chronic diseases.
Differences in Supply Chain
The EFSA uses a holistic “farm to fork” approach, ensuring safety at every stage. This integrated system allows EFSA to consider human, animal, and environmental health while providing independent scientific advice to policymakers. On the other side of the Atlantic, the US has a more fragmented system, with many more agencies involved in various parts of the food supply chain. The FDA oversees about 80% of the food supply, the USDA regulates meat, poultry, and egg products (excluding whole eggs in the shells, which are regulated by the FDA), and the EPA handles pesticide approvals. It does not help that food additives can enter the supply chain at various points, making oversight way more complex compared to the EU’s streamlined system.
Banned Additives Allowed in the US
Several food additives that have been banned in the 27 EU member states and dozens of other countries around the world due to concerns over their links to cancer, cardiovascular damage, hormone disruption, and behavioral issues in children are still allowed in the US. While the EU takes a cautious approach by removing additives from the food supply if they show even the slightest potential to be harmful, the FDA hasn’t followed suit. The US does have the Delaney Clause, which requires the FDA to ban any additive that has been found to cause cancer in animals or humans, but this is often bypassed through the GRAS loophole. The FDA also argues that the exposure levels to perform these studies are significantly higher than humans would ingest additives at and that the approved levels are safe for human consumption. This yet again shows how the system favors producers over consumers, allowing companies to self-regulate without FDA oversight.
Another major issue in the US is the lack of studies on long-term and compounding effects from these additives. Long-term research on the potential toxicity of additives is expensive, complicated, and not incentivized in the US. For example, think about a chicken breast: it may come from a chicken that was fed GMO grains with pesticide residues, given growth enhancers, then processed with additives in the final product. There’s very little research on how all these factors combined affect human health. While some research does exist, it usually focuses on a single additive rather than how multiple additives interact or their effects when consumed over time.
Many of the additives still used in the US have raised consumer concerns, prompting food companies to make changes. Product labels like “non-GMO” or “rBST-free” stemmed from responses to consumer demands and not FDA requirements. Another well-known example is when Subway removed azodicarbonamide, a dough conditioner, from its bread after public outrage when it was revealed the same chemical was used in yoga mats. Brominated Vegetable Oil (BVO), a common ingredient in orange soda that has been reported to cause harm to the nervous system, was also only recently banned by the FDA after years of research suggesting it was unsafe.
Conclusion
The differences between food regulation in the US and Europe are striking. The EU, through EFSA, prioritizes consumer safety, taking a cautious, science-backed approach that requires food additives to be thoroughly tested and proven safe before they hit the market. On the other hand, the US system, governed by the FDA, often relies on the food industry itself to determine the safety of these additives, leading to more relaxed regulations and allowing substances that have been banned in many other countries. This divided approach not only puts more burden on consumers but also raises concerns about long-term health impacts, given the lack of comprehensive studies on the combined effects of multiple chemicals.
Understanding these differences can help us make smarter choices about the food we eat and highlight the need for reform in the US regulatory system. By adopting stricter, more transparent practices like those in Europe, we could better protect our health and encourage food companies to prioritize safety. Ultimately, it’s a matter of shifting focus from what’s convenient for companies to what’s truly best for consumers.
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