By Julie Holt, Director, Global Advisory Services
FoodChain ID experts in Regulatory and Scientific Consulting offer global guidance to meet the evolving demands of the food and beverage marketplace.
Although both Europe and the United States share a common goal of protecting consumers, each has a fundamentally different approach to regulatory oversight in public health. While Europe employs a precautionary regulatory approach, the United States favors a risk-based approach. Each has its own set of pros and cons. The European regulatory framework utilizes the precautionary principle to remove uncertainties, while the United States prioritizes scientific evidence and a spectrum of risk management approaches. The fundamental differences also reflect cultural and historical context.
When looking at regulatory oversight of the food supply, it is important to remember that a lack of regulatory permission for an ingredient use is not the same thing as an outright ban. For example, for some ingredients, food manufacturers may have never sought permission because alternatives are available and approved. Some additives may not be approved in a country based on specific conditions unique to a given country, such as dietary exposure. Because every country has its own unique food and food additives legislation, there will always be nuances and differences.
In addition, there are examples of additives banned based on the data available at the time, followed by more recent science providing evidence of their safety. For example, the United States law prevents the addition of additives to food if there is any evidence of carcinogenicity in animal studies. Because of this regulation, some additives that were banned in the 1970s based on available data have more recently been demonstrated as safe by respected regulatory bodies such as the European Food Safety Authority (EFSA) or the World Health Organization Joint Expert Committee on Food Additives (JECFA). It is also important to note that a substance may cause illness or cancer in animals but not humans based on biological differences.
Example of Bleached Flour and Azodicarbonamide
Texas law SB 25, signed by Governor Abbott on June 22 and effective on September 1, lists 44 additives that require warning statements on foods such as beverages, snacks, cookies and pastries. A good example of an ingredient that appears on this list which is not permitted under the European Union food regulatory framework is bleached flour. Europe has legislation requiring that flour must be 100% pure grain without any additives, alterations or bleach. European authorities believe that the whitening agents and bleaches used to refine flour may be harmful to human health if not handled properly during the manufacturing process. The concerns are based largely on industry workers’ exposure when handling commercial quantities of chemicals like chlorine and peroxide.
In the United States, bleached flour is widely used in bread sold in grocery stores because of the benefits for shelf life. From the United States’ perspective, bleached flour has been used since the early 1900s with no recognized carcinogenic issues. While bleached flour does have lower fiber content compared to unbleached flour, it is often preferred for baking as it offers better baking performance. One of the most controversial substances used in bleaching flour is azodicarbonamide (ADA), which is banned in Europe and some other countries as well. The FDA approved the use of ADA in flour based on comprehensive safety studies, including multi-year feeding studies, and continues to review exposure studies. The FDA considers ADA to be safe for consumption when used at approved levels for purposes specified in the relevant regulations.
Example of Food Dyes
The Texas law also includes many colorant additives such as Yellow #5 and Yellow #6, which were approved for consumption at permitted levels and usage applications in the United States and many other countries. Synthetic petroleum-food dyes are now being phased out in the United States at the federal level, and the FDA is working with the food industry to establish a national timeline for the removal. Currently, the FDA is expediting the review and approval of natural color substitutes and working with the National Institutes of Health to conduct comprehensive studies on how consumption of food additives affects the health and development of children.
Example of rBGH/rBST
Another example is the use of hormones in dairy cows. rBGH/rBST are synthetic bovine growth hormones used to increase milk production in cows. The use of such hormones is banned in Canada due to concerns about animal health and animal welfare. These hormones are still approved for use in the United States because regulatory agencies test milk and meat for residues. There is no significant difference in the composition and nutritional value of milk from treated and untreated cows.
About the Author
Julie Holt is a subject matter expert in the areas of food and beverage, additives, and regulatory strategy. She has beverage industry expertise and currently provides consulting support across multiple beverage categories. Ms. Holt has more than 25+ years of regulatory experience in the food and food ingredients industries and managed her own advisory firm, Scientific & Regulatory Solutions LLC, prior to joining FoodChain ID. As a consultant, Julie supported several food and beverage clients including a Fortune 50 company. Julie has provided global regulatory knowledge covering more than 200 countries.
