A bill recently introduced in the California State Assembly would prohibit five chemicals: brominated vegetable oil, potassium bromate, polyparaben, red dye #3, and titanium dioxide – all banned in Europe – from food products in California. Let’s dig past the headline.
“We don’t love our kids any less here in the State of California than they do in Europe. And we need to take the same steps to protect our kids.”
- California Assemblyman Jesse Gabriel
Why are These Chemicals Banned in Europe and not the US?
According to the Bill, these five compounds have been linked to cancer, reproductive problems, and developmental and behavioral issues in children. The EU decision is based on their adaptation of the Precautionary Principle,
“If there is the possibility that a given policy or action might cause harm to the public or the environment and if there is still no scientific consensus on the issue, the policy or action in question should not be pursued. Once more scientific information becomes available, the situation should be reviewed.”
- Article 191 of the Treaty on the Functioning of the European Union [Emphasis added]
Simply put: Uncertainty about possible hazards is a strong reason to ban or limit new chemicals or technology.
The US has not adopted one uniform principle in evaluating risk. Most US agencies, including the FDA and EPA, use a risk assessment process to regulate and determine safe levels of chemicals by estimating the nature and probability of adverse health effects in humans exposed to chemicals in food, water, air, or soil.
The US considers the chance that people will experience health problems when exposed to different levels of a chemical before it is banned, while in Europe, the Precautionary Principle dictates that a chemical should be banned if there is even the possibility that it may cause harm. While the EU states that the situation should be reviewed when more scientific information is available, that seldom if ever, occurs.
The Five Chemicals
Brominated vegetable oil: A vegetable oil that has bromine added. It is used in some citrus-flavored beverages because these contain oil, and the bromine keeps the oil and the carbonated water mixed. It is regulated by the FDA as a direct food additive and is allowed at no more than 15 parts per million (ppm) in beverages.
Health concerns have focused on bromine since long-term exposure can cause memory loss, skin irritation, and problems of balance after drinking large amounts (more than a half-gallon) of soda containing brominated vegetable oil daily. These concerns led the two largest soft drink manufacturers in the US, Coca-Cola, and Pepsi, representing about 70% of the US soda market, to remove brominated vegetable oil from their products in 2020.
Potassium bromate: An oxidizing agent that interacts with starches, proteins, and fats to improve the volume, structure, and consistency of the bread. The FDA allows potassium bromate in food at levels up to 750 ppm, equivalent to 1 teaspoon of potassium bromate in 200 loaves of bread. [1]
The concern over potassium bromate began in the 1980s after a laboratory animal study showed an increase in kidney and thyroid tumors in rats exposed to very high levels of potassium bromate in drinking water, much higher than levels of human exposure. There is no evidence of adverse health effects in humans.
Polyparaben: One of many parabens used in foods and cosmetics as a preservative and anti-microbial agent. These chemicals are derived from para-hydroxybenzoic acid (PHBA) that occurs naturally in many fruits and vegetables, including cucumbers, cherries, carrots, blueberries, and onions. PHBA is also formed naturally in the human body from the breakdown of some amino acids.
The FDA designates Polyparaben as a “Generally Recognized as Safe” (GRAS) food additive at levels up to 0.1% in food. (More information about the FDA’s GRAS list here.) It is not regulated in cosmetics because cosmetic products and ingredients, other than color additives, do not require FDA approval before marketing.
Parabens came to the public’s attention after a 2004 study found parabens in breast cancer tissue. The study had no control group; they never looked at normal breast tissue to see if it contained parabens, making the results meaningless. While scientists wrote an editorial stating that the study did not mean that parabens caused breast cancer, the media ran with this study, concluding that parabens caused breast cancer. The American Cancer Society has stated that carefully designed studies have found no association between parabens and breast cancer, but the statement that parabens cause cancer continues to be made.
Red Dye #3: The color additive erythrosine is added to food items, including candies, cakes, and drinks, giving foods a bright, cherry-red color. It is also used in some medications and supplements, such as cough syrup and gummy vitamins.
The FDA banned red dye #3 from cosmetics in 1990 based on a study showing thyroid cancer after high-dose exposure in rats. However, there is no evidence that it causes cancer in humans. The main controversy about red dye #3 in foods is not about cancer, but concerns its possible effect on children’s behavior, specifically attention deficit hyperactivity disorder (ADHD). This is the one chemical in the California Bill with enough preliminary scientific evidence to warrant additional research.
The Center for Science in the Public Interest recently submitted a petition to the FDA requesting that synthetic food dyes, including red dye #3, be removed from food products due to their effects on children’s behavior. A recent review of 27 clinical studies of children exposed to synthetic food dyes concluded that there was an association between food dye exposure and adverse behavioral outcomes in children. However, these studies were all relatively small, with a mean number of 44 participants, and only three studies were on red dye #3. Red dye #3 was greater than the FDA recommendations only in children two or younger, and the effect size, a measure of the strength of the relationship, in this case, between Red Dye #3 and behavioral changes, was approximately 13%
Titanium dioxide: A powder that enhances the white color of foods and products, including coffee creamers, candies, sunscreen, and toothpaste. The FDA has designated it as GRAS, not to exceed 1% by weight of the food.
Some animal studies found lung tumors after animals inhaled high levels of titanium dioxide dust. Although the International Agency for Research on Cancer (IARC) considers breathing titanium dioxide dust possibly carcinogenic, it has concluded that food products containing titanium dioxide do not pose a cancer risk. The European Food Safety Authority (EFSA) disagrees, stating it is “no longer considered to be safe when used as a food additive.”
The California Bill
The concerns of California’s legislation appear to be equivalent to “shoot first, ask questions later.” It seems to be driven by emotion, not fact-based science. We care about our children just as much as they do in Europe. The difference is that the US uses risk assessment to evaluate the likelihood that chemicals cause harm; Europe’s assessment of the likelihood is the Precautionary Principle, where any risk is too great. To shift to the Precautionary Principle would mean banning chemicals without scientific evidence of harm and without balancing their benefits for society.
[1] A typical large loaf of bread has 500 grams or about 4 cups of flour.
