California, Candy and Consumers

If you’re a fan of jelly beans or Valentine’s Day conversation hearts, you may be curious about a new California law that will ban one red coloring agent and three other food additives from being made, distributed or sold in that state, starting in 2027. 

Processed foods like candy, baked goods and beverages contain additives to make them taste better, look more appealing or stay fresh longer. That’s the case with the four food additives that will be prohibited under the California Food Safety Act.

• Red Dye No. 3 is used to color jelly beans, conversation hearts and candy corn.
• Brominated vegetable oil keeps the citrus flavoring in some soft drinks and sports drinks from floating to the top. 
• Potassium bromate is a leavening agent for baked products.
• Propylparaben is a food preservative. 

California’s regulations, which are based on the potential for harmful health effects, will be stricter than national standards the U.S. Food and Drug Administration (FDA) has set. Should we be worried about these additives as consumers? How common are they? Will the ban affect the way processed foods are made? Will other states pass similar laws?

For answers, we consulted North Carolina State University experts on food safety and food processing. Ellen Shumaker directs outreach for Safe Plates, NC State Extension’s evidence-based food safety program for retail, community and home-based food safety. Keith Harris, an Alumni Distinguished Undergraduate Professor of Food Science, studies health effects of food, including coffee, and teaches courses on analytical techniques in food and bioprocessing, food toxicology and nutraceuticals.

Are the food additives included in the California ban used all over the world or do different regions have prohibitions against some of them?

Ellen Shumaker: We do see differing levels of what’s allowed to be used. Currently the (U.S.) Food and Drug Administration considers these ingredients safe. I think that’s also why it’s really interesting to watch this unfold with California taking a stance and banning them. A lot of places in the European Union have banned these ingredients. And the reason we see that is because the U.S. and the EU have different approaches to how they regulate what goes into foods. 

The U.S. takes what’s called a risk-based approach. This approach takes into account that risk is defined by the hazard and then the level of exposure, the “dose,” taking into account how much of that ingredient or product would be needed to actually cause harm. Whereas the EU takes more of a hazard-based approach — is it present or not, is it able to cause harm? And so that’s where you see the EU taking a stricter stance to these ingredients.

A recent New York Times article highlighted that the FDA was in the process of reevaluating two of the additives in the California ban: Red Dye No. 3 and brominated vegetable oil. When the FDA once considered a food additive to be safe, what leads it to reconsider?

Shumaker: I cannot speak to all of the specifics, but there’s an FDA list of what they call GRAS, which stands for “generally recognized as safe.” So there’s that kind of established list. Typically what we see is that as evidence arises, the FDA wants to be science-based, to base their decisions on the most current science. So as studies start to look at these different ingredients, they reevaluate that data. As new data comes forward, that brings weight to the fact that the FDA may need to reexamine an ingredient on the GRAS list.

Also, I think talking about that difference in how our systems operate — risk-based versus hazard-based — is really important. The FDA has a site with information about food ingredients and packaging as well as additives. They have their list of ingredients that are generally recognized as safe. Extension resources coming from food science departments are another great source of information for better understanding the functionality of different ingredients. I think sometimes it can be overwhelming to look at a food label if you don’t necessarily know what everything’s doing in there. But when you start to look at the different functionalities, that’s where we start to see, oh, this is why something can sit on a shelf and can be transported longer distances. And that’s when we really start to see the effects on shelf life and quality.

In terms of how additives are used in food processing, what stood out to you as you looked at the California legislation?

Keith Harris: What really struck me was that three of the four additives — brominated vegetable oil, potassium bromate and Red Dye No. 3 — are really very much restricted or on their way out. And so that was my first surprise. I thought these were going to be things that were really, really prevalent. I would say propylparaben is fairly commonly used, but the other three, not so much. So it was kind of curious to me that you would ban things that are already on the way out. And in the case of brominated vegetable oil, since 1970 the FDA has been trying to get rid of that. So it’s been a long time in terms of the limitations of at least three of the four ingredients.

To your point, some major food manufacturers and restaurant chains, including Coke, Pepsi, Dunkin’ and Panera, have already taken the four additives out of their products. How difficult will it be for other food processors to replace these additives?

Harris: When I looked at the list, I thought, well, if these are in really high use, this is going to be a challenge to replace these ingredients because they’re quite useful. If the lemon flavor in your soda rises to the top and separates, consumers don’t like that, and that’s what this brominated vegetable oil does. It weighs down flavor oils, like lemon, that will otherwise float on water, like other oils. But because it’s been such a long time, 50 years plus that this has been looked at, there are now other ingredients in the market which have the ability to weight those flavors. Essentially you’re trying to make oil and water mix. So other ingredients are now being used. To answer your question — I don’t think brominated vegetable oil, potassium bromate and maybe Red Dye No. 3 are going to be too difficult to replace, just because they’ve already been restricted to a very significant degree. And so that means that food companies have already had to adapt.

What about propylparaben, which is a preservative? 

Harris: Propylparaben is an antimicrobial. Antimicrobials are used typically to either extend shelf life to make things last a bit longer, or they may also be used in products where you may have things that are multiple use. You open a container, you use some of it, and then you put it back into the refrigerator or onto the shelf, you open it again and reuse it. This is why it’s found not just in baked goods, but also in many cosmetics, where multiple uses raise the possibility that you’re going to introduce some level of contamination. It (propylparaben) serves as a sort of insurance against contamination that might occur. It’s a way to maintain quality over the shelf life of the product and make sure it doesn’t spoil before its shelf life is up.

I think the challenge there, just trying to understand why it might have gone on that list, is going to be finding something that is as safe or nonreactive as propylparaben for products where long shelf life and multiple uses are desirable. It has relatively few concerns that are related to toxicity. The one thing that it does appear to do potentially is to raise sensitivities on the skin, but that seems to be more with broken skin or damaged skin. 

I saw that it required almost half a percent by weight in the original animal diet trials to produce any level of concern. And then in human trials, 5% to 15%, which is a lot, was what was required to produce reactions in human volunteers. You don’t put 5% to 15% of any antimicrobial in any food. If you make a cream and put that much in there, that’s way more than you would use normally. So it just seemed like this is something overall, unless you have a very high sensitivity to it — and there are individuals — but unless you are one of those individuals, this to me seemed like quite a safe product in terms of antimicrobials.

And you’d hope that any replacement would be even more inert in the sense that it wouldn’t cause any problems, including these potential skin sensitivities or skin reactions. I think that would be challenging to find a replacement there.

Could this be the start of a trend? A New York senator introduced similar legislation for his state that includes the same four additives, along with titanium dioxide, which was originally part of the California ban. 

Titanium dioxide is an oxide of a metal that’s used for brightening colors. It’s incredibly stable, so it will survive almost any processing or storage condition. One of its advantages is its stability. This is also its downside, since highly stable compounds that make it into our bodies may stick around. Other ingredients produce that brightening effect that titanium dioxide has, which could include things like starch. On a label, starch probably is not an issue whatsoever from a safety standpoint.

The question is whether that’s going to work in systems where you have high enough moisture. If you start mixing starch and water, you’re going to start making batter or maybe a gummy material, something that you’re not intending to do, and you’re going to lose some of those brightening properties.That’s just an example of the challenges in replacing titanium dioxide. I think if it’s a very dry product, you might actually be able to replace titanium dioxide with starch fairly easily. So on the one hand, that may be an easy fix. If you’re talking about a product with lots of moisture, you probably would have a hard time using something like starch.

New York may pursue the same course and I guess I would have the same question as to how it will significantly improve the safety of the food system in order to do this. The bottom line for me from a scientific perspective is that idea of the amount or dose of these additives we might consume. That’s the basis of toxicology: the idea being that the mere presence of something in a food, even if it’s not something we’d want to drink a glassful of, is not necessarily a cause for concern.

This post was originally published in College of Agriculture and Life Sciences News.