Center for Research on Ingredient Safety

One of the main concerns we see folks express around ingredient safety is a desire to ensure an ingredient is completely safe with no risk for harm.

It seems like a reasonable desire, to know that the ingredients in the foods and beverages we consume and the cosmetics and products we use are supporting our health, rather than harming our health. But, like all of science (and life for that matter), there is not an easy answer.

Science and evidence-based information don’t work with simple yes or no statements, as we’re often dealing with nature, humans, and organisms that follow specific patterns and rules, but each is biologically unique. When researchers are looking to evaluate the safety of an ingredient, they must take into consideration all the factors that impact the ingredient’s hazard score. Once researchers know the hazard score they can figure out an approximate risk by looking at human exposure to the ingredient.

Sounds complicated? Let’s break it down.

What is a hazard?

Hazards, in terms of ingredient safety, are any ingredient or process that we know can cause harm.

For example, we know that water can harm humans in many situations, such as over-consumption or drowning. Hazards remain static, meaning they are not actively causing harm unless we engage with the hazard. This concept shows us that water remains a hazard whether it's in a glass, on our table, a pond in our backyard, or locked in a maximum-security vault.

The hazard does not change.

What is exposure?

Exposure is how we’re introduced to hazards. For example, in seeds and pits found in fruits, we can find potentially harmful cyanogenic glycosides, which are compounds that upon digestion can break down into cyanide. That is a hazard.

But, if we eat a rogue apple seed, we won’t become ill because the hazard is present at a very low level, therefore exposure is low and no harm occurs. In fact, an average adult would need to consume 200 apple seeds in a short period of time to experience toxicity.

Exposure to a hazard doesn’t necessarily cause harm, but it does help determine our risk.

What is risk?Risk is calculated using the formula: (hazard) X (exposure) = risk.

The formula allows us to take hazard and exposure into consideration so we can determine risk. Once we've established the risk, we can then identify the safe levels for consuming an ingredient.

We know apples are a fiber-filled fruit that can be incorporated as part of a healthy, balanced diet. But, we also know it’s not risk-free. They contain hazardous seeds. We also know it’s improbable that we’d be exposed to hazardous seeds of sufficiently high quality that we’d be at risk for an adverse health event.

So, is the risk of eating an apple zero? No, in scientific terms it’s not zero. Is the risk low enough that we don’t need to be concerned? Yes, there’s no reason to omit apples from our diet due to a minuscule, improbable, risk.

Context is key.

Biological differences between people and between organisms determining risk difficult, but context is also key.

The same person in one situation may be exposed to a compound with no ill effects, but the same individual exposed to the same amount of the compound may experience toxicities in other contexts.

For example, over-the-counter medications containing acetaminophen are very safe and effective, when taken in the proper amount. But, if an adult consumes alcohol, while exposed to acetaminophen, liver damage can occur.

The risk now changes because the context and situation have changed by adding a new variable. In this case, acetaminophen with alcohol exposure increased the risk of an adverse health impact.

Read more about risk: https://www.canr.msu.edu/news/what-is-risk

Can we get to zero risk?

While apples are an easy example, other ingredients aren’t as easy to conceptualize. Especially when we’re talking about ingredients that sound complicated, may be human-made, or can be considered additives.

Scientists and regulators have developed risk assessment processes to evaluate an ingredient’s health and safety and determine if the risk will adversely impact human health if consumed and used in normal quantities.

A full risk assessment takes into consideration a broad range of potential hazards, exposure points, benefits, and other variables before delivering a final safety assessment that includes an ingredient's real and potential risks.

A risk assessment’s goal isn’t to get the risk to zero, rather, it’s to ensure no harm comes from any hazards associated with exposure to an ingredient. Or, any potential for harm is greatly-outweighs by the beneficial effects.

For example, a medication may have side effects, but the benefit is greater than the side effect. The health benefits of eating an apple far outweigh any potential hazard from ingesting a seed or two.

What is a risk assessment? 

Scientists take risk assessments seriously and use various research tactics, including data models, short and long-term animal research studies, and more to evaluate an ingredient and/or process for safety.

Before researchers can deliver the final safety assessment, they typically use a 4-step process to evaluate the risk:

1. Hazard Identification – looks at a compound to see if there is a potential to cause humans harm (1).
2. Dose Response Assessment – reflects the relationship between the dose (amount) of an ingredient and the effects in humans (1). This generates a safe use level.
3. Exposure Assessment – reflects the exposure to a quantity, frequency, and duration of a specific compound, taking into consideration the number and characteristics of the exposed population.
4. Risk Characterization – takes into consideration of the variables above and develops an estimation that reflects if humans will experience an impact from the compound.

How do scientists calculate a safe level for an ingredient?

Scientists use data to determine the highest dose of a compound an animal can be safely exposed to. Since animal systems and human systems are different, researchers need to ensure that humans are not negatively impacted more so than animals.

Then, researchers will use the data derived from animals and apply it to humans. The risk assessment evaluates an ingredient’s safety, so regulators can establish safe exposure levels.

If we can't get to zero, how do we know it’s safe?

Scientists calculate a safe dose for humans by dividing the animal safety dose typically by a default of 100 (10-fold for the uncertainty of extrapolating across different animal species and 10-fold due to uncertainty due to differences in sensitivity between individual people), if not more. The calculation generates a conservative estimation of safe exposure that takes into consideration vulnerable populations like children.

Read more about risk assessment: https://www.canr.msu.edu/news/risk-exploring-the-risk-assessment-process

What else do I need to know?

Risk evaluations are not one-time events. Periodically, regulatory agencies will conduct new risk analyses to ensure the ingredients still hold up to our current safety requirements. Or, they will do further risk analyses if there is a suspicion that an unanticipated harmful impact is occurring due to a prior approved ingredient. By reevaluating ingredients, our scientists and decision-making agencies help keep our food supplies safe.

Read more about using risk to make informed decisions: https://www.canr.msu.edu/news/risk-using-risk-to-make-informed-decisions 
 

The good news.

By understanding the risk assessment processes in our food and cosmetic system, we can use similar decision-making processes in our everyday lives. There are many activities, like driving, that are risky, but we choose to engage in them because the benefits far outweigh our risks.
 
Every action contains some risk, but we can use our own personal value system to determine the risk we are comfortable taking for the activities in our lives.

If you have any questions about foods and ingredients, please reach out to us on Twitter, send us an email, or submit your idea to us at go.msu.edu/cris-idea