Center for Research on Ingredient Safety

In our last post, we explored risk, hazard, and exposure, but there is much more to decision making than simply knowing risks. In this post, we’ll explore risk assessments, the precautionary principle, and how these concepts influence scientists and policymakers.

What is a risk assessment? 

In our last post, we discussed risk and how evaluating risks helps us make better, science-based decisions. The formula we provided for risk is only the first step in assessing hazards, exposures, and potential outcomes. A full risk assessment will delve deeper and take 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. 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.

Different scientific disciplines tend to focus on different areas of risk, and policymakers use all of the available information to make sure an ingredient will not cause undue harm before approving it for use. For example, one toxicologist may focus on ensuring an ingredient will not harm human health, an environmental toxicologist may only focus on the impact of an ingredient on our natural environments such as waterways or forests, while yet another toxicologist may focus solely on animal health to ensure an ingredient is safe for household pets. These are just basic examples to demonstrate the many angles researchers and regulators explore before determining the safety of any particular ingredient.

In many cases, there is significant overlap between these scientists and the risk assessment research they perform. This is important as it gives the scientific community greater access to data points that can help confirm the safety of an ingredient or tell us that we need to conduct further research when results are unclear, or an ingredient could be unsafe. Additionally, it allows researchers to see and review different methodologies and replicate relevant research when needed.

Decision-makers and regulators, such as individuals working for the U.S. FDA, use in-depth risk assessments and analyses to make their decisions around ingredient safety. Recently, some regulatory agencies, such as the European Food Safety Authority (EFSA) have begun to incorporate the precautionary principle in addition to risk analyses when making decisions.
 

What is the precautionary principle?

The precautionary principle is the idea that we are morally bound to ensure that our actions will not cause significant harm or that the benefits of our activities far outweigh the risks. This means that if there is a scientific possibility that something harmful COULD happen, but risk analyses have NOT proved that it WILL occur, we should avoid taking any action or diminish operations until we can scientifically prove safety or demonstrate that the benefits far outweigh the risks of something harmful occurring.

When regulatory agencies and scientists apply this principle to ingredient safety, it means an ingredient will not be approved if there is a concern that the ingredient could cause harm, especially if the data points needed to support safety are lacking or questionable.

The precautionary principle does not replace risk analyses. It’s meant to be used in conjunction with risk assessments. The precautionary principle applies to any risk that scientists or policymakers identify outside of the risk assessment or if the risk assessment shows a potential area of concern that requires more clarity. If an ingredient does not pass a precautionary principle evaluation, scientists would need to perform further research on the ingredient or find a different ingredient with less potential for harm.
 

How do decisions makers use these tools and ideas? 

Decision makers use the guidelines put forth by their governing bodies to ensure ingredient safety. The U.S. chose not to use the precautionary principle, rather decisions are based on in-depth risk analyses. The European Union decided to incorporate the precautionary principles into their decision-making processes.

This is where the U.S. FDA and the EFSA have divergent opinions on ingredients. In the United States, all ingredients that are approved and regulated are done so based on risk assessments that determine safety. If there is the potential for harm, researchers must prove how, when, in what form, and at what levels harm will occur before a regulatory agency rejects an ingredient.

In practice, this means researchers focus on answering the question, “what does it take to gain approval for safe use?” and risk assessors gather the data points used to determine with reasonable certainty that an ingredient will not cause harm when used as specified.

In the European Union, ingredients are approved and regulated once the risk assessment and precautionary principle demonstrate they are safe. Meaning an ingredient will not be accepted if researchers or policymakers suspect that an ingredient could cause harm even if researchers cannot quantify how, when, in what form, and at what levels this harm will occur.
 

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 decision-making agencies help keep our food supplies safe.

While the process of evaluating an ingredient may vary between governing bodies, knowing the core philosophies behind these decisions helps us make choices that reflect our personal preferences and values.

In our upcoming blog post, we will explore ingredients Generally Recognized As Safe (GRAS) by regulatory agencies.

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