Ever wonder how regulators decide if an ingredient is safe enough to be in your food? Let’s explore the science and philosophy behind these critical decisions.
Top Takeaways:
- Risk assessments are comprehensive scientific evaluations that determine whether ingredients are safe to use,
- The precautionary principle is an extra layer of caution some countries use, if an ingredient might cause harm (even without proof), it won’t be approved.
- The U.S. relies on proven risk assessments, while the European Union adds the precautionary principle into its decision-making.
- Both approaches prioritize safety, just through different philosophical lenses.
- Ingredients are regularly re-evaluated to ensure they continue meeting safety standards.
What is a risk assessment?
A risk assessment goes far beyond a simple risk calculation. It’s a comprehensive evaluation that examines:
- Multiple types of potential hazards
- Various exposure points and scenarios
- Benefits of the ingredient
- Long-term and short-term effects
- Real-world usage conditions
How scientists conduct risk assessments
Researchers use multiple methods to evaluate ingredient safety:
- Computer modeling and simulations
- Short-term and long-term animal studies
- Human exposure studies
- Environmental impact analyses
- Review of existing scientific literature
The team approach to safety
Different experts focus on specific areas of risk:
- Human toxicologists evaluate impacts on human health
- Environmental toxicologists study effects on waterways, forests, and ecosystems
- Veterinary toxicologists assess risks to household pets and animals
The multi-disciplinary approach ensures ingredients are examined from every angle. When research overlaps between disciplines, it strengthens our confidence in safety conclusions and allows scientists to verify each other’s findings using different methodologies.
Learn more about the Risk Assessment Process.
What is the Precautionary Principle?
The precautionary principle is built on the idea that we should avoid actions that could cause significant harm, even if that harm isn’t scientifically proven yet.
Here’s how it works in practice:
- Traditional Risk Assessment asks: “Can we prove this ingredient will cause harm?”
- Precautionary Principle asks: “Can we prove this ingredient won’t cause harm?”
Notice the difference? The precautionary principle shifts the burden of proof. If there’s scientific uncertainty or a possibility of harm, even without definitive evidence, the ingredient won’t be approved until:
- Additional research proves it’s safe, OR
- The benefits clearly outweigh potential risks
The precautionary principle doesn’t replace risk assessments; it’s supposed to work alongside them. Regulators still conduct thorough scientific evaluations, but they add an extra layer of caution when data is unclear or concerns exist.
How do the U.S. and EU differ in their risk assessment approaches?
United States Approach
Philosophy: Risk assessment-based decision making
In practice:
- The FDA requires proof that an ingredient will cause harm before rejecting it
- Researchers must demonstrate specific details: how, when, in what form, and at what levels harm occurs
- The key question is: “What evidence do we need to approve this for safe use?”
- If risk assessments show an ingredient is safe under specified conditions, it’s approved
European Union Approach
Philosophy: Risk assessment + precautionary principle
In practice:
- The EFSA requires ingredients to pass both risk assessments and precautionary evaluations
- If there’s suspicion of potential harm (even without quantifiable proof), the ingredient may be rejected
- The key question is: “Are we certain this won’t cause harm?”
- When in doubt, regulators err on the side of caution
What do the differences in the risk assessment process mean for us?
Both systems prioritize safety, but they come at it from different angles. The U.S. approach requires scientific proof of harm before restricting ingredients, while the EU approach requires scientific proof of safety before approving them.
Both approaches ensure ingredients are safe for the public when used as directed.
Are ingredient safety risk assessments only conducted once?
Risk evaluations are not one-and-done decisions. Regulatory agencies periodically:
- Conduct new risk analyses on previously approved ingredients
- Update safety requirements as scientific knowledge advances
- Investigate if unexpected health or environmental impacts emerge
- Re-evaluate ingredients when new research raises concerns
Continuous monitoring helps ensure that our ingredients remain safe as our understanding of them evolves.
What else do I need to know about ingredient safety?
- Multiple expert reviews: Ingredients are evaluated by diverse teams of scientists, each bringing specialized knowledge to catch potential issues others might miss
- Continuous improvement: Regulatory agencies don’t just approve ingredients and forget about them, they actively monitor and re-evaluate ingredients as new science emerges
- Transparent research: Scientists share methodologies and findings, allowing peer review and replication studies that strengthen our confidence in safety conclusions
- Global collaboration: Different regulatory approaches (U.S. and EU) mean ingredients are often examined through multiple philosophical lenses, providing a more complete safety picture
The good news.
Whether ingredients are evaluated through U.S. risk assessments or EU precautionary principles, robust scientific processes are working to keep your food safe. Multiple layers of review, ongoing monitoring, and diverse expert perspectives all contribute to protecting public health.
If you have any questions about ingredients or ideas for a blog post, please send us an email or submit your idea to us at go.msu.edu/cris-idea.