Precautionary vs risk-based
Risk-based models, like those often used in the US, typically require strong proof of harm before restrictions are applied to a substance.
Precautionary models, like those in the EU, may restrict an additive when safety cannot be confidently demonstrated, even if direct harm hasn’t been proven yet.
This fundamental difference in approach is the primary reason for many of the regional "bans" we see today.
The burden of proof
In a precautionary system, the burden of proof is often on the manufacturer to demonstrate that a substance is safe beyond a reasonable doubt.
In a risk-based system, the burden may effectively shift to the regulator to prove that a substance is unsafe after it is already on the market.
This shift in burden can lead to very different speeds of regulatory action when new scientific concerns arise.
Why the difference matters
Different standards can lead to the same ingredient being permitted in one region and restricted in another.
PRūF summarizes these differences to help users interpret ingredient lists.
By providing context on why a region has taken action, we empower users to make choices based on their own personal safety thresholds.
Frequently Asked Questions
The European Union is the most prominent user of the Precautionary Principle, but it is also integrated into the regulatory frameworks of many other countries to varying degrees.
Related pages
Sources
- PRūF Red Team Validation report — Internal synthesis provided by PRūF Labs (2025).
Summaries are educational and may be updated as regulations change.