The US framework
The US system relies on the Food Additives Amendment and the GRAS pathway.
The burden of proof can shift after market entry, which can slow regulatory change.
In the US, many substances enter the market based on a company’s own determination that they are safe, with minimal initial oversight.
Precautionary models
Some regions require stronger certainty of safety before approving additives.
This can lead to faster restrictions when new evidence emerges.
The European Union, for example, often applies the precautionary principle, which allows for regulatory action even when full scientific certainty is lacking.
Regulatory divergence
Different standards can lead to the same product being formulated differently by region.
PRūF summarizes these differences to help users compare context.
Global companies frequently use different ingredient sets for the same product brand depending on the local regulatory requirements of each country.
Why these differences exist
Regulation is shaped by a mix of scientific tradition, legislative history, and public health priorities.
Some systems prioritize innovation and rapid market entry, while others prioritize absolute certainty of long-term safety.
Understanding these frameworks helps consumers interpret why an ingredient might be "banned" in one country but "safe" in another.
Frequently Asked Questions
Not necessarily, but they operate under different legal mandates. The FDA often requires higher proof of harm to remove a substance, while the EFSA may require higher proof of safety to keep one.
This is usually due to the application of the Precautionary Principle in the EU, which can result in bans when there is unresolved scientific debate about an ingredient’s long-term safety.
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.