Solutions · Trust & Science

Scientificvalidation.

We help your team find the strongest path. Whether an ingredient is safe for your intended use is a question for qualified experts, and we support the independent scientific work that answers it.

How we work

How GRAS works today

A substance added to food needs premarket approval as a food additive unless it is generally recognized as safe among qualified experts. Today a company can reach that conclusion with an expert panel and a documented dossier, and notifying FDA is voluntary.

A GRAS conclusion needs the same quantity and quality of scientific evidence as a food additive approval. Food use before 1958 is the other route.

What FDA has proposed

FDA’s proposed rule of August 11, 2026 would require GRAS notices for substances purported to be GRAS. Comments are due December 9, 2026. It is a proposal only, and the current voluntary program remains in place.

As proposed, substances already affirmed in 21 CFR Part 184 or 186 would not need a notice if their conditions of use are not significantly different.

Independent review we support

Reformulation holds up better when the science is checked by people with no stake in the answer. We support the work of independent groups in this space, and we point customers to them when a project needs it.

Questions R&D teams ask

Can DyeConverter tell us an ingredient is GRAS?

No. We can show what the public record says and organize the evidence, but a GRAS conclusion belongs with qualified experts.

Has FDA ended self-affirmed GRAS?

No. The August 2026 rule is a proposal, with comments due December 9, 2026. The current voluntary program remains in effect.

Is a “no questions” letter an FDA approval?

No. It means FDA did not object to the notifier’s own GRAS conclusion for that substance and those uses.