technology

Feed-additive safety dossier

Toxicology, efficacy, characterization and exposure-assessment data organized to a specific regulator's evidentiary standard, spanning both the EU FEEDAP and US GRAS regimes.

Where it's used

Feed-additive authorization (EFSA FEEDAP, FDA GRAS)
Regulatory-affairs consultancies that prepare and submit the safety dossiers a feed-additive producer needs to sell in the EU (EFSA FEEDAP Panel review under Regulation (EC) No 1831/2003) or the US (FDA GRAS notification or self-affirmation for animal food) — a distinct market-access service from the ingredient science itself, sold by four specialists spanning both regulatory regimes (EAS Consulting Group, dicentra, Burdock Group, Pen & Tec Consulting/Argenta).
market-access-commercial 8 min