Nutraceutical compliance primer
Which regulations the standard encodes and where.
USP <2232> elemental contaminants
Permitted daily exposure: Pb 5, As (inorganic) 15, Cd 5, Hg 15 µg/day. Limit in ppm = PDE ÷ maximum daily dose in g. COA.daily_dose_g enables rule NB-R013: a result marked PASS may not exceed that limit.
US FDA 21 CFR Part 111 (cGMP)
Identity testing of every incoming dietary ingredient, specifications for each component, and batch records. PRODUCT.specification is the release specification; COA must report identity (IDENTITY analyte) and every specified test.
FSMA 204 traceability
Key data elements at critical tracking events (harvest, cooling, initial packing, shipping, receiving, transformation): traceability lot code, quantity, location (GLN), date. LOT_GENEALOGY, ASN and RECEIPT carry them; recalls must cover every downstream lot (NB-R010).
EU
Novel Food Regulation (EU) 2015/2283, Food Supplements Directive 2002/46/EC, contaminants Regulation (EU) 2023/915 (PAs, PAHs, mycotoxins, metals), allergen labelling Regulation (EU) 1169/2011 Annex II, all represented in the analyte and allergen code lists.
India FSSAI
FSS (Health Supplements, Nutraceuticals, …) Regulations 2022: FSSAI licence in PARTY identifiers, claims under IN_FSSAI, and Ayurvedic GMP (AYUSH_GMP) as a quality scheme.
HS 2028
From 1 January 2028 dietary supplements in measured doses classify under new heading 21.07 (2107.10), other retail supplements under 2107.90. Rule NB-R017 blocks 2106.90 for dose forms on orders and customs data dated from 2028.