21 CFR 101.12 — Reference Amounts Customarily Consumed
Summary
This eCFR section provides FDA reference amounts customarily consumed per eating occasion. HMI uses these values only as transparent serving-size assumptions when converting California Proposition 65’s lead MADL from an exposure value in ug/day into a ppb-equivalent concentration screen.
Category 1 values used for Prop 65 conversions
| Product category | Reference amount used in HMI | HMI conversion use |
|---|---|---|
| Cereals, dry instant | 15 g | Dry infant cereal Prop 65 ppb equivalent |
| Dinners, desserts, fruits, vegetables, or soups, ready-to-serve, junior or strained type | 110 g | Purees, infant meals, and mixed baby-food products |
| Dinners, stews, or soups for young children, ready-to-serve | 170 g | Toddler-meal sensitivity note |
| Juices, all varieties, for infants and young children | 120 mL | Juice ppb equivalent, approximated as 120 g |
| Other cereal and grain products, dry ready-to-eat, including teething biscuits and toasts | 7 g for infant teething/snack products | Teething and snack ppb equivalent |
Formula assumptions are not taken from this table. Formula rows use clearly labelled illustrative daily-intake assumptions until a formula-specific exposure model is approved.