| Regulatory Authority | FDA (U.S. Food and Drug Administration) | EFSA (European Food Safety Authority) & European Commission | FSANZ (Food Standards Australia New Zealand) | SAMR (State Administration for Market Regulation) | FSSAI (Food Safety and Standards Authority of India) |
| Major Regulation Governing Compliance | 21 CFR Part 106 & 107 – Infant Formula Regulations | Regulation (EU) No 609/2013 on Foods for Specific Groups (FSG) | Australia New Zealand Food Standards Code | GB Standards (e.g., GB 10765-2021) for infant formula | Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2019 |
| Pre-market Approval Required? | Yes – Manufacturer registration and notification | Yes – Pre-market notification and composition review | No – Comply with standards, but no pre-approval | Yes – Mandatory registration with SAMR | Yes – Prior approval and product registration required |
| Labeling Requirements | Must meet strict CFS 21 Part 107 labeling and nutritional information requirements for infant formula. | Must comply with harmonized EU labeling rules, including allergens, nutrition info | Must comply with FSANZ labeling codes | Must follow GB labeling standards, including mandatory warnings | Must follow specific infant food labeling rules under FSSAI |
| Nutritional Composition Requirements | Specific nutrient content, quality control & Good Manufacturing Practices (GMP) required | Detailed compositional criteria for energy, protein, vitamins, and minerals | Must meet nutrition content standards specified by FSANZ | Stringent GB compositional standards; new updates in 2021 | As per Schedules under FSSAI regulations, modeled on Codex guidelines |
| Claims Allowed | Limited; FDA approval required for structure-function or health claims | Only EU-authorized claims permitted; No health or nutritional claims on infant formula | Functional and nutrient claims allowed within Regulatory limits | Strict control; health/nutritional claims require SAMR review | Only pre-approved nutrition claims allowed; therapeutic claims not permitted |
| Clinical Evidence Required? | Yes – Especially for new formulations or ingredients | Yes – EFSA scientific dossier for novel ingredients or composition | Required for novel ingredients or changes in nutrient bioavailability | Yes – For new products or ingredient combinations | Yes – If deviating from standard composition or for novel formulations |
| Timeline for Registration | ~6–12 months, depending on product review | ~12–18 months, including EFSA evaluation | ~3–6 months for market entry if compliant | ~18–24 months, including safety and technical review | ~12–18 months for full Regulatory clearance |
| Need for Local Representative | Yes | Yes | No | Yes | Yes |