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"AHFND Knowledge Hub Latest Questions

AHFND
AHFND
Asked: December 18, 20242024-12-18T11:16:37+00:00 2024-12-18T11:16:37+00:00In: Supplier

What does the 40g/kg cumulative limit specified in Regulation 3.1.6 mean in percentage terms, and how should it be interpreted with GMP?

  • 40g/kg Limit:
    • The 40g/kg cumulative limit means 40 grams of an emulsifier or stabilizer can be used per kilogram (1000 grams) of the product.
    • This translates to 4% by weight
  • Other Emulsifying and Stabilizing Agents:
    • For emulsifiers or stabilizers listed under Regulation 3.1.6, the 40g/kg (4%) maximum limit applies unless a specific lower limit is explicitly mentioned.
  • Interpretation with GMP:
    • For ingredients covered under GMP (Good Manufacturing Practices) where no specific limit is provided:
      • Manufacturers must use only the minimum quantity required to achieve the intended functional purpose.
      • This ensures both product safety and compliance with quality standards.

By adhering to these limits, manufacturers can maintain compliance with FSSAI guidelines while ensuring product quality and consumer safety.

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  • Why is the 40g/kg maximum limit important under Regulation 3.1.6?

  • The supplier states that stabilizers and emulsifiers can be added ...

  • The supplier claims GMP allows flexibility with no specific limit ...

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