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"AHFND Knowledge Hub Latest Questions

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Asked: December 18, 20242024-12-18T11:10:52+00:00 2024-12-18T11:10:52+00:00In: Supplier

Can we rely on GMP alone when there are no specific limits for certain stabilizers and emulsifiers?

While GMP allows manufacturers to use additives at the minimum quantity required to achieve functionality, this approach may lead to ambiguity. For consistency and consumer safety:

  • The 40g/kg cumulative limit specified in Regulation 3.1.6 for “any other emulsifying and stabilizing agents” should serve as a clear maximum threshold.
  • For additives without explicit limits, 10g/kg (used for common stabilizers like guar gum and carrageenan) can be adopted as a reference to ensure controlled usage.
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  • Why is the 40g/kg maximum limit important under Regulation 3.1.6?

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