Tech Alert: New Permissible Ingredients Determination (No. 5) 2022 

A new Therapeutic Goods (Permissible Ingredients) Determination (No. 5) 2022 commenced on Tuesday 29 November 2022.

This Technical Alert contains all details of new, deleted and changed ingredients, and a comparison of all changes to the Determination for members. Please note that the information in this alert is included in a comparison table and is more detailed than the description published on the TGA website.

This alert details:

  • NEW ingredients and specific requirements that apply to that ingredient, including;
    • shea butter ethyl esters;
    • 3-fucosyllactose;
    • hemp seed oil; and
    • the addition of an ingredient for flavour PIs: ‘monomenthyl glutarate’.
  • CHANGED ingredients with the original requirements and the new or changed requirements, including:
    • aminocaproic acid;
    • atropine sulfate monohydrate;
    • sodium carbonate;
    • sodium carbonate monohydrate;
    • Curcuma zanthorrhiza;
    • Laurus nobilis;
    • Bay Oil; and
    • Laurel Leaf Oil
  • DELETED ingredients, including:
    • ‘aminobenzoic acid’; and
    • Amyl cinnamic alcohol.
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