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Therapeutic Goods Amendment (Permissible Ingredients) Determination (No. 1) 2019

3 September 2019

An amendment to the Therapeutic Goods (Permissible Ingredients) Determination commenced on the Federal Register of Legislation (FRL) on 2 September 2019. The amendment determination is titled the Therapeutic Goods Amendment (Permissible Ingredients) Determination (No. 1) 2019. A total of 21 changes have been made in the updated Determination. These changes include:

  • Addition of 3 new ingredient entries;
  • Changes to 8 existing ingredient entries, including making requirements clearer and less restrictive; and
  • Changes to caffeine and 9 caffeine containing ingredients to introduce more restrictive requirements following a safety review.

A complete list of changes to ingredients is below.

New ingredients

  • 3,7-dimethyl-1-octen-3-ol
  • Bacillus coagulans
  • polyglyceryl-2 distearate

Changed ingredients

Ingredient Reason for update
BRILLIANT SCARLET 4R Less restrictive requirements
BRILLIANT SCARLET 4R ALUMINIUM LAKE Less restrictive requirements
LAVANDULA ANGUSTIFOLIA Correction of error, SUSMP alignment
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA Correction of error, SUSMP alignment
LAVANDULA X INTERMEDIA Correction of error, SUSMP alignment
LAVENDER OIL Correction of error, SUSMP alignment
ORIGANUM MAJORANA Correction of error, SUSMP alignment
THYMOL Less restrictive requirements
CAFFEINE Safety review
CAMELLIA SINENSIS Safety review
COFFEA ARABICA Safety review
COFFEA CANEPHORA Safety review
COFFEE Safety review
COLA ACUMINATA Safety review
COLA NITIDA Safety review
ILEX PARAGUARIENSIS Safety review
PAULLINIA CUPANA Safety review