Update to listed medicine ingredients in September 2019

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

Published

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

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

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