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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 |