2 Final decisions made pursuant to regulation 4ZCZR - proposals referred to the November 2019 Joint Advisory Committee on Medicines and Chemicals Scheduling (ACCS-ACMS #23)
Note
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2.1. Final decision in relation to Caffeine
Final decision
Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to affirm the interim decision and amend the current Poisons Standard in relation to caffeine as follows:
Schedule 6 - New Entry
CAFFEINE except:
a. when included in Schedule 4; or
b. in divided preparations for internal human therapeutic use when labelled with a maximum recommended daily dose of no greater than 600 milligrams of total caffeine; or
c. in undivided preparations for internal human therapeutic use with a concentration of less than 5 per cent of total caffeine and when labelled with a maximum recommended daily dose of no greater than 600 milligrams of total caffeine; or
d. in preparations for external use; or
e. in other preparations with a concentration of less than 5 per cent of caffeine.
Schedule 4 - New Entry
CAFFEINE for internal human therapeutic use except:
a. in divided preparations when labelled with a maximum recommended daily dose of no greater than 600 milligrams of total caffeine; or
- b. in undivided preparations with a concentration of less than 5 per cent of caffeine and when labelled with a maximum recommended daily dose of no greater than 600 milligrams of total caffeine.
Index - New Entry
CAFFEINE
cross reference: PARACETAMOL, ASPIRIN, SALICYLAMIDE
Schedule 6
Schedule 4
Reasons for the final decision (including findings on material questions of fact)
I confirm the reasons for my final decision to create new Schedule 4 and Schedule 6 entries for caffeine are as detailed in my interim decision. In making my final decision, I have taken into account the material detailed in the interim decision and the submission received before the second closing date in response to the call for further submissions published on 6 February 2020 under regulation 42ZCZP of the Regulations. The public submission, however, has not been material to my decision. While supportive, the views expressed were not relevant as they related to matters outside the scope of scheduling.
Summary of public submissions on the interim decision
One public submission supporting were received in response to the second interim decision.
The main points in support with amendments of the proposed amendment were:
- The submission supported the schedule 4 entries in the Delegate's interim decision.
- The submission proposes increasing the current 1% limit in the listing for caffeine in the Permissible Ingredient Determination to align with the 5% limit set for food by FSANZ.
Date of effect of the decision
1 June 2020