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Final decisions and reasons for NCEs, medicines and chemicals, November 2018
Scheduling medicines and poisons
Part A - Final decisions on matters referred to an expert advisory committee (November 2018)
2. Joint meeting of the Advisory Committee on Chemicals and Medicines Scheduling (ACCS-ACMS #20)
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Delegate's final decision
The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the current Poisons Standard in relation to naphthalene as follows:
Schedule 10 - New Entry
Schedule 6 - Amend Entry
NAPHTHALENE (excluding its derivatives) except in liquid hydrocarbons
as an impurity.
Index - Amend Entry
Appendix E, Part 2
Appendix F, Part 3
1 June 2019
The delegate has confirmed that the reasons for the final decision align with those for the interim decision.
Additional reasons, including consideration of the public submissions on the interim decision:
The purpose of the Schedule 10 entry is to address public health risks associated with the importation, retail and use of non-compliant naphthalene in domestic situations for the control of moths and larvae which are destructive to natural-fibre textiles. However, having considered the public submissions on the interim decision, the interim decision has been qualified to ensure that legitimate domestic uses of naphthalene are not inadvertently captured.
Public submissions on the interim decision
Four (4) public submissions were received before the second closing date in response to an invitation published on 7 February 2019 under regulation 42ZCZP of the Regulations. All four submissions were not supportive of the proposed amendments.
The main points provided in opposition of the amendment were:
- The proposed Schedule 10 entry should be qualified as it is not currently clear as to what products would potentially be incorporated under the proposed entry.
- By extension, clarification is required as to what is meant by the Schedule 6 statement 'except in liquid hydrocarbons as an impurity'. Industry have been able to quantify the benzene content in fuels and solvents and schedule high boiling aromatic hydrocarbon solvents with particular exclusions, yet industry has been left in a state of unknown compliance in respect to when naphthalene should be considered to be an impurity. It would be useful to resolve the issue of what is a naphthalene solvent impurity at this stage to minimise the uncertainty to the manufacturing industry.
- Naphthalene in each Schedule needs to be considered on its own individual merit as presented, as there is no link or reference between the schedules. Consequently, anything that meets the Schedule 10 definition of naphthalene will be prohibited from sale and supply for domestic use and this will lead to prohibition of critical products from the market place, beyond the intention of the review.
- The proposal would have substantial and widespread impacts on the economy. If the decision is to maintain the current interim decision, the proposal is likely to have a measurable impact on business, community or individuals. Under such circumstances it is considered that a RIS (Regulatory Impact Statement) would be required to ensure the net impact is fully evaluated as recommended.
The interim decision was published on the TGA website on 7 February 2019 at Scheduling delegates' interim decisions and invitation for further comment: ACMS #25, November 2018 - 2.2 Naphthalene.
The pre-meeting scheduling proposal was published on the TGA website on 31 August 2018 at Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS-ACMS meetings, November 2018.