Part A - Final decisions on matters referred to an expert advisory committee (November 2017)
2. Joint meeting of the Advisory Committee on Chemicals and Medicines Scheduling (ACCS/ACMS #17)
2.3 Polihexanide
On this page: Delegate's final decision | Public submissions on the interim decision |Interim decision | Scheduling proposal
Delegate's final decision
Final decision:
The delegate's final decision is to amend the Schedule 6, Appendix F and index entries of the Poisons Standard for polihexanide as follows:
Schedule 6 - Amend Entry
POLIHEXANIDE except:
- in cosmetic preparations containing 0.3 per cent or less of polihexanide; or
- when packed and labelled for therapeutic use, or
- in other preparations containing 5 per cent or less of polihexanide.
Appendix F, Part 3 - Amend Entry
POLIHEXANIDE
Warning Statement: 28 (Repeated exposure may cause sensitisation).
Safety Directions: 1 (Avoid contact with eyes); 4 (Avoid contact with skin); 8 (Avoid breathing dust (or) vapour (or) spray mist).
Index Entry - Amend Entry
POLIHEXANIDE
cross reference: 1-(diaminomethylidene)-2-hexylguanidine, poly (iminocarbonimidoyliminocarbonimidoyl imino-1,6-hexanediyl), polyhexamethylene biguanide (PHMB)
Schedule 6
Appendix E, Part 2
Appendix F, Part 3
Implementation date: 1 June 2019
The delegate notes the public submissions on the interim decision and agrees that an implementation date of 1 June 2018 is insufficient time to allow for relabelling and re-formulation of affected products. An implementation of 1 June 2019 will allow for any necessary labelling changes.
Reasons:
The delegate notes the public submissions on the interim decision, and confirms that the final decision and reasons for the final decision for polihexanide are identical to the interim decision. However, the implementation date has been amended from 1 June 2018 to 1 June 2019 to allow for any necessary labelling changes.
Public submissions on the interim decision
Two (2) public submissions were received, both in support of the interim decision for polihexanide.
The main points in support were:
- Polihexanide is included in the TGA's Permitted Ingredients list and in the TGA eBS ingredients list; it is allowed as an excipient in over the counter and listed medicines for topical dermal use, in a concentration of 0.3% or less. The Delegate's interim decision to align the Schedule 6 entry with this 0.3% limit will therefore have no impact on the scheduling of therapeutic goods.
- The interim decision is in line with Annex V of the EU Cosmetics Regulation "List of preservatives allowed in cosmetic products" which allows a maximum in-use concentration of 0.3% polihexanide.
- There will be no impact on non-cosmetic preparations as the current 5% exemption for non-cosmetic products is retained.
- Inclusion of synonyms in the index with cross-reference to the polihexanide schedule entry will provide clarity.
Regarding the implementation date:
- There is no evidence that suggests immediate action is required for the risk management of these substances.
- An implementation date of 1 June 2018 is insufficient time to allow for relabelling and re-formulation of affected products. An adequate transition period of at least 12 months (1 June 2019) is requested.
Interim decision
The interim decision for polihexanide was published on the TGA website on 5 February 2018 at Scheduling delegates' interim decisions and invitation for further comment: ACCS/ACMS, November 2017 - 2.3. Polihexanide.
Scheduling proposal
The pre-meeting scheduling proposal for polihexanide was published on the TGA website on 6 September 2017 at Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, November 2017.