The TGA have provided an extension to the closing date for the Permissible Ingredients Determination low-negligible risk consultation. The consultation closing date is now 29 September 2021. Please note, this updated date is reflected in the Consultation Hub, but will not be reflected on the TGA web page. The date on the Consultation Hub is the correct date.
The changes proposed in the consultation changes relate to:
- Peripheral neuropathy associated with lower dose vitamin B6 - a proposed reduction of maximum daily intake from 200mg/day to 50mg/day; and extension of a warning statement for products providing between 10-50mg of equivalent pyridoxine.
- Artemisinin and pregnancy risk - proposed new label requirements for Artemisinin containing products, which may also affect products that have DAVANA OIL in a flavour or fragrance. These changes are proposed as part of the ongoing review of Artemisinin containing medicines and pregnancy risk by the TGA. If you sell DAVAN OIL in any format or in a fragrance or flavour , please contact email@example.com.
- Allergen Statement for mollusc derived ingredients - proposal for ingredients on the Permissible Ingredients Determination that are derived from a marine mollusc (substances derived from squid, oyster, green lipped mussel or homeopathic sepia) be updated to include the warning statement :Contains mollusc" or "Contains mollusc products", in alignment with FSANZ Plain English Allergen labelling (PEAL) reforms. it differentiates mollusc as an allergen from crustacea and fish allergens. if this change is made to mollusc ingredients in March 2022 as proposed, this statement would replace the existing requirements to include "Derived from seafood" from that point forward. Sponsors would have until March 2023 to transition existing listed products to include the new mollusc warning.
Mollusc warning note: CMA provisionally supports the change to the mollusc warning statement and also consider that this particular change is likely to be inevitable due to the necessary alignment with FSANZ PEAL best practice allergen reforms. As there is only a 12 months transition (March 2022 to March 2023), CMA has sought clarification from the TGA as to whether products who wish to transition between now and March 2022 (before the Determination is updated) may choose to include both the statements “Derived from Seafood” as currently required AND “Contains mollusc” as proposed to be required from March 2022 - the TGA have responded that they do not hold a compliance concern about the use of both statements on the label.
This provides an avenue for sponsors who may wish to transition products early if they are due for their next label run between now and when a final decision is made and implemented into the 26BB Determination in March 2022.