 Background
Naming and characterisation ambiguities associated with metal amino acid chelates was originally discussed at the Interim Joint Expert Advisory Committee on Complementary Medicines (IJEACCM) (20-21 July 2006), as part of the Permitted Ingredients List (PIL) Project. A list of ingredients for review was identified as part of this project. The TGA has since engaged in extensive pre consultation with the OCM/Industry Consultation Group (OICG) regarding the chelate ingredient names. Identification of the ingredients most relevant to the Australian market was provided by industry via the Complementary Healthcare Council of Australia and Australian Self-Medication Industry. New ingredient names available for metal amino acid chelates20 specific Australian Approved Names (AANs) for metal amino acid chelates have been made available for use in the Electronic Listing Facility (ELF). The new names have been added to allow sponsors to identify ingredients more accurately. The ingredient names in ELF include the approved name and molecular formula for each ingredient. The associated ingredient rules are consistent with the chelate names in Part 3 of Schedule 4 to the Therapeutic Goods Regulations 1990. That is, the relevant mineral is a mandatory component and the purpose for use for all metal amino acid chelates is restricted to mineral supplementation. In addition, the TGA would like to clarify that the availability of new specific names for metal amino acid chelates for use in listing a medicine on the Australian Register of Therapeutic Goods is not an approval of new ingredients for use in listed medicines. The new ingredient names are based on metal and amino acid components that are themselves already eligible and available for use in listed medicines. Generation of compositional guidelines and listing notices for gazettal of new ingredients is not required. The reference for all the new metal amino acid chelate names is 'TGA 2011'. In the absence of an easily accessible document for the reference, the molecular formula and structure, and the Chemical Abstracts Service (CAS) Registry number (where it exists), are the best way for sponsors to check whether a substance matches a particular AAN (see table below). The limits for the metal content are also provided in the table below. In the absence of a standard (Therapeutic Goods Order or a monograph), the TGA considers these assay limits acceptable for each substance.
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