EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2009 (No. 6)
Chlorella vulgaris
Section 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2009 (No. 6) (the Listing Notice) is a notice made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act).
The Listing Notice has the effect of permitting the use of Chlorella vulgaris as an active ingredient in Listed medicines for oral use.
The Listing Notice commenced on the day after it was registered on the Federal Register of Legislative Instruments (FRLI).
BACKGROUND
The Act provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.
Unless specifically exempted or authorised under the Act, therapeutic goods are required to be included in the Australian Register of Therapeutic Goods (the ARTG) before being supplied in, imported into, manufactured in or exported from Australia (sections 19B and 19D of the Act). Medicines are Registered or Listed in the ARTG, depending on the ingredients they contain and the therapeutic claims that are being made.
In Australia, products that contain low risk ingredients are referred to as Listed medicines. Most Listed medicines are considered to be of relatively low risk compared to other types of medicines, such as prescription and over-the-counter medicines, as they may only contain ingredients that have been approved by the TGA as being of low risk and may only make limited therapeutic claims.
Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out those therapeutic goods that are required to be included in the part of the ARTG for Listed medicines. At present, Schedule 4 of the Regulations does not include a reference to Chlorella vulgaris but it is anticipated that it will when the Regulations are next amended.
In order to facilitate the timely approval of new listable therapeutic goods, subsection 9A(5) of the Act allows the Minister for Health to publish a Listing Notice that has the effect of permitting the use of particular therapeutic goods in Listed medicines subject to any specified conditions.
Pursuant to subsection 9A(6) of the Act, if Schedule 4 of the Regulations is amended to include reference to a substance that has been the subject of a Listing Notice, that Listing notice ceases to have effect.
Chlorella vulgaris
Chlorella vulgaris is a single-celled, freshwater green alga, which contains significant amounts of protein, chlorophyll, lipid, carbohydrates, fibre, nucleic acids, vitamins and minerals. Chlorella also contains large amounts of long-chain polyunsaturated fatty acids (PUFA), including linoleic acid (omega 6) and alpha linolenic acid (omega 3). PUFAs are believed to have positive effects on the cardiovascular system.
Orally, chlorella is used as a food supplement and source of nutrients. It is widely sold in Australia and New Zealand as a nutritional supplement and is available as tablets, liquid extracts, capsules or in powder form in health shops, pharmacies and over the Internet. Chlorella has no typical dosage.
Similar to other algal species, Chlorella vulgaris contains iodine as a naturally occurring component. In Listed medicines for oral use, the recommended daily dose must contain less than 300 micrograms of iodine.
The Complementary Medicines Evaluation Committee (CMEC) is a statutory committee established under subsection 52G(1) of the Act which gives scientific and policy advice to the Minister for Health and the Secretary to the Department of Health and Ageing regarding controls on the supply and use of complementary Listed medicines, with particular reference to the safety and quality of products and, where appropriate, efficacy relating to the claims made for products.
The CMEC considered Chlorella pyrenoidosa at its meeting in June 2002. The Office of Complementary Medicines (OCM) presented a brief safety review on Chlorella pyrenoidosa and advised members of its intention to change the regulatory status of this ingredient from a listable excipient to a listable active. At that time, there had been no reports of adverse effects related to chlorella in the Australian database. The CMEC noted the OCM’s intention regarding this ingredient.
In the process of finalising approval for Chlorella pyrenoidosa for Listable ingredient status, it became apparent to the TGA that the taxonomy of chlorella had changed. According to the University of Texas at Austin algae database, Chlorella pyrenoidosa no longer existed as a strain itself. The database noted that other “valid” strains had been incorrectly known as Chlorella pyrenoidosa (e.g. Chlorella vulgaris).
The Herbal Ingredient Naming Committee (HINC), an informal, internal committee of the TGA comprised of relevantly qualified TGA employees, considered the correct naming of the substance on the 28 June 2006. The HINC recommended that the name of the substance be changed from the incorrect herbal name Chlorella pyrenoidosa to the correct herbal name of Chlorella vulgaris.
The delegate of the Minister made the Listing Notice, a legislative instrument for the purposes of the Legislative Instrument Act 2003, to provide for Chlorella vulgaris to be used as an active ingredient in oral Listed medicines, subject to the condition that the recommended daily dose must contain less than 300 micrograms of iodine.
Draft Compositional Guidelines are prepared by the TGA and intended to set out the standards and requirements for the specific forms or types of substances for use in Listed medicines where there is no monograph in the British Pharmacopoeia or other acceptable monograph.
The TGA has prepared draft Compositional Guidelines in relation to Chlorella vulgaris, and these will be available on the TGA’s Internet site (www.tga.gov.au) for consultation for six months following the registration of the Listing Notice on the FRLI.
CONSULTATION
Although the listing of the ingredient Chlorella vulgaris is minor and machinery in nature, the CMEC was consulted during the approval process for this ingredient.
REGULATION IMPACT STATEMENT
No Regulation Impact Statement is necessary in relation to the Listing Notice as the Listing of the ingredient Chlorella vulgaris is minor and machinery in nature with no or low compliance costs and impact on business, individuals or the economy.