Camphor and cineole content of rosemary oil

Sponsors are reminded that rosemary oil contains cineole and camphor, substances included in Schedule 6 of the Standard for the Uniform Scheduling of Drugs and Poisons. A declaration is required from sponsors indicating that products containing rosemary oil have levels of camphor and cineole which fall below that specified in the SUSDP if the product is to be listed. This declaration should be supported by analytical assays included on the Product Specification or Certificate of Analysis for that product.

Sponsors with products containing rosemary oil which have already been listed are advised to ensure that their products comply with the requirements for a listable product. The TGA will be liaising with industry associations to determine appropriate action to be taken to ensure that all products containing rosemary oil presently included in the ARTG are eligible for listing.

Endocrine disruptor chemicals - an emerging health issue

There have been reports that some synthetic chemicals in detergents, plastics, and pesticides could interfere with hormones, particularly sex hormones. These so-called endocrine disruptor chemicals (EDCs) may subtly affect growth and development in animals and humans. So far, there has been no firm evidence of a connection between environmental exposure to such substances and human health effects, including increases in breast and testicular cancers and decreases in male fertility.

In December 1995, in response to growing concerns, the OECD Chemicals Programme instigated a workplan to develop new guidelines for internationally standardised tests for EDCs, and to review and coordinate research and available information.

At recent international meetings, a number of countries pushed the OECD for an expansion of the guidelines development to cover a wider range of endocrine effects. This would significantly expand the scope of the work. Australia believes most concern focuses on the possible effects of chemicals on sex hormones, and that if all endocrine systems are unnecessarily addressed, this may delay the development of more appropriately-targeted OECD tests.

Australia has tried to ensure that only actions supported by sound science are undertaken at an international level, and that the research effort is coordinated.

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Introduction of new edition of sunscreen standard

A new edition of the joint Australian/New Zealand sunscreen standard (AS/NZS 2604:1997) has now been published. It allows a maximum claimable SPF (Sun Protection Factor) of 30+ for sunscreen products marketed in Australia.

The TGA is making arrangements to amend the Therapeutic Goods Regulations to clarify the status of the new edition. However, sponsors may start to market products with an SPF above 15 PROVIDED they first apply to amend the Australian Register of Therapeutic Goods to accurately reflect the product to be supplied, AND the register has been amended accordingly.

For newly formulated products or for those with changes to active ingredients or to the amount of existing active ingredients, a new listing will be required.

For existing products where SPF testing has already confirmed an SPF in excess of 15, and sponsors wish to claim this, there are two options. They can list a new product on the ARTG, or submit a grouping variation application seeking to change the name (as this generally includes the SPF), label, and indications (if appropriate). The first option may be the simplest course of action, as it removes the need to time the submission of the variation application so that no old stock is still being supplied after the new, varied product is approved.

Sponsors of sunscreen products already on the Australian market before the publication date (5 March 1997) of the 1997 edition of AS/NZS 2604 are being allowed two years to amend their products, when necessary, to comply with this latest edition.

Concerns have been expressed that with the ability to claim higher SPFs, products may be formulated which contain active ingredients at concentrations that may increase the risk of adverse effects on consumers. This matter has been considered by the Therapeutic Goods Committee (TGC), which has recommended that concentration limits allowed for sunscreen active ingredients in the United States or the European Union be introduced in Australia. Where there is a conflict between the maximum concentration allowed in these two markets, the TGC has recommended the higher level be allowed in Australia.

Sponsors with products that may be affected by these issues, or wishing to seek clarification on any of these matters, can contact their industry association or the TGA.

Sponsors urged to wait for green light

The TGA has urged sponsors seeking listing of drugs through the Electronic Lodgement Facility (ELF) process to wait for written confirmation before setting the marketing ball in motion.

Under the procedures that have been agreed with industry and introduced for listing drugs on the Australian Register of Therapeutic Goods (ARTG) for supply in Australia, products are accepted on the basis of the sponsor's declaration that they are eligible for listing - provided that the application submitted through the ELF passes the computer validation. A Certificate of Listing is then automatically sent to the sponsor.

TGA staff then check certain key parameters within 10 working days to confirm eligibility for listing. The TGA strongly recommends that sponsors await the written confirmation of eligibility before taking steps to bring their product to market.

There have been cases where sponsors have had final labels printed before receiving this confirmation, then the eligibility check has identified problems which require changes to the label.

In other cases, it seems Section 30 notices identifying problems may not have been received and sponsors have gone ahead to market a product without receiving written confirmation of eligibility. It is suggested that if sponsors have not received advice from the Australian Listed Drug Unit within three weeks of receiving a Certificate of Listing, they contact the unit.

Sponsors requiring more detailed information on the procedures should contact the TGA Information Office for copies of newsletters previously issued by the TGA.

The TGA and chemicals regulation

The TGA is now involved in providing advice on public health and safety aspects of agricultural, veterinary and industrial chemicals. The Chemical Unit which provides this advice has moved to the TGA from the Public Health Division.

The Chemicals and Non-Prescription Drug Branch (CNPDB) and several other government agencies provide advice to the National Registration Authority (NRA) for Agricultural and Veterinary Chemicals and the National Industrial Chemicals Notification & Assessment Scheme (NICNAS).

Most staff involved in chemicals regulation in the CNPDB are based at Woden, but they are expected to move to Symonston soon to join the rest of the branch.

Some of the major activities conducted by the branch are the toxicological assessment of new applications for agvet chemicals and products, including the provision of advice on public health standards such as the Acceptable Daily Intake (ADI); the systematic prioritisation and review of existing chemicals in the NRA's Existing Chemicals Review Program (ECRP); and the participation in international programs, including harmonisation of assessment reports and terminology, aimed at increasing the efficiency of chemicals regulation globally, and pesticide risk reduction.

The branch has recently completed major toxicological reviews on several chemicals (mevinphos, atrazine, and parathion) for the ECRP, with reviews on endosulfan and methyl parathion currently underway, and the data call-in for chemicals in the next round of the Program has begun (chlorpyrifos, diazinon, demeton-s-methyl, chlorfenvinphos, fenitrothion, monocrotophos, dichlorvos). Internationally, the branch has recently finalised a Guidance Document on Analysis and Evaluation of Repeat-Dose Toxicity Studies (with cooperation with the United States and Canada) as part of an OECD project to develop harmonised data reviews; participated as a technical expert in a WHO/IPCS Workshop on Identification of Issues Related to the Harmonization of Quantitative Risk Assessment Endpoints; and, participated as part of the Australian delegation to the recent Intergovernmental Forum on Chemical Safety (IFCS) in Ottawa.

TMEC action

Labelling of herbs containing hydroxyanthracene derivatives

Concerns have been raised about the use of products containing herbs with hydroxyanthracene derivatives - commonly known as anthraquinones - particularly when used other than as laxatives and where there is no warning on the label. (When indicated as laxatives, products containing these ingredients are required to carry a warning).

The Traditional Medicine Evaluation Committee (TMEC) has reviewed the issue of herbs containing hydroxyanthracene (including species of Aloe, Cassia (senna), Rhamnus (buckthorn, cascara, frangula) and Rheum (rhubarb), and recommended that:

• products with total hydroxyanthracene derivatives exceeding 10mg in the maximum daily dose may have a laxative action.
• to ensure safe use, products which include herbs containing hydroxyanthracene derivatives need to carry a warning.

Draft guidelines have been prepared relating to these issues. They outline how the levels of hydroxyanthracene derivatives in herbs may be determined, and what warning statements will apply to these products. The guidelines have been circulated to industry associations for comment. Responses are invited either via your industry representatives, or to the Alternative Medicines Unit directly.

The TGA will advise sponsors when the guidelines are finalised and take effect.