Therapeutic Goods (Listing) Notice 2012 (No. 5)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L00015 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

THERAPEUTIC GOODS (LISTING) NOTICE 2012 (NO. 5)

Caffeine

 

Subsection 9A(5), Therapeutic Goods Act 1989

 

OUTLINE

Therapeutic Goods (Listing) Notice 2012 (No. 5) (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 requiring that therapeutic goods that contain ‘caffeine’ as a therapeutically active ingredient and that are presented as oral preparations, subject to certain conditions, be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods.

 

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 on the Register before being supplied in, imported into, manufactured in or exported from Australia (sections 19B and 19D of the Act).  Medicines are registered or listed on the Register, depending on the ingredients they contain and the therapeutic claims that are being made.

 

In general, products that contain low risk ingredients are referred to as listed medicines in Australia.  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.

 

Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990 (the Regulations) sets out those therapeutic goods that are required to be included in the part of the Register for listed goods.  Part 1 of Schedule 4 does not currently include goods that are oral presentations containing ‘caffeine’ as a therapeutically active ingredient.

 

Subsection 9A(5) of the Act authorises the Minister for Health to publish a notice in the Commonwealth of Australia Gazette requiring that specified goods be included in the part of the Register for listed goods.  Such notices generally require that goods containing particular ingredients be included in that part of the Register.  Once the notice is in effect, persons may apply for the listing on the Register of new therapeutic goods that contain ingredients or substances of the kind set out in the notice.

 

If Part 1 of Schedule 4 to the Regulations is amended to require goods that are the subject of a subsection 9A(5) notice to be included in the part of the Register for listed goods, the notice ceases to have effect (subsection 9A(6) of the Act).

 

A person can apply for a new ingredient or substance to be specified in a notice under subsection 9A(5).  The TGA evaluates such applications, and the supporting data provided by the applicant, on the basis of safety and quality.  The safety-focussed element determines whether the ingredient or substance is of sufficiently low risk to allow its inclusion in listed medicines, and the quality-focussed element characterises the precise and correct nature of the ingredient or substance.

 

CAFFEINE

 

Caffeine is a natural constituent of foods such as tea, coffee and chocolate, which are available throughout the world.  In Australia, caffeine is present in many herbs currently used in listed medicines, and also as an ingredient in some registered medicines.

 

Australian adults have been estimated to have an average caffeine intake of approximately 232 mg/person/day from all sources.  The use of caffeine specifically as an active ingredient at a daily dose of 100 mg or less in oral listed medicines, for the adult population, would not be expected to add significantly to its current acceptable level of intake as a food component or medicine component and hence is not considered to raise any additional safety concerns.

 

One of the conditions on the use of purified caffeine in oral listed medicines is that it may only be formulated in a medicine that contains complementary medicine active ingredients. These ingredients are described in Schedule 14 to the Regulations.

 

The quality of caffeine is assured by mandatory compliance with the monograph in either the British Pharmacopeia or the United States Pharmacopeia.

 

To that end, the delegate of the Minister has determined that therapeutic goods containing caffeine as a therapeutically active ingredient be included in the part of the Register for listed goods, when such goods are oral preparations, when the preparations contain not more than 100 mg of the active ingredient ‘caffeine’ per daily dose (this condition will not apply to overall caffeine levels, as other ingredients in a relevant listed medicine may also contain caffeine), are for use in adults only and are restricted to products consisting principally of one or more designated active ingredients prescribed in Schedule 14 to the Regulations. 

 

CONSULTATION

 

Consultation was not undertaken in relation to the making of the Listing Notice, as the notice is considered to be minor and machinery in nature, with low compliance costs for affected industry.

 

The effect of this Listing Notice is that sponsors wishing to use caffeine in the formulation of a medicine can list the medicine on the Register rather than registering that medicine.  Applications for new registered medicines are fully evaluated by the TGA for quality, safety and efficacy prior to inclusion on the Register, a process that is considerably more expensive and lengthy than the listing process.

 

The Office of Best Practice Regulation (OBPR) has confirmed that a regulatory impact statement was not required in relation to the Listing Notice (OBPR ref. 14416).

 

In relation to compatibility with human rights, it is considered that the Listing Notice is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011, and a Statement of Compatibility setting that out in further detail is attached.

 

ATTACHMENTS

 

1.  Statement of compatibility for a legislative instrument that does not raise any human rights issues (Therapeutic Goods (Listing) Notice 2012 (No.5) – Caffeine).

 

Overview

The Therapeutic Goods (Listing) Notice 2012 (No. 5) was enacted to address a gap in the Australian Register of Therapeutic Goods (ARTG) concerning oral preparations containing caffeine as a therapeutically active ingredient. This notice, made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989, mandates that such goods be included in the ARTG for listed goods, subject to specific conditions. The primary policy objective is to streamline the process for listing these relatively low-risk products, reducing the burden on the industry while maintaining stringent safety and quality standards. This legislative measure allows for a more efficient pathway for the inclusion of these products in the ARTG by listing rather than requiring full registration, thereby facilitating timely access to therapeutic goods containing low-risk levels of caffeine.

Scope and Application

The Therapeutic Goods (Listing) Notice 2012 (No. 5) applies to therapeutic goods containing caffeine as a therapeutically active ingredient, specifically those presented as oral preparations. The notice mandates that such products must be included in the part of the Australian Register of Therapeutic Goods (the Register) designated for listed goods, subject to specific conditions. This applies to the national level in Australia, as the Therapeutic Goods Act 1989 establishes a national system for the control of therapeutic goods. The notice specifies that these oral preparations must contain no more than 100 mg of caffeine per daily dose and be for use by adults only, with the additional restriction that they must consist principally of one or more designated active ingredients prescribed in Schedule 14 to the Therapeutic Goods Regulations 1990. The Listing Notice does not explicitly state any exclusions but implies that therapeutic goods not meeting these criteria are not subject to its requirements. The application of this notice can be extended or restricted through subordinate instruments, but the primary legislation and the notice itself provide the foundational criteria.

Key Provisions

The Therapeutic Goods (Listing) Notice 2012 (No. 5) (the Listing Notice) mandates that oral therapeutic goods containing caffeine as a therapeutically active ingredient be included in the Australian Register of Therapeutic Goods (the Register) for listed goods (section 1). This inclusion applies to products that meet certain conditions, including the limitation that the daily dose of caffeine must not exceed 100 mg (section 1). The Listing Notice, made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act), was registered on the Federal Register of Legislative Instruments and commenced the day after registration (section 1). The Act itself establishes and maintains a national system of controls for the quality, safety, efficacy, and timely availability of therapeutic goods used in or exported from Australia (section 2). Therapeutic goods must be included on the Register unless they are specifically exempted or authorised under the Act (sections 19B and 19D of the Act). The Therapeutic Goods Administration (TGA) is responsible for administering the Act and ensuring compliance (section 2). The Listing Notice imposes several obligations and requirements on the parties or entities it governs. Sponsors wishing to use caffeine in the formulation of a medicine can list the medicine on the Register instead of registering it (section 1). This listing process is less extensive and less costly than the registration process, which involves a full evaluation by the TGA for quality, safety, and efficacy (section 1). The Listing Notice specifies that the therapeutic goods must contain not more than 100 mg of caffeine per daily dose (section 1). Additionally, these goods must be restricted to products consisting principally of one or more designated active ingredients prescribed in Schedule 14 to the Therapeutic Goods Regulations 1990 (the Regulations) and must be for use in adults only (section 1). The quality of caffeine must comply with the monograph in either the British Pharmacopeia or the United States Pharmacopeia (section 1). The Listing Notice does not explicitly state specific offences, penalties, or consequences for breach. However, failure to comply with the requirements of the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990 could result in regulatory actions by the TGA. This may include enforcement actions, such as product recalls, fines, or other administrative penalties for non-compliance with listing or registration requirements (section 2). Additionally, supplying therapeutic goods that do not comply with the Act or the Regulations could lead to criminal charges and penalties, which may include substantial fines and imprisonment (section 19E of the Act). The specific penalties for breach would depend on the nature and severity of the non-compliance and would be determined in accordance with the relevant provisions of the Act and Regulations.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.