Therapeutic Goods Order No. 67 - Standard for Dental Materials (23/02/2001)

Overview

The Therapeutic Goods Order No. 67, which was enacted under section 10 of the Therapeutic Goods Act 1989, establishes a standard for dental materials used in therapeutic goods in Australia. This legislation was introduced to address the need for consistent and high-quality dental materials, ensuring they meet safety and efficacy standards. The Therapeutic Goods Order was prepared by the Office of Legislative Drafting and Publishing, Attorney-General’s Department, and was signed by a delegate of the Minister for Health and Aged Care. The primary objective of this Order is to revoke the previous Therapeutic Goods Order No. 57 “Dental Materials” and to set new standards that align with International Organisation for Standardisation (ISO) standards for various dental materials, with specific modifications to marking requirements. The Order aims to provide clear guidelines for the safety and quality of dental materials used in Australia, thereby protecting public health.

Scope and Application

The Therapeutic Goods Order No. 67, as amended, pertains to the standards for dental materials in Australia and is made under section 10 of the Therapeutic Goods Act 1989. This legislation applies to various dental materials, including alloys for dental amalgam, dental mercury, dental root canal sealing materials, dental zinc oxide/eugenol cements and zinc oxide non-eugenol cements, dental resin-based pit and fissure sealants, and polymer-based filling, restoration, and luting materials. The scope of the Order is broad, encompassing the entire Commonwealth of Australia, and it mandates that specific International Standards set by the International Organisation for Standardisation (ISO) apply to the listed dental materials. These standards ensure that the therapeutic goods meet required safety and quality criteria. Notably, the Order revokes the previous Therapeutic Goods Order No. 57 and incorporates modifications to certain clauses to align with the General Requirements for Labels for Therapeutic Devices. The application of this Order is comprehensive, affecting entities and persons involved in the manufacture, supply, and importation of dental materials within Australia. The Order, through its amendments, seeks to maintain and update the standards to reflect advancements in dental technology and materials science.

Key Provisions

The Therapeutic Goods Order No. 67, made under section 10 of the Therapeutic Goods Act 1989, sets the standards for dental materials. It revokes the previous Therapeutic Goods Order No. 57 "Dental Materials" and establishes new standards based on the International Organisation for Standardisation (ISO) standards. Specifically, it adopts various ISO standards for different types of dental materials (sections 2(a) and Schedule). For water-based dental cements, it adopts ISO 9917:1991 and ISO 9917-2:1998 but modifies their marking requirements to align with the Therapeutic Goods Order No. 37 General Requirements for Labels for Therapeutic Devices (section 2(b)). This order came into effect on the date of its gazette publication. The Therapeutic Goods Order No. 67 imposes obligations on entities involved in the manufacture, supply, or distribution of dental materials in Australia. Manufacturers must ensure their products meet the specified ISO standards or the modified requirements for water-based dental cements. Suppliers and distributors must also comply by ensuring that the materials they handle adhere to these standards. Compliance is evidenced through proper labelling and documentation as per the specified standards. Failure to comply with the standards set out in the Therapeutic Goods Order No. 67 can lead to significant legal consequences. The Therapeutic Goods Act 1989 provides for both civil and criminal penalties for breaches. Civil penalties can include fines, with the exact amount determined by the court. Criminal penalties may apply for more serious breaches, such as knowingly supplying non-compliant therapeutic goods, with potential fines and imprisonment terms as stipulated by the Therapeutic Goods Act 1989. These penalties underscore the importance of adherence to the standards to ensure the safety and efficacy of dental materials in Australia.