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Review of the policy framework for regulating products at the cosmetic / therapeutic interface
This document was released in May 2004 for comment. It remains on this website as a historical reference.
The following letter was sent to stakeholders on 3 May 2004.
We are writing to seek your involvement in a review of the policy framework for regulating products at the cosmetic / therapeutic interface that is being conducted jointly by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and the Non-prescription Medicines Branch of the Therapeutic Goods Administration (TGA).
The review was commenced in accordance with recommendation 5.4 of the Final report and recommendations for NICNAS Low Regulatory Concern Chemicals Reform Initiative. It is intended to address the interface issues identified in this report as well as separate proposals from the Australian cosmetic industry to the TGA that certain sunscreens should be regulated as cosmetics. It is recognised that any examination of the cosmetic/therapeutic interface is likely to have implications for the regulatory approach for therapeutic products adopted under the joint trans-Tasman regulatory scheme that will commence operation in mid 2005. Therefore, the review will also examine the regulation of certain therapeutic products under the joint agency.
The outcome of the review will be a draft discussion paper that will be open for public comment before a final report is published and a regulatory impact statement prepared. Attachments to this letter give the background to the LRCC reform process (Attachment 1), the current policy framework for regulation of cosmetics and therapeutics in Australia (Attachment 2), the guiding principles for reform that the review will follow (Attachment 3), the terms of reference for the review (Attachment 4) and background details of Mr David Newgreen, the consultant who has been engaged to undertake the review (Attachment 5).
To ascertain the regulatory approach for therapeutic product categories under the trans-Tasman agency, TGA and Medsafe have agreed to use the following inclusive process when initiating consultations on change proposals in relation to their domestic regulation:
- inform the other agency of the consultation
- seek submissions on such proposals from both New Zealand and Australian stakeholder groups
- publish the consultation document on the joint agency project website (www.jtaproject.org)
- involve the joint trans-Tasman project team in the analysis of submissions and development of recommendations arising from the consultation
- progress the recommendations through the interim Ministerial Council for the joint agency as well as the appropriate domestic approval process
Once this consultation is completed, issues relating to the cosmetic/therapeutic interface will be addressed. NICNAS and the TGA have agreed to use the following process when initiating consultations on change proposals in relation to cosmetics regulation:
- inform the other agency of the consultation
- seek submissions on such proposals from relevant stakeholder groups.
In developing options for reform the intention is to undertake an open and consultative process. Preliminary comments can be submitted to firstname.lastname@example.org. The closing date for preliminary comment is 28 May 2004.
We encourage all interested parties from both Australia and New Zealand to engage in this review.
Dr Margaret Hartley
Mr Pio Cesarin
Director, Non-Prescription Medicines Branch
3 May 2004
Background to the LRCC Reform process
The Chemicals and Plastics Action Agenda provided the framework to pursue reform of industrial chemicals regulation (including cosmetics), and in particular, to pursue reform of the Low Regulatory Concern Chemicals (LRCC) category. The Australian Government agreed to consider options to fast track assessment processes to enable industry to access adequately assessed and/or tested chemicals more quickly. In addition, changes in international industrial chemicals management practices provided a further impetus for reform to ensure that Australia was not left behind in the reform process and that industry is able to compete in a global marketplace. Both industry and Government supported the need to pursue reform in this area and gave it a high priority in 2003.
An LRCC Task Force, made up of individuals from government, industry and the community was established to oversee the LRCC initiative and provide expert input where needed. The overall aim of the LRCC reforms was to introduce flexibility and optimise risk-resource allocation in the industrial chemicals assessment process to allow for fast tracking the introduction of chemicals of low risk or previously assessed chemicals without compromising public health, worker safety or environmental standards.
In developing the reform options, NICNAS, through the LRCC Task Force, established a number of technical groups to work on specific issues identified by industry as priority concerns. The Cosmetics Working Group comprised of representatives from industry, the community and Government. This Working Group proposed a range of specific options for reform, which it believed, would be in the best interests of the cosmetics industry as a whole. In addition, the Working Group noted that a large number of the LRCC reform initiatives would also be of benefit for the cosmetics industry.
Extensive stakeholder consultation was undertaken in a variety of formats including: one on one meetings with NICNAS; focus groups; discussions with industry work groups; discussions with key community interest groups; NICNAS formal networks such as its Industry Government Consultative Committee (IGCC); the Memorandum of Understanding (MOU) Group for States and Territories; and NICNAS's Technical Advisory Group (TAG). Special focus group meetings were held for the cosmetics industry in Sydney and Melbourne to discuss the draft recommendations.
The Final Report and Recommendations for NICNAS Low Regulatory Concern Chemicals Reform Initiative (Final Report) and the Implementation Strategy for NICNAS Low Regulatory Concern Chemicals (LRCC) Reform Initiative (Implementation Strategy) were published in June 2003 and July 2003, respectively. They are available from the NICNAS website at www.nicnas.gov.au.
Recommendation 5.4 of the LRCC Task Force Final Report was: "Recognising that negotiations are ongoing between industry and the TGA, the LRCC Task Force recommends that the Parliamentary Secretary asks NICNAS and the TGA to examine the reform options for addressing the interface issues, in particular issues dealing with antiperspirants, mass market antidandruff shampoos, moisturisers with SPF, antibacterial skin washes and anti-acne cleansers".
Following passage of the legislation through Parliament later this year, NICNAS will sequentially introduce the low concern notification and assessment categories.
Current policy framework for cosmetics and therapeutics
NICNAS regulates cosmetic products under Industrial Chemicals (Notification and Assessment) Act 1989. Packaging and labelling of cosmetic products is governed by the Trade Practices Act 1974, and the Trade Practices (Consumer Product Information Standards)(Cosmetics) Regulations, administered and enforced by the Australian Competition and Consumer Commission (ACCC). In addition, state/territory poisons and occupational health and safety legislation may also apply to cosmetic products.
Cosmetic products that make therapeutic claims are regulated by the TGA in accordance with the Therapeutic Goods Act 1989.
Products are classified as 'therapeutic goods' based on two factors; the product claims and its composition. The key consideration for classification is its proposed claim(s). A claim can be a word, a sentence, a paragraph or an implication on product labels, package inserts or advertisements.
The "Cosmetic Claims Guidelines" prepared by the National Coordinating Committee on Therapeutic Goods (NCCTG) provides guidance on acceptable and unacceptable cosmetic claims. Although the composition of a product alone does not determine its classification, it is possible that an ingredient, or the concentration of an ingredient, may make the product unsuitable for sale as a cosmetic. For example, where an ingredient is a scheduled substance in accordance with the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP).
Guiding principles for reform of the regulation of products at the cosmetic-therapeutic interface
The Therapeutic Goods Administration, through its NICNAS and Non-prescription Medicines regulators, is undertaking a review of the regulation of products at the interface between cosmetics and medicines. The review was commenced in response to recommendation 5.4 of the Final report and recommendations for NICNAS low regulatory concern chemicals (LRCC) reform initiative (June 2003).
The outcomes of this review may include recommendations for reform of the regulation of products at the cosmetic-therapeutic interface. Where this is the case, the following principles will apply.
- The primary consideration will be to maintain and enhance the protection of public health, safety and environmental standards, consistent with the objectives of the Therapeutic Goods Act 1989, the National strategy for the quality use of medicines, the Industrial Chemicals (Notification and Assessment) Act 1989 and the Trade Practices Consumer Product Information Standards (Cosmetics) Regulations 1991.
- Regulatory reform will be undertaken in accordance with 1997 Council of Australian Government (COAG) principles and guidelines.
- Regulatory reform must be consistent with the Agreement between the government of Australia and the government of New Zealand for the establishment of a joint scheme for the regulation of therapeutic products.
- Cost-recovery is Australian Government policy for medicines and chemicals.
- Government and industry acknowledge the need for a national approach to ecologically sustainable chemicals management and regulation.
- There will be no automatic listing ("grand-fathering") of unassessed chemicals onto the Australian Inventory of Chemical Substances (AICS) or the Australian Register of Therapeutic Goods (ARTG).
Terms of Reference for the Review
- Review the appropriateness of current legislation and guidelines in the regulation of products at the interface incorporating:
- A summary of the current Australian and New Zealand regulatory frameworks (including Commonwealth and State schemes);
- A summary, discussion and comparison of these regulatory frameworks with those in the USA, Canada and Europe;
- Identification of any 'grey areas' in the current regulatory frameworks;
- A review of the current Australian and New Zealand systems for the regulation of the following product categories to determine whether they would be most appropriately regulated as medicines through the joint regulatory scheme for therapeutic products or separately as cosmetics in Australia and New Zealand:
- mass market antidandruff shampoos;
- sunscreens (including moisturisers containing a sunscreen);
- antibacterial skin washes;
- antibacterial skin cleansers (anti-acne products);
- toothpastes and mouthwashes; and
- any other product categories that may be candidates for reform.
- Recommendations on changes that could improve regulation at the interface for product categories listed above, including changes that could enhance the transparency and useability of regulatory documents such as the 'Cosmetic Claims Guidelines'.
- Consultation with stakeholders including:
- The Therapeutic Goods Administration - Non-prescription Medicines Branch and NICNAS;
- The Australian Competition and Consumer Commission (ACCC);
- The Cosmetic, Toiletry and Fragrance Association of Australia (CTFA);
- The Cosmetic, Toiletry and Fragrance Association of New Zealand;
- The Australian Consumer & Specialty Products Association (ACSPA);
- The Australian Self-Medication Industry (ASMI);
- Australian Society of Cosmetic Chemists (ASCC)
- The New Zealand Self Medication Industry
- The Consumer Health Forum;
- Medsafe (New Zealand);
- Medicines Evaluation Committee;
- Complementary Medicines Evaluation Committee
- State and Territory governments;
- National Coordinating Committee on Therapeutic Goods (NCCTG).
Mr David Newgreen
David Newgreen BPharm, MBA, FPS is presently employed as Project Pharmacist with the Pharmacy Board of Victoria and has been a member of the Medicines Evaluation Committee since 1998. He lectures in forensic pharmacy at Monash and La Trobe, Bendigo universities.
He was formerly Pharmaceutical Advisor in the Department of Human Services (Victoria) and was the Victorian representative on the National Coordinating Committee on Therapeutic Goods. During that time, he was in charge of the Department's therapeutic goods unit.
Mr Newgreen was director of drug information services for Victoria's mental health services and began the psychotropic drugs newsletter, Pharmabulletin. He has published papers on pharmacy law and on psychotropic drugs.
He was President of the Pharmaceutical Society of Australia (Victorian Branch) from 1987 to 1989 and was a consultant to the Directorate of Army Health Services.