Changes to the TGA sunscreen guidelines and related legislation
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In May 2010, the Therapeutic Goods Administration (TGA) sought comments from interested parties on proposed revisions to the guidelines on sunscreens in Chapter 10 of the Australian Regulatory Guidelines for OTC (over the counter) Medicines 2003 (ARGOM).
A number of submissions were received and these included many helpful comments and suggestions for improvement of the guidelines. The TGA thanks those who prepared these submissions. Almost all of the recommend amendments were able to be made to the draft document.
At the same time as the TGA consultation, the Australian/New Zealand Sunscreen Standard AS/NZS 2604:1998 Sunscreen products - Evaluation and classification was being revised by Standards Australia and Standards New Zealand in consultation with the relevant stakeholders. The TGA decided, therefore, to delay finalisation of the TGA guidelines until the new Standard became available and the Therapeutic Goods Regulations 1990 (the Regulations) had been amended to adopt the new Standard.
The new Standard AS/NZS 2604:2012 was published on 30 May 2012 and is available for purchase from SAI Global.
Changes to the Regulations
Item 7 of Schedule 4, Item 8(g) of Schedule 5 and Item 14 of Schedule 7 of the Regulations have been amended to reference the new Sunscreen Standard AS/NZS 2604:2012 rather than the 1998 version. These amendments to the Regulations came into force on 10 November 2012. From that date, sunscreens to be listed in the Australian Register of Therapeutic Goods (ARTG) must comply with the 2012 Sunscreen Standard.
However, in accordance with the new Regulation 49, products that comply with AS/NZS 2604:1998 and were listed in the ARTG prior to 10 November 2012 may remain listed and lawfully marketed in Australia. Sponsors may make changes to those products (e.g. changes to labels or sites of manufacture) provided those changes do not change the product concerned in a way that makes it a new product requiring a new listing in the ARTG. If a new listing is required, the product will need to comply with AS/NZS 2604:2012.
The Australian regulatory guidelines for sunscreens
The TGA has revised the draft sunscreen guidelines in light of the new Standard and the amended legislation and in consultation with NICNAS, Accord Australasia, Australian Self-Medication Industry Inc (ASMI) and the Advisory Committee on Non-prescription Medicines (ACNM). The finalised document is now published as the Australian regulatory guidelines for sunscreens.
A total of eleven submissions (one confidential and ten non-confidential) were received in response to the consultation carried out in 2010. The non-confidential submissions were received from the following organisations and individuals:
- Consultation submission: Accord Australasia Ltd (pdf,156kb)
- Consultation submission: Antaria Ltd (pdf,37kb)
- Consultation submission: Australian Photobiology Testing Facility (APTF) (pdf,357kb)
- Consultation submission: Australian Self-Medication Industry Inc (ASMI) (pdf,421kb)
- Consultation submission: Cancer Council NSW (pdf,77kb)
- Consultation submission: Cancer Council Victoria (pdf,62kb)
- Consultation submission: Cancer Institute NSW (pdf,125kb)
- Consultation submission: Johnson & Johnson Pacific Pty Ltd (pdf,99kb)
- Consultation submission: Kim E. London (pdf,105kb)
- Consultation submission: Scental Pacific Pty Ltd (pdf,164kb)
TGA responses to submissions
Numerous amendments have been made to the text of the guidelines to address the comments and suggestions received and to improve clarity. Most of these are of an editorial nature designed to improve clarity, consistency and layout. Various changes have also been made throughout the document to bring it into line with the new Standard AS/NZS 2604:2012. The main changes are summarised below.
There was support from stakeholders for the sunscreen guidelines to be taken out of the ARGOM and to be published as a stand-alone document entitled Australian regulatory guidelines for sunscreens. The TGA agreed that this would be appropriate and the final document is stand-alone.
Section 1: Introduction
A summary has been provided of the changes to the Sunscreen Standard and the effects of adoption of AS/NZS 2604:2012 as the legal standard for sunscreens listed in the ARTG.
Section 2: Therapeutic sunscreen or cosmetic sunscreen?
The roles of the TGA, NICNAS and the ACCC in the regulation of sunscreens have been made clearer and a cross-reference to relevant ACCC guidelines has been incorporated.
Section 4: Labelling and advertising
The nature of the allowable sunscreening claims and the acceptability (or otherwise) of non-therapeutic claims that may be made for sunscreens regulated by the TGA have been clarified. The TGA policy on labelling of sunscreens containing nanoparticles and the requirement that advertisements for sunscreens comply with the Therapeutic Goods Advertising Code have been added.
Section 5: Reproducibility of SPF test results
This section has been revised in light of the statistical requirements for SPF testing according to the 2012 Sunscreen Standard.
Section 8 (previously sections 8 and 9): Manufacture and quality control
Section 8 and 9 of the draft Guidelines as published for consultation have been combined under one heading and later sections have been renumbered accordingly. The requirements for the quality control of sunscreen products and the ingredients used in their manufacture have been clarified.
Section 9 (previously section 10): Permitted ingredients
Some submissions included strong and convincing arguments against changing the current Australian Approved Names (AANs) of seven active ingredients as proposed in the consultation document. The TGA has considered and accepted these arguments and will retain the current AANs for those substances. The table of permitted active ingredients has been revised accordingly and rearranged where necessary to list the AANs in alphabetical order.
Section 11 (previously section 12): Glossary of terms and abbreviations
Definitions for the SUSMP and UV filters have been added.