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The Australian regulatory guidelines for sunscreens (ARGS) have been developed to provide guidance to sponsors and manufacturers, and to assist in the understanding of the regulatory requirements for sunscreens in Australia.
The Australian regulatory guidelines for sunscreens includes information about:
The TGA developed these guidelines in consultation with NICNAS, Accord Australasia, Australian Self-Medication Industry Inc (ASMI) and the Advisory Committee on Non-prescription Medicines (ACNM). A public consultation was also conducted.
The ARGS replaces Chapter 10 'Sunscreens' in the Australian regulatory guidelines for OTC medicines (ARGOM).
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These Guidelines replace Chapter 10, 'Sunscreens', in the Australian Regulatory Guidelines for OTC Medicines (ARGOM) published in 2003. They have been produced by the Therapeutic Goods Administration (TGA) in consultation with the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and the pharmaceutical and cosmetics industries.
The first draft of these Guidelines was published on the TGA web site in May-June 2010 for stakeholder and public consultation. The preparation of the finalised Guidelines has taken into account the comments received as a result of the consultation and also the changes to the Australian and New Zealand Sunscreen Standard (see below).
These Guidelines describe the regulatory requirements and standards for sunscreens and their ingredients in Australia as at the date of publication.
Many of the terms, such as therapeutic sunscreen, cosmetic, cosmetic sunscreen, primary sunscreen, secondary sunscreen, sun protection factor (SPF) referred to in these Guidelines are defined in section 11 'Glossary of terms and abbreviations'.
The legislation (Acts and regulations), standards and other relevant regulatory documents (Therapeutic Goods Orders, codes, etc.), referred to in these Guidelines are listed along with their sources in section 12 'Bibliography' at the end of the document. Sunscreens classified as therapeutic goods are, unless exempt, required to be included in the Australian Register of Therapeutic Goods (ARTG) maintained by the TGA before they can legally be marketed in Australia. To be listed, sunscreens must comply with the Australian and New Zealand Sunscreen Standard AS/NZS 2604 Sunscreen products-Evaluation and classification in force at the time of listing.
A new Australian and New Zealand Sunscreen Standard, AS/NZS 2604:2012 which replaces the previous Standard AS/NZS 2604:1998 has been developed by the Standards Australia and Standards New Zealand in consultation with stakeholders and the public. This was published on 30 May 2012. The Standard and the International Standards Organisation (ISO) standards to which it refers are available for purchase from SAI Global through its web site.
AS/NZS 2604:2012 includes the following significant changes from the previous Standard:
In recognition of this new Standard, Item 7 of Part 1 of Schedule 4, Item 8(g) of Schedule 5, and Item 14 of Schedule 7 of the Therapeutic Goods Regulations 1990 (the Regulations) have been amended to require sunscreens products listed in the ARTG as from 10 November 2012 to comply with AS/NZS 2604:2012 rather than AS/NZS 2604:1998.
However, regulation 49 of the Regulations allows products listed prior to that date (that come within Item 7 of part 1 of Schedule 4 or are able to be marketed in Australia because they are exempt under Item 8(g) of Schedule 5 of the Regulations) to continue to comply with AS/NZS 2604:1998.
Sponsors may make changes to those products (for example, changes to labels or sites of manufacture) provided the changes do not make the product a new product requiring a new listing in the ARTG.
A proposed change to a product will create a new product if it is of the kind referred to in s.16(1A) of the Act (different active ingredients, different quantities of active ingredients or different dosage form) or in regulation 11 of the Regulations (different name, different indications, different excipient or changes are made to or in relation to any restricted ingredients).
If a new listing is required because of such a change, the product concerned will need to comply fully with AS/NZS 2604:2012.
At the time the 2012 guidelines were published the majority of sunscreens listed in the ARTG carried claims of SPF30+ and provided broad spectrum protection.
An SPF30+ sunscreen may have originally produced an SPF test of 40 or higher and, therefore, could potentially carry a claim of SPF 40, SPF 50 or SPF 50+ allowed under AS/NZS 2604:2012. In most cases the SPF test results (and water resistance test, if relevant) obtained previously would have complied with the statistical requirements of AS/NZS 2604:2012 and retesting for these parameters would not be necessary. Any such product would, however, need to be retested according to AS/NZS 2604:2012 and ISO 24443:2012 for compliance with the requirements for 'broad spectrum' performance. If any such product passed the broad spectrum test, the product could be renamed and relabelled accordingly in compliance with AS/NZS 2604:2012. Prior to release into the Australian market it would need to be relisted in the ARTG as a new product with a new AUST L number.
If, on the other hand, the product failed the broad spectrum test in AS/NZS 2604:2012, it may be possible for it to be reformulated (for example, by adjusting the quantities of the active ingredients within the allowed limits or adding other approved active ingredients) in order to pass the test. The reformulated product would then need to be retested for SPF (and water resistance, if relevant), renamed and relabelled in full compliance with AS/NZS 2604:2012 and these Guidelines, and listed in the ARTG as a new product with a new AUST L number. Depending upon the degree of reformulation required, new stability data may also need to be generated to support the shelf life claimed for the reformulated product.
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For the purpose of these Guidelines, sunscreens that are regulated as therapeutic goods under the Act and the Regulations and are not classified and regulated as cosmetics (see subsection 2.2) are referred to as 'therapeutic sunscreens'. Included in this category are:
Some products contain an ingredient with sunscreening properties but the primary purpose of the product is neither sunscreening nor therapeutic. These products are regulated as cosmetics by the National Industrial Chemicals Notification & Assessment Scheme (NICNAS) rather than by the TGA as therapeutic goods. In accordance with the Therapeutic Goods (Excluded Goods) Order No. 1 of 2011, these products are not regulated under the Therapeutic Goods legislation and are not required to be included in the ARTG. For the purpose of these Guidelines such products are called 'cosmetic sunscreens'. They may also be referred to as 'excluded' sunscreens.
A cosmetic sunscreen product must meet the definition of a cosmetic under the Industrial Chemicals (Notification and Assessment) Act 1989 and any requirements set out in the current Cosmetics Standard and NICNAS Cosmetics Guidelines. Requests for regulatory information and enquiries about cosmetic products should be directed to NICNAS.
Section 5 of the Industrial Chemicals (Notification and Assessment) Act 1989 defines a cosmetic as follows:
The current Cosmetics Standard and the associated NICNAS Cosmetics Guidelines should be consulted for guidance on the conditions applying to the following secondary sunscreen products for them to be regulated as cosmetics rather than therapeutic goods:
The Cosmetics Standard and NICNAS Cosmetics Guidelines include specific requirements regarding the presentation and labelling of cosmetic sunscreen products. Sponsors are responsible for ensuring that such products comply with those requirements. Failure to comply with those requirements may make the product concerned a therapeutic good that must be listed or registered in the ARTG.
Other mandatory requirements applying to the labelling of all cosmetic products are set out in Cosmetic & toiletries ingredient labelling published by the Australian Competition & Consumer Commission (ACCC).
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Most therapeutic sunscreens marketed in Australia are currently defined as 'listable' therapeutic goods which means that they must be 'listed' in the ARTG. Other sunscreen products must be 'registered' in the ARTG, while others are exempt from registration or listing (see below). General information on listing and registration of therapeutic goods is available on the TGA Internet site. The current regulation of the various categories of sunscreens is summarised in Table 1 and explained in the text that follows.
| Product category | Sub-category | Currently regulated by: |
|---|---|---|
| Listable sunscreens |
|
Listing in the ARTG under s.26A of the Act |
| Registrable sunscreens |
Sunscreens that make therapeutic claims other than sunscreening and/or reduction of risk of skin cancer, solar keratosis, sunspots or premature ageing. (See subsection 3.3) |
Registration in the ARTG under s.25 of the Act |
| Exempt sunscreens |
Primary sunscreens with an SPF less than 4 and not containing ingredients of human or animal origin. |
Exempt from the requirement of listing or registration in the ARTG |
|
Cosmetic sunscreens (Excluded sunscreens) |
Some secondary sunscreens that are excluded from regulation by the TGA but meet the definition of a cosmetic. (See subsection 2.2) |
Regulated by NICNAS and the ACCC as cosmetics and not regulated under the Act |
A therapeutic sunscreen product is 'exempt' under Item 8(g) of Schedule 5 of the Regulations if:
Exempt therapeutic sunscreens do not require registration or listing in the ARTG, but are treated as therapeutic goods in all other respects and must comply with all relevant parts of the Therapeutic Goods legislation, including relevant standards such as the Labelling Order (Therapeutic Goods Order No. 69, and amendments) and the Therapeutic Goods Advertising Code.
The majority of therapeutic sunscreen products require listing in the ARTG in accordance with Item 7 of Part 1 of Schedule 4 of the Regulations.
Information on the listing process using the TGA's Electronic Listing Facility (ELF) and details of what information needs to be provided for listed products are provided in the Electronic Listing Facility (ELF) User Guide.
Under Item 7 of Part 1 of Schedule 4 of the Regulations, sunscreen products are eligible for listing where they come within the following description:
The SPF of therapeutic sunscreens must be determined by testing on human skin in accordance with the sunscreen standard AS/NZS 2604:2012 which references the International Organisation for Standardisation procedure ISO 24444:2010 Cosmetics - Sun Protection test methods - In vivo determination of SPF (Sun Protection Factor).
Note that, where in vivo SPF test results have been produced using the US FDA static SPF test procedure described in FDA Sunscreen Drug Products for OTC Human Use: Final Monograph, the individual SPF results may be used to calculate the mean SPF and the label SPF provided they meet the statistical criteria set out in ISO 24444:2010 as referenced in AS/NZS 2604:2012.
Therapeutic sunscreen products may only contain active sunscreening ingredients that are included in the list of sunscreening agents permitted as active ingredients in therapeutic sunscreens (see subsection 9.1) and are within the maximum concentrations stated in the list.
Sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure that the finished product is safe for its intended purpose.
Sunscreen products that make therapeutic claims other than sunscreening (for example, reduction of free radicals in or below the skin, or claims relating to reduction of UV induced immune suppression) and/or contain active therapeutic ingredients that are not included in the list of sunscreening agents permitted as active ingredients (see subsection 9.1) are not 'listable sunscreen preparations' and must be registered in the ARTG as OTC or prescription medicines depending on the active ingredients contained and therapeutic claims made (see subsection 3.3 for registration of therapeutic sunscreens). Subsection 4.1 lists the therapeutic claims permitted for listed sunscreens.
Sunscreens that are not 'listable', 'exempt' or 'cosmetic' (excluded) are evaluated by the TGA for quality, safety and efficacy as registered therapeutic goods under section 25 of the Act.
Data to support the quality, safety and efficacy of such products are required as detailed under the relevant chapters of the Australian Regulatory Guidelines for OTC Medicines (ARGOM).
Products in this category include:
It is a standard condition of listing or registration of a medicine that the sponsor has an appropriate system of pharmacovigilance and that the sponsor reports to the TGA adverse reactions experienced by users of the sponsor's products. This requirement applies to sponsors of therapeutic sunscreens.
Details of the TGA's requirements for pharmacovigilance and the reporting of adverse reactions can be found on the TGA Internet site.
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The labelling and advertising of therapeutic sunscreen products included in the ARTG must comply with the relevant requirements of each of the following:
A check list is provided at the end of this document (Appendix 1) to assist sponsors in designing their sunscreen labels in accordance with the requirements of the documents listed above. However, the check list is not exhaustive and sponsors are responsible for ensuring that their labelling complies with all of the relevant legislative requirements.
TGO 69, the Therapeutic Goods Advertising Code and the RASML do not apply to cosmetic sunscreens.
As required by sections 2 and 3 of the Labelling Order (TGO 69), the label (or labels) must:
As prohibited by section 4 of the Therapeutic Goods Advertising Code, the labelling must be free from claims, statements or pictures that:
Therapeutic sunscreens that are 'listable' are permitted to carry the following coded indications provided that the sunscreen meets the requirements of AS/NZS 2604:2012 for the indications designated:
In principle, indications considered appropriate for listed sunscreens are those that can be used safely and effectively without the intervention of a healthcare practitioner. For medicines generally this includes diseases, disorders or conditions that are normally of a benign or self-limiting nature that the average consumer can be expected to evaluate or diagnose accurately. Some indications that relate to a serious disease condition, ailment or defect such as skin cancer are restricted except those allowed above which have been approved by the TGA for therapeutic sunscreens.
The Act requires that, at the time of listing a medicine in the ARTG, a sponsor must certify that it holds the information or evidence to support indications and claims made in relation to the product. All indications and claims must be capable of substantiation - that is, evidence held by the sponsor must adequately demonstrate all indications and claims made for the product are true, valid and not misleading.
Listed medicines are not subject to pre-market evaluation for efficacy at the time of listing. However, data supporting the indications may be requested by the TGA for review after listing of a medicine. Hence, the TGA may request copies of labelling and the results of pre-market SPF, broad spectrum performance, water resistance or stability testing. If requested, it is expected that this information will be available and can be provided to the TGA within a reasonable time of the request.
Therapeutic sunscreens may also carry justified non-therapeutic claims (for example, 'contains Vitamin E', 'contains aloe vera', 'moisturising', 'antioxidant', 'free radical barrier') and information to support such claims may be requested by the TGA for review. If the certification by the sponsor that it holds this information or evidence is incorrect, the TGA can cancel the listing of the product from the ARTG.
The labelling may also carry company logos, other symbols and consumer information provided these do not create confusion for Australian consumers and they do not conflict with the requirements of the Therapeutic Goods legislation, the Labelling Order, the Sunscreen Standard or the Advertising Code.
If the formulation includes a proprietary ingredient, the sponsor should check with the manufacturer or supplier of the proprietary ingredient to ascertain that it does not contain any specified excipients that must be declared on the labels in accordance with TGO 69.
As required by subsection 3(2) of the Labelling Order and section 7 of the Sunscreen Standard AS/NZS 2604:2012, the main label on the container and the main label of the primary pack (for example, carton), if any, must ontain all of the following information:
All of the following information must be included either on the main label or on a rear or side panel [see subsection 3(3)(c) of the Labelling Order]:
All of the following information must be included somewhere on the label(s) or container:
In accordance with subsection 3(11) of the Labelling Order, if the immediate container has a capacity of 20mL or less AND the container is enclosed in a primary pack (for example, carton), the primary pack labelling must include all of the information listed above and the labelling on the container must include at least the following information:
Nanoparticulate titanium dioxide and zinc oxide are commonly used in sunscreens. The labels of therapeutic sunscreens are not required to declare the particle size of ingredients.
The TGA's policy on the safety of nanoparticulate ingredients in sunscreens is available from the TGA Internet site.
Advertisements for therapeutic sunscreens are required to comply with the Therapeutic Goods Advertising Code.
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The in vivo testing of the SPF of a sunscreen product according to the procedure in ISO 24444:2010 and AS/NZS 2604:2012 produces a reasonable estimate, but not a highly accurate and precise measure, of the true SPF of the product applied to the skin at a rate of 2 mg/cm2. The test data exhibit a considerable inherent variance which needs to be taken into account when interpreting the test results and labelling of the product, and also needs to be taken into account when interpreting the results of any subsequent retesting of the product.
The test procedure in ISO 24444:2010 and referenced by AS/NZS 2604:2012 requires the product to be tested on a minimum of 10 subjects and for the arithmetic mean, standard deviation and 95% confidence interval (95% CI) for the mean to be calculated using the formula 95% CI = m ± t.s/√n, where
There is a 95% probability that the true SPF of the product lies somewhere within the 95% CI.
For the test to be considered valid, the 95% CI must fit within ± 17% of the mean and, if not, the product must be tested on further subjects (up to a maximum of 20) until the 95% CI based on the data for all subjects does fit within ± 17% of the mean. If testing on 20 subjects does not bring the 95% CI within ± 17% of the mean the whole test must be rejected. In practice, use of more than 10 subjects would be necessary only if the coefficient of variation (CV = s/m) is greater than 24%, and testing on 20 subjects would only fail if the CV was greater than 37%.
Statistical analysis of the SPF test data submitted to the TGA over recent years in support of SPF claims made for a large range of sunscreen products has shown that the data typically exhibit a relative standard deviation (RSD) or coefficient of variation (CV) in the range 5-20%. Only rarely is the CV less than 5% or greater than 20%. Thus, in the majority of cases, testing on 10 subjects would yield a 95% CI well within the ±17% limits and testing on additional subjects would not be required.
Subsequent retesting of a sunscreen is likely to yield a mean SPF anywhere within the 95% CI from the original testing of the product or even a few SPF units beyond either end of that 95% CI. Consequently, if the original test result was close to the lower limit for a particular SPF claim allowed by the Standard, the retest result could be lower than that lower limit and appear to cast doubt on the validity of the labelled SPF claim. However, it would be necessary to retest the product several times and obtain consistently low mean results before any conclusion could be drawn about the labelled SPF being unjustified.
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Details of the requirements and procedures for making changes to the ARTG record of listed therapeutic goods are provided in the ELF User Guide.
The addition to or deletion of an active ingredient to a product or a change to the quantity of such an ingredient creates a new therapeutic good requiring an application to be made for a new entry in the ARTG (see subsections 16(1) and 16(1A) of the Act and regulation 11 of the Regulations). If successful, a new AUST L or AUST R number will be assigned to the new product.
The identities of excipients in a sunscreen product and the quantities of 'restricted ingredients' are required to be included in the ARTG record for the product.
Deletion or addition of excipients in a therapeutic sunscreen (other than the permanent removal or addition of a fragrance or colouring agent) creates a new therapeutic good requiring an application to be made for listing or registration in the ARTG as a new product. If successful, a new AUST L or AUST R number will be assigned to the new product.
If the excipient to be added or removed is a fragrance or colouring then, notwithstanding that a new therapeutic good is created, the new product can retain the same AUST L or AUST R number under the Therapeutic Goods (Groups) Order No. 1 of 2001 (the Grouping Order) provided the new formulation is intended to replace the existing formulation. However, an electronic application must be submitted to change the formulation recorded in the ARTG
Quantities of excipients other than restricted excipients are not required to be included in the ARTG record for listed sunscreens.
Where a change is to be made to the quantity of a restricted excipient and grouping applies in accordance with the Grouping Order subsection 5.1(a)(i) and (ii) and (b) an electronic application must be lodged to change the formulation details recorded in the ARTG. When grouping does not apply, such a change will require a new product application and a new AUST L or AUST R number.
Sponsors should recognise that the SPF and other physical properties of a sunscreen are affected not only by the active ingredients, but also by the base. Therefore, qualitative or quantitative changes in the excipients may adversely affect the SPF. Testing of a changed formulation to confirm its SPF or stability may be required if the changes are likely to affect the emulsion properties or the adhesion of the product to the skin in a way that could alter its sun protection properties.
Changes to the ARTG details of a sunscreen product must be approved by or notified to the TGA (using the ELF system in the case of a listed sunscreen). Whether or not grouping applies, a change to the product name requires approval.
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Therapeutic sunscreens marketed in Australia must be labelled with an 'expiry' or 'use by' date. That date must be supported by experimental data that support the shelf life of the sunscreen product in the container intended for marketing (or at least a container made of the same materials and with similar shape, size and wall thickness to that of the market container) under the recommended storage conditions (that is, 'Store below 25°C' for product to be stored in air-conditioned premises or 'Store below 30°C' for product to be stored at room temperature). The data must substantiate the physical, chemical and microbiological stability of the product for at least the claimed shelf life.
Sponsors of all therapeutic sunscreen products are expected to have performed stability testing on each product to at least the standard set out in these Guidelines. The claimed shelf life and storage conditions for each product should be derived from the results of the stability testing on that product. Generation of adequate stability data to support the assigned shelf life for a therapeutic sunscreen is the responsibility of the sponsor.
While the stability data supporting the shelf life of a sunscreen product are not required to be submitted to the TGA at the time of listing, they may be requested for review by the TGA at any time. Sponsors should, therefore, ensure that the data are available in a form suitable for submission to the TGA if and when requested.
Stability testing guidelines for sunscreens Guidelines for Stability Testing of Sunscreens April 1994 were developed by the Australian industry peak bodies and accepted by the TGA. They are now incorporated below with some minor amendments to improve clarity and consistency with the stability guidelines for medicines adopted by the TGA (see ARGOM chapter on Quality). This section (7) now supersedes the Guidelines for Stability Testing of Sunscreens April 1994.
Prior to listing and market launch, the shelf life must be established with real time testing for the whole of the required shelf life or with adequate certainty using accelerated testing (that is, 6-9 months at 10°C or 15°C above the stated maximum storage temperature - see Table 2) or justified on the basis of supporting stability data for a closely related formulation.
Pre-listing or pre-registration stability testing should be carried out using at least two batches of the formulation intended for marketing manufactured in a manner that closely mirrors the production-scale manufacturing process. A formulation very similar, but not identical, to that intended for marketing formulation may be used provided any differences are very minor and unlikely to affect the physical, chemical or microbiological stability or in-use performance of the product.
The batches tested in stability studies may be pilot-scale but should have been manufactured in a manner sufficiently similar to that of commercial production scale batches that they adequately reflect the properties of the product intended for the market.
If the shelf life assigned at the time of listing is based on data generated using pilot-scale batches and accelerated studies, the shelf life should subsequently be confirmed by real time studies covering the whole of that shelf life using at least two production-scale batches stored at the maximum recommended storage temperature. These production scale batches should be tested initially at manufacture and then annually until the end of the shelf life.
Physical testing should include at least the following quality parameters: appearance, emulsion stability, absence of crystallisation, odour, viscosity, compatibility with the immediate container and the condition of the inside surface of the container in contact with the product.
Chemical stability testing should include: pH (if water is the continuous phase) and the content of each of the active ingredients assayed using a validated, stability-indicating analytical procedure (for example, HPLC). Active ingredients should remain within the limits 90% to 120% of label claim.
Overages of active ingredients in the formulation are acceptable provided they do not result in concentrations exceeding the limits provided in subsection 9.1.
For water-containing sunscreens, microbiological stability should be confirmed by means of preservative efficacy testing at the start and end of accelerated stability testing and at the end of the shelf life during the subsequent real-time stability testing.
The temperature of storage used in stability studies should be controlled, monitored and logged to ensure the integrity of the results.
The frequency of testing for accelerated studies should be adequate to allow regression and statistical analysis to support extrapolation of the data. Appropriate testing time points would typically be 0, (1 or 2), (3 or 4), (5 or 6), 9 and 12 months (followed by 24 and 30 months, depending on the shelf life required to be justified).
The accelerated stability data should only be extrapolated as in subsection 7.5 if their accuracy, reproducibility and fit around a straight time-line are adequate. A minimum of 4 time-points with a reasonably even spread over the time period concerned are needed for meaningful line-fitting and 95% confidence interval calculations.
For a product exhibiting no discernable changes or trends, a 2-year shelf life for storage conditions of 'store below 30°C' (that is, storage at room temperature in Australia) may be supported by stability data covering 6 months storage at 40°C, and a 3-year shelf life for storage conditions of 'store below 30°C' may be supported by data covering either 9 months at 40°C or 6 months at 45°C.
A shelf life of greater than 3 years should be supported by data from storage at 40°C covering at least half of the shelf life (for example, 2.5 years accelerated data would be required to support a 5-year shelf life).
For a product exhibiting no discernable changes or trends, a 2-year shelf life for storage conditions of 'store below 25°C' (that is, the product should be stored in air-conditioned premises) may be supported by stability data covering 6 months storage at 35°C, and a 3-year shelf life for storage conditions of 'store below 25°C' may be supported by data covering either 9 months at 35°C or 6 months at 40°C.
A shelf life of greater than 3 years should be supported by data from storage at 35°C covering at least half of the shelf life.
Generally, the maximum shelf life permitted for any therapeutic good is 5 years.
| Temperature above labelled storage conditions | Time period | Test time points | Possible shelf life prediction |
|---|---|---|---|
| +10°C | 6 months | 0, (1 or 2), (3 or 4), 6 months | 2 years |
| +10°C | 9 months | 0, (1 or 2), (3 or 4), (5 or 6), 9 months | 3 years |
| +15°C | 6 months | 0, (1 or 2), (3 or 4), 6 months | 3 years |
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In accordance with Part 3-3 of the Act and Part 4 of the Regulations, manufacturers of 'listed' or 'registered' therapeutic goods destined for the Australian market or for export from Australia to an overseas market must be licensed or approved by the TGA and must also comply with manufacturing principles as determined by the Minister. These manufacturing principles are set out in the TGA's requirements for good manufacturing practice (GMP).
Where an Australian manufacturer is nominated in an application to list or register a sunscreen, that manufacturer must be licensed by the TGA to manufacture such products and must comply with the TGA's GMP requirements as relevant to sunscreens. Where the product is imported, each nominated overseas manufacturer is expected to comply with a code of GMP equivalent to that applying to Australian manufacturers and the TGA must have issued a GMP clearance for that manufacturer.
Further information on licensing or approval of manufacturers is available on the TGA Internet site.
It is the responsibility of the manufacturer of the finished therapeutic product to ensure the quality of the product and also that of the active ingredients and excipients used in its manufacture.
Section 40(4)(a)(i) of the Act requires the manufacturer to ensure that the product complies with any standard applicable to the product.
In accordance with the definitions in section 3 of the Act, the default standards applying to therapeutic goods registered or listed in the ARTG are the British Pharmacopoeia (BP), European Pharmacopoeia (Ph Eur) and United States Pharmacopeia-National Formulary (USP-NF). Other standards in addition to the pharmacopoeia that apply to sunscreens include relevant Therapeutic Goods Orders made under section 10 of the Act (for example, TGO No. 69 for labelling and TGO No. 77 for microbiological quality).
This means that if there is a monograph for a finished product in one (or more) of the BP, Ph Eur and USP-NF, then the sponsor must ensure that the product will comply with the specifications in that monograph (or at least one of those monographs).
Sunscreen finished products are not the subject of a monograph in the BP, Ph Eur or USP-NF and therefore must to be controlled, instead, by appropriate "in house" quality control specifications that control and ensure their identity and relevant physical, chemical and microbiological properties. Test methods must be validated, as appropriate.
Therapeutic sunscreen products in all categories are required to comply with the relevant requirements of sections 8 and 9 of Therapeutic Goods Order No. 77 Microbiological Standards for Medicines.
Sunscreen manufacturers are responsible to ensure that batches of product released to the market comply with their specifications.
Subsection 13(5) of the Act requires that, when a finished product is not the subject of a monograph in the BP, Ph Eur or USP-NF, but any of its ingredients is the subject of a monograph in one or more of those pharmacopoeia, that ingredient must comply with at least one of the monographs concerned, unless the Minister has issued an order determining that this requirement does not apply to the goods concerned. Note that, as at the date these Guidelines were published, no such order exempting sunscreens had been issued by the Minister.
Many of the organic chemicals used as active ingredients in sunscreens are the subjects of monographs in the USP-NF (generally under their International Non-proprietary Names [INNs]) while the inorganic substances titanium dioxide and zinc oxide are the subject of monographs in each of the BP, Ph Eur and USP-NF.
Many of the excipients (including solvents) used in sunscreen products are the subjects of monographs in one or more of the BP, Ph Eur and USP-NF.
Ingredients that are not the subject of a monograph in the BP, Ph Eur or USP-NF must be controlled by appropriate quality control specifications that control and ensure their identity, relevant physical and chemical properties, and purity. Test methods must be validated, as appropriate.
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The only sunscreening active ingredients permitted in therapeutic sunscreens are those included in the Therapeutic Goods (Permissible Ingredients) Determination Sponsors should consult the Determination for restrictions applying to each ingredient. The labelling must include the Australian Approved Name (AAN) for each active sunscreening ingredient.
Sponsors wanting to market a therapeutic sunscreen product containing a sunscreening active ingredient which is not on the list of permitted substances in therapeutic sunscreens must submit data to establish the safety and efficacy of the ingredient under its proposed conditions of use (see section 10).
Only those excipients approved by the TGA for use in topical medicines may be used in therapeutic sunscreens. In some cases the TGA has set limits on the amounts of such ingredients and sunscreens must comply with those limits. For more information on the substances that may be used in Listed medicines supplied in Australia and the restrictions applying to their use, please consult the Therapeutic Goods (Permissible Ingredients) Determination.
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The information below should be read in conjunction with the guidelines for the approval of new substances given in the ARGOM section on applications for new substances.
A 'Proposed Name for a Chemical Substance Used in a Therapeutic Good' application form needs to be submitted to the TGA to enable the establishment of an identity and an appropriate 'Australian Approved Name' (AAN) for the substance. Information on the naming of substances and applying for an AAN can be found on the TGA Internet site.
There are no fees for the AAN applications and approval of ingredient names (at the time of publication). However, fees will apply to the evaluation of the data for the new substance and for the listing or registration of the product as specified in the summary of fees and charges available from the TGA Internet site.
Sponsors wishing to market a product containing an active ingredient which is not on the Therapeutic Goods (Permissible Ingredients) Determination must submit data to establish the safety and efficacy of the ingredient under its proposed conditions of use.
Table 4 lists the topics of relevant guidelines for the types of safety data that are usually required for a new sunscreen active ingredient or new excipient (see also new excipient section).
The list of relevant European Union (EU) 'non-clinical' guidelines that have been adopted by the TGA can be found on the TGA Internet site. They are not detailed in this Sunscreen Guideline document because there are frequent changes and sponsors should, therefore, consult the current list on the TGA Internet site. These EU guidelines relate to sunscreens because sunscreening products (as defined earlier in this Guideline) are treated as therapeutic goods in Australia.
The intention in listing relevant guideline topics is not to set absolute requirements but to assist sponsors in assessing the type and depth of information needed to support an application with the understanding that primary sunscreen products are treated as therapeutic goods in Australia as opposed to 'cosmetics' in Europe.
If a particular guideline is not applicable or other data are available that adequately address the same criteria, alternative approaches based on adequate scientific justification will be considered by the TGA during evaluation of the application, or pre-submission. Relevant human studies are acceptable in the assessment of potential skin irritation and sensitisation using the repeat 'insult patch test' or other relevant validated tests.
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Photostability
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| Acute toxicity (oral and dermal; animal data) |
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Local tolerance:
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Allergenicity:
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Toxicokinetics:
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| Repeat dose toxicity (oral and dermal) at least 3 months |
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Genotoxicity:
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Reproductive toxicity
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Carcinogenicity
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Interaction potential
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More details on different safety tests for chemicals for pharmaceutical use can be found at the Internet sites of the following organisations:
More details on different safety tests for chemicals that are for cosmetic sunscreens used in Europe can be found in The SCCS's Note for Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation 7th Revision 14 December 2010 SCCS/1416/11.
In circumstances where particular tests specified in the table above (TGA-adopted European guidelines) are not feasible or appropriate, sponsors should submit a justification for not including these tests in the dossier which is based on sound scientific argument.
In the case of in vivo carcinogenicity bioassays, a justification for not including long-term studies could be based around the following issues as they apply to the ingredients or product:
Other studies that are not currently referenced in EU guidelines may be useful in supporting particular applications. Reference to these studies is included only as a guide. They will not be relevant in all cases, nor should they be seen as a complete list of relevant studies. Examples include the following studies and referenced Internet sites which may be useful in providing information on the potential of a substance to cause tumours in people:
Additionally, the following references may be useful when investigating the use of ingredients with a potential for skin corrosion/irritation:
In addition to the requirements stated in the ARGOM chapter on Quality, sponsors should provide data to establish the UV absorption range of the new substance enabling confirmation of UVA/UVB absorption profile. Data addressing the potential for physical interaction with other commonly used sunscreening agents should also be provided.
Where a therapeutic sunscreen contains an excipient ingredient which is not in any product currently included in the ARTG for supply in Australia, the excipient must be assessed for use by the TGA. The following information is required as a minimum:
The following additional studies may be requested in individual cases where concern becomes evident at the time of evaluation:
All of the above information should be submitted for safety evaluation of the new substance for use in therapeutic sunscreens. Additional studies may be requested in individual cases where concerns become evident at the time of evaluation.
Once the substance is approved (and an AAN has been assigned), it will thereafter be able to be used in other therapeutic sunscreens without the need for further evaluation, but only up to the safety limit that has been approved. Any increase in that safety limit requires submission and approval of a formal application. The substance may also be able to be used in other topically applied medicines (subject to any conditions or limitations) without the need for further evaluation. However, additional data may be required if the characteristics of the substance are considered to change in different formulations or patterns of use in new products or if the substance is to be used outside the stated conditions and/or limitations.
Alternative sources of data on the safety of the excipient will be considered. For example, if the excipient has been assessed by NICNAS or by the US Cosmetic Ingredient Review (CIR) group, the review document may be sufficient in itself. Copies of CIR reviews are available from the Internet site www.cir-safety.org. Copies of NICNAS reviews may be available from the supplier of the excipient.
Required study reports should be submitted in full as well as in summary form (as described in the ARGOM Chapter on Applications). Simple summaries or synopses of studies without the full study reports are not acceptable for assessment.
All studies submitted must be in English or be provided with an accompanying English translation.
The EU guidelines that have been adopted by the TGA for therapeutic goods should be referred to for detailed guidance on the appropriate tests and how they should be conducted. Studies can be rejected as 'invalid' if appropriate and scientifically robust methodology is not followed (for example, low animal numbers, lack of or inappropriate controls).
Proper and comprehensive identification of the substance(s) being tested in all studies is required; laboratory codes, trade names and synonyms must be linked to the substance identified in the new substance application form for the AAN.
Concentrations of the new substance used in all studies must be clearly and unambiguously stated. The intended final concentration of the new excipient in therapeutic goods to be marketed in Australia must be stated; this allows a comparison to establish that the submitted studies were conducted at concentrations to support the proposed levels to be used in marketed goods.
Where a substance is present in the product with the listed purpose of excipient, no therapeutic claims can be listed against its presence.
If a substance with a known active function is classified as an excipient, evidence of excipient function and purpose will be required.
Furthermore, a justification must be provided for the inclusion of that substance as an excipient at a concentration in excess of the concentration typically used for its role as an active ingredient. If that concentration is above the approved safety limit for use in listed products, then the product with that concentration of the substance must be registered.
The concentrations of excipients with a known active function in the formulation must be below the concentration associated with its established active function. If the excipient concentration is above the minimum threshold of active function then the substance should not be classified as an excipient in the product but, instead, should be classified as an active substance in the product and it will be evaluated as an active component of the product. In this case a therapeutic sunscreen containing that substance must be listed or registered on the ARTG.
Version 1.2
This guideline is currently under review.
Note: Where relevant, references to particular definitions are provided in brackets (…)
ACCC means the Australian Competition and Consumer Commission.
Active ingredient (in relation to a sunscreen) means an active substance included in a sunscreen to protect the skin from ultraviolet (UV) radiation. It is an ingredient in a therapeutic good's formulation that is responsible for its physiological or pharmacological action (see regulation 2 of the Regulations).
Antimicrobial preservative means an ingredient added to a product to inhibit the growth of micro-organisms in the product. (TGO 69).
ARGOM means the Australian Regulatory Guidelines for OTC Medicines.
ARTG means the Australian Register of Therapeutic Goods.
AS/NZS 2604:2012 - The Australian and New Zealand Standard for Sunscreen Products (2012 edition)
Australian Approved Name (AAN) - The approved name applied to a therapeutic substance, as outlined in the TGA Approved Terminology for Medicines, which includes: Approved Biological Substance Names (ABNs); Approved Chemical Substance Names; Approved Herbal Names (AHNs); and Approved Herbal Substances (AHSs).
Batch number means a number, or a combination of numerals, symbols or letters, which is given by a manufacturer to a batch of goods, to uniquely identify that batch and from which it is possible to trace that batch through all stages of manufacture and distribution (TGO 69).
Batch number prefix means the prefix which precedes the batch number and clearly indicates that the number is the batch number. Examples of acceptable batch number prefixes include 'Batch Number', 'BATCH NUMBER', 'Batch No.', 'BATCH NO.', 'Batch', 'BATCH', 'B', '(B)', 'B/N', 'Lot Number', 'LOT NUMBER', 'Lot No.', 'LOT NO.', 'Lot' or 'LOT'; or words or symbols to this effect.
Broad spectrum product means a sunscreen product which has been shown, using the in vitro test method defined in AS/NZS 2604:2012 to provide protection from the sun's terrestrial UVA and UVB rays. (AS/NZS 2604:2012)
Category description means the designation of the level of protection given by a grouping of label sun protection factors (AS/NZS 2604:2012).
Container means an article (for example, bottle, jar, tube, sachet) that immediately covers the goods, and includes an ampoule, blister pack, bottle, sachet, dial dispenser pack, strip pack, syringe, tube, vial, wrapper or other similar article, but does not include an article intended for ingestion (TGO 69).
Cosmetic (For the full definition, see subsection 2.2.)
Cosmetic sunscreen product means a product containing a sunscreening ingredient that is regulated as a cosmetic by the Industrial Chemicals (Notification and Assessment) Act 1989 and by the Cosmetics Standard and is not a therapeutic good (see subsection 2.2).
Excipient ingredient (in relation to a sunscreen) means an ingredient of a sunscreen other than an active ingredient. Excipient ingredients may have multiple uses such as fragrance, preservative and/or solvent.
Excipient mix is a Proprietary Ingredient formulation comprised of a mixture of excipient ingredients that may be used in a therapeutic good. Examples include emulsifiers and anti-oxidants. Excluded sunscreen means a sunscreen product that is not regulated under the Therapeutic Goods Act 1989 (see the Therapeutic Goods (Excluded Goods) Order No. 1 of 2011).
Exempt sunscreen means a sunscreen product that is regulated under the Act but is not required to be registered or listed in the ARTG (see Item 4(g) of Schedule 5 of the Regulations).
Expiry date means the date (month and year) after which the goods should not be used, being a date not more than five years after the date of manufacture (TGO 69).
Expiry date prefix means the prefix which precedes the expiry date, and clearly indicates that the following information is the expiry date. Examples of acceptable prefixes include 'Expiry Date', 'EXPIRY DATE', 'Expiry', 'EXPIRY', 'Expires', 'EXPIRES', 'Exp. Date', 'EXP. DATE', 'Use before', 'USE BEFORE', 'Use By', 'USE BY', 'Exp', or 'EXP' but terms such as 'Best by' or words to this effect are not acceptable (TGO 69).
Fragrance (or perfume) is a substance whose primary purpose is to alter the smell of a therapeutic good.
Ingredients of human or animal origin are those derived directly from a human or animal source. They are also listed in the Regulations.
INCI means International Nomenclature Cosmetic Ingredient.
INN means International Non-proprietary Name.
Label means a display of printed information upon, or securely affixed to, the container and any primary pack containing the goods (TGO 69).
Label Sun Protection Factor (SPF) means the SPF indicated on the label.
Letter height means the height of upper case (capital) letters or lower case letters having an ascender or descender, unless otherwise stated (TGO 69).
Listing or registration number means the combination of numbers, symbols and letters assigned to the goods by the TGA under section 27 of the Act (TGO 69).
Medicine means a therapeutic good that is represented to achieve, or is likely to achieve, its principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human or animal (see subsection 3(1) of the Act).
Minimum Erythemal Dose (MED) means the lowest dose of ultraviolet radiation that produces the first perceivable unambiguous erythema with defined borders appearing over most of the field of UV exposure 16-24 hours after UV exposure (AS/NZS 2604:2012).
New substance is an ingredient (chemical, herbal or biological) that is currently not used in a medicine for supply in Australia, or is proposed for a new route of administration to the previous use of the ingredient. This ingredient may or may not have an Australian Approved Name.
NICNAS means the National Industrial Chemicals Notification and Assessment Scheme.
Primary pack, in relation to therapeutic goods, means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers (see subsection 3(1) of the Act).
Primary sunscreen product means a product which is represented as being primarily to protect the skin from ultraviolet radiation (AS/NZS 2604:2012).
Principal or main label means (a) where there are two or more labels or two or more portions of a single label - that label or portion of the label where the product name is more or most conspicuously shown; or (b) where the product name is equally conspicuous on two or more labels or portions of a label - each such label or portion (TGO 69).
RASML means Required Advisory Statements for Medicine Labels
Secondary sunscreen product means a product that is represented as having a primary purpose other than sun protection whilst providing some protection of the skin from ultraviolet radiation (AS/NZS 2604:2012).
Sun Protection Factor (SPF) means the arithmetic mean of all valid individual SPF values obtained from all subjects in the test (AS/NZS 2604:2012). See also, Minimum Erythemal Dose (MED).
SUSMP means the Standard for the Uniform Scheduling of Medicines and Poisons (previously called the Standard for the Uniform Scheduling of Drugs and Poisons [SUSDP]).
TGO 69 - see the Labelling Order.
The Act means the Therapeutic Goods Act 1989.
The Labelling Order means Therapeutic Goods Order (TGO) No. 69 - General requirements for labels for medicines (or any subsequent order amending or replacing TGO 69).
The Regulations means the Therapeutic Goods Regulations 1990.
Therapeutic good includes a good that is represented in any way to be, or that is, whether because of the way in which the good is presented or for any other reason, likely to be taken to be for therapeutic use or for use as an ingredient or component in the manufacture of therapeutic goods (subsection 3(1) of the Act).
Therapeutic sunscreen product means a primary or secondary sunscreen product that meets the definition of a therapeutic good rather than the definition of a cosmetic (see subsection 2.1).
Therapeutic use means use in or in connection with preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals, or influencing, inhibiting or modifying a physiological process in persons or animals (subsection 3(1) of the Act).
Topical - for sunscreen use means applied to a certain area of the skin for a localised effect.
TSEs means the transmissible spongiform encephalopathies.
Ultraviolet radiation (UV) means the terrestrial solar ultraviolet radiation in the range 290-400 nm. Ultraviolet radiation A (UVA) is the terrestrial solar ultraviolet radiation in the range 320-400 nm and ultraviolet radiation B (UVB) is the terrestrial solar ultraviolet radiation in the range 290-320 nm.
UV filter, for the purposes of these Guidelines, means a substance that is exclusively or mainly intended to protect the skin against certain UV radiation by absorption, reflection or scattering of UV radiation.
Water resistant product means a sunscreen product which has been shown after designated periods of water immersion, using in vivo Sun Protection Factor test methods to provide protection against certain of the sun's UV rays (AS/NZS 2604:2012).
Version 1.2
This guideline is currently under review.
Version 1.2
This guideline is currently under review.
Note: This check list is not mandatory. It is designed to assist sponsors in designing their labels for therapeutic sunscreens in accordance with the TGA's requirements. It is not exhaustive. Sponsors are reminded that they are responsible for ensuring that their labelling complies with all of the relevant legislative requirements. These labelling requirements do not apply to those secondary sunscreen products categorised as cosmetics.
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Version 1.2
This guideline is currently under review.
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication | Office of Medicines Authorisation | 10/10/2012 |
| V1.1 |
Updated to reflect the changes to the Therapeutic Goods Regulations 1990 by removing references to sunscreens with a claimed SPF of <4 that contain certain human or animal derived ingredients. Updated the relevant sections by including reference to the recently made Therapeutic Goods (Permissible Ingredients) Determination No.1 of 2015. Updated the table listing the permitted active ingredients by adding the newly approved sunscreen active Tris-biphenyl triazine. |
Complementary and Over the counter Medicines Branch OTC Medicines Evaluation |
22/01/2016 |
| V1.2 | Updated to remove Table 3 - Permitted active ingredients for therapeutic sunscreens and replace with links to the Therapeutic Goods (Permissible Ingredients) Determination | Complementary and Over the Counter Medicines Branch | 30/08/2019 |