Improving the regulation of sunscreens in Australia

HEWAGE, Nishie  0:27
Good afternoon. Thank you for joining us. We'll wait a couple of minutes before we begin to allow time for more people to join. Thank you.

Good afternoon and thank you for joining today's webinar on improving the regulation of sunscreens in Australia. I would like to begin with an acknowledgement of country. In spirit of reconciliation, the Department of Health, Disability and Ageing acknowledges the traditional custodians of country throughout Australia
and their connections to land, sea and community. We pay our respect to their elders past and present and extend their respect to all Aboriginal and Torres Strait Islander people today.

Before we get started, I would like to give a brief introduction of our presenters today. Our first presenter will be Avinash Clark, who is the Assistant Secretary of the Complementary and Over-the-Counter Branch, followed by Doctor Lisa Kerr, who is the Assistant Secretary of the Laboratories Branch, and Hongxia Jin, who is the Assistant Secretary of the Manufacturing Quality Branch here at the TGA. 

Now, without further ado, I would like to pass it on to Avinash Clark to get started with today's presentation. Over to you, Avinash.

CLARKE, Avinash  2:24
Hello all, my name is Avi, so thank you for joining us today. Here are the list of topics we will be covering. These will be followed by answers to pre-submitted questions, and if time permits, live questions from the group.

So, I now will outline some context. Why are we all here?

So, as the participants of this webinar will know, sunscreens are critical in protecting Australians from the harmful effects of ultraviolet radiation and in reducing the incidence and impact of skin cancer. In Australia, primary sunscreens are generally regulated as listed medicines. They do not undergo a pre-market evaluation.
but need to meet a range of requirements. They are also subject to post-market monitoring.

There have been various developments overseas and domestically that have highlighted areas where we can improve current regulation.

The report published by Choice, along with our own TGA reviews and investigations, prompted a review of many aspects of current sunscreens regulation and associated frameworks. A team of experts from the TGA was formed to lead work on this matter, which in part, has culminated in the consultation paper published late last month.

Now, what are we trying to achieve?

The current regulatory framework for sunscreens has been in place for some time now. Technology and the regulatory landscape has changed during this period.

These proposals are intended to strengthen this framework, maintaining and building public confidence in sunscreen performance, as well as providing up-to-date SPF testing guidance for sponsors.

Here are the issues in scope. These include SPF testing, potential issues with specific formulations and ingredients, SPF labelling, cosmetic sunscreens with high SPF claims and sunscreen manufacturing guidance.

Matters not in scope of this process, but which are being considered through our existing framework, include the safety of sunscreen ingredients, sunscreens marketed to children, the regulation of sunscreen as a therapeutic good, and labelling for novel dosage forms such as foams.
So that's some broad context, and I will now hand it over to my colleague, Dr. Lisa Kerr.

KERR, Lisa   5:45
Thanks, Avi.
So, I'll be covering a couple of different topics. The first one is SPF matters. 

I am Lisa Kerr and I am the head of the TGA’s Laboratories Branch. 

So, it is a known issue that there is variability in the current in vivo testing
method ISO 24444. I should mention at this point, that the TGA do not conduct the testing to this particular standard because we don't conduct testing on humans or animals. And so therefore, we have not been conducting the testing against this particular standard. However, we, as has been mentioned in the consultation paper, there are new standards available that are in vitro that don't require testing on humans or animals, they're laboratory-based methods and we are currently implementing them, this type of testing in-house. 

Another thing to mention also is that we have already published advice for sunscreens sponsors and manufacturers regarding when they can use the new in vitro or hybrid methods versus the in vivo method. So that information is already on our website.

Part of the consultation is adopting the new methods that were only published in December 2024. So that's something that we're looking at. And, we are also aware that ISO is looking at the full suite of testing methods that they have currently published and are potentially going to be redrafting some of those. 

And in particular, we know that they're paying attention to water resistance claims, which we know has been a concern for some stakeholders. 

So, the proposed options when it comes to this type of issue is, the first one is maintaining the status quo, so making no difference or changes to the existing situation. 

Option 2 is enabling sponsors to comply with either the in vitro method, the hybrid method or the in vivo testing, as appropriate. 

And option 3 is to mandate in vitro testing only where appropriate. As I mentioned, this will take into consideration water resistance claims as well.

So, one of the things I wanted to cover in this webinar was the concept of testing methodology and the ability of manufacturers and sponsors to hit SPF targets accurately over time. 

So, I have a graph here which is entirely made-up, which represents SPF on the y-axis and time on the x-axis. The green dots representing SPF testing values over time for different batches. The blue line is the average SPF or the typical performance of a particular formulation over time and the two red lines represent the lower acceptable limit and the higher acceptable limit. 

This is something that we would like to see being implemented in a new framework, such that, manufacturers understand the performance of the product over time. 

So sunscreens are expected to perform according to their label claim over time to the end of their shelf life. However, there are natural variations in the content of active ingredient from batch to batch. This is not unique to sunscreens. So, for example, if we're looking at something that's within the TGA remit, for example, we allow variation in the content of small molecule pharmaceuticals.

So for example, my favourite example is paracetamol. If we're looking at a product like that, there is an allowable variation in the test results for products from 95 to 105%. 

So in other words, if you go and buy a packet of paracetamol from a pharmacy, not every tablet and not every batch will hit 100% of the target active ingredient, which is 500 milligrams for every single time.

For some other products like biological medicines, the allowable variation is 
wider because biological medicines are inherently more variable. 

One of the points that I wanted to get across that there is allowable variation in manufacturing processes and that extends to other industries. So for example, if you're looking at aeroplane parts or microchips or foodstuffs sold by weight,
there is a normal variation that is allowed, and that will vary from industry to industry.

So, for example, you probably don't want too much variation in your airline parts, but if you're looking at foodstuffs that are sold by weight, a greater degree of variation is probably okay. 

The variation in the manufacturing and in the testing is due to conditions that are naturally variable. So, for example, conditions during manufacture, the quality of starting materials, environmental conditions, and when you're talking about instrument accuracy, the accuracy of the instruments that you're using in your test. 

So, it's impractical and unrealistic to expect each, and every batch, of a sunscreen to hit the target SPF exactly every time. But, we do acknowledge that improvements are needed to understand the upper and lower acceptable limits for a particular product so that, manufacturers understand if their product has deviated over time and, they are able to institute corrective actions in time.

The current situation means that manufacturers have few testing results to rely on. So, what this means is there's a great deal of weight that's placed on a small number of results. So, for example, if an adverse testing result comes in, so for example, with the Choice result, manufacturers are unable to explain the performance of their product over time and whether the adverse finding is within normal limits or not. 

So, in other words, a lot of weight can be placed on an adverse finding. So, without testing over time, there isn't enough testing information to really judge
the performance of the product.

I will also just mention that variability in testing methods is also normal, and it is accounted for in regulatory or regulated laboratories via a quality system, noting that, the variation that we see in ISO 24444 is somewhat unusual. 

The new labelling categories, which Avi will go through in just a moment, have been proposed (just a proposal, we are consulting on them) to support understanding of the normal variation in manufacturing processes and in testing. 

So, for example, one of the examples of how this could work, this is just for consultation, is that for manufacturers to be confident that their product performs according to the label, one of the things that could happen is that the SPF category or SPF value is set based on the lower acceptable limit for that product.

The next matter that I'd like to talk about, which has been a topic of some conversation, is the limited regulatory oversight for laboratories performing SPF testing. 

So, sponsors must hold SPF testing at the time of ARTG listing, but this information is not provided to the TGA up front, which limits regulatory oversight of testing laboratories and methods. 

The TGA doesn't regulate, or accredit, SPF testing laboratories, and so responsibility for selecting an appropriate and competent laboratory rests with the sponsor. However, we have provided advice for sponsors and manufacturers
on our website, including what to look for in a laboratory. 

The use of low reliability laboratories by some sponsors has likely contributed to products being supplied that do not always achieve their claimed SPF protection. 

Many SPF testing laboratories, which are mostly located overseas, lack formal accreditation. So, for example, the type of accreditation that we would normally look for would be ISO 17025, which is the international standard for the competence of testing and calibration laboratories. This is outside our jurisdiction, but there is already a framework and an existing system in place which could be used.

There's no current requirement for release testing of sunscreens and therefore there's no GMP oversight for this type of testing. 

So, the options here are option 1, which is always we're proposing the status quo, there's no change to the current situation, and then the second option is that we require that SPF testing results must come from an accredited or certified laboratory. As mentioned, we've already provided some information on our website about the different levels of weight that we would apply to a particular laboratory depending on the type of accreditation that they have. With the highest level being a testing laboratory that has SPF testing specifically within their scope of accreditation. That's the highest level that you can get, all the way down to a laboratory may or may not have a validation report for the test method that they're using.

So, the next matter that we want to talk about is the lack of flexibility to accommodate new testing requirements for sunscreens in a timely matter. 

So, sunscreens have to comply in Australia with the Australian Standard 2604, which has legal effect because it's specifically referenced in therapeutic goods legislation.
And, updates to both the Australian standard and to ISO standards, do not automatically apply in our country. Any change to SPF testing or labelling requirements requires a formal Standards Australia process - the changes need to be agreed to under consensus by the Standards Australia Committee. And then, it needs to be followed by a separate legislative process for the TGA to adopt the new standard. 

So, this multi-step process is lengthy and complex and involves consultation, regulatory impact assessments and legislative approvals, which can significantly delay implementation. As a result, there can be substantial time lags between scientific improvements and regulatory adoption. So, for example, the 2021 version of the Australian Standard was not adopted until 2024 and it's still under a transition period, so it's not fully enforced yet. 

We want to see if we can improve that situation. So, the current framework provides limited regulatory flexibility to respond quickly to safety, quality or efficacy issues.
The TGA is therefore, considering a more responsive mechanism to adopt updated international standards, while maintaining the important role of Standards Australia as a key technical stakeholder. And I will just mention that we have been talking to them throughout this process and, they have been great.
So the proposed options for this are, again, status quo, we maintain the current approach. Option 2 is directly referencing the Australian standard in a new instrument for sunscreen testing requirements. And then option 3, directly reference international ISO standards in a new instrument for sunscreen testing requirements.

Interested to hear what you've got to say, encourage you to put a submission in so that we can read it.

The next matter that I will cover is sponsor evidence in the base formulation. So, at the moment, sponsor evidence to support SPF claims is generally based on a base formula and not the final finished product. So, as I mentioned before, sponsors hold evidence for their development batches. And, the likes of Choice and the TGA test the market formulation. 

Sponsors are currently permitted to rely on SPF testing conducted during product development, including pilot or representative formulations rather than testing commercially released batches. So, there's a variety of reasons for that.
There are no prescriptive requirements on when retesting is required after formulation changes, or how frequently testing should occur, or whether testing must be conducted on the final marketed formulation. 

So the lack of clarity has created regulatory gaps, reducing confidence in the reliability of SPF claims and making it difficult to link tested batches to products that are actually supplied on the market. 

So our options here are maintain the status quo again, provide guidance to sponsors on when additional product testing is advised, or ramping it up a bit in option 3 to mandate SPF testing at the time of listing on the finished product and periodically while the product is still on the ARTG.

So, the next matter that we addressed in the consultation paper, which we have heard stakeholders talk about, is sponsors are not required to make the SPF testing data available to the TGA at the time of listing, or indeed, publicly available to consumers. 

So, sponsors are not required to submit SPF data to the TGA at the time of ARTG listing and it's not captured in the ARTG entry either. So, while sponsors must hold this evidence to support SPF claims, the data is only provided to us if we request it, and that limits proactive regulatory oversight. There's no requirement for SPF testing data to be made publicly available, which results in limited transparency for both us and consumers. 

As a result, SPF testing results underpinning SPF claims is not routinely visible, reducing confidence in the robustness of claimed SPF protection. 

So, there's three options that we've proposed in the paper. Happy to hear if you've got a different one. The first option is status quo. The second option is requiring sponsors to provide testing data to us at the time of listing, which we'll hold in confidence. And then the other option is to require sponsors to make their testing data available publicly.

So, that's the end of that section, and the next is just a brief slide on ingredient and formulation matters.

So, throughout our reviews and the work that we've been doing with the testing team, the SPF and sunscreen team and the TGA, we've been discussing potential efficacy or quality issues with specific formulations and ingredients.

We note that there is a lack of quality standards for sunscreens that address ingredient level properties, finished product formulation requirements or even, performance considerations. 

So, for example, with some other, or most other pharmaceutical products, there's a pharmacopoeial monograph. So, a pharmacopoeia is a book of chapters that have testing requirements and testing results for particular ingredients and for products.

A monograph is just a chapter in a pharmacopoeia. So, they exist already for zinc oxide, but they don't address the product or the ingredient characteristics that might be important for sunscreens. So, for example, particle size distribution, which we think is important for sunscreens. It doesn't address the issues that might affect the quality, safety and performance. So, for example, skin penetration, UV attenuation, and, we've heard from some areas, some stakeholders, that coating of zinc oxide particles might be important. 

No standardised monographs exist for many chemical UV filters either, such as avobenzone or octocrylene or other mineral active ingredients like titanium dioxide, 
especially in the context of their use in sunscreens. So that's something that we have addressed in the consultation paper. The proposed options are, we maintain the status quo - we maintain the current oversight or the current level of advice to sponsors and manufacturers about the quality of their products. 

Option 2 is that the TGA will develop an instrument for ingredient quality requirements to ensure efficacy - we plan to do that through external consultation with external experts. And option 3 is to require pre-market evaluation for safety, quality and efficacy for all sunscreens, i.e. a registered product model.

And I believe that's the end of my slides, so I will hand over to Miss Jin. 
Sorry to Avi, Avi it's you.

CLARKE, Avinash   22:52
Yeah, I think it's me. Yeah, thanks Lisa.
Yeah, so on to SPF labelling. So the SPF rating system, introduced in the 60’s, remains the internationally accepted method for indicating UVB protection. However, it is based on controlled laboratory testing and may not always reflect real world use. 

SPF is a relative measure of sunburn protection influenced by multiple factors. So these include solar intensity, skin type, amount applied, reapplication frequency, and activities such as swimming or sweating. 

We understand there's some consumer misunderstanding of the SPF scale, which is not linear. The difference in protection between SPF 30 and SPF 50 is relatively small, so approximately 97% versus 98% of UVB filtration when a sunscreens is applied correctly.
In vivo SPF testing methods can produce variable results, which can make it difficult for sponsors to confidently determine precise SPF values, which Lisa also discussed, which also increases the risk of regulatory non-compliance. 

Potential misunderstanding of SPF values, combined with test variability,
highlights for us the need to consider clearer labelling to improve consumer understanding, as well as provide sponsors with greater regulatory certainty. 

And, you'll see on the screen here. the options which we are proposing to consider. That includes the status quo. Option 2 is to provide additional labelling requirements for the SPF ratings, and option 3, is around changing the labelling requirements.
So, here are examples of potential labelling options that could address the issues that I've just discussed.  I just want to highlight we're really keen to hear thoughts on this. We really want to engage in this consultation process openly, and
and hear people's views about this, so we can really have all information available when we consider what steps to take next.

And so now I'll talk about cosmetic sunscreens. So, certain cosmetic sunscreens, such as a tinted foundation, can make high SPF claims of 50 plus, for example, but they are not regulated as therapeutic goods. 

These products are currently considered excluded goods within the therapeutic goods framework and are not regulated by the TGA.  Tere are historical considerations that have affected that. 

Australian consumers are likely to select these goods as primary sunscreens, regardless of whether they are considered a therapeutic or a cosmetic sunscreen. And so, we've proposed options to address this issue which are on the slide here. 

One of the options, option 3, involves us really keeping a consistent limit for what a cosmetic sunscreen can claim as an SPF. And so, that would mean that potentially all sunscreens above a certain SPF are regulated as therapeutic sunscreens.

I will now hand over to my colleague, Hongxia JIN.

JIN, Hongxia   27:00. 

Thank you, Avi and Lisa. 

As Avi and Lisa have touched on earlier, the recent sunscreens performance and compliance matters have provided us with an opportunity to review and strengthen our regulatory framework. This also includes the good manufacturing practice space. 

As most of you would know, the current GMP guideline for sunscreens was published in 2018, and that predates several technical and regulatory developments. 

Whilst our recent investigation and inspections did not identify specific manufacturing issues, based on the current regulatory requirements, that could explain the low SPF results seen in some of the products. Our inspections did identify, and highlight a number of areas, that clearer guidance could help manufacturers to better meet existing GMP expectations. 

There are a couple of key areas that could help the industry, this includes identification and control of critical quality attributes and the process parameters, roles and responsibilities of sponsors and manufacturers, and product release responsibilities. 

As mentioned by Dr. Kerr earlier, a lack of ingredient standards, or formulation standards, is also creating a level of confusion and challenge for industry.

So, ability to develop and implement new standards would also help manufacturers have a better control of the manufacturing process. Having a clearer practical GMP guideline, particularly at the manufacturer and a sponsor interface, could also reduce quality and compliance risks and, it would also improve consistency and strengthen confidence in sunscreens supplied to Australian consumers. 

In our consultation paper, we've put two proposals. Option 1, maintaining the status quo, and option 2 is updating the existing guidance.
We look forward to receiving your feedback on these proposals.

Now, this actually concludes the presentation part of today's webinar. I'll now hand over to my colleague, Ms Diane Wilkinson, who will facilitate and moderate the Q&A session. 

Over to you, Diane. Thank you.

WILKINSON, Diane   29:49
Thanks, Hongxia. 

Good afternoon, everybody. We have some other TGA colleagues joining for the Q&A session. 

I have Chris Hidayat from the Listing Compliance section – he will help convening the questions. We also have Jenny Cheng from the Listing Compliance section. I have Matt Davis from the Manufacturing Branch and Sonia Tafalgar from the Laboratories. 

What we will do first is go through the pre-submitted webinar and I'd like to thank those that have put those questions in already.  And when we've gone through those, we'll go through the live questions as well. 

And then if we don't get to any of your questions, we will have an e-mail address at the end of the Webinar that you are welcome to provide any questions to us.

So, I'll start off with: Will the webinar be recorded? And the answer is yes, the webinar will be recorded, and we'll post a copy on our website in the next coming weeks. 

Then the next question is for Avi: Does the TGA have regulatory oversight of toxicology reports for cosmetic products?

CLARKE, Avinash   30:55
So generally no, and that's because the TGA does not regulate cosmetics. Cosmetics are generally regulated by the Australian Industrial Chemical Introduction Scheme, who look at ingredients as well as the ACCC.

WILKINSON, Diane   31:08
Thanks, Avi. 

And following on from that question:  Do sunscreens regulated by the TGA require a toxicology report?

CLARKE, Avinash   31:17
So as listed medicines, therapeutic sunscreens can only use low-risk ingredients that are included in a TGA pre-approved list. So, when the TGA evaluates a new ingredient, we assess safety data, including toxicological reports.

Sponsors also certify that their sunscreen is safe for the purposes for which
it is to be used for when listing a sunscreen on the ARTG. And these toxicological reports can be used as supporting data for this certification.

WILKINSON, Diane   31:48
Great. Another one for you, Avi. 

How will the TGA streamline labelling, manufacturing and other regulatory requirements of sunscreens to make sure changes are clear? And how will you ensure consistency with other guidance such as the sunscreen standard and your own sunscreen guidance?

CLARKE, Avinash   32:05
So part of this is we don't know what we're necessarily streamlining. So, what will need to be streamlined will depend on what changes are made and what decisions are made. And this consultation will very much inform that. 

If any changes are implemented as an outcome of this consultation process, the TGA will consider transitionary periods and where we can streamline. Education will also be a key part of this in implementing any new requirements. So, that could be through guidance materials and holding webinars,such as this.

WILKINSON, Diane   32:42
Thanks, Avi. And another one for you. 

Is regulating therapeutic sunscreens as low risk listed medicines the most appropriate framework? Should there be a new unique regulatory framework for sunscreens?

CLARKE, Avinash   32:56
So at this stage, we are proposing improvements to the current framework for listed sunscreens. 

As you would have heard when Lisa spoke that we have put an option in the consultation paper where sunscreens would be pre-market evaluated, as registered medicines. But that said, we welcome views. So, if there is an alternative suggestion, I encourage you to submit it as part of our response to the consultation paper.

WILKINSON, Diane   33:27
Thanks, Avi. And now a question for Lisa. 

If sponsors had to use testing laboratories that were accredited, some of the recent product recalls may have been prevented. Will SPF testing laboratories now have to be deemed technically competent?

KERR, Lisa   33:44
Thanks, Diane.

So having more regulatory oversight of SPF testing laboratories, such as requiring the ISO 17025 accreditation, is one of the options that we're considering at the moment, noting that the TGA doesn't have jurisdiction over overseas laboratories or indeed, laboratories in Australia. 

However, there's a couple of different options that we put in the paper. So, I guess one of the things that we're not saying is that laboratories, specific laboratories, are not competent, but the current system of accreditation and conformance, that is already in existence, means that you get externally audited so that, an external auditor comes and has a look at your actual compliance. 

We're aware that some of the sunscreens testing laboratories claim compliance with particular standards, but that doesn't necessarily mean they've had a visit from an external accreditation body. So the short answer is yes, we are considering that and there are already some options available, on the TGA website.

WILKINSON, Diane   34:45
Thanks, Lisa. Another question for you. 

SPF testing is known to be subjective. Why has the in vivo test method remained in use for so long?

KERR, Lisa   34:56
That's a good question. So SPF testing methods have been under development for a really long time. The current method within vivo testing was only published by ISO in 2010 and updated in 2021. That has been sort of the only internationally recognised method as far as we're aware, until just recently, as I mentioned,

The 2 new methods that allow for in vitro or hybrid testing were only published in December 2024. So, they're only recently available. And the validation data for those two standards were only published in September last year. So, it's only sort of a recent thing that we've been able to have a different option for the testing.
of SPF.

WILKINSON, Diane   35:40
Thanks, Lisa. Back to you, Avi. 

Will the addition of a fragrance in a very small quantity to an approved base formulation require full SPF ISO compliant testing?

CLARKE, Avinash   35:56
Thank you for the question. 

Requiring finished product testing is one of the options being considered in the consultation paper, but we would welcome feedback in relation to that option on the issue of fragrances.  So, there's no decision that's been made.

So, while those options are being considered, just to be clear, currently, it is up to the sponsor to demonstrate the efficacy of their sunscreen. So, if the base formulation has been modified, it is up to the sponsor to demonstrate that, that base formulation efficacy data can still apply to a finished product, with the addition of a fragrance, using scientific justification that is substantiated by evidence. So, if a sponsor cannot do this, then they should be conducting further SPF testing in accordance with the standard to ensure the efficacy of the finished product.

WILKINSON, Diane   36:47
Thanks, Avi. I have another one for you which isn't in scope of the consultation paper, but I think it will be of interest to the audience. 

Why are sunscreen testimonials treated so strictly? Wouldn't accounts of personal experience help increase consumer usage of sunscreens?

CLARKE, Avinash   37:06
As you mentioned, Diane, advertising is out of scope for this consultation. 

However, from our perspective, consumers should be able to trust the testimonials used in advertisements of therapeutic goods and that they're genuine unbiased accounts of an ordinary consumer's use of the product.

So as such, testimonials in advertisements about therapeutic goods from people that are involved in the production, marketing, or supply of those goods, or who may receive a benefit or some kind of incentive for making the testimonial, that's prohibited. But people not involved in this way are free to make testimonials about their sunscreens experience.

WILKINSON, Diane   37:46
Great, thank you. Another one for you, Avi. 

Would the new regulations apply to sunscreens made overseas, such as Korea or Japan, which are popular with consumers due to having a thinner texture in the product? Should makeup be excluded from any new rules?

CLARKE, Avinash   38:04
I'll just reiterate a lot of options are under consideration. 

So, to be supplied in Australia, sunscreens must meet the relevant Australian regulatory requirements. So, one of the proposals in the paper is for sunscreens that make high level sunscreen protection claims to be regulated consistently as primary therapeutic sunscreens.

So, under this proposal, cosmetic sunscreens will still be able to make sunscreen protection claims. However, there will be lower-level claims. Higher level claims won't be allowed under this option.

WILKINSON, Diane   38:36
Thanks, Avi. Hongxia, a question for you. 

Why isn't there mandatory access to formulations and manufacturing information?

JIN, Hongxia   38:47
Thank you, Diane. 

All sunscreen products must be entered on the Australian Therapeutic Goods Register, the ARTG, before they can be supplied unless there is a specific exemption. 

The product entry in the ARTG includes a lot of information that's publicly available, including active and inactive ingredients. As most therapeutic sunscreens are regulated as listed medicines, there's currently no requirements to include excipient information on product labels, unless there are special requirements attached to an ingredient such as an allergen claim. 

Manufacturing information are commercially confidential information and it's not publicly available at the moment. 

WILKINSON, Diane   39:32
Thanks, Hongxia. Avi, back to you. 

When do you expect the changes to be implemented?

CLARKE, Avinash   39:48
No decisions have been made yet. While this is a fair question, we really do want to partake in this consultation process as openly and constructively as possible. 

So, following consideration of consultation responses, we will publish the outcome on our website, and that includes any decisions on regulatory reform,
and implementation plans.

WILKINSON, Diane   40:13
Thanks, Avi. Another one for you. Will consumers be further consulted?

CLARKE, Avinash   40:18
Yes, so in addition to this public consultation, we will undertake targeted consultation, as needed, based on certain decisions that are made around where we go. 

This would definitely include consumer groups, particularly if labelling changes are made for SPF claims - we would very much anticipate further consultation.

WILKINSON, Diane   40:43
Thanks. Another one for you. 

Will the TGA conduct evaluation, after any proposed changes, to see if the changes affect people's behaviours?

CLARKE, Avinash   40:56
The TGA will work closely with relevant organisations to monitor and get feedback on consumer uses of sunscreens, and work together as much intelligence as we can, on how any potential change may affect a person's behaviour.

WILKINSON, Diane   41:13
Thanks, Avi. Back to you, Lisa. It has been reported that certain laboratories falsify their SPF test results. How is the TGA going to ensure that every day Australians are not harmed by fraudulent operators?

KERR, Lisa   41:28
Thanks, Diane. 

So, as we discussed before, having accreditation of the SPF testing laboratories is one way to do that. 

This involves not just claiming that you are complying with a particular standard, but an external auditing body actually comes and has a look at your records, has a look at the testing that you're doing. 

There's a traceability element to that as well. So, for example, if you receive a visit from an auditor, as we do, because we have this type of accreditation, they will pick a sample and they will trace back all of the calibration of your instruments, the training of your staff, the raw results of your testing, even to the procurement of the instruments that you've had. So, there's an external independent review of the performance and competence of the laboratory.

WILKINSON, Diane   42:25
Great. Lisa, one more for you. 

Has the TGA considered engaging universities to conduct SPF testing on behalf of the TGA? This could be a great opportunity to train STEM students and for Australia to become real global leaders in sun protection.

KERR, Lisa   42:41
Thank you for the question. 

The short answer is no, although the TGA is engaging with universities at this point in time, and it's not necessarily in scope of our discussions with universities. 

I do agree that it would be great for local industry to have access to more testing laboratories, but that accreditation part is the critical thing. So, if a testing laboratory in a university wanted to take up this type of work, then they also would be expected to get the relevant type of accreditation to demonstrate their competency of their work,  plus the reliability of their test results.

WILKINSON, Diane   43:22
Thanks, Lisa. 

Avi, will you consider requiring products to provide information about applying combinations of physical and chemical sunscreens?

CLARKE, Avinash   43:36
Thank you for the question. 

So, I suppose from the TGS perspective, all sunscreens are made from chemicals, but they work in different ways depending on their active ingredients.

Mineral sunscreens, also called physical, use the chemical zinc oxide and or titanium dioxide as their active ingredients. Both mineral and other chemical sunscreens ingredients protect against the harmful effects of UV radiation and offer advantages and disadvantages. So, for example, mineral sunscreens may be gentler on the skin, but can feel thicker and heavier, or other chemical sunscreens are generally more lightweight and non-greasy. 

We recommend that consumers choose the product they prefer, as they're likely to use it more frequently.

But, in general, we're not at this time considering providing advice on combining different sunscreens products at this time. But again, welcome to receive feedback through consultation.

WILKINSON, Diane   44:34
Thanks, Avi. 

The sunscreen label warnings and advisory statements used to be included in the TGA's guidance, which used to be called Australian Regulatory Guidelines for Sunscreens, and now it's updated to Understanding the Regulatory Framework for Therapeutic Sunscreens. 

Do you have intentions of putting those label warnings and advisory statements back in the guidance?

CLARKE, Avinash   44:58
So current labelling requirements for sunscreens are across multiple pieces of legislation.  So, for example, the permissible ingredients determination has requirements for individual sunscreens, whereas the sunscreen standard includes advice on labelling statements for usage. 

I think, at this point in time, we'd really encourage current legislation to be referred to, so this ensures that sponsors are using the most up-to-date information and mitigates the risk of any guidance that may be temporarily outdated. 

But that given, we have recently consulted on the Therapeutic Goods Order 92, which is a labelling order. And there, we propose to include labelling instructions for different sunscreens, dosage forms in the revised order.

WILKINSON, Diane   45:43
Thanks, Avi. Lisa, another one for you. 

Will the TGA permit the actual SPF of sunscreens to be advertised by the manufacturer, rather than general SPF claims such as SPF 30 or SPF 50?

KERR, Lisa   45:58
Well, that's covered by the consultation paper and happy to receive views on that. I think that question may have come from the base of some manufacturers trying to formulate sunscreens that claim well above SPF 50, so SPF 60 or 70. 

Under the current consultation, and the framework that we're looking at this point in time, if you're trying to formulate a sunscreen with an SPF that's that high, it seems to be unlikely that that will be permitted at this particular point in time. 

I hope I've interpreted that question accurately, but we're happy to hear your views on that. So, please put a submission in.

WILKINSON, Diane   46:38
Great. Thanks, Lisa. 

Another one for you that's not in scope of the consultation paper, but an interesting one. 

The current broad-spectrum claim does not tell consumers or clinicians how strong the UVA protection is. This is important information for consumers with higher UVA protection needs, such as patients taking targeted cancer therapies. Will the TGA consider requiring communication of stronger UVA, UVA1 protection to meet the growing needs of patients and clinicians?

KERR, Lisa   47:08
Thanks, Diane. That is a really good question. 

And yes, it's not currently a focused topic of the current consultation, but that doesn't mean that we won't look at it in the future. 

I do just want to cover off on a couple of things with the current situation for UVA. So the current framework requires if you're going to claim broad spectrum in your label for a sunscreens sponsor manufacturer, there is 2 aspects to consider. The first one is that there's a requirement for a critical wavelength to be reached and in the current setting, that's equal to or over 370 nanometres and, that's the critical wavelength. So 90% of the absorption has to be reached by 370 nanometers. 

So what that tells us is that the formulation absorbs over the range of UVA, or most of the range of the UVA, but not necessarily how strong the protection is. So, there's another requirement under the current framework whereby the UVA protection factor, which is tested through another mechanism, must be at least a third of the SPF value. So, for example, if you're a sponsor making a label claim of SPF 50, your SPF, under the current situation, must be SPF 60, which means that your UVA protection factor must be at least 20. So those are already in existence.

If you've got a different view, you think that that should be strengthened, please let us know.

WILKINSON, Diane   48:41
Thanks, Lisa. Back to you, Avi. 

Why does the TGA think that the proposed labelling changes for SPF claims will be better understood by consumers than the current SPF ratings?

CLARKE, Avinash   48:53
Thank you. 

This is a fair question. And we talked about a little in the presentation. So, we understand that the current labelling has been in place for a long time, over 50 years, and consumers are used to it, and we very much appreciate that consumers are used to it. 

But from what we know, there's a general lack of understanding among consumers about the SPF rating scale, itself, and what the figures would mean in real terms. And so. that includes what was discussed previously that it's not a linear scale and the difference between 30 and 50 is quite small, 97% versus 98% protection. 

And also, that there is variability in the testing, that the precision with which a test could potentially identify a very specific SPF number is limited. So those are the reasons.

I just want to highlight that no decisions have been made, and if there was a decision to change SPF label, we would engage further with consumers and ensure that there is an education campaign and adequate transition time. We really acknowledge that any further changes to SPF labelling will require more discussion and take time. It is not something we will do overnight, at all.

WILKINSON, Diane   50:15
Thanks, Avi. 

Given the importance of sunscreens in Australia, why does the TGA consider making it a requirement that all sunscreens should provide a minimum of SPF 50? 

I will put that to you, Avi.

CLARKE, Avinash   50:28
That's an interesting proposal.

I think from our perspective, allowing other SPF claims gives sponsors flexibility and enables greater choice among consumers. So, for example, a consumer may wish to use a product for another primary purpose, such as a cosmetic, where they might not be exposed to high levels of UV radiation and, only may have very smaller incidental sun exposure.

It's important to point out that only sunscreens that provide an SPF over 30 can make the high level sun protection claims, such as preventing some skin cancers.

WILKINSON, Diane   51:09
Thanks, Avi. 

How does the TGA regulate ingredients that are included in a sunscreen for cosmetic purposes? Can non-therapeutic claims be made for these ingredients and can their presence be declared on the label?  Again, Avi.

CLARKE, Avinash   51:24
This is a good question. 

So, from our perspective, therapeutic sunscreens may also carry non-therapeutic claims, provided they are truthful, not misleading, and a sponsor holds evidence to support these claims, such as cosmetic claims like moisturising.

Given an active ingredient in a medicine or sunscreen is a therapeutically active component, responsible for the medicine's physiological or pharmacological action, a cosmetic ingredient can only be an excipient. Sponsors may elect to include all ingredients on their sunscreen labels, such as including all excipients.

However, sponsors need to be careful about the presentation of excipient ingredients on the label to ensure that it does not suggest the ingredient has a therapeutic purpose.

WILKINSON, Diane   52:13
Thanks, Avi. We've just got another 8 minutes to go. 

That's all our pre-submitted questions, so I'll move on to the live questions and just the first ones that have come in. 

And as I said, if we don't get through all your questions, please feel free to e-mail us on the e-mail address that is on the screen now.
So, the first question is: Who does the testing of SPF for sunscreens? Is it the manufacturer or the product owner? Lisa, would you like to answer that one?

KERR, Lisa   52:44
Thank you.

The testing is done on the pilot batch, so it's the manufacturer, but the sponsors are expected to have those results. Hopefully that answered that question.

WILKINSON, Diane   52:56
Fantastic, thanks, Lisa. Another one for you.

CLARKE, Avinash   52:58
I’ll just add that it is a sponsor who lists the medicine. So, a sponsor really needs to ensure that all the evidence they have, they're satisfied with.

WILKINSON, Diane   53:10
Thanks, Avi. 

Another one for you, Lisa: Is there consideration being given to requiring brands to make their testing results publicly available to customers, such as ‘Playface SPF’ is championing?

KERR, Lisa   53:24
Well, that's actually part of the consultation paper, so we look forward to hearing what people have to say. 

So, the short answer is yes, we are considering that, but it really does come down to what the consultation comes up with.

WILKINSON, Diane   53:37
Fantastic. 

For mineral sunscreens, aside from tightening up on the specification of zinc oxide, is the TGA looking to restrict the use of so-called booster excipients, that as analogues of known approved filters are also organic filters? 

Products using these are often misleading labelled and confusing to sponsors.
They may also compensate for underperforming primary filters. 

CHENG, Jenny   54:10

So, these sunscreens can only use ingredients on the permissible ingredients determination.  And currently, ingredients on the determination can either be used as active ingredients or excipients.

Ultimately, it's up to the sponsor to define which ingredients that they're using are actives versus excipients. There are also restrictions in the determination on whether some ingredients can even be used as actives.

Thanks Jenny,

Just another one about the timelines. 

Avi, do you just wany to reiterate the estimated timelines for  implementation of changes and any subsequent grace period.

CLARKE, Avinash   55:05
I just want to reiterate that no decisions have been made. 

And so, we will closely consider all the feedback we received through the consultation responses. 

And I think the other thing, is that we don't intend to do everything all at once, that certain changes might be easy and straightforward. And we might do those and other larger ones, for example, SPF labelling, is something that we would really take time to do and likely talk about and discuss further.

WILKINSON, Diane   55:38
Thanks. 

Put it to the panel, a question on cosmetic sunscreens. 

What SPF limit is being considered for cosmetic products? What is the evidence basis for setting this limit and how will this impact existing SPF 50 cosmetic products already in the market? 

On labelling, the new sunscreen labelling system would not be aligned with the rest of the world. Would this create issues for sunscreen produced outside of Australia? So 2 questions there, I guess. 

The first one is the cosmetic sunscreens and what is the SPF limit being considered for cosmetic products?

CLARKE, Avinash   56:18
I can probably start, but Jenny, chime in if you need.

In terms of cosmetic products in other, so generally, secondary sunscreens and primary sunscreens, in other cases, 15 plus is generally considered therapeutic, but we haven't made a decision. 

So, we're open to hearing feedback. 

I think in terms of aligning with the rest of the world, I think that's something we'll need to think about and really open to hear views around if we do end up going down that road, how we can be as closely aligned as possible, noting
that this might move away from what might be happening in other jurisdictions. 

But I'll just check if anyone else on the panel wanted to chime in.

CHENG, Jenny   57:15
I'll just add to that.

So there was a question about how would it impact on existing SPF 50 complexion products. 

If those businesses want to continue to claim SPF 50, those products will then have to be listed on the ARTG and be SPF tested in the way that other therapeutic sunscreens currently have to as well. 

The consultation paper is asking for feedback as to, should we limit the cosmetic products and so, we would really love feedback on that.

WILKINSON, Diane   57:58
Thanks, Jenny and Avi. One for the labs. 

With the new ISO test method, has there been enough testing done to give weight to the deviation of results?

KERR, Lisa   58:12
I'll take that one. 

So, unusually for an ISO standard, the drafting group. that wrote the new in vitro and hybrid standards, did a pretty comprehensive statistical design of the validation study that they did. That normally is just available to the committee that does the drafting, but the drafters chose to actually publish those results, the validation study, in an international journal, so the International Journal for Cosmetic Science. 

And it's open access, so anybody can go and read it. There's about 8 papers that have been published on the performance of the in vivo or the older standard versus the new in vitro standards. 

I have heard some stakeholders say that, you know, it's all very well and good to have an ISO standard - which is officially published, by the way , so, it's not going through a process, it has been published and, in some jurisdictions available to
be used freely already.  So, the comments have been around, is there enough real world evidence? The validation study says that the two methods, in vivo and in vitro, are quite comparable and so, there shouldn't be any deviation of results other than the natural variation, that I was talking about before in the webinar.

Sonia, did you want to add anything to that?

TAFLAGA, Sonia   59:36
I was just going to agree with you and also, state that in the validation, it was part of their purpose was to make sure that it met the in vivo current 2444 in terms of the strength of the validation. So from our perspective, it's looking better than the 2444 original data.

KERR, Lisa   59:57
Okay, so like I said, we're comfortable enough to have put on our website in September last year that we'll accept test results using the new standard.

WILKINSON, Diane   1:00:08
Thanks both. We've come to 2pm. 

I've got a few questions that we didn't get to, but reiterate that you're welcome to send them to our e-mail address. 

But I will just ask this one, is “ You've mentioned that you'd like to hear about opinions on SPF label changing - how and when by?

So ,our consultation is closing on the 23rd of May and the link is available on our website and you can just click on that and everyone is welcome to put their submissions in, either via the Citizen Space questionnaire, or you can also just submit a response by e-mail. 

I'll hand over to Nishi to conclude the webinar. Thanks everybody.

HEWAGE, Nishie   1:00:52
Thank you very much, Diane. 

And with that, we have come to the end of today's webinar. A big thank you to everyone who joined us and to our speakers for their insightful presentations and for taking the time to respond to questions during this session. 

Just a quick reminder that a recording of today's webinar will be published on the TGA website in the upcoming weeks.

And as Diane just reminded as well, if your question was not answered today, you're very welcome to contact us by e-mail after the session. 

Thank you again for your time and engagement, and we hope you have a great rest of the day.