In the 4th and final post in the Spotlight on Sun Protection series, we’ll take a look at Australia, New Zealand & India and wrap up with some final thoughts on this series and manufacturing sunscreens. If you’ve just discovered the spotlight on sun protection series, you can click the links to take a look at part 1, where we covered sunscreen regulations in the USA, part 2: the EU and part 3: Asia. Australia and India were presented by Alain Khaiat, Ph.D. of Seers Consulting during a very informative half day scientific seminar I attended at In-Cosmetics Barcelona. Australia and India both have rigidly outlined stability data requirements when compared to other regions of the world, most likely due to the fact that both areas of the world can experience extreme heat.
Australia has a maximum SPF rating of 30+. There are 2 different classifications for sunscreens depending on the SPF rating. If the sunscreen has an SPF less than 15, it is considered a cosmetic; if it’s greater than 15, it’s listed as a medicine. The registration lead time is 1 month and requires the complete formulation and manufacture process, which must be conducted in a TGA approved site that has GMP (good manufacturing practice) pre-clearance. While the lead time is only a month, Australia requires a very specific stability testing report be completed first. The report needs to show the product is stable for anywhere from 6 months to a 3-year shelf life, and has rigid requirements as to the temperatures the sunscreen must be exposed to for the shelf life claim. Any accelerated testing the formulator uses for this specific data must also be confirmed by real-time testing. Since all data is required for submission to complete the 1 month registration process, the manufacturer needed to begin collecting the data over 3 years prior in order to obtain a 3 year shelf life rating. The manufacturer does not need to provide a product sample unless it’s requested, but must submit final packaging along with any proprietary ingredients (this usually means the fragrance) which also need to be registered with TGA. A separate SPF certificate is also required.
You may recall that we discussed Hong Kong’s lack of requirements in part 3… Like Honk Kong, New Zealand does not have a registration or notification process for bringing sunscreen to market. There is also no limit on the SPF factor that can be claimed on the label. So if you happen to find an SPF of 70 over there, it does not mean it’s any more powerful than the SPF 30+ you may have picked up in Australia, it’s solely the labeling claims that the country is allowed to print by law.
In India, sunscreen is considered a cosmetic and there is no maximum SPF rating. India has different registration lead times for sunscreens depending on if the product is made locally (3 months), or for import (9 months). India requires the manufacturer to release the full product formulation, including the quantitative formula with declaration and disclosure of functions of ingredients. All label text must be disclosed during the registration process along with the product specs, manufacturing process, chemical and microbiological testing methods and any data supporting product claims. India requires the manufacture to run a minimum of 2 pilot batches before registering a sunscreen. India requires specific stability testing requirements to show shelf life of the sunscreen. Testing may be done using accelerated methods of exposure to extreme heat. However, any data that is accelerated also needs to be confirmed by real time testing, so the process takes longer than the 3 or 9 months since the real time data (for up to a 3 year shelf life) needs to be available to register.
If you’ve followed this 4-part series, you’ll see that while there is no global harmonization in sunscreen or SPF ratings the different areas of the world do have one thing in common… It’s a very expensive, involved and a time consuming process to bring a sunscreen to market! As the owner of a small cosmetic company located in sunny Southern California that manufactures products, we are often asked why we don’t make sunscreen. The answer is simple; small and indie manufacturers simply cannot afford to manufacture their own sunscreen. The only way for a small or indie manufacturer could sell a sunscreen under their brand name is through a private label process where a registered lab has gone through what I’ve outlined in the past 4 posts (depending on the region of the world) and is manufacturing the sunscreen for their brand. You should be able to decipher this by looking at the “manufacturer information” on the product label which is required in most regions of the world. Hopefully this series has enlightened you a bit when it comes to sunscreens… remember, the higher the SPF # rating does not always mean the “better” sunscreen; there are so many factors due to consider the different laws and lack of continuity across the globe.