I Just Found Out That I Have to Reformulate my Sunscreen!
?John Staton: SciPharm
I Just Found Out That I Have to Reformulate my Sunscreen!
It is unfortunately inevitable, given todays regulatory and safety environment that, from time to time, your sunscreen will be impacted by one or many requirements to re-formulate. This is independent of changes to efficacy requirements. The current review of toxicity of sunscreen actives is a good example. In both the E.U. [1] and U.S.A. [2], the suitability of UV actives, particularly those with a long history of use, has been challenged. Whilst the FDA has taken a blanket approach and called for updated/additional safety data across the board of organics, the E.U. approach is to consider each active as a separate exercise. Whilst the science would tell us that both should be considered, each approach generates is own set of issues.
For the USA, the FDA blanket approach currently taken means that re-formulation is somewhat in limbo until it is known if generation of the required additional safety data for older actives is financially viable. It is unlikely that FDA would ever defer to accepting a review from another jurisdiction as an alternative to data submitted by the suppliers of the UV actives.
For Europe, the process of more or less “picking the active off” one at a time will create and on-going moving target for re-formulation into the foreseeable future.
For Australia, the original list of approved actives was established on approval in at least one of the two above regulatory environments although several newer materials may have been added based on more recent toxicity data packages. If this process is followed, then it means that the priority for review will likely, for the time being, defer to considering E.U. changes, rather than a blanket approach as taken by the FDA.
How Long Will It Take to Reformulate?
The simple answer is “a long time”. See the flow chart below. Fig. 1.
You can put your own time interval on each step) but they will generally add up to around a minimum of 2 years. In the meanwhile, another change could have occurred and again impact! Perhaps the first consideration is that each active has its unique contribution to protecting from UV Light across the wavelengths required for sunburn and long-term damage protection. i.e. they are not simply interchangeable. Additionally, for the now very prevalent SPF 50 and SPF 50+ category, multiple actives have to be cocktailed together in order to achieve efficacy. Typically, such formulations contain 4, 5, or more individual actives.
Another factor to consider is that a change can be required because of several differing issues. In the past, the simple removal of a chemical prevailed i.e. negative or positive lists, together with maximum limits. Perhaps driven primarily by advances in analytical chemistry, limit tests for contaminants of both actives and excipients is now an additional challenge. If a chemical contaminant of concern is generated during raw material manufacture, then this is mostly controllable by Q.C. before or on delivery. ?However, if it is generated by degradation during product shelf life or use, then this requires longer term stability testing and post market retesting over the shelf life. Sunscreens have a shelf life of 2 or 3 years, so this period alone may be needed in order to confirm compliance and can add to the time line indicated by Fig. 1
The Issue of Regulatory Lag times
In Australia, the adoption of the revised Sunscreen Standard, AS/NZS 2604:2021 Amd 1 in the legislation [3] commenced from 1st July 2024 with a 5 year transition. Thus, we are already in a transitionary stage with potential cost impact for sun protection efficacy testing.
An additional consideration is the seasonal nature of the market, where R & D for any replacement formula has to co-ordinate with a timeline for ingredient purchase, manufacture and then finisher product distribution.
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How can I pre-prepare?
It is also certainly prudent to be pro-active and to have a professional review the “big picture”. For example, if there is an action on a particular type of chemical, then an active with a similar molecule might be impacted. A current example might be Homosalate [Homomenthyl Salicylate] which has recently which has recently been the subject of an SCCS Opinion significantly reducing its allowable usage in the E.U. ?Other salicylates used as UV actives may need an up-to-date tox review. Whereas simple substitution might appear to be a quick fix, it is not so simple!
Cost Impacts
Wow! So Many! Beyond the obvious direct R & D expenses, it is very likely that the substitute actives will be more expensive. This would impact substantially for large pack sizes such as marketed for schools, outdoor workers and similar … and the cost of having to accept stock returns from retail – and potential product relaunch! For some brands, changes specifically related to one market may mean having to run differing formulations for that market – so separate manufacturing costs. In a worse case, the brand could simply leave the market of the country or countries – again with impacts on product availability.
Are Sunscreens Less Safe Than Sun Exposure?
The answer to this is almost certainly going to be NO! This is the likely position that the educators in the market would support – think Cancer Councils and other skin cancer professionals. Essentially, the concern is that instant or even short time frame banning of an ingredient has potential for generating shortages of products and is thus counter-productive. Whilst time might appear to some to be of the essence, the industry needs this in order to ensure that safety and efficacy of any new substitute formulation is fully evidenced. At least 5 years is a more realistic time frame unless the issue is of an urgent nature.
Love to have your feedback!
References
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Investigation Officer at Office of the Commonwealth and ACT Ombudsman
2 周great to see u r still on top of it! Robyn
International dispute resolution expert, external general counsel, non-executive director
3 周A very interesting and thought provoking article
Account Manager at Ingredients Plus
3 周Great article as always John.
Photobiology Manager at Eurofins | CRL, Inc.
3 周Thanks John, excellent flowchart!
Fantastic post, John! You really captured the complexity of sunscreen product development and global regulations.