Sincere and reliable SPF: a quality process that can be deployed worldwide
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Presented by: Florence POURADIER
OBJECTIVE:
The Sun Protection Factor (SPF) is an international reference to express the protection from erythema, mostly due to UVB rays. It is used for labelling purposes to help consumers on the appropriate choice for the level of protection. Sun Protection Factor is one of the rare cosmetic claims which is determined through a standardized method, such as the globally adopted ISO 24444:2019 standard or FDA 2011 (revision ongoing) OTC sunscreen monography. Despite this standardization, variability in results can be encountered.
The present communication aims at describing the process that our Group put in place to develop worldwide with our partners a high collaborative work in order to get the sincerest and most reliable SPF, with the same global high level of quality, in the respect of the different local regulations.
METHODS:
An international Photoprotection Community was created within R&I teams of our Group with strong local anchorage. This community built and deployed a strategy with global rules and universal measurement following an objective of quality and sincerity of claims.
The key point of this strategy was to set up and developed a common process of selection and validation of a new CRO to integrate a CROs core list.
The main points of this process take into account each step of the protocol and are aligned with the frame of both ISO24444 and FDA methods:
RESULTS:
Through this worldwide community, key steps of a robust quality process which meets both ISO and FDA specifications were identified and deployed in our partners, ensuring more reliable SPF results. Through our ring tests and the regular use of reference formulas, we see that this process reduces the variability that we could observe in the past.
This process has become a key element of the collaboration between our Group and the CROs of this core list, reinforcing the win-win partnership as it has a positive influence for both parties. From our perspective, we appreciate the fluidity brought to the monitoring of our studies and the confidence in the results provided, and from the CROs' side they are pleased with the increased quality of their positioning in the inter-laboratory campaigns organized by BIPEA.
To formalize this process and get these results known within our Group by all the teams in charge of conducting SPF testing, a “Sun Barometer” of CROs was deployed, and regularly updated thanks to regular monitoring done on CROs of the core list.
All the work performed on data quality allows us to be a source of proposal in industry associations and normalization bodies such as Cosmetics Europe, FEBEA, PCPC, ABHIPEC, ISO, ABNT.
CONCLUSION:
This quality guidance put in place by our Group, in partnership with our partners, allows us to enhance reliability of the SPF worldwide in respect with local regulation while deploying a high level of quality control, in order to avoid any risk to the consumer health and claiming sincere SPF. This quality process can be applied the same for other in-vivo photoprotection index and methods, such as UVA-PF or Water-resistance.
The Sun Protection Factor (SPF) is an international reference to express the protection from erythema, mostly due to UVB rays. It is used for labelling purposes to help consumers on the appropriate choice for the level of protection. Sun Protection Factor is one of the rare cosmetic claims which is determined through a standardized method, such as the globally adopted ISO 24444:2019 standard or FDA 2011 (revision ongoing) OTC sunscreen monography. Despite this standardization, variability in results can be encountered.
The present communication aims at describing the process that our Group put in place to develop worldwide with our partners a high collaborative work in order to get the sincerest and most reliable SPF, with the same global high level of quality, in the respect of the different local regulations.
METHODS:
An international Photoprotection Community was created within R&I teams of our Group with strong local anchorage. This community built and deployed a strategy with global rules and universal measurement following an objective of quality and sincerity of claims.
The key point of this strategy was to set up and developed a common process of selection and validation of a new CRO to integrate a CROs core list.
The main points of this process take into account each step of the protocol and are aligned with the frame of both ISO24444 and FDA methods:
- Inclusion of volunteers (skin color homogeneity),
- Application of formulae: Spreading, homogeneity check. “Digital” monitoring is deployed for first validation of technicians, then confirmed in situ,
- UV Exposure, deploying measurements of fluxes before each exposure,
- Readings: training on MED atlases
RESULTS:
Through this worldwide community, key steps of a robust quality process which meets both ISO and FDA specifications were identified and deployed in our partners, ensuring more reliable SPF results. Through our ring tests and the regular use of reference formulas, we see that this process reduces the variability that we could observe in the past.
This process has become a key element of the collaboration between our Group and the CROs of this core list, reinforcing the win-win partnership as it has a positive influence for both parties. From our perspective, we appreciate the fluidity brought to the monitoring of our studies and the confidence in the results provided, and from the CROs' side they are pleased with the increased quality of their positioning in the inter-laboratory campaigns organized by BIPEA.
To formalize this process and get these results known within our Group by all the teams in charge of conducting SPF testing, a “Sun Barometer” of CROs was deployed, and regularly updated thanks to regular monitoring done on CROs of the core list.
All the work performed on data quality allows us to be a source of proposal in industry associations and normalization bodies such as Cosmetics Europe, FEBEA, PCPC, ABHIPEC, ISO, ABNT.
CONCLUSION:
This quality guidance put in place by our Group, in partnership with our partners, allows us to enhance reliability of the SPF worldwide in respect with local regulation while deploying a high level of quality control, in order to avoid any risk to the consumer health and claiming sincere SPF. This quality process can be applied the same for other in-vivo photoprotection index and methods, such as UVA-PF or Water-resistance.