The Formulation of Guidelines fortheEvaluation of Cosmetic Functions
Makoto Kawashima, Chairman of the Committee for Studying Evaluation Methods for Cosmetic Functions
As Japanese society ages, consumers have increasingly higher expectations of products to counteract wrinkles, pigmented spot, and other signs of aging. Research and development have been carried out to further increase the functionality of cosmetics (including quasi-drugs) that are designed to keep the skin healthier, so that these products can meet the hopes and expectations of consumers. At the same time, there have been huge advances in the techniques and instruments used to evaluate the efficacy of cosmetic products. However, while there is now a large body of data relating to efficacy, the way it is evaluated varies depending on the company. Both consumers and the cosmetics industry itself have pointed to the need to unify evaluation standards.
Given this situation, the Japanese Cosmetic Science Society (JCSS) has been holding repeated discussions at symposiums and seminars since 2000 on topics such as standards for evaluation method, efficacy, cosmetic efficacy and its regulation and cosmetics based on evidence. In addition, in 2003, with the aim of establishing objective evaluation methods, the board of directors decided to address these topics across the JCSS by setting up the Committee for Studying Evaluation Methods for Cosmetic Functions under the guidance of the president of the JCSS, Shotaro Harada. Each of relevant committees is made up of JCSS members and includes dermatologists, pharmaceutical researchers, members with a background in government, and cosmetics researchers.
On 14 February 2004, a full meeting of the Committee for Studying Evaluation Methods for Cosmetic Functions was held with the four task force committees established under it: the Task Force Committee for Evaluation of Antiaging Function, the Task Force Committee for Evaluation of Whitening Function, the Task Force Committee for Evaluation of Sunscreen Function, and the Task Force Committee for Evaluation of Safety. At this meeting, the directionality and objectives of the committee were confirmed. The task force committees and working groups subsequently met repeatedly for diligent discussions, and an intermediate report was released at the 30th Convention of the JCSS in 2005. The final report, which was released at the 31st Convention of the JCSS in June, 2006, incorporated the views of the committee members and cosmetics industry experts with regard to the draft guidelines that were announced in January of 2006.
The evaluation methods must, of course, be scientific, objective, and reproducible. The guidelines are divided into four specific areas that share a common approach. First, as a basic condition, objectivity and homogeneity must be maintained throughout, for example, ensuring uniform test conditions and using third-party institutions to implement tests or allocate samples. In addition, visual and safety evaluations must be performed by dermatologists as specialists or dermatologists with equivalent clinical experience, or otherwise, trained experts with expertise in the relevant functional evaluation. The instruments used for measurements must be currently available and must be used internationally for evaluating cosmetics. In addition, the use of materials such as reference criteria for image correction or skin tone color charts as supplementary measures is recommended to ensure further the objectivity of evaluations.
An outline of the guidelines for each area is given below.
Guidelines for Evaluation of Anti-Wrinkle Products
The guidelines for tests to evaluate anti-wrinkle functions are divided into those for cosmetics and those for quasi-drugs. Judgements of efficacy should be made on the basis of visual and photographic evaluations using photographs showing the standards for the wrinkle grades, in combination with the results of instrument measurements of wrinkles. With cosmetics, product application and non-application groups should be compared, and efficacy should be determined on the basis of significant differences found in wrinkle improvement in either visual, photographic, or instrument evaluations. With quasi-drugs, active ingredient and placebo application groups should be compared in a double-masked trial, and efficacy should be determined on the basis of significant changes in wrinkle improvement in visual, or photographic, and instrument evaluations. The test period is 2 weeks or more for cosmetics and 2 months or more for quasi-drugs. Cosmetics to be tested are products intended to make dryness-induced wrinkles less obvious, and quasi-drugs to be tested are products intended to improve wrinkles. Supplementary Guidelines are the Wrincle Photography, for use with photographic evaluation, the Wrinkle Measurements, for use when using instrument to measure wrinkles, and the Standard Wrincles Grades, for measuring wrinkle grades.
Guidelines for Evaluation of Quasi-Drug Whitening Products
Efficacy is determined by means of a double-masked trial comparing active ingredient and placebo application groups, and the product is judged to be effective if a significant difference in the visual or photographic evaluation that is not contradicted by the results of instrument measurements is observed. Considering the mode of action of whitening formulations, the test period is a minimum of 1 month. Products to be tested are quasi-drugs that are intended to gently improve pigmentation. Supplementary Guidance is the Guidance for Pigmentation Measurements, for use with instrument measurements.
Guidelines for New Efficacy Claims of Sunscreen Products
Unlike the other guidelines, these do not set out measurement methods. Measurements should be carried out using the Standard Sun Protection Factor Test Method or Measurement Standards for UVA Protection Efficacy that have already been established. A review of the literature in regard to protection against UV light shows that UVA protection is effective for the prevention of photoaging, and that products with SPF 15 or greater are needed. Sunscreen is fully recognized in the field of dermatology to be effective in preventing photoaging. Nonetheless, it is essential to maintain objectivity in the measurement of SPF and UVA, which are fundamental to the efficacy of sunscreens; therefore, the establishment of a third-party institution in Japan to check SPF and UVA measurement results needs to be considered.
Guidelines for Evaluation of Safety of Functional Cosmetics
The present evaluation methods check the efficacy of functions such as improvement or prevention of wrinkles and improvement of pigmentation, which go beyond the scope of the current regulations. Conventional thinking that the effects of cosmetics go only as far as the level of the stratum corneum is no longer sufficient, and the directionality of the guidelines is that safety evaluations for formulations should be carried out in humans. With regard to the safety of ingredients, the safety checks that have been stipulated to date are essential.
As mentioned above, the formulation of the present guidelines was a task requiring the fullest efforts of the JCSS. The formulation of the guidelines and publication of the text were only possible through the dedicated cooperation of over 50 dermatologists, pharmaceutical researchers, members with a background in government, and cosmetics researchers.
In particular, I would like to thank Yoshinari Matsumoto, Chairman of the Task Force Committee for Evaluation of Antiaging Function, Katsumi Hanada, Chairman of the Task Force Committee for Evaluation of Whitening Function, Itsuro Matsuo, Chairman of the Task Force Committee for Evaluation of Sunscreen Function, and Masafumi Iijima, Chairman of the Task Force Committee for Evaluation of Safety, who kindly took on the difficult task of completing the Guidelines within a short space of time.
The formulation of the present guidelines is the first step toward new evaluations of usefulness for cosmetics. Revisions to accommodate new findings and further discussions based on developments at international level may be needed in the future. Education will also likely be needed to maintain the level of expertise and technical skills of the specialists carrying out the tests. I sincerely hope that these guidelines will further evolve through the frank opinions and cooperation of JCSS members and other parties, and that ultimately, these guidelines will benefit the consumer.
◆The guidelines can be downloaded here (free)
Guidelines for Evaluation of Cosmetic Functions
- Guidelines for Evaluation of Anti-Wrinkle ProductsTask Force Committee for Evaluation of Anti-Aging Function
- Guidelines for Evaluation of Quasi-Drug Whitening ProductsTask Force Committee for Evaluation of Whitening Function
- .Guidelines for New Efficacy Claims of Sunscreen ProductsTask Force Committee for Evaluation of Sunscreen Function
- .Guidelines for Evaluation of Safety of Functional CosmeticsTask Force Committee for Evaluation of Safety
The JCSS is unable to respond to any inquiries regarding filing for approval of new active ingredients and/or quasi-drugs, the details or validity of evaluation testing methods, or efficacy claims under The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices.
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