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FANCL貫徹最高生產標準 符合日本及中國監管要求

功效毋庸置疑 安心安全


FANCL 對於香港消費者委員會於2020年10月15日發表的防曬產品測試報告表示失望。FANCL無添加高效防曬露防曬功效經過嚴格的內部與第三方權威機構實驗室測試。根據中國法規以及日本化妝品工業聯合會(JCIA) 的建議測試方法,ISO24444及ISO24442防曬產品體內臨床實驗證實,效果達到SPF50+及PA++++級別。


FANCL認為消委會不接納其他獨立產品測試報告、國際文獻及大學學者建議,在測試結果出現差異的情況下,仍堅持以單一實驗所的測試結果審視產品,可能會誤導消費者,並令公眾對產品及相關企業出現誤解。


就消委會今日發表的測試報告,當中指FANCL 無添加高效防曬露的檢測結果與產品標示的防曬指數出現差異。FANCL就事件曾向消委會提供兩份獨立產品測試報告,一個是美國實驗所(Cantor Research Laboratories),一個是國家藥監局批核防曬產品認可的實驗所(重慶市中醫院化驗所),兩家實驗所的報告均顯示,FANCL 無添加高效防曬露的防曬水平達到SPF50+及PA++++,完全乎合標示。然而,消委會的測試報告卻是SPF14.3及PA++。三份測試報告當中可見,就FANCL相同配方、規格及生產方法的產品進行測試,消委會的報告結果與FANCL委託所做的兩個測試結果,出現了差異的現象。


重慶市中醫院化驗所是國家藥監局於全國認可的九家實驗所之一。由於國家藥監局所採用的標準已涵蓋國際標準化組織(ISO)之標準,並加上國家的規範,故重慶市中醫院化驗所的產品測試報告,達國家監管標準。

三家實驗所所採用的測試樣本,均採用同一配方、標準及生產方式製造。


國際文獻指出 單一測試結果不能作準


FANCL在過去一個月持續與消委會聯絡,並提供兩份獨立產品測試報告、不同的國際文獻及本地大學學者意見,旨在提出進行防曬產品測試時,如果防曬指數出現極端差異的情況,應該重新進行測試,並公佈多於一份國際認可的產品測試報告,以便讓消費者有更可靠、更全面的認知。然而,消委會並没有採納相關建議,堅持以單一實驗所的測試結果審視產品,FANCL對此表示失望。


學者指出 測試結果出現極端差異必須重新檢驗


根據國際文獻及專家指出,由於SPF值是根據受訓練技術人員對紅斑反應的主觀視覺評估計算^1,有可能會因為觀察人員之間的差異而出現系統性偏差;而國際文獻亦指出,即使相同產品,於不同實驗所得出的SPF值,有機會出現極大差異,因而不應只靠單一實驗所的報告作準^2,3


就此差異現象,歐洲皮膚科學會於2020年的立場報告^4亦指出,目前的SPF測試方法,仍然受某些方法上的差異影響,令結果出現可變性。該學會認為應繼續研究對SPF的新測試方法,並作出持續改良。


就PA值而言,FANCL委託的兩間實驗所均於人體皮膚進行測試(ISO24442:2011),而消委會委託的實驗所並未採用人體皮膚進行測試,反而採用了 (ISO24443:2012) 非人體皮膚進行測試。專家提醒,在臨床功能證據等級 (hierarchy of evidence)中,體外測試屬最低等級;而於人體皮膚進行測試的結果,則有更高關連性,亦更具參考價值。


而且,FANCL基於對產品質素的高要求及不加入傷害肌膚的化學物質,採用了物理性防曬,而沒有使用化學性防曬劑,以確保消費者安全。就物理性防曬劑而言,是通過反射紫外線達致防曬效果。故此,使用前必須搖勻及塗抹均勻。此特性相比其他含化學性防曬劑的産品的檢查結果,出現差異的可能更大。


貫徹最高生產標準 符合各地監管要求


事實上,香港並沒有監管護膚品及化妝品的條例,但此産品在日本、中國、新加坡等地均用同樣標示,亦受當地條例規管。加上,國家藥監局認可的實驗所是批核產品入口的化驗所,報告為監管部門使用。


FANCL強調,消委會是香港具公信力的機構。然而,面對產品的多樣性、功能的進化,以至檢測科技不斷推陳出新,消委會有需要定期檢視國際最新資料及測試技術;當出現檢測結果有極端差異時,應該「先求證,後公布」,為公眾提供最適切的產品檢測資訊。


^1 ISO 24444:2010. Paragraph 6.7.3

^2 Miksa et al. (2016) International Journal of Cosmetic Science. 38:541-549.

^3 Trullàs et al. (2019) Photodermatology, Photoimmunology & Photomedicine. 36:351–356

^4 Krutmann et al. (2020) Journal of the European Academy of Dermatology and Venereology. 34:447-454


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FANCL Upholds the Highest Production Standards

Products comply with the regulatory requirements in both Japan and mainland China


FANCL SUNGUARD 50+ PROTECT UV

Photoprotection efficacy reaches SPF 50+ and PA++++


FANCL expresses its regret over the approach the Hong Kong Consumer Council has taken for its latest test report on sunscreen products released on 15th October, 2020. The photoprotection efficacy of FANCL SUNGUARD 50+ PROTECT UV complies with stringent internal testing and evaluation conducted by accredited third-party laboratories. Based on the approved testing methodologies that conform with the regulatory requirements of the People’s Republic of China and the Japan Cosmetic Industry Association (ISO24444 and ISO24442), as well as in-vivo evaluation, the product’s photoprotection efficacy is SPF50+ and PA++++.


The Consumer Council has ignored the test reports conducted by two other independent laboratories which differed from its own report, and rejected international literature and expert opinions on the need to re-test the product before publishing its results from a single laboratory. This approach creates misunderstanding over the reliability of the tested products and the brands involved.


The Consumer Council’s latest report mentioned that FANCL SUNGUARD 50+ PROTECT UV has a photoprotection efficacy at SPF 14.3 and PA++. This result differed greatly from the two test reports commissioned by FANCL, which the company has proactively shared with the Consumer Council. The two reports were conducted by US-based Cantor Research Laboratories and PRC-based Chongqing Traditional Chinese Medicine Hospital (CTCMH), a laboratory approved by the National Medical Products Administration (NMPA) in China. Both tests reported that the product achieved mean SFP values of well above 50 and a PA value of PA++++.


CTCMH is one of the nine laboratories recognized by the NMPA in the whole country. Product tests conducted by the CTCMH are authoritative, as the standard stipulated by the NMPA is not inferior to the standards set by the International Organization for Standardization (ISO).


The samples tested by all three laboratories were produced with the same formula, specifications and manufacturing method.


International literature advises that test results reported by a single laboratory should not be deemed conclusive


FANCL has been engaging with the Consumer Council over the past month, sharing the two independent test reports and other supporting materials, such as international research papers and opinions from local academics. Given the substantial variation in test results, FANCL suggested to the Consumer Council to re-test the product in other laboratories, thus giving consumers more reliable and all-round information. The Consumer Council unfortunately did not accept this suggestion from FANCL.


Experts suggest re-testing when results show substantial variation


International literature and experts in the field point out that the SPF value of a sunscreen product is calculated based on the subjective visual assessment of the erythema reaction by a trained technician^1. This approach can lead to between-observer variations and importantly, systematic bias. Indeed, international literature has highlighted that SPF values for the same product could vary substantially when tested by different laboratories. Hence, results coming from a single laboratory should not be deemed conclusive^2,3.


In light of the issue of substantial variations in testing, the European Academy of Dermatology and Venereology published a position paper in early 2020^4 confirming that current SPF testing methods are still beset with endpoint and method-driven variability. It is therefore important to introduce improvements on existing testing methods to limit the sources of variability.


For the PA value, the two laboratories commissioned by FANCL used in-vivo evaluation (ISO24442:2011) to test photoprotection efficacy, while the Consumer Council’s testing used an in-vitro (ISO24443:2012) testing method. Academic experts remind us that in-vitro studies are regarded as the lowest level of evidence for clinical efficacy; whereas results of in-vivo tests in human subjects are more relevant and have greater reference value.


In addition, in line with the Fancl philosophy of producing high quality products that are gentle on the skin, its product is a physical sunscreen and not a chemical sunscreen. For physical sunscreens, the active ingredients are in a suspended state and therefore, the bottle must be well shaken before use and the lotion should be applied evenly. Therefore, compared with the test results of other chemical sunscreens, the difference may be more significant.


Upholds the highest production standards

Products comply with regulatory requirements in different markets


In fact, there is no regulations and restrictions regarding skincare and cosmetic products in Hong Kong. The product, with the same labeling, complies with all regulatory requirements in markets that include Japan, China and Singapore. It is also tested by a laboratory approved by the National Medical Products Administration of China, whose test reports are used for regulatory approval.


FANCL respects the Consumer Council as a trusted voice for Hong Kong consumers. Due to the multitude of products in the market, continuous improvement in product features and evolution in testing technology, the Consumer Council has a duty to keep abreast of the latest literature and evaluation methodologies. When there are huge discrepancies in test results, re-testing should be conducted before announcing the findings to the public. The public is entitled to receive the most fair and accurate information in its test reports.


^1 ISO 24444:2010. Paragraph 6.7.3

^2 Miksa et al. (2016) International Journal of Cosmetic Science. 38:541-549.

^3 Trullàs et al. (2019) Photodermatology, Photoimmunology & Photomedicine. 36:351–356

^4 Krutmann et al. (2020) Journal of the European Academy of Dermatology and Venereology. 34:447-454


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