2024年8月12日
在歐盟《Regulation (EC) No 1223/2009》法規的指導下，化妝品被定義為用於人體外部應用的物質，強調非醫療效益，並嚴格禁止動物實驗。根據此法規，化妝品的宣稱必須與其標示的預期用途一致。隨著環境污染物與UV光化反應，對皮膚健康影響的關注日益增加，我們的研究重點探討了含有二氧化鈦（TiO2，MoS為511.6）和Silica（MoS為1514.34）的防護化妝品的有效性。本研究不僅呼應了歐盟對可持續發展和非動物測試的承諾，還能增強肌膚健康的配方，符合聯合國可持續發展目標（SDG 3），同時確保消費者的安全並遵守法規。
The European Union's Regulation (EC) No 1223/2009 defines cosmetics as substances intended for external application on the human body, emphasizing non-medical benefits and prohibiting animal testing. This regulation mandates that cosmetic claims align with their intended use, as indicated on product labeling. Our study, motivated by the increasing concern over environmental pollutants' impact on skin health, investigates the effectiveness of protective cosmetics containing Titanium Dioxide (TiO2) margins of safety (MoS) is 511.6 and Silica (MoS 1514.34). This research aligns with the EU's commitment to sustainable development and non-animal testing, aiming to create formulations that enhance skin health in accordance with Sustainable Development Goals (SDG 3), while ensuring consumer safety and regulatory compliance.
Conducted from October to December 2023, our study assessed the impact of these protective cosmetics on 180 Taipei residents. Using the VISIA 7 Imaging System (Canfield, NJ, USA) and facial image analysis software, we measured skin health indicators such as facial spots, UV spots, brown spots, pores, sebum production, and signs of aging. Demographic data and air pollution exposure levels were analyzed using the Chi-square test (P>0.05) to ensure a homogeneous study population. The protective cosmetics' efficacy was statistically evaluated through a t-test analysis of mean differences in skin features, with a significance level set at p<0.05.
Among the participants, only 47 used protective cosmetics. Compared to the non-user group (n=133), significant improvements were observed in facial pores reduction (mean difference of 101.47, p=0.032, 95% CI 8.73-194.10) and sebum production decrease (mean difference of 349.924, p=0.011, 95% CI 80.13-619.72). The Protective Cosmetics intervention significantly reduced sebum production and improved facial pores, with p-values of less than 0.001 and 0.020, respectively, and 95% confidence intervals indicating substantial decreases. No significant differences were found in other skin features.
This study demonstrates that protective cosmetics can offer immediate defense against pollution-induced skin issues, contributing valuable insights to human health data development and highlighting the potential of cosmetic formulations in providing effective environmental protection for the skin.
Keywords: margins of safety (MoS), Product Information File (PIF), sebum production , facial pores , alternative non-animal testing