我們在產品品質與安全上絕不妥協,這是我們對美妝專業人士和消費者始終堅持的根本承諾。我們擁有陣容堅強的國際專家團隊(毒物學家、內科醫師),實施業界最嚴格的法規安全標準。我們所採取的四階段管控作業始於產品設計,一路延續至產品行銷。

1.對原料的深入知識:產品的安全性評估有賴於對其組成中所用每種原料和物質的詳盡瞭解。目標是取得在其化學組成及品質方面均有完整資訊的原料,包括可能存有的微量元素。經由對原料的充分瞭解,我們得以彙整每項直接採用物質或相關物質的所有可得科學與毒物學資料(專家電腦系統、體外實驗測試整合式策略、累積毒性資料、臨床及美妝安全監控資料),因此能掌握與每種原料有關的危險;透過分析也有助於精確判定不致引起負面作用的正確劑量。

2.有關原料的風險評定:此階段是安全評定的關鍵,其重點在於以一組重要參數對各種原料或物質的本質危險性進行加權,從而確保成品的安全使用。與人體接觸有關的加權係數首要的是產品種類,包括沖洗式產品(洗髮精)及非沖洗式產品(臉部保養品),用於全身的產品(身體乳液)或僅用於身體局部的產品(睫毛膏);加權係數也包括產品使用頻率及對產品產生特定限制的消費者特性(孩童、敏感性皮膚、隱形眼鏡配戴者)。在此階段後,即可確認產品中每項原料或物質的使用濃度上限。為了確保消費者安全無虞,成品中的成分濃度均為無副作用門檻劑量的百分之一以下。

3.產品安全的確認:我們在一般使用條件與可預見使用條件下對成品安全進行雙重確認,藉此發現未來可能發生於消費者身上的最微小客觀徵象或不適。在本集團獨有專家系統的協助下,我們首先對新產品與廣大的既有臨床資料庫進行比對分析。若有必要,我們會進一步對新產品採取體外實驗安全測試,並以特定消費者族群(隱形眼鏡配戴者、敏感性皮膚等)所構成的健康志願者為對象進行臨床試驗。所有研究都是在第三方專業研究中心,遵循極為嚴格的方法與倫理架構實施。在此最後階段順利完成後,由安全評估員審定簽核產品安全報告,並將此報告納入產品管控檔案中。

4.上市產品監控:在首度上市時,我們會特別嚴格監控產品對消費者的安全性。為此,我們建立了國際美妝安全性監控網路,收集消費者或保健專業人士在產品用後通報的不良反應並加以分析。經過與產品的深入潛在因果關係研究後,即使發現的是極為微小的負面效應,我們也可為此調整產品組成以確保消費者能安心使用我們的產品。

 

We never compromise on the quality and safety of our products and this remains a fundamental commitment to beauty-care professionals and consumers. We have an international expert team (toxicologists, physicians) who implement the most stringent regulatory safety standards within our industry. The approach, which is implemented in 4 stages, is initiated during product design and pursued throughout the duration of product marketing.

1. In-depth knowledge of raw materials: The safety evaluation of a product always begins with a detailed knowledge of each of the raw materials and substances used in its composition. The aim is to make available raw materials that are perfectly defined with respect to their chemical composition and quality, including the potential presence of trace elements. A perfect understanding of the raw material enables complete synthesis of all the available scientific and toxicological data (in silico expert systems, in vitro test integrated strategies, accumulated toxicological, clinical and cosmetic safety monitoring data) for each substance or related substances. Thus the hazards associated with each raw material are mapped. The analysis also enables determination of an adverse effect-free dose.

2. Assessment of the risk associated with raw materials: This stage is one of the most essential in safety assessment. The stage consists in weighting the intrinsic hazard of each raw material or substance by a set of key parameters which will enable safe use in the finished product. The weighting factors, which are related to the exposure of the human body, incorporate, first and foremost, the product category. The product may be a product that is rinsed off (shampoo) or not rinsed off after use (facial care), applied to the whole body (body milk) or to a small area of the body (mascara). The weighting factors also include the frequency of product use and certain consumer characteristics (children, sensitive skins, contact-lens wearers), which impose certain restrictions. Following this stage, a maximum concentration for use of each raw material or substance in the product is determined. In order to ensure a wide safety margin for the consumer, the concentrations in the finished product are always at least 100 times lower than the no-effect dose.

3. Confirmation of product safety: We confirm finished product safety under the normal or foreseeable conditions of use in order to detect the smallest objective sign or discomfort for the future consumer. Thanks to a proprietary expert system, we first conduct an analysis comparing our new product with our extensive existing clinical database. If necessary, we subject our new products to complementary in vitro safety tests and clinical trials conducted on healthy volunteers constituting particular consumer groups (contact-lens wearers, sensitive skins, etc.). The studies are always conducted in third party specialized centers and are undertaken in a very strict methodological and ethical framework. When this last stage has been successfully completed, the safety assessor is in a position to finalize and sign the product safety report, which will then be included in the regulatory dossier on the product.

4. Marketed product monitoring: We strictly monitor the safety of our products for consumers as of first marketing. In order to do so, we have set up an international cosmetic safety monitoring network which collects and analyzes the adverse events occurring after use of our products and reported by consumers or healthcare professionals. After in-depth study of the potential causal relationship with our products, we may sometimes decide to adjust product composition to correct certain untoward effects, even if they are very benign, in order to ensure that consumers use our products with every confidence.