歐盟化妝品安全評估
所有在歐盟販售的化妝品都必須經過其安全性的評估,評估其與歐盟法規(Cosmetics Regulation 1223/2009)的合規性,該評估必須由歐盟境內合格的安全評估者執行。安全評估專家會在讓你沒有壓力幫您檢視各項合規程度,根據你的產品規格與實驗結果,我們會進行完整的安全評估,並完成你化妝品產品的安全報告(CPSR),讓你的產品可以安全合法的販售。
為何我們是您最佳的化妝品安全評估的夥伴
不可置信的快速回應時間
我們理解時間就是金錢。您可以越快開始販售您的產品,您就可賺多前!這就為何我們最可能的快速執行產品安全評估,我們不但自建完整的原料毒性檔案資料庫,也開發出我們的軟體讓我們可以更快速地執行安全評估,通常其他評估專家必須數週完成安全評估,反之我們可以從您那獲得所有所需文件後,可在數天內完成評估。
產業專家
並非所有的安全評估都是有品質的,也不是所有的評估都能確實符合歐盟化妝品規範,我們的評估專家有多年經驗且有藥物碩士學位,並擁有Vrije大學有關歐盟化妝品安全評估的證書及化妝品科學家協會(Society of Cosmetic Scientists)的畢業證書。因此您可以確定您的安全評估一定符合歐盟化妝品法規1223/2009的規範。
可負擔的費用
快速回應時間與有品質的評估報告一定是高價格的嗎?一點也不!我們維持著公平合理的價格。我們的客戶並非都是大企業,我們也協助中小企業,甚至是初創公司,所以我們理解把關所有輸歐安排的預算是多麼重要,如果您的產品無法符合歐盟法規,我們也會提供建議做必要修改來讓您可以販售產品-這些建議是免費的。
取得您免費的配方預審以得知其歐盟法規符合度
EU Cosmetic Safety Assessment
One of the legal requirements before placing a cosmetic product on the EU market is to have a safety assessment of the product. This means that there should be an evaluation by a qualified professional to guarantee the safety of the cosmetic product and its ingredients. As stated in Article 10.1 of Cosmetic Regulation (EC) No. 1223/2009, the safety assessor should possess a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognized as equivalent by an EU Member State.
But how is the assessment of the safety of cosmetic products done? The safety assessment is made based on the cosmetic product safety information in Part A of the Cosmetic Product Safety Report (CPSR). The safety assessor takes into account the product’s quantitative and qualitative composition, physical and chemical characteristics, stability, microbiological quality, packaging material, normal and reasonably foreseeable use, data on undesirable effects and the anticipated systemic exposure to individual ingredients in a final formulation. He/she uses an appropriate weight-of-evidence approach for reviewing data from all existing sources and takes particular consideration to the toxicological profile of the substances contained in the product.
The safety assessor makes a conclusion on the safety of the cosmetic product and provides an explanation of the scientific reasoning leading to the assessment conclusion. Where relevant, margins of safety, possible interactions of the substances contained and the impacts of the stability on the product’s safety shall be assessed and discussed. He/she also states whether there is a need to label any particular warnings and instructions of use in accordance with Article 19.1(d). For cosmetic products intended for use on children under the age of three (3) and for cosmetic products intended exclusively for use in external intimate hygiene, a specific assessment inter alia shall be accomplished.
The duly signed safety assessment and the proof of credentials of the safety assessor are then included in Part B of the CPSR which is compiled in the product’s Product Information File (PIF). Upon placing the product on the market, the safety assessment shall be kept up to date in view of additional relevant information generated.
我們的客戶如何評論
常見問答
整個流程是什麼?
首先,我們須彼此確認要進行安全評估的品項數;接著,我們會通知您需要準備提供的文件;並於您傳送後審閱這些文件,並開始執行安全評估。