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2021/04/23

替代動物試驗 IN VITRO TOXICOLOGY TESTING SERVICE

資料來源 健康產業服務
  • 2027

SGS供相關替代動物試驗,協助化妝保養品產業轉型並與國際化妝品法規接軌。

法規補給站

台灣禁止化粧品動物測試

台灣成為第一個禁止對化粧品進行動物測試的亞洲國家。根據台灣化粧品衛生安全管理法第六條規定,化粧品業者於於國內進行化粧品或化粧品成分之安全性評估,不得以動物作為檢測對象,自2019119日起施行。
Taiwan Bans Cosmetics Animal Testing
Taiwan become the first Asian nation to ban animals testing on cosmetics. According to Taiwan Cosmetic Hygiene and Safety Act Article 6, cosmetics businesses shall not subject animals to testing when conducting safety evaluation of cosmetics or cosmetic ingredients, which shall be enforced from November 9, 2019.

歐盟動物試驗禁令
歐盟於2013年頒布化妝品法規(1223/2009)正式禁止在歐洲銷售的所有新化粧品及其成分的動物測試禁令。該禁令亦適用已在歐洲以外接受動物測試的產品或成分。
EU BAN ON ANIMAL TESTING
In 2013, EU Cosmetic Regulation (1223/2009) o_cially introduced a ban on animal testing for all new cosmetics and their ingredients sold in Europe. The ban also applies to products, or ingredients, which have been subject to animal testing outside Europe.

美國動物測試與化
根據美國聯邦食品,藥品和化粧品法(FDC Act)的規定,在美國之化妝品必須經過適當且有效的測試,以證實成分與成品的安全性始能進行銷售。未全面禁止動物測試,但建議製造商考慮使用經過科學驗證的替代方法。美國食品藥品監督管理局(FDA)大力倡導開發並執行不使用動物的測試方法。
US ANIMAL TESTING & COSMETICS
Regulated by the US Federal Food, Drug & Cosmetic Act (FD&C Act), cosmetics in the USA must undergo appropriate and e_ective testing to substantiate the safety of both the ingredients and the finished product – before they are marketed. Testing on animals is not banned, however, manufacturers are advised to consider the use of scientifically validated alternatives. The US Food and Drug Administration (FDA) strongly advocates the development and use of testing methods that do not employ the use of animals.
此外,美國加州參議院宣布第1249號法案,該法案定義之化粧品,適用於202011日起或之後的製造商及所有供應商,簽約、開發或製造進行動物試驗,於該州進口之利潤、出售或供銷之化粧品,皆為非法。
In addition, the California Senate announced Bill No.1249, this bill would make it unlawful for a manufacturer to import for profit, sell, or o_er for sale in this state, any cosmetic, as defined, if the cosmetic was developed or manufactured using an animal test that was conducted or contracted by the manufacturer, or any supplier of the manufacturer, on or after January 1, 2020.

IN VITRO TOXICOLOGY TESTING SERVICE 替代動物試驗
SGS提供相關替代動物試驗,協助化粧保養品產業轉型與國際法規接軌

  1. Cytotoxicity test is the first test to provide reliable insight into the safety of cosmetics.
    細胞毒性試驗是首要為化粧保養品提供可靠見解的試驗:
    MTT Assay, Colony formation Assay, XTT assay. NRU assay.
  2. Skin irritation test assess the potential for chemically induced skin damage that is reversible (irritation)
    皮膚刺激試驗評估化學性皮膚損傷:
    (1)人體皮膚模型試驗-Reconstructed human epidermis (RhE) test / OECD 439
    (2)Corrositex 體外膜阻隔試驗法membrane barrier test Corrositex / OECD 435
  3. Phototoxicity test 光毒性試驗:
    3T3 NRU phototoxicity test / OECD 432
  4. Skin corrosion test assess the potential of a substance/mixture to cause irreversible damage to the skin
    皮膚腐蝕試驗評估物質與混和物對皮膚損傷:
    Reconstructed human epidermis (RhE) test method (OECD 431)
  5. Skin sensitization tests 皮膚致敏性
    (1)直接胜肽反應試驗-Direct peptide reactivity assay (DPRA) / OECD 442C
    (2)ARE-Nrf2 螢光酶試驗-ARE-Nrf2 luciferase test method (KeratinoSens TM assay) / OECD 442D
    (3)人體細胞株活化試驗-Human cell line activation test (h-CLAT) / OECD 442E
  6. Skin absorption test 皮膚吸收穿透性
    體外擴散法- di_usion method / OECD 428
  7. Eye damage 體外眼損傷
    (1)重建人類角膜上皮細胞試驗-Reconstructed human cornea-like epithelium (RhCE) test method / OECD 492
    (2)螢光素滲漏試驗- Fluorescein leakage (FL) test method / OECD 460
    (3)短時間暴露體外試驗- Short time exposure (STE) in vitro method / OECD 491
  8. Genotoxicity test increase understanding of the potential for genotoxic hazard (DNA changes/damage)
    基因毒試驗了解潛在基因毒損傷:
    (1)Ames test in accordance with OECD 471
    (2)Mammalian Cell Gene Mutation Test (TK Test) with OECD 490
  9. in vitro Whitening Test: including cytotocity, Tyrosinase activity test, Melanin content test, DPPH scavenging test
    美白試驗透過一連串細胞/酪胺酸酶活性/黑色素含量/抗氧化能力試驗, 推論美白效能

相關文件:文件

關鍵字: #替代動物試驗 #化粧品 #Skin corrosion test #Cytotoxicity test #Skin irritation test #Genotoxicity test #cosmetic #OECD 439 #IN VITRO TOXICOLOGY