Risk assessment of nanomaterials in cosmetics: a European union perspective

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• 作者：Frank Henkler (1)
  Tewes Tralau (1)
  Jutta Tentschert (1)
  Carsten Kneuer (1)
  Andrea Haase (1)
  Thomas Platzek (1)
  Andreas Luch (1)
  Mario E. G?tz (1)
  
• 刊名：Archives of Toxicology
• 出版年：2012
• 出版时间：November 2012
• 年：2012
• 卷：86
• 期：11
• 页码：1641-1646
• 全文大小：206KB
• 参考文献：1. EFSA (2009) Scientific opinion of the scientific committee on a request from the European commission on the potential risks arising from nanoscience and nanotechnologies on food and feed safety. EFSA J 958:1-9
  2. FAO/WHO (2009) Food and agriculture organization of the United Nations und World Health Organization: FAO/WHO expert meeting on the application of nanotechnologies in the food and agriculture sectors: potential food safety implications: meeting report. Rome
  3. Gamer AO, Leibold E, van Ravenzwaay B (2006) The in vitro absorption of microfine zinc oxide and titanium dioxide through porcine skin. Toxicol In Vitro 20:301-07 CrossRef
  4. Gulson B, McCall M, Korsch M, Gomez L, Casey P, Oytam Y, Taylor A, McCulloch M, Trotter J, Kinsley L, Greenoak G (2010) Small amounts of zinc from zinc oxide particles in sunscreens applied outdoors are absorbed through human skin. Toxicol Sci 118:140-49 CrossRef
  5. OECD (2010) Series on the safety of manufactured nanomaterials no. 27: list of manufactured nanomaterials and list of endpoints for phase one of the sponsorship programme for the testing of manufactured nanomaterials (revision), ENV/JM/MONO(2010)46
  6. Osmond MJ, McCall MJ (2010) Zinc oxide nanoparticles in modern sunscreen: an analysis of potential exposure and hazard. Nanotoxicology 4:15-1 CrossRef
  7. Roberts MS, Roberts MJ, Robertson TA, Sanchez W, Th?rling C, Zou Y, Zhao X, Becker W, Zvyagin AV (2008) In vitro and in vivo imaging of xenobiotic transport in human skin and in the rat liver. J Biophotonics 1:478-93 CrossRef
  8. Ryman-Rasmussen JP, Riviere JE, Monteiro-Riviere NA (2006) Penetration of intact skin by quantum dots with diverse physicochemical properties. Toxicol Sci 91:159-65 CrossRef
  9. SCCP (2007) Preliminary opinion on safety of nanomaterials in cosmetic products. http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_099.pdf
  10. SCCP/1215/09; Clarification on opinion SCCNFP/0932/05 on zinc oxide. http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_167.pdf
  11. SCENIHR (2007) Scientific committee on emerging and newly-identified health risks: the appropriateness of the risk assessment methodology in accordance with the technical guidance documents or new and existing substances for assessing the risk of nanomaterials
  12. Schilling K, Bradford B, Castelli D, Dufour E, Nash JF, Pape W, Schulte S, Tooley I, van den Bosch J, Schellauf F (2010) Human safety review of “nano-titanium dioxide and zinc oxide. Photochem Photobiol Sci 9:495-09 (Review)
  13. SCCNFP/0932/05; Statement on zinc oxide used in sunscreens. http://ec.europa.eu/health/archive/ph_risk/committees/04_sccp/docs/sccp_o_00m.pdf
  14. SCCNFP/0649/03; Opinion concerning zinc oxide; http://ec.europa.eu/health/ph_risk/committees/sccp/documents/out222_en.pdf
  15. SCCNFP/0005/98, Opinion of the SCCNFP intended for consumers concerning titanium dioxide. http://ec.europa.eu/health/ph_risk/committees/sccp/documents/out135_en.pdf
  
• 作者单位：Frank Henkler (1)
  Tewes Tralau (1)
  Jutta Tentschert (1)
  Carsten Kneuer (1)
  Andrea Haase (1)
  Thomas Platzek (1)
  Andreas Luch (1)
  Mario E. G?tz (1)
  
  1. German Federal Institute for Risk Assessment (BfR), Berlin, Germany
  
• ISSN：1432-0738

文摘

In Europe, the data requirements for the hazard and exposure characterisation of chemicals are defined according to the REACH regulation and its guidance on information requirements and chemical safety assessment (Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), and its guidance documents; available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:396:0001:0849:EN:PDF; and at: http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm). This is the basis for any related risk assessment. The standard reference for the testing of cosmetic ingredients is the SCCP’s ‘Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation-(The SCCP’s Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (2006); available at: http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_03j.pdf), which refers to the OECD guidelines for the testing of chemicals (The OECD Guidelines for the Testing of Chemicals as a collection of the most relevant internationally agreed testing methods used by government, industry and independent laboratories to assess the safety of chemical products; available at: http://www.oecd.org/topic/0,2686,en_2649_34377_1_1_1_1_37407,00.html). According to the cosmetics directive [76/768/EEC], compounds that are classified as mutagenic, carcinogenic or toxic to reproduction are banned for the use in cosmetic products. Since December 2010, the respective labelling is based on the rules of regulation (EC) No. 1272/2008 (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, Official Journal L 353, 31/12/2008, pages 1-355; available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:en:PDF) on classification, labelling and packaging of substances and mixtures (CLP). There is no further impact from the CLP regulation on cosmetic products, because regulation (EC) No. 1223/2009 on cosmetic products defines its own labelling rules (Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products; available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF). Special notification procedures are mandatory for preservatives, colourants and UV-filters where a safety approval from the European ‘Scientific Committee on Consumer Safety-(SCCS) is needed prior to marketing. The risk assessment of nanomaterials in consumer products still poses a significant challenge as highlighted by the example of UV-filters in sunscreens since nanomaterials cannot be classified as a homogenous group of chemicals but still need to be addressed in risk characterisation on a case by case basis.