Alternative (Non-Animal) Methods for Cosmetics Testing: Current Status and Future Prospects - 2010

The 7th amendment to the EU Cosmetics Directive prohibits to put animal-tested cosmetics on the market in Europe after 2013. In that context, the European Commission invited stakeholder bodies (industry, non-governmental organisations, EU Member States, and the Commission's Scientific Committee on Consumer Safety) to identify scientific experts in five toxicological areas i.e. toxicokinetics, repeated dose toxicity, carcinogenicity, skin sensitisation, and reproductive toxicity for which the Directive foresees that the 2013 deadline could be further extended in case alternative and validated methods would not be available in time. The selected experts were asked to analyse the status and prospects of alternative methods and to provide a scientifically sound estimate of the time necessary to achieve full replacement of animal testing. In summary, the experts confirmed that it will take at least another 7 to 9 years for the replacement of the current in vivo animal tests used for the safety assessment of cosmetic ingredients for skin sensitisation. However, the experts were also of the opinion that alternative methods may be able to give hazard information, i.e. to differentiate between sensitisers and non-sensitisers, ahead of 2017. This would, however, not provide the complete picture of what is a safe exposure because the relative potency of a sensitiser would not be known. For toxicokinetics, the timeframe was 5 to 7 years to develop the models still lacking to predict lung absorption and renal/biliary excretion, and even longer to integrate the methods to fully replace the animal toxicokinetic models. For the systemic toxicological endpoints of repeated dose toxicity, carcinogenicity and reproductive toxicity, the time horizon for full replacement could not be estimated.

ADLER Sarah;  BASKETTER David;  CRETON Stuart;  PELKONEN Olavi;  VAN BENTHEM Jan;  ZUANG Valerie;  ANDERSEN Klaus;  ANGERS Alexandre;  APTULA Aynur;  PRICE Anna;  BENFENATI Emilio;  BERNAUER Ulrike;  BESSEMS Jos;  BOIS Frederic;  BOOBIS Alan;  BRANDON Esther;  BREMER Susanne;  BROSCHARD Thomas;  CASATI Silvia;  COECKE Sandra;  CORVI Raffaella;  CRONIN Mark;  DASTON George;  DEKANT Wolfgang;  FELTER Susan;  GRIGNARD Elise;  GUNDERT-REMY Ursula;  HEINONEN Tuula;  KIMBER Ian;  KLEINJANS Jos;  KOMULAINEN Hannu;  KREILING Reinhard;  KREYSA Joachim;  LOIZOU George D.;  MAXWELL Gavin;  MAZZATORTA Paolo;  MUNN Sharon;  PFUHLER Stefan;  PRIETO PERAITA Maria Del Pilar;  PHRAKONKHAM Pascal;  PIERSMA Aldert;  POTH Albrecht;  REPETTO Guillermo;  ROGIERS Vera;  SCHOETERS Greet;  SCHWARZ Michael;  TAHTI Hanna;  TESTAI Emanuela;  VAN DELFT Joost;  VAN LOVEREN Henk;  VINKEN Mathieu;  WORTH Andrew;  ZALDIVAR COMENGES Jose';  SERAFIMOVA Rositsa;  LEITE Sofia Batista; 

2012-01-04

SPRINGER

JRC64619

0340-5761,   

http://ihcp.jrc.ec.europa.eu/our_activities/alt-animal-testing/report-alternative-non-animal-methods-for-cosmetics-testing-current-status-and-future-prospects-2010,    https://publications.jrc.ec.europa.eu/repository/handle/JRC64619,   

10.1007/s00204-011-0693-2,