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Cosmetics 2017, 4(1), 1;

Cosmetics Europe Guidelines on the Management of Undesirable Effects and Reporting of Serious Undesirable Effects from Cosmetics in the European Union

Cosmetics Europe, Brussels 1160, Belgium
Fédération des Entreprises de la Beauté, Paris 75007, France
Industrieverband Körperpflege- und Waschmittel e.V., Frankfurt am Main 60329, Germany
Pierre Fabre Dermo-Cosmétique, Lavaur 81500, France
L’ORÉAL Research & Innovation, Paris 92100, France
KAO USA Inc., Cincinnati, OH 45214, USA
Cosmetica Italia, Milano 20131, Italy
Avon Cosmetics Limited, Northamptonshire NN1 5PA, UK
Cosmetics Toiletries and Perfumery Association UK, London W1J 0DR, UK
Procter & Gamble, Surrey KT13 0XP, UK
Colgate Palmolive, Milmort 4041, Belgium
LVMH Recherche, Saint-Jean-de-Braye 45800, France
Henkel Beauty Care, Düsseldorf 40589, Germany
Author to whom correspondence should be addressed.
Academic Editor: Lidia Sautebin
Received: 6 October 2016 / Revised: 17 November 2016 / Accepted: 28 November 2016 / Published: 3 January 2017
Full-Text   |   PDF [382 KB, uploaded 3 January 2017]   |  


The European Union (EU) Cosmetics Regulation (EC) No. 1223/2009 requires companies to collect and assess reports of adverse health effects from the cosmetic products (undesirable effects) they market. Furthermore, undesirable effects that are considered as serious need to be reported to the national competent authorities. Cosmetics Europe, representing the European cosmetics industry, has developed these guidelines to promote a consistent practical approach for the management of undesirable effects and the notification of serious undesirable effects. Following these guidelines allows companies concerned to demonstrate due diligence and compliance with the legal requirements. View Full-Text
Keywords: cosmetovigilance; causality assessment; adverse event reporting cosmetovigilance; causality assessment; adverse event reporting

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Renner, G.; Audebert, F.; Burfeindt, J.; Calvet, B.; Caratas-Perifan, M.; Leal, M.E.; Gorni, R.; Long, A.; Meredith, E.; O’Sullivan, Ú.; Paye, M.; Perriere, C.; Schlotmann, K. Cosmetics Europe Guidelines on the Management of Undesirable Effects and Reporting of Serious Undesirable Effects from Cosmetics in the European Union. Cosmetics 2017, 4, 1.

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