On 11 July 2013, a new regulation for cosmetics was applied in Europe, Regulation (EC) 1223/2009, replacing Directive 76/768/CEE. This new regulation clarifies the roles and responsibilities of all stakeholders and introduces new notions such as cosmetovigilance and online notification. Compliance and safety of cosmetic products must now be clearly documented for them to be placed on the EU market. Professional medical writers are well positioned to help prepare the documentation needed for cosmetic approval according to this new directive.