Following the European Commission decision to revise the Annex of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00 Rev. 1), a multidisciplinary group of experts was created in 2011 to update the labelling of selected excipients listed in the annex of the guideline and to add new excipients to the list, based on a review of their safety. Draft Q&A documents on excipients are progressively released for public consultation. They include proposals for new or updated information for the labelling and package leaflet. A corresponding background report supporting the review is published for information only.