Benzoic acid and benzoates

This document supports the revision of the annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' with regard to benzoic acid and benzoates. It includes updated information for the package leaflet and needs to be read in conjunction with the background scientific review.

Keywords: Excipients, package leaflet, benzoic acid, benzoates

Current effective version

Questions and answers on benzoic acid and benzoates used as excipients in medicinal products for human use

AdoptedReference Number: EMA/CHMP/508189/2013

Document history

Overview of comments received on the draft 'Questions and answers on benzoic acid and benzoates’

Reference Number: EMA/CHMP/349506/2014

Questions and answers on Benzoic acid and Benzoates in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’

Draft: consultation closedConsultation dates: 24/02/2014 to 31/05/2014Reference Number: EMA/CHMP/508189/2013Summary:

The objective of this group is to update the labelling of selected excipients listed in the Annex of the above mentioned EC guideline, as well as to add new excipients to the list, based on a review of their safety. The main safety aspects to be addressed were summarised in a concept paper published in March 2012.

Benzyl alcohol and benzoic acid group used as excipients Report published in support of the ‘Questions and answers on benzyl alcohol used as an excipient in medicinal products for human use’ (EMA/CHMP/508188/2013) and t...

Reference Number: EMA/CHMP/272866/2013