New safety advice for excipients demands improved labelling information

The European Medicines Agency (EMA) and the European Commission have updated the annex to the European Commission’s guideline on ’Excipients in the label and package leaflet of medicinal products for human use’. The purpose of the updated annex is to improve the labelling of excipients for the safe use of medicinal products.

By Susanne Tovborg-Jensen

A highlight of the changes

Excipients in a medicinal product can be defined as all ingredients other than the active substance(s). Most excipients are considered inert; however, in certain circumstances and in certain individuals some excipients may have an effect, and these excipients must be declared in the labelling of medicinal products.

As per 9th October 2017 the annex now includes updated safety warnings for ten excipients:

  • Aspartame, benzalkonium chloride, benzoic acid and benzoates, benzyl alcohol, fructose, phenylalanine, propylene glycol and esters of propylene glycol, sodium, sorbitol and wheat starch containing gluten.

In addition to the above, five new excipients have been included:

  • Boric acid and borate, cyclodextrins, fragrance allergens, phosphate buffers and sodium laurilsulfate.

The updated annex applies to both centrally and nationally (incl. MRP and DCP) authorised products, with various deadlines across 3 groups:

  • New marketing authorisations: Effective as of 9th October 2017.
  • Already authorised products: The labelling should be updated in accordance with the updated annex at the earliest opportunity.
  • Products with no foreseeable variations: A type IB variation must be submitted before 9th October 2020.
Full information is available on the EMA Excipients labelling site

Get guidance to get it right

For more information on legislation, deadlines, guidelines or assistance in updating your package leaflets, please contact: Susanne Felumb.

Contact information

For an initial talk, please feel free to contact Susanne directly at: +45 4450 3206, or via

Susanne FelumbCEO and QA Manager, MSc. Pharm.
Susanne is the owner and CEO of PharmAdvice, and has more than 20 years of experience in the international pharmaceutical industry with QA, and regulatory affairs.