09/06/2023, 11:51 Excipients labelling | European Medicines Agency
Excipients labelling
Table of contents
EU guideline
Excipients with a known action or effect
Timeline for implementing revisions
Background information on individual excipients
Marketing authorisation holders and applicants need to identify the excipients included in any
human medicine authorised in the European Union (EU) in its product information. Guidance is
available from the European Commission and European Medicines Agency (EMA) on what needs
including in the labelling and package leaflet.
An excipient is a constituent of a medicine other than the active substance, added in the formulation for a
specific purpose. While most excipients are considered inactive, some can have a known action or effect in
certain circumstances. These must be declared in the labelling and package leaflet of the medicine for its safe
use.
The legal basis for requirements on excipient labelling in the EU is Article 65 of Directive 2001/83/EC .
EU guideline
https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/reference-guidelines/excipients-labelling 1/5
09/06/2023, 11:51 Excipients labelling | European Medicines Agency
Marketing authorisation holders and applicants should list excipients on the medicine's labelling and in the
package leaflet in line with the following European Commission guideline:
Guideline on 'Excipients in the labelling and package leaflet of medicines for human use'
This guideline requires marketing authorisation holders to display excipients in the following ways:
Type of excipient Type of medicine Type of information Display location
All medicines List of excipients Package leaflet
All excipients
Parenteral, ocular and topical medicines List of excipients Labelling
List of excipients Labelling
Excipients with a known action or effect All medicines
Agreed safety information Package leaflet
These requirements apply to all medicines in the EU, irrespective of whether they are centrally or nationally
authorised.
Excipients with a known action or effect
The list of excipients that have a known action or effect, and which must appear on the labelling of all
medicines in the EU, is available in the annex to the above EU guideline:
Annex to guideline on 'Excipients in the labelling and package leaflet of medicines for human use'
The annex also includes the safety information that must appear in the medicine's package leaflet for the
listed excipients. It is available in all EU languages, Icelandic and Norwegian.
https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/reference-guidelines/excipients-labelling 2/5
09/06/2023, 11:51 Excipients labelling | European Medicines Agency
EMA may revise the annex to update the required safety information on existing excipients, or to add new
excipients. Revisions of the annex are endorsed by the European Commission.
Timeline for implementing revisions
For authorised medicines, marketing authorisation holders should use the first opportunity to implement
any revised wording in the package leaflet.
For medicines with no foreseeable regulatory submissions, marketing authorisation holders should submit a
type IB variation within 3 years of the revision date of the relevant excipient.
Marketing authorisation holders can find the revision date for a particular excipient in the column ‘updated
on’, next to the excipient's name in the annex.
Background information on individual excipients
Background information supporting the EU requirements for individual excipients can be found on the relevant
webpages, which are listed below.
Aspartame and phenylalanine
Benzalkonium chloride
Benzoic acid and benzoates
Benzyl alcohol
Boric acid and borates
Cyclodextrins
Dextrans
Ethanol
Fragrances containing allergens
Fructose and sorbitol
https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/reference-guidelines/excipients-labelling 3/5
09/06/2023, 11:51 Excipients labelling | European Medicines Agency
Lactose
Phosphates
Polysorbates
Proline
Propylene glycol and esters
Sodium used as an excipient in medicinal products for human use
Sodium laurilsulfate
Wheat starch containing gluten
Related content
Scientific guidelines on quality: excipients
Product information
Use of phthalates as excipients in human medicinal products
Use of methyl- and propylparaben as excipients in human medicinal products for oral use
Non-clinical Working Party
Related documents
CHMP SWP opinion on diethanolamine and coconut oil diethanolamine condensate as excipients
(PDF/389.13 KB)
First published: 20/07/2021
EMA/275956/2021
Topics
https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/reference-guidelines/excipients-labelling 4/5
09/06/2023, 11:51 Excipients labelling | European Medicines Agency
Regulatory and procedural guidance
Product information
European Medicines Agency
Domenico Scarlattilaan 6
1083 HS Amsterdam
The Netherlands
Tel: +31 (0)88 781 6000
How to find us
Postal address and deliveries
Business hours and holidays
For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent
foreseen in the Protocol on Ireland / NI.
© 1995-2023 European Medicines Agency European Union agencies network An agency of the European Union
https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/reference-guidelines/excipients-labelling 5/5
