By Davide Turchi – RA/QA Consultant
European Cosmetics Regulation EC 1223/2009 set out many mandatory guidelines and requirements for labeling and clearly communicating relevant safety information on cosmetic products. Each of these guidelines and cosmetic requirements (read more about the full list of requirements here), labeling included, must be strictly adhered to by manufacturers for any cosmetic product seeking to enter the European Market. Two important inclusions under the regulation that some manufacturers and consumers alike often find confusing are the Expiration Date and the Period After Opening (PAO). In this article we will shed some light on the differences between both of these mandatory labeling requirements and how Regulation EC 1223/2009 affect them.
Expiration date and PAO are covered under the Stability Testing section of the cosmetics compliance process, a component of a product’s Safety Assessment. Both factors are evaluated during this process in an effort to ensure maximum safety for the consumer.
Expiration Date
A product’s expiration date (or “shelf life”) is generally accepted as the amount of time it takes a product to cease performing as outlined or advertised. Essentially, the period of time it is safe to use and will perform its function within. Depending on the type and nature of the product, an expiration date can very. This can be relative to a number of factors:
- How the product is used or handled (interaction with human bodies, bacteria, fungi, etc.)
- Where and how the product is stored (temperature and exposure to light)
- Whether the product can dry out or become too moist (change its consistency) over time
- Chemical make-up of the product and whether that may lead to a product separating into its various elements
Under Regulation EC 1223/2009, if a cosmetic product has a shelf life of less than 30 months, an expiration date must be clearly indicated on the product’s packaging. In cases where the shelf life exceeds 30 months an expiration date is not required to be placed on the packing, however a period after opening (PAO) is.
Period After Opening
Period after opening (PAO) refers to the amount of time a product will remain stable and safe for human use after it has first been opened. As such, it is very much involved with the scale of degradation a product faces in the same way as the shelf life is, however in this instance it is far more directly influenced by its first use or first interaction with the consumer (and the inevitable risk of microbial contamination therein).
Determination of PAO takes a number of factors into account, including product type and its claimed effects. Extremities in certain factors can heavily influence a product’s PAO, including use on children or use on sensitive body parts.
Consumers can differentiate between a product’s expiration date and its PAO by paying attention to their distinctive markings:
Expiration Date symbol
Period After Opening indicated using this ISO symbol
It is important to note that in many cases these symbols can be misused. Products must have completed all appropriate stability tests by EU Accepted protocols in order to affix these markings. Improper use, or inclusion, of these symbols (among other misappropriated label components) can serve as a red flag for Competent Authorities in their ongoing Post-market Surveillance and In-Market control activities.
For more information on how expiration date and PAO may affect your product, for cosmetic compliance and legislation advice, or to find out more about Obelis’ European Responsible Personservices, contact our team of regulatory.