People are very sensitive about expiry dates. But, what do expiry dates tell a customer or a manufacturer? How is this field regulated and monitored?
All manufacturers of cosmetic products must follow EC Regulation No 1223/2009, which establishes rules that any cosmetic product made available within the European Union has to comply with. These rules seek to ensure the effective functioning of the internal market and protect human health.
According to EC Regulation No 1223/2009 all cosmetic products with a minimum durability under 30 months must show the expiry date on the product. For products with a minimum durability above 30 months, however, an expiry date is not required. Instead, the regulation requires the latter products to indicate how long after the date of opening they may be used without causing harm to the consumer.
We are talking about ‘Expiry date’ or “best used before end of”.date and the Period After Opening (PAO). Particularly, the use of PAO usually stirs up many dilemmas and may result in negative publicity among end users. However, we would like to shed some light on this issue from the point of view of a manufacturer.
Expiry date and PAO are discussed in 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.
A product’s expiry date (or “shelf life”) is generally accepted as the amount of time it takes for a product to cease performing as outlined or advertised. Essentially, this denotes the period the product is safe to use and will perform its function. Depending on the type and nature of the product, an expiry date can vary. This can depend on 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 product separating into its various elements (stability).
Period After Opening (PAO)
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, PAO is very much dependent on the scale of degradation a product faces, in the same way as the shelf life is. However, the scale of degradation in this instance is far more directly influenced by the first use or first interaction with the consumer (and the inevitable risk of microbial contamination therein).
How do cosmetic manufacturers deal with product expiry deadlines?
Let us tell you about our practice. We will deliberately not simplify it, so that you can get the idea of manufacturing cosmetics on a bigger scale, and that it is not same as cooking jam for home use. Especially if the manufacturer exports the products outside EU (to Asia, USA, etc.) it has to face numerous controls from national health inspections, as well as foreign country authorities. Exported products must be accompanied with all the relevant documentation and certificates that prove the product’s stability, absence of microorganisms or heavy metals and the claimed efficiency of the product.
When manufacturing a new product, we set down:
1. benchmarks for ORGANOLEPTICS tests. This include benchmarks for physical appearance of products (stability), odour and viscosity.
2. We perform MICROBIOLOGICAL TESTS, where our products must conform to the following criteria:
|Total aerobic mesophilic microorganisms:|
|< 1 x 103 CFU per g or ml|
Absent in 1 g or 1 ml
Absent in 1 g or 1 ml
Absent in 1 g or 1 ml
Absent in 1 g or 1 ml
Absent in 25 g
Microbiological control also involves performing Challenge tests. For these tests we artificially contaminate the finished product, and then evaluate the subsequent decrease of contamination, thus verifying the effectiveness of preservatives and ensuring that the levels are within the allowed microbial limits. The microorganisms used in the challenge test may be issued from official collection of strains from any state in the EU, to ensure reproducibility of the test, and those microorganisms are: Pseudomonas aeruginosa, Staphyloccocus aureus, Candida albicans and Aspegillus brasiliensis.
3. TEST FOR HEAVY METALS, where our products need to comply with the following limitations:
|Chemical control – Heavy metals||Limits|
|< 3 ppm|
< 10 ppm
< 5 ppm
< 1 ppm
< 3 ppm
-/- not specified
During product development we also need to make so called COMPATIBILITY and VISCOSITY TESTS, where we check the compatibility of the product with the packaging.
If product passes all the tests, we consider it safe for human beings. We start selling it, however, we still do all the above-mentioned tests on sample products (that we keep in stock) in 3, 6, 12, 24, 36, 48, 60, etc. months. Why? Because we are gathering extremely important internal information for ourselves; for example – how effective are the preservatives used, how active ingredients behave in time, how different packaging effects/ protects the products, etc.
For products that we have been producing for longer period, we make tests in case of special circumstances or once they get 24 months old – to make sure that they are still effective and safe for customers. If products do not pass all the above-mentioned criteria, we are obliged to remove them from the market.
However, if the products are not defective even after the expiry date, why should they be thrown away? On one hand, we all keep saying that we should start taking better care of our environment and our planet, live in a more conscientious manner, reduce waste, reduce CO2 footprint, etc, but on other hand, we are throwing things away just because some indicative expiry date has passed. And manufacturers are destroying completely usable products and polluting the environment because:
- We cannot reduce the price, because that would devalue our brand;
- We cannot re-label the products, as this is too expensive and time consuming;
- It is not good for the company image, as customers are very sceptical towards expiry date extensions.
That is why the use of PAO is more manufacturer friendly. It allows us to behave in a rational and environmentally protective manner, but at the same time it requires us to behave consciously towards the end users. It requires us to make sure that products which are on the shelves are safe and adequate. We owe this not just to our customers, but also to our business partners – distributors and retailers. To everyone who trusts us.
We live in times where there is less and less trust among people and we follow guidelines as the ultimate Law. Don’t! When you have an expired cosmetic product in front of you, open it, smell it and try it on your hand. If a product has gone off you will know. Just trust your senses and feelings. Do not throw away products that are ok. Even if you get rid of them and do not see them anymore, these products are still (unnecessary) waste that must be processed.