Are all cosmetics dermatologically tested before they go on sale?
The safety of cosmetic products made in the European Union is strictly regulated.
And not only those products actually made here, but all those sold on the EU market in any way whatsoever — including through import by distribution companies; formally, the rules also cover cosmetics that individuals order from foreign markets for their own use (China, USA). It is, admittedly, well known that in practice enforcement often falls short, particularly where private individuals import cosmetics themselves for their own use through assorted online shops such as TEMU, Shein or Aliexpress. Policing so great a volume of small consignments, as has been the practice in recent years, is all but impossible — which is why it matters that consumers also acquaint themselves with the risks awaiting them once they leave the ground of European cosmetics.
The European cosmetics market is among the most strictly regulated markets in the world, which is in fact excellent news for all of us. Worry about dangerous cosmetics is therefore quite unnecessary, even though we know that over the past decade brand advertising has been very fond of so-called ‘fearmongering’ — the artificial manufacture of fear about particular kinds of cosmetics or their ingredients. Fear of parabens, silicones, aluminium salts and similarly demonised chemicals is in truth quite unwarranted, even though negative publicity has by now driven them almost entirely off the market.
The aim of all this? A change of fashion and of buying habits in an already thoroughly saturated cosmetics industry, and the pushing forward of much more expensive, newer and not infrequently less effective cosmetic raw materials. But that is not the subject of today's article.
The point is that cosmetics placed on the EU market are subject to strict safety requirements. From the cheapest products to the most expensive, and from conventional to natural or organic cosmetics, the same regulatory framework applies. Regulation (EC) No 1223/2009 requires a product-specific safety assessment and sets prohibitions and restrictions for substances, as well as positive lists for specific categories such as colourants, preservatives and UV filters. It also lays down the EU rules on animal testing and the marketing of cosmetic products tested on animals for cosmetic purposes.
Safety data and product-specific testing before placing a cosmetic product on the EU market
Every cosmetic product placed on the EU market must be supported by the safety information, assessments and testing relevant to that specific product. The exact testing programme depends on the formulation, microbiological risk, intended use, target population, packaging and claims.
Cosmetic Product Safety Report
This is the first and most fundamental examination of a cosmetic product's safety parameters.
The safety assessment covers a theoretical examination of the suitability of every raw material used, of its dosage in the product, and of the calculated toxicity parameters. It contains data on ingredients, chemical properties, toxicological data and safety margins for each raw material in the product individually.
The cosmetic product safety assessment must be carried out by a person holding a university-level qualification, or an officially recognised equivalent qualification, in pharmacy, toxicology, medicine or a similar discipline as required by Regulation (EC) No 1223/2009.
If the product was formulated by a specialist, there should be no problem at this point — in developing the product, a specialist will have used only raw materials that are not prohibited under the Regulation, and will have observed their restrictions and maximum permitted concentrations. The safety assessment will then merely confirm that the product is composed in a safe manner.
From here on come the practical laboratory tests.
Stability testing
For the safety assessment, adequate data are needed on whether the product remains in a suitable condition to the end of its shelf life. The product is exposed in cycles to varying thermal and other stresses, simulating an accelerated ageing process. It can be run in laboratory packaging, but preferably in the actual pack in which the product will be sold.
The packaging itself often dictates how long a product will hold up on the shelf before a customer buys and opens it. The type of packaging material matters, as it can interact with certain raw materials in the product, most commonly preservatives. The packaging's water-vapour barrier properties matter too. That matters because of moisture ingress, which can cause bacterial growth, or conversely because of water evaporating out of the product, which changes its concentration and final weight.
The stability protocol is chosen and justified for the product, its packaging and its intended use. The standard itself prescribes no single set of conditions, parameters or criteria for every cosmetic — it is a technical and scientific framework, and we draw on the guidelines of ISO/TR 18811.
Microbiological testing / total viable count
It checks for the presence of living microorganisms in the product, usually bacteria and moulds. Cosmetic products are not generally required to be sterile. They must, however, meet appropriate microbiological quality criteria for the product category and intended use, including applicable limits for total microbial counts and the absence of specified microorganisms. Cosmetics as a rule contain preservatives, which keep the quantity of microorganisms under control throughout the product's life cycle.
The total viable count therefore establishes at the outset whetherthe product is properly conceived, and how susceptible it is to microbial growth. It is worth repeating this test later on as well, during the product's life cycle.
If we have, say, a cream stored in a jar which is designed to be reached into with the fingers, there is a strong likelihood that the microbiological load of the product will change.
Preservation efficacy testing – the challenge test
One of the more demanding tests, checking whether the preservatives chosen for the product effectively prevent the growth of microorganisms.
Conceptually it is the reverse of the total viable count. Where the total count merely observes whether microorganisms are present in the product and in what quantity, the challenge test deliberately contaminates the product.
We introduce, on purpose, prescribed strains of certain more dangerous bacteria whose presence in cosmetic products is absolutely prohibited under the Regulation, and we watch what happens.
If the product is correctly formulated, the preservatives will quickly suppress the introduced bacteria and prevent them multiplying. If it is not, the bacteria will multiply and that will be observable. The test is carried out according to the guidelines of ISO 11930.
After inoculation the introduced microorganisms are followed at the time points the method sets out, and the result is judged against that method's acceptance criteria. There is no universal rule that every microorganism introduced must simply be at zero.
Mandatory notification in the European CPNP database (Cosmetic Products Notification Portal)
Before a cosmetic product is placed on the EU market, it must be notified through the European CPNP (Cosmetic Products Notification Portal). This is an administrative notification requirement, not a final stage of regulatory control or a product approval.
The responsible person submits the information required by Article 13 of Regulation (EC) No 1223/2009 electronically before the product is placed on the market. CPNP notification is mandatory, but it does not constitute an authorisation or approval of the product.
For a product on the EU market there must therefore be adequate data supporting its safety: an expert safety assessment, together with stability and microbiological quality data and — where this is relevant to the product's microbiological risk — the results of a challenge test. Notification in the CPNP database is a separate step in placing the product on the market.
If a product meets all of the above requirements, then under Regulation (EC) No 1223/2009 it is safe to use.
What about animal testing? Testing on volunteers? Dermatological testing?
Isn't every product tested on people before a consumer can buy it and, well, 'test' it on themselves?
Supplementary testing a manufacturer may opt for (not mandatory, but advisable)
Alongside the testing and safety data relevant to the specific product, a manufacturer may also choose supplementary studies that provide additional evidence on efficacy, tolerability or other product properties. Depending on the nature of the product, these studies can help characterise particular effects or substantiate specific benefits. They can also provide evidence for claims used in advertising and support additional instructions or warnings for the product's use.
Examples of such tests:
Patch test (skin irritation test) – checks whether the product causes irritation or allergy more frequently than the average
*Ophthalmological testing – may be appropriate for products intended for use around the eyes, depending on the product, its intended use, claims and safety assessment; Regulation (EC) No 1223/2009 does not impose it as a general requirement.
SPF testing – for products claiming to offer UV protection; checks the actual protection factor.
Dermatological testing – dermatologists assess the product on test subjects, confirming any property of the product the manufacturer wishes to verify. Establishing hypoallergenicity is one such example.
*The Regulation requires particular attention to the microbiological quality of products intended for use around the eyes, on mucous membranes and on damaged skin. A specific safety assessment is expressly required for products intended for children under three years of age and for products intended exclusively for external intimate hygiene. These requirements should not be confused with a general obligation to perform ophthalmological testing.
So dermatological testing is not mandatory for every cosmetic product?
A common misconception is that every cosmetic product sold in the EU must be dermatologically tested on volunteers. That is not a general legal requirement.
EU cosmetics legislation does not contain one positive list of every ingredient that may be used in cosmetics. It prohibits certain substances, restricts others and provides positive lists for specific categories such as colourants, preservatives and UV filters. Other ingredients are assessed in the context of the finished product, taking into account their identity, purity, concentration, exposure and intended use.
The safety assessor evaluates the available toxicological and quality data for the ingredients together with the safety of the finished formulation. Dermatological testing on volunteers may be useful or necessary to support a specific claim, investigate tolerability or address a particular product profile, but it is not automatically required for every cosmetic product.
This does not mean that a product can be placed on the market without evidence. The responsible person must ensure that the product has an appropriate safety assessment and that the relevant product-specific testing and documentation are available before it is placed on the EU market.
And what about animal testing?
A much-discussed subject, and one that comes up constantly. More than that, 'not tested on animals' is a selling point for a good many brands.
EU cosmetics legislation prohibits animal testing of finished cosmetic products in the EU and, within the scope of the Cosmetics Regulation, also restricts the marketing of cosmetics whose final formulation, ingredients or combinations of ingredients were tested on animals for cosmetic purposes. A “not tested on animals” claim is therefore not automatically prohibited or misleading, but it must comply with the EU rules for cosmetic claims and the conditions set out in Article 20(3) of Regulation (EC) No 1223/2009.
Animal testing — the EU ban and its exceptions
This does not mean that no ingredient used in cosmetics can ever be associated with animal-testing data. Some substances also have uses outside cosmetics and may be subject to testing requirements under other legislation, such as REACH. Animal-testing claims should therefore be worded precisely and supported by appropriate evidence.
The one global exception is China
Until recently China required animal testing of imported cosmetic products, but in 2021 they too relaxed the rules for most products. Even so, testing in China may still be carried out for particular product categories, such as hair dyes or sunscreens.
Cosmetic safety is strictly regulated in the EU and is assessed at the level of the finished product. Ingredient restrictions, quality and toxicological data, exposure, the product's intended use and the relevant product-specific tests all contribute to the safety assessment. EU cosmetics legislation also contains specific rules on animal testing and encourages the use of scientifically validated non-animal methods wherever applicable.
