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 — whether through import by distribution companies, and formally the rules also cover cosmetics that individuals order from foreign markets for their own use (China, USA). It is, admittedly, well known that v praksi nadzor rad zataji, particularly where private individuals import cosmetics themselves for their own use through assorted online shops such as TEMU, Shein ali 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 najbolj strogo reguliranimi svetovnimi trgi, 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 subject is that all cosmetics found on the EU market are safe. From the cheapest products to the dearest, from the greenest and most organic to those… well, less green and less organic. Fear is unnecessary: we are protected by the measures of the EU Cosmetics Regulation (Regulation (EC) No 1223/2009), which sets out mandatory testing, the list of permitted ingredients and, of course, the ban on animal testing. You may not know that a complete ban on animal testing of cosmetic products has been in force in the EU since 2013.

Mandatory testing of cosmetic products before release onto the EU market

Every cosmetic product sold in the EU has to pass the following tests and requirements without fault, and these are usually gathered together at the end into the so-called PIF dossier izdelka — the set of documents that serves as every product's identity card.

Cosmetic Product Safety Report

This is the first and most fundamental examination of a cosmetic product's safety parameters.

Ocena varnosti zajema 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.

It can be drawn up and signed only by qualified personnel — as a rule a pharmacist or a cosmetologist, though it may also be another suitably qualified specialist in medicine or toxicology. 

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 those raw materials permitted 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.

Test stabilnosti

This is a mandatory test, checking 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 of the product's raw materials (najpogosteje konzervansi) ter parna nepropustnost. 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.

Stability tests are carried out according to smernicah standarda ISO/TR 18811.

Microbiological testing / total viable count

Preverja the presence of living organisms in the product, usually bacteria and moulds. Cosmetic products do not always have to be entirely sterile, though usually they are. 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.

Test perzistence konzervansov – Challenge test

The most demanding mandatory test, 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 producto.

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 intercept 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 standarda ISO 11930.

A product passes the mandatory challenge test only if, at the end of the inoculation period, the presence of the introduced bacteria is zero.

Obvezna notifikacija v evropsko bazo CPNP (Cosmetic Products Notification Portal)

The final stage of control is obvezen vnos of a product that will be sold on the EU market, v evropsko bazo CPNP. 

Entry is mandatory and requires certain technical specifications of the product, which are then collected in a common database, creating a list of every cosmetic product authorised for sale on the European market.

The mandatory safeguards protecting the user of cosmetic products on the EU market are therefore: an expert safety assessment, a stability test, a total microbiological count, a challenge test, and mandatory registration of the product in the CPNP database.

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 mandatory tests there are also tests that further confirm a product's efficacy or safety. Depending on the nature of the product, it makes sense for a manufacturer to opt for certain additional tests that better characterise any unforeseeable effects, or confirm particular benefits. Those additional tests then yield the evidence for the efficacy claims used in advertising, ter additional warnings for the product's use. 

Primeri tovrstnih testov:

• Patch test (skin irritation test) – checks whether the product causes irritation or allergy more frequently than the average

• *Ophthalmological testing – mandatory for products intended for use around the eyes.

• SPF testiranje – 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 identifies two special groups of cosmetics for which additional tests are mandatory. These are cosmetics intended for the care of the skin around the eyes, ter kozmetiko, intended for the care of children under 3 years of age. Safety is emphasised further still for these products.

So dermatological testing is not mandatory for every cosmetic product?

A common misconception among consumers is that absolutely every cosmetic product is dermatologically tested. Ampak niso. Zakaj?

Ker v resnici to ni potrebno. The Regulation lays down strict instructions and restrictions on which raw materials products may or may not contain, and in what quantity. Every raw material and dose it permits has been extensively tested and demonstrates many years of safe use. All ingredients on the list have been tested through toxicological and dermatological studies establishing their safety. If a manufacturer follows the instructions of the Regulation, the likelihood of unexpected trouble is extremely small.

Every ingredient under the Regulation has been tested individually, in combination, and through long-term presence on the market. A system of this kind means manufacturers do not need additional dermatological tests for each individual product, provided they use verified ingredients at permitted concentrations.

This is one of the key functions of EU legislation — to provide enough information and proven data that there is no room for improvisation, while keeping products safe in a straightforward way and at lower formulation cost. 

If the safety of every combination of raw materials a brand dreamed up had to be dermatologically tested independently, developing a cosmetic would cost hundreds of thousands of euros and take several years. As it is, we opt for dermatological testing only where there are particular requirements; otherwise products can be released to market with the basic tests alone, and without concern.

Every ingredient on the permitted list has previously undergone extensive safety testing, assessing its toxicological safety and potential effects on health. This means manufacturers do not need additional tests for each ingredient, provided it is used within the permitted limits.

That reduces needless repetition of tests, lowers production costs, and allows faster development of new formulations without compromising consumer safety.

And what about animal testing? 

A much-celebrated subject, mentioned so frequently. More than that, 'not tested on animals' is a selling point for a good many brands.

Animal testing has been entirely prohibited in the EU since 2013. Advertising that a product is not tested on animals is therefore thoroughly misleading: – no cosmetic product sold here is, or may be, tested on animals.

Animal testing — the EU ban and its exceptions

The EU prohibited animal testing of cosmetic products back in 2013, and it is likewise not permitted to market products that were tested on animals outside the EU. This means every new ingredient in cosmetics has to be assessed for safety by alternative methods, such as in vitro tests (cell cultures) ali computer simulations (QSAR models).

The one global exception is China

Until recently China mandatorily 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.

Testing of cosmetic products is strictly regulated in the EU and secures a high level of consumer safety. Thanks to precisely specified permitted ingredients and their concentrations, manufacturers do not need additional tests for raw materials already assessed as safe. Animal testing is prohibited in the EU, and the alternative is modern, humane and scientifically advanced methods of safety assessment.