Safety assessment for cosmetics: Everything you need to know

What is a safety assessment for cosmetics?

When is the last time you brushed your teeth and wondered “is this toothpaste actually safe?”. You probably rarely do this, if ever. And that’s exactly the point!

Cosmetics, according to the law, must always be safe for consumers to use. Consumers simply need to be able to assume product safety is in order.

The safety of cosmetic products must be established before the product can be sold in stores. Checking cosmetic product safety is called a cosmetic safety assessment.

You can actually compare this with a drivers license; someone is not allowed to hit the road until their driving skills have been safely assessed by an examiner. The law specifies how and by whom a cosmetics safety assessment may be performed.

A safety assessment is an assessment of all aspects of the product, i.e. the recipe, the packaging, the labelling, and so on. When all parts are properly checked, the product is considered safe.

The safety assessment is written down in a report, so the competent authorities – in the Netherlands this is the NVWA – can always check whether the product is safe. This report is called a cosmetic product safety report, or a CPSR.

What do we actually mean by cosmetics?

When you think of cosmetics, you initially only think of make-up and other products intended for enhancing appearance. However, this is just one part of what cosmetics are.

To find out which products fall under the cosmetics category, we can always fall back on the definition of cosmetics as it’s included in European law. The European Regulation EC 1223/2009 article 2.1a contains this definition of cosmetic products:

cosmetic product: any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;

That’s a lot of terms. Let’s group them first and then look at them one by one.

• Any substance or mixture
• Which is intended to be brought into contact
• With the parts of the human body surface or with teeth and molars and the oral mucosa
• For the sole or main purpose of cleaning, perfuming, changing the appearance and/or protecting or maintaining the aforementioned body parts or correcting body odours

Any substance or mixture…

A mixture is a combination of several substances. A substance is an ingredient, such as water, alcohol, or a dye. What falls outside this definition are so-called “articles”.

An article is a substance or mixture with a certain form, where the form is much more important than the substance(s) of which the article consists.

Think about glasses; it doesn’t really matter if glasses are made of plastic or metal or some other material – that the material has the shape of glasses is the most important thing.

Conversely, a block of soap happens to look like a block, but this shape is not more important than the substances contained in the soap. The soap can be any shape, as long as it contains the right ingredients.

Which are intended to be brought into contact…

This means cosmetic products must actually touch hair, skin or mouth for them to function properly.

An air freshener also has the purpose of perfuming, but because you do not touch the air freshener to use it, the air freshener is not a cosmetic product. A body lotion is a cosmetic product, because you have to put the lotion on your skin for it to work.

With the parts of the human body surface or with teeth and molars and the oral mucosa…

First of all, the word “human” is mentioned here. This means that products intended for animals are not cosmetic products.

A dog shampoo doesn’t have to comply with the cosmetics law, but with another legislation.

Subsequently, ‘body surface’ is mentioned. So the outside of the body. If a product is introduced into the body (exception: oral cavity), then it doesn’t count as a cosmetic product.

So lubricants, nasal sprays, and nutritional supplements; none of those are cosmetic products.

For the sole or main purpose of cleaning, perfuming, changing the appearance and/or protecting or maintaining the aforementioned body parts or correcting body odours.

The function of the product must primarily have a cosmetic function.

If the product also has a non-cosmetic function, different parties will assess in which category the product ultimately falls. Examples of non-cosmetic functions are biocidal functions (antibacterial, against mosquitoes) and medicinal functions (healing, restoring).

Who’s allowed to carry out a cosmetics safety assessment?

Just like being a drivers license examinator is a specific profession, there is also a specific profession for assessing cosmetics safety. Such a person is called a safety assessor. Kind of a cool name, right?

A safety assessor has studied pharmacy, biomedicine, toxicology or general medicine for years and has also acquired a lot of practical experience. The more experience, the better!

Which tests are part of a safety assessment for cosmetics?

Tests are also required to assess cosmetics safety. These cosmetics tests are aimed at finding out whether the product is currently safe and will remain safe when in use.

The most standard test is the shelf-life test. A product must of course be stable for quite some time, and the shelf-life test determines what the expiration date could be.

A shelf-life test is also called a stability test, or a compatibility test. The compatibility test is a stability test in which the product is tested in its final packaging.

Very handy, of course, because this way you can also check in advance whether the product will not leak from the packaging.

Another commonly used test is a microbiological test. Many products can rot or mould over time. That is why these products are protected with preservatives.

The microbiological test checks whether the preservation works well enough against bacteria and fungi. In this test, a lot of bacteria and fungi are deliberately added to the product to ‘challenge’ the preservation of the product.

That is why this microbiological test is also called a ‘challenge test’ or ‘preservation efficacy’ test.

Other tests that can be done are, for example, for specific cosmetic products.

Think of sunscreens, where they test whether the sunscreen factor (SPF) is correct, or an aerosol with deodorant, where they test whether the aerosol can handle the high pressure and does not explode spontaneously.

All very important tests, which are necessary to properly assess the safety of a product.

How does a safety assessment relate to GMP?

GMP stands for Good Manufacturing Practices. All cosmetics factories must comply with GMP. If a factory works according to GMP, it means that the quality of products remains consistent during production.

So it cannot be the case a product made today is much larger or has a different colour when produced in the future. To achieve this consistency, a factory follows many different protocols and checklists.

For instance, checklists for the recipe (have I added all ingredients, in the right quantity, in the right order?), for cleaning (mixing kettles must be rinsed in between), and traceability (where does this raw material come from, how long has this barrel been open?).

Producing cosmetics under GMP is required by law. A factory may assess this itself or have itself certified by a certification company.

GMP is therefore also necessary for a good safety assessment; if the quality of products fluctuates greatly due to inconsistent production, then a safety assessor can’t actually make a safety assessment of that product.