When the word ‘cosmetic’ is said, makeup usually comes to people’s minds first, then skincare, hair care and even fragrance. These are all correct but the definition of a cosmetic is very specific and even differs in different regions. Europe and America have different definitions of what is called a cosmetic, and for a beauty founder, both of these definitions are important to know. For legalities, European cosmetic legislation falls under the EU Cosmetic Directive and for American markets, cosmetic legislation falls under the FDA. So for these legal bodies, the definition of a cosmetic is:
The FDA Definition
The Federal Food, Drug & Cosmetic Act (FD&C Act) defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.”
The EU Definition
A “cosmetic product” shall mean any substance or mixture intended to be placed in contact with the various 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 and/or correcting body odours and/or protecting them or keeping them in good condition.
Why This Matters
The main reason for these definitions is because there are ingredients that have to be regulated. Unfortunately, there are business people out there who put profit before people and will put anything in a shampoo bottle to make a quick buck – regardless if it is something harmful or something useless. Another important thing about these legal bodies is that they describe what the safe limits are for some ingredients. So for example, the EU Cosmetic Directive gives information on:
- ingredients which are prohibited in cosmetic products
- ingredients which are restricted in cosmetic products
- substances that are preservatives, UV filters and colourants which are permitted in cosmetic products
Both the FDA Cosmetic Act and the EU Cosmetic Directive are updated regularly to make sure that the information stays relevant.
If a product formulation is in breach of any regulations, it either cannot be sold on the market or needs to be marketed as a drug and not as a cosmetic – whether marketing claims are made or not made about certain ingredients. In the US there are some drugs that can be bought without a prescription and are known as Over The Counter drugs (OTC). Often times, products that are cosmetics in the EU are OTC drugs in the US. See the table above for examples.
If a product that is a cosmetic in Europe, but is an OTC drug in America, the product must be registered as a drug in the US or the company will be liable. This is because the legislation for drugs (including OTC drugs) is more rigorous in its testing, manufacturing and labelling. Getting a product passed as drug is more expensive than getting it passed as cosmetic – both in Europe and the US.
What marks the difference between drugs, OTC drugs and cosmetics? The answer lies in the amount of active ingredient(s). An active ingredient means it is what alleviates a symptom or a problem. The following examples goes into more details about this:
Example 1: Salicylic Acid
Salicylic Acid is a well known keratolytic agent (it removes dead skin cells without having to use beads). This property makes salicylic acid useful in both anti-dandruff formulations (it helps to shift the flaky dead skin) and anti-acne formulations (it helps to unblock pores).
- Issue 1: The percentage differs for both products. Salicylic acid used in anti-acne products has to be ≤2% and in hair care products ≤4%. Go over this amount for both products and it is a drug.
- Issue 2: Even if a product is made with 2% salicylic acid and is a cosmetic in the EU, that same product is now an over the counter drug in the US and must be registered as such. This is because FDA regulates salicylic acid differently than the EU. These differences are usually because scientists differ in opinions on activities of an ingredient.
Example 2: Sunscreen
Although there are different rigorous testing methods for sunscreen values, the ingredients that are used is what determines their status. In the EU, sunscreens are cosmetics whilst they are OTC drugs in the US. The same thing applies for mouthwash, toothpaste antiperspirants and antibacterial handwashes.
Example 3: Dettol
Dettol is a well known antiseptic product and when diluted, it can be used to treat acne and dandruff. However the active ingredient is chloroxylenol which is a restricted ingredient and as such, the product Dettol is classed as an over the counter drug. People do use it to treat acne and dandruff, but the brand does not position this product as a cosmetic. For that reason, you will see suggested use on the back of the bottle describing it’s use for acne.
What does that mean for you?
This information is not to cause you to worry. It’s just one of the foundational nuggets of knowledge that people new to the cosmetic industry should know and understand whether or not it applies to their product idea. So when clients come to me saying they want a product that ‘treats a rash’ I tell them that is a pharmaceutical drug. Even if we use the same ingredients, treating implies curing a symptom and that is not what cosmetics do. Another question I ask is where will the product potentially be sold in. I once worked on a project where an ingredient the client wanted to use was ok in America but was under scrutiny in Australia and as the client had customers in Australia, we changed the ingredient. In this article, I only mentioned Europe and the US but some countries have their own legislation such as Japan, Italy and Australia. Again, not to worry, with correct ingredients, testing and labels you will not fall short of any of these legislations.
- In the UK, the Cosmetic, Toiletry and Perfumery Association (CTPA) is the authority on cosmetic regulation. Read their guide on supplying cosmetic products on the UK market here.
Go through the EU Cosmetic website here.