In cosmetics industry, unlike pharmaceuticals, one of the main problems is that the definitions, categories of ingredients, claims language… are often arbitrary, confusing, and misunderstood!
Based on what I’ve come across over the years, here are some of the most common myths and misconceptions:
Penetration
One hears and reads (too much) frequently that “a cosmetic product must stay on the surface of the skin” (i.e. is not allowed to penetrate). This is total nonsense and is only based on a superficial reading and bad interpretation of the legislation.
While the EU regulation defines a cosmetic by its mode of application (put in contact with external surfaces) to distinguish it from oral, subcutaneous, intravenous or other forms of administration, it says nothing about what the product and/or its ingredients become of, once applied topically to the epidermis or the mucous membranes.
The law cannot “forbid” a molecule to do what its physical/chemical nature forces it to do.
Caffeine, glycerine, fatty acids, sterols, lipopeptides: they ALL penetrate, if we wanted it or not!
Besides, the concept of penetration means nothing if amount, depth, percentage of applied dose, metabolism and kinetics are not mentioned/measured and specified. The word “penetration” does not even figure in the text of the regulation.
On the contrary, only the guidelines for establishing the safety file of a product make reference to the problem of penetration: to know the amount of an ingredient that does penetrate and possibly enters the blood stream is needed to be able to calculate the
Margin of Safety (MoS).
Hence, the fact of potential penetration of ingredients is clearly accepted by the legislation, even into the blood stream, as long as whatever penetrates has no systemic effect on the body!
Activity
In the same vein, the idea that “a cosmetic product must only act at the surface” is misunderstood. Once substances penetrate (and many do), they will act at the site (and along the way?) where they end up:
epidermis, EDJ, dermis, hypodermis, encountering cell membranes, receptors, enzymes, hormones…
This is not incompatible with the definition (and distinction from drugs) of a cosmetic product. EU jurisprudence confirms this clearly:
“
the capacity to restore, correct or modify physiological functions should NOT LEAD to the classification as medicinal products by function of products which, while having an effect on the human body, do not significantly affect the metabolism and thus do not strictly modify the way in which it functions”
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Placebo
The notion of «
placebo controlled studies » for cosmetic products makes no sense! This is so because there is no legal distinction for «
cosmetic active ingredients ». This is contrary to what we know of pharmaceutical active substances (APIs). In an INCI list of a consumer product with sometimes more than 50 ingredients, with numerous:
...it is quite impossible to distinguish the « actives » from the « excipient »! And there is no legal requirement to do so.
Often mentioned as counterexamples are the
sunscreen products in the US which, however, are not regulated as cosmetics, but as over the counter (OTC) drugs ! Only here and in Japanese Quasi-drug (QD) and Korean “Functional Cosmetics” do we encounter a similar official term of “actives”, e.g. for the UV filters or authorized
skin “whitening” ingredients.
However, the words « actives » and « placebo » appear in many commercial documents and some scientific or technical publications about cosmetic ingredient activities. This is a purely marketing jargon, understood by all, but without any regulatory basis.
Of course, the specialized companies who develop and market innovative ingredients for which they (want to) claim certain cosmetic activities, often run some clinical trials in which, preferentially, they test a base cream (also called “vehicle”, or placebo) against the same cream containing their “active” substance. Such “
placebo controlled clinical tests” afford higher credibility to the claims being made to promote the ingredient to formulators. But there is absolutely no legal requirement to do such studies, neither for the supplier nor for the cosmetic manufacturer and marketer.
Notion of « Cosmeceuticals », « Dermocosmetics », « Active Cosmetics »
These have no basis and should be avoided. Which brand would say that its product is not active? Besides, the term “cosmeceutical” is used by some to designate the entire finished formula that is claimed to have certain bioactivities, and by others to designate a specific ingredient (retinol, kinetin, ceramide,
peptides…).
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- To whit, glycerine is a ligand to aquaglyceroporins (receptors in cell membranes) and thus, in the strictest sense, exerts pharmacological action. Does it become a “cosmeceutical” by that fact?
- "Fatty acids influence skin physiology via their effects on skin barrier function, eicosanoid production, membrane fluidity and cell signaling” (C.W. Lynde, MD, in Skin Therapy Letters Vol 6, N° 13, p. 3-5); and so on… A PUFA containing formulation then would also be a “cosmeceutical”?
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The fact that today we know more about the bio-activity of these ingredients does not change the nature of the products. They are still cosmetics by any definition (as long as claims language respects the rules imposed by the various legislations).
Facts Regarding Cosmetics Ingredients
Even the term “Cosmetic ingredients” is ambiguous. There is NO a priori definition of a cosmetic ingredient (except in China, since the introduction of their national legislation of a “positive list” of a few years ago). In Europe, in the US, even in Japan and Korea and practically all other countries, regulations list a number of ingredients that are NOT allowed in a cosmetic.
In the EU, the Annexe II with about 1500 substances is such a “negative list”; apart from those prohibited substances, EVERYTHING can be used in a cosmetic, as long as it is employed safely. An ingredient as absurd as “hygienic nightingale droppings” was a fashionable item a few years ago, perfectly legal.
How to Classify Ingredients
The
INCI dictionary lists about 20000 ingredients, and every year a good number of new substances is added to the list. It is surprising to realize how many people still misunderstand the scope of the INCI dictionary! There can be no notion of these listed substances as being:
- “Allowed”
- “Authorized”
- “Registered”
- “Safe”
- “Efficacious”
There is not even a guarantee that all of these substances have in the past been used, are used today or will some future day be used in cosmetics. All INCI does, is to supply a name, a nomenclature for the substances being submitted. A nomenclature that should be used to inform consumers about the ingredients in the products they buy.
In the INCI “book” (now online), a minimum amount of information is available about the
nature of the substances. But they are all just listed in alphabetical order - no data on specifications, on safety, on activity or detailed function are supplied (the all-purpose “
skin conditioning” being one of the most frequent “function” given for the entries).
In summary, a substance becomes a cosmetic ingredient by the simple fact of having been or being presently used in a cosmetic product, but not until then. But everything is a potential cosmetic ingredient, unless listed as a prohibited material.
To classify cosmetic ingredients, we can proceed along three lines:
- By chemical nature (proteins, peptides, lipids, saccharides, minerals, and their subclasses): this may be of some technical interest to formulators for reasons of solubility, stability, compatibility
- By origin (animal derived, plant derived, synthetic, biotechnology derived): these categories are often used for marketing purposes (the sad story of “natural” vs. “chemical”). But they are often hard to define, to delimitate, given complex pathways of manufacturing. For instance, take Vitamin C production that involves plant derived sugar, a few steps of organic chemical synthesis (hydrogenation, ring closure) and also fermentative processes… So what is it? Plant derived, synthetic, or biotech?
- By function and/or activity: this is the most important aspect for choosing ingredients to use in cosmetics: “what do they do?” “What are the benefits for the formulator (technical, financial) or the consumer (claims and documented activity)?”
But even those categories are ambiguous, as there is so much in this field.
Take the example of
chelating agents:
- For stabilization of the formula, sometimes EDTA is used to complex certain metals. While EDTA is a substance no-one would talk about, alternatively phytic acid can be employed for the same purpose.
- Phytic acid, extracted from plant material (e.g. rice bran) can also be claimed as anti-pollution protectant, binding unwanted cadmium or other heavy metal.
- Vitamin E can also be used as an anti-oxidant to protect the formula, or as a protecting agent to detoxify free radicals…
Both (and many others) can thus be considered as auxiliary “excipient” ingredients or as “actives” if some marketing story can be construed.
Cosmetics Professionals Stay Alert!
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