Paolo Giacomoni, PhD, Insight Analysis Consulting10.02.23
For many years, the cosmetics market was a sort of intellectual Wild West and products were marketed without much regulatory constraints. The legislator was perhaps betting on the determination of manufacturers and distributors to make sure their products are safe, lest they lose market shares.
In the US, cosmetics are considered “cosmetics” as long as claims relative to their action are confined to the surface of the skin that cosmetics are meant to make “better;” i.e., softer, luminous, moist, even, smooth, beautiful, etc. As soon as the claim evokes a non-surface biochemical activity, the product becomes a “drug” and must undergo the rigorous, expensive, time-consuming tests required for putting a drug on the market. Two categories of skincare products are considered to be over-the-counter (OTC) drugs: sunscreens and anti-acne products. They can be sold without prescription and are regulated by appropriate monographs.
In recent years, the European Union (EU) and the US became more attentive to cosmetics and addressed the safety of new ingredients.
“the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act”
The “responsible person” must provide the FDA with a list of each marketed cosmetic product, including the ingredients, with annual updates. The responsible person must keep records about the safety assessments of their products. These assessments can be either generated by the responsible person itself or found in the scientific literature. They are acceptable as long as all the data are obtained following scientifically-sound methods.
Animal testing is not a requirement for marketing a cosmetic product.
Despite having trust in the sense of responsibility of the“responsible” person, and perhaps to avoid entrusting the henhouse to the fox, the FDA reserves the right of intervening to check and analyze products that might reasonably be thought of being dangerous for the consumer. The FDA reserves the right of withdrawing dangerous products from the market if the responsible person refuses to do so voluntarily.
One of the most puzzling claims is that a product is “natural.” Is synthetic vitamin C less natural than the one extracted from oranges?
The EU considers that “natural” and “safe” are not synonymous and that it might be important for the consumer, that a safe product be labelled as “natural,” as long as the word “natural” is legally defined. In this frame of thinking, the International Organization for Standardization has promulgated a norm allowing to calculate the percent of “naturality” of a cosmetic product. The ISO 16128 guideline defines “natural” in a cosmetic product when it is made by more than 50% by raw materials obtained from botanicals with mechanical extraction methods. Since this definition is sometimes subject to “creative” interpretations, let’s see how to calculate the naturalness of a cosmetic product. As an example, let us consider the above composition, which was found on the internet. One should notice in this example, that the preservative as a whole, is present at 12% with a natural index of 9.6 and that vegetable oil as a whole is present at 2.2% with a natural index of 0.5
Claims as “Free-from-X,” “No X added,” “X-free” or “Without X” do not mean the same thing and are differently defined in the US, in Canada and in the EU. The claim easiest to check is the “No X added.” This means that the manufacturer mixes the ingredients in a vat to achieve a finite product, and that ingredient X as such is not added in the process of mixing. The claim does not exclude, though, that X be present as preservative or contaminant or by product in one or more of the other ingredients added to the vat. “X-free” is the most eye-catching claim, and is the most difficult to prove. As a matter of fact, it is impossible to prove that something does not exist, and a statement claiming the absence of X in a concoction means in reality that the presence of X is below the threshold of detection by state-of-the-art technology.
Organic, sustainable, hypoallergenic, green, etc. are other words that lack a rigorous and legal definition. These words are used without restraint to advertise products, and create confusion in the mind of the consumer. A regulatory intervention in the US and in the EU about these and other words would be more than welcome.
Paolo Giacomoni, PhD
Insight Analysis Consulting
paologiac@gmail.com
516-769-6904
Paolo Giacomoni acts as an independent consultant to the skin care industry. He served as Executive Director of Research at Estée Lauder and was Head of the Department of Biology with L’Oréal. He has built a record of achievements through research on DNA damage and metabolic impairment induced by UV radiation as well as on the positive effects of vitamins and antioxidants. He has authored more than 100 peer-reviewed publications and has more than 20 patents. He is presently Head of R&D with L.RAPHAEL—The science of beauty—Geneva, Switzerland .
In the US, cosmetics are considered “cosmetics” as long as claims relative to their action are confined to the surface of the skin that cosmetics are meant to make “better;” i.e., softer, luminous, moist, even, smooth, beautiful, etc. As soon as the claim evokes a non-surface biochemical activity, the product becomes a “drug” and must undergo the rigorous, expensive, time-consuming tests required for putting a drug on the market. Two categories of skincare products are considered to be over-the-counter (OTC) drugs: sunscreens and anti-acne products. They can be sold without prescription and are regulated by appropriate monographs.
In recent years, the European Union (EU) and the US became more attentive to cosmetics and addressed the safety of new ingredients.
Regulation in the EU
For topical applications that could possibly lead to mutagenesis, the regulatory directions in the EU follow the principle of the positive list: manufacturers can use only allowed substances. There is a list of allowed colorants, a list of allowed preservatives and a list of allowed UV filters. There are also substances that are prohibited or restricted, the restriction concerning the concentration, the association with other substances and the site of the application. In addition to this, there are guidelines for a New Approach Methodology (NAM) and a Next Generation Risk Assessment (NGRA) describing how to perform experiments for a new ingredient to be agreed for use in cosmetics. New ingredients should be proven not to be endocrine disruptors, toxic to reproduction, mutagenic or cancerogenic. In particular, new ingredients for baby or child care, nanomaterials, dyes and colorant must be tested for safety. Last but not least, the presence of a fragrances in a product must appear on the label when the fragrance itself is in a list of restricted fragrances.Regulation in the US
In the US, there is a list of ingredients Generally Recognized As Safe (GRAS) and the recently promulgated Modernization of Cosmetic Regulation Act (MoCRA) maintains the principle that manufacturers and distributors are reasonable people. The FDA defines the Responsible Person as:“the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act”
The “responsible person” must provide the FDA with a list of each marketed cosmetic product, including the ingredients, with annual updates. The responsible person must keep records about the safety assessments of their products. These assessments can be either generated by the responsible person itself or found in the scientific literature. They are acceptable as long as all the data are obtained following scientifically-sound methods.
Animal testing is not a requirement for marketing a cosmetic product.
Despite having trust in the sense of responsibility of the“responsible” person, and perhaps to avoid entrusting the henhouse to the fox, the FDA reserves the right of intervening to check and analyze products that might reasonably be thought of being dangerous for the consumer. The FDA reserves the right of withdrawing dangerous products from the market if the responsible person refuses to do so voluntarily.
Other Interventions
In addition to guidelines to assess safety and efficacy, legislators provide definitions for words used in claims.One of the most puzzling claims is that a product is “natural.” Is synthetic vitamin C less natural than the one extracted from oranges?
The EU considers that “natural” and “safe” are not synonymous and that it might be important for the consumer, that a safe product be labelled as “natural,” as long as the word “natural” is legally defined. In this frame of thinking, the International Organization for Standardization has promulgated a norm allowing to calculate the percent of “naturality” of a cosmetic product. The ISO 16128 guideline defines “natural” in a cosmetic product when it is made by more than 50% by raw materials obtained from botanicals with mechanical extraction methods. Since this definition is sometimes subject to “creative” interpretations, let’s see how to calculate the naturalness of a cosmetic product. As an example, let us consider the above composition, which was found on the internet. One should notice in this example, that the preservative as a whole, is present at 12% with a natural index of 9.6 and that vegetable oil as a whole is present at 2.2% with a natural index of 0.5
Claims as “Free-from-X,” “No X added,” “X-free” or “Without X” do not mean the same thing and are differently defined in the US, in Canada and in the EU. The claim easiest to check is the “No X added.” This means that the manufacturer mixes the ingredients in a vat to achieve a finite product, and that ingredient X as such is not added in the process of mixing. The claim does not exclude, though, that X be present as preservative or contaminant or by product in one or more of the other ingredients added to the vat. “X-free” is the most eye-catching claim, and is the most difficult to prove. As a matter of fact, it is impossible to prove that something does not exist, and a statement claiming the absence of X in a concoction means in reality that the presence of X is below the threshold of detection by state-of-the-art technology.
Organic, sustainable, hypoallergenic, green, etc. are other words that lack a rigorous and legal definition. These words are used without restraint to advertise products, and create confusion in the mind of the consumer. A regulatory intervention in the US and in the EU about these and other words would be more than welcome.
Paolo Giacomoni, PhD
Insight Analysis Consulting
paologiac@gmail.com
516-769-6904
Paolo Giacomoni acts as an independent consultant to the skin care industry. He served as Executive Director of Research at Estée Lauder and was Head of the Department of Biology with L’Oréal. He has built a record of achievements through research on DNA damage and metabolic impairment induced by UV radiation as well as on the positive effects of vitamins and antioxidants. He has authored more than 100 peer-reviewed publications and has more than 20 patents. He is presently Head of R&D with L.RAPHAEL—The science of beauty—Geneva, Switzerland .