GLOBAL REGULATIONS
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How technology demystifies global compliance
Dr. Chiara Zaffino, Ph.D – Selerant, US
You have probably heard it already, but there are not a lot of common definitions among global regulators when it comes to cosmetics. Requirements in one country might have very little in common with another. The lack of agreement spans several silos,
from the definition of a cosmetic product to an ingredient to primary use. But the onus falls on you, the owner and developer of the product, to verify and clearly present your claims. This grey area, specifically the lack of
consensus between various authorities, muddles the development space, making it difficult for the cosmetics industry to create and quickly deliver new products to consumers. With safety on the top of everyone’s
mind, clear practices and tools have been created to untangle some of this semantic confusion. This technology not only brings clarity, but also helps improve agility and speed to market. Here are some ways
technology helps to demystify global regulations around cosmetics. Let’s dive in.
So, what is a cosmetic? In the United States, a product can be both a cosmetic and an over-the-counter drug, depending on intended use. In Europe, specific claims determine whether the product is or is not a cosmetic. And in Japan, it is a cosmetic largely depending on the purposes and effects of the product. Out of the gate, it is easy to see how varying
regulatory definitions of a cosmetic product creates confusion. Depending on specific rules and regulations, it is likely that a cosmetic has different classifications in different countries. Returning to Japan, regulators there categorise
products as medicines, quasi-drugs, and cosmetics. This classification determines how a product can be marketed. The difference between the three classifications? A medicine is a cure or designed for healing. Quasi-drugs are preventative. Cosmetics are for maintaining one’s beauty. But it is a bit more complicated than that. Also included among quasi-drugs are “cosmetic drugs”, which have an intended use similar to a cosmetic, but are not classified as such. Claiming special aesthetic effects through the designation of an active ingredient designates the product as a quasi-drug,
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not a cosmetic. The first
step is assessing which category the product falls under
in any given market. This requires careful research and documentation. Do not be surprised if
different markets have different classifications but knowing and verifying these requirements help advance a compliant go-to-market strategy. Using technology can focus on the key
aspects of entering a new market. Solutions exist to help support these efforts, including tools that reduce the amount of time spent on significant compliance tasks.
When is a cosmetic just a bunch of chemicals? Take a second and imagine a tanker truck rolling down the highway carrying a load of liquid irritant, most likely very flammable. The cargo is a tank full of fragrance, moving from chemical manufacturer to a cosmetics company where it will be used as an ingredient in a mixture. From a regulatory perspective, are we talking about a chemical or a cosmetic?
The overlapping relationship between
chemicals and cosmetics is another example of how easy it is to introduce confusion into regulatory compliance checks for cosmetics. It is not uncommon for cosmetic ingredients to be part of chemical inventories maintained by regulators. This leads to further contradictions, where chemical ingredients are classified differently across borders. The TSCA, used in the United States, does not account for cosmetic ingredients, whereas the Canadian Domestic/ Non-domestic Substances List (DSL/NDSL) considers cosmetic ingredients in its chemical substances inventory. The blurry regulatory boundaries between
chemical ingredients and cosmetic products creates additional inconsistencies. Companies looking to develop products with global reach should rely on digital repositories and databases that can hold current information for differentiating cosmetic and chemical ingredients in a given market. Moreover, if the need is to manage huge
quantities of a cosmetic that is not yet in its final, ready-to-consumer form, digital tools help create the mandatory documentation for mixtures of chemicals, including during transportation.
July 2021 PERSONAL CARE
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