The EU puts the beauty industry through its paces, with a thorough — and often time-consuming — registration process for new products. Knowing what to expect from the process lets you plan accordingly so you can get your beauty products to market on schedule and with as few headaches as possible.
You’ve spent months developing the first, or next, product in your beauty brand. Huge amounts of time, money, and resources have been devoted to perfecting the formula, identifying the target market, crafting the branding and design, and preparing for the product launch. The only thing left to do should be to get it approved and on its way to store shelves.
Simple, right?
Not in the European Union, unfortunately. The EU’s registration process for beauty products is where many brands have run into unexpected issues and delays that push back their launch schedule or, if their product has already made it to store shelves, result in a lengthy and expensive product recall.
The best way to avoid these kinds of headaches is to do your due diligence up front by knowing what rules and regulations apply to you and how you can comply fully with each and every one.
This post will provide an overview of the EU’s cosmetic registration process and requirements, beginning with what’s known as new approach methodologies, or NAMs.
What are NAMs and how do they impact the regulatory process?
NAMs are used to analyze and evaluate the safety of chemicals, including those used in beauty products. They measure such elements as product potency, skin sensitization, and potential toxicity.
NAMs came about in response to conventional safety testing for chemicals, and the slow, inefficient page it typically proceeded at. They also replaced older methods of safety testing that relied on animal subjects, which is now prohibited in the EU. While NAMs are still a work in progress, with a need for standardization and analysis being top priority, they do offer hope of a faster, more efficient route for getting beauty products to market.
How to navigate EU regulatory bottlenecks and get your products to market
Where brands have the most power to cut through red tape and speed up the registration process is in ensuring their products adhere to all of the relevant regulations. That starts with knowing what the regulations are and whether they apply to your product or not.
Register your products
The first thing to know is that all brands, no matter their size, must register their products. Whether you’re a multinational corporation or someone who whips up beeswax lip balm in your kitchen to sell at the farmer’s market, if your products are to be sold in the EU, they must be registered.
The products must also meet the definition of a cosmetic or beauty product, as opposed to a drug or a therapeutic agent. In brief terms, the EU defines a cosmetic in the following way:
“[A]ny 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.”
Check for applicable regulatory conditions
Once you’ve established that your product qualifies as a cosmetic, the next step is to check for the regulatory conditions that apply to your product. These regulations pertain to things like allergens, prohibited ingredients, or ingredients that may only be used in certain amounts. You can find this information by searching the cosmetic ingredient, or "CosIng," database.
A word of advice to brands who use “natural” and “organic” ingredients — you can’t bypass this step. Even natural and organic ingredients can contain potential allergens that need to be listed in full on your product packaging. Essential oils, for instance, are considered allergens when they exceed certain limits in a product’s formula.
Appoint a responsible person
Part of the EU registration process for beauty products is appointing what’s known as a “responsible person” who is accountable for submitting the product information and ensuring it is compliant and up to date.
If your company is based in the EU, you can act as the responsible person yourself. If your company is based outside of the EU, you will need to appoint someone who is in the EU as your responsible person.
Create a product information file
Next is creating a product information file. This step is the most time-consuming and labor-intensive in the process, and where mistakes or oversights are most likely to occur.
In putting together your product information file, you have to include the following information:
● Product formula
● Raw materials specifications
● Various finished product specifications
● Packaging specifications
● Documentation about the manufacturing process and good manufacturing practices
● Labels
● Claims substantiations
● Product safety assessments
A common misstep that brands make at this stage is failing to list out all the components of every ingredient. It’s not enough to list the major components or the trade names of ingredients — each building block has to be spelled out in full (and spelled correctly!) and listed in descending order.
Plant materials are another common stumbling block. The EU has strict regulations on how ingredients are named. For instance, it would be an error to list “rosehip oil” as an ingredient; the correct term according to EU standards is “Rosa Canina (rosehip) fruit oil.”
To save time and avoid the risk of failure in the product registration process, search for the correct name in the CosIng database.
Complete a CPNP Notification
The final step in the registration process is to complete a product notification on the Cosmetic Product Notification Portal (CPNP). This step must be performed by the responsible person.
Once your product notification is complete, you can start selling your product in the EU. Keep in mind, however, that you are also responsible for ensuring all of your product information remains accurate and up to date.
Get help navigating EU regulations
The help of an experienced science consultant can make the registration process faster and simpler. Get in touch with me to find out more.
—-----------------------------
Sources
Barthe, Bavoux, C., Finot, F., Mouche, I., Cuceu-Petrenci, C., Forreryd, A., Chérouvrier Hansson, A., Johansson, H., Lemkine, G. F., Thénot, J.-P., & Osman-Ponchet, H. (2021). Safety Testing of Cosmetic Products: Overview of Established Methods and New Approach Methodologies (NAMs). Cosmetics, 8(2), 50. https://doi.org/10.3390/cosmetics8020050
EU Cosmetic Regulations – learn how to comply - https://www.youtube.com/watch?v=U_RwlEesugM
Steps to selling cosmetic products on the EU market - https://www.youtube.com/watch?v=4UdOpbx8Zmg
Mondou, M., Hickey, G. M., Rahman, H. T., Maguire, S., Pain, G., Crump, D., Hecker, M., & Basu, N. (2020). Factors Affecting the Perception of New Approach Methodologies (NAMs) in the Ecotoxicology Community. Integrated environmental assessment and management, 16(2), 269–281. https://doi.org/10.1002/ieam.4244
Meigs, L., Smirnova, L., Rovida, C., Leist, M., & Hartung, T. (2018). Animal testing and its alternatives – the most important omics is economics. ALTEX - Alternatives to Animal Experimentation, 35(3), 275–305. https://doi.org/10.14573/altex.1807041
Comments