What Do You Need to Be Aware of Regarding EU Regulations on Cosmetics?
Thanks to the internet, we now live in a globalized world. This means that many businesses are interested in expanding their reach and selling their products in new geographical territories. While that can be an excellent way to reach new markets and improve profitability, it also comes with a number of special considerations. One of these is regulatory compliance.
In the world of cosmetics and personal care products, each country and territory has its own regulations. If you want to sell in those locales, you must develop an in-depth understanding of their legislative and regulatory requirements to ensure you remain compliant.
The European Union, or EU, is one of the world’s biggest markets. Encompassing 27 member nations and covering 1,707,642 square miles, the EU is a political and economic union that was home to just under 6% of the world’s population as of 2020. Due to its unique nature, selling to the EU market comes with some special considerations.
In today’s article, we’ll take a close look at how the EU regulates cosmetics and what you need to know if you are aiming to sell to this large, lucrative market.
Why Does the EU Regulate Cosmetics Differently?
Though each state within the U.S. has some of its own laws and regulations, they ultimately all come under the banner of the same country. The EU, however, is made up of 27 independent sovereign states, each of which has its own separate laws as well as being beholden to EU laws.
Each charter member state of the EU must agree to follow certain regulations and protocols, including those for many industries. Due to the nature of the EU, additional complexities are in place when it comes to the making of laws.
How Are Cosmetics Regulated in the EU?
The EU has its own advisory and regulatory bodies that make recommendations and decisions impacting all member states. It also has its own regulatory charter, known as EC No. 1223/2009, which must be followed by anyone looking to sell cosmetic products or cosmetics ingredients within the EU.
The Scientific Committee on Consumer Safety (SCCS) provides research and insights into the health and safety risks of cosmetics, personal care products, and household products. The Joint Research Centre (JRC) provides scientific insights and evidence-based knowledge to EU policymakers.
These organizations conduct yearslong independent studies and solicit feedback from various stakeholders within industries and the scientific community, then release suggestions on how the framework for a new regulation should look. After a debate process involving all of the EU’s member states, a final regulation is drafted and set forth.
The EU utilizes a regulatory structure known as Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), which addresses the production and use of chemical substances and how they impact both human health and the environment. This serves as a comprehensive chemical registry for all member states of the EU.
Any chemical substance produced in, sold in, or imported into the EU must have a REACH number. This includes all chemical ingredients used in cosmetics and personal care products. Producers must register with REACH and provide a comprehensive safety and hazard profile, going through a potentially lengthy process before approval is granted.
The JRC and SCCS conduct extensive research into which ingredients are safe and which should be banned outright in the EU. These requirements are updated regularly.
Is the EU Stricter Than the U.S.?
Overall, it is accurate to say that the EU is stricter than the U.S. in the regulation of cosmetics ingredients and chemical substances. The EU takes a much more hazard-focused approach, assessing the hazard profile of each chemical and legislating against any that might damage human health or the environment. Interestingly, this can include chemicals that might only be dangerous in specific situations that are unlikely to happen in a real-world scenario. Moreover, member states may also go above and beyond the EU’s regulations and adopt even stricter standards on a national level.
The U.S. Food and Drug Administration (FDA) takes a much more risk management-focused approach, acknowledging that a chemical may be hazardous under certain conditions but taking into account how likely those conditions are during regular consumer use. The FDA also relies more on manufacturers to provide relevant safety testing data and attestations. This is why the FDA seems to ban far fewer chemicals than the EU’s equivalent regulatory bodies.
The trade-off to this approach, however, is that the FDA is less likely to ban a chemical unless there is overwhelming evidence that it is unsafe. In response, some U.S. states impose their own stricter regulations for any chemicals used commercially within their boundaries (for example, California’s Prop 65).
How Many Cosmetic Ingredients Are Banned in Europe?
Due to the difference in approach discussed above, the EU’s regulatory bodies have banned far more chemicals than the U.S.’ FDA and Environmental Protection Agency (EPA). At the time of writing, over 2,000 ingredients are banned in the EU compared to only a few dozen in the U.S., with nearly 1,700 ingredients banned outright via Annex II (1223/2009) and several hundred heavily restricted via Annex III (1223/2009).
It’s important for suppliers and manufacturers to pay close attention to these regulations as they change frequently. For example, 23 new ingredients (including zinc pyrithione, imiprothrin, diisooctyl phthalate, and silicon carbide fibers) were added to the banned ingredients list in March 2022.
How Do You Adhere to EU Cosmetic Compliance?
If you wish to sell cosmetic ingredients or chemicals within the EU, you need to apply for a REACH number for each relevant product or ingredient if the imported tonnage amount per ingredient will surpass 1 ton per year. This process can be expensive; depending upon the type, value, hazard profile, and quantity of the products you want to import, getting a REACH number can cost anywhere from $50,000 to $100,000 USD for smaller manufacturers, with large amounts of chemicals potentially costing millions.
It is essential to note that, even if the generic version of an ingredient is approved and on the REACH registry, you will still need to register your specific chemical as an individual supplier. In other words, REACH operates not only on a per-substance basis but also on a per-supplier basis.
Due to the expense and lengthy process involved, certification to sell in the EU may seem inaccessible to many smaller chemical manufacturers, since the market tends to be dominated by larger suppliers both inside and outside of the EU. However, REACH does have a scaling fee schedule to reduce the requirements for smaller businesses, which helps lower barriers to entry.
If you wish to sell cosmetic products to end users in the EU, you will need to make sure that each of the ingredients in your products has a REACH registration number. However, it’s not necessarily your responsibility to acquire the registration number for each chemical in your product. That will normally fall to your ingredients supplier.
EU Cosmetic Labeling Requirements
Labeling requirements within the EU are similar to those within the U.S. Responsible parties, countries of origin, drug identification, and hazard labeling are all required parts of label declarations. All ingredients must be clearly listed, typically in descending order, starting with the most prominent ingredient first. Those appearing in amounts of less than 1% of the entire formulation can be listed in any order, and those used exclusively as processing aids may not need to be listed at all.
One area in which labeling requirements differ is when it comes to nanomaterials. Unlike the U.S., the EU has a specific definition of what constitutes a nanomaterial. According to the EU 1223/2009 regulations, “‘nanomaterial’ means an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.”
Another difference lies in the reporting of allergens. For instance, the EU requires 26 fragrance allergens to be listed on labels. That being said, the long-awaited updates to U.S. cosmetic regulations in the recent passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) do include new allergen reporting requirements to be phased in over the next two years.
Learn More and Purchase EU-Approved Ingredients
Here at Applechem, we are proud to say that all of our ingredients are approved for use in the EU. If you would like to learn more about any of our products, how they align with EU regulations, or how you can ensure that your products are compliant with EU regulations, we would love to hear from you.
Please contact us at any time, and one of our friendly team members will be in touch to assist you.