EU vs. U.S. INCI Labeling Requirements After MoCRA: What Cosmetic Brands Need to Know
For cosmetic companies selling products internationally, understanding the differences between European and U.S. ingredient labeling requirements is essential.
While both markets rely on the INCI to identify cosmetic ingredients, the legal obligations surrounding ingredient disclosure are not identical.
As we said, both markets rely on the International Nomenclature of Cosmetic Ingredients (INCI) to identify cosmetic ingredients.The introduction of the Modernization of Cosmetics Regulation Act (MoCRA) has significantly strengthened cosmetic regulation in the United States. Although it does not completely transform U.S. labeling rules, it introduces new compliance obligations and reinforces FDA oversight, making it more important than ever for manufacturers to understand the regulatory differences between the two markets.
1. The Regulatory Framework: EU vs. United States
Within the European Union, cosmetic labeling is governed by Regulation (EC) No. 1223/2009, which establishes detailed requirements covering ingredient lists, allergen disclosure, and consumer information. The regulation provides a harmonized framework that applies consistently across all EU Member States.
In the United States, cosmetic labeling is primarily regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR Part 701. Since the adoption of MoCRA, manufacturers must also comply with new regulatory obligations, including facility registration, product listing, and enhanced post-market surveillance. However, the overall structure of INCI labeling itself remains largely unchanged.
2. Main Differences Between EU and U.S. INCI Lists
Although the two systems share several common principles, important differences remain.
A. Fragrance Allergen Disclosure
One of the most significant differences concerns fragrance allergens.
The European Union requires certain fragrance allergens to be individually declared once they exceed specific concentration thresholds, as defined in Annex III of Regulation 1223/2009. Recent amendments have expanded the list of allergens that must be disclosed to consumers.
In contrast, U.S. regulations generally continue to allow manufacturers to declare fragrance mixtures simply as “Fragrance” (or “Flavor” where appropriate), protecting confidential formulations while providing less ingredient transparency.
MoCRA gives the FDA additional authority to establish future fragrance allergen disclosure requirements, suggesting that U.S. regulations could gradually evolve toward greater transparency.
B. Ingredient Order
Both jurisdictions require ingredients present at more than 1% of the formulation to appear in descending order of concentration. Ingredients below this threshold may be listed in any order.
The EU legislation defines these requirements through a harmonized regulatory framework, while U.S. compliance relies more heavily on FDA oversight and enforcement activities.
C. Colorants
Color additives are also regulated differently.
Within the EU, permitted colorants are listed in Annex IV of Regulation 1223/2009 and are identified using their Colour Index (CI) numbers.
In the United States, color additives are regulated separately under 21 CFR Parts 70–82, with certain substances requiring FDA batch certification before they can be marketed.
D. Nanomaterials
The European Union has adopted specific provisions for nanomaterials. Cosmetic ingredients manufactured in nano form must generally be identified in the ingredient list by adding the word “(nano)”, and many require prior safety assessment by the Scientific Committee on Consumer Safety (SCCS).
The U.S. regulatory framework does not currently require equivalent labeling for nanomaterials, although manufacturers remain responsible for demonstrating product safety.
3. How MoCRA Changes Compliance
While MoCRA does not substantially modify the format of INCI ingredient lists, it considerably strengthens the regulatory framework surrounding cosmetic products.
Among its major requirements are:
- Mandatory facility registration;
- Cosmetic product listing with the FDA;
- Enhanced adverse event reporting;
- Safety substantiation requirements;
- Designation of a Responsible Person.
These obligations improve traceability and reinforce the connection between product formulation, regulatory documentation, and labeling compliance.
4. Regulatory Strategy for International Cosmetic Brands
As regulatory expectations continue to evolve, managing ingredient lists is no longer simply a labeling exercise. Companies marketing cosmetics in both Europe and the United States should consider INCI labeling as part of a broader regulatory compliance strategy.
The European Union continues to apply one of the world’s most detailed ingredient disclosure systems, particularly regarding allergens and emerging technologies such as nanomaterials. Meanwhile, the United States is moving toward stronger regulatory oversight through MoCRA, even if ingredient labeling remains comparatively less prescriptive.
For many international manufacturers, adopting labeling practices that already meet EU requirements can simplify regulatory management, facilitate market expansion, and help anticipate future regulatory developments in other jurisdictions.
Key Takeaways
- Both the EU and the U.S. use the INCI system for cosmetic ingredient names.
- EU regulations require greater transparency, particularly for fragrance allergens and nanomaterials.
- MoCRA strengthens FDA oversight without fundamentally changing U.S. INCI labeling rules.
- Cosmetic companies should integrate ingredient labeling into their overall regulatory compliance strategy.
- An EU-oriented labeling approach may help improve regulatory harmonization across international markets.
Disclaimer:
The information provided in this article is for informational and educational purposes only. It does not constitute legal advice nor a personalized regulatory consultation. Despite the care taken in drafting this article and verifying its sources, regulations evolve regularly and may be subject to differing interpretations depending on the specific context of each company, product, or market.
Toxi Plan®, its directors, and its employees shall not be held liable for any use made of the information contained in this article without further analysis tailored to a specific situation. Any regulatory or strategic decision should be based on a specific assessment carried out by a qualified professional, with due regard to the applicable regulations, including any provisions or regulatory practices entering into force after the date of publication.