A cosmetic ingredient that has been approved in the US may not be allowed to be launched in the EU. This may cause unexpected re-formulations, delayed approvals, varying packaging, and higher compliance costs to regulatory and product teams that are concerned with international expansion.
The difficulty is the disparity in FDA and EU regulations of cosmetics. The EU has a more precautionary strategy and has a large list of banned and restricted ingredients. Whereas the US FDA has more responsibility on manufacturers to demonstrate the safety of their products.
Knowledge of cosmetic banned ingredients in the US vs EU is now important in developing formulations that can be scaled in the global market without bottlenecks in compliance.
The Importance of Ingredient Compliance in International Cosmetics
For cosmetic companies that are entering various markets, ingredient compliance has a direct impact on the launch schedule, formulation strategy, and scalability of the product. A formula that has been cleared in the US might need to have its ingredients altered or further compliance checks before entering the EU.
This poses significant operational problems to regulatory and product teams:
- Delay in reformulation following product development.
- Several safety and stability tests.
- Revisions of packaging and artwork.
- Supplier qualification issues.
- Late entry to regions.
Regulation (EC) No. 1223/2009 has an extensive list of banned and restricted substances maintained by the EU, whereas the US FDA has a smaller list of federally prohibited cosmetic ingredients.
Overview of Ingredient Regulations in the US
The US regulatory system provides more freedom in formulation to cosmetic companies, yet it puts more responsibility on manufacturers to demonstrate the safety and compliance of products.
Role of the U.S. Food and Drug Administration (FDA)
The compliance with cosmetic ingredients in the US is governed by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA does not pre-approve most cosmetic ingredients or cosmetic products prior to their introduction into the market, as the EU does.
Restricted Proscribed Drugs by FDA
The list of substances that are officially restricted or prohibited is by FDA is:
- Bithionol
- Mercury Compounds
- Vinyl Chloride
- Chloroform
- Certain Halogenated Salicylanilides
- Complexes of Zirconium in Cosmetic Aerosols
- Methylene Chloride
- Prohibited Cattle Materials
The FDA also regulates the use of color additives independently, thus necessitating approvals for the use of color additives in cosmetics.
Focus on Substantiation of Safety
Manufacturers are given the main responsibility of ensuring the safety of cosmetics by the FDA. Under the legal obligation, companies have the responsibility of ensuring that products are safe under the labeled or customary conditions of use. They must keep up with sufficient safety substantiation records internally. The FDA does not mandate companies to provide safety data prior to commercialization.
Overview of Ingredient Regulations in the EU
The EU has a more restrictive and centralized method of compliance with cosmetic ingredients than the US.
Role of the European Commission
Cosmetic regulations in EU member states are regulated by the European Commission, and revised ingredient restrictions are based on scientific safety evaluations by the Scientific Committee on Consumer Safety (SCCS).
Long Lists of Banned and Restricted Ingredients
EU has one of the most comprehensive systems of restriction of cosmetic ingredients in the world pursuant to Regulation (EC) No. 1223/2009. The ingredients are controlled with the help of certain annexes:
- Annex II: substances which are not allowed in cosmetic products.
- Annex III: substances permitted with restriction, like concentration limits, product type restrictions or warning labels.
According to the latest updates of the EU regulations:
- In annex II, there are over 1,600 prohibited substances.
- Hundreds of restricted substances can be found in Annex III.
Typical illegal or severely restricted drugs are:
- Certain Parabens
- Formaldehyde And Formaldehyde Releasers
- Cmr Substances (Carcinogenic, Mutagenic Or Reproduction Toxic)
- Hydroquinone in the majority of cosmetics uses
- Several Phthalates
- Specific Fragrance Allergens
- Some Hair Dye Products
These annexes are updated by the European Commission on a regular basis, depending on the reviews of SCCS safety and scientific evidence. To regulatory and formulation teams, this renders constant ingredient checks pivotal in the production of products to be commercialized in the EU.
Key Differences: US vs EU Ingredient Regulations
The US and EU follow very different approaches to cosmetic ingredient compliance, creating major challenges for companies developing products for both markets.
| Area | US FDA |
EU Regulation (EC) No. 1223/2009
|
| Regulatory approach | Reactive enforcement model |
Precautionary approach
|
| Pre-market approval | Most cosmetics not pre-approved |
Compliance required before market entry
|
| Banned substances | Limited prohibited ingredient list |
1,600+ banned substances
|
| Safety responsibility | Manufacturer-led safety substantiation |
Mandatory safety assessment and CPSR
|
| Compliance oversight | FDA post-market enforcement |
Centralized EU regulatory framework
|
| Ingredient restrictions | Fewer federal restrictions |
Extensive banned and restricted annexes
|
| Documentation | Safety substantiation records |
Product Information File (PIF) required
|
| Market accountability | Manufacturer responsibility |
Responsible Person (RP) mandatory
|
For regulatory and formulation teams, the biggest challenge is that a formulation considered compliant in the US may still fail EU ingredient restrictions, concentration limits, allergen requirements, or safety assessment reviews. This often leads to reformulation delays, repeated testing, and slower global product launches.
Common Ingredients Banned in EU but Allowed in the US
Several cosmetic ingredients restricted or banned in the EU are still permitted in parts of the US market.
| Ingredient | EU Status | US Status | Concern |
| Formaldehyde | Prohibited in cosmetic products | Not federally banned | Carcinogenicity |
| Dibutyl Phthalate (DBP) | Banned | No federal cosmetic ban | Reproductive toxicity |
| Isopropylparaben | Banned | No federal ban | Endocrine disruption |
| Isobutylparaben | Banned | No federal ban | Reproductive toxicity |
| Lilial (Butylphenyl Methylpropional) | Banned | Not federally banned | Reproductive toxicity |
| Hydroquinone | Restricted to professional/artificial nail uses | Allowed in certain OTC drug products | Skin toxicity |
| Triclosan | Restricted | Limited restrictions |
Endocrine and environmental concerns
|
How to Ensure Compliance of Ingredients in Different Countries
Follow the strategies below to ensure compliance with ingredients in different countries.
1. Carry out Ingredient Reviews Early
Review of ingredients must occur prior to formulation, approval of suppliers, and packaging design. Compliance checks that are done late in the process usually result in changes in products and retesting.
2. Formulate According to the Toughest Market
The reason why many brands are formulated in line with the EU requirements is firstly due to the more rigorous banned and restricted ingredient regulations in the EU compared to the US. This minimizes the risk of reformulation as it expands globally.
3. Keep Records of Ingredients and Suppliers
Regulatory teams ought to have:
- INCI names
- CAS numbers
- supplier declarations
- allergen information
- ingredient concentrations
These documents aid in FDA safety substantiation as well as EU Product Information File (PIF).
4. Monitor Regulatory Updates
The EU periodically revises the lists of banned and restricted ingredients in Annex II and Annex III. The companies have to keep track of the changes in ingredients and safety.
5. Integrate Regulatory, R&D, and Procurement
The problem of ingredient compliance can frequently occur when sourcing, formulation, and regulatory teams operate independently. Early cross-functional reviews enable the detection of limited ingredients and supplier risks at a quicker rate.
How Ingredient Checks Become Simpler with Compliance Software
When products are introduced in a variety of countries, manual review of ingredients will be challenging.
1. Automates Ingredient Screening
Formulations can be automatically checked against compliance software:
- The EU prohibits and limits lists of ingredients
- FDA restricted ingredients
- allergen requirements
- concentration limits
2. Tracks Regulatory Changes
Restrictions on ingredients vary on a regular basis, particularly in the EU. Compliance systems are useful in keeping teams abreast of updates in annex and reclassification of ingredients at a central location.
3. Reduces Reformulation Delays
Early screening of ingredients assists in raising compliance concerns prior to packaging, testing and launching of the product.
4. Centralizes Compliance Documentation
The compliance systems are useful in ensuring:
- Supplier Documents
- Safety Records
- Ingredient Declarations
- Formulation History
- Audit Trails
Conclusion
The disparity between FDA and EU regulations of cosmetic ingredients poses significant compliance challenges to companies entering the market with products worldwide. Products that are permitted in the US can still be prohibited or limited in the EU, adding to the risk of reformulation and slowing entry to the market.
Ingredient compliance has a direct impact on the launch timelines, product scalability, and commercialization costs, on regulatory, formulation, and product teams.
To minimize reformulation and compliance delays and market-entry risks, companies going global can get in touch with regulatory experts at Artixio. We can help you with ingredient compliance and cosmetic products registration across different countries. Whether you are launching in the USA or the EU, our team can ensure your products are compliant. For more details, reach out to us at info@artixio.com.
