Planning to export your cosmetics to Europe? Be careful, EU compliance rules are very different from those in the United States, and failing to anticipate them can be costly. The EU applies strict, preventive regulations, while the US follows a more reactive approach. Here are the key points to prepare your products for a successful launch in Europe.
1. Two Different Regulatory Philosophies
In the United States, cosmetics compliance is regulated by the Modernization of Cosmetics Regulation Act (MoCRA).
The system relies on manufacturer responsibility, the FDA does not require pre-market approval for each product and typically intervenes after an issue arises or a complaint is filed.
That said, MoCRA does require some pre-market obligations, such as:
- Facility registration with the FDA
- Product listing for each cosmetic placed on the market
- Safety substantiation (Toxicological Risk Assessment, TRA) to demonstrate product safety
In Europe, cosmetics compliance is governed by Regulation (EC) No 1223/2009, which follows a preventive approach. No product can be sold without meeting a strict set of pre-market obligations, including:
- Appointing an EU-based Responsible Person
- Compiling a complete Product Information File (PIF)
- Conducting a safety assessment by a qualified expert
- Notifying the product in the EU’s Cosmetic Products Notification Portal (CPNP)
2. Key Compliance Obligations in the EU
Once you understand this difference in approach, here are the key steps to place a cosmetic product on the EU market:
- Appoint an EU Responsible Person: The official contact for authorities, holding legal responsibility for the product.
- Prepare a PIF: A complete file with formula details, manufacturing information, safety data, and proof of compliance.
- Conduct a safety assessment: Performed by a qualified safety assessor (toxicologist) to ensure consumer safety.
- Notify the product in the CPNP: A mandatory administrative step before any sales.
- Comply with ingredient restrictions: The EU bans or limits many substances still allowed in the US. Allergens are also strictly regulated, with specific lists for each market. Check out our cosmetic allergens guide to understand the requirements.
- Follow labelling rules: Mandatory information and translations into the official languages of each target country.
- Plan for environmental requirements: Packaging management, recycling, sorting, and compliance with the Packaging and Packaging Waste Regulation (PPWR).
3. Common Pitfalls for US Brands
Many US brands only discover these requirements late in the process, causing delays and extra costs. Common issues include:
- Restricted ingredients: Some UV filters, preservatives, or colorants allowed in the US are prohibited or more strictly regulated in the EU.
- Mandatory multilingual labelling.
- Total ban on animal testing, including for ingredients.
- Strict recall and vigilance procedures.
- Specific rules for nanomaterials, requiring separate notification.
4. Why Plan EU Compliance Early
Adapting a product already on the US market to meet EU requirements may involve a full reformulation, new labelling, and several months of procedures — leading to extra costs and launch delays.
By integrating EU compliance requirements from the development stage, you can:
- Avoid costly reformulations
- Accelerate your market launch
- Reduce the risk of customs delays or product seizures
- Build trust with European consumers
5. How EcoMundo Can Help
At EcoMundo, we help US brands navigate every step of EU compliance:
- Regulatory review of your formulas
- Safety assessment by certified toxicologists
- Full PIF creation
- Appointment as your EU Responsible Person
- CPNP notification and post-market follow-up
With over 15 years of experience, we ensure a fast, compliant, and secure market entry for your cosmetics in Europe.
Contact us now to know more!
Planning to export your cosmetics to Europe? Be careful, EU compliance rules are very different from those in the United States, and failing to anticipate them can be costly. The EU applies strict, preventive regulations, while the US follows a more reactive approach. Here are the key points to prepare your products for a successful launch in Europe.
1. Two Different Regulatory Philosophies
In the United States, cosmetics compliance is regulated by the Modernization of Cosmetics Regulation Act (MoCRA).
The system relies on manufacturer responsibility, the FDA does not require pre-market approval for each product and typically intervenes after an issue arises or a complaint is filed.
That said, MoCRA does require some pre-market obligations, such as:
- Facility registration with the FDA
- Product listing for each cosmetic placed on the market
- Safety substantiation (Toxicological Risk Assessment, TRA) to demonstrate product safety
In Europe, cosmetics compliance is governed by Regulation (EC) No 1223/2009, which follows a preventive approach. No product can be sold without meeting a strict set of pre-market obligations, including:
- Appointing an EU-based Responsible Person
- Compiling a complete Product Information File (PIF)
- Conducting a safety assessment by a qualified expert
- Notifying the product in the EU’s Cosmetic Products Notification Portal (CPNP)
2. Key Compliance Obligations in the EU
Once you understand this difference in approach, here are the key steps to place a cosmetic product on the EU market:
- Appoint an EU Responsible Person: The official contact for authorities, holding legal responsibility for the product.
- Prepare a PIF: A complete file with formula details, manufacturing information, safety data, and proof of compliance.
- Conduct a safety assessment: Performed by a qualified safety assessor (toxicologist) to ensure consumer safety.
- Notify the product in the CPNP: A mandatory administrative step before any sales.
- Comply with ingredient restrictions: The EU bans or limits many substances still allowed in the US. Allergens are also strictly regulated, with specific lists for each market. Check out our cosmetic allergens guide to understand the requirements.
- Follow labelling rules: Mandatory information and translations into the official languages of each target country.
- Plan for environmental requirements: Packaging management, recycling, sorting, and compliance with the Packaging and Packaging Waste Regulation (PPWR).
3. Common Pitfalls for US Brands
Many US brands only discover these requirements late in the process, causing delays and extra costs. Common issues include:
- Restricted ingredients: Some UV filters, preservatives, or colorants allowed in the US are prohibited or more strictly regulated in the EU.
- Mandatory multilingual labelling.
- Total ban on animal testing, including for ingredients.
- Strict recall and vigilance procedures.
- Specific rules for nanomaterials, requiring separate notification.
4. Why Plan EU Compliance Early
Adapting a product already on the US market to meet EU requirements may involve a full reformulation, new labelling, and several months of procedures — leading to extra costs and launch delays.
By integrating EU compliance requirements from the development stage, you can:
- Avoid costly reformulations
- Accelerate your market launch
- Reduce the risk of customs delays or product seizures
- Build trust with European consumers
5. How EcoMundo Can Help
At EcoMundo, we help US brands navigate every step of EU compliance:
- Regulatory review of your formulas
- Safety assessment by certified toxicologists
- Full PIF creation
- Appointment as your EU Responsible Person
- CPNP notification and post-market follow-up
With over 15 years of experience, we ensure a fast, compliant, and secure market entry for your cosmetics in Europe.
Contact us now to know more!
