中國化妝品 exported to the EU:備案 guide

With the increasing number of Chinese cosmetic brands entering the European market, understanding the requirements for cosmetic product registration with the EU is crucial for successful market entry. This guide provides a comprehensive overview of the registration process, regulations, and key considerations for cosmetic products sold in the EU from China.

1. Background and Importance

The European Union (EU) market presents significant opportunities for cosmetic brands from China. However, entering this highly regulated market requires careful compliance with EU regulations. The EU has strict safety and labeling requirements for cosmetic products, which are designed to protect consumers and ensure product quality. cosmetic products sold in the EU must meet these standards to be legally marketed.

2. EU cosmetic regulations

The EU has implemented several regulations for cosmetic products, including:

- CE Regulation: This is the primary requirement for cosmetic products sold in the EU. Products must be certified by a Notified Body (authorised representative) with a CE mark. The CE mark ensures that the product complies with EU safety standards.

- MPSA Regulation: The Multi-Pollutant Skin Assessment (MPSA) is a directive requiring cosmetic products to declare the presence of potentially harmful substances, such as benzotropin and phenoxyethanol. This regulation aims to reduce harm to the skin and improve ingredient transparency.

- MOR Regulation: The Margin of Risk Regulation (MOR) sets the acceptable margin of risk for cosmetic substances. Products must demonstrate that the risk to consumers is within acceptable limits.

- SGL Regulation: The Single-Gangulation Limit (SGL) regulation imposes limits on the concentration of certain substances, such as parabenzamid and phenoxyethanol, in cosmetic products.

In addition to these EU regulations, cosmetic products sold in the EU must comply with the Harmonised System (HS) code for cosmetic products, as well as the EU's Good Manufacturing Practices (GMP) requirements.

3. cosmetic product registration process

The cosmetic product registration process with the EU involves several key steps:

a) Product information and labeling

The product information and labeling must comply with EU cosmetic regulations. This includes:

- Product name and indications: The product name and indications must be clear and accurate. cosmetic products sold in the EU must have a valid indication, which specifies the intended use of the product.

- Active substances: The active substances (ingredients) in the cosmetic product must be declared, along with their concentrations. The cosmetic product must declare any potentially harmful substances, such as benzotropin and phenoxyethanol.

- Safety data: The cosmetic product must provide sufficient safety data to demonstrate compliance with EU regulations. This includes information on the potential risks and benefits of the product.

b) File preparation

To submit a cosmetic product for registration with the EU, the following files must be prepared:

- cosmetic product information file (CPF): This file contains detailed information about the cosmetic product, including its ingredients, formulation, and safety data. The CPF must be prepared in accordance with the EU cosmetic directive.

- ATHENA cosmetic database: The ATHENA cosmetic database is a database of cosmetic products that is maintained by the EU. The cosmetic product must be submitted to the ATHENA database before it can be registered.

- Documentation: Additional documentation, such as lab reports and manufacturing processes, may be required depending on the complexity of the cosmetic product.

c) Technical evaluation

The cosmetic product will undergo a technical evaluation by a Notified Body. The Notified Body will assess the cosmetic product's compliance with EU regulations and provide feedback. If any issues are identified, the cosmetic product will need to be revised and resubmitted for evaluation.

d) Marketing authorization

Once the cosmetic product has been approved for registration, the manufacturer must obtain a marketing authorization (AMC) from the EU Commission. The AMC allows the cosmetic product to be marketed in the EU. The cosmetic product's labeling and advertising must comply with EU regulations.

4. Key considerations

Entering the EU cosmetic market requires careful consideration of several factors:

- Compliance with regulations: cosmetic products sold in the EU must comply with EU regulations, including the CE, MPSA, MOR, and SGL regulations. Failure to comply with these regulations can result in legal penalties and damage to the cosmetic brand's reputation.

- Good manufacturing practices (GMP): cosmetic products must be manufactured in accordance with GMP requirements. This includes ensuring that the manufacturing process is clean, safe, and traceable.

- Labeling requirements: The cosmetic product's labeling must be clear and accurate. The labeling must include the product name, indications, active substances, and safety data.

- Market surveillance: The EU performs ongoing market surveillance to ensure compliance with cosmetic regulations. cosmetic brands must be prepared to provide additional information and documentation if requested by the EU authorities.

5. Conclusion

Entering the EU cosmetic market requires careful planning and compliance with strict regulations. cosmetic brands from China must understand the EU cosmetic regulations, prepare the necessary files, and comply with technical evaluation and marketing authorization processes. By following this guide, cosmetic brands can successfully enter the EU market and establish themselves as reputable and high-quality cosmetic brands.