US & EU Cosmetics Brands: Chinese Ingredients – FDA/EU Cosmetics Regulation Compliance

In recent years, Chinese cosmetics ingredients have gained increasing attention and application in the global cosmetics market due to their unique advantages, such as rich natural resources, long history of use, and cost-effectiveness. However, for US and EU cosmetics brands importing Chinese ingredients, compliance with the FDA and EU cosmetics regulations is critical. This article provides a detailed guide to help US and EU cosmetics brands navigate the complexities of importing Chinese ingredients and achieve regulatory compliance.

Overview of US and EU Cosmetics Regulations

FDA Cosmetics Regulations in the US

• Prohibited and Restricted Ingredients: The FDA maintains a list of prohibited and restricted cosmetic ingredients, such as lead, mercury, and certain carcinogenic or allergenic chemicals. Under the Modernization of Cosmetics Regulation Act (MoCRA), all foreign cosmetic manufacturers must designate a US Agent to legally market their products in the US. The US Agent serves as the official point of contact between the company and the FDA, handling communications, inspection requests, and regulatory updates. The FDA also conducts inspections of cosmetic manufacturing facilities and can order the removal of non-compliant products from the market. It may also perform laboratory testing to ensure products meet safety standards. Additionally, California enforces Proposition 65, which requires warning labels for products containing certain harmful chemicals. The California Safe Cosmetics Program (CSCP) mandates the reporting of specific toxic chemicals, with products listed publicly in the CSCP database.
• Labeling Requirements: Cosmetics must be properly labeled with clear and accurate information about ingredients and safety warnings. Labels must follow FDA formatting guidelines, and non-compliant claims must be corrected. Dual-language labeling may also be required.

EU Cosmetics Regulation (Regulation (EC) No. 1223/2009)

• Prohibited and Restricted Ingredients: The EU Cosmetics Regulation (EC) No. 1223/2009 lists over 1,300 prohibited and restricted cosmetic ingredients. Annex II specifies prohibited substances, while Annex III lists restricted substances with usage limits and conditions. For example, substances like tetrachlorodibenzo-p-dioxin (TCDD) and hexachlorophene are prohibited. Restricted substances include pyrithione sodium and 2,6-dimethyl-1,3-dioxan-4-yl acetate (Dimethoxane), which have usage limits and restrictions. In 2025, the EU will implement new restrictions on ingredients such as genistein, daidzein, kojic acid, and vitamin A. For instance, the new limit for genistein will be 0.007%, and kojic acid will be restricted to 1% in facial and hand products, permitted only as a skin-lightening agent.
• Safety Assessment Requirements: Cosmetic products must undergo rigorous safety assessments to ensure they do not pose health risks to consumers. Manufacturers must appoint a qualified person responsible for product safety (PRPS) to prepare and sign off on safety assessment reports. The safety assessment must cover ingredient safety, product usage, and potential risks.
• Nanomaterial Regulations: Nanomaterials used in cosmetics must be clearly labeled, and their safety must be thoroughly assessed. Nanomaterials listed in Annex II are prohibited, while those in Annex III are subject to usage restrictions.
• Cosmetic Product Notification (CPNP): Before placing a product on the EU market, manufacturers or importers must submit product information to the EU Cosmetic Products Notification Portal (CPNP) for registration.
• Labeling and Packaging Requirements: Cosmetic product labels must include the product name, list of ingredients (INCI), expiration date, usage instructions, and safety warnings. Packaging must ensure the product remains uncontaminated and undamaged during storage and use.

Differences Between US and EU Cosmetics Regulations

• Scope of Restricted Ingredients: The EU generally has stricter restrictions on cosmetic ingredients compared to the US. The EU prohibits or restricts over 1,300 substances, while the FDA has banned or restricted fewer than 100. For example, the EU prohibits the use of formaldehyde-releasing preservatives like bronopol (2-bromo-2-nitropropane-1,3-diol), whereas the FDA only imposes usage restrictions.
• Safety Assessment Requirements: Both the EU and the US require safety assessments for cosmetic products. However, the EU mandates that a qualified PRPS prepare and sign off on safety assessment reports, while the FDA does not explicitly require a designated individual. Instead, manufacturers are responsible for ensuring product safety.
• Labeling Requirements: The EU requires cosmetics containing nanomaterials to be labeled as such, while the FDA does not have specific labeling requirements for nanomaterials but encourages manufacturers to conduct safety assessments.
• Post-Market Surveillance: The EU requires manufacturers to establish a post-market surveillance system to monitor adverse reactions to cosmetic products and report serious incidents to national competent authorities. The FDA also encourages manufacturers to monitor product safety but does not mandate a post-market surveillance system.

Compliance Strategies for Chinese Ingredients in US and EU Cosmetics Regulations

Ingredient Selection and Quality Control

• Understand Regulatory Requirements: Manufacturers should thoroughly study the prohibited and restricted ingredient lists of the FDA and the EU and avoid using non-compliant ingredients in their formulations. For example, when selecting Chinese herbal ingredients, ensure they do not contain substances restricted or banned by the FDA and the EU.
• Strict Supplier Audits: Choose reputable Chinese ingredient suppliers and conduct rigorous audits of their production processes and quality control systems to ensure ingredients meet the quality and safety standards of the US and EU. Request certificates of analysis (COA) and safety data sheets (SDS) from suppliers to verify ingredient quality and safety.
• Quality Testing: Implement strict quality testing protocols for incoming Chinese ingredients. Test for heavy metals, microorganisms, pesticides, and other contaminants to ensure they comply with US and EU regulatory limits.