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China: Rigorous Registration and Filing System
China's cosmetic regulations are governed by the National Medical Products Administration (NMPA) under the Cosmetics Supervision and Administration Regulation (CSAR), implemented in 2021. The system categorizes cosmetics into "special" and "general" cosmetics, with substantially different requirements.
Special Use Cosmetics (e.g., sunscreens, hair dyes, whitening, and anti-aging products) require pre-market registration, a rigorous process involving technical documentation, safety assessment reports, and human efficacy tests conducted in China. The entire registration process can take 12–18 months.
General Cosmetics only require filing with the NMPA before sale, but still demand a full safety assessment, product testing reports (often from Chinese laboratories), and labeling compliance. All imported cosmetics must also have a Chinese Responsible Agent (CRA) to liaise with authorities.
Key Considerations for China:
- All product labels and instructions must be in Simplified Chinese.
- Ingredient names must comply with China's Inventory of Existing Cosmetic Ingredients (IECIC).
- New cosmetic ingredients require separate registration.
- Post-market surveillance is strict, with frequent spot checks.
Europe & United States: Risk-Based Frameworks
European Union
The EU's cosmetic regulation (EC) No 1223/2009 is a comprehensive, centralized framework emphasizing product safety, consumer protection, and free movement within the EU market. Key requirements include:
- Product Information File (PIF): Must be prepared before market entry, containing safety assessments, product description, manufacturing information, and proof of effect.
- Safety Assessor: A qualified safety assessor must evaluate product safety.
- CPNP Notification: Products must be notified via the Cosmetic Products Notification Portal before being placed on the market.
- Ban on Animal Testing: Cosmetic products and ingredients marketed in the EU cannot be tested on animals.
- Labeling: Must include ingredient listings in INCI nomenclature, a list of nanomaterial ingredients, and a Responsible Person (RP) established within the EU.
United States
The U.S. system, governed by the FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act), is generally less pre-emptive than China or the EU. However, it still imposes critical obligations:
- FDA Registration: Cosmetic facility registration and product listing are voluntary but highly recommended for market credibility. Note: The Modernization of Cosmetics Regulation Act (MoCRA) enacted in 2022 will make registration mandatory and introduce stricter safety substantiation and reporting requirements.
- Adverse Event Reporting: Brands must maintain records and report serious adverse events.
- Ingredient Restrictions: Compliance with FDA prohibitions and restrictions on certain ingredients (e.g., color additives require approval).
- Labeling: Must include an ingredient declaration, net quantity, and business address.
Key Consideration for EU/US: While the EU requires pre-market safety assessment, the U.S. operates on a post-market surveillance principle (though MoCRA is shifting this). Both prioritize consumer safety but through different regulatory philosophies.
Southeast Asia: Diverse and Evolving Landscape
Southeast Asia is not a uniform bloc; each country has its own regulatory agency and requirements, though many reference ASEAN Cosmetic Directive (ACD) as a baseline.
ASEAN Cosmetic Directive (ACD)
Member states (e.g., Thailand, Malaysia, Indonesia, Philippines, Vietnam, Singapore) aim to harmonize regulations under the ACD, which resembles the EU model in many aspects:
- Product Notification: Required in each country before sale.
- Safety Assessment: Mandatory for all products.
- Ingredient Compliance: Must adhere to ACD positive and negative lists.
- Labeling Requirements: Include full ingredient listing, country of origin, and name and address of the Responsible Person or local agent.
Country-Specific Nuances:
- Indonesia (BPOM): Requires a local Indonesian Responsible Person and often extensive product testing.
- Thailand (FDA): Has specific labeling rules and may require additional documentation for certain claims.
- Vietnam (MOH): Demands a Free Sale Certificate or Certificate of Analysis from the country of origin.
- Malaysia (NPRA): Requires notification and adherence to halal certification standards if making halal claims.
- Philippines (FDA): Mandates company and product registration with detailed dossier submissions.
Key Consideration for Southeast Asia: While harmonization is progressing, brands must prepare for country-by-country compliance, engage local agents, and consider cultural/religious factors like halal certification.
Strategic Recommendations for Cross-Border Brands
1. Plan Early: Regulatory processes, especially in China, can be lengthy. Integrate compliance into your product development timeline.
2. Local Partnerships are Crucial: Whether a Chinese Responsible Agent, EU Responsible Person, or local importer in ASEAN, an in-region partner is often legally mandatory and operationally invaluable.
3. Invest in Formulation Flexibility: To adapt to different ingredient restrictions and claim requirements across regions.
4. Centralize Documentation: Maintain a master regulatory dossier to streamline adaptations for each market.
5. Stay Updated: Cosmetic regulations are dynamic. Monitor changes like China's expanding ingredient lists, EU's evolving SCCS opinions, and the full implementation of U.S. MoCRA.
Conclusion
Successful global expansion in the cosmetics industry requires more than just marketing and distribution-it demands proactive regulatory strategy. Understanding the fundamental differences between China's permission-based system, the EU's safety-focused framework, the U.S.'s evolving regulations, and the diverse ASEAN landscape allows brands to allocate resources efficiently, mitigate risks, and accelerate their time to market. By prioritizing compliance as a core component of market entry, brands can build sustainable and trustworthy international presence.