由 caicai8478 “Sensitive products” generally refer to goods that don’t meet the strict classification criteria for “dangerous goods,” but due to their characteristics may be subject to strict regulations in the importing country. Common categories include lithium batteries, electrical products, cosmetics, health supplements, food contact materials, medical devices, drones, and privacy-related electronic products.
China is a major manufacturer and exporter of these products, but fundamental differences exist between the European, American, and Southeast Asian markets in regulatory philosophies, compliance requirements, and market strategies.
I. Overview of Core Differences
Comparison Dimensions: European and American Markets (EU/US) Southeast Asian Markets
Regulatory Philosophy: Precautionary Principle: Assume risk exists, and companies must demonstrate safety. Regulations are complex, systematic, and strictly enforced. Development-First Principle: Striving for a balance between ensuring basic safety and promoting trade development. Regulations are relatively fragmented and undergoing rapid development and improvement.
Compliance Core: Technical Certification: Mandatory third-party certification (CE, FCC, FDA, etc.).
Document Review: Detailed Technical Documentation (TD) and Safety Data Sheets (SDS). Registration and Filing: Mostly involves submitting documents to local regulatory agencies for registration or filing.
Standard Adoption: Mostly directly adopts or references international standards (such as IEC and ISO).
Market Characteristics: Mature, High Value-Added, Clearly Defined Responsibilities: Strong consumer awareness and high litigation risk. Brand and reputation are crucial. Rapid Growth, Price Sensitive, Diverse Channels: A rapidly expanding middle class, active e-commerce platforms, and a greater emphasis on value for money.
Customs Clearance Process: Transparent but cumbersome: Pre-emptive supervision based on declaration and certification. High sampling rates, with tracing and severe penalties for any problems discovered. Flexible but uncertain: Pre-emptive and post-event supervision is predominant. Customs clearance efficiency may be affected by document submission, official discretion, and even informal costs.
II. Detailed Comparison by Item
- Regulatory and Compliance Requirements
Product Category: European and American Market Requirements: Southeast Asian Market Requirements
Lithium Batteries/Electrical Products: EU: CE (including LVD, EMC, RoHS, RED), UN38.3 Test Summary, MSDS, Battery Directive. US: FCC certification, UL standards (voluntary but almost mandatory for market access), and DOT (for transportation). Most countries require ICC certification (based on IEC standards), such as Singapore’s PSB certification, Thailand’s TISI certification, and Indonesia’s SNI certification. A CB report transfer is usually required, and the process is relatively streamlined.
Cosmetics/Skincare: EU: Registration is required through the CPNP portal, with a long list of banned ingredients and a strict prohibition on animal testing.
US: FDA registration, Declaration of Contents (VCRP), and strict labeling regulations. Most are filing-based, such as notifications from the Thai FDA and the Malaysian MCA. Proof of ingredients, a Certificate of Free Sale (CFS), and a test report are generally required. Animal testing restrictions are less stringent.
Food Contact Materials: EU: Framework Regulation (EC) No. 1935/2004, with strict overall migration limits (OML) and specific migration limits (SML).
US: Compliance with FDA CFR 21 Parts 170-189. Requirements vary by country, but are generally based on European, American, or Chinese standards. Food-grade compliance certification (such as a test report based on GB 9685) is required.
Medical Devices: EU: MDR regulations have extremely strict requirements, requiring the designation of an EU Authorized Representative (EC Rep) and CE certification.
US: FDA registration, categorized by Class I, II, and III, with a complex 510(k) or PMA approval process. Classified management, most countries require registration (such as Malaysia’s MDA and Singapore’s HSA). Low-risk products have a faster process, while high-risk products have requirements similar to those in Europe and the United States.
- Logistics and Customs Clearance
European and American Markets:
Logistics: Transport packaging and declaration requirements for sensitive items (especially those containing electrical components) are extremely strict. Airlines and transit ports conduct very careful cargo inspections.
Customs Clearance: The “Importer of Record” (IOR) carries significant responsibility and must be a local entity and bear regulatory compliance responsibilities. The customs clearance process is highly digitized, but all submitted certifications and documents must be authentic and valid. Random inspections are routine.
Southeast Asian Market:
Logistics: Logistics channels are diverse. In addition to traditional sea/air freight, cross-border e-commerce small parcel channels are highly developed. However, the level of identification and handling of sensitive goods varies.
Customs Clearance: Importer qualifications are crucial. Many countries require importers to hold specific licenses to import sensitive goods (such as electrical products and cosmetics). Customs clearance documents may be repeatedly requested. The information on commercial invoices, packing lists, and bills of lading must be absolutely consistent, otherwise delays are likely. “Gray customs clearance” channels may exist, but they are extremely risky.
- Market and Channel Strategy
European and American Market:
Channels: Primarily traditional offline channels, independent brand websites, and mainstream platforms such as Amazon and eBay. Platforms have strict audit procedures and require direct upload of relevant certifications.
Strategy: Prioritize branding and compliance. Investing in completing all certifications and building brand credibility is essential; otherwise, entry into mainstream channels will be denied and you risk being delisted and fined.
Southeast Asian Market:
Channels: E-commerce platforms, such as Lazada, Shopee, and Tokopedia, are the primary players. Social e-commerce (TikTok Shop) is growing rapidly.
Strategy: Speed and cost-effectiveness. Leverage platforms’ “overseas warehouse” models (such as Lazada Global Shipping) to quickly test the market. Initially, test market response with small batches of samples before gradually improving certification. Marketing and traffic strategies are more important.
III. Summary and Recommendations
Aspects: Exporting to Europe and the United States; Exporting to Southeast Asia
Strategic Positioning: Long-term focus, high-value markets. View them as core battlegrounds for brand upgrading. Growth engines, rapid trial and error. View them as key markets for scale expansion and capacity utilization.
Compliance Preparation: Upfront investment is essential. Research the regulations of target countries during the product development phase, and budgets must include the high certification fees and time costs. Follow a gradual and dynamic approach. First, ensure basic customs clearance requirements are met, then gradually complete strong certification in various countries based on sales performance. Closely monitor the trend of regulatory convergence among ASEAN countries.
Partners: Select professional certification agencies (such as SGS and TÜV), experienced freight forwarders, and reliable local importers (who assume legal responsibility). Choose a freight forwarder familiar with local customs clearance regulations, a qualified local importer (very important!), and an efficient e-commerce partner.
Risk Warning: Guard against product liability lawsuits and environmental fines. Product liability insurance is recommended. Guard against customs clearance delays, loss of goods ownership, and intellectual property disputes. Choose partners carefully and clarify responsibilities.
In short, exporting to Europe and the United States is like an “exam” with fixed answers (standards) and requires diligent study (certification) to enter the market. Exporting to Southeast Asia, on the other hand, is like a “project” with evolving rules and demands greater local resources and flexibility, but the entry threshold is relatively low. Chinese companies should develop differentiated market entry strategies based on their product strengths and strategic goals.