Challenges of Specialty Goods: Key Points for Dual Customs Clearance for Food, Cosmetics, and Medical Devices

For cross-border sellers dealing in specialty goods, dual customs clearance isn’t just about “two processes”; it’s also about “two rigorous compliance tests.” These goods are directly related to consumer health and safety, as well as national public health. Therefore, countries have set extremely high entry barriers. Your customs clearance strategy must shift from “how to ship” to “how to ship compliantly.”

Core Principle: Destination Country Access is the Ultimate Threshold

No matter how relaxed the policies of a transit point (such as Hong Kong), the laws and regulations of the destination country (such as the US or EU) ultimately determine the fate of your goods. Passing transit customs clearance doesn’t guarantee a worry-free destination. A forward-looking approach, using the destination country’s requirements to guide all preparations, is crucial.

1. Food

The core of dual customs clearance for food lies in “access permission” and “traceability and security.”

Customs Clearance Stage: Core Challenges and Key Points. Key Documents/Actions Sellers Must Prepare

Customs Clearance at the Transit Location (e.g., Hong Kong): 1. Proof of Non-Prohibited Goods: Ensure that the goods are not prohibited from entering the transit location.

2. Safe Temporary Storage: The goods must meet the storage conditions of the transit warehouse (e.g., refrigerated or frozen). 1. Ingredient List
3. Certificate of Origin

Customs Clearance in the Destination Country (e.g., the US/EU): This is the main battleground:

1. Company Registration: The manufacturer in the exporting country must register with the competent authority of the destination country (e.g., the US FDA).
2. Declaration and Standards: Compliance with local food additive standards, labeling regulations, pesticide residue limits, etc. is mandatory.
3. High Inspection Rate: Food is a key area of ​​customs inspection. 1. FDA registration number (US) or EU food import permit
4. Sanitary certificate/health certificate (issued by an official agency in the exporting country)
5. Ingredient analysis report
6. Certificate of origin
7. Foreign language label (compliant with the formatting requirements of the destination country)
8. Bill of lading, commercial invoice, packing list
   Action recommendations:

Research months in advance: Before shipping, be sure to clarify the specific requirements of the destination country for your product type. The US primarily relies on the FDA, while the EU relies on EFSA and member state regulations.

Labeling is key: Nutritional information, allergen information, net weight, etc. must strictly comply with regulations; otherwise, the product will be rejected.

II. Cosmetics
The core of cosmetics lies in “ingredient safety” and “official certification.”

Customs Clearance Stage: Core Challenges and Key Points: Key Documents/Actions Sellers Must Prepare
Customs Clearance at the Transit Location (e.g., Hong Kong) 1. Declaration of Conformity: Proves that the product meets the basic safety requirements of the transit location.

2. Dangerous Goods Review: Products containing alcohol or pressure vessels must be transported according to dangerous goods regulations. 1. Product ingredient list (MSDS may be required)
3. Safety statement
   Customs clearance in the destination country (e.g., the US/EU) is extremely strict:
4. Ingredient filing/permit: The EU registers through the CPNP portal; while US cosmetics do not require premarket approval, they must comply with regulations such as the FD&C Act, and a new registration and filing system is about to be implemented.
5. Animal testing ban: The EU, the UK, and other countries explicitly prohibit the sale of cosmetics tested on animals.
6. Responsible person system: The EU market must designate a responsible person within the EU. 1. CPNP filing number (EU) or VCRP filing (US, voluntary but recommended)
7. Product safety report (CPSR, required in the EU)
8. Toxicological evaluation report of the ingredient
9. Declaration of Conformity (DoC)
10. Certificate of manufacturing specifications
11. Foreign language labeling (including ingredient and responsible person information)
    Suggested action:

Pay attention to prohibited ingredients: The banned/restricted lists of cosmetic ingredients vary greatly between countries/regions, so each list must be verified.

Finding a Compliance Partner: We strongly recommend working with a testing agency or consulting firm familiar with the cosmetics regulations of the destination country to complete the necessary testing and filing.

III. Medical Devices
This is the most strictly regulated area, focusing on “classification management” and “marketing authorization.”

Customs Clearance Phase: Key Challenges and Key Points: Key Documents/Actions Sellers Must Prepare
Customs Clearance at the Transit Location (e.g., Hong Kong): 1. Product Declaration: Clearly declare the product as a “medical device,” not a commodity.

2. Storage Conditions: Ensure that the transit warehouse meets special storage requirements, such as sterility and temperature control. 1. Manufacturer’s Qualifications
3. Product Instructions
   Customs Clearance in the Destination Country (e.g., the US/EU): Highest Barriers:
4. Accurate Classification: Accurately classify products by risk level (Class I, II, III), with requirements varying significantly between levels.
5. Premarket Approval: In the US, Class II and III devices require FDA PMA (Premarket Approval) or 510(k) clearance; in the EU, CE certification and review by a Notified Body (MDR regulations) are required.
6. Quality Management System: The manufacturer must have passed an audit (e.g., QSR820 in the US, ISO 13485 in the EU). 1. FDA registration listing number (US) or CE certificate (EU) (this is the passport for customs clearance)
7. Declaration of Conformity (DoC)
8. Product technical documentation
9. Authorized representative information (Agent in the US, Authorized Representative in the EU)
10. UDI-DI information (Device Identification Number)
11. Commercial documents, etc.

Recommended Action:

Professional certification is a prerequisite: Without the required certifications (e.g., CE, FDA approval) in the destination country, absolutely do not attempt to ship your device. Your shipment will almost certainly be detained or destroyed.

Consult a professional organization: Medical device compliance is extremely complex. It is essential to seek assistance from a legal or professional consulting firm and complete the lengthy certification process before considering sales.

General Golden Rule: Partner selection is paramount: When shipping specialized products, it is essential to choose a freight forwarder with proven experience in this category. They understand the specific requirements of transit and the destination country and can provide crucial guidance.

Documents first, goods not yet in hand: All certifications, certificates, and reports must be fully prepared before shipment. “Shipping first, documents later” is a suicidal strategy.

Transparent Declaration: Product names and attributes must be accurately and fully declared at every stage. Concealment or obfuscation can have serious consequences.

Summary: Handling double customs clearance for specialized goods requires sellers to transition from being “merchants” to “compliance experts.” The key to success lies in forward-looking planning, a deep understanding of the destination country’s regulations, and close collaboration with professional partners. This is a competition of detail and expertise, and only the most prepared will succeed.