由 caicai8478 When your powdered goods fall under the categories of food, pharmaceuticals, or certain chemicals, you’ve entered the “deep waters” of global trade regulation. These products directly relate to public health, environmental safety, and even national security; therefore, regulatory agencies in various countries have established entry barriers far higher than those for ordinary goods.
Simply completing hazardous materials identification and standard packaging is far from sufficient. This article will delve into the additional regulatory requirements for these three types of sensitive powders, helping you build a comprehensive compliance perspective.
Chapter 1: Food Powders – Touching the “Safety on the Tip of Your Tongue” Red Line
Food powders (such as protein powder, plant extracts, flavorings, and nutritional fortifiers) are among the most strictly regulated categories globally, with the core focus on ensuring consumer “safety on the tip of their tongue.”
Core Regulatory Logic: Regulatory agencies consider every importer primarily responsible for food safety, requiring them to establish a complete traceability and verification system.
- Core US Regulation: FDA and the FSMA Act
Facility Registration: Overseas factories producing food powders must register with the US FDA; products from unregistered companies will be rejected. Advance Notification: An electronic notification must be submitted to the FDA before the goods arrive in the United States.
Supplier Verification Program: This is central to the Food Modernization Act. U.S. importers must audit their overseas suppliers (i.e., your factory) to ensure their production processes meet U.S. safety standards. You will need to prepare relevant documentation for auditing.
Labeling Requirements:
A nutrition facts label must be included.
Allergens (such as soy and milk components) must be accurately labeled.
Ingredients must be listed in descending order of content.
Claiming “organic” requires USDA organic certification.
- EU Core Regulation: EFSA and Comprehensive Regulations
EU Representative: Non-EU companies must designate a representative within the EU responsible for product compliance and communication.
Declaration of Conformity: Products must comply with EU comprehensive regulations on food additives, contaminants, labeling, etc.
Novel Food Approval: If your food powder was not widely consumed in the EU before May 1997, it may be considered a “novel food” and requires a lengthy safety assessment and authorization process before it can be marketed. Organic Certification: Claims of “organic” must comply with EU organic standards and hold certification.
Key Points for Customs Clearance:
Prepare health certificates, ingredient analysis reports, production process flowcharts, and other documents in advance for inspection.
Ensure hygiene standards for both inner and outer packaging to prevent microbial contamination.
Chapter Two: Pharmaceutical Powders (APIs) – A Quality Barrier for Life
Pharmaceutical active ingredient (API) powders are the starting point of pharmaceutical manufacturing, and their quality directly affects the safety and efficacy of drugs. Regulatory oversight of APIs spans the entire supply chain.
Core Regulatory Logic: Ensure the absolute reliability of the identity, purity, quality, and origin of every batch of APIs.
- Globally Accepted Standard: GMP
What is it: Good Manufacturing Practice (GMP) is a mandatory quality management system.
Why it’s important: Your manufacturing plant must pass GMP compliance inspections by the importing country’s regulatory agency (or international certification body). Without GMP, nothing can be done.
Core Content: Covers comprehensive requirements for plant facilities, equipment, personnel, production processes, quality control, and documentation.
- US FDA Regulatory Requirements
DMF Documentation: You need to prepare a master drug file for your API, detailing its chemical properties, manufacturing method, quality control standards, and stability data. This file is submitted to the FDA for review, but its contents are confidential to your clients (pharmaceutical manufacturers).
On-site Inspection: The FDA has the right to conduct surprise inspections of overseas API manufacturing facilities to verify their GMP compliance.
- EU Regulatory Requirements
CEP Certification: The Certificate of Suitability for the European Pharmacopoeia issued by the European Medicines Agency (EMA) is the “golden passport” to the EU market. It proves that your API quality meets European Pharmacopoeia standards and that the manufacturing process complies with GMP.
Importer Audit: EU marketing authorization holders must conduct rigorous on-site audits of their API suppliers.
Key Points for Customs Clearance:
Provide analytical certificates listing test results and standards for key quality attributes.
Strict prevention of cross-contamination and temperature/humidity imbalances during transportation is essential; complete transportation validation data must be provided.
All related documents (invoices, packing lists, waybills) must accurately use the drug name and CAS number, avoiding the use of vague commercial aliases.
Chapter 3: Specialty Chemical Powders – Risk Management for Dual-Use Items
Some high-performance chemical powders (such as specific metal powders, nanomaterials, and high-purity catalysts) are subject to strict export controls and environmental regulations due to their unique physicochemical properties.
Core Regulatory Logic: Preventing the proliferation of technologies and materials that can be used for weapons manufacturing or military purposes, and assessing their long-term potential risks to the environment and health.
- Export Controls and “Dual-Use Items”
Wassenaar Arrangement: An international agreement on export controls for conventional weapons and dual-use items and technologies. Many countries have developed their own lists based on this.
US Department of Commerce Bureau of Industry and Security List: Controls “dual-use” items with military applications. If your powder is on the list, an export license is required for export.
EU Dual-Use Items Regulation: Similar to the US BIS list, the EU has its own unified control list.
Examples of controlled items: Tungsten powder, silicon carbide powder, certain rare earth powders, etc., with specific particle sizes.
- Regulation of Substances of Very High Concern (SVHCs)
SVHCs under the EU REACH Regulation:
If your chemical powder contains SVHCs in amounts exceeding 0.1%, you are legally obligated to notify downstream users.
If the SVHC content in the article exceeds 0.1% and the annual export volume exceeds 1 tonne, you must also notify the European Chemicals Agency.
Notification of Nanomaterials: The EU and other regions have begun requiring special registration and risk assessment for nanomaterials.
Key Points for Customs Clearance:
Conduct end-user and end-use screening to ensure that the final application of your customers and products is civilian and legal.
Conduct REACH/SVHC screening during the product development stage to avoid the use of restricted substances.
Prepare detailed technical specifications (such as particle size distribution and purity) to respond to customs technical inquiries.
Summary: Establishing a Compliance Mindset Beyond Transportation Handling sensitive powder products requires companies to establish a comprehensive compliance system covering the entire supply chain, from R&D and production to sales and transportation.
Your Action Checklist:
Identity Verification: Accurately determine the legal status of the product in the target market (is it food, pharmaceutical, or industrial chemical?).
Qualifications First: Plan ahead and obtain necessary qualifications such as factory registration, GMP certification, organic certification, and REACH registration.
Documentation is King: Prepare technical documentation beyond commercial documents, including CoA, MSDS, health certificates, GMP declarations, etc.
Professional Consultation: Before entering a new market, always seek assistance from professional advisors or importers familiar with local regulations.
Only by integrating compliance awareness into every stage of the product’s lifecycle can your sensitive powder shipments navigate the turbulent waters of international trade successfully.