What are the Chinese product registration requirements for food contact materials?
Introduction
Navigating the Chinese product registration requirements for food contact materials is one of the most critical steps for international manufacturers and importers looking to access China’s massive consumer market. Understanding the Chinese product registration requirements for food contact materials is essential because China enforces some of the world’s most stringent standards for items that contact food, including packaging, kitchenware, and processing equipment. The regulatory framework, centered around the GB standards system, demands migration testing, comprehensive documentation, and compliance certification before products can be legally sold within the country. Failure to comply can result in customs seizures, fines, recalls, and lasting brand damage. This guide covers the registration process, testing standards, documentation, timelines, costs, and common pitfalls for bringing compliant food contact products to market.
Throughout this guide, you will find practical insights supported by Reliable manufacturing and procurement partner China expertise, which helps businesses navigate complex compliance landscapes and establish trustworthy supply chains for food contact products.
What Are Food Contact Materials?
Food contact materials (FCMs) are defined under Chinese regulations as any materials or articles intended to come into direct or indirect contact with food during production, processing, storage, transportation, preparation, or consumption. This broad category encompasses everything from the plastic wrap around fresh produce to the ceramic bowl used for serving soup, and even the industrial-grade stainless steel tanks used in food processing plants.
Categories of Food Contact Materials
The Chinese regulatory system classifies food contact materials into several major categories:
| Category | Examples | Typical Uses |
|---|---|---|
| Plastics | Polyethylene (PE), Polypropylene (PP), Polycarbonate (PC), Melamine | Food packaging, containers, bottles, cutting boards, utensils |
| Ceramics and Glass | Porcelain, stoneware, borosilicate glass | Dinnerware, bakeware, storage jars, drinking glasses |
| Metals and Alloys | Stainless steel, aluminum, enamel-coated steel | Cookware, bakeware, food processing equipment, cans |
| Paper and Board | Kraft paper, cardboard, coated paper | Food wrapping, takeaway containers, baking paper, beverage cartons |
| Rubber and Silicone | Natural rubber, silicone elastomers | Baby bottle nipples, baking molds, sealing gaskets, spatulas |
| Coatings and Varnishes | Epoxy coatings, non-stick coatings | Interior coatings for cans, cookware non-stick surfaces |
| Wood and Bamboo | Natural wood, bamboo fiber | Cutting boards, chopsticks, serving platters |
Why Regulation Matters
Food contact materials can transfer chemical substances into food through a process called migration. These migrating substances—monomers, additives, heavy metals, colorants, or degradation byproducts—can pose serious health risks when consumed over time. China’s regulatory system is designed to: (1) limit the types and amounts of substances allowed in FCMs, (2) set maximum migration limits for those substances, (3) ensure overall food safety throughout the supply chain, and (4) provide clear traceability and accountability for manufacturers and importers.
Products Requiring Registration
Not all food contact products require the same level of regulatory scrutiny in China. The system uses a risk-based classification approach similar to the EU framework but with important distinctions.
High-Risk Products Requiring Full Registration
The following product categories are classified as high-risk and require formal registration with the National Health Commission (NHC) before they can be marketed:
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Food contact materials using new substances — Any product that incorporates a new chemical substance not listed in the GB standards’ positive lists (such as GB 9685 for additives) requires a full safety assessment and registration. This process typically takes 12–24 months and requires extensive toxicological data.
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Food packaging for special dietary purposes — Packaging intended for infant formula, baby food, medical foods, or foods for special dietary uses receives elevated scrutiny. These products require more stringent migration testing and may need to undergo review by the China National Center for Food Safety Risk Assessment (CFSA).
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Active and intelligent food contact materials — These are materials that intentionally release substances into food (e.g., preservative-releasing packaging) or monitor food condition (e.g., freshness indicators). They require special approvals under GB 4806.1-2016 Article 4.6.
Low-Risk Products Requiring Self-Declaration
Most conventional food contact products manufactured from substances already listed in the positive lists can be brought to market through a compliance declaration process. The manufacturer or importer must:
- Ensure the product meets all applicable GB standards
- Obtain testing from a CNAS-accredited laboratory
- Prepare a compliance declaration document
- Maintain technical documentation for inspection
- Label the product appropriately
While this self-declaration route is faster and less expensive, the legal responsibility for product safety remains fully with the manufacturer and importer. The authorities conduct market surveillance and can take enforcement action if products are found non-compliant, even if they were self-declared.
Exempt Products
Some products are partially or fully exempt from food contact material registration, though they must still meet general product safety requirements:
- Primary packaging for exported goods intended only for re-export (not for Chinese domestic consumption)
- Antiques and collector items that are clearly not intended for food contact use
- Fixed public water supply equipment covered under separate water safety regulations
Registration Process Steps
The Chinese food contact material registration process, while methodical, can be complex for first-time applicants. Below is the step-by-step procedure broken down into actionable phases.
Phase 1: Pre-Assessment and Material Identification
Step 1: Determine Applicable Standards
Before any testing begins, identify which GB standards apply to your product. A single product often falls under multiple standards. For example, a non-stick frying pan with a plastic handle involves GB 4806.9-2016 (metal), GB 4806.7-2016 (plastic handle), and potentially GB 4806.3-2016 (enamel coating). Create a matrix of applicable standards and specific testing requirements for each.
Step 2: Ingredient and Substance Review
Review all raw materials, additives, colorants, and processing aids against the permitted substance lists in GB 9685-2016 and the relevant GB 4806 series standards. Every substance that will contact food—even indirectly—must be on the approved list. Any substance not listed triggers the new substance registration pathway, which is significantly more complex.
Phase 2: Laboratory Testing
Step 3: Select a CNAS/CMA-Accredited Laboratory
China requires that compliance testing be performed by laboratories accredited by CNAS (China National Accreditation Service) and certified by CMA (China Metrology Accreditation). Testing by non-Chinese laboratories may be accepted as supplementary evidence but will not substitute for accredited Chinese laboratory reports.
Step 4: Perform Migration Testing
Conduct overall migration and specific migration testing according to GB 31604 series methods. Key parameters include:
- Overall migration limit (OML): typically 10 mg/dm² or 60 mg/kg
- Specific migration limits (SMLs): varies by substance
- Heavy metal release: lead, cadmium, chromium, nickel, arsenic, antimony, etc.
- Sensory testing: the product must not impart any odor, taste, or color to food
Phase 3: Documentation and Declaration
Step 5: Compile Technical Documentation
Assemble all required documents, including test reports, material composition declarations, a product description, processing parameters, and intended use conditions.
Step 6: Draft the Compliance Declaration
Prepare the compliance declaration statement as required by GB 4806.1-2016. This document must confirm that the product meets all applicable standards and must identify the responsible party (manufacturer or authorized representative in China).
Step 7: Product Labeling
Ensure labeling includes the “food contact” graphic symbol (a wine glass and fork icon) or the text “For Food Contact,” along with the manufacturer’s name and address, product name, date of manufacture, shelf life, and any special storage or usage instructions.
Phase 4: Submission and Market Access
Step 8: Submit Registration (High-Risk Products Only)
For high-risk products requiring NHC registration, submit the application dossier through the government’s online portal. The CFSA reviews the dossier and may request additional data. The review timeline ranges from 6 to 24 months.
Step 9: Market Entry and Ongoing Compliance
Once compliance is established, products can be imported and sold. Maintain records for at least two years after the last production batch. Be aware that standards are updated periodically, and products must remain compliant as regulations evolve.
A qualified China sourcing agent for cross border ecommerce can manage the entire registration workflow, from lab selection through dossier preparation, saving time and reducing the risk of submission errors.
Testing Requirements for Compliance
Testing is the cornerstone of compliance, and China’s testing protocols are among the most comprehensive in the world. Understanding exactly what tests are required for your specific product type is crucial for both cost management and regulatory success.
Overall Migration Testing
Overall migration testing measures the total amount of non-volatile substances that migrate from the food contact material into food simulants under defined conditions. The standard test conditions are:
| Food Simulant | Application |
|---|---|
| 10% Ethanol | Simulates aqueous, acidic, and alcoholic foods (alcohol content ≤ 10%) |
| 4% Acetic Acid | Simulates acidic foods (pH < 4.5) |
| 20% / 50% Ethanol | Simulates alcoholic beverages and dairy products |
| Olive Oil (or substitute) | Simulates fatty foods |
| Poly(2,6-diphenyl-p-phenylene oxide) | Simulates dry foods (alternative to olive oil) |
Test conditions (time and temperature) must represent the worst-case foreseeable use. For example, a microwaveable container is tested at higher temperatures than a refrigerated storage container.
Specific Migration Testing
Specific migration tests target individual substances with established specific migration limits (SMLs). Common substances tested include:
- Bisphenol A (BPA) — SML of 0.05 mg/kg for polycarbonate and epoxy coatings
- Formaldehyde — SML of 15 mg/kg for melamine and phenolic resins
- Primary aromatic amines — Not detectable (limit of detection 0.01 mg/kg) for polyurethane adhesives and colored plastics
- Phthalates — Varying SMLs for plasticizers (e.g., DEHP: 1.5 mg/kg, DBP: 0.3 mg/kg)
- Heavy metals — Lead, cadmium, mercury, chromium VI with specific limits
Material-Specific Testing Matrix
| Material Type | Key Tests | Reference Standard |
|---|---|---|
| Plastics | Overall migration, specific migration of monomers & additives, heavy metals | GB 4806.7-2016, GB 31604 series |
| Ceramics | Lead and cadmium release (4% acetic acid, 22°C, 24 hours) | GB 4806.4-2016 |
| Glass | Lead, cadmium, arsenic, antimony release | GB 4806.5-2016 |
| Metals | Heavy metal migration based on metal type (Al, Cr, Ni, Mn, etc.) | GB 4806.9-2016 |
| Paper & Board | Fluorescent whitening agents, heavy metals, microbial limits, PCBs | GB 4806.8-2022 |
| Silicone/Rubber | Volatile methyl siloxanes, heavy metals, overall migration | GB 4806.11-2016 |
| Wood | Preservatives (pentachlorophenol), heavy metals | GB 4806.12-2022 |
Sensory Testing
Sensory testing evaluates whether the material imparts any off-odor, off-taste, or discoloration to food simulants. This test is performed with a trained sensory panel under controlled conditions. A product that passes chemical migration testing but fails sensory evaluation cannot be certified.
Documentation Needed for Registration
Preparing a complete and accurate documentation package is often the most time-consuming phase of the registration process. Missing or incorrect documents are a leading cause of application delays and rejection.
Core Documentation Requirements
1. Compliance Declaration (符合性声明)
A formal written declaration stating that the product complies with all applicable GB standards. Required elements include:
- Product name, specifications, and intended use conditions
- List of applicable GB standards and verification that each has been met
- Results summary of migration testing
- Name and address of the manufacturer and the importer/distributor
- Date and authorized signature
2. Technical Specification Sheet
A detailed document describing the product’s material composition, including:
- Full list of all raw materials and their CAS numbers
- Additives, colorants, stabilizers, processing aids, and their concentration levels
- Layer structure (for multi-layer materials)
- Manufacturing process description
- Dimensional specifications and surface area
3. Migration Test Reports
Original test reports from a CNAS/CMA-accredited laboratory, including:
- Overall migration results for each applicable food simulant
- Specific migration results for all restricted substances
- Sensory evaluation report
- Test conditions and methods used (referencing specific GB 31604 standards)
4. Product Labeling and Instructions
Samples or mock-ups of product labels and user instructions must demonstrate:
- The food contact symbol or explicit “For Food Contact” statement
- Manufacturer identification
- Usage instructions including temperature limits, microwave safety, dishwasher safety, etc.
- Storage conditions and shelf life
- Any restrictions (e.g., “Not for oven use”)
5. Importer/Manufacturer Business License
A copy of the business license for the Chinese entity responsible for the product (manufacturer, importer, or authorized representative). Foreign companies must designate a Chinese legal representative or subsidiary.
6. Production Process Description
A document describing the manufacturing process in sufficient detail to demonstrate quality control, including:
- Raw material receiving and inspection procedures
- Production line parameters (temperatures, pressures, cycle times)
- In-process quality control checks
- Final inspection and testing protocols
- Traceability system description
7. Material Safety Data Sheets (MSDS)
For each raw material used, an MSDS or equivalent documentation showing chemical composition, hazard classification, and safe handling information.
Timeline and Costs
Understanding the realistic timelines and costs involved in food contact material registration helps businesses budget appropriately and plan market entry strategies.
Estimated Timelines
| Phase | Duration | Notes |
|---|---|---|
| Pre-assessment and standards review | 2–4 weeks | Depends on product complexity and number of applicable standards |
| Laboratory testing | 4–12 weeks | Migration testing timelines vary by material type and test menu |
| Documentation preparation | 2–6 weeks | Translation, notarization, and compilation of documents |
| Compliance declaration (self-declaration route) | 1–2 weeks | Once all test reports are available |
| NHC registration (high-risk route) | 6–24 months | Includes CFSA review, potential supplemental data requests |
| Market surveillance registration | 1–2 weeks | Online filing with local SAMR office |
Total timeline (self-declaration): 3–6 months
Total timeline (NHC registration): 12–30 months
Estimated Costs
| Cost Category | Estimated Range (USD) |
|---|---|
| Pre-assessment consulting | $2,000–$8,000 |
| Laboratory testing (basic package) | $3,000–$10,000 |
| Laboratory testing (comprehensive, including specific migration) | $8,000–$25,000 |
| Documentation preparation and translation | $2,000–$6,000 |
| NHC registration fees (high-risk) | $5,000–$20,000 |
| Legal representation and agent fees | $5,000–$15,000/year |
| Annual compliance maintenance | $2,000–$5,000 |
Typical total cost (self-declaration): $10,000–$30,000
Typical total cost (NHC registration): $30,000–$80,000+
Comparison Table: Food Contact Material Requirements
The following table provides a side-by-side comparison of registration requirements across different food contact material categories. Use this as a quick reference guide when planning your compliance strategy.
| Aspect | Plastics | Ceramics/Glass | Metals | Paper/Board | Silicone/Rubber |
|---|---|---|---|---|---|
| Primary GB Standard | GB 4806.6/7 | GB 4806.3/4/5 | GB 4806.9 | GB 4806.8 | GB 4806.11 |
| Additive Standard | GB 9685-2016 | GB 9685-2016 | GB 9685-2016 | GB 9685-2016 | GB 9685-2016 |
| Overall Migration Test | Required (10 mg/dm²) | Not typically required | Required for coated metals | Required | Required |
| Specific Migration Tests | Monomers, oligomers, additives | Lead, cadmium | Heavy metals | Fluorescent agents, heavy metals | Volatile siloxanes, heavy metals |
| New Substance Needed | Likely | Unlikely | Likely for alloys | Unlikely | Likely for new elastomers |
| Registration Route | Self-declaration (or NHC for new substances) | Self-declaration | Self-declaration | Self-declaration | Self-declaration (or NHC for new substances) |
| Testing Complexity | High | Medium | Medium | Medium | Medium-High |
| Average Testing Cost | $8,000–$20,000 | $3,000–$8,000 | $4,000–$10,000 | $4,000–$10,000 | $6,000–$15,000 |
| Average Timeline | 4–6 months | 3–5 months | 3–5 months | 3–5 months | 4–6 months |
| Common Failure Points | Additive not in GB 9685; OML exceeded | Lead/cadmium release above limits | Element composition off-spec | Fluorescent whitener detected | Volatile content too high |
| Labeling Requirements | Food contact symbol + instructions | Food contact symbol + instructions | Food contact symbol + instructions | Food contact symbol + instructions | Food contact symbol + instructions |
Case Study: Importer Completes Registration Successfully
Background
EuroKitchen GmbH, a mid-sized German manufacturer of high-end silicone bakeware, wanted to enter the Chinese market through cross-border ecommerce and wholesale distribution. Their product line included silicone baking mats, muffin molds, and spatulas, all manufactured at their facility in Stuttgart using platinum-cured liquid silicone rubber.
The Challenge
The company initially underestimated the complexity of Chinese food contact requirements. Their products were already CE-marked for the European market and complied with EU Regulation 1935/2004. They assumed Chinese requirements would be similar. However, three critical issues emerged:
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GB 9685 Additive Compliance — Two of their color pigments, perfectly legal in the EU, were not listed in GB 9685-2016. This triggered a new substance evaluation pathway they were unprepared for.
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Silicone-Specific Migration Limits — China’s GB 4806.11-2016 has specific volatile methyl siloxane migration limits that are stricter than EU limits. Their initial production formulation exceeded the Chinese limits.
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Testing Laboratory Requirements — Their existing European test reports were not accepted by Chinese customs without supplementary testing from a CNAS-accredited lab in China.
The Solution
EuroKitchen engaged a specialized compliance consulting firm with deep experience in Chinese food contact regulations. Together, they implemented the following action plan:
Month 1–2: Compliance Gap Analysis
- Mapped all product components against GB 9685-2016
- Identified the two non-compliant colorants
- Reformulated the silicone compound by substituting approved alternatives from the additive list
- Adjusted the curing parameters to reduce volatile content
Month 3–4: Reformulation and Pre-Testing
- Produced pilot batches with the new formulation
- Conducted internal migration tests to verify volatile siloxane levels
- Sent samples to a CNAS-accredited lab in Shanghai for pre-compliance testing
- Iterated on the formulation until all migration results were within limits
Month 5–6: Official Testing and Documentation
- Submitted final product samples for official CNAS testing
- Obtained overall migration, specific migration, and sensory test reports
- Compiled the compliance declaration and technical dossier
Month 7–8: Market Access and Launch
- Filed the compliance declaration with local authorities
- Updated product labels for the Chinese market
- Listed products on Tmall Global and JD Worldwide
- Began wholesale distribution through a Chinese partner
Results
| Metric | Before | After |
|---|---|---|
| Timeline expectation | 3 months | 8 months (realistic) |
| Testing budget (USD) | $5,000 estimated | $18,000 actual |
| Total compliance cost (USD) | $15,000 estimated | $38,000 actual |
| GB 9685 additive compliance | 2 non-compliant pigments | All 100% compliant |
| First-year sales (USD) | $0 (delayed) | $1.2 million |
| Customs clearance rate | 0% (shipments held) | 100% clearance |
Key Takeaways
- Don’t assume EU compliance equals China compliance. Chinese standards have substance-specific differences that require proactive investigation.
- Budget for reformulation. Material adjustments are common; budget for at least one reformulation cycle.
- Start with a CNAS-accredited lab early. Early engagement with a recognized Chinese laboratory prevents last-minute surprises.
- Work with experienced partners. Having a knowledgeable Reliable manufacturing and procurement partner China accelerated the process and prevented costly mistakes.
Reliable manufacturing and procurement partner China
Reliable manufacturing and procurement partner China
Reliable manufacturing and procurement partner China
Bulk product sourcing from China wholesale suppliers
Bulk product sourcing from China wholesale suppliers
Bulk product sourcing from China wholesale suppliers
China sourcing agent for cross border ecommerce
China sourcing agent for cross border ecommerce
China sourcing agent for cross border ecommerce
FAQ
1. Do all food contact products need to be registered individually in China?
Not necessarily. Products that share the same materials, manufacturing process, and intended use conditions can be grouped under a single compliance declaration. For example, a set of silicone spatulas in different colors can be covered by one declaration if the only difference is the colorant and all colorants are GB 9685-approved. However, fundamentally different products (e.g., a plastic container and a silicone baking mat) require separate declarations.
2. Can I use EU or US test reports for Chinese registration?
EU or US test reports can serve as supplementary evidence but cannot replace testing from a CNAS/CMA-accredited laboratory in China. Chinese authorities require that migration testing be performed by domestically accredited labs. Some international testing organizations have CNAS-accredited branches in China, which can streamline the process. Expect to spend $3,000–$10,000 for duplicate testing even if you have existing foreign reports.
3. How long does the Chinese food contact material registration take?
For products following the self-declaration route (most common), the entire process from initial assessment to market entry takes 3–6 months. For high-risk products requiring NHC registration (new substances, baby food packaging), the timeline extends to 12–30 months. The longest phase is typically laboratory testing and any required reformulation.
4. What happens if I change my product formulation after registration?
Any change in formulation, particularly changes to additives, colorants, or base materials, may require re-testing and a new compliance declaration. Minor changes that do not affect food contact safety (such as changing a non-food-contact outer layer color) may not require re-testing, but it is best practice to document all changes and consult with your compliance advisor. Major changes always require full re-testing.
5. Is there an annual renewal requirement for food contact material registration?
There is no annual renewal requirement for the compliance declaration itself. However, you must: (a) maintain compliance records for at least two years after the last batch produced, (b) monitor for updates to GB standards—when a standard is revised, you have a transition period (typically 6–12 months) to update your compliance, and (c) renew your business license, import permits, and any agency agreements as required.
6. What are the most common reasons for registration rejection or customs detention?
The top five reasons applications fail or shipments are detained include: (1) substances not listed in GB 9685-2016 additive positive list, (2) overall migration exceeding the 10 mg/dm² limit, (3) heavy metal levels (especially lead and cadmium in ceramics) exceeding limits, (4) incomplete or incorrectly formatted compliance declarations, and (5) missing or incorrect labeling, particularly the absence of the food contact symbol.
7. Do I need a Chinese legal entity to register food contact materials?
Yes. Foreign companies must have a Chinese legal entity—either a wholly foreign-owned enterprise (WFOE), a joint venture, or a contractual relationship with a Chinese importer/distributor who acts as the responsible party. The Chinese entity’s name and address appear on the compliance declaration, and that entity bears legal responsibility for product safety. Many foreign companies work with a China-based agent or sourcing partner who handles registration and compliance on their behalf.
8. Can I register food contact materials for both ecommerce and offline retail simultaneously?
Yes, the same compliance declaration applies regardless of sales channel. However, labeling requirements may differ slightly: ecommerce platforms often require digital compliance documents to be uploaded to their systems, while offline retail may require physical labeling on each product unit. The underlying safety and migration testing requirements are identical. A Bulk product sourcing from China wholesale suppliers partner can help ensure your product labeling meets both channel requirements.
9. What is the difference between GB 4806 and GB 9685 standards?
GB 4806 series standards cover the finished product safety requirements—migration limits, sensory properties, and general safety for specific material types (plastics, ceramics, metals, etc.). GB 9685 is specifically about additives—it lists which chemical substances are permitted for use in food contact materials and under what conditions. Think of GB 4806 as the “what the final product must achieve” standard and GB 9685 as the “what ingredients you are allowed to use” standard. Both must be satisfied for compliance.
10. How often do Chinese food contact standards change?
China has been actively updating its food contact material standards since the major reform began in 2016. On average, the GB standards bodies issue 3–5 amendments or new standards per year. Companies should designate a responsible person or subscribe to regulatory monitoring services to track changes. The most impactful changes typically involve the GB 9685 additive list (new substances added or restrictions modified) and updates to migration testing methods under the GB 31604 series.
Conclusion
Navigating the Chinese product registration requirements for food contact materials demands careful planning, adequate budgeting, and a thorough understanding of China’s unique regulatory framework. The system, built around the GB 4806 series of standards, GB 9685 additive management, and CNAS-accredited laboratory testing, presents both challenges and opportunities for international businesses. While the self-declaration route offers a manageable pathway for most conventional products, even this route requires meticulous attention to substance compliance, migration testing, documentation, and labeling.
The key success factors are: start early, engage CNAS-accredited labs proactively, verify every substance against GB 9685 before production, budget realistically for testing and potential reformulation, and work with experienced compliance partners who understand the nuances of Chinese regulations. The case study of EuroKitchen GmbH illustrates that while the process may take longer and cost more than initially anticipated, proper compliance opens the door to one of the world’s largest and fastest-growing consumer markets.
China’s food contact material market continues to expand, driven by urbanization, rising disposable incomes, and increasing consumer awareness of food safety. Companies that invest in compliance from the outset build a strong foundation for long-term success, avoiding the severe consequences of non-compliance including fines, recalls, blacklisting, and reputational damage.
For businesses new to the Chinese market, partnering with an experienced Reliable manufacturing and procurement partner China who understands the full spectrum of food contact material regulations is not just helpful—it is essential. From material selection through regulatory submission, a knowledgeable partner can transform compliance from a barrier into a competitive advantage, enabling you to enter the market with confidence and build lasting success in China’s dynamic food contact products industry.
Tags
- Chinese food contact material registration
- GB 4806 standards China
- Food contact materials compliance
- China product registration requirements
- GB 9685 additive list
- Migration testing China
- CNAS accredited lab testing
- China food safety law
- Import food packaging China
- China FCM regulations
