GB 4806.7-2026: New Specific Migration Limits for Plastic Additives | China FCM Compliance

The regulatory landscape for food contact materials (FCMs) in China has undergone a fundamental transformation. Following the consolidation of GB 4806.6-2016 and GB 4806.7-2016 into GB 4806.7-2023 (effective September 6, 2024), the 2026 amendment cycle has introduced several important technical updates—most notably, stricter specific migration limits (SMLs) for plastic additives and tighter controls on additives in the complementary standard GB 9685. For foreign manufacturers, importers, and supply chain stakeholders, understanding these new specific migration limits for plastic additives is essential for maintaining customs clearance and market access. This guide provides a comprehensive breakdown of the latest SMLs, the interaction between GB 4806.7 and GB 9685, and practical steps for compliance.

1. The GB 4806.7 Framework: Positive List Management for Plastic Resins and Additives

GB 4806.7-2023 “National Food Safety Standard – Plastic Materials and Articles for Food Contact” applies to all plastic food contact materials and articles, including unvulcanized thermoplastic elastomers and starch-based plastics. Like its predecessor, the 2023 standard retains the positive list management approach—only plastic resins listed in Appendix A of GB 4806.7, and additives listed in GB 9685 or related announcements, are permitted for use. The 2023 edition consolidated the resin provisions (previously in GB 4806.6) and article provisions (previously in GB 4806.7) into a single standard, while also adding starch-based plastics as a newly regulated category. For plastic additives, this means that any additive used in a food contact plastic product must be expressly listed in GB 9685 (or an approved announcement). Absence from the positive list constitutes a violation, regardless of the additive‘s safety profile or approval in other jurisdictions.

2. Understanding Specific Migration Limits (SMLs) vs. Overall Migration Limits (OML)

Under GB 4806.7, migration limits are categorized into two key types: Overall Migration Limit (OML) and Specific Migration Limit (SML). The OML measures the total quantity of all non‑volatile substances that migrate from the plastic material into food simulants under defined test conditions. The standard requires OML ≤10 mg/dm² (surface area basis) or ≤60 mg/kg (mass basis). The OML serves as a broad screen for overall chemical release; if a product exceeds it, further analysis is required to identify the specific migrating substances.

In contrast, SMLs are established for known hazardous substances (e.g., bisphenol A, phthalates, heavy metals, and specific monomers). Each SML sets a maximum permitted concentration for an individual migrating substance. For substances with SMLs, compliance must be demonstrated through targeted analytical methods. The 2026 amendment cycle has focused heavily on revising these SMLs downward for several high-risk substances, while also adding new SMLs for substances previously unregulated. Additionally, for some substances, the standard also specifies maximum residue limits (QM, max. residue quantity in final product) and SML(T) group limits (e.g., for primary aromatic amines). These parameters are detailed in Appendix A of GB 4806.7 (for monomers and starting substances) and in GB 9685 (for additives).

3. Key SML Revisions in the 2026 Amendment Cycle

The most impactful changes affecting plastic additives under GB 4806.7 derive from the complementary amendment to GB 9685 “Standard for Use of Additives in Food Contact Materials and Articles”. On July 3, 2025, the China National Center for Food Safety Risk Assessment (CFSA) published a draft amendment to GB 9685 proposing significant revisions, including revised or new SMLs for various additive substances. Key revisions include:

• Bisphenol A (BPA): Lowered from 0.6 mg/kg to 0.05 mg/kg, aligning with the EU Plastics Regulation. This tightening applies to all food contact plastics that may contain BPA-based additives or epoxy coatings. BPA has endocrine‑disrupting properties, and the reduced limit reflects growing global consensus on minimizing exposure. Manufacturers of polycarbonate (PC) plastics or BPA-based epoxy can coatings should test for BPA migration immediately and consider alternative additive systems.
• Aluminum: New SML of 1 mg/kg.
• Zinc: Revised from 25 mg/kg to 5 mg/kg (also aligning with the EU Plastics Regulation). Zinc-based additives and pigments used in plastics must now meet this stricter migration limit.
• Primary Aromatic Amines (PAAs): New total migration limit: not detectable (detection limit 0.01 mg/kg). PAAs may be present as residual monomers or breakdown products of azo dyes and certain additives; this provision effectively bans the use of azo dyes that can reductively cleave to form carcinogenic aromatic amines in food contact plastics.
• Phthalates: Six phthalates (high‑risk plasticizers) are proposed for complete removal from GB 9685. These include DEHP, DBP, BBP, DINP, DIDP, and DNOP—all of which have been linked to endocrine disruption and reproductive toxicity. Their removal means that any food contact plastic product containing these phthalates will be illegal for sale or import into China.
• Perfluorinated substances (PFAS): Four perfluorinated substances are proposed for deletion from GB 9685. Manufacturers using non‑stick coatings or grease‑resistant additives should confirm their additives do not contain these prohibited PFAS.
• Nonylphenol derivatives: Two nonylphenol derivatives are also proposed for deletion, affecting some plastic stabilizers and surfactants.
• Other SML revisions: The SMLs for six additional substances will be amended in the revised GB 9685, all aligned with the SMLs in the EU Plastics Regulation, as currently amended.

The CFSA proposal also includes a carry‑over principle, allowing a food contact additive to be carried over via raw materials if certain conditions are met, and adds magnesium and zinc salts to the list of permitted salts of cleared acids, alcohols, and phenols.

4. New Ban on Primary Aromatic Amines (PAAs)

The zero‑tolerance approach to primary aromatic amines (PAAs) represents one of the most significant changes in GB 4806.7-2023, further reinforced by the 2026 amendment cycle. Under this requirement, PAAs must be not detectable (detection limit 0.01 mg/kg) in food contact plastics. This requirement applies to all plastic materials, regardless of intended food contact type.

PAAs can originate from several sources: residual monomers in certain polymers (especially polyurethanes and polyamides), breakdown products of azo dyes used for coloring plastics, impurities in some additives, and degradation products from adhesive layers in multi‑material composites. For imported products, the PAA requirement is strictly enforced. Common non‑compliant scenarios include:

• Colored plastic parts (e.g., brightly colored lids, utensils, or containers) where azo dyes were used without proper fixation or where dye impurities lead to detectable PAA migration.
• Nylon (polyamide) kitchen utensils, where residual monomer aniline may be present.
• Polyurethane‑based coatings or adhesives used in multi‑layer laminates.

Manufacturers should specifically audit any product with colored plastics, nylon components, or multi‑material constructions for potential PAA migration risk. Pre‑shipment testing for PAAs using HPLC method with a detection limit ≤0.01 mg/kg is strongly advised.

5. The Role of GB 9685: Mandatory Additive Approval

It is essential for importers to understand the division of responsibility between GB 4806.7 and GB 9685. GB 4806.7 governs plastic resins (via Appendix A positive list) and certain monomers/starting substances. GB 9685 establishes the positive list for additives—a separate, essential standard that must be consulted for every additive used in a food contact plastic product. The draft amendment to GB 9685 is particularly consequential, as it narrows the standard‘s scope by removing substances now covered by separate material standards (e.g., monomers for coatings, adhesives, and rubbers are moved to those respective standards).

Critically, the draft amendment proposes to remove a total of 3 substances from the plastics additive table, 105 from coatings, 12 from rubbers, 62 from printing inks, and 219 from adhesives. For plastic additives specifically, the three substances removed likely reflect those no longer considered safe or technically necessary. Additionally, 13 “high‑risk” substances are proposed for complete deletion across multiple material categories, including:

• Four perfluorinated substances (PFAS)
• Two nonylphenol derivatives
• Six phthalates (DEHP, DBP, BBP, DINP, DIDP, DNOP)
• Sodium perchlorate

Given that many plastic products incorporate additives from multiple categories (e.g., printed inks, adhesive layers), manufacturers and importers must ensure that every additive—whether used in the plastic itself, in printing inks applied to the plastic, or in adhesives used in laminates—is listed in the appropriate positive list and complies with all applicable SMLs. The “carry‑over principle” proposed in the GB 9685 amendment allows an additive to be carried over via raw materials (e.g., recycled content) only if certain conditions are met, but this exception is narrow and well‑defined.

6. Testing Methods and Food Simulants Under GB 4806.7

Migration testing under GB 4806.7 must be conducted using the food simulants specified in GB 4806.1, selected based on the intended use of the plastic product. Testing conditions (temperature and time) also depend on the intended use scenario. The key testing standards referenced include:

• Overall migration (total migration): Conducted according to GB 31604.8 (volatile loss method).
• Specific migration of additives and monomers: Conducted according to GB 31604 series (e.g., GB 31604.15 for bisphenol A, GB 31604.16 for heavy metals).
• Primary aromatic amines (PAAs): Determined by HPLC method, with detection limit ≤0.01 mg/kg.
• High‑manganese potassium consumption (organic reducing substances): Conducted according to GB 31604.2.
• Heavy metals (lead, cadmium, antimony, etc.): Determined by atomic absorption spectrophotometry (AAS) or inductively coupled plasma mass spectrometry (ICP‑MS).

For imported plastics, customs officials typically require test reports from CNAS‑accredited laboratories, showing compliance with all applicable GB 4806.7 and GB 9685 limits. Reports must include sample identification, test conditions (temperature, time, simulant), equipment calibration certificates, and raw data. Any deviation from standard test methods will invalidate the report.

7. Practical Compliance Roadmap for Plastic Product Importers

To ensure smooth customs clearance and full compliance with GB 4806.7-2023 and the 2026 additive limit updates, foreign manufacturers and importers should follow this six‑step plan:

1. Conduct a full additive inventory review (Month 1): Obtain full formulation information from your plastic product supplier, including all additives (colorants, plasticizers, stabilizers, antioxidants, antistatic agents, etc.). Cross‑reference every additive against the GB 9685 positive list (including the latest draft amendments). If an additive is not listed, reformulation is required.
2. Implement supply chain compliance clauses (Immediate): Amend supply contracts to require that all raw materials (resins, additives, colorants) comply with GB 4806.7-2023 and GB 9685, including all future amendments. Request certificates of analysis (COAs) for each additive batch, specifically addressing SML compliance.
3. Pre‑shipment testing for high‑risk parameters (Month 2-3): Engage a CNAS‑accredited food contact testing lab to perform migration tests on your finished products. Prioritize testing for BPA (if BPA‑based materials or coatings are present), PAAs (especially for colored or nylon products), phthalates (if plasticizers are used), and heavy metals (lead, cadmium, antimony).
4. Verify labeling compliance (Month 3): Ensure that the Chinese label includes the mandatory “食品接触用” (for food contact use) statement, the plastic material type (e.g., “食品接触用 PP”), and for infant products, the “婴幼儿专用” (special for infants) designation. The product standard number (GB 4806.7) must appear on the label or packaging.
5. Maintain compliance documentation (Ongoing): Retain all test reports, supplier declarations, and label proof files for at least 2 years (or longer if required by your importer’s quality management system). Customs may request these records during random post‑clearance inspections.
6. Monitor regulatory updates (Ongoing): The GB 9685 amendment is expected to become final in 2026-2027. Subscribe to NHC and SAMR official announcements. Engage a China compliance partner to track changes to SMLs and positive lists.

Total lead time for full compliance planning and testing is approximately 3‑5 months. Companies with large product portfolios should prioritize high‑volume SKUs and those with colored plastics, nylon components, or known additive risk factors.

Summary: GB 4806.7-2023 and the complementary GB 9685 amendment introduce the most significant tightening of food contact plastic additive regulations in over a decade. Key changes include drastically reduced SMLs for BPA (0.05 mg/kg), aluminum (1 mg/kg), and zinc (5 mg/kg); a new ban on detectable migration of primary aromatic amines (PAAs); and the removal of six phthalates, four PFAS, and other high‑risk substances from the additive positive list. The positive list management framework requires that every additive in a food contact plastic product be listed in GB 9685. Importers who conduct full additive inventories, implement supply chain controls, perform pre‑shipment testing, and monitor regulatory updates will ensure uninterrupted market access. With customs enforcement now targeting additive compliance, proactive preparation is not optional—it is essential.