Food Contact Packaging Regulations – Major Countries (2025)

Australia & New Zealand: Fit-for-Purpose Standards

Under the binational Food Standards Code, FCMs must be safe and suitable.

Key Regulations:

• Food Standards Code Standard 3.2.2: General requirements—fit for purpose, no contamination, GMP, traceability.

• AS 2070:1999: Plastics—migration limits, simulants.

• AS 4371:2012: Ceramics—performance standards.

June 2025 Code compilation confirms no big changes.

Why It Matters for You: Test ceramics for lead if glazing baked goods.

Specific Controls:

• Styrene: <60 mg/kg in AS 2070.

• Recycled Paper: National migration testing.

• Lead: Material-specific (e.g., ≤1 mg/kg in plastics).

• Colorants: Allowed lists in AS 2070; inertness for ceramics.

Canada: Migration Bans and Voluntary Reviews

Canada emphasizes preventing harmful migration without mandatory premarket for most FCMs, but voluntary reviews help.

Key Regulations:

• Food and Drugs Act, Division 23 (B.23.001–007): Prohibits harmful substance transfer; packaging must be traceable with unique IDs.

• Divisions 24–28: For special foods like infant formula—mandatory premarket.

• Voluntary Pre-market Assessment: Submit for Letter of No Objection (LONO).

• Positive Lists: For polymers, monomers, additives with SMLs.

Update: As of January 2025, pre-market for incidental additives discontinued, but safety still required.

Why It Matters for You: For baby food packaging, get LONOs. Test for migration in labs.

Specific Controls:

• Styrene: Polystyrene needs LONO or list approval; migration below acceptable limits.

• Recycled Paper: Voluntary submission for LONO.

• Lead: No specific limit, but must not adulterate food; case-by-case.

• Colorants: Listed in LONOs or pre-1958 lists; positive lists for polymers.

China (Mainland)

Key Regulations and 2025 Updates

· Food Safety Law of the PRC: The overarching statute. All FCMs and related articles (including prepackaged food labeling) regulated under this umbrella. The law was most recently revised in April 2021.

· GB 4806.1 (General Safety Requirements for Food Contact Materials and Articles, draft update 2025): Fundamental safety principles include three mandates: no endangerment of health, no alteration of food properties, and maintenance of intended material function. Introduces new requirements for NIAS assessment and functional barrier effectiveness.

· GB 31603 (GMP Requirements): Specifies mandatory good manufacturing practice protocols—controls throughout production, supplier verification, and documentation.

· GB 9685-2016, as amended 2025: The “positive list” for permitted additives and their use limits, which now also includes some new allowed substances for silicone rubber, clarified references for rubber, magnitude limit changes for certain additives, and labeling & calculation clarifications. The 2025 amendment is immediately effective.

· GB 4806 series (Product Standards): Specifies limits for plastics, rubber, paper, coatings, adhesives (GB 4806.7/15), and, as of 2023-2025, new standards for composite materials and inks (GB 4806.13-2023, GB 4806.14-2023). Migrant and residue levels must be tested for each layer of multi-layered/laminated packaging as per newest GB 4806.1 and corresponding standards.

· GB 31604 Series (Testing Standards): Five testing standards (GB 31604.30, .31, .61, .62, .63) updated in 2025, taking effect September 16, 2025—covering phthalate migration, vinyl chloride, and others. Enterprises have a 6-month period to adjust.

· GB 7718-2025 & GB 28050-2025 (Labeling): Mandates extensive new requirements for ingredient/allergen labeling, digital QR labeling, ingredient QUID on labels, and restrictions on certain marketing phrases. All prepackaged food must update labels by March 16, 2027. Imported food must include country of origin, importer info, and registration numbers on the label.

· Supervisory Measures: Routine risk-based inspections (e.g., GB 14934 for microbial limits) and robust documentation audits are strictly enforced, particularly for imports.

Specific Controls

· Migration Testing: Plastic, composite, paper, and inked articles must undergo rigorous migration and residue tests per corresponding GB 31604 standards.

· Heavy Metals: Aggregate limits for lead, cadmium, mercury, etc.<0.5mg/kg in food per GB 4806/etc.

· Additives: Only listed, permitted additives may be used (GB 9685, amended 2025). New substances must be evaluated and approved by the NHC.

· Labeling: Mandatory compliance with updated GB 7718-2025 and product-specific rules by March 16, 2027. Non-compliant items may be blocked from import or subject to recall.

China (Hong Kong SAR): Premises Licensing and Testing

Hong Kong prohibits harmful leaching, tied to food business licenses.

Key Regulations:

• Public Health & Municipal Services Ordinance (Cap. 132): No harmful substances from packaging.

• Food Business Regulation (Cap. 132A): Supplier records required.

• CFS Guidance: On plastics, paper, inks; random testing for phthalates, etc.

Update: Food Adulteration (Metallic Contamination) Amendment effective Sept 2025 tightens metals.

Why It Matters for You: Keep supplier records; test for migrants.

Specific Controls:

• Styrene: Inert plastics; tested under CFS limits.

• Recycled Paper: Discouraged; risk assessments needed.

• Lead: Prohibited if leaches; under Cap. 132H for inks.

• Colorants: Listed in Cap. 132H; prescribed labels.

European Union (EU)

Key Regulations (2025 Updates)

· Regulation (EC) No 1935/2004: The framework law, covering all FCMs, mandates safety and traceability, requiring that materials do not endanger human health, alter food’s taste, or have unacceptable migration.

· Commission Regulation (EC) No 2023/2006: Enforces Good Manufacturing Practices for FCM manufacture.

· Commission Regulation (EU) No 10/2011: The main specific legislation for plastic food contact articles. Contains positive lists of monomers/additives and specific/overall migration limits (SMLs, OMLs).

· Regulation (EU) 2022/1616: Covers recycled plastics, requiring authorization and compliance declarations for input/output materials.

· Commission Regulation (EU) 2024/3190: Adopted December 2024 and effective 20 January 2025, this landmark regulation bans the use of Bisphenol A (BPA) and other hazardous bisphenols in most FCMs, including plastics, adhesives, coatings, rubbers, inks, and varnishes. There is an 18-month transition period, with limited exceptions where alternatives do not exist. Previous statements attributing the BPA ban to Regulation (EU) 2025/351 were incorrect – Reg 2025/351 is a separate amendment focused on plastics testing and purity standards, not bans of substances.

· Regulation (EU) 2025/351: In force since March 2025, this amendment broadens the definition of “additive” in plastics, clarifies NIAS (non-intentionally added substances) purity, and creates new documentation, labeling, and migration testing protocols—but does not introduce further substance bans or cover adhesives, coatings, or inks.

Specific Controls

· Styrene in Polystyrene: 60 mg/kg SML.

· Lead and Heavy Metals: <100 mg/kg aggregate limit.

· Colorants: Only those on EU positive lists; additional rules for ceramics, inks, and coatings.

India: Food-Grade Mandates and Bans

India bans certain recyclables and sets strict standards.

Key Regulations:

• FSS Act 2006: Hygienic, traceable food-grade materials.

• Food Safety & Standards (Packaging) Regulations 2018: Bans recycled plastics/newspaper; OML/SML for materials; comply with 17 IS standards (e.g., IS 10146 for plastics).

• Indian Standards: Test methods, lists, labeling (e.g., reuse instructions).

Update: Amendments 2025 allow recycled PET with guidelines.

Why It Matters for You: Use virgin layers in multi-packs; get NABL certs.

Specific Controls:

• Styrene: <60 mg/kg in IS 10605/15495.

• Recycled Paper: Banned direct contact; virgin inner layers only.

• Lead: Limits in IS for paper, inks, etc.

• Colorants: Conform to IS 15495/9833; bans heavy metals, toluene in inks.

Japan: Testing Methods and Positive Lists in Full Swing

Japan's rules focus on hygiene and migration testing. The Positive List for synthetic resins kicked in June 2025, with phased enforcement to 2030.

Key Regulations:

• Food Sanitation Act (Act No. 233/1947): Defines specs for all FCMs.

• MHLW Notification No. 370/1959: Test methods, OMLs (e.g., 30 mg/L for evaporation residue), SMLs for materials like plastics, ceramics.

• Positive List System: For resins—monomers, additives must be listed; label with material type and manufacturer.

Why It Matters for You: If handling imported Japanese packaging, check for JCII certificates (replaced JHOSPA).

Specific Controls:

• Styrene: On positive list; migration <60 mg/kg under Notification 196.

• Recycled Paper: Hygiene assessments with local migration testing.

• Lead: Defined limits in specs; batch testing enforced.

• Colorants: Designated additives or non-migratory under 370.

Singapore: Importer Responsibility and ASEAN Alignment

Singapore holds importers accountable for safety.

Key Regulations:

• Sale of Food Act 1973 / Food Regulations: No leaching of carcinogens, heavy metals, vinyl chloride.

• ASEAN FCM Guidelines: Reference for testing, positive lists, labeling (e.g., for vinyl chloride).

Amendments 2025 focus on labeling, effective 2026.

Why It Matters for You: Conduct risk assessments; get test reports.

Specific Controls:

• Styrene: Below safe thresholds via ASEAN testing.

• Recycled Paper: Risk assessment for contaminants.

• Lead: Below SFA limits; compliance checks.

• Colorants: No carcinogenic/heavy-metal based; ASEAN lists.

United Arab Emirates: GCC Standards and Conformity

UAE aligns with Gulf standards for inert materials.

Key Regulations:

• Cabinet Resolution No. 21/2015: Conformity to GSO 2231.

• UAE.S GSO 2231/2012: General FCM—GMP, no harmful migrants, "for food contact" label.

• GSO Standards (e.g., 839 ceramics, 1863 paper): Material-specific.

No 2025 updates noted.

Why It Matters for You: Get ESMA certs; audit suppliers.

Specific Controls:

• Styrene: <60 mg/kg in GSO 1863.

• Recycled Paper: ESMA cert with testing.

• Lead: Below GSO limits.

• Colorants: GSO-permitted; conformity marks.

United States: Premarket Approvals and Additive Focus

In the US, FCMs are treated as "indirect food additives" under FDA oversight. This means rigorous premarket checks. Food handlers should source from FDA-compliant suppliers and watch for state-level bans (e.g., polystyrene foam in some areas).

Key Regulations:

• Federal Food, Drug, and Cosmetic Act (FD&C Act): Core law prohibiting adulterated food, including from packaging migration.

• 21 CFR Parts 174–179: Covers indirect additives like resins, adhesives. Each material has permissible substances and use conditions.

• 21 CFR 175.300: Specific for rubber articles.

• Threshold of Regulation (TOR) Exemptions (21 CFR 170.39): For low-migration substances.

• Food Contact Substance Notification (FCN): Premarket process for new substances; effective only for the notifier unless GRAS (Generally Recognized as Safe).

Update: As of January 2025, 35 FCNs for PFAS (forever chemicals) in grease-proofing are no longer effective—phase out by 2027. Also, FD&C Red No. 3 revoked in July 2025 for foods.

Why It Matters for You: Using non-compliant wrappers could lead to FDA seizures. Get letters of guarantee from suppliers confirming FDA clearance.

Specific Controls:

• Styrene: Polystyrene cleared via FCNs with migration criteria (typically low levels via extractive testing).

• Recycled Paper: Needs FCN or GRAS; migration data required to prove no contaminants.

• Lead: Extractives limits under 21 CFR (e.g., <0.5 ppm migration); case-by-case.

• Colorants: Listed in 21 CFR 178.3297 for polymers, 176.170 for paper; prior-sanctioned or TOR-exempt.

United Kingdom: Building on EU Foundations with Local Twists

Post-Brexit, the UK retains much of the EU framework but adapts it. Great Britain (England, Scotland, Wales) follows retained laws, while Northern Ireland aligns with EU rules via the Protocol. For food handlers in the UK, this means dual checks if operating across regions.

Key Regulations:

• Materials and Articles in Contact with Food (England) Regulations 2012: Enforces safety, traceability, and GMP. Requires registration of FCM businesses with local authorities and clear manufacturer/batch labeling.

• Retained EU Regulations (EC 1935/2004, 2023/2006, 10/2011): Same as EU—safety, positive lists for plastics, migration limits. DoCs are mandatory for plastics, ceramics, etc.

No major FCM updates in 2025, but extended producer responsibility (EPR) for packaging waste starts affecting costs and recycling obligations.

Why It Matters for You: If you're a takeaway shop using plastic containers, ensure they're from compliant suppliers. Keep records for at least two years.

Specific Controls:

• Styrene: Same as EU—60 mg/kg SML for polystyrene.

• Recycled Paper: National safety assessments with migration testing required.

• Lead: Under Packaging (Essential Requirements) Regulations 2015, heavy metals limit is 100 mg/kg.

• Colorants: Retained EU positive lists; inks/coatings need DoCs.

Next Steps for Food Handlers

· Always consult the most recent official regulatory documentation for any jurisdiction before making material or packaging decisions.

· Work with accredited laboratories for migration and residue testing.

· Maintain up-to-date compliance records for all packaging suppliers.

· Stay alert for changes related to emerging contaminants such as PFAS, new additive restrictions, or shifts in positive lists/labeling laws.

Disclaimer

This blog provides a high-level summary of food contact packaging regulations as of September 2025 and is intended for informational purposes only. Regulations evolve frequently – always verify requirements with official government sources or qualified laboratories before acting on packaging compliance decisions. The authors accept no liability arising from use of this information.

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