BIOTEN™ Compliance Knowledge

Compliance roadmap for key markets

Market and claim boundaries

Covering China, the United States, the European Union, Germany, Switzerland, Japan, South Korea, Australia and New Zealand, focusing on food contact materials, migration testing, PFAS statements, compostability and repulpability verification. Select a map marker or market entry to view applicable frameworks, priority verification and documentation requirements.

Compliance roadmap for key markets

Light green areas indicate key markets for which preliminary compliance paths have been sorted out. Select the market code mark or the market entry below to view the regulatory framework, verification sequence and documentation requirements. Germany and Switzerland are respectively listed outside the EU common path due to different applicable requirements.

No market allocated The preliminary path has been sorted out market entrance

China

The Chinese market is based on the national food safety standard system, which requires separate review of general safety requirements, paper and cardboard, food contact paints and coatings, positive lists of additives, and migration test methods.

Market positioning and basis

China Market Coordination: Beijing / Shanghai
Map location: Beijing, 39.90° north latitude, 116.40° east longitude. The main basis includes the National Health Commission (NHC) Food Safety National Standard Catalog, as well as the GB 4806, GB 9685, and GB 31604 series of standards.

Suggested information package

TDS / SDSRecipe Compliance MatrixMigration pilot plan and third-party reportingPFAS statements and screening information not intentionally addedEvidence of repulpable or compostable pathways

Compliance framework

Core standards and applicable basis

GB 4806.1 stipulates the general safety baseline for food contact materials and products.
Fiber substrates generally apply to GB 4806.8; food contact paints and coatings generally apply to GB 4806.10, and need to be checked in conjunction with the current GB 4806 series requirements and transitional rules.
GB 9685-2016 is used to review additives, scope of use, limits and restrictions.
GB 31604.1-2023 and related GB 31604 methods are used to support the test design of items such as total migration, specific migration, heavy metals, PFOS/PFOA and primary aromatic amines (PAA).

Verify path

Priority verification order

Migration test conditions are determined based on food type, contact temperature, contact time and surface area to volume ratio.
Check the formula ingredients item by item with the positive list or restriction requirements of GB 9685 and applicable GB 4806.
Develop verification plans for paper cups, paper bowls, trays, hot drinks, fatty foods, microwave use and heat sealing conditions.
If the statement "PFAS not intentionally added" is used, it should be accompanied by a screening report, method information and detection limit.

declare boundaries

External representation boundaries

Barrier performance data alone cannot establish a conclusion of food contact compliance.
External statements should state the applicable standards, sample structure, intended use and test conditions.

official basis

Official inquiry portal

NHC National Food Safety Standard Catalog NHC Food Safety Standards and Monitoring and Evaluation Department

Current Market Compliance Summary

Summary of China Compliance Framework
Market positioning: Map positioning: Beijing, 39.90° north latitude, 116.40° east longitude. The main basis includes the National Health Commission (NHC) Food Safety National Standard Catalog, as well as the GB 4806, GB 9685, and GB 31604 series of standards.

1. Core standards framework:
1. GB 4806.1 stipulates the general safety baseline for food contact materials and products.
2. Fiber substrates generally apply to GB 4806.8; food contact paints and coatings generally apply to GB 4806.10, and need to be checked in conjunction with the current GB 4806 series requirements and transition rules.
3. GB 9685-2016 is used to review additives, scope of use, limits and restrictions.
4. GB 31604.1-2023 and related GB 31604 methods are used to support the test design of total migration, specific migration, heavy metals, PFOS/PFOA and primary aromatic amines (PAA).

2. Priority verification path:
1. Determine the migration test conditions according to food type, contact temperature, contact time and surface area to volume ratio.
2. Check the formula ingredients item by item with the positive list or restriction requirements of GB 9685 and applicable GB 4806.
3. Develop verification plans for paper cups, paper bowls, trays, hot drinks, fatty foods, microwave use and heat sealing conditions.
4. If the statement “PFAS not intentionally added” is used, it should be accompanied by a screening report, method information and detection limit.

3. Project information package:
1. TDS/SDS
2. Formula Compliance Matrix
3. Migration trial plan and third-party reports
4. Failure to intentionally add PFAS statements and screening information
5. Evidence of repulpable or compostable pathways

4. Declare boundaries:
1. Barrier performance data alone cannot establish a food contact compliance conclusion.
2. The external presentation should state the applicable standards, sample structure, intended use and test conditions.

Quick overview of key market frameworks

market	core standards framework	Priority verification path
CN China	GB 4806.1 stipulates the general safety baseline for food contact materials and products. ; Fiber substrates generally apply to GB 4806.8; food contact coatings and coatings generally apply to GB 4806.10, and need to be checked in conjunction with the current GB 4806 series requirements and transition rules. ; GB 9685-2016 is used to review additives, scope of use, limits and restrictions. ; GB 31604.1-2023 and related GB 31604 methods are used to support the test design of items such as total migration, specific migration, heavy metals, PFOS/PFOA and primary aromatic amines (PAA).	Migration test conditions are determined based on food type, contact temperature, contact time and surface area to volume ratio. ;Check the formula ingredients item by item with GB 9685 and applicable GB 4806 positive list or restriction requirements. ; Develop separate verification plans for paper cups, paper bowls, trays, hot drinks, fatty foods, microwave use and heat sealing conditions. ; If the statement "PFAS not intentionally added" is used, it should be accompanied by a screening report, method information and detection limit.
US USA	21 CFR Part 176 applies to indirect food additives in paper and paperboard components. ;21 CFR 176.170 covers paper and paperboard components in contact with aqueous and fatty foods. ;21 CFR 176.180 covers paper and paperboard components in contact with dry food. ;Coatings, resins, additives, polymers and non-paper components may require further verification of Parts 175, 177, 178, or FCN, TOR pathways. ; The FDA has announced that PFAS oil repellents used in paper and cardboard food packaging are no longer sold for food contact use in the United States; the statement "PFAS not intentionally added" should still be supported by screening data.	First classify food types and usage conditions according to water-based, acidic, fatty, dry, hot filling, reheating or storage. ;Confirm that each component has applicable CFR listing, GRAS or prior sanction basis, FCN or other authorization path. ;Determine extraction, migration, residual monomers or non-intentionally added substances (NIAS) assessment based on the customer's actual use. ; Do not use the absolute “PFAS-free” statement before the method, LOD/LOQ and batch range are clarified.
EU European Union	Regulation (EC) No 1935/2004 sets out the principles of safety, inertness, traceability and documentation for all food contact materials. ; Regulation (EC) No 2023/2006 stipulates Good Manufacturing Practice (GMP) requirements. ; Regulation (EU) No 10/2011 manages plastic or synthetic resin layers through Union List, Overall Migration Limit (OML), Specific Migration Limit (SML), Declaration of Conformity (DoC) and supporting documents. ;Paper, board, coatings, inks and adhesives should be assessed in conjunction with material structure, EU measures, Member State requirements and customer specifications.	Create a material structure diagram covering fiber substrates, coatings, inks, adhesives, functional layers and food contact surfaces. ; Determines whether a plastic or synthetic resin layer triggers EU 10/2011. ; Overlay BfR XXXVI, Swiss regulations, French, Dutch or other member state requirements depending on the customer's target market. ;form DoC and supporting documentation and cannot rely solely on barrier performance data.
DE germany	EU 1935/2004 and EU 2023/2006 form the horizontal basis. ;BfR Recommendation XXXVI Applicable to paper, cardboard and molded fiber food contact materials, typically including serving and reheating conditions up to 90°C. ;XXXVI/1 involves thermal extraction uses such as tea bags, thermal filter paper and boiled bags. ;XXXVI/2 relates to baking and microwave use. ;XXXVI/3 relates to cellulose fiber absorbent pads. ; For composite, multi-layer or coated materials, the paper or cardboard layer on the food contact side shall comply with XXXVI, and other layers shall not cause harmful migration or sensory effects.	Choose XXXVI, XXXVI/1, XXXVI/2 or XXXVI/3 based on actual usage. ; Prioritize the evaluation of cold water extraction, lead/cadmium, aluminum migration, azo dyes, optical brighteners, PAA and other related projects. ;The BfR recommendations are not mandatory EU-wide regulations, but are generally considered an important safety benchmark for the German market. ;The BfR will no longer accept new PFAS substances, so projects should strengthen evidence of PFAS exclusion and screening.
CH Switzerland	FDHA Ordinance SR 817.023.21 manages materials and articles intended to come into contact with food. ; FSVO guidance states that substances in packaging may migrate into food and are therefore subject to regulation. ;Packaging inks should be checked against current Annex 10 listings and CMR or non-migration requirements; Annex 6 may still be referenced in older materials. ;Concern for evidence of non-migration of SML, PAA, pigments, nanoforms, and unevaluated substances.	First identify the ink, coating, adhesive, plastic layer and fiber functional layer. ;Check Annex 10 or other applicable checklist item by item. ; When using non-migration limits such as not detected or 0.01 mg/kg, the method and detection limit should be stated. ; An independent assessment of the Swiss market cannot be completely replaced by EU data.
JP Japan	Food Sanitation Act related standards cover general requirements, material-specific requirements, purpose-specific requirements and manufacturing requirements for utensils, containers and packaging. ; The Positive List system for synthetic resin raw materials has been implemented since 2020 and will be continuously updated. ;Synthetic resins include thermoplastics, thermosetting plastics and thermoplastic elastomers; rubber is not included. ; When non-synthetic resin materials such as paper or wood constitute the food contact layer, according to Q&A rules, the additional synthetic resin layer usually does not fall within the scope of PL; if the synthetic resin layer directly contacts food, a PL review is required. ;Chemically modified cellulose is incorporated into synthetic resin PL; Unmodified natural cellulose and regenerated cellulose are excluded according to Q&A guidelines.	Create a layer structure diagram: fiber substrate, coating, adhesive, ink and food contact surface. ; Determine whether the coating forms a continuous film layer; surface treatment agents that do not form a film can be further judged whether to exclude them based on Q&A logic. ;PL mapping by Table 1 base polymers and Table 2 additives. ; Exclusion from the scope of PL does not exempt operators from their responsibility for food hygiene and safety.
KR South Korea	The Food Sanitation Act sets out standards and specifications for utensils, containers and packaging. ; MFDS Standards and Specifications cover general requirements, material-specific specifications, test methods and limits. ; English MFDS information can be used for communication, but it still needs to be compared with Korean regulations and local customer or laboratory requirements. ;Fiber substrates, coatings, resin layers, printing, adhesives and food types should be identified for specific applications.	The English version can be used to establish a customer communication framework while retaining a review of the Korean terms. ; Select migration, heavy metals, residual monomers, evaporation residue and other related tests according to material category. ; Korean import customers may require verification from local laboratories or recognized methods. ; PFAS, fatty food contact, hot drinks and microwave use need to be stated separately.
AU Australia	The Australia New Zealand Food Standards Code applies to food sold in Australia and New Zealand. ;Standard 1.1.1 stipulates the structure and general provisions of the Codex, including food, packaging and import-related requirements. ; Food contact packaging, articles or materials should not be capable of being swallowed or causing a risk of obstruction if swallowed, nor should they be likely to cause injury, pain or discomfort. ;The current Chapter 1 no longer uses the old Standard 1.4.3 as the main path; historical data should be updated to Standard 1.1.1.	Building a food contact safety assessment around a customer's end product cannot rely on a single positive list. ; Prepare evidence of migration, odor and sensory effects, heavy metals, PFAS, NIAS or material safety. ; Packaging and labeling provisions may also apply to imported foods and should be consistent with the importer's information. ; When customers adopt AS/ISO, EU, BfR or FDA evidence, they should make it clear that it is a customer acceptance standard and is not automatically equivalent to the Australian legal path.
NZ new zealand	The Australia New Zealand Food Standards Code applies to related foods sold, processed, handled or imported in New Zealand. ;Standard 1.1.1 stipulates basic safety requirements for packaging and contact materials, and involves imported food packaging. ; Projects should also confirm additional requirements from local importers, brands, regulatory agencies or laboratories. ;EU, BfR or FDA evidence should be positioned as supplementary evidence and cannot be expressed as a New Zealand statutory positive list.	Use the ANZ Code as a baseline to confirm its applicability to New Zealand import or sales scenarios. ; Summarizes material safety, migration, PFAS, heavy metals, odor/sensory and customer specification evidence. ; Compostable, recyclable and repulpable claims should be verified separately from food contact compliance. ;Confirm whether the New Zealand importer requires local laboratory testing or third-party legal review.

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Compliance roadmap for key markets

Compliance roadmap for key markets

Quick overview of key market frameworks