| Framework | Jurisdiction | Key Document | Enforcement Body |
|---|---|---|---|
| India — FSSAI regulations | India domestic market | Food Safety and Standards (Packaging) Regulations 2018 | FSSAI — state food authorities |
| India — BIS standards | India domestic market | IS 10146 (PE), IS 10142 (PP), IS 11998 (PET), IS 14182 (multilayer) | BIS |
| EU Regulation 10/2011 | European Union | EU Regulation 10/2011 on plastic food contact materials | EFSA, national competent authorities |
| US FDA 21 CFR | United States | 21 CFR 174–186 (indirect food additives) | FDA |
| Germany BfR recommendations | Germany, widely referenced globally | BfR Recommendations XXI (polypropylene) etc. | German Federal Institute for Risk Assessment |
The Food Safety and Standards (Packaging) Regulations 2018 govern food contact materials in India. Key requirements: plastic materials must use only BIS-approved resins and additives (positive list approach); migration testing may be required for materials not covered by BIS standards; packaging must not transfer harmful substances to food; recycled plastic may only be used with FSSAI/CPCB authorisation for the specific recycling process. BIS certification (ISI mark) is mandatory for packaging materials falling under the relevant IS standards. Under FSSAI’s evolving guidance, multinational food companies operating in India increasingly apply EU or FDA standards as a benchmark even where not strictly required by Indian law.
| Material | India (BIS/FSSAI) | EU Regulation 10/2011 | FDA 21 CFR |
|---|---|---|---|
| PET | IS 11998 | Listed — general use | 21 CFR 177.1630 |
| PP (all types) | IS 10142 | Listed — general use | 21 CFR 177.1520 |
| HDPE/LDPE/LLDPE | IS 10146 | Listed — general use | 21 CFR 177.1520 |
| PS (GPPS, HIPS) | IS 10141 | Listed — some restrictions | 21 CFR 177.1640 |
| PVC (unplasticised) | IS 12235 | Permitted — plasticiser-dependent | Plasticiser-specific |
| PC (BPA-based) | Limited guidance | RESTRICTED — not for infant food contact | Restricted for infant use |
| Nylon (PA6, PA66) | BIS referenced | Listed — specific use conditions | 21 CFR 177.1500 |
| PVDC | — | Listed | 21 CFR 177.1950 |
Migration testing quantifies the transfer of chemical substances from plastic to food or food simulants under standardised conditions. Two key limits apply: Overall Migration Limit (OML) — total transfer of all substances combined must not exceed 10 mg/dm² or 60 mg/kg food equivalent; Specific Migration Limit (SML) — individual substances have their own limits based on toxicological assessment (e.g., bisphenol A SML = 0.05 mg/kg food; most restricted pigments have SML = 0).
EU 10/2011 food simulants for testing: 10% ethanol (simulant A — aqueous and acidic below pH 4.5); 3% acetic acid (simulant B — acidic food below pH 4.5); 20% ethanol (simulant C — alcoholic beverages below 20% alcohol); 50% ethanol (simulant D1 — above 20% alcohol, oil and fat-containing); Isooctane or modified polyphenylene oxide (simulant D2 — fatty food); Tenax (simulant E — dry food).
Key substances restricted or banned in food contact plastics: Bisphenol A (BPA) — banned in baby bottles in EU, USA, Canada; restricted in food contact PC applications for sensitive end-uses; Phthalate plasticisers (DEHP, DBP, BBP) — restricted in all food contact PVC applications under EU and many national regulations; Certain azo pigments — those that cleave to release listed aromatic amines are prohibited in all food and skin contact applications; Lead and cadmium stabilisers — prohibited in food contact PVC across EU and progressively in India. See our colour masterbatch guide for food-safe pigment selection guidance.
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