Quick Answer
Every country that allows food-contact cling film requires some form of compliance documentation. The two dominant frameworks are FDA (USA) and EU Regulation No 10/2011. Most other countries reference one or both. SUNWRAP provides FDA declarations, EU Declarations of Conformity, and SGS migration test reports as standard with every shipment — plus market-specific documents on request.
Regulatory Framework by Market
| Market | Regulation | Key Requirement | SUNWRAP Provides |
|---|---|---|---|
| USA | FDA 21 CFR 177.1975 (PVC) FDA 21 CFR 177.1520 (PE) | Material must be listed as food-contact safe; overall migration within limits | Declaration of Compliance + SGS report |
| EU / EEA | Regulation (EU) No 10/2011 | Overall migration ≤10 mg/dm²; specific migration limits for each substance; DEHP prohibited | Declaration of Conformity + SGS specific migration report |
| UK | Retained EU Regulation 10/2011 | Same as EU (post-Brexit retained) | Same EU DoC accepted |
| Saudi Arabia | SABER + SFDA | Product conformity certificate via SABER platform; SFDA food-contact approval | Test reports for SABER application |
| UAE | ESMA / GSO standards | GSO 839 (plastic food contact); often accepts FDA or EU compliance | FDA + EU docs cover GSO |
| Nigeria | SONCAP | Product certificate + shipment certificate (SC) for every container | Test reports for SONCAP application |
| India | BIS + FSSAI | BIS certification for plastics; FSSAI food-contact registration | Test reports for BIS application |
| Indonesia | SNI + BPOM | SNI standard compliance; BPOM food-contact registration | Test reports for SNI/BPOM application |
| Japan | Food Sanitation Act | Positive list system; migration testing required | Migration test report |
| Latin America | Mercosur / ANVISA (Brazil) / ANMAT (Argentina) | Varies by country; most reference FDA or EU frameworks | FDA + EU docs typically accepted |
The PVC Plasticiser Question
The single biggest compliance issue for PVC cling film is the type and amount of plasticiser used. Here is what you need to know:
| Plasticiser | Status | EU Migration Limit | SUNWRAP Usage |
|---|---|---|---|
| DEHP (di-2-ethylhexyl phthalate) | PROHIBITED for food contact (EU, FDA) | Banned | Never used |
| DEHA (di-2-ethylhexyl adipate) | Approved food-contact plasticiser | 18 mg/kg | Primary plasticiser |
| ATBC (acetyl tributyl citrate) | Approved food-contact plasticiser | 57 mg/kg | Alternative plasticiser |
Key point: "PVC cling film" is not inherently unsafe. PVC with DEHP is prohibited. PVC with DEHA or ATBC is legal and widely used. The safety issue is the plasticiser, not the polymer.
What Documents You Need (Checklist by Market)
Selling in the USA
- FDA Declaration of Compliance (DoC) from the manufacturer
- SGS or equivalent lab report showing compliance with 21 CFR 177.1975 (PVC) or 177.1520 (PE)
- No pre-import registration required — FDA operates on a self-certification basis
Selling in the EU
- Declaration of Conformity per EU Regulation No 10/2011
- SGS specific migration test report (DEHA or ATBC within limits)
- Overall migration test result (≤10 mg/dm²)
- Traceability documentation (batch number traceable to raw materials)
Selling in Saudi Arabia / GCC
- SABER product conformity certificate (applied through a Conformity Assessment Body)
- SFDA registration for food-contact materials
- Supporting test report from an accredited lab (SGS, Intertek, TUV)
- Arabic labelling on packaging
Selling in Nigeria
- SONCAP product certificate (PC) — applied before shipping
- Shipment certificate (SC) — required per container
- SGS test report as supporting evidence
- SON standard compliance (NIS 236 for plastics)
How SUNWRAP Supports Your Compliance
- Standard with every shipment: FDA Declaration of Compliance, EU Declaration of Conformity, SGS per-batch migration test report
- On request: SONCAP/SABER/BIS/BPOM supporting documentation — test reports formatted for your certification body's requirements
- Batch traceability: Every roll is traceable to raw material batch, production date, and QC test results
- Customs support: HS code guidance, Certificate of Origin (CCPIT, Form A, Form E, RCEP as applicable), commercial invoice in your required format