You found a cheaper Chinese factory for your kitchenware, food storage, bakeware, or tableware line. The sample looks great and the price beats your current supplier by 30%. But if the materials that touch food are not compliant, a smooth sample can become a detained shipment at CBP, a European Rapid Alert (RAPEX) notification, or a brand-destroying recall. Food contact material (FCM) compliance is the single biggest hidden risk in this category, yet it is also one of the easiest to control if you ask the right questions before the PO.
This guide walks US and EU buyers through the three regulatory frameworks that matter most—FDA, the EU Plastic Regulation, and Germany’s LFGB—the migration tests suppliers must run, the materials that cause the most problems, and the documents you should demand before production starts.
1. The Three Regulatory Frameworks You Must Understand
United States — FDA 21 CFR Parts 174–199. In the US, food contact substances are regulated as indirect food additives under Title 21 of the Code of Federal Regulations. Subparts cover general provisions (Part 174), resins and polymers (Part 177), and paper/coatings (Part 176). For a substance not already listed, manufacturers rely on a Food Contact Notification (FCN) approved by the FDA, or a Threshold of Regulation exemption. As an importer you are not expected to read the CFR yourself, but you should ask your supplier whether the specific grade of stainless steel, silicone, PP, or coating they use has an FCN or a relevant CFR listing.
European Union — Regulation (EU) No 10/2011. This is the flagship EU rule for plastic materials and articles intended to come into contact with food. It defines a positive list of authorized monomers and additives, and sets two hard limits: the Overall Migration Limit (OML) of 10 mg of constituents per dm² of contact surface (equivalent to 60 mg/kg food for an empty vessel test), and Specific Migration Limits (SML) for individual substances such as primary aromatic amines, phthalates, and bisphenol A. It also mandates a written Declaration of Compliance (DoC) and traceability down the supply chain.
Germany — LFGB (Lebensmittel- und Futtermittelgesetzbuch). Section 30 and Section 31 of the German Food and Feed Code cover consumer goods, including food contact articles. In practice LFGB incorporates the EU framework but adds stricter BfR (German Federal Institute for Risk Assessment) recommendations, especially for silicone, stainless steel, and metal coatings. Many EU retailers—especially German supermarkets—require an LFGB test report even when the product already carries an EU 10/2011 report.
2. Migration Testing: What Actually Happens in the Lab
Migration testing simulates what leaches out of the material into real food. Labs use standardized simulants instead of actual food:
- 10% ethanol (simulates aqueous, acidic foods)
- 3% acetic acid (simulates acidic foods, e.g. dressings)
- 20% or 50% ethanol (simulates alcoholic or fatty foods)
- Olive oil or an alternative fat simulant such as isooctane/95% ethanol (for high-fat contact)
The material is exposed to the simulant under defined time-and-temperature conditions (for example 10 days at 40°C, or 2 hours at boiling point for bakeware), then the lab measures total migration and screens for restricted substances. For metal items such as stainless steel cookware, the key screens are heavy-element migration (lead, cadmium, chromium, nickel) into acid simulants—this is the LFGB §30/§31 “overall migration” test that most often fails cheap 201-grade stainless steel.
3. Materials That Cause the Most Problems
- Stainless steel. 304 (18/8) and 316 (18/10) are food-safe grades. Budget factories often use 201 grade, which has higher manganese and nickel leaching and routinely fails nickel and chromium migration. Always specify grade on your spec sheet.
- Silicone. Food-grade silicone must meet FDA 21 CFR 177.2600 and EU 10/2011 plus BfR Recommendation XV. Look for peroxide-cured, not condensation-cured, silicone; the latter can leave residual byproducts and smell.
- Polypropylene (PP). PP is generally safe (FDA 21 CFR 177.1520), but recycled PP, color masterbatches, and slip additives are common sources of SML failures. Ask for a food-grade virgin resin certificate.
- Internal coatings (non-stick, epoxy, PTFE). Bisphenol A (BPA) is restricted in the EU; primary aromatic amines (PAA) from polyamide coatings are a notorious RAPEX trigger. Require a specific PAA screen.
4. Documents You Must Demand Before Production
A reputable FCM manufacturer in China should be able to hand you a complete compliance pack within a week:
- Declaration of Compliance (DoC)—named to your buyer entity, listing the material, the food types it contacts, the test standard, and the lab reference number.
- Third-party test report from an ISO/IEC 17025-accredited lab such as SGS, Intertek, Bureau Veritas, or TÜV. Reports must be dated within the last 2–3 years and match the actual resin grade and color.
- FCN number or CFR reference (US) / EU positive-list reference (EU).
- Material safety and resin data sheet confirming virgin food-grade polymer.
Do not accept “we have a report for a similar product.” Migration is formula- and color-specific; a report for a white cup does not cover your red cup. Budget roughly USD 400–1,200 per material/food-contact scenario for a fresh third-party test—cheap compared with a customs detainment.
5. A Practical Pre-Production Checklist
- Specify material grade (e.g. “SUS304, 18/8”) on the PO, not just “stainless steel”.
- Declare intended food contact types (acidic, fatty, alcoholic, hot/cold) so the lab chooses the right simulants.
- Require the DoC and test report before mass production, and re-test whenever resin supplier, color, or factory changes.
- Run a pre-shipment inspection that includes visual food-contact-surface checks and a spot sample for re-test if the order is large.