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Food-Contact Plastics for Injection Moulding: EU 10/2011 & FDA Explained

"Food grade" is not a property of a plastic — it is a legal status of a specific grade, in a specific market, under specific use conditions. A part moulded from the wrong batch of colourant can be non-compliant even in a compliant resin. This guide covers the two frameworks buyers meet, what they require, and how to keep a food-contact project documented end to end.

What do the EU and US frameworks require?

Framework Scope Key mechanism
Regulation (EU) No 10/2011 Plastics contacting food in the EU Union list of authorised substances; overall migration limit 10 mg/dm²; specific migration limits per substance; Declaration of Compliance (DoC) mandatory
2024/3190 Covered food-contact materials, including plastics BPA prohibition; specified exemptions and transitions; current supplier documentation
Framework Regulation (EC) 1935/2004 All food-contact materials, EU General safety: no transfer that endangers health or changes food unacceptably
FDA 21 CFR (US) Food-contact substances in the US Compliance via listed regulations per polymer (e.g. 21 CFR 177.xxxx) or Food Contact Notification
GMP Regulation (EC) 2023/2006 Manufacturing, EU Food-contact articles must be produced under good manufacturing practice

2024/3190: Regulation (EU) 2024/3190 prohibits BPA use in covered food-contact materials and the placing on the Union market of articles manufactured using BPA, subject to specified exemptions and transitional provisions. The ordinary deadline for first placement of previously compliant BPA-made final articles was 20 July 2026; some specified uses, including professional food production equipment, have longer transitions. Check the current consolidated rules, exact application and supplier declarations before choosing BPA-based PC. An older EU 10/2011 declaration alone is insufficient.

The buyer-side translation: for EU sale you need a DoC for the exact grade; for US sale, an FDA compliance statement; and for both, the use conditions (food type, temperature, contact time) must sit inside the tested envelope.

Which resins work for food contact?

PP is the dominant food-contact resin — containers, closures, kitchenware — with broad compliant grade availability and hot-fill capability in suitable grades. HDPE and LDPE serve caps, bottles and flexible items. PET covers clear rigid containers. Copolyesters (Tritan-type) replaced polycarbonate in much reusable clear tableware following BPA restrictions. Assess BPA-based PC against the current EU bisphenol rules and the intended market and use. TPE and LSR grades cover seals, valves and teats — LSR is the standard for infant-contact articles in compliant compounds.

Two traps: "the resin is FDA-approved" is never sufficient — the complete formulated grade including colourant must be covered; and compliance is condition-bound, so a grade fine for dry goods may fail for fatty food at 70 °C. State your actual use conditions in the RFQ.

What do colourants, regrind and processing change?

Colourants are regulated substances too: a compliant base resin plus a non-compliant masterbatch makes a non-compliant part. Specify compliant colour from the start. Regrind use requires application-specific approval, permitted sources, traceability and evidence that the final article meets the applicable food-contact rules. Processing matters as well: mould-release agents, lubricants and machine-side contamination must all be food-appropriate, which is why food-contact production runs under GMP discipline.

Regrind and recycled-content guidance.

What should the documentation package look like?

For a typical food-contact part, expect: the material grade's Declaration of Compliance (or FDA statement) with migration data matching your conditions, colourant compliance confirmation, GMP confirmation from the moulder, and traceability of material lots to production batches. Nordmould sources documented food-contact grades and structures the paperwork with the quote — flag the application in your RFQ so compliant grades are proposed from day one.

Frequently asked questions

What makes a plastic 'food grade' for injection moulding?

A food-grade plastic is a specific grade whose formulation — base resin, additives, colourants — complies with food-contact regulation in its market: Regulation (EU) No 10/2011 in the EU, FDA 21 CFR in the US. Compliance is grade-specific and documented with a Declaration of Compliance, not a property of the polymer family.

What is EU Regulation 10/2011?

The EU's plastics food-contact measure: it lists authorised substances (the Union list), sets overall and specific migration limits, and defines the testing and Declaration of Compliance each material or article needs before it can legally touch food in the EU market.

What is migration testing for food-contact plastics?

Migration testing measures how much substance moves from the plastic into food simulants under defined time and temperature. The overall migration limit is 10 mg/dm²; specific limits apply to individual substances. Ratings depend on use conditions — a grade compliant for cold drinks may fail for hot-fill or fatty food.

Which injection-moulding resins are commonly food-contact compliant?

Food-contact grades exist in several resin families, including PP, PE, PET, POM, TPE and LSR. Nordmould needs the exact grade and intended use. For EU sale, BPA-based PC also requires assessment under Regulation (EU) 2024/3190; an older compliance statement does not establish current suitability.

Do colourants and regrind affect food compliance?

Yes, both. Colourants must be food-contact compliant themselves — the base resin's compliance does not extend to the masterbatch. Regrind use requires application-specific approval, permitted sources, traceability and evidence that the final article meets the applicable food-contact rules.

What documentation should a buyer demand for food-contact parts?

A Declaration of Compliance for the exact material grade (EU 10/2011) or FDA 21 CFR compliance statement for US sale, plus supporting migration data for your use conditions, and confirmation that colourants and any secondary materials are compliant. Nordmould sources documented food-contact grades through its partner network.

Last reviewed: 2026-08

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