Food-contact migration testing measures how much of a packaging material transfers into the food (or a stand-in “food simulant”) under defined time and temperature conditions, then checks that figure against a legal limit. The two regimes a buyer importing into Egypt meets most often are the EU’s Regulation (EU) No 10/2011 — which sets an overall migration limit of 10 mg/dm² plus substance-specific limits, tested in defined simulants — and the US FDA 21 CFR food-additive regulations, which for the common resins cap solvent-extractable fractions. This guide explains both methods, what evidence to demand, and how the two differ in practice.
The short answer: what migration testing proves
Migration testing answers one question a Declaration of Compliance asserts: does this material, used this way, stay within the legal migration limits? Two flavours of migration matter:
- Overall migration — the total mass of all non-volatile substances that move from the plastic into food. The EU caps this at 10 mg/dm² (equivalently 60 mg/kg of food) under EU 10/2011. It is a hygiene/inertness limit, not a toxicity limit.
- Specific migration — the amount of a named substance (a particular monomer, additive or contaminant) that migrates. The EU sets Specific Migration Limits (SMLs) per substance, derived by EFSA from toxicity data.
The US system reaches the same goal differently: instead of a single overall-migration number, FDA’s resin regulations (for olefins, 21 CFR 177.1520) cap solvent-extractable fractions as end-test specifications, and clear new substances through migration-based Food Contact Notifications (FCNs). Both regimes share the same logic: pick conditions and a simulant that represent the real use, then measure against a limit.
Why migration, not just composition
A food-contact material can be made entirely from listed, compliant substances and still fail in use, because what reaches the food depends on the food type, the contact temperature, the contact time and the surface-to-volume ratio — not just the recipe. That is the gap migration testing closes. It also reinforces the trade distinction this cluster keeps intact: food-grade is not food-safe. A resin offered as food-grade to a specification still has to be shown, as a finished article used a particular way, to meet the migration limits — which is what makes it food-safe for that use. (See Food-grade vs food-safe resins.)
The EU system: Regulation (EU) No 10/2011
Where it sits in the legal stack
EU 10/2011 is the specific measure for plastics. Above it sit two horizontal rules every food-contact material must also meet:
- Regulation (EC) No 1935/2004 — the framework regulation. Materials must not transfer constituents to food in quantities that endanger health, change the food’s composition unacceptably, or deteriorate its taste or smell (ChemLinked).
- Regulation (EC) No 2023/2006 — Good Manufacturing Practice (GMP), mandatory across every production and marketing stage of the material (EUR-Lex).
EU 10/2011 then adds the Union list of authorised substances, the migration limits, and the test rules in its annexes.
The two migration limits
| Limit | Value | What it covers |
|---|---|---|
| Overall Migration Limit (OML) | 10 mg/dm² of contact surface (≈ 60 mg/kg food) | Sum of all non-volatile migrants — material inertness |
| OML, infant/young-child articles | 60 mg/kg food simulant | Articles for food for infants and young children |
| Specific Migration Limit (SML) | per substance, in mg/kg food | Individual listed monomers/additives, set by EFSA |
| Functional-barrier non-detection | 0.01 mg/kg | Substances behind a functional barrier must be non-detectable to this LOD |
Sources: OML and SML from getEnviroPass and Pack-Lab; infant OML expressed as 60 mg/kg simulant and the 0.01 mg/kg functional-barrier non-detection limit are set in the Regulation’s articles (EUR-Lex 10/2011).
The OML and SML are independent: a material must pass both. Overall migration testing is performed to the EN 1186 series of methods (Measurlabs).
Food simulants — Annex III
You do not test in real food; you test in standardised liquids (and one solid) that stand in for food categories, defined in Annex III:
| Simulant | Composition | Represents |
|---|---|---|
| A | 10% ethanol (v/v) | Hydrophilic / aqueous foods |
| B | 3% acetic acid (w/v) | Hydrophilic foods, pH below 4.5 (acidic) |
| C | 20% ethanol (v/v) | Hydrophilic foods and alcoholic up to ~20% |
| D1 | 50% ethanol (v/v) | Alcoholic above 20%, oil-in-water emulsions, dairy |
| D2 | Vegetable oil (<1% unsaponifiable matter) | Fatty foods / free fat at the surface |
| E | Poly(2,6-diphenyl-p-phenylene oxide), i.e. Tenax® | Dry foods |
Source: Annex III, Regulation (EU) No 10/2011 as summarised by EU testing labs; compositions confirmed against the consolidated text (EUR-Lex). For food category 01.04, simulant D2 is replaced by 95% ethanol.
You choose the simulant(s) that match the foods the article will actually contact. A multi-purpose container may have to pass against several.
Test conditions — the OM time/temperature matrix
Annex V sets standardised overall-migration (“OM”) conditions, each representing a real contact scenario; you pick the one that matches (or is the worst case for) the intended use (Innoform):
| Condition | Time / temperature | Represents |
|---|---|---|
| OM0 | 30 min at 40 °C | Short, low/room-temperature contact |
| OM1 | 10 days at 20 °C | Frozen/refrigerated, long contact |
| OM2 | 10 days at 40 °C | Long-term storage at room temperature (the common default) |
| OM3 | 2 h at 70 °C | Hot-fill / short heating |
| OM4 | 1 h at 100 °C (or reflux if 100 °C is difficult) | Higher-temperature applications |
| OM5 | 2 h at 100 °C / reflux, or 1 h at 121 °C | Sterilisation-type contact |
| OM6 | 4 h at 100 °C / reflux | Worst case for hot fill / long high-temp contact |
| OM7 | 2 h at 175 °C | Worst case for high-temperature fatty contact |
Source: Innoform Testservice, cross-checked to the Regulation’s Annex V. A key practical point: the harsher conditions cover the milder ones — for example, OM2 (10 days at 40 °C) is established as the testing condition for indeterminate room-temperature contact and covers OM0, OM1 and OM3 (Innoform). So a result at the right worst-case condition can demonstrate compliance for a range of gentler uses.
The Declaration of Compliance (DoC)
EU 10/2011 requires a written Declaration of Compliance to accompany plastic food-contact materials at every stage except retail. It states the regulation met, the identity of the material, any use restrictions (which simulants/foods, which conditions, temperature and time limits), and is backed by supporting documentation (migration test data, the substances used and any SML-restricted ones) held available for the authorities. The DoC is the document your purchase order should require; the supporting migration data is what you ask for when a claim is load-bearing.
The US system: FDA 21 CFR
How FDA frames it
US food-contact materials are regulated as indirect food additives under 21 CFR Parts 174–186 (plus the FCN program). Rather than one overall-migration number, FDA clears each material/substance and sets end-test extraction limits that act as quality-control checks of equivalence to the material the clearance was based on.
The correct language throughout is “compliant with / meets the requirements of 21 CFR [section]” — never “FDA-approved resin.” FDA approves neither resins nor finished packaging in the way the phrase implies; it issues regulations a compliant material meets, and accepts FCNs that become effective for a specified use.
Olefin polymers — 21 CFR 177.1520
PP, HDPE and LDPE are cleared under 21 CFR 177.1520, “Olefin polymers.” Compliance is shown against identity (density, melt point) plus caps on the fraction extractable by solvents that represent fatty (n-hexane) and aqueous/soluble (xylene) contact:
| Resin (177.1520 item) | Density (g/cm³) | Max n-hexane extractable | Max xylene soluble |
|---|---|---|---|
| Polypropylene (item 1.1) | 0.880–0.913 | 6.4% at reflux | 9.8% at 25 °C |
| Polyethylene, general food contact (item 2.1) | 0.85–1.00 | 5.5% at 50 °C | 11.3% at 25 °C |
| Polyethylene, packing/holding during cooking (item 2.2) | 0.85–1.00 | 2.6% at 50 °C | 11.3% at 25 °C |
| Poly(methylpentene) (item 4) | 0.82–0.85 | 6.6% at reflux | 7.5% at 25 °C |
Source: 21 CFR 177.1520, eCFR. The n-hexane and xylene methods are defined in the regulation: a 2-hour reflux extraction in n-hexane for PP, and dissolution/precipitation in xylene to measure the soluble fraction (eCFR). Note the tighter cooking-duty limit (2.6% vs 5.5% n-hexane), reflecting hotter, fattier contact.
Conditions of Use and food types
FDA expresses temperature/use restrictions through the Conditions of Use in 21 CFR 176.170(c), Table 2:
| Condition | Use |
|---|---|
| A | High-temperature heat-sterilised (e.g. >212 °F / 100 °C) |
| B | Boiling-water sterilised |
| C | Hot-filled or pasteurised above 150 °F |
| D | Hot-filled or pasteurised below 150 °F |
| E | Room-temperature filled and stored |
| F | Refrigerated storage |
| G | Frozen storage |
| H | Frozen/refrigerated, to be reheated in container |
Source: FDA: Food Types & Conditions of Use and 21 CFR 176.170(c). FDA later added Conditions I (irradiation) and J (cooking above 250 °F) via guidance. A grade is cleared for specific Conditions of Use and food types; match them to how your food is filled and stored.
Food Contact Notifications (FCNs)
For substances not covered by an existing regulation, suppliers use the FCN route: a premarket notification with migration and toxicology data for a specified use that becomes effective for that notifier. An FCN is specific to the notifier, the substance and the intended use and its limitations — so “covered by FCN 1234” is only meaningful for that exact use. FDA’s published 177-series extraction tests are equivalence/QC checks, not the migration study behind an FCN (Steptoe, FDA FCN inventory).
Worked logic: choosing the test from the use
The conditions and simulants are only useful if you can pick the right ones. Three common cases show how the choice falls out:
- Ambient bottled water, PET or HDPE, 12-month shelf life. Food is aqueous and stored at room temperature for a long, indeterminate period — so simulant A (10% ethanol), condition OM2 (10 days at 40 °C), tested against the 10 mg/dm² OML. OM2 is the established stand-in for indeterminate room-temperature contact.
- Hot-filled tomato sauce, PP tub. Food is acidic and fatty, filled hot — so simulant B (3% acetic acid) and the fatty simulant D2 (vegetable oil), at a hot condition such as OM3 (2 h at 70 °C) or higher to cover the fill, plus OM2 for the storage life. The fatty simulant is the demanding one here.
- Retort meal tray, PP, sterilised in-pack. Sterilisation contact points to OM5 (e.g. 1 h at 121 °C) or the relevant worst-case condition, against the simulant(s) matching the food.
The principle: identify the harshest realistic combination of food type and time/temperature, pick the simulant and OM condition that represent it, and a pass there demonstrates compliance for the gentler uses it covers.
Recycled content and the extra layer of scrutiny
Recycled food-contact plastic carries an additional compliance burden because the input stream may have picked up contaminants. In the EU, recycled plastic for food contact is governed by Regulation (EU) 2022/1616, which requires authorised recycling processes; in the US, recyclers obtain FDA’s view through the Letter of No Objection (LNO) process for a specific recycling technology and input. For a buyer specifying rPET or recycled HDPE/PP, the migration question is sharper — ask for the authorised process or LNO reference and the migration data, not just a “recycled, food-grade” label. (We cover the rPET case in PET vs rPET for food packaging.)
EU vs FDA: the same goal, different mechanics
| Dimension | EU 10/2011 | US FDA 21 CFR |
|---|---|---|
| Core test | Migration into food simulants | Solvent-extractable fraction (end-test) + FCN migration data |
| Headline limit | OML 10 mg/dm² (60 mg/kg) + per-substance SMLs | Per-resin extractable caps; no single OML |
| Fatty-food stand-in | Simulant D2 (vegetable oil) / 95% ethanol | n-hexane extraction |
| Aqueous/acidic stand-in | Simulants A, B, C (ethanol/acetic acid) | Xylene-soluble fraction; water/aqueous food types |
| Conditions | OM0–OM7 time/temperature matrix | Conditions of Use A–H (+I, J) |
| Document you request | Declaration of Compliance + migration data | Statement of compliance with the cited 21 CFR section + extractives data / FCN reference |
| Correct phrasing | “complies with EU 10/2011” | “meets the requirements of 21 CFR 177.1520” — not “FDA-approved” |
The practical upshot: a resin sold for both markets needs a DoC referencing EU 10/2011 and a statement of compliance with the relevant 21 CFR section, each backed by data. They are not substitutes for one another, and neither is satisfied by the phrase “food-grade” alone.
How Innovote sources this
Migration compliance is something we build into the sourcing brief, not bolt on at the end:
- We define the contact reality first. Food type (aqueous, acidic, alcoholic, fatty, dry), contact temperature and time (hot-fill? retort? ambient? frozen?), and surface-to-volume — because those choose the simulant and the OM condition (or the FDA Condition of Use) that the test must run at.
- We name the target regime(s). EU 10/2011, FDA 21 CFR, or both — and the specific section (e.g. 177.1520 for PP/HDPE/LDPE). The spec we send the supplier states the regulation, food type and use conditions explicitly.
- We collect the right evidence. A Declaration of Compliance (EU) and/or a statement of compliance with the cited 21 CFR section (US), plus the underlying migration or extractives data, the technical data sheet, and the lot COA. We relay these as supplier documentation — never as an Innovote “approval,” and never as a health claim.
- We verify when it’s load-bearing. Where the migration claim carries real risk (new supplier, fatty/hot duty, infant-food articles, recycled content), we arrange independent migration/extractives testing at an accredited lab against the right simulant and OM condition — folded into pre-shipment QC. (See Pre-shipment QC and inspection: AQL sampling, lab tests.)
- We keep the language clean. Everything is phrased as compliant with / meets the requirements of, with certificates and specs available on request — the standard a responsible supplier and a careful importer both hold.
Tell us the spec; we will come back with grade, MOQ, lead time and a landed-cost path — with the compliance evidence the food and the market actually require.
FAQ
What is the difference between overall migration and specific migration?
Overall migration is the total mass of all non-volatile substances that transfer from the plastic into food or simulant — the EU caps it at 10 mg/dm² (≈60 mg/kg). Specific migration is the amount of a single named substance (a particular monomer or additive) that migrates, capped by its own Specific Migration Limit (SML) in mg/kg, set by EFSA from toxicity data. A material must pass both the overall and the relevant specific limits.
Which food simulant should my packaging be tested in?
Match the simulant to the food the article will contact: 10% ethanol (A) for aqueous foods, 3% acetic acid (B) for acidic foods below pH 4.5, 20% ethanol (C) and 50% ethanol (D1) for alcoholic foods and emulsions/dairy, vegetable oil (D2) for fatty foods, and Tenax® (E) for dry foods (Annex III, EU 10/2011). Multi-use articles may have to pass against several. The simulant and the OM time/temperature condition together must represent the worst case of the intended use.
Is “FDA-approved resin” a correct claim?
No. FDA does not “approve” resins or finished packaging. It issues regulations (such as 21 CFR 177.1520 for olefin polymers) that a compliant material meets, and it accepts Food Contact Notifications that become effective for a specified use. The accurate phrasing is “compliant with / meets the requirements of 21 CFR 177.1520” — and we hold supporting extractives data and any FCN reference available on request.
Does food-grade mean a material passed migration testing?
No — and this is the distinction we keep intact. “Food-grade” means the resin is offered for food use to a specification; it does not, by itself, prove the finished article meets the migration limits for a specific food and use. Demonstrating compliance with the OML/SMLs (EU) or the extractive caps and Conditions of Use (FDA) — i.e. migration testing for the actual use — is what makes a part food-safe for that use. See Food-grade vs food-safe resins.
How are the EU and US migration tests different?
The EU measures migration into food simulants against an overall limit (10 mg/dm²) plus per-substance SMLs, using simulants A–E and OM0–OM7 conditions. The US, for the common resins, caps solvent-extractable fractions (n-hexane for fatty, xylene for soluble) as end-test QC checks and clears new substances through FCN migration data, with temperature limits set by Conditions of Use A–H. Same objective (food doesn’t pick up unsafe amounts of the material), different machinery — so a dual-market resin needs evidence for each regime.
What document should I require from a supplier?
For the EU, a Declaration of Compliance referencing Regulation (EU) No 10/2011 (with use restrictions, simulants, conditions) plus supporting migration data. For the US, a statement of compliance with the relevant 21 CFR section plus extractives data or an FCN reference. In both cases also request the technical data sheet and the lot COA. Write the purchase order as “must comply with / meet the requirements of [regulation]” and ask for certificates and specs — that is the verifiable standard.
Sourcing compliant packaging into Egypt
Bring us the food, the contact conditions and the target market(s), and we will spec the material, set the right migration/extractives evidence, and quote a landed-cost path. Tell us the spec; we will come back with grade, MOQ, lead time and a landed-cost path.
Related reading:
– Food-Grade Packaging Resins (PET, PP, HDPE, LDPE): Compliance, Grades & Supply — the pillar guide
– Food-grade vs food-safe resins: what the distinction means for your purchase order
– Pre-shipment QC and inspection: AQL sampling, lab tests and what to check at origin
By the Innovote Trade Desk. Capability statements are phrased as “compliant with / meets the requirements of”; certificates and specs available on request. Innovote does not issue regulatory approvals and makes no health claims.
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