Food Simulants for Migration Testing: EU and FDA Rules

Food simulants for migration testing are standardized liquids and solids that laboratories use in place of real food to measure what leaches out of packaging. The EU assigns six lettered simulants (A, B, C, D1, D2, and E) matched to food categories in Regulation 10/2011, while the FDA pairs numbered food types with 10% or 50% ethanol, food oil or a synthetic triglyceride like HB307 or Miglyol 812, and for coatings adds water, heptane, and 8% alcohol under 21 CFR 175.300. Which simulant applies depends on what the packaging will contact; the temperature and duration of the test depend on how the packaging will be used.

Why Labs Test With Simulants Rather Than Real Food

Real food is a poor laboratory medium. Milk carries fats, proteins, and sugars that mask trace chemicals leaching from a plastic liner. Tomato sauce corrodes differently than water. A lasagna sits in its tray at shifting temperatures for months. None of that variability helps when the point is to measure how much of substance X moved from packaging into food.

Simulants give a chemically stable, reproducible environment. A 10% ethanol solution behaves the same in Berlin as it does in Chicago, and it does not interfere with the mass spectrometers that detect migrants at parts-per-billion concentrations. Each simulant is chosen to be at least as aggressive as the worst-case food in its category, so packaging that passes with the simulant will pass with the real product.

EU Simulants A Through E

Regulation (EU) No 10/2011 lists six standard simulants, each targeting a different extraction mechanism.

Simulant A, 10% ethanol, represents aqueous hydrophilic foods such as soups, syrups, and non-acidic beverages.
Simulant B, 3% acetic acid, covers foods with a pH below 4.5, including fruit juices, vinegar, and tomato sauce.
Simulant C, 20% ethanol, is assigned to alcoholic beverages up to 20% ABV such as wine and beer, and to foods with organic ingredients that make them slightly lipophilic.
Simulant D1, 50% ethanol, applies to alcoholic beverages above 20% ABV, cream liqueurs, and oil-in-water emulsions.
Simulant D2 is vegetable oil with less than 1% unsaponifiable matter, used for foods with free fats at the surface: butter, cooking oils, fried items.
Simulant E is Tenax, a porous synthetic polymer (poly(2,6-diphenyl-p-phenylene oxide)), used for dry foods like bread, pasta, and cereal. It adsorbs volatile migrants from the packaging surface rather than dissolving them.

Annex III of the regulation matches these simulants to specific food categories. Milk is assigned simulant A; cheese gets both A and D2; alcoholic beverages between 6% and 20% use simulant C, while spirits above 20% shift to D1.¹ The match matters in both directions. A simulant that is too mild understates risk; one that is too harsh imposes an unrealistically punishing test.²

EU Test Conditions OM1 Through OM7

Choosing a simulant is half the job. The lab also has to reproduce the thermal and time stress the packaging will face, from a hot-fill step to months of ambient storage. Regulation 10/2011 defines seven standardized protocols:

OM1: 10 days at 20°C, for frozen and refrigerated storage.
OM2: 10 days at 40°C, for long-term room temperature storage, including short heating up to 70°C for two hours or 100°C for 15 minutes.
OM3: 2 hours at 70°C, for short heating without subsequent long-term storage.
OM4: 1 hour at 100°C, for high-temperature applications up to 100°C.
OM5: 2 hours at 100°C or 1 hour at 121°C, for sterilization-grade heat such as retort pouches.
OM6: 4 hours at 100°C, for extended high-temperature contact with aqueous, acidic, or alcoholic simulants.
OM7: 2 hours at 175°C, for extreme heat applications with fatty foods, exceeding OM5.

The lab selects the OM level matching the worst-case thermal exposure the packaging will endure. A microwavable tray might test at OM5. A candy wrapper sitting at room temperature for a year tests at OM2.³

EU Migration Limits

Two limits apply in parallel. The overall migration limit (OML) caps the total mass of all substances migrating from a plastic material at 10 mg per square decimeter of packaging surface, or equivalently 60 mg per kilogram of food. This measures the material’s general inertness. A material leaching 11 mg/dm² of otherwise harmless substances still fails.⁴

Layered on top are specific migration limits (SMLs) for individual substances, set based on toxicological assessments by the European Food Safety Authority. These apply to listed monomers, additives, and other starting substances. A material can pass the OML and still fail because a single regulated chemical exceeds its SML, and more hazardous substances carry lower limits, sometimes down to non-detectable levels.

FDA Simulants by Food Type

The FDA takes a different route. Under 21 CFR 176.170 it classifies foods into nine numbered types (Type I through Type IX) and assigns simulants by chemical character.⁵ The recommended simulants are:

10% ethanol for aqueous and acidic foods (Types I, II, IVB, VIB, and VIIB). Where food acidity is expected to drive higher migration than ethanol alone, labs substitute separate extractions in water and 3% acetic acid.
10% or 50% ethanol for alcoholic beverages, with the concentration adjusted to match the product’s actual alcohol content.
Food oil, HB307, or Miglyol 812 for fatty foods (Types III, IVA, V, VIIA, and IX). HB307 is a synthetic triglyceride blend; Miglyol 812 is derived from coconut oil. When analyzing a migrant directly in oil is impractical, the FDA provides a polymer-specific list of alternative solvents.

For resinous and polymeric coatings, 21 CFR 175.300 adds water, heptane, and 8% alcohol as extraction solvents, each paired with specific times and temperatures depending on how the packaging will be used.⁶ The FDA’s system is less uniform than the EU’s: different regulations govern different material types, so the simulant can depend on whether the item is a plastic film, a paper liner, or a can coating.⁷

FDA Conditions of Use

The FDA’s time-and-temperature framework uses letters (Conditions A through H) tied to how food is processed and stored. Condition A covers high-temperature heat sterilization above 212°F, with water extraction at 250°F for two hours. Condition E covers room-temperature fill and storage, tested at 120°F for 24 hours. Condition H addresses frozen foods reheated in the container before serving. Each condition specifies different extraction solvents and exposure times depending on the food type.⁶

One correction is easy to miss. Heptane extraction results for fatty foods must be divided by a factor of five before comparison to limits, because heptane is more aggressive than real food oil. Applying this correction in the wrong direction turns a passing result into a failure.

FDA Limits and the Threshold of Regulation

The FDA does not set one universal overall migration limit. Acceptable extractable levels vary by regulation and material type. For resinous coatings under 21 CFR 175.300, the regulation itself lists maximum extractive levels for each solvent-and-condition combination.⁶ For newer substances cleared through the Food Contact Notification (FCN) process, the FDA evaluates safety through the Cumulative Estimated Daily Intake (CEDI), combining migration data with consumption factors reflecting how much of the diet contacts that packaging type. The higher the estimated daily intake, the more toxicological data the FDA requires.⁷

Very low migration can sidestep food additive review entirely. Under 21 CFR 170.39, a food-contact substance is exempt from regulation as a food additive when its use produces dietary concentrations at or below 0.5 parts per billion, corresponding to no more than 1.5 micrograms per person per day based on a diet of 1,500 grams of solid food and 1,500 grams of liquid food daily.⁸⁹

What Manufacturers Need to Give the Lab Before Testing

Before a lab can pick a simulant or set a temperature, it needs specifics from the manufacturer. The important inputs are the full chemical composition of the food contact material (including additives, catalysts, and processing aids), the food types the packaging will contact, the maximum and minimum temperatures during processing, shipping, and consumer use, and the intended duration of food contact. A retortable pouch aimed at two years of shelf life faces a very different protocol than a single-use paper coffee cup.

This information is compiled into a testing request or technical data sheet. Most delays start here. If the manufacturer understates expected temperature or omits a food category, the lab runs the wrong test, and the results are useless when the regulator reviews the file. Labs cannot guess on the manufacturer’s behalf.

How the Test Is Run

Once the simulant, temperature, and duration are set, the physical test is straightforward. Packaging that contacts food on all sides is fully immersed in a controlled bath of liquid simulant. For materials that contact food on only one surface, such as a tray lid or pouch interior, the lab uses a migration cell that exposes just the food-contact side while sealing the exterior. The container can also be filled directly.

After the prescribed contact period, the simulant is collected. For overall migration, it is evaporated under controlled heat and the residual mass is weighed on precision balances; that weight is everything that moved from the packaging into the simulant. For specific migration, the analysis shifts to chromatography paired with mass spectrometry: GC-MS for volatile and semi-volatile organics, LC-MS for non-volatile or thermally sensitive compounds, and ICP-MS for metals such as lead, cadmium, or chromium from inks or pigments. The instruments quantify how much of each substance migrated, which the lab then compares against the applicable OML, SML, or FDA extractive limit. A detection at 0.003 mg/kg means one thing when the limit is 0.01 mg/kg and something else entirely when it is 60 mg/kg.

1
Legislation.gov.uk. Commission Regulation (EU) No 10/2011 – Annex III
2
Legislation.gov.uk. Commission Regulation (EU) No 10/2011 – Annexes
3
legislation.gov.uk. Commission Regulation (EU) No 10/2011 – Annex V Chapter 3
4
European Commission. Legislation – Food Safety – Food Contact Materials
5
eCFR. 21 CFR 176.170 – Components of Paper and Paperboard in Contact With Aqueous and Fatty Foods
6
eCFR. 21 CFR 175.300 – Resinous and Polymeric Coatings
7
U.S. Food and Drug Administration. Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances (Chemistry Recommendations)
8
eCFR. 21 CFR 170.39 – Threshold of Regulation for Substances Used in Food-Contact Articles
9
U.S. Food and Drug Administration. Threshold of Regulation Exemptions for Substances Used in Food-Contact Articles