Selecting Food Simulants and Contact Conditions under EU Regulation

Assignment

European Regulation (EU) No 10/2011 links specific food categories directly to six designated food simulants. Choosing the right simulant depends on the chemical nature of the food contact material as well as the foodstuff’s physical state, acidity, alcohol content, and fat distribution. Annex III mandates five liquid media and one solid sorbent matrix to model hydrophilic, lipophilic, acidic, and dry contact conditions.

Testing with the wrong simulant makes a Declaration of Compliance legally void and undermines the safety demonstration required by Framework Regulation (EC) No 1935/2004.

Hydrophilic foods with a pH above 4.5 are tested in Simulant A (10 percent ethanol by volume in water). Acidic foods below pH 4.5 call for Simulant B, a 3 percent acetic acid solution by weight. For alcoholic beverages up to 20 percent ethanol or foods with notable lipophilic components, Simulant C uses 20 percent ethanol by volume.

Oil-in-water emulsions, dairy products, and alcoholic liquids above 20 percent alcohol require Simulant D1, formulated as 50 percent ethanol by volume. Fatty foods with surface free fat take Simulant D2, which consists of vegetable oil ~ typically refined olive, sunflower, or corn oil. Finally, dry foods without surface fat use Simulant E, poly(2,6-diphenyl-p-phenylene oxide), known commercially as Tenax.

Selecting simulants for general-contact or multi-food articles follows the worst-case rules set out in Annex III. Universal items ~ like multi-use kitchen utensils or generic storage containers ~ are tested in Simulants B, C, and D2 to cover acidic, amphiphilic, and lipophilic extraction paths at once. If the item will touch dry matrices such as flour, sugar, or cereal grains, it also needs testing in Simulant E. Leaving out any required simulant narrows the legal scope of the final declaration, excluding unexamined food categories from coverage.

Special rules apply to specific food categories in Annex III, Table 2. Margarine, butter, and spreadable fats are tested in Simulant D2, though the rules allow applying a Fatty Food Reduction Factor based on the fat content. Dairy items like fresh cheese and yogurt call for Simulant D1 because of their emulsion characteristics, while hard cheeses with dry surfaces take Simulant D2 along with reduction factors.

For acidic sauces containing vegetable oil, processors must run tests in both Simulant B and Simulant D2 to check for acid-catalyzed hydrolysis and fatty extraction together.

• Hydrophilic Assignment Rules designate 10 percent ethanol for non-acidic aqueous products, establishing baseline mass transfer rates for water-soluble plastic constituents.
• Acidic Extraction Protocols use 3 percent acetic acid to isolate heavy metal leaching from pigments and stabilizers, specifically targeting organotin, zinc, and lead release.
• Amphiphilic Medium Selection applies 20 percent and 50 percent ethanol mixtures to measure mass transfer across films intended for spirits and dairy cream.
• Lipophilic Sorption Criteria mandate vegetable oil testing to capture low-polarity slip agents, phosphite antioxidants, and polyolefin oligomeric saturated hydrocarbons.

For articles contacting dry foodstuffs, thermal conditioning during Simulant E testing must account for the physical stability of the polymer substrate. Tenax functions as a sink for volatile and semi-volatile substances, catching migration from printing inks, adhesives, and recycled paperboard behind plastic barrier films. Laboratories extract the migrants from Tenax with solvent and analyze them using gas chromatography coupled with mass spectrometry.

Testing with Tenax instead of liquid simulants prevents sensitive polymers like polyethylene terephthalate from swelling while still capturing organic migrants.

A compliance dossier based on migration values in water rather than 10 percent ethanol will fail regulatory review during customs audits. EU rules set 10 percent ethanol as the baseline hydrophilic simulant, leaving pure water out of official protocols except for historical comparisons. Likewise, testing non-fatty dry foods in liquid simulants causes artificial polymer degradation and skewed results.

Matching the simulant precisely to the food matrix is essential for valid compliance documentation.

Testing across acidic, alcoholic, and fatty media provides a safety margin that keeps packaging suitable for distribution across all European food markets.

Swell

How a polymer matrix interacts with liquid media dictates how fast and how far additives migrate. When organic solvents penetrate polyolefins, styrenics, or polyesters, they increase the free volume between polymer chains, speeding up mass transfer far beyond normal storage rates. Vegetable oil (Simulant D2) is analytically awkward because of its high viscosity, low volatility, and tendency to interfere with gas chromatography.

Regulation (EU) No 10/2011 therefore permits substitute fatty simulants, provided they induce solvent absorption equal to or greater than vegetable oil.

Under Annex V, isooctane and 95 percent ethanol serve as the main substitute simulants for lipophilic migration testing. Isooctane rapidly penetrates non-polar polymers like low-density polyethylene and polypropylene, pulling non-polar migrants into solution over shorter exposure times. Meanwhile, 95 percent ethanol targets semi-polar matrices such as polyamides, polycarbonates, and polyesters, reaching into polar and aromatic structures that non-polar solvents cannot enter.

Choosing between them comes down to matching the solvent solubility parameter with the Hildebrand solubility index of the polymer.

How Are Alternative Solvents Calibrated for Polyolefins?

Laboratories establish extraction equivalency by measuring weight gain and volumetric swelling in polyolefin film samples exposed to candidate substitute solvents. For instance, polypropylene held in isooctane at 60 °C for 24 hours swells to the same extent as it would in vegetable oil at 40 °C for 10 days. Polyethylene absorbs non-polar solvents so quickly that exposure times must be tightly controlled to prevent the matrix from dissolving entirely.

If substitute testing shows migration above legal limits, regulatory rules give final authority to confirmatory testing done in vegetable oil.

Simulant D2 substitute testing using 95 percent ethanol at 60 °C for 4 hours models 10 days of olive oil exposure at 40 °C for high-density polyethylene films.

Fatty Food Reduction Factors allow laboratories to adjust measured migration values in Simulant D2 or its substitutes so they reflect realistic exposure. Article 11 and Annex III set reduction factors from 1 to 5 depending on how readily a food absorbs lipophilic compounds. Fresh meat with moderate surface fat carries a reduction factor of 2, so the lab divides the raw migration result by 2 before checking it against the Specific Migration Limit.

Chocolate gets a reduction factor of 5 because its saturated fat is bound in a cocoa butter matrix, making real-world absorption much lower than direct exposure to liquid oil.

These reduction factors must be applied carefully during screening. They cannot be used for overall migration limits, which remain capped at 10 milligrams per square decimeter regardless of the food type. Reduction factors are also prohibited if the migrant reaches saturation solubility in the simulant, or if the article is sold as general-purpose packaging for unspecified foods.

Misapplying reduction factors to overall migration failures is a common reason for market surveillance rejections across Europe.

Polymer swelling behavior dictates whether a lab can use substitute solvents or must rely on official referee testing. Styrenic polymers, such as high-impact polystyrene and acrylonitrile butadiene styrene, crack severely or dissolve outright in isooctane, generating false migration spikes. For styrenics, 95 percent ethanol offers a controlled extraction environment that leaves the test sample intact.

Conversely, polyethylene terephthalate resists both isooctane and ethanol, often requiring 50 percent ethanol or direct vegetable oil at higher temperatures to yield measurable migration.

When an alternative solvent causes sample degradation and leads to an invalid test failure, regulatory responsibility remains with the importer to prove compliance using non-destructive referee methods. If a substitute solvent destroys the packaging, testing has to revert to vegetable oil under standard times and temperatures. Labs that rely on substitute screening without verifying polymer compatibility risk issuing certificates that will not hold up under scrutiny.

Duration

Test times and temperatures must cover the worst-case conditions expected during manufacturing, storage, distribution, and final use. Annex V of Regulation (EU) No 10/2011 standardizes these into Overall Migration (OM) protocols, numbered OM1 through OM7. Choosing the wrong protocol invalidates the test report and leaves the manufacturer vulnerable to recalls if real-world exposure exceeds the tested limits.

Long-term storage at ambient or refrigerated temperatures requires condition OM2 (10 days at 40 °C). This protocol covers any duration under ambient or cold conditions, as well as hot-fill processes followed by extended storage at room temperature. Brief contact, such as kitchen utensils used at high temperatures, takes condition OM3 (2 hours at 70 °C).

Applications involving boiling, like retort pouches or cook-in bags, require OM4 (1 hour at 100 °C or 2 hours at 70 °C, depending on the thermal profile).

1. Determine the maximum expected temperature during processing, packaging, and home preparation.
2. Identify the intended shelf life, distinguishing short-term contact (under 30 minutes) from long-term storage (over 30 days).
3. Map these operating conditions to the matching OM protocol in Annex V, selecting the highest temperature condition if the packaging has multiple uses.
4. Run screening tests under accelerated conditions if the polymer degrades during standard extended testing.
5. Record the rationale for the selected test condition in the technical file supporting the Declaration of Compliance.

High-temperature uses in microwave or conventional ovens call for condition OM5, OM6, or OM7. Condition OM5 (2 hours at 100 °C or 1 hour at 121 °C) models high-temperature sterilization or hot-filling followed by long-term storage. Condition OM6 (4 hours at 60 °C) covers articles used at temperatures up to 60 °C, short of high-temperature baking.

Condition OM7 requires 2 hours at 175 °C in Simulant E or vegetable oil to simulate the extreme conditions seen in ovenware and microwave susceptors.

Under EN 1186-1 rules, testing carried out at 40 °C for 10 days covers all storage durations at room temperature or below, including freezing conditions.

Accelerated testing formulas replace long-term exposure with shorter tests at higher temperatures, provided the polymer does not melt or pass its glass transition point. Based on Arrhenius kinetics, diffusion rates roughly double for every 10 °C temperature rise. For example, testing a polyolefin film for 10 days at 60 °C simulates room-temperature storage over a year.

However, exceeding the glass transition temperature ~ 78 °C for amorphous polyethylene terephthalate or 100 °C for polystyrene ~ changes how molecules move through the polymer, invalidating the test legally.

Selecting test conditions below actual operating temperatures leaves manufacturers exposed to enforcement actions and recall liabilities. For instance, testing packaging for hot-fill juices processed at 85 °C under condition OM2 (40 °C) will trigger an audit failure. Test reports must clearly state the duration and temperature used so auditors can compare them directly against the product’s technical specifications.

Setting test parameters below actual processing conditions ensures rejection whenever regulatory authorities conduct confirmatory testing under real thermal stress.

Replication

Repeat-use items ~ including conveyor belts, food processing machinery, reusable bottles, and kitchen utensils ~ require specialized testing to evaluate long-term migration. Article 12 of Regulation (EU) No 10/2011 requires three consecutive test cycles on the same sample, using fresh simulant each time. Compliance hinges on the third exposure cycle, which cannot exceed the relevant Specific or Overall Migration Limit.

Evaluating repeat-use articles requires tracking results across all three cycles to spot material degradation. If migration rises between the first and third exposure, the article fails ~ even if the third result stays under the legal limit. An upward trend suggests matrix breakdown, surface erosion, or chemical attack from the simulant.

Conversely, flat or declining migration across cycles confirms that the material remains stable during repeated use.

• First Exposure Screening measures initial surface wash-off, capturing unbound additives, anti-static agents, and molding contaminants.
• Second Cycle Quantification tracks medium-term diffusion as internal additives move toward the surface layer.
• Third Exposure Verification establishes the legal compliance figure, reflecting steady-state migration into the simulant.
• Trend Line Analysis checks differences between cycles to confirm that chemical degradation does not accelerate over time.

Surface-to-volume ratios significantly alter migration calculations for repeat-use items and small containers. Regulation (EU) No 10/2011 assumes a default ratio of 6 square decimeters of plastic surface per kilogram of food (6 dm²/kg). For containers holding 500 milliliters to 10 liters, labs use the container’s actual surface-to-volume ratio.

Small containers under 500 milliliters, infant food packaging, and unformed sheet materials default to the 6 dm²/kg standard factor when evaluating specific migration results.

A packaging supply agreement specifying compliance under EN 1186 requires third-exposure migration results to fall below 10 milligrams per square decimeter with no upward trend across cycles.

Non-intentionally added substances (NIAS) pose significant compliance challenges in repeat-use articles exposed to heat or harsh chemicals. Degradation products, reaction side-products, raw material impurities, and recycled polymer contaminants can leach into simulants over extended use. Mass spectrometry screening (GC-MS and LC-MS) isolates unknown NIAS migrants, triggering safety evaluations for any unlisted substance found above the threshold of toxicological concern (0.01 milligrams per kilogram of food).

Suppliers of multi-use processing equipment must state surface area conversion factors and repeated exposure results clearly in their compliance files. Without the surface-to-volume ratio used in testing, food processors cannot accurately calculate migrant levels when scaling from small retail containers to large industrial vats.

Under standard EN 1186-1, Clause 4.3, repeat-use materials are compliant only if third-cycle migration remains within the limits of Regulation (EU) No 10/2011 and shows no upward trend across cycles.

Discharge

The Declaration of Compliance (DoC) is the central legal document confirming that a plastic food contact material complies with European regulations. Article 15 and Annex IV of Regulation (EU) No 10/2011 define what must appear in the DoC at every manufacturing stage, from resin synthesis to final conversion. Operating without a valid DoC or relying on incomplete test reports creates immediate non-compliance under EU law, leaving companies vulnerable to sanctions and product seizures.

A valid DoC must clearly identify the issuer, the manufacturer or importer, the specific materials or intermediate products, and the date of declaration. Crucially, it must state that the plastic materials, intermediates, or breakdown products satisfy Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011. Details on dual-use additives, restricted substances subject to SMLs, and conditions of use must be stated explicitly on the document.

Compliance documentation for food contact plastics must list all restricted substances with specific migration limits alongside dual-use additive designations under European food additive regulations.

Dual-use additives must be listed in the DoC so downstream processors can calculate total additive levels in their products. These substances perform a technical role in the plastic (such as calcium stearate or silicon dioxide) while also being authorized food additives under Regulation (EC) No 1333/2008. Food manufacturers must factor in migrated amounts to ensure final concentrations stay within statutory food composition limits.

• Issuer Identity Line names the legal entity responsible for compliance, including full corporate registration and address details.
• Material Scope Specification lists specific polymer grades, layer structures, masterbatch codes, and surface coatings covered by the declaration.
• Restricted Substance Inventory discloses specific migration limits, CAS numbers, and EFSA reference numbers for restricted monomers and additives.
• Operational Boundary Limits defines maximum contact temperatures, storage times, and suitable food categories verified by testing.

Supporting documentation kept by the manufacturer must back up every statement in the DoC. Test reports from accredited ISO/IEC 17025 laboratories, recognized migration diffusion models, and raw material traceability records make up this technical file. Customs officials and market surveillance inspectors have the right to review these records, and manufacturers must produce the file within 10 working days of an official request.

How far must an importer trace secondary reaction products and non-intentionally added substances back through multi-layer chemical supply chains before issuing a final Declaration of Compliance?

Sanction

Failing to follow food simulant and test condition rules carries direct commercial and legal penalties across EU member states. National authorities enforce Regulation (EU) No 10/2011 through control frameworks under Regulation (EU) 2017/625. Border posts regularly sample imported plastic items and test them against declared claims.

Any mismatch between laboratory results and the technical file can trigger immediate detention, customs rejection, and forced destruction or re-export at the importer’s expense.

Enforcement actions are shared across member states via the Safety Gate system (formerly RAPEX). Public alerts publish brand names, origin countries, specific migration exceedances, and administrative actions taken. The financial damage of a public warning goes well beyond destroying inventory, often leading to lost retailer listings, damaged brand equity, and legal claims from distribution partners.

Weighing testing fees against potential recall costs highlights the financial exposure involved. A full migration panel covering Simulants A, B, and D2 with specific migration screening typically runs between 1,500 and 4,000 euros per polymer grade. In contrast, managing a product recall ~ retrieving stock, warehousing, disposal, and legal defense ~ can easily cost hundreds of thousands of euros.

Cutting corners on lab testing to save upfront procurement costs is a critical risk management mistake.

Supply contracts should link product acceptance directly to verified migration test reports. Standard procurement terms usually make payment conditional on presenting an accredited ISO/IEC 17025 lab report proving compliance under exact EU 10/2011 simulants and worst-case test conditions. Mandating batch-level testing also stops suppliers from swapping in cheaper resin grades that lack food-grade additive clearances.

Customs authorities at major European ports use tools like portable X-ray fluorescence spectrometers to catch heavy metal pigments and infrared spectroscopy to check polymer identity against technical files. If physical testing turns up unlisted additives or migration exceedances, enforcement agencies issue administrative fines. Fines imposed by food safety authorities scale based on health risks, corporate turnover, and prior infractions.

Maintaining compliance requires reviewing testing parameters whenever manufacturing changes. Switching polymer suppliers, altering masterbatch formulations, shifting molding temperatures, or modifying intended uses means simulant selections and test durations must be re-evaluated. Keeping the physical product in the container aligned with the chemical profile documented in the laboratory file is what protects market access across the European Union.