Guide

Migration Testing: Simulants, Conditions and the Defensible Test Plan

Migration testing is the analytical core of any food-contact compliance file. Under Commission Regulation (EU) 10/2011, the Overall Migration Limit (OML) of 10 mg/dm² applies regardless of composition, while substance-level Specific Migration Limits (SMLs) apply to every listed monomer and additive. Annex III assigns food simulants A (10 % ethanol), B (3 % acetic acid), C (20 % ethanol), D1 (50 % ethanol), D2 (vegetable oil) and E (modified poly-2,6-diphenyl-p-phenylene oxide / Tenax) to food categories; Annex V defines the time-and-temperature test conditions OM0–OM7. FDA 21 CFR Part 175–178 and the FDA Chemistry Recommendations (Chapter 3 of the Food Contact Substance Notification guidance) define the parallel US extraction protocols. A test plan that doesn't reflect the customer's worst-case use has no defence in audit.

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Simulant assignment and the worst-case principle

Annex III of 10/2011 maps food categories to simulants. Aqueous foods get simulant A; acidic foods (pH < 4.5) get B; alcoholic foods up to 20 % ABV get C; fatty foods get D1 or D2; dry foods get E. The worst-case principle means a film cleared with simulant A at 40 °C for 10 days has no defence when the converter uses it for hot-fill at 80 °C — the test must cover the most severe foreseeable use. The 2016 amendment introduced reduction factors for D2 (DRF), but those apply only with documented evidence; defaulting to a DRF without a Tenax study is a recurring inspection finding.

Annex V conditions and FDA Chapter 3 protocols

Annex V conditions OM0 through OM7 cover frozen storage (OM0, 10 days at –20 °C) through hot-fill / pasteurisation / sterilisation (OM6, 2 h at 100 °C / 70 °C / 121 °C as relevant) and repeated long-term use (OM7). Conditions for the test must match the harshest realistic use. FDA Chapter 3 sets parallel extraction protocols at 40 °C, 70 °C, 100 °C or 121 °C against food-type-equivalent simulants (water, 10 % ethanol, 50 % ethanol, food-oil) for the assigned conditions of use A–J. A grade serving both markets typically runs both programmes; running only one and cross-claiming to the other fails on close reading.

Calculation, surface-to-volume and the food-to-surface ratio

OML is expressed as 10 mg per dm² of food-contact surface; SMLs are expressed in mg/kg of food. The conversion uses the conventional 6 dm² per kg surface-to-food ratio for general articles, with specific ratios for small or large containers. The DoC must declare the highest food-to-surface ratio for which compliance has been verified. The recurring failure mode is a calculation done at the conventional ratio for an article whose real geometry gives a different ratio — the verified SML compliance does not carry over. The same calculation rigor applies to multi-layer structures, where each layer's contribution requires either testing or modelling (e.g. with the FACET / Piringer migration models accepted by the JRC).

NIAS screening — the analytical step beyond targeted SMLs

Article 19 of 10/2011 obliges the manufacturer to assess Non-Intentionally Added Substances (NIAS) — impurities of authorised substances, reaction intermediates, decomposition products — for compliance with Article 3 of the Framework Regulation. Modern NIAS programmes typically run GC-MS and LC-HRMS untargeted screening with deconvolution and library matching, plus oligomer assessment for polyesters and polyamides. A one-line NIAS risk statement no longer survives an EU competent-authority audit and increasingly fails US customer technical review.

A 45-day migration programme refresh

Days 1–10: customer use-condition survey — most severe foreseeable use, food type, contact time, temperature, surface-to-volume. Days 11–20: simulant assignment and Annex V / FDA Chapter 3 condition selection per grade and use. Days 21–35: testing — OML, substance-level SML for restricted additives, NIAS screening, oligomer assessment where relevant. Days 36–45: DoC reissue against Annex IV / customer letter of guarantee with the calculation, results and worst-case use-condition embedded in the supporting documentation.

Where this lives in V5 Ultimate

The clauses above aren't theoretical — every one maps to a shipped module and an industry profile. Jump to the parts of the product that turn this guide into evidence on a Monday morning.

Modules that do the work

Polymer QMS

Test plan, calculation and DoC on one spine.

Test records

Chromatograms and calculations versioned with the grade.

Industries this hits hardest

Plastics & resins

Frequently asked

Can modelling replace migration testing?

Partly. The JRC accepts the Piringer / FACET model for screening and for substances with known diffusion behaviour. For OML and for substances close to the SML, experimental testing is still expected; modelling alone is not a defensible substitute for the final compliance decision.

What about repeated-use articles?

Annex V condition OM7 covers repeated long-term use. The DoC must verify compliance at the third sequential migration test (the convention) — first and second extractions typically show higher migration, so a defensible result is at the third.

How do simulants A–E map to FDA food types?

Approximate mapping: FDA Type I (non-acid, aqueous) ↔ simulant A; Type II (acidic aqueous) ↔ B; Type III/IV (alcoholic) ↔ C; Type V (fatty) ↔ D1/D2; Type VI (dry) ↔ E. The mapping is approximate; the formal test conditions differ and a serious file runs both protocols rather than cross-claiming.

Do colourants need migration testing?

Colourants intentionally added must be Union List substances or covered by a national derogation; their migration must hold against the OML at minimum, and where a colourant has an SML it must hold that. Heavy-metal SMLs in Annex II (lead, cadmium, mercury, chromium, etc.) apply across the article regardless of colourant origin.

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