Migration Testing: Simulants, Conditions and the Defensible Test Plan
Migration testing is the analytical core of any food-contact compliance file.
In Short
- Annex III of 10/2011 maps food categories to simulants.
- 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…
- OML is expressed as 10 mg per dm² of food-contact surface; SMLs are expressed in mg/kg of food.
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.
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.
More on simulant assignment and the worst-case principle
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.
More on annex V conditions and FDA Chapter 3 protocols
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.
Common gap. 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.
More on calculation, surface-to-volume and the food-to-surface ratio
The DoC must declare the highest food-to-surface ratio for which compliance has been verified. 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.
More on nIAS screening — the analytical step beyond targeted SMLs
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.
Questions
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.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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