EU Plastic Packaging Migration Testing

In the EU, plastic food packaging must meet two migration limits under Regulation (EU) No 10/2011: an overall migration limit (OML) of 10 mg/dm² (60 mg/kg for food for infants and young children), and specific migration limits (SMLs) for individual substances listed in Annex I and Annex II. Testing follows the Article 18 rules: food simulants are chosen from Annex III, and time, temperature, repeated-use and uncertainty rules come from Annex V. The results then go into the supporting documents and the declaration of compliance.

Approach: I read the current consolidated Regulation 10/2011 (consolidated version dated 14 July 2026), its amending acts, the framework Regulation (EC) No 1935/2004 and the BPA Regulation (EU) 2024/3190. EUR-Lex wouldn't open, so I confirmed the deletion of Article 11(2) from the amending act itself.

1. The limits you test against

• General safety duty: under normal or foreseeable conditions of use, materials "shall not" transfer constituents to food in quantities that could endanger health or change the food's composition, taste or smell (Regulation 1935/2004, Art. 3) ^[1].
• OML (Art. 12): 10 mg of total constituents per dm² of food contact surface. For food for infants and young children the limit is 60 mg/kg of food simulant ^[2].
• SMLs (Art. 11): the substance limits in Annex I, in mg/kg food.
  • Where a substance must not migrate at all ("ND"), the default detection limit is 0.01 mg/kg unless a specific one is set.
  • Additives that are also authorised food additives or flavourings must not migrate in quantities that have a technical effect in the food ^[3].
  • There is no longer a default 60 mg/kg SML. Regulation (EU) 2016/1416 deleted Article 11(2), because the OML already caps total migration ^[4][5].
• Annex II (metals and aromatic amines):
  • Metal SMLs include, for example, aluminium 1, antimony 0.04, nickel 0.02 and zinc 5 mg/kg. Arsenic, cadmium, chromium, lead and mercury must be not detectable.
  • Primary aromatic amines listed in REACH Annex XVII entry 43 (Appendix 8) must not be detectable at a detection limit of 0.002 mg/kg per amine.
  • Other primary aromatic amines with no SML in Annex I are capped at 0.01 mg/kg as a sum ^[6].

2. How compliance is shown (Art. 18)

• Packaging already filled with food: test in the food itself (Annex V, Chapter 1) ^[7].
• Packaging not yet in contact with food:
  • Verify SMLs in food or Annex III simulants (Annex V, Chapter 2.1).
  • Verify the OML in simulants (Annex V, Chapter 3).
  • Screening is allowed. If a material fails a screening test, non-compliance has to be confirmed by full verification ^[7].
• Which result wins: results in food prevail over results in simulants, and simulant results prevail over screening. Correction factors are applied before results are compared with the limits ^[7].

3. Food simulants (Annex III)

Simulant	Medium	Used for
A	10% ethanol	Water-based foods
B	3% acetic acid	Foods with pH below 4.5
C	20% ethanol	Alcoholic foods up to 20%, or more lipophilic aqueous foods
D1	50% ethanol	Alcoholic foods above 20%, and oil-in-water emulsions
D2	Vegetable oil	Foods with free fat at the surface
E	Poly(2,6-diphenyl-p-phenylene oxide)	Dry foods (specific migration)

^[8]

• Food categories: Table 2 assigns simulants per food category. Where a D2 or E entry carries "X/3" (or another figure), the result is divided by that figure, but never for substances that must not be detectable.
• Allowed omissions: simulant B can be omitted for foods with pH above 4.5 where marked (*), and D2 where marked (**) if there is no fatty contact ^[9].
• OML simulants (Table 3): for "all types of food", the OML test uses water or simulant A, plus simulant B and simulant D2.
• Single-simulant derogation: one simulant is enough if it is shown to be the most severe, with the evidence kept in the Article 16 file ^[10].
• Specific migration, all foods: packaging for all food types is tested in A, B and D2. B can be dropped if no acid-reactive substances are present ^[11].

4. Test time and temperature (Annex V)

• Specific migration: test under the worst foreseeable contact time (Table 1, e.g. up to 24 h tested as 24 h, 3 to 30 days tested as 10 days) and temperature (Table 2, e.g. 20 to 40 °C tested at 40 °C). Temperatures above 100 °C apply only to D2 and E ^[12].
• Hot-fill only: a single 2-hour test at 70 °C, unless the packaging is also used for storage ^[11].
• Storage above 30 days at room temperature or below: accelerated 10-day tests ^[12]:
  • 10 d at 20 °C covers frozen storage.
  • 10 d at 40 °C covers refrigerated and frozen storage.
  • 10 d at 50 °C covers up to 6 months at room temperature.
  • 10 d at 60 °C covers more than 6 months.
  • Other conditions use the formula t₂ = t₁·exp(9627·(1/T₂ − 1/T₁)).
• Overall migration: standard conditions OM0 to OM7 ^[13]:
  • OM0: 30 min at 40 °C
  • OM1: 10 d at 20 °C
  • OM2: 10 d at 40 °C, for long-term ambient storage
  • OM3: 2 h at 70 °C
  • OM4: 1 h at 100 °C
  • OM5: 2 h at 100 °C or 1 h at 121 °C
  • OM6: 4 h at 100 °C
  • OM7: 2 h at 175 °C
• When D2 isn't feasible: use 95% ethanol and isooctane, plus simulant E above 100 °C. OM8 and OM9 replace OM7 ^[13].

5. Expressing and judging results

• Surface-to-volume ratio: SML results are expressed in mg/kg using the real surface-to-volume ratio ^[14].
  • A conventional ratio of 6 dm²/kg or more may be used for containers under 500 ml or over 10 l, for sheets and films not yet in contact with food, and for shapes where the ratio can't be estimated. This option does not apply to infant and young-child food.
  • Caps and closures have their own rules, expressed in mg/kg or mg/article.
• Measurement uncertainty and pass/fail: the method must cover at least 0.2× to 2× the SML. The relative uncertainty is set by a formula (CVR) that depends on the migration level, and a result is non-compliant only where (mc − SML)/u(mc) > 1.64 ^[15].
• Fat reduction factor: may be applied where Annex I allows it, but never for infant food. Specific migration must not exceed 60 mg/kg before the factor is applied. The fat reduction factor combined with the simulant reduction factor is capped at 5, unless the Annex III factor itself is higher ^[16][17].
• Repeated-use articles: run three successive tests on the same sample. Compliance is judged on the third test, and migration must not increase from one test to the next. A detected "must not be detectable" substance in any test means failure ^[18].
• Residual content per area (QMA): used where Annex I says so. Screening by overall migration, residual content, modelling or substitute simulants is also allowed ^[18][19].

6. Multilayer packaging, documentation and recent changes

• Plastic multilayers: the final article must meet both the SMLs and the OML. Substances not on the Union list, used behind a functional barrier, must not migrate (0.01 mg/kg detection limit) and must not be CMR substances or nanoforms ^[20].
• Multi-material multilayers: Articles 11 and 12 apply when the food-contact layer is plastic ^[21].
• Supporting documents (Art. 16): must contain the test conditions and results, calculations or modelling, and be made available to competent authorities on request ^[22].
• Declaration of compliance (Annex IV): must state the food types, the time and temperature of use, and the highest surface-to-volume ratio for which compliance was verified. It "shall be renewed" when changes alter migration ^[23][24].
• Regulation (EU) 2025/351: rewrote the Annex V uncertainty and repeated-use rules ^[25].
  • Packaging that met the old rules and was first placed on the market before 16 September 2026 may be sold until stocks run out. Anything placed on the market since then must meet the new rules ^[26].
  • The same act requires the Chapter V testing rules of Regulation 10/2011 to apply to recycled plastics under Regulation (EU) 2022/1616 ^[27].
• Bisphenols (Regulation (EU) 2024/3190):
  • Testing for BPA and hazardous bisphenols must use the EU reference laboratory's method where one exists, with a 1 µg/kg detection limit unless another is set. Migration results follow Article 17, Article 18, Annex III and Annex V of Regulation 10/2011.
  • Single-use articles that met the old rules could be placed on the market until 20 July 2026. Certain fruit, vegetable and fishery-product packaging has until 20 January 2028 ^[28].

If you tell me the polymer, food type and use conditions, I can work out the exact simulants, OM test and Annex I SMLs for your pack.