Migration testing for food packaging limits and simulants
Migration testing for food packaging checks transfer into food. EU plastics need overall and specific migration checks matched to intended use.
Migration testing for food packaging measures chemical migration from the pack into food, or into a food simulant used in place of that food. For EU plastic food contact materials, Regulation 10/2011 sets a general overall migration limit (OML) of 10 mg/dm² and applicable specific migration limits (SMLs). Those figures are not universal limits for every packaging material or destination market, and a migration test for food packaging that only passes overall migration is not complete proof of compliance. Articles 2, 11, 12 and 18
Check scope first. Article 2 covers plastic materials and articles, and specified plastic layers placed on the EU market. It is not a testing code for paper, metal, glass or a mixed-material package. Match the construction to that scope before you apply these limits or commission a test. Article 2
Overall and specific limits for food contact materials
Overall migration is the total mass of constituents released. Specific migration addresses individual substances and the restrictions that apply to them. Both belong in the assessment. The evidence still depends on the material, the substances and the intended use. Articles 11, 12 and 18
| Check | EU plastics requirement |
|---|---|
| General overall migration limit | 10 mg of total constituents released per dm² of food-contact surface, into food simulant |
| Overall migration for articles contacting food intended for infants and young children | 60 mg/kg of food simulant under Article 12(2) |
| Specific migration | Applicable substance limits, in mg substance/kg food, plus group restrictions and specifications |
Article 12 sets the general limit as 10 mg of constituents released per dm² into food simulant. Use 60 mg/kg only where the plastic contacts food for infants and young children. It's an overall migration figure in mg/kg of food simulant, not a unit you can swap for 10 mg/dm² on any pack, and not a generic SML. Read the Annex I entry and Annex II before you assume one number covers the constituents. Articles 11 and 12, Annexes I and II
But you do not always need a separate laboratory test for every substance. Article 18 allows specified screening approaches, and it keeps a result in food, a result in simulant and a screening result distinct. A failed screen does not by itself prove non-compliance. The file has to show which route you used. Articles 16 and 18, Annex V
Choose food simulants for migration testing
A food simulant stands in for the food in the migration test. Annex III names the simulants and assigns them to food categories. Pick them for the foods this pack will contact, not the laboratory's usual set. Annex III
| Code | Simulant in Annex III, Table 1 |
|---|---|
| A | Ethanol 10% v/v |
| B | Acetic acid 3% w/v |
| C | Ethanol 20% v/v |
| D1 | Ethanol 50% v/v |
| D2 | Vegetable oil meeting the prescribed specification |
| E | Specified poly(2,6-diphenyl-p-phenylene oxide) |
B is assigned to acidic foods below pH 4.5. D1 covers alcoholic foods above 20% and oil-in-water emulsions. D2 is for foods with free fat at the surface. E is for specific migration into dry foods. Those four lines do not replace the food-category assignments or the correction factors in Annex III, Table 2.
Overall migration has its own simulant assignments. Don't treat E as the overall-migration method for dry-food packaging. If one simulant is justified as the most severe, keep that justification in the file. Annex III
Read the substance notes too. Regulation 2026/245 adds Annex I note 31 for FCM 1094: water is used for verification instead of the Annex III Table 1 simulants. A note like that overrides a generic pick from the simulant table. Regulation 2026/245
Match test conditions to actual use
Specific-migration testing has to represent the worst foreseeable conditions of use. Overall migration uses standard conditions OM0 to OM7, and each condition has a defined application. OM2 is 10 days at 40°C. It is one overall-migration condition, not a specific-migration test and not the default for every pack. Annex V, Chapters 2 and 3
The annoying gap is a supplier report with no storage temperature. Tell the laboratory the contact time and the temperatures, including treatment and storage, and say whether the article is single-use or repeated-use. Those details drive the test choice, and Annex IV includes the intended time and temperature in the declaration of compliance. Annexes IV and V
Repeated-use rules mean successive contacts on one sample, each with fresh simulant, then a third-contact assessment and a stability check. Exceptions and performance criteria apply as well. The shorthand "only the third result matters" drops part of that test. Annex V, sections 2.1.6 and 3.3.2
Compare a result with the limit on the right surface-to-volume basis. Article 17 normally uses the real contact ratio, and specified derogations exist. Because the conventional-ratio option does not apply to infant and young-child food, one assumed conversion will not fit every pack. Article 17
Specify the evidence you need from suppliers
A report that only says "overall migration passed" still leaves the substance restrictions and the intended use open. Article 15 requires a written declaration of compliance at marketing stages other than retail. Article 16 requires supporting evidence that competent authorities can ask for. That evidence includes test conditions, results, calculations, other analysis and safety evidence or reasoning. Use this as a specification checklist. It is not a statutory form, and completing it does not by itself prove compliance. Articles 15 and 16
- Identify the material, construction and intended market.
- List the intended food types.
- Define contact duration, treatment and storage temperatures.
- State whether use is single or repeated.
- Identify applicable substance limits, group restrictions and specifications.
- Record the selected simulants and test conditions.
- Explain the surface-to-volume basis.
- Connect the results and other evidence to the declaration's intended-use coverage.
These points track Articles 2 and 11 to 18, and Annexes IV and V. Annex IV includes the intended foods, the treatment and storage time and temperature, and the highest surface-to-volume ratio for which compliance was verified. Match those lines to the use you actually propose before you accept the supplier's evidence.
Check amendments before relying on an older report
As of 31 October 2026, EUR-Lex shows the 14 July 2026 consolidation. A consolidation is a documentation tool. It has no legal effect of its own. Regulation 2026/2412, dated 28 October 2026 and published on 29 October 2026, amends Annex I and enters into force on 18 November 2026. Read Annex I in that act before you rely on an older substance list for use on or after that date. Consolidated text and Regulation 2026/2412
Regulation 2025/351 changed the testing, repeated-use, purity and documentation rules. Article 4 lets qualifying plastic materials and articles that were first placed on the market before 16 September 2026 continue to be placed on the market until stocks are exhausted. They must have met the previous requirements and other relevant Union law. Intermediate products and substances have separate provisions. Do not assume every older report or stock item qualifies. Regulation 2025/351
Does the same test cover the UK or US?
For Great Britain, use the UK-revised text. Do not assume later EU amendments applied on their own. UK Article 12 still has the general 10 mg/dm² limit and the infant and young-child limit of 60 mg/kg. Shared headline numbers are not the same rulebook. UK legislation and Article 12
A UK-wide assumption is unsafe. GOV.UK guidance separates Great Britain and Northern Ireland, and it notes rules that apply under the Windsor Framework. Check the material and the supply route before you decide which requirements govern the pack. Authorisation guidance and EU rules and UK implications
An EU overall migration pass does not authorise a substance for a US use. FDA chemistry guidance looks at the substance, the intended use and dietary exposure. It recommends migration conditions that reflect the most severe intended time and temperature, and it accepts reliable analyses in food or suitable simulants. Those are guidance recommendations, not independently binding test mandates. FDA chemistry guidance
A US food contact notification (FCN) is effective for the food contact substance manufactured or prepared by the manufacturer or supplier identified in that notification. 21 CFR 170.100
RegAffairs AI's answer on EU plastic packaging migration testing links the rules behind these checks.