Migration Test — (EU) 10/2011 / EN 1186 / EN 13130

What Is Migration?

The migration test measures the amount of substance transferring from a food-contact material into food, using defined simulants in place of food. There are two types of migration: OVERALL MIGRATION gives the total mass of all substances transferred into the simulant; SPECIFIC MIGRATION measures the amount of a particular substance (monomer, additive, heavy metal) individually.

Purpose of Migration

The purpose is to show the packaging does not transfer substances into food at an unacceptable level, and to produce the basis for a declaration of compliance under (EC) 1935/2004 and (EU) 10/2011.

Which Products Is Migration Applied To?

Plastic food packaging and containers
Coated metal cans
Paper and board food packaging
Kitchenware and cookware
Cap, gasket and stopper materials

In Which Sectors Is Migration Used?

PackagingLogisticsRetailFoodPlastics & Rubber

Standards Related to Migration

TS EN 1186 series (overall migration — by simulant and method)
TS EN 13130 series (specific migration — by substance)
TS EN 14372 (child use and care articles)
TS EN 15136 (certain epoxy derivatives)
ISTApackaging transport performance test series test

Migration Conditions

Simulants: Defined in Annex III of (EU) 10/2011: A, B, C, D1, D2 and E; selected per food type
Time and temperature: Pairs defined in Annex V representing the worst-case use conditions
Contact area/volume: Ratio defined in the standard; calculated per the packaging geometry
Repeats: Three consecutive migration cycles for repeat-use materials

Equipment for Migration

Migration cells and ovens
Analytical balance (0.0001 g)
GC-MS and LC-MS/MS
ICP-MS
Rotary evaporator

Sample Requirements for Migration

The material or finished package as offered for sale
Food type and intended use condition (temperature, time) must be provided
Material composition and the list of additives used must be provided
The food-contact layer must be stated for multilayer structures

Duration of Migration

The migration step runs for the time defined in the standard, which ranges from hours to days depending on the use condition. For repeat-use materials, three consecutive cycles are required, multiplying the duration; instrumental analysis then adds to this.

Migration Procedure

1Simulant, time and temperature are determined per the food type and use condition.
2The specimen is exposed to the simulant at the defined contact-area-to-volume ratio.
3It is held for the defined time and temperature.
4For overall migration, the simulant is evaporated and the residue weighed.
5For specific migration, target substances are measured by chromatographic methods.
6Results are calculated in mg/kg food or mg/dm².

Migration Acceptance Criteria

(EU) 10/2011 defines a general limit for overall migration; specific migration limits are given individually for each substance in the list in Annex I. Certain substances also carry use restrictions and purity requirements. Applicable limits are confirmed from the regulation's current text.

Evaluation of Results

The choice of simulant and condition determines the result's validity: a test done with the wrong simulant is not considered proof of compliance. The result must also represent the worst case of the use condition; a test at room temperature is insufficient for a container to be heated in a microwave.

Migration Report

Material identification and food-contact layer
Simulant, time and temperature selected, and the justification
Contact-area-to-volume ratio
Overall migration result
Specific migration results and limits of quantification
Regulatory limits compared against

Accreditation

EUROLAB holds internationally recognised accreditation obtained from accreditation bodies party to the IAF and ILAC multilateral recognition arrangements, under ISO/IEC 17025 for laboratory testing, ISO/IEC 17020 for inspection and surveillance, and ISO/IEC 17021-1 and ISO/IEC 17065 for system and product certification. This chain ensures the reports and certificates issued are accepted worldwide.

Whether this test can be offered within accredited scope depends on your product and the standard applied; since accreditation is method-based, the scope is confirmed in writing at the quotation stage.

Scope and authorisations

Related Regulations

(EC) 1935/2004 Regulation on Materials and Articles Intended to Come into Contact with Food
(EU) 10/2011 Regulation on Plastic Materials and Articles Intended to Come into Contact with Food
(EC) 2023/2006 Good Manufacturing Practice Regulation

Ambalaj Testleri — What Does This Testing Field Cover?

The section below describes the field that the Migration test belongs to; the conditions and acceptance criteria of this particular test are given in the sections above. The scope specific to your product is confirmed in writing at the quotation stage.

Packaging testing examines two different functions separately: does the packaging protect the product during transport, and does the packaging material transfer harmful substances into its contents? These two questions require different laboratory infrastructure and must not be confused.

On the protection side, distribution simulation is carried out: drop, vibration, compression, stacking and, where needed, low pressure tests are applied in sequences representing the real shipping chain. These tests are meaningful as a SEQUENCE rather than individually; in real life too, packaging is exposed to successive loads and each load builds on the damage left by the previous one. Specifications such as ISTA and ASTM D4169 define these sequences by shipment type.

The shipment type determines the sequence itself. The exposure of a palletised load differs from that of a parcel shipped individually: the latter sees far more handling, more drops and impacts in a wider variety of orientations. The growth of e-commerce has brought this second scenario to the fore and turned parcel shipping simulation into a specification group of its own.

On the food contact side, MIGRATION is what counts: the amount of substance passing from the packaging material into the food is compared against overall and specific migration limits. For plastic packaging the list of permitted substances and the limits are defined in separate legislation; the declaration of conformity (DoC) rests on this assessment and is a document that every link in the supply chain must carry.

In a migration test the choice of SIMULANT is critical. Because testing with real food is not practical, liquids representing food are used: different simulants for aqueous foods, for fatty foods and for acidic foods. Choosing the wrong simulant invalidates the result; the choice depends on which food type the packaging will contact and at what temperature.

Barrier properties are a third axis. Oxygen and water vapour permeability directly determine the shelf life of the product; in pharmaceutical and food packaging these values are a design input. Barrier performance is sensitive to temperature and relative humidity, so the measurement conditions are part of the report.

Sterile medical device packaging is the most tightly regulated sub-body of this family. Here the packaging is a barrier maintaining sterility; seal strength, leak testing, distribution simulation and shelf-life studies run together as a validation package.

The packaging legislation side is becoming rapidly more demanding. Recyclability, recovered content ratio, packaging reduction and reuse targets must now be measurable and declarable; this turns packaging design from a material selection exercise into a conformity exercise.

Method groups in this field

Distribution simulation
Drop, random and fixed frequency vibration, compression, stacking, low pressure; as ISTA and ASTM D4169 sequences.
Mechanical strength
Edge crush (ECT) in corrugated board, bursting strength, box compression strength, tape peel adhesion.
Barrier measurements
Oxygen transmission rate (OTR), water vapour transmission rate (WVTR), permeability in film and sheet materials.
Migration
Overall and specific migration tests; simulant and temperature conditions are chosen according to the use scenario.
Seal and integrity
Seal peel strength, leak detection by dye penetration, bubble test, headspace analysis.
Shelf life
Real-time and accelerated ageing; part of the validation package in sterile packaging.

Commonly confused in this field

A single drop test is not a distribution simulation; the tests are applied as the sequence defined in the specification.
A migration test carried out with the wrong simulant or the wrong contact temperature is invalid.
Accelerated ageing does not replace real-time ageing; a shelf life claim is supported by real-time data.
Barrier values are valid together with the measurement temperature and relative humidity; an OTR/WVTR value given without conditions cannot be compared.
A packaging change (film supplier, seal parameter, box design) may require the validation to be repeated.
A food contact declaration of conformity is not a test report; it is a document that rests on reports but summarises a broader assessment.

Which decisions these results support

Reducing shipping damage and verifying the packaging design
Declaration of conformity for food contact packaging
Supporting the shelf-life claim
Validation of sterile device packaging
Recyclability and content declarations under packaging legislation

Related Tests

Frequently Asked Questions About Migration

Which simulant should I choose?

The food type determines it: different simulants are defined for aqueous foods, acidic foods, alcoholic products and fatty foods. If the packaging will be used with more than one food type, the simulant representing the worst case, or more than one simulant, is used.

Is my raw material supplier's declaration of compliance sufficient?

No. The declaration covers the raw material; in the final package, layer structure, processing temperature and printing ink change migration behaviour. Compliance is demonstrated on the finished product.

What does NIAS mean?

Non-intentionally added substances (degradation products, impurities). (EU) 10/2011 also requires a risk assessment of these; a targeted migration analysis alone does not satisfy the NIAS assessment — a screening analysis and risk assessment are required.