Food Contact Compliance — 1935/2004 / (EU) 10/2011 / FDA 21 CFR

What Is Food Contact?

Food contact compliance assessment is not a single test but a programme built around the material type. Overall and specific migration for plastics, element release for metal and coatings, lead-cadmium release for ceramics and glass, specific-substance analyses for paper and board, and separate provisions for elastomers are all applied. The programme's output is the basis for the declaration of compliance issued down the supply chain.

Purpose of Food Contact

The purpose is to show the material does not transfer substances that would endanger food composition, harm health, or unacceptably change its organoleptic properties. This is the fundamental requirement of (EC) 1935/2004.

Which Products Is Food Contact Applied To?

Plastic packaging and containers
Metal cans and their coatings
Ceramic, glass and enamel kitchenware
Paper and board food packaging
Silicone and rubber gaskets, spatulas and moulds

In Which Sectors Is Food Contact Used?

PackagingLogisticsRetailFoodPlastics & RubberCeramics

Standards Related to Food Contact

TS EN 1186 series (overall migration)
TS EN 13130 series (specific migration)
TS EN 1388-1/-2 (ceramic surfaces — release of lead and cadmium)
TS EN 601 / 602 (aluminium alloys)
Council of Europe technical guidelines (for metals, paper and coatings)
ISTApackaging transport performance test series test

Food Contact Conditions

Material type: The applicable legislation and test programme vary by material
Use condition: Temperature, time and repeat use are taken at their worst case
Target market: 1935/2004 and 10/2011 for the EU; FDA 21 CFR provisions for the US

Equipment for Food Contact

Migration cells and ovens
GC-MS, LC-MS/MS
ICP-MS / ICP-OES
Sensory evaluation panel facilities
Analytical balance

Sample Requirements for Food Contact

Finished product as offered for sale
Material composition, additive list and supplier declarations
Intended food type and use conditions
Information on any printing or coating applied

Duration of Food Contact

Duration depends on the programme's scope. Migration tests impose their own duration; total duration extends markedly when consecutive cycles for repeat-use materials and sensory evaluation are added.

Food Contact Procedure

1Material type and target market are determined.
2The intended food type and use conditions are defined.
3The applicable regulatory provisions and test list are drawn up.
4Migration and release tests are carried out.
5Sensory evaluation is carried out if required.
6Results are compared against the regulatory limits and form the basis for the declaration of compliance.

Food Contact Acceptance Criteria

The acceptance criterion is that the migration and release limits in the legislation applied are not exceeded. (EC) 1935/2004 also requires no unacceptable change in the food's organoleptic properties; this is shown by sensory evaluation, not a numerical limit.

Evaluation of Results

Compliance is not just test results: (EU) 10/2011 also requires the substances used to be on the authorised list, good manufacturing practice to be applied, and a written declaration of compliance to be issued. Even if the results are compliant, the material is non-compliant if these steps are missing.

Food Contact Report

Material identification, composition and food-contact surface
Intended food types and use conditions
Legislation applied and test list
Result, limit of quantification and the limit compared against, for each test
Compliance assessment

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
(EC) 2023/2006 Good Manufacturing Practice Regulation
FDA 21 CFR 170–199 (US market)

Ambalaj Testleri — What Does This Testing Field Cover?

The section below describes the field that the Food Contact 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 Food Contact

Who issues the declaration of compliance?

The operator placing the material on the market issues it, backed by test results. The declaration must clearly state which food types and use conditions the material is suitable for; an unlimited declaration of compliance is not accepted.

Is an EU report also valid for the US?

No. The FDA uses a different framework: substance-by-substance authorisation, pre-approved uses, and different simulant/condition definitions. Separate assessment is required for the two markets.

Can I use recycled material?

There is a separate authorisation regime for recycled plastic in food contact, and the recycling process must be approved. Compliance obtained for virgin material does not apply to recycled content.