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

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)

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)

Food Testing — 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.

Food testing shows that a product is safe for consumption and contains what its label states. The family works along three axes: microbiological safety, chemical safety and nutritional composition. All three require different laboratory infrastructure, a different body of methods and a different turnaround time.

The most distinctive feature of the field is TIME PRESSURE. A steel specimen can wait on a shelf; a raw milk or fresh meat sample cannot. The time the sample was taken, the transport temperature and how long it takes to reach the laboratory directly determine the validity of the result. In food microbiology the cold chain record is therefore an inseparable part of the test report.

On the microbiological side there are two different questions and they must not be confused. DETECTION of a pathogen is a qualitative question: is Salmonella present in the sample or not? ENUMERATION of indicator organisms is a quantitative question and an indicator of production hygiene. The absence of a pathogen in a product does not show that hygiene is good; if the total mesophilic aerobic count is high, there is a problem in the process.

On the chemical side, pesticide residues, mycotoxins, heavy metals, additives, veterinary drug residues and process contaminants (acrylamide, furan, PAH) are measured. Multi-residue methods in this area (QuEChERS-based LC-MS/MS and GC-MS/MS) can screen hundreds of active substances in a single analysis; limits are defined separately for each product–substance pair.

On the composition side, protein, fat, moisture, ash, fibre, sugar profile, fatty acid composition, vitamin and mineral content are determined. These values are the basis of the nutrition declaration on the label and the tolerance ranges are defined in legislation — the difference between the declared value and the measured value must stay within that tolerance.

There is NO CE marking on food, and this shapes how the field works. Conformity is demonstrated through operating a HACCP-based food safety system, complying with labelling rules and not exceeding contaminant, residue and microbiological limits. A test result produces evidence not for a certificate but for a functioning system.

Allergen management carries particular weight. The presence of an undeclared allergen in a product is one of the most frequent causes of food recalls. Analysis here runs together with cleaning validation: it is shown that the line has been cleaned adequately after a production run containing an allergen and that the risk of cross-contamination is under control.

Voluntary schemes have become effectively mandatory in this field. Retail chains require their suppliers to hold a certificate under a GFSI-recognised scheme (BRCGS, IFS, FSSC 22000); without it, getting onto the shelf is practically impossible.

Method groups in this field

Pathogen detection
Detection of Salmonella, Listeria monocytogenes, Campylobacter, Cronobacter and Shiga toxin-producing E. coli; culture-based and molecular methods.
Indicator counts
Total mesophilic aerobic count, Enterobacteriaceae, coliforms and E. coli, coagulase-positive staphylococci, yeasts and moulds, lactic acid bacteria, sulphite-reducing Clostridia.
Pesticide and veterinary residues
Multi-residue screening by LC-MS/MS and GC-MS/MS with QuEChERS extraction.
Mycotoxins and contaminants
Aflatoxins, ochratoxin A, deoxynivalenol, patulin; heavy metals (ICP-MS), acrylamide and PAH compounds.
Nutritional composition
Kjeldahl protein, fat and fatty acid profile, moisture, ash, dietary fibre, sugar profile, vitamin and mineral analyses.
Allergens and authenticity
Gluten, milk, egg, nut and soy allergen analyses; molecular methods for species identification and adulteration detection.

Commonly confused in this field

Sampling is half the result. A sample transported at the wrong temperature or delayed gives an invalid result even if it is analysed correctly in the laboratory.
The absence of a pathogen does not show that hygiene is good; indicator counts give separate information and the two are read together.
A result from a sample taken from a lot can be generalised to the whole lot only if the sampling plan was set up statistically.
Limits are defined in separate regulations by product group and are updated regularly; a conformity decision based on an outdated limit table may be wrong.
For exports, the limits of the destination country may differ from EU limits; the same product may be compliant in one market and non-compliant in another.

Which decisions these results support

Verification of the HACCP plan and process monitoring
The basis for the nutrition declaration and allergen information on the label
Health certificates before export and compliance with destination market limits
Supplier and lot-based acceptance control
Shelf-life studies and determining storage conditions
Producing evidence for audits under GFSI-recognised schemes

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.