Compliance Assessment for Food Contact Materials Exported to the European Union and the United State

Compliance assessment for food contact materials (FCM) exported to Europe and the United States is an essential regulatory process that verifies whether tableware, kitchenware, packaging, and appliance components meet the safety requirements of Regulation (EC) No 1935/2004, Regulation (EU) No 10/2011, and the US FDA 21 CFR framework. This article provides a technical overview of the applicable EU and US regulations, sample types, testing items, testing methods, and typical applications, helping manufacturers build a reliable compliance strategy before export. All migration and extractables testing described below can be performed by accredited third-party laboratories under ISO/IEC 17025 quality systems.

Technical Overview

Food contact materials (FCM) refer to all materials and articles intended to come into contact with food, or materials and articles already in contact with food and intended for that purpose, including packaging, containers, tableware, kitchen utensils, cookware, seals, and food processing components. Because substances can migrate from these materials into food under real-use conditions, both the European Union and the United States impose strict legal frameworks that must be evaluated before export.

In the European Union, the framework Regulation (EC) No 1935/2004 establishes the general safety principle that FCM must not transfer substances to food in quantities that could endanger human health, bring about an unacceptable change in composition, or deteriorate organoleptic properties. It is supported by Regulation (EC) No 2023/2006 on Good Manufacturing Practice (GMP), the plastics Regulation (EU) No 10/2011 (as amended, most significantly by Regulation (EU) 2020/1245), the Ceramics Directive 84/500/EEC, and sector-specific measures for regenerated cellulose films. For materials not yet harmonized at EU level, such as paper and board, metals, rubber, silicone, coatings, and adhesives, national legislation applies, including the German Food and Feed Code (LFGB) with BfR recommendations, the French DGCCRF requirements, and the Italian Ministerial Decree for food contact materials.

In the United States, food contact substances are regulated as food additives under the Federal Food, Drug, and Cosmetic Act. The implementing regulations are codified in 21 CFR Parts 174 to 179, covering indirect food additives such as adhesives and coatings (21 CFR 175), paper and paperboard (21 CFR 176), polymers (21 CFR 177), and adjuvants and production aids (21 CFR 178). Substances not listed may be authorized through the Food Contact Notification (FCN) program or qualify as GRAS (Generally Recognized As Safe). In addition, California Proposition 65 imposes warning requirements and exposure limits for listed chemicals such as lead, cadmium, bisphenol A, and certain phthalates.

Non-compliance carries significant commercial risk. In the EU, non-conforming products are published through the Safety Gate (formerly RAPEX) and RASFF systems and may be rejected at the border or recalled by national authorities. In the US, the FDA may issue import alerts and detention orders, preventing market entry. A systematic compliance assessment performed by accredited third-party laboratories is therefore a critical part of any export quality plan.

Testing Samples

Plastic Materials and Articles

Finished or semi-finished articles made from polypropylene (PP), polyethylene (PE), polyethylene terephthalate (PET), polystyrene (PS), acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polyamide (nylon), polyvinyl chloride (PVC), melamine-formaldehyde resins, and biobased plastics. Samples are typically submitted in their final form, including any printing inks, adhesives, and coatings, since the finished article must comply as placed on the market.

Paper and Paperboard

Food packaging cartons, paper bags, baking and greaseproof paper, coffee filters, paper cups, paper straws, and molded fiber trays. Assessment focuses on substances originating from recovered fibers, wet-strength agents, fluorochemical water and grease repellents, and printing ink components, in addition to colorfastness in contact with aqueous and fatty food simulants.

Metals and Alloys

Stainless steel cutlery and cookware, aluminum cans and trays, tinplate, cast iron, copper articles, and metal articles with organic or non-stick coatings. Assessment is based on the Council of Europe guideline on metals and alloys used in food contact materials, together with specific national requirements and migration limits for elements such as lead, cadmium, chromium, nickel, and arsenic.

Ceramics, Glass, and Vitreous Enamels

Ceramic tableware, cookware, glass containers, drinking glasses, crystalware, and enamel-coated hollowware. The primary concern is the release of lead and cadmium from glazes, decorations, decals, and rim areas, evaluated under Directive 84/500/EEC and corresponding EN and ISO test methods.

Rubber and Silicone

Rubber seals, gaskets, hoses, teats and soothers, silicone bakeware, molds, oven mitts, and flexible tubing. Assessment covers volatile matter, peroxide decomposition residues, nitrosamines and nitrosatable substances, formaldehyde, and total and specific migration into aqueous, acidic, and fatty simulants.

Testing Items

The testing scope is determined by the target market, the material type, the intended food type, and the foreseeable conditions of use (contact time and temperature). Typical assessment packages include the following items.

European Union Scope

• Overall Migration (OM): compliance with the overall migration limit (OML) of 10 mg/dm², or 60 mg/kg for containers between 500 mL and 10 L, into food simulants under worst-case foreseeable conditions.
• Specific Migration (SM): quantification of authorized monomers, starting substances, and additives against the SML and QM restrictions in the Union list of Regulation (EU) No 10/2011.
• Heavy metals and elements: lead, cadmium, chromium (including hexavalent chromium), nickel, cobalt, barium, zinc, arsenic, mercury, aluminum, and others depending on the material.
• Substances of high concern: bisphenol A, phthalates (DEHP, DBP, BBP, DINP, DIDP), primary aromatic amines (PAAs), melamine, formaldehyde, styrene, acrylonitrile, vinyl chloride, caprolactam, per- and polyfluoroalkyl substances (PFAS), and mineral oil saturated hydrocarbons (MOSH) and aromatic hydrocarbons (MOAH) for paper-based materials.
• Ceramic-specific items: lead and cadmium release from flatware, small and large hollowware, cookware, and drinking-rim areas.
• Rubber- and silicone-specific items: volatile organic matter, peroxide residues, nitrosamines and nitrosatable substances, and formaldehyde release.
• Sensory testing: transfer of taint or odor under DIN 10955-type methodology, as required by Regulation (EC) No 1935/2004.
• Non-Intentionally Added Substances (NIAS): risk-based evaluation of impurities, reaction intermediates, and degradation products.

United States Scope

• Polymer specification compliance: extraction characteristics and compositional limits defined in the applicable 21 CFR sections, for example 21 CFR 177.1520 for olefin polymers, 21 CFR 177.1630 for PET, 21 CFR 177.1460 for melamine-formaldehyde resins, and 21 CFR 177.2600 for rubber articles intended for repeated use.
• Coatings and adhesives compliance: extractables testing under 21 CFR 175.300 for resinous and polymeric coatings and 21 CFR 175.105 for adhesives.
• Paper and paperboard compliance: extraction requirements of 21 CFR 176.170 for aqueous and fatty food contact and 21 CFR 176.180 for dry food contact.
• Total extractables and calculated dietary concentration: estimation of consumer exposure compared with the applicable migration or dietary concentration limits.
• California Proposition 65 screening: lead, cadmium, BPA, phthalates, and other listed chemicals against safe harbor levels.

Testing Methods

Migration testing simulates the transfer of substances from the article into food. Because testing directly in food is generally impractical, standardized food simulants and accelerated test conditions are used to represent the worst foreseeable use of the product.

Simulant Selection

For EU assessment under Regulation (EU) No 10/2011, simulants are assigned according to the food classification system: simulant A (10% ethanol) for aqueous foods, simulant B (3% acetic acid) for acidic foods, simulant C (20% ethanol) for alcoholic foods, simulant D1 (50% ethanol) for dairy-type and high-alcohol foods, simulant D2 (vegetable oil or the solid simulant poly(2,6-diphenyl-p-phenylene oxide), commonly known as Tenax) for fatty foods, and simulant E (95% ethanol) for certain dry and high-alcohol applications. For US FDA assessment, the food-type categories of 21 CFR are represented by 8% aqueous ethanol, 50% ethanol for alcoholic and low-water foods, water for acidic aqueous foods where appropriate, and n-heptane for fatty foods.

Test Conditions

Test time and temperature combinations are selected to reproduce the most severe contact conditions. Representative EU overall migration regimes include 10 days at 20°C or 40°C for long-term ambient storage, 2 hours at 70°C or 1 hour at 100°C for hot-fill and pasteurization, 30 minutes at 100°C for boiling-water contact, and 2 hours at 175°C using Tenax for oven-use articles, corresponding to the OM1 to OM7 regime classification of the EN 1186 series. US FDA conditions of use A through H range from high-temperature heat sterilization (for example, 121°C) down to frozen and refrigerated storage, with the extraction protocol defined by the intended use category.

Standardized Methods and Instrumentation

• EN 1186 series: overall migration into aqueous, acidic, alcoholic, and olive oil simulants using total immersion, cell, or pouch methods.
• EN 13130 series: determination of specific migration of monomers such as vinyl chloride, acrylonitrile, 1,3-butadiene, and caprolactam.
• EN 1388-1 and EN 1388-2, ISO 6486-1 and ISO 6486-2, and ISO 8391: release of lead and cadmium from ceramic ware and glass in contact with food.
• ISO 4531-1 and ISO 4531-2: release of lead and cadmium from vitreous enamels.
• EN 645 and EN 646: colorfastness of paper and board in cold and hot water extraction.
• Gravimetric determination for overall migration; GC-MS, GC-FID, HPLC, and LC-MS/MS for organic migrants such as BPA, phthalates, melamine, formaldehyde, PAAs, MOSH/MOAH, and PFAS; ICP-OES and ICP-MS for heavy metals and elemental migrants; UV-Vis spectrophotometry for selected colorimetric determinations.
• FDA extraction procedures based on the chemistry recommendations for food contact notifications, including sequential extraction for repeated-use articles under 21 CFR 177.2600.

Upon successful assessment for EU plastic articles, a Declaration of Compliance (DoC) must be issued in accordance with Article 16 of Regulation (EC) No 1935/2004 and Annex IV of Regulation (EU) No 10/2011, accompanied by supporting test reports and compliance documentation.

Applications

Compliance assessment for food contact materials applies to a wide range of consumer and industrial products exported to Europe and North America, including:

• Tableware and kitchenware: plates, bowls, cups, mugs, cutlery, chopsticks, straws, and reusable food containers.
• Cookware and bakeware: non-stick pans, pots, silicone molds, baking sheets, oven-safe glassware, and grill accessories.
• Food packaging: plastic films, rigid containers, beverage bottles, cartons, cans, jars, lids, and closures.
• Small kitchen appliances: blender jars, coffee machine components, kettle internals, air fryer baskets, and food processor bowls.
• Food processing and catering equipment: conveyor belts, seals, gaskets, tubing, tanks, and dispensing components.
• Special-care products: baby bottles, feeding teats, children's drinking ware, and school lunch boxes, which are frequently subject to enhanced market surveillance and stricter buyer specifications.

FAQ

Q1: What is the main difference between EU and US food contact regulation?

A1: The EU system is based on a horizontal framework Regulation (EC) No 1935/2004 with positive lists and migration limits for harmonized sectors such as plastics, supplemented by national law for non-harmonized materials. The US system regulates food contact substances as food additives under 21 CFR Parts 174 to 179 and the FCN program, focusing on compositional specifications, extractables data, and calculated dietary exposure rather than a universal overall migration limit.

Q2: Which food simulant and test condition should be used for my product?

A2: Simulants and conditions are determined by the intended food type, contact time, and maximum use temperature declared by the manufacturer. A reusable PP lunch box used with hot food, for example, would typically be tested at 2 hours at 70°C or the equivalent accelerated condition, whereas a PET beverage bottle for long-term room-temperature storage is tested for 10 days at 40°C. Accredited third-party laboratories select the worst foreseeable conditions based on the declared use.

Q3: Is a Declaration of Compliance mandatory for exports to the EU?

A3: Yes, for plastic materials and articles, regenerated cellulose films, and ceramics covered by EU harmonized legislation, a written Declaration of Compliance must be available at all stages of the supply chain except retail. Professional buyers and EU importers routinely request the DoC together with the supporting test reports before shipment.

Q4: How many samples are required for testing?

A4: Sample quantity depends on the material types, colors, sizes, and test scope. As a general rule, each distinct material and color combination should be evaluated separately, with approximately 30 to 100 pieces or 100 to 300 grams of material per configuration, depending on the item geometry and whether overall migration, specific migration, and heavy metals are all included.

Q5: How long is a test report valid?

A5: Test reports reflect the composition of the tested sample. Re-testing is required when the formulation, raw material supplier, production process, or design changes, and most professional buyers accept reports no older than one year, in line with typical supply-chain quality agreements. Annual verification testing is a common industry practice.

Q6: Can domestic test reports, such as those issued under GB 4806 standards, be used for EU and US export?

A6: No. GB 4806 compliance demonstrates conformity with Chinese national standards, which differ in simulants, test conditions, and limit values from Regulation (EU) No 10/2011 and FDA 21 CFR requirements. Separate assessments against the target market regulations are necessary, although GB test data can provide useful preliminary information during product development.

Q7: What should be done if a product fails the assessment?

A7: Failure typically indicates excessive migration or the presence of a non-authorized substance. Corrective actions include reformulating the material, changing the raw material grade, adjusting processing parameters, adding functional barriers, or restricting the declared conditions of use. A re-test of the modified article should confirm compliance before export.