Food Contact Materials Safety and Compliance

What Are Food Contact Materials (FCMs)?

Food Contact Materials (FCMs) are any materials or articles intended to come into contact with food. This includes a wide range of products that serve as packaging, containers, processing equipment, utensils, kitchenware, and machinery components used throughout the entire food supply chain. Whether it is the plastic wrap around your sandwich, the metal can containing your soup, or the stainless-steel conveyor belt in a food processing plant, each of these is a food contact material.

These materials are not merely passive holders of food. They serve multiple functions including preserving freshness, extending shelf life, preventing contamination, enhancing convenience, and often contributing to the product’s appearance and appeal. Because they are in direct contact with food, any interaction between the material and the food can potentially affect both the safety and the quality of the food.

Examples of food contact materials include

Plastic containers used for storage and packaging
Glass jars for preserved goods
Metal cans for beverages and canned foods
Paper and cardboard used in fast food packaging
Ceramic plates and cookware
Coated or lined materials such as coffee cups or soup cartons
Adhesives and inks used in labeling and seals
Rubbers and elastomers used in machinery seals or kitchen tools

The scope of food contact materials extends beyond obvious packaging items. Machinery used during food production and processing often contains parts that touch the food directly. Therefore, even industrial equipment components are categorized under FCMs if they have food contact surfaces.

The importance of carefully controlling the quality, composition, and compliance of these materials cannot be overstated. Any failure in these materials may introduce chemical contaminants, microbiological hazards, or physical particles into food products. Regulatory bodies worldwide have established stringent rules to manage these risks, but ensuring safety still requires vigilant testing, certification, and supply chain oversight.

Common Types of Food Contact Materials

Not all food contact materials are created equal. Each type comes with its own set of advantages, challenges, and regulatory concerns. Understanding these distinctions is essential for manufacturers, regulators, and brands that need to ensure both safety and compliance. Here is a deep dive into the most widely used categories of food contact materials.

Plastics

Plastics dominate the world of food contact materials due to their versatility, cost-effectiveness, and functional properties. They are used in everything from flexible packaging and containers to caps, lids, films, and coatings.

Common types of plastics in FCMs include:

Polyethylene (PE): Widely used for films, bags, and liners due to its moisture barrier properties.
Polypropylene (PP): Known for its heat resistance, making it ideal for microwaveable containers and hot-fill packaging.
Polyethylene Terephthalate (PET): Common in beverage bottles and food trays because of its strength, clarity, and recyclability.
Polystyrene (PS): Used in disposable cutlery, cups, and food trays.
Polyvinyl Chloride (PVC): Used in some cling films and industrial food processing equipment.

Metals and Alloys

Metals play a crucial role in food processing, storage, and packaging, especially for products requiring long shelf lives or high-strength containment.

Common metals in food contact applications:

Stainless Steel: The workhorse of food processing equipment, cookware, and utensils. Known for its corrosion resistance, durability, and non-reactivity.
Aluminum: Lightweight and highly formable, used extensively in beverage cans, foils, trays, and lids.
Tinplate and Tin-Free Steel (TFS): Used for canned foods due to their corrosion protection after being coated.

Paper and Cardboard

Paper-based materials are widely used for packaging, especially in takeaway food containers, coffee cups, bakery boxes, and frozen food packaging.

Advantages of paper materials:

Lightweight and often recyclable
Cost-effective
Highly printable for branding purposes

Key concerns:

Functional barriers: Many paper materials require coatings or liners to resist moisture, oil, and heat. These coatings can introduce migration risks.
Ink and adhesives: Printing inks and adhesives used in paperboard packaging can contain substances that may migrate into food.
Recycled content: Paperboard made from recycled materials may contain contaminants if not properly treated and controlled.

Regulatory bodies often impose strict controls on paperboard intended for direct food contact, particularly when recycled fibers are used.

Glass and Ceramics

Glass and ceramic materials are favored for their inertness, stability, and reusability. They are widely used for:

Beverage bottles and jars
Baking dishes and storage containers
Tableware and cookware

Advantages:

No chemical migration under normal use
High resistance to heat, cold, and chemical reactions

Risks:

Heavy metals in glazes: In some older or non-compliant ceramics, lead or cadmium may leach from decorative glazes.
Breakage risk: Physical integrity is a safety factor, particularly in commercial foodservice.

Modern regulations strictly control the composition of glazes and decorative finishes to prevent toxic metal release.

Coatings and Adhesives

Coatings play a silent but critical role in many multilayer food contact materials. They act as barriers, prevent corrosion, and enhance shelf stability.

Where coatings and adhesives are found:

Inside metal cans (epoxy resins, acrylics)
On paperboard containers (polyethylene, biodegradable coatings)
Between layers in multilayer laminates (adhesives)

Concerns:

Migration of monomers, plasticizers, and curing agents
Incomplete polymerization can leave reactive residues
Complex supply chains make verification challenging

Adhesives and coatings often have substance-specific migration limits defined in regulatory frameworks.

Recycled Materials

As the food industry moves toward circular economy models, recycled materials are gaining traction. However, they introduce significant complexity in compliance.

Challenges with recycled food contact materials:

Potential contamination: Previous uses may introduce unknown contaminants.
Traceability issues: Full knowledge of input streams is required to ensure safety.
Barrier technologies: Many recycled materials require functional barriers to isolate food from potential contaminants.

These diverse materials serve specific roles across the food industry, but all share one thing in common: they must comply with strict regulatory standards to protect public health. Manufacturers need to fully understand the properties, behaviors, and risks associated with each material type to ensure consistent compliance and product safety.

Key Regulations Governing Food Contact Materials

The world of food contact materials is heavily regulated. Every country that produces or imports food imposes strict standards to ensure that materials in contact with food do not endanger human health. While regulations may differ in structure and scope across jurisdictions, they share one common objective: to prevent harmful substances from migrating into food.

Here is an expert breakdown of the key regulatory frameworks that govern food contact materials globally.

European Union (EU)

The European Union maintains one of the most sophisticated and stringent regulatory systems for food contact materials globally. Compliance within the EU requires navigating a multi-layered framework combining general principles, material-specific rules, substance lists, and continuous updates driven by scientific assessments.

a. Framework Regulation (EC) No. 1935/2004

This is the cornerstone regulation for all food contact materials across the EU. It establishes that FCMs must:

Not endanger human health by transferring harmful substances into food
Not alter the food’s composition, taste, or organoleptic properties
Be manufactured following good manufacturing practice (GMP)

It applies universally across all 17 categories of food contact materials.

b. Plastics Regulation (EU) No. 10/2011

Plastics are governed by Regulation (EU) No. 10/2011, which details:

The Union List of authorized substances (monomers, additives, processing aids)
Specific Migration Limits (SMLs) for individual substances
Overall Migration Limits (OMLs)

Subsequent amendments further refine and tighten these standards:

EU 2016/1416: Updates on specific migration and corrections in the Union List.
EU 2017/752: Modifications to substance authorizations and testing conditions.
EU 2020/1245: The latest consolidated amendment revising numerous SMLs and adding new authorized substances.

c. Ceramic Materials Directive 84/500/EEC & 2005/31/EC

Ceramic food contact articles are regulated separately under Directive 84/500/EEC and its amendment 2005/31/EC, which establish limits on the migration of heavy metals, specifically:

Lead (Pb)
Cadmium (Cd)

d. Epoxy Derivatives Regulation (EC) No. 1895/2005

This regulation restricts the use of BADGE, BFDGE, and NOGE (epoxy derivatives often used in can coatings) due to concerns over their genotoxic potential.

e. AP (2004) Council of Europe Resolutions

Although non-binding EU law, many EU countries incorporate these resolutions into national regulations or use them as scientific guidance:

AP(2004)1: Paper and board intended for food contact
AP(2004)4: Rubber materials
AP(2004)5: Silicone elastomers
AP(2004)2: Coatings

f. DGCCRF (France)

The DGCCRF (Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes) issues additional guidance and national controls, especially around paper and recycled materials, which add complexity for market access in France.

g. LFGB (Germany)

Although Germany follows EU legislation, it also enforces national requirements through the LFGB (Lebensmittel- und Futtermittelgesetzbuch):

LFGB Chapters 30 and 31: Cover general FCM safety, especially regarding consumer product safety, non-food chemical safety, and administrative testing authorization for certain products entering Germany.

United States (FDA)

The United States Food and Drug Administration (FDA) governs food contact materials under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The US regulatory approach is substance-based, with a strong emphasis on pre-market safety evaluation for each component that may migrate into food.

a. FDA 21 CFR 170-189: Federal Code of Regulations

The core regulatory framework is detailed in Title 21 of the Code of Federal Regulations (21 CFR), which covers:

21 CFR 170: General food additives provisions (including food contact substances)
21 CFR 174-178: Specific indirect food additive categories
21 CFR 177: Polymers (e.g., polyethylene, polypropylene, polycarbonate)
21 CFR 178: Adjuvants, production aids, and sanitizers used in processing or packaging
21 CFR 181: Prior-sanctioned substances
21 CFR 182-184: GRAS substances
21 CFR 189: Prohibited substances

Manufacturers must ensure that every substance used in contact with food either falls within these approved listings or has received individual authorization.

b. Compliance Policy Guides (CPG 7117.05, 7117.06, 7117.07)

FDA’s Compliance Policy Guides (CPGs) provide critical guidance for enforcement and interpretation of regulatory boundaries for food contact materials:

CPG 7117.05: Color additives used in polymers for food contact.
CPG 7117.06: Adjuvants and indirect additives in processing aids.
CPG 7117.07: Clarifies acceptable levels of incidental additives and residue tolerances.

These CPGs guide FDA inspectors during facility audits and product evaluations.

c. Proposition 65 (California)

Beyond federal FDA regulations, California enforces its own stringent chemical disclosure law known as Proposition 65:

Officially titled The Safe Drinking Water and Toxic Enforcement Act of 1986.
Requires businesses to provide public warnings if their products expose consumers to chemicals identified as carcinogens or reproductive toxins.
Many food packaging materials can fall under Proposition 65 scrutiny if they contain even trace levels of listed substances such as BPA, phthalates, or certain heavy metals.
Compliance is mandatory for products sold in California, regardless of federal FDA clearance.

China (GB Standards)

China’s regulatory framework for food contact materials has undergone rapid modernization, establishing a comprehensive and highly specific system under the National Food Safety Standards (GB standards). Compliance is mandatory for all food contact products entering or manufactured in the Chinese market.

a. Framework System

The overarching framework is based on:

GB 4806.1-2016: General Safety Requirements for Food Contact Materials and Articles
This core standard sets general principles applicable to all materials, covering safety assessment, migration limits, and labeling obligations.
GB 9685-2016: Standards for the Use of Additives in Food Contact Materials and Articles
This functions as China’s positive list, specifying all permitted additives, their application scopes, and maximum usage levels. Any additive not listed must undergo a formal safety assessment and approval process before use.

b. Material-Specific Standards

China has developed detailed technical standards for individual categories of food contact materials. Each category must meet both general safety requirements (GB 4806.1-2016) and its corresponding specific standard:

GB 4806.2-2015: Pacifiers
GB 4806.3-2016: Enamelware
GB 4806.4-2016: Ceramics
GB 4806.5-2016: Glass
GB 4806.7-2023: Plastics
GB 4806.8-2022: Paper and Cardboard
GB 4806.9-2023: Metals
GB 4806.10-2016: Coatings
GB 4806.11-2023: Rubber
GB 4806.12-2022: Bamboo and Wood
GB 4806.13-2023: Composite Materials
GB 4806.14-2023: Printing Inks
GB 4806.15-2024: Adhesives

Other Jurisdictions

While the EU, US, and China dominate global standards, many other countries maintain their own food contact material regulations that require careful consideration for international trade.

a. Japan

Regulated under the Japanese Food Sanitation Act.
The Japan Hygienic Olefin and Styrene Plastics Association (JHOSPA) provides voluntary but widely recognized industry standards.

b. Korea

Regulated under the Food Sanitation Act administered by the Ministry of Food and Drug Safety (MFDS).
Maintains mandatory material-specific standards and a Positive List System covering base polymers, additives, colorants, and coatings.

d. Australia and New Zealand

Regulated under Food Standards Australia New Zealand (FSANZ).
Adopt a risk assessment-based approach aligned with Codex Alimentarius guidelines.

d. MERCOSUR (South America)

Applies unified standards across member countries like Brazil, Argentina, Paraguay, and Uruguay.
Regulations are generally compatible with EU standards but contain local variations.

e. ASEAN (Southeast Asia)

Working toward regional harmonization through the ASEAN Food Contact Material Framework, though national regulations still differ considerably between countries.

Food contact materials sit at the core of modern food safety. While often invisible to the consumer, they serve as the first barrier protecting food from contamination, degradation, and safety risks. From the most common plastic packaging to sophisticated multilayer laminates and high-grade processing equipment, every material that touches food plays a role in safeguarding public health.

To maintain leadership in the global marketplace, staying ahead of evolving food contact material regulations is critical. As regulatory authorities continue to refine their frameworks in response to new scientific findings and emerging materials, only those with deep technical knowledge and robust compliance systems will thrive.

For businesses seeking reliable expertise in testing, compliance, and certification of food contact materials, partnering with a trusted laboratory like ECQA offers the assurance needed to protect products, brands, and most importantly, consumers.