Electronics Guide

Food Contact Substance Framework

The FDA defines a food contact substance (FCS) as any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect on the food itself. Electronic components in food processing equipment typically fall under this definition when they may contact food directly or indirectly.

Substances may be authorized for food contact use through several pathways. Prior-sanctioned substances received FDA or USDA approval before 1958 and remain authorized for their original uses. Generally recognized as safe (GRAS) substances have been determined safe by qualified experts based on scientific procedures or, for substances in use before 1958, through experience based on common use in food. Food additives require premarket approval through the food additive petition process. Food contact notifications provide an expedited pathway for substances meeting specific criteria.

Food Contact Notification Program

The Food Contact Notification (FCN) program, established in 2000, allows manufacturers to notify FDA of new food contact substances rather than submitting full food additive petitions. An FCN becomes effective 120 days after FDA receives a complete notification unless the agency objects. The FCN is specific to the notifier and the described use conditions, meaning other manufacturers cannot rely on an FCN for their products without their own authorization.

For electronic applications, the FCN program has been used to authorize various polymers, coatings, and adhesives that may contact food. The notification must include comprehensive safety data including migration studies, toxicological evaluations, and detailed descriptions of manufacturing conditions. Environmental assessments or claims of categorical exclusion must also be provided to address potential environmental impacts of the substance's use.

Indirect Food Additives Regulations

Title 21 of the Code of Federal Regulations (CFR) Parts 174 through 179 contain specific regulations for indirect food additives. Part 175 covers adhesives and coatings, Part 176 addresses paper and paperboard components, Part 177 regulates polymers, and Part 178 covers adjuvants and production aids. These regulations specify authorized substances, use conditions, and any limitations on food types or temperatures.

Electronics manufacturers must identify which specific regulations apply to their materials. For example, a conformal coating on a circuit board used in food processing equipment must comply with applicable sections of Part 175. Polymer housings and encapsulation materials must meet the requirements of Part 177. When existing regulations do not cover a material, manufacturers must pursue FCN submission or demonstrate that the substance qualifies as GRAS.

General Requirements

Framework Regulation 1935/2004 establishes the fundamental principle that materials and articles must be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could endanger human health, bring about an unacceptable change in the composition of the food, or bring about a deterioration in the organoleptic characteristics of the food.

The regulation requires that materials be accompanied by a declaration of compliance stating that they conform to applicable rules. This declaration must be made available to competent authorities upon request. Adequate documentation must demonstrate compliance, including migration testing results, compositional information, and safety assessments for substances used.

Plastics Regulation

Regulation (EU) No. 10/2011 on plastic materials and articles establishes detailed requirements including a Union list of authorized monomers, additives, and polymer production aids. Only substances included in this positive list may be intentionally used in plastic food contact materials, with specified restrictions on their use. The regulation establishes migration limits including an overall migration limit (OML) of 60 mg/kg food or 10 mg/dm2 of food contact surface area, and specific migration limits (SMLs) for individual substances.

For electronics applications, plastic housings, encapsulants, and coatings must be evaluated against these requirements. Many traditional electronic-grade polymers may not appear on the Union list or may contain additives not authorized for food contact. Manufacturers must carefully select materials or work with suppliers to obtain food-contact-grade variants suitable for their applications.

Other Material-Specific Measures

Beyond plastics, specific EU measures address regenerated cellulose film, ceramics, active and intelligent materials, and recycled plastics. For materials without specific EU measures, including many metals and alloys used in electronics, national measures of EU member states apply. This creates a complex compliance landscape where different requirements may apply in different member states for the same product.

Council of Europe resolutions provide guidance for some materials lacking specific EU measures, including metals and alloys, coatings, rubber, silicones, and paper and board. While not legally binding, these resolutions represent agreed technical guidance that national authorities typically follow when evaluating products. Electronics manufacturers should consider these resolutions when selecting materials for food contact applications.

Food Simulants

Because testing with actual foods would be impractical and irreproducible, regulatory frameworks define food simulants that represent different food categories. EU Regulation 10/2011 specifies five simulants: ethanol 10% (simulant A) for aqueous foods, acetic acid 3% (simulant B) for acidic foods, ethanol solutions from 20% to 50% (simulant C) for alcoholic foods, vegetable oil or substitute (simulant D) for fatty foods, and poly(2,6-diphenyl-p-phenylene oxide) known as Tenax (simulant E) for dry foods.

FDA guidance similarly specifies food simulants appropriate for different food types, though the specific simulants and test conditions may differ from EU requirements. Manufacturers seeking approval in both jurisdictions must often conduct testing with multiple simulant systems to satisfy both sets of requirements.

Testing Conditions

Migration testing must reflect worst-case foreseeable conditions of use including contact time, temperature, and the types of food that may contact the material. For electronics in food processing equipment, this may require testing at elevated temperatures representative of cooking or sterilization conditions. The EU specifies standard conditions ranging from 10 minutes at 20 degrees Celsius for brief room temperature contact to 2 hours at 175 degrees Celsius or higher for high-temperature applications.

Contact ratio, expressed as the ratio of surface area to food volume, significantly affects migration results. Standard conditions typically specify 6 dm2 per kilogram of food simulant. For electronic components where the exact contact ratio in use may be uncertain, testing under conservative assumptions provides confidence that actual use conditions will not exceed tested limits.

Analytical Methods

Overall migration is determined gravimetrically by evaporating the food simulant after contact and weighing the residue. Specific migration requires analytical methods capable of detecting and quantifying individual substances of concern. Gas chromatography, liquid chromatography, and mass spectrometry techniques are commonly employed depending on the substances being measured.

Method validation is essential to demonstrate that analytical results are reliable. Validation parameters include specificity, linearity, accuracy, precision, detection limits, and quantification limits. Laboratories conducting food contact testing should operate under quality management systems and ideally hold accreditation to ISO/IEC 17025 for the relevant test methods.

EU Union List

The Union list in Annex I of Regulation 10/2011 contains over 1,000 authorized substances for plastic food contact materials. Each entry specifies the substance name, CAS number, any restrictions on use, and applicable migration limits. Substances are classified as monomers, other starting substances, macromolecules obtained from microbial fermentation, additives, or polymer production aids.

New substances may be added to the Union list through an authorization process administered by the European Food Safety Authority (EFSA). Applicants must submit comprehensive dossiers including substance identification, manufacturing information, intended uses, migration data, and toxicological evaluations. The evaluation process typically requires 12 to 18 months before a favorable opinion, followed by amendment of the regulation to add the substance to the list.

FDA Inventory

The FDA maintains an inventory of effective food contact notifications and threshold of regulation exemptions. Unlike the EU Union list, FDA clearances through the FCN program are manufacturer-specific. However, substances listed in 21 CFR Parts 174-179 are available for use by any manufacturer meeting the specified conditions. The GRAS status of substances used before 1958 provides another pathway for authorization.

Electronics manufacturers should consult FDA databases and regulations early in the design process to identify authorized materials suitable for their applications. When no existing authorization covers needed materials, the timeline for obtaining new authorizations must be factored into product development schedules.

EU GMP Regulation

Regulation (EC) No. 2023/2006 establishes GMP requirements for all materials and articles intended to contact food. The regulation requires documented quality assurance systems, quality control systems adequate to ensure compliance with applicable rules, and documentation systems that maintain records of manufacturing operations. Detailed documentation requirements apply to materials containing recycled plastics.

For electronics manufacturers producing components for food contact applications, GMP compliance extends to their operations. This may require modifications to manufacturing processes, enhanced documentation, and additional quality controls beyond those typically applied to electronic components. Some manufacturers establish dedicated production lines for food contact products to ensure segregation and prevent contamination.

FDA Current Good Manufacturing Practice

While FDA has not issued specific GMP regulations for food contact materials comparable to EU Regulation 2023/2006, the agency expects manufacturers to follow appropriate quality practices. The FCN program requires information about manufacturing processes, and deficiencies in manufacturing controls may lead FDA to object to notifications. Many manufacturers voluntarily implement GMP systems aligned with industry guidance or international standards.

EU Declaration Requirements

EU Framework Regulation 1935/2004 requires written declarations for materials and articles covered by specific measures. Regulation 10/2011 specifies detailed content requirements for declarations concerning plastic materials, including identification of the material, confirmation of compliance with applicable requirements, identity of substances subject to restrictions, and specifications for use conditions under which compliance has been verified.

Declarations must be updated when significant changes occur in composition, processing, or use conditions. Supporting documentation demonstrating compliance must be made available to enforcement authorities upon request. This documentation typically includes migration test reports, compositional analyses, and safety assessments for any non-listed substances present.

Supply Chain Communication

Effective supply chain communication ensures that compliance information flows from raw material suppliers through component manufacturers to finished product producers. Each participant must receive sufficient information to verify that materials are suitable for their intended use and must provide appropriate information to their customers.

For electronics applications, this creates challenges because traditional electronic component supply chains were not designed to transmit food contact compliance information. Manufacturers of food contact electronics must establish appropriate communication channels with their suppliers to obtain necessary compliance documentation and must communicate relevant information to their customers.

Barrier Requirements

EU Regulation 10/2011 permits the use of non-authorized substances behind a functional barrier, subject to conditions. The substances must not be mutagenic, carcinogenic, or toxic to reproduction. Migration of any non-authorized substance must not exceed 0.01 mg/kg food. Detection limits of analytical methods must be capable of verifying compliance with this migration limit.

For electronics applications, functional barriers can enable the use of standard electronic materials by preventing their contact with food. Barrier materials might include food-grade coatings, metal layers, or structural separations that isolate electronic components from food contact surfaces. Barrier effectiveness must be demonstrated through appropriate testing.

Barrier Integrity Verification

Demonstrating functional barrier effectiveness requires testing that confirms substances behind the barrier do not migrate through it under worst-case use conditions. Testing protocols must account for potential barrier degradation over time, at elevated temperatures, or through mechanical stress. Manufacturing processes must ensure consistent barrier integrity across all production units.

GRAS Determination

A GRAS determination requires that safety be generally recognized among qualified experts. This recognition must be based on publicly available information demonstrating safety under the conditions of intended use. The scientific evidence must be sufficient that experts would not disagree significantly about its safety.

Companies may make their own GRAS determinations (self-determination) or may notify FDA through the GRAS notification program. While self-determination is legally valid, GRAS notification provides FDA review and public transparency that may be valuable for risk management purposes. FDA responds to GRAS notifications with "no questions" letters when it agrees with the determination.

GRAS for Food Contact Use

Many substances used in electronics manufacturing would not qualify as GRAS due to limited publicly available safety data or concerns about their safety profile. However, some materials with extensive use histories and safety data may qualify. Manufacturers should carefully evaluate whether GRAS status provides an appropriate pathway for their specific materials and use conditions.

Regulatory Classification

The classification of a substance as a food contact substance versus a direct food additive affects which regulations apply. If a substance is intended to migrate into food to perform a function there, it must meet food additive requirements even though it also functions in the contact material. Migration of dual-use additives may require authorization under both food contact and direct food additive frameworks.

Antimicrobial Substances

Antimicrobial substances incorporated into food contact materials exemplify dual-use additives. If the antimicrobial is intended only to protect the material itself from microbial degradation, it may be regulated solely as a food contact substance. If it is intended to migrate into food to provide antimicrobial protection there, direct food additive authorization is required. The intended function, not just the actual migration behavior, determines regulatory classification.

EU Approach

EU Regulation 10/2011 requires specific authorization for nanoparticles even when the bulk form of a substance is authorized. The Union list indicates which authorizations cover nanoforms. EFSA has published guidance on risk assessment of nanomaterials in food and feed applications, emphasizing that safety conclusions for bulk materials cannot automatically be extended to nanoforms.

For electronics applications, nanomaterials increasingly appear in sensors, conductive inks, and functional coatings. Manufacturers must verify whether nanomaterial forms of authorized substances require separate authorization or whether existing authorizations adequately cover nanoscale uses.

FDA Approach

FDA has issued guidance on the use of nanomaterials in food and food contact applications. The agency recommends that manufacturers consult with FDA before marketing products containing nanomaterials, even when the non-nanoscale form has been authorized. FDA evaluates nanomaterials case-by-case, considering factors such as particle size, surface properties, and potential for migration and bioaccumulation.

Susceptor Technology

Susceptors typically consist of metallized films that absorb microwave energy and can reach temperatures of 200 degrees Celsius or higher during use. Electronic components such as moisture sensors or doneness indicators incorporated into susceptor packaging must be designed for these extreme conditions.

Regulatory Requirements

Both FDA and EU regulations require evaluation of susceptor materials under conditions representative of actual use. Migration testing must account for the high temperatures achieved during microwave heating. Substances authorized for general food contact use at lower temperatures may not be suitable for susceptor applications without additional safety evaluation.

Technology Categories

Intelligent packaging technologies include time-temperature indicators that track thermal exposure, freshness indicators that detect spoilage gases, RFID tags for product tracking, and electronic displays that communicate product information. Each technology involves different electronic materials with distinct compliance considerations.

EU Active and Intelligent Materials Regulation

EU Regulation (EC) No. 450/2009 establishes specific requirements for active and intelligent materials and articles. Intelligent components must comply with general food contact requirements and must not transfer information to the food that could mislead consumers. The regulation requires Community authorization for substances released by active components but permits intelligent components that do not release substances to follow general food contact requirements.

For intelligent packaging, the regulation requires that the intelligent component be separated from the food by a functional barrier or that all substances in the component be authorized for food contact. Labeling requirements indicate that the component is not edible, and materials must be traceable throughout the supply chain.

Regulatory Framework

Active packaging falls under EU Regulation 450/2009, which requires that substances released by active components be authorized as food additives or through the active and intelligent materials authorization process. The active component must not transfer substances to food in quantities that could endanger human health or bring about unacceptable changes in food composition or characteristics.

Electronic Active Systems

Electronic active packaging systems may include battery-powered heaters or coolers, electrochemically activated antimicrobial generators, or electronically controlled atmosphere modification systems. These systems introduce additional regulatory considerations including battery safety, electromagnetic compatibility, and the compliance status of all components that may contact food.

EU Recycled Plastics Regulation

EU Regulation 2022/1616 establishes requirements for recycled plastic materials and articles in food contact applications. The regulation requires that recycling processes be authorized and that input materials come from controlled sources. Recycling technologies must demonstrate their ability to reduce contamination to safe levels through challenge testing with surrogate contaminants.

For electronics applications, recycled plastics in housings or other components must comply with these requirements when they may contact food. The complexity of electronics recycling streams and the potential for contamination from hazardous substances used in electronics may limit recycled content options for food contact applications.

FDA Approach to Recycled Materials

FDA evaluates recycled materials through its general food contact framework. Letters of no objection may be issued for specific recycling processes that demonstrate adequate contamination reduction. The agency considers the source of recycled material, the recycling process controls, and the potential for contamination when evaluating recycling processes.

Certification Programs

NSF International offers certification programs for food equipment and food contact materials under NSF/ANSI standards. Underwriters Laboratories provides food contact material testing and certification services. European notified bodies offer conformity assessment services for regulated products. These programs typically involve document review, testing, factory inspection, and ongoing surveillance.

Benefits of Certification

Third-party certification provides several advantages for electronics manufacturers serving food contact markets. Certification demonstrates commitment to compliance and may satisfy customer qualification requirements. Ongoing surveillance helps ensure continuing compliance as materials or processes change. Certification marks may enhance market acceptance and customer confidence.

Selecting Certification Bodies

When selecting certification bodies, manufacturers should verify accreditation status, relevant scope of accreditation, and recognition in target markets. Accreditation to ISO/IEC 17065 for product certification or ISO/IEC 17025 for testing laboratories provides assurance of competence. Recognition by regulatory authorities in target markets ensures that certification will be accepted.

Material Selection

Material selection should begin with regulatory research to identify authorized materials suitable for the intended application. Food-grade variants of common electronic materials are increasingly available from specialized suppliers. When standard materials must be used, functional barriers or other design approaches may enable compliance. Early engagement with suppliers and regulatory specialists helps identify viable material options.

Design for Compliance

Design decisions significantly impact compliance feasibility and cost. Minimizing the number of materials in food contact zones simplifies compliance. Incorporating functional barriers can enable the use of standard electronic materials. Designing for cleanability ensures that equipment meets sanitary design requirements beyond material compliance.

Documentation Systems

Comprehensive documentation supports compliance demonstration and facilitates ongoing maintenance. Documentation should include material specifications, supplier declarations, test reports, risk assessments, and compliance determinations. Document control systems should ensure that current documentation is available and that changes are properly managed.