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A substance intended for use as a component of materials used in manufacturing, packaging, transporting, or holding food is regulated as food contact material. In the United States, food contact materials are considered as indirect additives and are incorporated into the food additive safety regulatory system. The FDA primarily controls most food contact products through the Food Additives Petition (FAP). If a food contact material is approved for use under the FAP, this material will be entered into the US FDA CFR 21 PARTS 170-189 or some other corresponding regulations.
The US food contact materials regulations or policy guidelines are the cornerstone of the US food contact material safety regulatory regime. They determined the functional division and enforcement scope of the food safety materials regulatory agencies in the US and ensured the quality and safety of food contact materials. According to the Food Drug and Cosmetic Act (FD&C Act) and Title 21 Code of Federal Regulations (21 CFR), Food contact materials or articles meet the requirements only if all food contact materials are FDA-approved. Unlike the EU, declaration of compliance (DOC) is not compulsory for food contact materials in the USA. However, the customer can ask the manufacturer for a letter of guaranty that the substance or material can be used for the intended food contact.
It should be noted that only food-contact materials that migrate into food require FDA clearance before marketing. If a substance can be separated from food by a functional barrier and prevent migration, the substance will not be considered as a food contact materials and therefore not require FDA clearance.
Manufacturers can operate in accordance with the GMP system (Quality management procedures and specifications of Hygienic production)
Use materials approved in accordance with the regulations (U.S. FDA CFR 21 Part 170-189)
Approved raw materials should meet the technical indicators in the specification (U.S. FDA CFR Part 170-189)
Any new materials entering the market must be reviewed and approved by U.S. FDA (similar with the new EU food grade regulations 2004/1935/EC)
If a food contact substance does not migrate or has little leakage to the food, the FCN program can be used to request an FDA license to submit relevant chemical and toxicological information to demonstrate the safety of its use.
There are two types of FCN programs:
1. A single new component of the FCN program
2. The FCN procedure for the ingredients that the FDA has collected
The FCN license has certain specialties and only the holder of the FCN has the right to produce and sell the product. Once a food contact company obtains an FCN license, it can increase the competitiveness of the company and obtain a fixed customer base, thereby achieving considerable economic benefits. However, the FCN application requires a large amount of information, professionalism, and complex regulatory requirements. The company can entrust a professional consulting company to assist in the completion, which can shorten the application period and increase the success rate of the application.
Products normally involved in food contact materials include:
1. Electrical products in contact with food such as toasters, sandwich ovens and electric kettles
2. Food storage products, reinforced glass cutting board, stainless steel and other kitchen utensils
3. Tableware, cutlery, spoon, cup and other dishes
Vessels shipped to California must comply with the California Proposition 65 regulations (including the part of the vessel that is in contact with the food, the exterior trim, the cup side). The products are:
1. Glass and ceramics for storing and carrying food or beverages
2. Glass and ceramic products not in contact with food or beverages (commodity)
Table 1 FDA Certification Testing Items for Food Contact Materials (ten of them)
|Material||Testing Item||Testing Standard|
|Olefin polymers||Density, Melting Point (MP) or softening point(SP), Maximum extractable fraction in N-hexane, Maximum soluble fraction in xy-lene||21CFR177.1520|
|Polycarbonate resins||Water extractive, 50% alcohol extractives, n-hexane extractives||21CFR177.1580|
|Acrylonitrile/styrene copolymer||Maximum residual acrylonitrile monomer content of finished article, Nitrogen content of copolymer, Maximum extractable fractions at specified temperatures and times, Conformance with certain specifications||21CFR177.1040|
|Polystyrene and rubber-modified polystyrene||Total residual styrene monomer content||21CFR177.1640|
|Styrene block polymers||Maximum extractable fraction in distilled water, Maximum extract-able fraction in 50% ethanol at specified temperatures, times, and thicknesses||21CFR177.1810|
|Acrylonitrile copolymers and resins||The amount of Acrylonitrile monomer migrated into the distilled water, 8% or 50% ethanol, 3% acetic acid, and either n-heptane||21CFR181.32|
|Closures with sealing gaskets for food containers||Chloroform fraction of water, heptane and alcohol extractives||21CFR177.1210|
|Resinous and polymeric coatings||The extractants from water, heptane and 8% alcohol||21CFR175.300|
|Melamine-formaldehyde resins in molded articles||The extractants from water, heptane and 8% alcohol||21CFR177.1460|
|Nylon resins||Specific gravity, Melting point, Solubility in boiling 4.2N HCl, Viscosity, Maximum extractable fraction in selected solvents(Water, 95% ethylalcohol, ethylacetate and benzene)||21CFR177.1500|
21 CFR 170-199, Revised as of April 1, 2013, FDA
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