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◉ FDA Introduction of Food Contact Materials
The U.S. Food and Drug Administration (FDA) is one of the executive agencies of the U.S. government under the Department of Health and Human Services (DHHS). As a scientific management agency, the US FDA's responsibility is to ensure the safety of food (including food additives), food contact materials, medical devices, radioactive products and pharmaceuticals produced or imported in the United States. The above products must be registered or certified by the FDA before they can be sold in the US market. The US FDA considers food packaging materials to be within the scope of food additive management.
◉ Control Requirements
FDA's regulatory requirements for food contact materials and articles depend on the single substance (FCS) contained in the article. A single substance that will migrate to food in the intended use of food contact materials and articles shall meet one of the following conditions:
(1) Regulated by Title 21 of the Code of Federal Regulations (21 CFR)
(2) Belonging to generally recognized as safe substances (GRAS, generally recognized as safe)
(3) Prior-sanctioned substances
(4) Meet the threshold exemption (TOR, Threshold of Regulation)
(5) Food Contact Substance Notification (FCN, Food Contact Substance Notification)
If food contact materials and articles contain any food contact substances that do not meet the above 5 conditions, that is, new food contact substances or uses, it is necessary to submit a food contact notification (FCN) to the FDA and obtain approval.
If food contact materials and products do not contain new food contact substances or have no new uses, companies can test food contact materials to prove that they meet the requirements of relevant FDA regulations.
◉ Food Contact Substance Notification (FCN)
Section 409 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) establishes the Food Contact Substance Notification (FCN) process as FDA's primary means of regulating food contact substances (FCS). The FCN notification must contain sufficient scientific information, such as chemical information, toxicological information, etc., to demonstrate that the food contact substance is safe for its intended use.
Notification process: (1) Background investigation; (2) Data gap analysis, PNC consultation (if necessary); (3) Arrangement of experiments; (4) Evaluation materials, dossier preparation; (5) Dossier submission; (6) FDA first Phase review (dossier integrity); (7) FDA Phase II review (safety assessment); (8) FCN entry into force.
Information requirements for notification:
The first part PART I - basic information of the enterprise
PART II - CHEMICAL INFORMATION
PART III PART III - SAFETY ASSESSMENT INFORMATION
Part IV - Environmental Assessment Information
Part V PART V - Statement
Part VI PART VI - Attachment List
◉ Common FDA Testing Items
(1) Organic coatings, metals and electroplated articles require U.S. FDA CFR 21 175.300.
Deionized water leaching method, 8% alcohol leaching method, n-heptane leaching method
(2) Requirements for paper products U.S. FDA CFR 21 176.170
Chloroform soluble extract (deionized water leaching method, 8% alcohol leaching method, 50% alcohol leaching method, n-heptane leaching method)
(3) Timber requirements U.S. FDA CFR 21 178.3800
Pentachlorophenol PCP
(4) ABS requires U.S. FDA CFR 21 181.32 or 180.22.
Deionized water leaching method, 3% acetic acid leaching method, 8% alcohol leaching method, n-heptane leaching method
(5) Acrylic resin (Acrylic) requires U.S. FDA CFR 21 177.1010
Total extract (in water, 8%, 50% alcohol fraction, heptane) deionized water, 8% alcohol
KMnO4 oxidizable extractive(in water,8%,50%alcohol fraction)
Ultraviolet-absorbing(in water,8%,50%alcohol fraction)
Ultraviolet-absorbing (in heptane fraction)
(6) Requirements for sealing rings and sealing gaskets of food containers, such as silicone rubber rings U.S. FDA CFR 21 177.1210
chloroform soluble extract
(7) EVA requirements U.S. FDA CFR 21 177.1350
Chloroform extraction
(8) Requirements for melamine resin (melamine) U.S. FDA CFR 21 177.1460
chloroform soluble extract
(9) Requirements for nylon plastics U.S. FDA CFR 21 177.1500
Density, melting point, solubility in hydrochloric acid, deionized water leaching, 95% alcohol leaching, ethyl acetate leaching, benzene leaching
(10) PP requirements U.S. FDA CFR 21 177.1520
Density, melting point, n-hexane leaching method, xylene leaching method ..
(11) PE, OP requirements U.S. FDA CFR 21 177.1520
Density, n-hexane leaching method, xylene leaching method
(12) PC Requirements. U.S. FDA CFR 21 177.1580
Water reflux extraction, 50% alcohol reflux extraction, n-heptane reflux extraction
(13) PET requirements U.S. FDA CFR 21 177.1630.
Chloroform soluble extract (deionized water leaching method, 8% alcohol leaching method, 95% alcohol leaching method, n-heptane leaching method)
(14) PS requirements U.S. FDA CFR 21 177.1640
Residue of styrene monomer
(15) Polysulfone resin requirements U.S. FDA CFR 21 177.1655
Deionized water leaching method, 3% acetic acid leaching method, 50% alcohol leaching method, n-heptane leaching method
(16) Polyimide resin (PU) requirements U.S. FDA CFR 21 177.1680
Abrasion test, deionized water leaching method, 8% alcohol leaching method
(17) Styrene block polymer U.S. FDA CFR 21177.1810
Deionized water leaching method, 50% alcohol reflux extraction, solubility, molecular weight, glass transition temperature
(18) MMA, MBS requirements.. U.S. FDA CFR 21 177.1830
Non-volatile residue
KmnO4 oxidized water extractives
KmnO4 oxidized 8% ethanol extractives
UV absorbing water extractives
UV absorbing 8% ethanol extractives
UV absorbing n-heptane extractives
(19) Urea-formaldehyde resin (UF) requirements U.S. FDA CFR 21 177.1900
Deionized water leaching method, 8% alcohol leaching method, n-heptane leaching method
(20) PVC requirements U.S. FDA CFR 21 175.300
Deionized water leaching method, n-heptane leaching method, 8% alcohol leaching method, VCM monomer residue
(21) Polyester resin requirements U.S. FDA CFR 21 177.2420
chloroform soluble extract
(22) Rubber requirements (SBS, TPR, TPE) silicone and other elastomers U.S. FDA CFR 21 177.2600
Deionized water leaching method, n-hexane leaching method (only for fatty food contact)
(23) Requirements for silver-plated products U.S. FDA CPG 7117.05
lead extraction
(24) Requirements for ceramics, glass, and enamelware U.S. FDA CPG 7117.06,07
Dissolution lead and cadmium test
(25) Metal requirements U.S. FDA CFR 175.300 & CPG 7117.05
Deionized water leaching, 8% alcohol leaching, n-heptane leaching, lead extraction
◉ What is the FDA Registration Process for Food?
(1) Consultation - the applicant provides product information pictures or describes the products that need to apply for FDA through description;
(2) Quotation --- Quotation to the applicant;
(3) The applicant shall fill in the test application form after confirming the quotation;
(4) The engineer registers on the FDA system according to the information provided by the customer;
(5) Receive FDA confirmation letter + certificate (agent).
◉ Standard sample size requirements
Different products require different sample sizes.
The following standard sample size is available for reference: 600cm2 for plastic products. 50 grams of stainless steel. Six molded ceramic products. Glass and sugar porcelain products are the same as ceramic products. Paper products 1000cm2. Coating sample 400cm2. Silicone and rubber products 100cm2.
◉ Compliance Services
The United States is one of the main export regions for Chinese kitchenware, small kitchen appliances, and other products. Food contact products exported to the United States shall comply with the requirements of Title 21 of the Code of Federal Regulations (CFR).
Jiayu Testing has a professional testing technology team, equipped with advanced instruments and equipment, proficient in various regulatory standards, and specializes in providing FDA food contact material testing services for various food contact materials to ensure that your products meet regulatory requirements. Welcome to contact us at 400-9269-886!
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