US Food Contact Material Testing

1. Introduction to US Food Contact Material FDA

The U.S. Food and Drug Administration (FDA) is one of the executive agencies under the Department of Health and Human Services (DHHS) of the U.S. government. As a scientific regulatory body, the FDA is responsible for ensuring the safety of food (including food additives), food contact materials, medical devices, radiation products, and drugs produced or imported into the United States. These products must be registered or certified by the FDA before they can be sold in the U.S. market. The FDA considers food packaging materials to fall under the scope of food additive regulation.

2. Regulatory Requirements

The FDA's regulatory requirements for food contact materials and articles depend on the individual substances (FCS) contained in the article. The individual substances in food contact materials and articles that may migrate into food under intended conditions of use must meet one of the following conditions:

(1) Regulated under Title 21 of the Code of Federal Regulations (21 CFR)

(2) Generally Recognized as Safe (GRAS)

(3) Prior-sanctioned substances

(4) Meeting the Threshold of Regulation (TOR)

(5) Having a Food Contact Substance Notification (FCN) submitted

If a food contact material or article contains any food contact substance that does not meet the above five conditions, i.e., a new food contact substance or use, a Food Contact Notification (FCN) must be submitted to the FDA for approval.

If the food contact material or article does not contain new food contact substances or new uses, companies can demonstrate compliance with relevant FDA regulations by conducting food contact material testing.

3. 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 the FDA's primary means of regulating food contact substances (FCS). An FCN must contain sufficient scientific information, such as chemical and toxicological data, 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 needed); (3) Arranging testing; (4) Material evaluation, dossier preparation; (5) Dossier submission; (6) FDA Phase I review (dossier completeness); (7) FDA Phase II review (safety assessment); (8) Effective.

Notification documentation requirements:

Part I – Basic company information

Part II – Chemical information

Part III – Safety assessment data

Part IV – Environmental assessment data

Part V – Declaration

Part VI – List of attachments

4. Common FDA Testing Items

(1) Organic coatings, metal and electroplated products: U.S. FDA CFR 21 175.300.

Deionized water extraction, 8% alcohol extraction, n-heptane extraction

(2) Paper products: U.S. FDA CFR 21 176.170

Chloroform-soluble extractives (deionized water extraction, 8% alcohol extraction, 50% alcohol extraction, n-heptane extraction)

(3) Wood: U.S. FDA CFR 21 178.3800

(4) ABS: U.S. FDA CFR 21 181.32 or 180.22.

Deionized water extraction, 3% acetic acid extraction, 8% alcohol extraction, n-heptane extraction

(5) Acrylic resins: U.S. FDA CFR 21 177.1010

Total extractives (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) Sealing rings and gaskets for food containers, e.g., silicone rubber rings: U.S. FDA CFR 21 177.1210

Chloroform-soluble extractives

(7) EVA: U.S. FDA CFR 21 177.1350

Chloroform extraction

(8) Melamine resin: U.S. FDA CFR 21 177.1460

Chloroform-soluble extractives

(9) Nylon plastics: U.S. FDA CFR 21 177.1500

Density, melting point, solubility in hydrochloric acid, deionized water extraction, 95% alcohol extraction, ethyl acetate extraction, benzene extraction

(10) Requirements: U.S. FDA CFR 21 177.1520

Density, melting point, n-hexane extraction, xylene extraction..

(11) PE, PP: U.S. FDA CFR 21 177.1520

Density, n-hexane extraction, xylene extraction

(12) PC: U.S. FDA CFR 21 177.1580

Water reflux extraction, 50% alcohol reflux extraction, n-heptane reflux extraction

(13) PET: U.S. FDA CFR 21 177.1630.

Chloroform-soluble extractives (deionized water extraction, 8% alcohol extraction, 95% alcohol extraction, n-heptane extraction)

(14) Requirements: U.S. FDA CFR 21 177.1640

Residual styrene monomer

(15) Polysulfone resin: U.S. FDA CFR 21 177.1655

Deionized water extraction, 3% acetic acid extraction, 50% alcohol extraction, n-heptane extraction

(16) Polyurethane resin (PU): U.S. FDA CFR 21 177.1680

Abrasion resistance test, deionized water extraction, 8% alcohol extraction

(17) Styrene block polymer: U.S. FDA CFR 21 177.1810

Deionized water extraction, 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): U.S. FDA CFR 21 177.1900

Deionized water extraction, 8% alcohol extraction, n-heptane extraction

(20) PVC: U.S. FDA CFR 21 175.300

Deionized water extraction, n-heptane extraction, 8% alcohol extraction, residual VCM monomer

(21) Polyester resin: U.S. FDA CFR 21 177.2420

Chloroform-soluble extractives

(22) Rubber requirements (SBS, R, E), silicone and other elastomers: U.S. FDA CFR 21 177.2600

Deionized water extraction, n-hexane extraction (only for contact with fatty foods)

(23) Silver-plated products: U.S. FDA G 7117.05

Lead extraction

(24) Ceramic, glass, enamelware: U.S. FDA G 7117.06,07

Lead and cadmium leaching test

(25) Metal requirements: U.S. FDA CFR 175.300 & G 7117.05

Deionized water extraction, 8% alcohol extraction, n-heptane extraction, lead extraction

5. What is the FDA Registration Process for Food?

(1) Consultation---The applicant provides product information, images, or describes the product requiring FDA registration;

(2) Quotation---Provide a quote to the applicant;

(3) After confirming the quote, the applicant fills out the test application form;

(4) The engineer registers the product in the FDA system based on the information provided by the client;

(5) Receive FDA confirmation letter + certificate (from the agent).