FCN(Food Contact Notifications). In order to ensure food safety, the 1958 regulation required that all food additives (direct and indirect) be approved by the Food and Drug Administration (FDA) before they could be used. For indirect food additives (food contact substances), the FDA has established a food contact notification procedure, which stipulates that substances that are not approved by the FDA and are not prohibited from permitted use need to prepare detailed materials and submit a notice to the FDA, which is called a food Contact Notice (FCN). FCN specificity: The FCN notification in the United States is only valid for the manufacturer/supplier of the substance that has applied, and other manufacturers/suppliers need to declare the same substance to the FDA, and can only use/sell it after the declaration is passed.

Pass declaration of conformity

Manufacturers of food contact materials and products may also be required by downstream customers to provide a Letter of conformity (Guaranty) to certify that the company's products are suitable for the intended food contact use. Section 303 of the Federal Food, Drug, and Cosmetic Act provides that anyone who receives a warranty of conformity from upstream will not be penalized for receiving or providing an adulterated or mislabeled food additive.

· Food Contact Substance (FCS) : Any substance intended to be used in the manufacture, packaging, packing, transportation, or storage of materials used in food, while the use of the substance is not intended to have any technical effect on food. Food contact substances are single substances, such as antioxidants, stabilizers, additives in plastic or paper.

·   Food Contact Material (FCM) : made from food contact substance FCS and other substances, usually a mixture or material, such as resins, adhesives, and inks.

·   Food Contact Article: Finished products made from food contact materials, such as bottles, bags, trays, etc.

FDA's regulatory requirements for food contact materials and products depend on the individual substances (FCS) contained in the product. Food contact materials and products that migrate to food in their intended use as a single substance should meet one of the following conditions:

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

·   generally recognized as safe (GRAS, generally recognized as safe)

·   Prior-sanctioned substances

·   Meeting Threshold of Regulation (TOR)

·   Food Contact Substance Notification (FCN, Food Contact Substance Notification)

If food contact materials and products contain any food contact substance that does not meet the above five conditions, that is, a new food contact substance or use, a food contact notification (FCN) is required to be submitted to FDA for approval.

·   PART I - Basic Information

·   PART II - Chemical Information

·   PART III - Safety Assessment Data

·   PART IV - Environmental Assessment Data

·   PART V - Declaration

·   PART VI - List of Attachments