Close
Loading the player ...
Download Avery Dennison compliance certificates
Close
Loading the player ...
Food Contact Substances Flowchart
Close
Loading the player ...
Food Contact Notifications
Close
Loading the player ...
FDA on Food Contact Substances
Close
Loading the player ...
21 CFR Parts 170-199

 

 

 

 

 

 

 

 

 

 

 

 

 

Close
Loading the player ...
FDA Guidance on FCNs
Close
Loading the player ...
Inventory of Effective Food Contact Substance (FCS) Notifications

Food Ingredients and Packaging

 

The most common case in which FDA requirements may be applicable to Avery Dennison materials and products is for food contact substances. Food contact substance (FCS) means any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food, if use of the substance is not intended to have any technical effect in such food. An FCS can be considered an indirect additive (see below). There are specific FDA requirements for FCSs. See the FCS flowchart. Manufacturing conditions for food contact products need to meet general standards of suitable purity for the intended use.

Food additive means a substance, the intended use of which results or may reasonably be expected to result, directly or indirectly, either in its becoming a component of food or otherwise affecting the characteristics of food.

There are several categories of food additives:

  • direct additive is intended to have a technical effect on food. Approved direct additives are listed in 21 CFR Part 172.
  • secondary direct additive is intended to have a technical effect during food processing, but not in the finished food as consumed. Approved secondary direct additives are listed in 21 CFR Part 173.
  • An indirect additive in intended to have a technical effect in (e.g., be a component of) a food contact material. Approved indirect additives are listed in 21 CFR parts 175 – 178. The regulations contain separate sections for adhesive and coatings; paper and paperboard; polymers; and adjuvants, production aids, and sanitizers.
  • Any substance that is added to food and imparts color to the food is a color additive.
 

Food additives need to be cleared by FDA, either through listing in 21 CFR Parts 173-186, or submission of food additive petition or food-contact notification. See the FCS flowchart for additional information on exemptions as relevant to FCSs. FDA's Center for Food Safety and Applied Nutrition (CFSAN) implements many other programs to regulate the food supply, the content of food labeling, and dietary supplements. Product labels, literature, and other information should not make general approval claims such as "Approved by FDA."

Food Contact Notifications

 

In some cases it may be necessary to submit a food contact notification (FCN) to FDA before manufacturing or using a food contact substance (FCS). An FCN generally is not necessary if the substance is listed as a food additive in 21 CFR Parts 173-186 or meets exemption conditions. See the Food Contact Substances Flowchart for additional information on exemptions.

A manufacturer or supplier of an FCS may submit an FCN to FDA. If FDA does not object in writing, the FCN clears in 120 days, and the submitter and its customers may market the substance for the described use. Under certain circumstances (related to increase in dietary intake or potential carcinogenicity), a full petition may be required for an FCS. FDA has issued guidance on FCNs.

FCNs are proprietary and apply only to the submitter and its customers. Persons who purchase a food contact substance manufactured or supplied by a manufacturer or supplier identified in an effective notification may rely on that notification to legally market or use the food contact substance for the use that is the subject of the notification, consistent with any limitations in that notification. FDA's keeps a database Inventory of Effective Food Contact Substance (FCS) Notifications.

FCNs require information on chemical identity, intended conditions of use, intended technical effect, estimation of dietary intake, and toxicity and environmental information. 

There are two types of FCNs:

  • Notification for a new use of a FCS (Form 3480).
  • Notification for the use of an FCS formulation (Form 3479). This is used to verify that components of a formulation may be used when there is no new FCS (or new use of an FCS) in the formulation.

A new FCN is necessary:

  • when substantive changes are made to specifications for the FCS; and
  • for a manufacturer other than the specified manufacturer;
  • when changes are made in the manufacturing method that result in substantive changes in the identity of the product or its impurities.

The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.