Packaging Requirements for FCM

Packaging Requirements for FCM
USA

The below version control table serves to document all updates made to the report. The purpose is to ensure the information is always accurate and up-to-date.

1. Overview of Regulatory Standards of Food Contact Materials

Definitions [1]

• Food Contact Substance (FCS) is any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food. The Food Contact Substance is a single substance, such as a polymer or an antioxidant in a polymer. As a substance, it is reasonably pure and has a well-defined composition.
• Food Contact Material (FCM) is made with the FCS and (usually) other substances. It is often (but not necessarily) a mixture, such as an antioxidant in a polymer. The composition may be variable.
• Food Contact Article is the finished film, bottle, dough hook, tray, or whatever that is formed out of the FCM.
• Food Additive: any substance the intended use of which results in or may reasonably be expected to result in it becoming a component of food.  A substance that migrates from food packaging into the food itself is considered an indirect food additive.

Standards for food contact material

Food contact substances or substances that come into contact with food through food packaging, storage, or other handling that are food additives must be authorized through either:

1. a food additive regulation,
2. a food contact notification or, 
3. be the subject of a Threshold of Regulation exemption.

The path to compliance is determined by the materials used in the packaging itself [2].

2. Regulatory Requirements on Food Contact Materials (Including Coatings & Materials)

2.1 Food Contact Material Listed in FDA Regulations

These regulations are laid out in 21 CFR Parts 170-190.

These regulations cover almost all classes of food packaging, including plastics, polyolefins, polyesters, polystyrene, polyamides, paper and cardboard, polymeric coatings, additives, and adhesives.

The relevant parts of the CFR are as follows:

• 170-173 - Direct Food Additives
• 174 - Indirect Food Additives: General
• 175 - Indirect Food Additives: Adhesives and Components of Coatings
• 176 - Indirect Food Additives: Paper and Paperboard Components
• 177 - Indirect Food Additives: Polymers
• 178 - Indirect Food Additives: Adjuvants, Production Aids and Sanitizers
• 181 - Prior-sanctioned Food Ingredients
• 182-186 - Substances Generally Recognized as Safe
• 189 - Substances Prohibited from Use in Human Food

Each part is further subdivided into sections. For example, Part 177 is broken into sections that cover different types of polymers. Each section then lists definitions of material types, permitted additives, specifications, test methods, and end-use restrictions.

A compilation of the names of food contact substances (or combinations of substances in the case of, for example, polymers and resins) found in 21 CFR parts 173, 175 - 178, 179.45, 180.22, 181, and 186 can be found at Inventory of Food Contact Substances Listed in 21 CFR [3].

When checking the inventory, the regulation(s) cited for specific substances should always be consulted to understand the regulatory status of a given substance, its allowed intended uses, and conditions of use. 

The inventory also contains information on substances listed in 21 CFR 189 that are prohibited from use as food contact substances.

2.2 Food Contact Notification (FCN) Program

The FCN program is a formal process for the notification (in effect, registration) of food contact materials*.  

Food contact notifications are specific to the company submitting the notification and to the specified intended use of the substance. Manufacturers must ensure that food contact substances follow the specifications and limitations in all applicable authorizations.

Typically, the producer of the food contact substance applies for FCN approval for a new food contact substance or a new application for an approved substance. Users of food contact substances usually don’t apply for FCNs. 

A Food Contact Notice must contain the information noted in the regulation 21 CFR 170.101 [4]. There is no cost to file an FCN.

All effective premarket notifications for food contact substances that have been demonstrated to be safe for their intended use are listed in the Inventory of Effective Food Contact Substance (FCS) Notifications [5]. The list includes the food contact substance (FCS), the notifier, the manufacturer of the FCS, the intended use, the limitations on the conditions of use for the FCS and its specifications, the effective date, and its environmental decision. All 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.

2.3 Threshold of Regular Exemption

The FDA may also grant a substance used in a food-contact article (for example, food-packaging or food-processing equipment) that migrates, or that may be expected to migrate, into food an exemption from regulation as a food additive. In a process described in 21 CFR 170.39 [6], a manufacturer can request a threshold of regulation exemption. This exemption is based on the premise that, below a certain dietary exposure level, the use of a non-carcinogenic substance in a food-contact article is so negligible (below 0.5 ppb) that it does not pose any public health concerns. Threshold of regulation exemptions may be used by any manufacturer or supplier for the specified uses of the food contact substance under the intended conditions of use. The Threshold of Regulation Exemptions database lists these exemptions [7].

3. Summary Table

The following link provides a more detailed algorithm to follow: Determining the Regulatory Status of Components of a Food Contact Material [8].

4. References

1. FDA webpage “Food Ingredient & Packaging Terms”

https://www.fda.gov/food/food-ingredients-packaging/food-ingredient-packaging-terms

2. FDA Webpage “Understanding How the FDA Regulates Substances that Come into Contact with Food"

https://www.fda.gov/food/food-packaging-other-substances-come-contact-food-information-consumers/understanding-how-fda-regulates-substances-come-contact-food

3. Inventory of Food Contact Substances Listed in 21 CFR

https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=IndirectAdditives

4. 21 CFR 170.101 Information in a premarket notification for a food contact substance (FCN)

https://www.ecfr.gov/current/title-21/section-170.101

5. Inventory of Effective Food Contact Substance (FCS) Notifications

https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=FCN

6. 21 CFR 170.39 Threshold of regulation for substances used in food-contact articles

https://www.ecfr.gov/current/title-21/section-170.39 

7. Threshold of Regulation Exemptions for Substances Used in Food-contact Articles

https://www.fda.gov/food/packaging-food-contact-substances-fcs/threshold-regulation-exemptions-substances-used-food-contact-articles

8. Determining the Regulatory Status of Components of a Food Contact Material

https://www.fda.gov/food/packaging-food-contact-substances-fcs/determining-regulatory-status-components-food-contact-material