Food Contact Substance Notification

This article discusses in detail the food-contact substance notification programme in the US A, which came into effect in January 2000, where manufacturers must notify the US Food Drag Administration of new substances they wish to use in such applications and, if there is no objection from the FDA within 120 days, the substance may be legally marketed. Unlike food additive regulations, the notification will be proprietary, and may be relied upon only by the submitter or notifier, and its customers. 

Division of Food Contact Substance Notification Review... 

Table 2.3 Useful links on the Food Ingredients and Packaging Food Contact Substance Notification Program section of the CFSAN website (http //www.cfsan.fda.gov/ lrd/ foodadd.html)...

Food Additives Food Contact Substance Notification System, US Food and Drug Administration, Federal Register, May 21st 2002,67, 98 (Rules and Regulations), p.35724-35731. 

Inventory of effective food contact substance notifications, limitations, specifications and use, FCN No.l03 US Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Additive Safety, August 2002. [http //www.cf an.fda.gov/ dms/opa-fcn2.html ... 

No specific regulatory limits or listings of cadmium compounds, including cadmium pigments, were located in FDA packaging and food contact substances databases at http //www.fda.gov/Food/IngredientsPackagingLabeIing/PackagingPCS/ default.htm (e.g., EAFUS, Inventory of Effective Food Contact Substance Notifications, List of Indirect Additives Used in Food Contact Substances, and Cumulative Estimated Dietary Intake databases). 

USFDA Premarket Notifications for Food Contact Substances, United States Food and Drug Administration, Washington, DC, June 6, 2000. 

As discussed in FDA s Preparation of Food Contact Notifications for Food Contact Substances Toxicology Recommendations (FDA, 2002), FDA has set forth minimum testing recommendations for tiered levels of expected consumer exposure. These recommendations are based on the general principle that the potential risk is likely to increase as exposure increases. In addition, submitters are encouraged to discuss the structural similarity of their food contact material or its constituents to known mutagens or carcinogens. This analysis is termed structure-activity relationship (SAR) analysis and is recommended for all exposures (discussed further below). Table 7.1 summarizes... 

FDA. (2002), Guidance for Industry. Preparation of Food Contact Notifications for Food Contact Substances Toxicology Recommendations. Final Guidance. 4/2002. Accessed online at http //www.cfsan.fda.gov/ dms/opa2pmnt.html... 

A significant change in the FDA approval procedure was instituted in January 2000 with the new Food Contact Notification (FCN) system. To get approval for a new food-contact substance (FCS), the producer submits information including composition intended use including additive level, usage temperature, and type of food the substance will contact and data on migration of the substance into food. 

Inventory of Effective Food Contact Substance (FCS), Notifications No.178, US Food and Drug Administration, Silver Spring, MD, USA, 2002. 

FDA. Inventory of ElFective Food Contact Substance (ECS) notifications, http //www.cfsan.fda. gov/wdms/opa-fcn.html. FCN (2007). 

Section 11 D (C) Food Simulents, Appendix 11, Selected Migration Testing Protocols Guidance for Industry Preparation of Pre-Market Notification for Food Contact Substances Chemistry Recommendations, April 2002. 

The USFDA approach to assessing exposure to migrants from FCMs is explained in CFSAN/Office of Food Additive Safety, April 2002 and is available on their web site (http //www.cfsan.fda.gov/). It describes the use of exposure estimates for use in food contact notifications (FCNs) which would normally be based upon simulant rather than food migration data, as is the case for new materials. The USFDA approach is described in more detail in Chapter 2. In the USFDA approach a consumption factor is combined with a food distribution factor and concentration data to derive an estimate of exposure from all food types and all FCMs containing the substance of interest. 

As discussed above, the Delaney clause applies to substances proposed for use as food additives, but does not apply to individual constituents of a food additive. Examples of constituents would include residual monomers or catalysts. The constituents policy, subjected to judicial review in Scott v. FDA, 728 F. 2d 322 (6th cir. 1984), states that FDA may consider the potential risks of constituent exposure under the general safety standards set forth in FFDCA. The notification process places the responsibility upon the notifier for addressing the carcinogenic risk of constituent exposure from a proposed use of a food additive. FDA recommends that notifiers include in their food contact notification a safety narrative that addresses the safety of each carcinogenic constituent at any exposure (in addition to the recommendations listed in Table 7.1). This narrative should include an estimate of the potential human cancer risk from the constituent due to the proposed use of the food contact material (FDA, 2002). 

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