Food contact substance

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. 

The Scientific Committee for Food (SCF) lays down for toxicological evaluation of food contact substances three levels of toxicological tests dependent on the amount of migration (mg/kg food simulant) Level 1 < 0.05 level 2 0.05-5 level 3 >5. 

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

The term food additive is used to cover any substance that is expected to become a component of human food. This covers substances intentionally added to food for their nutritional, chemical, or physical benefits (e.g., colorants and gelling agents) and substances used in the manufacture or packaging of foods (i.e., food contact substances, formerly known as indirect food additives ). The US Federal Food, Drug, and Cosmetic Act defines food additives as substances whose intended use results or may reasonably be expected to result, directly or indirectly, in its becoming a component of food or otherwise affecting the characteristics of food. ... 

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)...

Table 2.7 Toxicology testing recommendations for food contact substances based on dietary concentration (EXT) and corresponding estimated daily intake (EDI) values. Note that the cumulative exposures are based on non-biocidal chemicals biocidal tiers are one-fifth the cumulative dietary concentration (CDC) and cumulative estimated daily intake (CEDI) values expressed. DC and CDC values are in units of mass of migrant per mass food consumed. EDI and CEDI values are in units of mass of migrant per person per day. Abbreviations are as follows p,g (microgram), kg (kilogram), mg (milligram), < (less than or equal to), < (less than), > (greater than), and > (greater than or equal to)...

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... 

Table 7.1 Toxicology testing recommendations for food contact substances based on dietary concentration (DC) and corresponding estimated daily intake (EDI) values. Note that the cumulative exposures are based on non-biocidal chemicals biocidal tiers are one-fifth the cumulative dietary concentration (CDC) and cumulative estimated daily intake (CEDI) values expressed...

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... 

Earlier versions of the Redbook focused on direct food additives and color additives used in food. The Redbook 2000 provides guidance for the safety assessment of food ingredients, including direct food additives, color additives used in food, generally recognized as safe substances, food contact substances and constituents, or impurities of any of the above. 

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. 

Approved by the FDA for use as a food additive and food-contact substance. 

Approval from the European Food Safety Authority (EFSA, 2005), the Japan Hygienic PVC Association (JHPA), and the German Institute for Risk Assessment (German BfR) for use as a food-contact substance. Waiting for FDA approval. 

FDA, Guidelines for preparation of premarket submissions for food-contact substances chemistry recommendations,... 

FDA21CFR 177.1630 (Indirect additive used in food contact substances). 

The FDA has recently pronulgated new rules which describe in detail the notice required for treshold analysis of new food contact substances including colors. 

The Federal Food and Drug Administration (FDA) regulates the use of food colors and food contact colors in the United States. Food colors must be approved in an extensive petition process with the FDA. There are two methods by which food contact colors can be used. First there is the traditional food additive petition for use of a food contact substance. If successful, this process leads to listing in the Code of Federal Regulations (CFR) as a new color available for various substrates. Restrictions may be applied to the use of listed colors. The CFR should be consulted and... 

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

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. 

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