Food contact notification

A formal meeting is conducted 20-30 days after receipt of the FCN to discuss the submission, identify deficiencies that inhibit going forward with the review, and discuss potential concerns that may arise during phase 2 review (discussed in more detail below). If deficiencies are noted, the FCN 

I Nonacid, aqueous products may contain salt, sugar or both (pH 5) Aqueous 

III Aqueous, acid or nonacid products containing free oil or fat may contain salt, and including water-in-oil emulsions of low- or high-fat content Fatty 

VII Bakery products (other than those under types VIII or IX)  

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It is explained that the Food Contact Notification process of the US Food Drug Administration has been in place officially for three months This article asks, and then strives to answer, many questions about the system. 

Bailey, A.B., Chanderbhan, R., Collazo-Braier, N., Cheeseman, M.A., Twaroski, M.L. (2005). The use of structure-activity relationship analysis in the food contact notification program. Regul. Toxicol. Pharmacol. 42 225-35. 

Table 2.2 Regulatory options relevant to food contact materials with regard to the food additive petition (petition), food contact notification (FCN) and threshold of regulation (TOR) exemption processes...

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. 

Within the FDA s Center for Food Safety and Applied Nutrition, the Office of Food Additive Safety administers premarket approval processes for new direct food additives and food additives that are components of food contact materials. Most food contact materials are regulated via the food contact notification process and authorization of new food contact materials is administered by the Division of Food Contact Notifications (see Chapter 2 for further information). The notifier has the primary responsibility to demonstrate the safety of the proposed use of the food contact material. Review scientists within FDA perform a fair evaluation of the data in a food contact notification, as well as other relevant information, to determine if the knowledge base supports the finding with reasonable certainty that no harm will result from the intended use of the food additive. FDA maintains a number of public online listings that include useful information... 

As noted above, the FFDCA tasks FDA with determining whether a food contact notification has demonstrated the safety of the proposed use. The food additive Delaney clause of the FFDCA states that no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal... . Therefore, demonstration of carcinogenicity in any animal species is deemed sufficient to prohibit approval as a food additive. 

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 s recommendations. The regulations for submitting food contact notifications stipulate that all relevant toxicity data available to the notifier be made available to FDA. The rationale and utility of the recommended genetic toxicity tests are discussed in detail by the FDA s Redbook (FDA, 2004). 

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). 

Potential concerns for a constituent of an additive raised by a qualitative SAR analysis may be addressable by a more in-depth, quantitative SAR (QS AR) analysis. The approach to QSAR used in the food contact notification program is to identify the most appropriate specific structural analogs from the pool of chemicals for which adequate carcinogenicity data are available. If, in the expert judgment of FDA reviewers, the analogs can reasonably be considered to be as toxic or more toxic than the compound of concern, these analogs can be used to develop a quantitative estimate of its upper bound LCR. 

The use of structure-activity relationship analysis in the food contact notification program . Regulatory Toxicology 42 225-235. 

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... 

Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations, Office of Food Additive Safety, Division of Food Contact Notifications HFS-275, Center for Food Safety and Applied Nutrition, Food and Drug Administration 5100 Paint Branch Parkway, College Park, MD 20470, August 2006 internet URL http //www.cfsan.fda.gov/ dms/opa2cg3b.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. 

Ticona Topas 8007. In compliance with FDA under Conditions of Use C through H , extraction studies show no migration, FDA Regulation 21 CFR 177.1520 (3.9), FDA Food Contact Notification (FCN No.75),... 

Guidance for Industy - Preparation of Premarket notifications for Food Contact Notifications and Food additive Petitions for Food Contact Substances Chemistry Recommendations, US Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Premarket Approval, April 2002. [http //.cfsan.fda.gov/ dms/opa2pmnc.html ... 

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