by clicking the arrows at the side of the page, or by using the toolbar.
by clicking anywhere on the page.
by dragging the page around when zoomed in.
by clicking anywhere on the page when zoomed in.
web sites or send emails by clicking on hyperlinks.
Email this page to a friend
Search this issue
Index - jump to page or section
Archive - view past issues
FLEXO Magazine : August 2014
petition process, where it could take an average of two to four years for FDA to promulgate a food additive regulation for a new substance. Under the FCN program, the Agency is required by law to clear the substance in 120 days unless FDA objects to the noti cation. Unlike food additive regulations, FCNs are propriety; therefore, only the manufacturer and its customers can rely on the noti cation. EXCEPTIONS TO THE RULES As for the TOR exemption, FDA can exempt a food contact substance from regulation as a food additive based on de minimis dietary expo- sure to the compound. e TOR exemption can be relied upon in two scenarios: • e intended use of the substance results in dietary exposures of less than 0.5 ppb • e substance is cleared as a direct food additive and the dietary exposure of the compound from food contact uses is less than 1 percent of the Acceptable Daily Intake2 e exemption is valid so long as the food contact substance does not contain any carcinogenic constituents or impurities. If the intended use of the substance is not the subject of one of FDA's formal regulatory vehicles we've discussed, certain exemptions from FDA premarket clearance may be available. Under the Act, a company is entitled to determine independently whether the use of a substance in a particular food contact application poses a food additive situa- tion. As mentioned above, substances that are not reasonably antici- pated to become components of food are not food additives under the Act and, as a result, are not subject to FDA premarket clearance. is exemption, known as the "no migration" exemption, is supported by case law and has been used by industry for many years to substantiate the FDA status of various food contact materials. As already discussed, the Act also exempts "prior sanctioned" sub- stances from the de nition of food additive. Whether a substance is prior sanctioned is a matter of fact and refers to substances that are subject of letters issued by FDA or the U.S. Department of Agriculture prior to 1958. Some, but not all, of these prior sanctions are listed in 21 CFR § 181. Substances that are properly considered GRAS also are excluded from the de nition of "food additive" and thus exempt from FDA premar- ket clearance. e Act de nes a GRAS substance as one that, when used as intended, is generally recognized as safe by scienti c experts quali ed to evaluate its safety. Where a compound was used in food prior to 1958, the GRAS status of a substance is established through either scienti c procedures or experience based on common use in food.3 While a number of GRAS substances are listed in 21 CFR § 182, 184 and 186, the food additive regulations acknowledge that the list of GRAS substances is not exhaustive.4 us, manufacturers are free to determine on their own whether a substance is GRAS, without autho- rization or notice by FDA. It is important to keep in mind that, even if your exible packaging is the subject of a relevant regulatory clearance or exemption, the pack- age also must comply with FDA's good manufacturing practice (GMP) regulation. e regulation is found at 21 C.F.R. § 174.5 and requires a food contact material to be of a "purity suitable for its intended use." is means that food contact materials may not impart a taste or odor to food, so as to render the food un t for consumption or contain impurities at levels so high as to result in the adulteration of food. Suitable purity may be particularly relevant to the exible packaging sector, where issues like set o may be of potential concern. ere are myriad materials that can be used in exible packaging for food. Manufacturers along the supply chain will best maximize their opportunities in this growing market by ensuring that their materials comply with FDA's food contact regulatory scheme. About the Author: Mitzi Ng Clark is a partner at the law o ces of Keller and Heckman LLP. She practices in the area of food and drug law, with an emphasis on food packaging. Ms. Clark assists domestic and international corporations in establishing a suitable regulatory status for products under the laws and regulations administered by the FDA and other federal and state agencies. She also assists clients in compliance and good manufacturing practice issues relating to the manufacture of products and packaging. In addition, she counsels clients on a broad range of food contact matters in other countries, including Canada, the European Union, the Paci c Rim and Latin America. 2 The ADI is the amount of a substance that can be ingested on a daily basis over a lifetime without an appreciable health risk. 3 See supra note 1. 4 21 C.F.R. 182.1. 22 FLEXO | AUGUST 2014 " There are myriad materials that can be used in flexible packaging for food. Manufacturers along the supply chain will best maximize their opportunities in this growing market by ensuring that their materials comply with FDA's food contact regulatory scheme."