The European Food Safety Authority (EFSA) has issued new guidance for the submission of food additive applications that reflects recent scientific advances as well as “the latest risk assessment principles.” Developed by EFSA’s Panel on Food Additives and Nutrient Sources Added to Food, the new data submission guidelines aim to streamline the testing process while still generating “the data necessary to demonstrate the high level of consumer safety required.” Food companies seeking market authorization from the European Commission must provide EFSA with “the necessary information and data supporting the safety of the food additive.” In particular, the guidance introduces “a new tiered approach for the risk assessment of food additives” that will assist applicants with their toxicological testing strategy. Under the new guidance, Tier 1 tests must meet “a minimal dataset applicable to all compounds,” while Tier 2 testing “will be required for compounds which are absorbed, demonstrate toxicity or…
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The European Food Safety Authority (EFSA) has issued a scientific opinion on dietary exposure to mineral oil hydrocarbons (MOH) found mainly in “food packaging materials, food additives, processing aids, and environmental contaminants such as lubricants.” According to a June 6, 2012, press release, EFSA’s Panel on Contaminants in the Food Chain (CONTAM) focused on two types of MOH: (i) aromatic hydrocarbons identified as potentially genotoxic and carcinogenic; and (ii) saturated hydrocarbons that “can accumulate in human tissue and may cause adverse effects in the liver.” The CONTAM Panel apparently found low levels of saturated MOH in all of the food groups tested, “with some high levels found in ‘Bread and rolls’ and ‘Grains for human consumption’ due to their use, respectively, as release/ non-sticking agents and spraying agents (used to make grains shiny).” It also reported the presence of both saturated and aromatic MOH in dry foods such as “‘pudding’…
The U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) has issued a final rule ordering “the disclosure of the presence of cochineal extract and carmine on the labels of any alcohol beverage containing one or both of these color additives.” According to TTB, the rule responds to a Food and Drug Administration (FDA) regulation that took effect on January 5, 2011, and requires manufacturers to label these two additives on all food and cosmetic products due to the potential for severe allergic reactions. Effective March 16, 2012, with a final compliance date of April 16, 2013, the TTB rule notes that FDA does not compel labels to disclose that cochineal extract and carmine are derived from insects native to subtropical South America and Mexico. In issuing its final decision, TTB rejected one comment that called for listing the additives’ source despite industry concerns that some consumers “would find the thought…
Part II of the American Bar Association’s (ABA’s) Nanotechnology Project, this recently released book comprehensively considers, by product category, how the Food and Drug Administration (FDA) reviews nanotechnology-based products. Shook, Hardy & Bacon Agribusiness & Food Safety Attorney James Andreasen was among those practitioners contributing to the work. Among the chapters are “Color Additives,” “Food Additives and Related Substances,” “Dietary Supplements,” “Food and Animal Feed Products,” and “Biological Products.” They address “how FDA can, and to some extent, has, regulated nanomaterials in products falling under its multiple areas of responsibility,” and (i) identify “products that already feature nanomaterials”; (ii) review “FDA’s regulatory program for the specific product category (such as particular pre-market and post-market controls)”; and (iii) discuss “how that program might apply to nanomaterials.”
German researchers claim that “elevated serum phosphate concentrations have recently been found to be correlated with mortality in patients with chronic renal failure, while high-normal serum phosphate concentrations have been found to be correlated with cardiovascular morbidity in the general population.” Eberhard Ritz, et al., “Phosphate Additives in Food—a Health Risk,” Deutsches Ärzteblatt International, 2012. Noting that naturally occurring phosphate in foods, “including meat, potatoes, bread, and other farinaceous products,” is not completely absorbed in the gastrointestinal tract and thereby poses less concern, the researchers contend that “inorganic phosphate in food additives is effectively absorbed and can measurably elevate the serum phosphate concentration in patients with CKD [chronic kidney disease].” According to the authors, foods with large amounts of added phosphate include processed meats, canned fish, cheeses, baked goods, and cola beverages and other soft drinks. The ingredient is apparently added as a preservative, acidifying agent and buffer, and emulsifying…
Three consumer advocacy organizations have filed a petition with the Office of Food Additive Safety of the Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition requesting that ABT Technologies’ application to approve genetically engineered (GE) salmon be reviewed under the food additive provisions of the Food, Drug, and Cosmetic Act. The company’s new animal drug application for the GE salmon is currently pending before the agency’s Center for Veterinary Medicine. According to Food & Water Watch, Consumers Union and the Center for Food Safety, the company’s GE process “significantly alters the salmon’s composition . . . in a way that is reasonably expected to alter its nutritive value or concentration of constituents, and the new substance raises safety concerns. Under the Agency’s regulations and guidelines, such a substance must be treated as a food additive and the Agency must make a closer inquiry into the safety…
The Center for Science in the Public Interest (CSPI) has petitioned the Food and Drug Administration (FDA) to require the disclosure of food color additives on front-of-package labeling. Citing “the ubiquity of food colorings” in the American diet, the petition claims that consumers are misled when colorings are used to either mask less-nutritious ingredients or make a product “appear to be of higher quality or nutritional value than it actually is.” The group also points to studies suggesting a link between certain food additives and behavioral effects in children. CSPI urges FDA to “amend the labeling requirements set forth at 21 C.F.R. § 101.22” to require foods containing such additives to state “Artificially Colored” “on the product display package next to the product name in bold letters not less than half the height and weight of the name of the food.” According to CSPI, FDA already possesses the statutory authority and…
The Food and Drug Administration (FDA) has issued a final rule requiring animal and pet food labels to list “the common or usual names” of any certified color additives used in the products. Issued in response to the Nutrition Labeling and Education Act of 1990, the final rule brings animal food labeling in line with current human food regulations by adding “paragraph (k) to the animal food labeling regulations at § 501.22 (21 CFR 501.22).” The first part of paragraph (k) explains that any FDA-certified color additive used in animal foods “must be declared in the ingredient list” under the name listed in 21 CFR part 74 or 21 CFR part 82, although manufacturers are permitted to “parenthetically declare an appropriate alternative name of the certified color additive following its common or usual name.” In addition, the new rules require that the term “Lake” be included “in the declaration of…
A recent study analyzing federal oversight of substances added to food has reportedly concluded that the current program, while expediting the review process, both inhibits transparency and delegates critical food safety decisions to manufacturers. Thomas Neltner, et al., “Navigating the U.S. Food Additive Regulatory Program,” Comprehensive Reviews in Food Science and Food Safety, October 2011. Based on research conducted by the Pew Health Group, the study was designed “to assist food science and technology professionals and others to navigate the food additive regulatory program to more fully understand the program’s structure and operation.” In particular, the authors examined how FDA has used the Food Additives Amendment Act of 1958 to categorize and regulate (i) food additives, (ii) substances generally recognized as safe (GRAS), (iii) pesticide chemicals or residues, (iv) substances sanctioned before the Act came into effect, (v) color additives, (vi) drugs in animal feed, and (vii) dietary supplements. The researchers reported…
The European General Court (ECG) has determined that the European Commission (EC) erred in removing the antibacterial chemical 2,4,4’-tricihloro2’-hydroxydiphenyl ether (triclosan) from the list of additives that may be used to make plastic materials and other articles that come into contact with foods. Microban Int’l Ltd. v. EC, No. T-262 (ECG, decided October 25, 2011). The court first determined that the EC’s action constituted a regulatory act of direct concern to the applicants, companies that make the additive. The court then ruled both that the EC based its decision on the wrong law and failed to follow the correct procedures in removing triclosan from the list. The court noted that the chemical was previously included on the provisional list of additives which can continue to be used subject to national law on the basis of a European Food Safety Authority determination in 2004 that “although triclosan was a substance for which an…
