The U.S. Department of Agriculture and Food and Drug Administration have scheduled an October 28, 2014, public meeting in Washington, D.C., to solicit comments about draft positions to be considered at the 36th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) of the Codex Alimentarius Commission in Bali, Indonesia, on November 24-28. Issues on the October 28 meeting agenda include a (i) discussion paper on biofortification, (ii) proposed draft revision of the Codex General Principles for the Addition of Essential Nutrients to Foods, (iii) proposed draft revision of the list of food additives, and (iv) a proposal to review the Codex Standard for Follow-Up Formula. See Federal Register, September 10, 2014. Issue 537
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Discussing the expedited approval process for food additives that took effect 17 years ago, U.S. Food and Drug Administration (FDA) Deputy Commissioner for Food Michael Taylor recently told Washington Post reporter Kimberly Kindy that the agency does not have “the information to vouch for the safety of many of these chemicals.” According to the August 17, 2014, article, the number of additives in the food supply has increased to 9,000 from 800 over a 50-year span, in part because a voluntary certification system dependent on industry safety data has eclipsed FDA’s independent review process. Under the Generally Recognized as Safe (GRAS) scheme, companies need only submit a summary of their safety research to FDA, shortening time to approval even for new and novel food additives. In particular, the Post highlights how a mycoprotein marketed as “Quorn” achieved GRAS status despite one undisclosed study allegedly showing that 5 percent of test…
The U.S. Food and Drug Administration (FDA) has amended food additive regulations pertaining to the safe use of vitamin D3 in response to a petition from Abbott Laboratories. The company requested that FDA approve use of the fat-soluble hormone “as a nutrient supplement at levels not to exceed 500 IUs per 240 mL in meal replacement beverages that are not intended for special dietary use in reducing or maintaining body weight and that are represented for use such that that the total amount of vitamin D3 provided by the product does not exceed 1,000 IU per day, and at levels not to exceed 1.0 IU per kilocalorie in food represented for use as a sole source of nutrition for enteral feeding.” Objections to FDA’s approval of Abbott’s petition or requests for a hearing must be filed by September 11, 2014. See Federal Register, August 12, 2014. Issue 534
Representatives of more than 170 countries, the European Union and governmental and non-governmental organizations convened in Geneva, Switzerland, on July 14-18, 2014, for the annual meeting of the Codex Alimentarius Commission. Delegates reportedly adopted a recommendation that no more than 0.01 mg/kg of lead be allowed in infant formula and that raw materials be sourced from geographical areas where lead is less prevalent, citing the particular vulnerability of infants and young children to developmental health effects from lead exposure. Codex also set a maximum allowable level for arsenic in rice of 0.2 mg/kg because long-term exposure to the naturally occurring chemical has been linked to the development of cancer, heart disease and diabetes. Other decisions made during the annual meeting related to restricting the use of eight veterinary drugs (chloramphenicol, malachite green, carbadox, furazolidone, nitrofural, chlorpromazine, stilbenes and olaquinadox) in food-producing animals to prevent any residual quantities in meat, milk,…
Food Standards Australia New Zealand (FSANZ) has issued the first phase of its Australian Total Diet Study (ATDS), which analyzed chemicals in Australian foods and beverages and concludes that acrylamide and aluminum levels are lower than or consistent with those found in similar foods in other countries. Still, FSANZ CEO Steve McCutcheon said that it was working with industry “to look at ways to reduce acrylamide levels in food, such as encouraging industry to use enzymes that reduce acrylamide formation.” Aluminum levels, which are at their highest levels in cakes, pikelets and pancakes, evidently showed “a slight exceedance for 2-5 year old high consumers.” According to FSANZ, this exceedance is unlikely to “represent a public health and safety issue—however, FSANZ is investigating whether the current permissions for aluminum-containing food additives are still appropriate.” The second ATDS phase will focus on chemicals such as bisphenol A, phthalates and perfluorinated compounds. See…
The European Food Safety Authority’s (EFSA’s) Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) has issued an opinion on Bacillus species used in animal production as microbial feed additives or as the source of other feed additives, mainly enzymes. Noting that the main “concern for humans, and, to a lesser extent livestock, associated with Bacillus is a capacity for toxin production,” the FEEDAP Panel cautions that the capacity for toxin production and the nature of the toxins produced is “unevenly distributed over the genus, occurring frequently in some species and more rarely in others.” According to the panel, the selection of strains belonging to the B. cereus taxonomic group for direct use in animal production is considered inadvisable. For other species, “concerns appear to be associated to the production of surfactin like-lipopeptides, although the relation between the presence of these compounds and/or other toxic factors and the…
The U.S. Food and Drug Administration (FDA) has issued a final rule, effective April 14, 2014, amending its food additive regulations to allow the use of ionizing radiation on crustaceans (e.g., crab, shrimp, lobster, crayfish, and prawns) to control foodborne pathogens and extend shelf life. In response to a petition first filed in 2001, FDA concluded that use of irradiation to treat chilled or frozen raw, cooked or partially cooked crustaceans, or dried crustaceans, with or without spices, minerals, inorganic salts, citrates, citric acid and/or calcium disodium EDTA used in accordance with applicable laws and regulations, is safe, provided that the absorbed dose does not exceed 6.0 kGy. At this dose, FDA notes, ionizing radiation will reduce but not entirely eliminate, the number of illness-causing microorganisms in or on crustaceans. The agency also observes that irradiation is not a substitute for proper food-handling practices and that crustaceans treated with ionizing…
The Natural Resources Defense Council (NRDC) has issued a report claiming that the U.S. Food and Drug Administration’s (FDA’s) generally recognized as safe (GRAS) process for identifying food additives not required to undergo premarket approval is flawed and calling for legislation to change the process. According to NRDC, minimal FDA supervision and “a gaping loophole that allows companies to simply declare as safe hundreds of chemicals added to our foods—without any notification to the FDA or the public,” mar the U.S. food safety protection system. Under federal law, substances added to food are deemed food additives subject to FDA’s premarket approval unless they are considered GRAS by qualified experts or otherwise excluded from the food additive definition. While food companies can notify the agency that experts have made a GRAS determination, the law does not required them to do so. NRDC claims that it has identified “275 chemicals from 56…
The European Food Safety Authority (EFSA) will host a workshop on April 28, 2014, in Brussels, to discuss the agency’s work related to the re-evaluation of food additives, as required by Commission Regulation No. 257/2010 of the European Parliament and the Council on Food Additives. With an aim to “engage with interested business operators, scientific experts, the European Commission representatives, EFSA scientific staff and other interested parties,” the workshop will include sessions that address (i) “why, how and when scientific uses, use level data and other information should be made available to EFSA”; and (ii) “the extent to which the engagement of stakeholders during the re evaluation process would be of mutual benefit for EFSA and stakeholders themselves.” Participants may register until April 10, 2014. Issue 519
The European Food Safety Authority (EFSA) has issued a call for data from member states and other stakeholders on a third batch of food additives, including tertiary-butyl hydroquinone, agar, carrageenan, and xanthan gum, used in food and beverages. The action follows Commission Regulation No. 257/2010 of the European Parliament and the Council on Food Additives, requiring re-evaluation of substances permitted in the EU before January 2009. Specifically, the agency seeks (i) “figures from industry on the amounts of these additives they report using in their products”; and (ii) “data derived from analyses indicating actual levels of these additives found in foods and drinks from national food authorities, research institutions, academia, food industry and other stakeholders.” EFSA will accept data submissions until July 31, 2014, and will reportedly publish further calls for similar data later this year. Issue 517
