Category Archives Legislation, Regulations and Standards

The European Commission (EC) has released the results of its investigation into beef products contaminated with horsemeat, reporting that 5 percent of tested products were contaminated with horse DNA and 0.5 percent of tested horse carcasses were contaminated with the pain reliever phenylbutazone (bute). The investigation apparently involved 7,259 tests carried out by 27 member states in addition to 7,951 tests conducted by food business operators, including producers, processors and distributors. Based on these results, the Commission has reiterated the European Food Safety Authority’s (EFSA’s) assessment that bute contamination poses a low risk to consumers. “Today’s findings have confirmed that this is a matter of food fraud and not of food safety,” said EU Commissioner for Health and Consumers Tonio Borg. “Restoring the trust and confidence of European consumers and trading partners in our food chain following this fraudulent labeling scandal is now of vital importance for the European economy…

The National Toxicology Program (NTP) recently released its peer-reviewed report on the toxicology and carcinogenesis of Ginkgo biloba, “an herbal remedy and dietary supplement purported to improve memory and brain function.” Based on long-term studies in which researchers “deposited solutions of Ginkgo biloba extract in corn oil directly into the stomachs of male and female mice and rats five times a week for two years,” the report concluded that animals exposed to Ginkgo biloba extract “experienced increased rates of a variety of lesions in the liver, thyroid, and nose” as well as “increased incidences of cancers of the thyroid gland… in male and female rats and male mice and liver cancers in male and female mice.” Citing these studies, the Center for Science in the Public Interest (CSPI) has since issued a warning to consumers, advising them to avoid a number of products, including energy drinks, that list ginkgo as…

Food and Drug Administration (FDA) Commissioner Margaret Hamburg has reportedly informed Senate appropriators that the agency would extend for 120 days the comment period for two proposed rules—one relating to fresh produce and the other to food processors issued in January 2013 to implement the Food Safety Modernization Act (FSMA). According to Hamburg, “We appreciate that these are complex rules, the proposed rules, to go through and analyze, and we do intend to extend the comment period so that we can hear all of the concerns and address them fully, and I think it’s a reasonable request.” Hamburg also reportedly indicated that a rule requiring restaurants to post calorie information is a “high priority” for the agency, but hesitated when asked if it would be issued by October 1, at the start of the new fiscal year. See CQ Healthbeat News, April 18, 2013.

The Food and Drug Administration (FDA) has issued a proposed rule that would add selenium to the list of nutrients required in infant formula as well as establish minimum and maximum levels for the mineral in this context. Under the proposed rule, which recognizes selenium as an essential nutrient, infant formula labels would also need to list the amount per 100 kilocalories of formula. According to FDA, the selenium content of soil varies widely by geographic region, leading to either chronic selenium toxicity or dietary deficiencies that can result in diseases such as cardiomyopathy. Recognizing that formula “is intended to be the sole source of nutrition for infants,” FDA has proposed “2.0 µm selenium/100 kcal as the minimum level for selenium in infant formulas and 7.0 µm selenium/100 kcal as the maximum level.” The agency will accept comments on the proposed rule until July 1, 2013. See Federal Register, April 16,…

The Food and Drug Administration (FDA) has reportedly received “more than 30,000 comments” in response to its request for information about a petition filed by dairy-industry groups asking the agency to drop special labeling requirements for flavored milks that contain artificial sweeteners such as aspartame. The International Dairy Foods Association (IDFA) and the National Milk Producers Federation (NMPF) have asked FDA “to amend the standard of identity for flavored milk and 17 other dairy products (including nonfat dry milk, heavy cream, eggnog, half-and-half and sour cream) so that nonnutritive sweeteners are among the standard ingredients,” thus exempting the products from having to make nutrient content claims such as “reduced calorie” in a more prominent location. “If we granted the petition, a carton of chocolate milk made with nonnutritive sweeteners would simply say ‘chocolate milk,’ the same as a carton made with nutritive sweeteners, such as sugar,” said FDA Food Labeling…

A proposal in the Obama Administration’s 2014 budget would prohibit the funding of horsemeat inspection, essentially eliminating the possibility that horse slaughter—which has reportedly been banned since 2006—will resume in the United States. Language in the budget specifies that no federal funds may be used to pay the “salaries or expenses of personnel” to inspect horses slaughtered for human consumption. A ban on horse slaughter has been in place since 2006, but a rider that prevented the U.S. Department of Agriculture (USDA) from financing the inspection of horsemeat expired in 2011. According to a news source, no horse slaughter facilities currently operate in the United States, but the USDA reportedly says it has recently received several applications to open slaughtering facilities. Animal and horse advocates claim that horse slaughter is cruel and poses serious food safety issues because horses are sometimes dosed with drugs that are allegedly harmful to humans.…

In a recent paper, a member of European Food Safety Authority and Norwegian Scientific Committee for Food Safety genetically modified organism (GMO) panels has explored whether biosafety data provided to regulatory authorities by companies developing GMOs should be protected from disclosure. K.M. Nielsen, “Biosafety Data as Confidential Business Information,” PLOS Biology, 2013. Noting that standards or criteria as to what constitutes “legitimate” confidential business information (CBI) in GM product applications are lacking, the author argues that CBI claims are used indiscriminately and prevent independent research and monitoring. The article concludes with the author’s suggested criteria for “warranted CBI claims.” Among other things, the criteria would exclude from protection “information present in patent documents or for information not considered to be or not under confidentiality agreements in other companies/locations/countries.”

California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has added bisphenol A (BPA) to the “list of chemicals known to the State to cause reproductive toxicity for purposes of Proposition 65” (Prop. 65). The listing, which will require warnings to consumers, took effect April 11, 2013. Failure to provide the warnings can result in significant financial penalties, and alleged violations can be enforced by private citizens. OEHHA based its determination on a National Toxicology Program report which concluded that the chemical “causes reproductive toxicity (developmental endpoint) at high doses.” BPA is commonly found in cash register receipts, CDs and DVDs, and food packaging material, including plastic containers and bottles, and metal cans and lids. When OEHHA proposed listing the chemical, it also proposed adopting a maximum allowable dose level (MADL) of 290 micrograms per day. Additional information about the MADL proposal appears in Issue 468 of this Update. When…

The U.K. Food Standards Agency (FSA) has launched public consultations on two sets of proposed legislation, “The Contaminants in Food (England) Regulations 2013” and “The Food Additives, Flavourings, Enzymes, and Extraction Solvents (England) Regulations 2013.” The first set of regulations related to food contaminants will revoke the 2010 version and take into account new European Commission regulations regarding (i) “maximum levels for nitrate in foodstuffs”; (ii) “maximum levels for the presence of coccidiostats and histomonostats in food resulting from the unavoidable carry-over of these substances in non-targeted feed”; and (iii) under-enforcement of EU provisions providing for “the labeling of groundnuts, other oilseeds, derived products thereof and cereals.” The Contaminants in Food Regulations will also revoke “national legislation on mineral hydrocarbons in food and revoke and remake[] the provisions of the Erucic Acid in Food Regulations 1977.” The second set of regulations will consolidate “all legislation within [FSA’s] remit covering food…

The National Toxicology Program (NTP) and the Office of Dietary Supplements are seeking information and comments on an approach document titled “Identifying Research Needs for Assessing Safe Use of High Intakes of Folic Acid.” According to NTP, the information gathered through the request will be used to prioritize topics for a workshop the agency is planning “to identify research needs based on consideration of the state of the science related to the safe use of high intakes of folic acid.” Although “[t]he benefit of supplemental folic acid for pregnant women to prevent neural tube defects in their children is well established,” NTP stated, “at the same time, there is interest in understanding potential adverse health impacts from high intakes of folic acid.” The agency is specifically seeking information on the following topics: (i) “health effects of most concern for high folate intake”; (ii) “assessments of folic acid intake and folate levels…

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