The European Food Safety Authority (EFSA) has launched a public consultation on its draft assessment of the human health risks posed by bisphenol A (BPA). According to a January 17, 2014, press release, the agency has recommended temporarily lowering the current tolerable daily intake (TDI) for BPA from its current level of 50 µg/kg bw/day to 5 µg/kg bw/day over concerns that exposure to the substance is likely to adversely affect the liver and kidney, in addition to affecting the mammary gland. EFSA’s Panel on Food Contact Materials, Enzymes, Flavorings and Processing Aids (CEF Panel) apparently arrived at the new TDI after reviewing more than 450 studies related to the potential health hazards associated with BPA. The draft scientific opinion also considers “the possible effects of BPA on the reproductive, nervous, immune, metabolic and cardiovascular systems, as well as the development of cancer,” concluding that these effects—while not likely at…
Category Archives European Food Safety Authority
The European Food Safety Authority’s (EFSA’s) Panel on Dietetic Products, Nutrition and Allergies (NDA) has launched a public consultation for its draft scientific opinion on dietary reference values for iodine. Using data from “a large epidemiological study in European school-aged children showing that goiter prevalence is lowest for a urinary iodine concentration ≥ 100 μg/L,” NDA has proposed setting adequate intake (AI) levels for iodine at 150 μg/day for adults and between 70 μg/day and 130 μg/day for infants aged 7-11 months and all children. The panel has also recommended an AI of 200 μg/day for pregnant and lactating women, which takes into account “the additional needs due to increased maternal thyroid hormone production and the iodine uptake by the fetus, placenta and amniotic fluid” as well as “the existence of large iodine stores in conditions of adequate iodine status before pregnancy.” EFSA will accept comments on the draft scientific…
The European Food Safety Authority’s (EFSA’s) Panel on Food Additives and Nutrient Sources Added to Food (ANS) has published its full risk assessment on aspartame, concluding that the food additive is safe at current levels of exposure. In addition to noting that aspartame’s breakdown products— phenylalanine, methanol and aspartic acid—occur naturally in other foods, EFSA’s experts found that aspartame’s acceptable daily intake (ADI) of 40 mg/kg bw/day “is protective for the general population,” with the exception of those individuals with phenylketonuria, a medical condition that necessitates a diet low in phenylalanine. At the request of the European Commission, the ANS Panel analyzed “all available information” in an effort to resolve uncertainties related to the re-evaluation of aspartame as a food additive. In particular, the panel’s final scientific opinion assessed both human and animal studies submitted in response to public calls for data; previous evaluations; and additional literature that became available during…
The European Food Safety Authority (EFSA) has issued a statement finding that a published review of observational studies ultimately failed to establish a causal relationship between high intakes of phosphate additives in food and increased cardiovascular risk in the general population. In addition to considering the data on the association between serum phosphate levels and cardiovascular disease, the review in question apparently proposed a mechanism by which the metabolism of inorganic phosphate could contribute to vascular calcification, in the process suggesting that “intake of phosphate as a food additive, especially through consumption of processed and ready-to-eat food, is of particular concern.” Additional details about the review, which was initially published in the January 2012 edition of Deutsches Ärzteblatt International, appear in Issue 428 of this Update. After assessing these findings at the request of the European Commission, EFSA concluded that (i) the limitations of the observational studies included in the…
The U.S. Food and Drug Administration (FDA) has issued draft guidance for the food industry “to help growers, manufacturers and food service operators take steps to reduce levels of acrylamide in certain foods.” A chemical formed in some foods during high-temperature cooking, acrylamide has been characterized by the National Toxicology Program as “reasonably anticipated to be a human carcinogen.” Suggesting “a range of possible approaches to acrylamide reduction,” the draft guidance stops short of identifying a specific maximum level or action level for acrylamide, but includes recommendations for potato-based foods, cereal-based foods and other products. To reduce acrylamide formation during the cooking process, the draft guidance addresses what types of raw ingredients to use; how to transport, handle, store, and process ingredients; and how to prepare both fresh and par-cooked ingredients. In particular, FDA recommends, among other things, that the food industry (i) use certain kinds of potatoes and grains,…
At the behest of the European Commission, the European Food Safety Authority’s (EFSA’s) Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) has published population reference intakes (PRIs) for vitamin C and adequate intakes (AIs) for manganese “as part of its ongoing work on Dietary Reference Values (DRVs).” Basing its conclusions on the quantity of vitamin C that balances metabolic vitamin C losses in healthy adults, the scientific opinion on vitamin C proposes (i) an average requirement (AR) of 90 mg/day and a PRI of 110 mg/day for men; (ii) an AR of 80 mg/day and a PRI of 95 mg/day for women; and (iii) a PRI of 20 mg/day for infants aged 7-11 months. For children and adolescents, the NDA Panel has set PRIs ranging from 20 mg/day for children aged 1-3 years, to 100 and 90 mg/day for boys and girls aged 15-17 years. It also notes that pregnant…
The European Food Safety Authority’s (EFSA) Panel on Additives and Products or Substances Used in Animal Feed (FEEDAP) has issued guidance to assist applicants “in the preparation and submission of technical dossiers for the renewal of the authorization of additives for use in animal nutrition.” According to EFSA, EU regulations require applicants to renew feed additive authorizations every 10 years by submitting stand-alone dossiers that take into account “the most up-to-date scientific knowledge” as well as “the current scientific/methodological approaches.” Although the information included in each dossier will depend on “the additive nature, the functional group, the substance itself, the target animals, and the conditions of use,” the submission must enable regulators to assess the additive in question “based on the current state of knowledge” and to determine whether the additive complies with the “fundamental principles for the renewal of authorization.” “During the last years, the FEEDAP Panel has developed several guidance…
Corporate Europe Observatory (CEO) recently joined a coalition of nongovernmental organizations in criticizing the European Food Safety Authority (EFSA) ahead of the agency’s October 3, 2013, stakeholder meeting on transparency in risk assessment. Led by CEO and backed by groups such as Cancer Prevention and Education Society, Friends of the Earth Europe and GMWatch, the coalition argues in an October 1 open letter that EFSA’s current system for approving food products for market is flawed insofar as the agency’s decision-making process relies on confidential dossiers submitted by industry. In particular, the signatories claim that under international and EU law, EFSA must disclose the contents of these dossiers and should also ensure that the studies used to support its market approvals adhere to the same high standards as those set by peer-reviewed journals. To this end, the coalition recommends that EFSA provide “complete, unrestricted and proactive online publication of applicants’ files,”…
The European Food Safety Authority (EFSA) has issued guidance principles for conducting two-year whole food studies “to assess the risk of cancer and/or toxicity from the long-term consumption of such foods by humans.” Acting at the behest of the European Commission, EFSA relied on testing guidance (TG) 453 from the Organization for Economic Co-operation and Development in addition to considering the views of member state experts consulted through the Scientific Network for the Risk Assessment of GMOs. The agency has cautioned, however, that testing individual chemicals in animal models “may result in adverse effects caused by dietary imbalance rather than any potential toxicity of the whole food itself,” urging researchers to carefully design studies to avoid this outcome and to use a larger number of animals when conducting whole food studies. “[I]t is essential that scientists implementing its guiding principles should define clear and specific objectives before starting a two-year…
The European Food Safety Authority (EFSA) has proposed adequate intake (AI) levels for fluoride and molybdenum as part of its effort to provide dietary reference values (DRVs) for micronutrients, including vitamin C, folate, iron, zinc, calcium, and iodine. Finalized by EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) after a public consultation, the proposed AI for fluoride is 0.05 mg/kg body weight per day “for children aged 7 months to 17 years as well as adults, including pregnant and lactating women,” and the proposed AI for molybdenum is 65 micrograms per day for all adults and 10-65 micrograms per day for infants, children and adolescents. According to EFSA, the NDA Panel has already proposed DRVs for energy, macronutrients—protein, fats and carbohydrates—dietary fiber, and water. In turn, such DRVs are used “to establish reference values for nutrition labeling, for the assessment and planning of diets and for developing food-based…
