Category Archives Europe

At the request of the Hellenic Food Authority, the European Food Safety Authority’s (EFSA’s) Panel on Contaminants in the Food Chain (CONTAM Panel) has issued a scientific opinion on the public health risks associated with the presence of nickel (Ni) in food—especially vegetables—and drinking water. Citing the established tolerable daily intake (TDI) of 2.8 µg Ni/kg body weight (bw) per day, the CONTAM Panel concluded that chronic dietary exposure to nickel represents a concern for the general population and that consumers already sensitized to nickel through dermal contact may develop eczematous flare-up skin reactions at the current levels of acute dietary exposure levels. The CONTAM Panel relied on a total of 18,885 food samples and 25,700 drinking water samples to estimate dietary exposure to nickel, finding that the following food groups were the main contributors across age categories: (i) grain and grain-based products; (ii) non-alcohol beverages (except milk-based beverages); (iii)…

The European Food Safety Authority (EFSA) has announced a March 5, 2015, stakeholder meeting to discuss its draft opinion on the safety of caffeine. Authored by the agency’s Nutrition Unit, the draft opinion finds, among other things, that “single doses of caffeine up to 200 mg and daily intakes of up to 400 mg do not raise safety concerns for adults.” It also considers the following: (i) “caffeine consumption during pregnancy, and adverse health effects on the fetus”; (ii) “acute and long-term effects of caffeine consumption on the central nervous system (e.g. sleep, anxiety, behavioral changes) in adults, adolescents, and children”; (iii) “long-term adverse effects of caffeine consumption on the cardiovascular system in adults”; (iv) “acute effects of caffeine consumption in ‘energy drinks’ and risk of adverse health effects in adolescents and adults involving the cardiovascular and central nervous systems, particularly when consumed within short periods of time, at high…

The European Ombudsman has issued a January 28, 2015, decision directing the European Food Safety Authority (EFSA) to revise its conflict-of-interest rules after the agency “failed to ensure that those experts who work in academia declare all relevant information to EFSA.” Stemming from a complaint filed by GeneWatch, the decision focused on an EFSA working group on genetically modified (GM) insects that included an academic expert whose employer has financial ties to a biotechnology company that “promotes genetically modified insects.” In particular, the European Ombudsman dismissed the agency’s reasoning that “employment by a university has never been considered a conflict of interest at EFSA,” as such a prohibition would disqualify the most qualified individuals from working groups. The decision instead places the onus on EFSA to gather additional information about the nature of the university’s financial relationships and the mechanisms in place “to prevent communication and instructions from the investment arm…

The European Food Safety Authority’s (EFSA’s) Panel on Food Contact Materials, Enzymes, Flavorings and Processing Aids (CEF) has issued a scientific opinion finding that bisphenol A (BPA) poses “no health concern for any age group from dietary exposure or aggregated exposure.” Published January 21, 2015, the scientific opinion assessed exposure in three ways: (i) “external (by diet, drinking water, inhalation, and dermal contact to cosmetics and thermal paper”; (ii) “internal exposure to total BPA (absorbed dose of BPA, sum of conjugated and unconjugated BPA)”; and (iii) “aggregated (from diet, dust, cosmetics and thermal paper), expressed as oral human equivalent dose (HED) referring to unconjugated BPA only.” Using new data and methodologies, EFSA previously established a temporary tolerable daily intake (t-TDI) for BPA at 4 micrograms per kilogram of body weight per day, from 50 µg/kg bw/day. This latest scientific opinion confirms that the highest estimates for human exposure to BPA…

Confirming a December 2014 “hand-shake” agreement, the European Parliament has reportedly approved a law giving member states the authority to regulate the cultivation of genetically modified organisms (GMOs) within their borders. Until the new rules take effect in spring 2015, EU member states can limit cultivation of approved GMOs only if they present new evidence to the European Food Safety Authority that demonstrates the crop is not safe for consumption. The new rules allow member states to prohibit GMO growth and cultivation on several grounds, including “town and country planning requirements, socio-economic impact, avoiding the unintended presence of GMOs in other products and farm policy objectives.” The legislation also creates a procedure allowing a GMO crop company to consent to proposed restrictions to avoid a unilateral ban on its product. Additional information about the 2014 political agreement appears in Issue 548 of this Update. See European Parliament Press Release, January 13,…

The European Food Safety Authority (ESFA) has opened a public consultation on a draft scientific opinion finding that “single doses of caffeine up to 200 mg and daily intakes of up to 400 mg do not raise safety concerns for adults.” Authored by EFSA’s Nutrition Unit, the draft opinion also concludes that (i) “it is unlikely that caffeine interacts adversely with other constituents of ‘energy drinks’—such as taurine and D-glucurono-γ-lactone—or alcohol”; (ii) “for pregnant women, caffeine intakes of up to 200mg a day do not raise safety concerns for the fetus”; (iii) “for children (3-10 years) and adolescents (10-18 years), daily intakes of 3mg per kg of body weight are considered safe”; and (iv) “single doses of 100mg may increase sleep latency (the amount of time it takes to fall asleep) and shorten sleeping time in some adults.” EFSA has requested comments by March 15, 2015. See EFSA News Release,…

The French Directorate-General for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF) has released a guidance document detailing the implementation of new rules that ban the use of bisphenol A (BPA) in all food contact materials in their finished state as of January 1, 2015. The second part of a law that first prohibited BPA in products intended for children younger than age 3, the new rules apparently bar the use of BPA in (i) packaging and articles intended to come into contact with food, and (ii) containers and utensils, including kitchen utensils, tableware and dishes. These rules do not apply to industrial materials and equipment used in the production, processing, storage, or transportation of foodstuffs. See DGCCRF Guidance, December 8, 2014. In a related development, the European Food Safety Authority (EFSA) has announced that it has finalized a scientific opinion on BPA. Slated for release in January 2015, the…

A “hand-shake” agreement between the European Union’s Parliament and Council will reportedly end an ongoing dispute over member state control of internal food markets in relation to genetically modified organism (GMO) cultivation. European Commissioner for Health and Food Safety Vytenis Adriukaitis reportedly said, “The agreement, if confirmed, would meet member states’ consistent calls since 2009, to have a final say on whether or not GMOs can be cultivated on their territory, in order to better take into account their national context and, above all, the views of their citizens.” Under the proposal, each EU country would have the authority to prohibit or restrict GMO cultivation for reasons other than food safety, including those involving socioeconomic effects, environmental concerns and agricultural policy goals. Current law allows member states to petition the European Food Safety Authority to limit such cultivation, but they must present scientific evidence showing the product is not safe to…

The European Food Safety Authority (EFSA) has launched a risk assessment in response to the European Commission’s urgent request for scientific advice on the H5N8 avian influenza A virus detected in Germany, the Netherlands and the United Kingdom. Focusing on the role of wild birds as vectors, EFSA plans to release a December 2014 report that will provide risk managers “with independent scientific advice and assistance on animal health and welfare related to avian influenza and any possible food safety issues.” See EFSA News Release, November 26, 2014. In a related development, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service has amended an interim rule restricting the importation of live birds and poultry, hatching eggs and poultry products “from regions where any subtype of highly pathogenic avian influenza (HPAI) is considered to exist.” Effective December 1, 2014, the final rule now permits the importation of HPAI-resistant species, including pigeons…

Sazerac Co. has recalled its Fireball Cinnamon Whiskey from Sweden, Norway and Finland because some batches contain levels of flavoring chemical propylene glycol that exceed European limits. The company says that it mistakenly shipped batches to Europe that were intended for the United States, where the U.S. Food and Drug Administration (FDA) allows higher levels for the Generally Recognized As Safe ingredient. The recall drew media attention to the regulation discrepancy, with many noting that industrial-grade propylene glycol is used in antifreeze. The company clarified October 29, 2014, that it uses food-grade propylene glycol, which it says is also used in many other consumable products, including salad dressing, beer, ice cream, and cake. Sazerac called the ingredient “ideal for use in a large variety of flavors to give most of today’s food and beverages their distinctive taste. Flavor companies use it to carry flavor ingredients through to the final product,…

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