Category Archives European Food Safety Authority

The European Food Safety Authority (EFSA) has issued a public call for data “on the artificial sweetener aspartame (E 951) for consideration in a full re-evaluation to be completed in 2012 as requested by the European Commission [EC].” EFSA has asked interested parties and stakeholders to submit “scientific or technical data—published, unpublished and newly generated—related to the use of aspartame in food and drinks and as a tabletop sweetener.” Originally scheduled for 2020, the aspartame review is “part of the systematic re-evaluation of all authorized food additives in the European Union.” EFSA apparently agreed to move up the proceedings after European Parliament members voiced concerns about the sweetener. “Due to EFSA’s scientific cooperation efforts, particularly with its partners in EU Member States, ongoing liaison with international partners and its stakeholder dialogue, EFSA can draw on a well-established network to ensure that all the relevant data are considered,” stated the agency, which…

The European Food Safety Authority (EFSA) has published its first guidance document assessing the risk of engineered nanomaterial (ENM) applications in food and feed. Prepared in response to a European Commission request, the May 10, 2011, guidance comes after a six-week public consultation period during which EFSA received 256 comments from 36 organizations, including academia, industry, Member States, international authorities, and non-governmental groups. The guidance covers potential risks from applications of nanoscience and nanotechnologies across the food supply chain, including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives, and pesticides. Outlining six toxicity testing methods, the guidance stresses the need for ongoing risk assessments in the burgeoning field of engineered nanomaterials and additional data on physical and chemical ENM characteristics in comparison with conventional applications. “A thorough characterization of the engineered nanomaterials followed by adequate toxicity testing is essential for the risk assessment of these applications,” EFSA…

The European Food Safety Authority (EFSA) has issued an April 6, 2011, statement on food irradiation that summarizes the 2010 scientific opinions adopted by the Panel on Biological Hazards and the Panel on Food Contact Materials, Enzymes, Flavorings and Processing Aids, which together assessed the procedure’s efficacy and safety. Using the latest available evidence, these panels have evidently concluded “that there are no microbiological risks for the consumer linked to the use of food irradiation,” and “that most of the substances formed in food by irradiation are also formed during other types of food processing, with levels comparable to those arising, for instance, from the heat treatment of foods.” According to EFSA, “only a very limited quantity of food consumed in Europe is irradiated,” a practice considered part of “an integrated food safety management program… that includes good agricultural, manufacturing and hygienic practices.” Still, panel experts have recommended that “decisions…

The European Food Safety Authority’s (EFSA’s) Scientific Panel on Food Additives and Nutrient Sources Added to Food (ANS) “has assessed the safety of a group of caramel colors authorized for use in food in the European Union,” concluding that all four classes “are neither genotoxic, nor carcinogenic and that there is no evidence to show that they have any adverse effects on human reproduction or for the developing child.” The ANS Panel evidently reevaluated the safety of Class I Plain Caramel or Caustic Caramel (E 150a), Class II Caustic Sulfite Caramel (E 150b), Class III Ammonia Caramel (E 150c) and Class IV Sulfite Ammonia Caramel (E 150d), setting a group acceptable daily intake (ADI) of 300 mg per kg body weight per day (mg/kg bw/day). It also set a more restrictive ADI of 100 mg/kg bw/day for caramel E150c. As ANS Panel Chair John Christian Larsen explained, “This means that…

The European Food Safety Authority’s (EFSA’s) Panel on Dietetic Products, Nutrition and Allergies has rejected an article 13.5 application submitted by Piimandusühistu E-Piim, the manufacturer of a probiotic cheese, claiming that its product “helps to maintain the cardio-vascular system/heart health through reduction of blood pressure.” The applicant evidently submitted 38 publications and four proprietary reports related to the maintenance of normal blood pressure and the Lactobacillus plantarum TENSIA™ bacteria found in its “semi-hard Edam-type” Harmony™ “heart cheese.” EFSA ruled, however, that “none of these publications addressed the effects of L. plantarum,” while three of the four unpublished proprietary reports were uncontrolled and therefore inadmissible. The fourth study, according to EFSA, “was a randomised, double-blind, placebo-controlled, cross-over human intervention,” but ultimately failed “to show an effect of L. plantarum TENSIA™ on blood pressure.” The panel therefore concluded that “a cause and effect relationship has not been established between the consumption of Lactobacillus plantarum…

The European Food Safety Authority (EFSA) has announced a preliminary program for a consultative workshop on draft guidance on the selection of comparators, or controls, for the risk assessment of genetically modified organism (GMO) plants. Scientists and risk assessors from European Union (EU) member states, industry and non-governmental organizations are expected to attend the March 31, 2011, workshop in Brussels. According to EFSA’s website, agenda items include (i) “Principles of risk assessment in the EU legal framework”; (ii) “GMO risk assessment: pros and cons of different approaches”; (iii) “Specific food and feed/molecular characterization and environmental needs for selection comparator”; and (iv) “Risk assessment when no comparator is available.” Meanwhile, EU’s Standing Committee on the Food Chain has reportedly “returned no definitive opinion” on whether to approve or veto the use of three GMOs for maize and cotton. According to a news source, the inconclusive vote could thwart other forms of…

The European Food Safety Authority (EFSA) has requested public comments on its draft “Guidance on risk assessment concerning potential risks arising from applications of nanoscience and nanotechnologies to food and feed.” The comment period closes February 25, 2011. The draft guidance outlines under what circumstances nanomaterials in food and animal feed should be tested for potential health risks and how the risk assessment process should be conducted. According to the guidance, the risk of an engineered nanomaterial “will be determined by its chemical composition, physico-chemical properties, its hazard characterization and potential exposure.” At an initial stage for the proposed use of a nanomaterial in food or feed applications, where internal exposure, a high level of reactivity or mobility, and persistence of the nanomaterial exist, “in-depth testing” would be appropriate. While the guidance recognizes that characterization parameters “will depend on the nature, functionalities, and intended uses of the” engineered nanomaterial, certain…

In its ongoing review of food product health claims, the European Food Safety Authority (EFSA) has adopted 75 new opinions addressing 808 claims. EFSA’s independent scientists opined that claimed functional-food effects, such as improves the “immune system” or “immune function,” “supports immune defences,” “reduces inflammation,” or “decreases potentially pathogenic gastro-intestinal microorganisms,” were either insufficiently defined or unsupported by scientific data. The authority also turned aside claims that the probiotic bacteria in a specific brand of yogurt maintain immune defenses against the common cold. According to a news source, the scientific studies that yogurt-maker Yakult submitted to justify such claims were inadequate. Some suggest that this week’s rulings by EFSA have seriously compromised industry efforts to promote functional foods, in which companies have made significant investment. Industry is reportedly challenging the determinations, complaining that the authority is applying excessively rigorous standards, and has asked for meetings to discuss the criteria used.…

European Food Safety Authority (EFSA) Chair Diana Banati has reportedly dismissed conflict-of-interest allegations arising from her involvement with the International Life Sciences Institute (ILSI), a public health nonprofit whose membership includes academic, government and industry scientists. According to Greens MEP José Bové, Banati failed to disclose her industry ties as an ILSI board member when installed at EFSA. “The commission should never have approved her appointment given her clear links to the food industry, which is completely at odds with the need for independence at the EFSA,” Bové was quoted saying. “There can be no alternative but to replace Banati as chair of the EFSA.” Bové has purportedly raised the issue to cast doubt on EFSA’s credibility as the European Commission looks to reform both the food safety body and the approval process for genetically modified organisms. A Banati spokesperson, however, has publicly denied the claims, noting that the chair’s…

The European Food Safety Authority’s (EFSA’s) panel on food contact materials, enzymes, flavorings, and processing aids has released its latest risk assessment for bisphenol A, concluding that there was not any “new evidence which would lead them to revise the current Tolerable Daily Intake [TDI] for BPA of 0.05 mg/kg body weight set . . . in its 2006 opinion and re-confirmed in its 2008 opinion.” The CEF panel undertook the reassessment at the request of the European Commission, which directed scientists to (i) decide on the basis of recent literature whether to update the TDI; (ii) “assess a new study on possible neurodevelopmental effects”; and (iii) advise on a risk assessment made by the National Food Institute at the Technical University of Denmark. Although one minority opinion evidently raised questions about “adverse health effects below the level used to determine the current TDI,” panel members agreed on shortcomings in…

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