Category Archives European Food Safety Authority

As part of an ongoing food additive assessment, the European Food Safety Authority (EFSA) has requested additional scientific data on aspartame “related to 5-benzyl-3,6-dioxo-2-piperazine acetic acid (DKP) and other primary or secondary degradation products from aspartame.” Asked by the European Commission in 2011 to reevaluate the safety of aspartame as a food additive, EFSA’s Scientific Panel on Food Additives and Nutrient Sources Added to Food initially called for aspartame data by September 30, 2011, but has since determined that there is further need for “data on products which can be formed from aspartame in different types of foodstuffs, in particular on [DKP], depending [for example] on pH, temperature and storage time.” As a result, EFSA has delayed its findings and instead requested data on “the presence and levels of DKP found in aspartame-containing foodstuffs (including beverages) found on the market” as well as “the formation of DKP and other primary…

The European Food Safety Authority (EFSA) has issued new guidance for the submission of food additive applications that reflects recent scientific advances as well as “the latest risk assessment principles.” Developed by EFSA’s Panel on Food Additives and Nutrient Sources Added to Food, the new data submission guidelines aim to streamline the testing process while still generating “the data necessary to demonstrate the high level of consumer safety required.” Food companies seeking market authorization from the European Commission must provide EFSA with “the necessary information and data supporting the safety of the food additive.” In particular, the guidance introduces “a new tiered approach for the risk assessment of food additives” that will assist applicants with their toxicological testing strategy. Under the new guidance, Tier 1 tests must meet “a minimal dataset applicable to all compounds,” while Tier 2 testing “will be required for compounds which are absorbed, demonstrate toxicity or…

At the European Commission’s request, the European Food Safety Authority (EFSA) has published a scientific statement on the safety of food products derived from animal clones. In its June 2012 statement, EFSA reaffirms its earlier statements and opinions, noting that no new information has changed its conclusion that meat and milk from healthy cattle and pig clones and their offspring are no different “compared with those from healthy conventionally bred animals.” EFSA also finds no evidence that cloning farmed animals poses any particular threats to genetic diversity or biodiversity. Still, the scientific statement underlines that animal health and welfare “were compromised in a proportion of clones, mainly observed as increased mortality within the postnatal and juvenile period of calve and piglet clones, as well as in a proportion of the surrogate dams that were affected by abnormal pregnancies.” See EFSA News Release, July 5, 2012.

The European Food Safety Authority (EFSA) has issued a scientific opinion on dietary exposure to mineral oil hydrocarbons (MOH) found mainly in “food packaging materials, food additives, processing aids, and environmental contaminants such as lubricants.” According to a June 6, 2012, press release, EFSA’s Panel on Contaminants in the Food Chain (CONTAM) focused on two types of MOH: (i) aromatic hydrocarbons identified as potentially genotoxic and carcinogenic; and (ii) saturated hydrocarbons that “can accumulate in human tissue and may cause adverse effects in the liver.” The CONTAM Panel apparently found low levels of saturated MOH in all of the food groups tested, “with some high levels found in ‘Bread and rolls’ and ‘Grains for human consumption’ due to their use, respectively, as release/ non-sticking agents and spraying agents (used to make grains shiny).” It also reported the presence of both saturated and aromatic MOH in dry foods such as “‘pudding’…

The European Food Safety Authority’s Panel on Genetically Modified Organisms (EFSA GMO Panel) has issued an opinion on the French government’s move to prohibit the planting of a certain GM maize variety, concluding that “there is no specific scientific evidence, in terms of risk to human and animal health or the environment, that would support the notification of an emergency measure under Article 34 of Regulation (EC) No 1829/2003.” According to EFSA, which noted that most of the studies cited by French authorities were recycled from a 2008 submission on the same topic, the agency was unable to identify “any new science-based evidence” to support the country’s ongoing ban. Citing risks to environmental health, French Agricultural Minister Bruno Le Maire in March 2012 reinstated a ban against this particular variety of GM maize after French courts overturned a previous emergency measure. As one spokesperson explained to media sources, however, EU…

The European Food Safety Authority (EFSA) has issued a call for data as part of its ongoing risk assessment of bisphenol A (BPA) that includes an exposure assessment from both dietary and non-dietary sources. Spurred in part by a September 2011 report published by the French Agency for Food, Environmental and Occupational Health and Safety, EFSA has asked member states, researchers and other stakeholders to submit (i) “occurrence data in food and beverages intended for human consumption”; (ii) “migration data from food contact materials”; and (iii) “occurrence data in food contact materials.” According to EFSA, its latest BPA assessment will consider the “most vulnerable groups of the population (e.g. pregnant women, infants and children, etc.)” and rely on occurrence data “available in the public domain and from scientific literature” as well as any available biomonitoring data. The agency will accept data submissions until July 31, 2012.

The European Food Safety Authority (EFSA) has announced the resignation of Management Board Chair Diána Bánáti, describing her decision to accept a position at the International Life Sciences Institute (ILSI) as “incompatible” with her agency duties. Bánáti apparently agreed to step down after critics raised concerns about EFSA’s supposed lack of transparency “in its links with lobbyists for biotech and food companies,” noted a May 9, 2012, Parliament article. Additional details about a Corporate European Observatory report that focused on EFSA members with ILSI ties appear in Issue 399 of this Update. Although EFSA stressed that board members must consider public perception in undertaking “any activities which could raise doubts about their independence,” Bánáti in her resignation speech reportedly defended the agency as “one of the most transparent organizations I know.” She also reiterated that ILSI Europe, where she will serve as executive and scientific director, is not an industry lobbying…

The European Food Safety Authority’s (EFSA’s) Panel on Dietetic Products, Nutrition and Allergies (NDA) has issued a scientific opinion on the use of egg-derived lysozyme in wine manufacturing after the Oenological Products and Practices International Association (OENOPPIA) applied to permanently exempt the anti-microbial stabilizer from labeling requirements. According to NDA, which was tasked with assessing the likelihood of allergic reaction to lysozyme-treated wine, the additive is approved for use in some foods to control lactic acid bacteria but “must follow purity specifications set forth in European legislation.” Because it can evidently be used “at different stages of wine production and at different doses,” lysozyme was detected in some wines at residual amounts “considered sufficient to trigger allergic reactions in susceptible individuals.” OENOPPIA had apparently argued that lysozyme is not only “the weakest allergen among the four major egg white proteins,” but unlikely to cause a clinical reaction in egg-allergic individuals…

The European Union (EU) has temporarily prohibited the importation of some seeds and bean sprouts from Egypt after a European Food Safety Authority (EFSA) report linked the products to an E. coli O104:H4 outbreak that reportedly killed 51 people, including as many as six U.S. citizens. According to a July 5, 2011, EU press release, all imported seeds and beans “for sprouting” will be frozen until October 31, 2011, and all fenugreek seeds imported from one Egyptian company since 2009 will be destroyed. The ban apparently covers “seeds, fruit and spores used for sowing; leguminous vegetables, shelled or unshelled, fresh or chilled; fenugreek; dried leguminous vegetables, shelled, whether or not skinned or split; soya beans, whether or not broken; other oil seeds and oleaginous fruit, whether or not broken.” Officials apparently traced the E. coli outbreaks in France and Germany to a single importer that shipped Egyptian fenugreek seeds to both…

The Corporate European Observatory (CEO) has published a report accusing European Food Safety Authority (EFSA) food additive experts of concealing conflicts of interest and industry ties. CEO claims that 11 out of 20 experts on EFSA’s Panel on Food Additives and Nutrient Sources in Food (ANS) “have a conflict of interest, as defined by the Organization for Economic Cooperation and Development,” which states that such conflicts arise when an individual or corporation “is in position to exploit his or their own professional or official capacity in some way for personal or corporate benefit,” whether or not an unethical or improper act results. The report also alleges that four ANS members have “failed to declare active collaborations with the food-industry funded think-tank and lobby group, the International Life Sciences Institute (ILSI).” In particular, CEO faults EFSA for failing to adopt a “red list” similar to the one used by the European Medicines…

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