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…
Category Archives Europe
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 Commission has apparently sent “a reasoned opinion” to 10 member states “that have failed to correctly implement Directive 1994/74EC which introduces a ban on the use of un-enriched cages for laying hens,” according to a June 21, 2012, EU press release. The Commission has given Belgium, Greece, Spain, France, Italy, Cyprus, Hungary, the Netherlands, Poland, and Portugal two months to ensure compliance with the directive before referral to the EU Court of Justice. These countries apparently still permit the use of “un-enriched cages” for laying hens “despite the ban which came into force in January 2012 for which they have had 12 years to prepare.” Under the directive, “all laying hens must be kept in ‘enriched cages’ with extra space to nest, scratch and roost,” or in systems with at least 750 square centimeters of cage area as well as “a nest-box, litter, perches and claw-shortening devices, allowing…
The Council of the European Union has issued a “One Health” perspective document recognizing that antimicrobial resistance (AMR) “is accelerated by excessive and inappropriate use of antimicrobial agents” and asking member states to “develop and implement national strategies or action plans for countering AMR.” According to the perspective document, which underlined the need for “an active holistic approach” to combating AMR, “some practices in human and in animal healthcare including the possible incentives deriving from the prescription and subsequent sale of antimicrobial agents may lead to inappropriate use and overuse of antimicrobial agents.” In particular, the Council has advocated restrictions on both the human and veterinary use of critically important microbials (CIAs) and newly developed microbials “with the aim in the future to reserve CIAs as much as possible for human use.” To this end, the Council has requested that member states curb the prophylactic use of all antimicrobials while…
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 Commission has approved a list of 222 health claims—“for example on the role of calcium and bone health or vitamin C and the immune system”—that are permitted for use on food labeling and advertising. According to a May 16, 2012, press release, food manufacturers must adapt their practices to the new requirements by the beginning of December 2012, at which point “all claims that are not authorized and not on hold/under consideration shall be prohibited.” “Today’s decision is the culmination of years of work and marks a major milestone in regulating health claims on food,” said Health and Consumer Policy Commissioner John Dalli. “The EU-wide list of permitted health claims will be available on-line and will allow consumers everywhere in the EU to make an informed choice. Non-scientifically backed claims will have to be removed from the market after a short transition period.”
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 Parliament recently adopted a resolution setting priorities for the Seventh Environmental Action Program (7EAP) and urging the Commission to present a 7EAP proposal “without delay.” Set to expire July 22, 2012, the Sixth EAP (6EAP) aimed to provide “an overarching framework for environment policy” and substantially consolidated environmental regulations, although it failed to fulfill several of its objectives and did not account for new challenges such as those concerning mixed chemicals, pesticides and water. The latest resolution calls for 7EAP to improve implementation, enforcement and integration of the policies laid out in 6EAP and to address additional goals in the following areas: (i) climate change; (ii) sustainability; (iii) biodiversity and forestry; and (iv) environmental quality and human health. In particular, the European Parliament has asked the next program to develop measures to counter “emerging human and animal health threats” as well as “examine the effects of new developments…
