European Food Safety Authority

欧洲食品安全局
  • 文章类型: Journal Article
    欧洲食品安全局(EFSA)最近得出的双酚A(BPA)的每日摄入量(TDI)为0.2ng/kgbw/天。EFSA的危险评估审查过程有几个问题,包括它是基于相关研究的有限子集。EFSA对BPA评估草案的多个公众评论者,包括几个欧洲监管机构,注意到这些问题,然而,EFSA在最终评估中没有充分解决这些问题。BPA的TDI是基于在其他物种中未观察到的小鼠中的中等免疫毒性终点;没有证据表明它是任何下游病理结果的前兆事件。TDI比全球机构确定的BPA安全剂量的估计值低几个数量级,包括EFSA于2015年建立的BPA临时TDI(t-TDI)。总的来说,EFSA危害评估审查过程得出的结论是,双酚A的低剂量效应基于极少数,质量较低的实验动物研究。这一结论没有得到全部现有证据的支持,其中包括EFSA未考虑的多项高质量研究,并表明2015年建立的t-TDI对人类健康具有保护作用。
    The European Food Safety Authority (EFSA) recently derived a tolerable daily intake (TDI) for bisphenol A (BPA) of 0.2 ng/kg bw/day. There are several issues with EFSA\'s hazard assessment review process, including that it was based on a limited subset of relevant studies. Multiple public commenters on EFSA\'s draft evaluation of BPA, including several European regulatory agencies, noted these issues, yet they were not adequately addressed by EFSA in the final evaluation. The TDI for BPA was based on an intermediate immunotoxicity endpoint in mice that has not been observed in other species; there is no evidence that it is a precursor event to any downstream pathological outcome. The TDI is several orders of magnitude lower than estimates of safe doses of BPA established by agencies worldwide, including EFSA\'s temporary TDI (t-TDI) for BPA established in 2015. Overall, the EFSA hazard assessment review process has led to a conclusion that there are low-dose effects of BPA based on very few, lower quality experimental animal studies. This conclusion is not supported by the totality of the available evidence, which includes multiple high-quality studies not considered by EFSA and indicates that the t-TDI established in 2015 is protective of human health.
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  • 文章类型: Journal Article
    欧洲食品安全局(EFSA)修订了对双酚A(BPA)毒性的估计,因此,建议将每日摄入量(TDI)减少20000倍。这将基本上禁止在食品包装中使用BPA,例如罐头衬里,塑料食品容器,在消费品中。得出这个结论,EFSA根据预先建立的协议使用了系统方法,并在分析中包括了所有指南和非指南研究。他们发现Th-17免疫细胞在BPA暴露量非常低的情况下增加,并利用这一终点将TDI修改为保护人类健康。包括欧洲药品管理局(EMA)在内的许多监管机构都对EFSA提案的几个要素提出了正式的异议。欧盟委员会现在将决定是否接受EMA反对的EFSA的建议。如果委员会接受EFSA的建议,这将是一项里程碑式的行动,利用通过专注于慢性病生物标志物的独立科学研究获得的知识来保护人类健康。这个观点的目的是清楚地阐明这场辩论和决定的巨大性质,并解释利害关系。我们的观点是,证据的分量清楚地支持EFSA将TDI减少20000倍的提议。
    The European Food Safety Authority (EFSA) has revised their estimate of the toxicity of bisphenol A (BPA) and, as a result, have recommended reducing the tolerable daily intake (TDI) by 20 000-fold. This would essentially ban the use of BPA in food packaging such as can liners, plastic food containers, and in consumer products. To come to this conclusion, EFSA used a systematic approach according to a pre-established protocol and included all guideline and nonguideline studies in their analysis. They found that Th-17 immune cells increased with very low exposure to BPA and used this endpoint to revise the TDI to be human health protective. A number of regulatory agencies including the European Medicines Agency (EMA) have written formal disagreements with several elements of EFSA\'s proposal. The European Commission will now decide whether to accept EFSA\'s recommendation over the objections of EMA. If the Commission accepts EFSA\'s recommendation, it will be a landmark action using knowledge acquired through independent scientific studies focused on biomarkers of chronic disease to protect human health. The goal of this Perspective is to clearly articulate the monumental nature of this debate and decision and to explain what is at stake. Our perspective is that the weight of evidence clearly supports EFSA\'s proposal to reduce the TDI by 20 000-fold.
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  • 文章类型: Retraction of Publication
    欧洲食品安全局(EFSA)最近得出的双酚A(BPA)的每日摄入量(TDI)为0.2ng/kgbw/天。EFSA的危险评估审查过程有几个问题,包括它是基于相关研究的有限子集。EFSA对BPA评估草案的多个公众评论者,包括几个欧洲监管机构,注意到这些问题,然而,EFSA在最终评估中没有充分解决这些问题。BPA的TDI是基于在其他物种中未观察到的小鼠中的中等免疫毒性终点;没有证据表明它是任何下游病理结果的前兆事件。TDI比全球机构确定的BPA安全剂量的估计值低几个数量级,包括EFSA于2015年建立的BPA临时TDI(t-TDI)。总的来说,EFSA危害评估审查过程得出的结论是,双酚A的低剂量效应基于极少数,质量较低的实验动物研究。这一结论没有得到全部现有证据的支持,其中包括EFSA未考虑的多项高质量研究,并表明2015年建立的t-TDI对人类健康具有保护作用。
    This article has been withdrawn at the request of the author(s) and/or editor. The Publisher apologizes for any inconvenience this may cause. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/policies/article-withdrawal.
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  • 文章类型: Journal Article
    2017年,欧洲食品安全局(EFSA)关于使用谷氨酸及其盐作为食品添加剂的意见导致每日可接受摄入量(ADI)为30mg/kg体重/天。然后,2021年,EFSA的一份声明提出了一项建议,以协调为也是受管制物质(包括食品添加剂)的营养素建立基于健康的指导值。本综述认为2017年谷氨酸ADI不适合,因为谷氨酸的安全性应首先考虑其作为营养素的地位,而不仅仅是作为添加剂。
    谷氨酸是在氮稳态中起关键作用的非必需氨基酸。成年人的饮食中接触谷氨酸是广泛的,由于它在食物中无处不在,在三种形式下:与蛋白质结合,作为添加剂添加的自然自由和自由形式。蛋白质中天然包含的谷氨酸是膳食谷氨酸的主要来源。因此,因为它在氮稳态中起作用,在成为添加剂之前,它是一种营养素。它的药代动力学在很大程度上受到伴随食物摄入的影响,但是,在日常饮食中食用谷氨酸的人中,从未遇到过血浆谷氨酸浓度必须升高以产生有害影响的程度。这是由于谷氨酸在内脏区域高度代谢的事实。
    在被风险评估者视为添加剂之前,应将谷氨酸视为安全营养素。
    In 2017, a European Food Safety Authority (EFSA) opinion on the use of glutamate and its salts as food additives led to an Acceptable Daily Intake (ADI) of 30 mg/kg body weight/day. Then, in 2021, an EFSA statement presented a proposal for harmonizing the establishment of Health-Based Guidance Values for nutrients that are also regulated substances (including food additives). The present review argues that the 2017 glutamate ADI is unsuitable because safety of glutamate should firstly consider its status as a nutrient and not only as an additive.
    Glutamate is a non-essential amino acid playing a key role in nitrogen homeostasis. The dietary exposure to glutamate in adults is extensive, due to its ubiquitous presence in foods, under three forms: bound to proteins, naturally free and free form added as an additive. Glutamate naturally included in proteins is the major source of dietary glutamate. Thus, since it plays a role in nitrogen homeostasis, it is a nutrient before being an additive. Its pharmacokinetics are largely impacted by concomitant food intake, but the extent to which plasma glutamate concentration must rise to have deleterious effects is never encountered in humans consuming glutamate in their daily diets. This is due to the fact that glutamate is highly metabolized in the splanchnic area.
    Glutamate should be considered as a safe nutrient before being considered as an additive by risk assessor.
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  • 文章类型: Journal Article
    The European Commission (EC) recommends that policy within the EU should consider how to make the regulation of new genomic techniques \'more resilient, future-proof and uniformly applied\' than is presently the case. In this article, we explore what this might mean for the EU and what solutions might exist.
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  • 文章类型: Journal Article
    自2006年以来,欧盟对食品含有健康成分或对消费产生有益影响的建议进行了监管。本文介绍了该营养和健康索赔法规如何导致300多项授权索赔的分析,以及授权要求和过程如何影响食品索赔的使用。确定了五个挑战,这些挑战对当前有关营养和健康声明的立法产生了负面影响:未经审查的植物学声明(以及对婴儿和幼儿的搁置声明),缺乏营养概况和对单一成分的索赔重点,消费者的理解,研究营养对健康的影响,最后,执法。这些挑战被证明会影响法规的目标:保护消费者免受虚假和误导性主张的侵害,并刺激欧盟公平竞争环境的发展。促进创新。解决这些健康声明的政治和科学证据问题,以及不断分析消费者和运营商对索赔的理解和使用情况,将确保NHCR保持有效,今天和未来。
    Suggestions that a food contains healthy ingredients or that it can provide beneficial effects upon consumption have been regulated in the EU since 2006. This paper describes the analysis of how this nutrition and health claim regulation has resulted in over 300 authorised claims and how the authorisation requirements and processes have affected the use of claims on foods. Five challenges are identified that negatively affect the current legislation dealing with nutrition and health claims: non-reviewed botanical claims (as well as on hold claims for infants and young children), the lack of nutrient profiles and the focus of claims on single ingredients, consumer understanding, research into health effects of nutrition and finally, enforcement. These challenges are shown to influence the goals of the regulation: protecting consumers from false and misleading claims and stimulating the development of a level playing field in the EU, to foster innovation. Tackling these political and scientific substantiation questions for health claims, together with continuously analysing the understanding and usage of claims by consumers and operators will ensure that the NHCR will stay effective, today and in the future.
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  • 文章类型: Journal Article
    食品补充剂行业的过度增长凸显了需要将注意力集中在其适当消费所涉及的所有方面;其中一个中心是广告。这项研究的目的是分析食品补充剂广告中虚假和误导性声明的存在。为此,在不同类型的健康相关声明和它们所基于的物质之间建立了关系,无论是否获得欧洲食品安全局(EFSA)的授权。
    这项实证工作对整个2017年在新闻/谈话广播电台广播的所有广播提及进行了内容分析。
    西班牙。
    所有广播都在西班牙的新闻/谈话商业广播电台播出,受众水平最高。该语料库由437个广告组成。
    结果表明,所分析广告中包含的功能声明中有80·3%未经EFSA授权,而20%的疾病索赔是欧盟法规不允许的。同样,几乎一半的物质(43·7%)是非法的:54·1%的功能声明,在疾病索赔中占57·3%,在降低疾病风险索赔的情况下占73·7%。
    这项工作揭示了在遵守欧洲食品补充剂广告法规方面的一贯失败。作为有说服力的论点,间接求助于疾病加剧了未经授权的健康声明和物质的广泛使用,将所谓的利益描述为产品属性和遗漏基本信息。这导致危险的错误信息,并可能造成严重的健康风险。需要更强有力的法律机制来有效保护消费者。
    The excessive growth of the food supplements\' industry highlights the need to focus attention on all aspects involved in their proper consumption; one that takes centre stage is advertising. The aim of this research is to analyse the presence of false and misleading claims in food supplements advertising. To this end, a relationship is established between the different types of health-related claims and the substances on which they are based, whether authorised or not by European Food Safety Authority (EFSA).
    This empirical work conducts a content analysis of all radio mentions broadcast throughout 2017 on news/talk radio stations.
    Spain.
    All radio mentions broadcast on news/talk commercial radio stations in Spain with the highest audience levels. The corpus is composed of 437 advertisements.
    Results indicate that 80·3 % of function claims included in the analysed advertisements are not authorised by EFSA, while 20·4 % of disease claims are not allowed by EU regulation. Likewise, almost half of the substances referred to (43·7 %) are illicit: 54·1 % in function claims, 57·3 % in disease claims and 73·7 % in the case of reduction of disease risk claims.
    This work reveals consistent failures to comply with European regulation on food supplements advertising. The widespread use of unauthorised health claims and substances is aggravated by the indirect recourse of illness as a persuasive argument, descriptions of alleged benefits as product attributes and the omission of essential information. This leads to dangerous misinformation and can pose serious health risks. Stronger legal mechanisms are needed for effective consumer protection.
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  • 文章类型: Journal Article
    属性框架效应的信息泄漏说明提出了通信者对框架的选择提供了信息价值,这样不同的帧在信息上是不等效的。在五项传达食品风险的研究中,我们通过操纵沟通者表面上对信息如何构成框架的选择程度,调查了沟通接受者(我们的参与者)对框架信息使用的适应性.在所有研究的所有条件下都观察到参与者内部的框架效应。仅在研究4中(唯一一项在参与者内部操纵传播者选择的研究),有任何证据表明框架效应减弱,而传播者不负责信息的框架方式。总的来说,无论框架效果是否由通信者选择的框架中包含的信息值驱动,人们对这种选择被删除的情况表现出很少的敏感性。
    The informational leakage account of attribute framing effects proposes that a communicator\'s choice of frame provides informational value, such that different frames are not informationally equivalent. Across five studies communicating food risks, we investigated the adaptability of communication recipients\' (our participants) use of frame information by manipulating the degree to which the communicator ostensibly had a choice over how the information was framed. Within-participants framing effects were observed across all conditions of all studies. Only in Study 4 (the only study in which communicator choice was manipulated within-participants) was there any evidence for an attenuation of framing effects where the communicator was not responsible for how the information was framed. Overall, regardless of whether or not framing effects are driven by the informational value contained in a communicator\'s choice of frame, people show little sensitivity to situations where that choice is removed.
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  • 文章类型: Letter
    代表欧洲食品安全局(EFSA),Kass和Lodi最近发表了一封信,声称“驳斥”我们2019年7月对EFSA2013年12月对阿斯巴甜风险评估的分析。我们以前曾声称,EFSA小组评估了一些研究,这些研究表明,阿斯巴甜的危害可能比没有表明危害的危害更大。我们报告说,EFSA认为73项暗示伤害的研究中的每一项都是不可靠的。Kass和Lodi提供了一张表格,其中的数字在每个细节上都与我们不同。这篇评论显示,当Kass和Lodi对我们的分析做出回应时,他们还没有接近反驳。我们的分析提供了每项研究的详细特征,以及小组如何解释它们,但是Kass和Lodi根本没有提供相应的信息.Kass和Lodi声称,EFSA认为35项表明可能造成伤害的研究中有21项是可靠的。但如果是这样的话,我们现在问:为什么EFSA小组不建议禁止阿斯巴甜,或者至少严格限制?
    On behalf of the European Food Safety Authority (EFSA), Kass and Lodi recently published a letter purporting to \'refute\' our July 2019 analysis of EFSA\'s December 2013 assessment of the risks of aspartame. We had previously claimed inter alia that the EFSA panel had evaluated studies that had indicated that aspartame might be harmful far more sceptically than those that had not indicated harm. We reported that EFSA had deemed every one of 73 studies suggesting harm to have been unreliable. Kass and Lodi provided a tabulation with figures that differed from ours in every detail. This commentary shows that, while Kass and Lodi provided a response to our analysis, they have not come close to refuting it. Our analysis provided detailed characterisations of each of the studies and how the panel interpreted them, but Kass and Lodi provide no corresponding information at all. Kass and Lodi claim that EFSA deemed 21 of 35 studies that had indicated possible harm to have been reliable. But if that is so, we now ask: why did the EFSA panel not recommend that aspartame should be banned, or at least tightly restricted?
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  • 文章类型: Journal Article
    最近的观点捍卫了欧洲食品安全局(EFSA)在风险评估中使用同时种植的非GE品种子集评估基因工程(GE)作物的成分正常性的方法。虽然EFSA的方法管理了错误声称等价的风险,这是以低功率为代价来实现的,以检测真正的等效性。基于所选择的非GE比较器,这在同一GE事件的研究中产生了不一致的发现和安全性结论。因为转基因作物成分的变化与安全性无关,我们建议改善政策,以更好地配合消费者保护。
    A recent perspective defends the approach of the European Food Safety Authority (EFSA) for evaluating the compositional normality of genetically engineered (GE) crops using a concurrently grown subset of non-GE varieties within the risk assessment. While the approach of the EFSA manages the risk of falsely claiming equivalence, this is achieved at the expense of low power to detect true equivalence. This generates inconsistent findings and safety conclusions across studies for the same GE event based on the selected non-GE comparators. Because variation in GE crop composition has not been associated with safety, we suggest policy improvements that would better align with consumer protection.
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