EFSA

EFSA
  • 文章类型: Journal Article
    在欧洲,运动食品补充剂(SSF)受特定法律法规的约束。多达70%的运动员受到SSF标签或广告上的信息的高度影响,这通常与科学证据不符,比如健康声明。目的是分析商业信息中与运动饮料(SD)有关的此类声明。为此,我们根据欧洲食品安全局(EFSA)对SDs标签或技术数据表上显示的健康声明的内容和适当程度进行了观察性和横断面研究.SSF是通过亚马逊和谷歌购物搜索的。共评估了114项健康索赔。没有索赔完全符合建议。共有14项索赔(n=13种产品)几乎符合建议;它们是“在需要延长耐力的运动中保持耐力水平”,“改善体育锻炼中的吸水性”,和“在高强度下改善了物理性能,受过训练的成年人进行长时间的体育锻炼,“,占总数的12.3%(n=114)。查明的绝大多数索赔都表明了未经证实的因果关系,应予以修改或消除,这相当于对消费者的食品欺诈。
    In Europe, sports food supplements (SSFs) are subject to specific laws and regulations. Up to 70% of athletes are highly influenced by the information on the label or the advertisement of the SSF, which often does not correspond to the scientific evidence, such as health claims. The aim is to analyze such claims relating to sports drinks (SDs) in commercial messages. To this end, an observational and cross-sectional study was conducted based on the analysis of the content and degree of adequacy of the health claims indicated on the labelling or technical data sheet of the SDs with those established by the European legislation in force according to the European Food Safety Authority (EFSA). The SSFs were searched for via Amazon and Google Shopping. A total of 114 health claims were evaluated. No claim fully conformed with the recommendations. A total of 14 claims (n = 13 products) almost conformed to the recommendations; they were \"Maintain endurance level in exercises requiring prolonged endurance\", \"Improve water absorption during physical exercise\", and \"Improved physical performance during high intensity, high duration physical exercise in trained adults\", representing 12.3% of the total (n = 114). The vast majority of the claims identified indicated an unproven cause-effect and should be modified or eliminated, which amounts to food fraud towards the consumer.
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  • 文章类型: Journal Article
    了解孕妇的微量营养素摄入和饮食习惯如何影响妊娠期糖尿病(GDM)至关重要。对797名孕妇的数据进行前瞻性分析,以通过口服葡萄糖耐量试验(OGTT)评估GDM状态。使用经过验证的食物频率问卷(FFQ)评估了两个时期的营养摄入量:A期,涵盖怀孕前6个月,B期,从妊娠开始到妊娠中期(24周)。将微量营养素摄入量与欧洲食品安全局(EFSA)的饮食参考值(DRV)进行比较,并用于估计平均充足率(MAR)以评估饮食充足性。14.7%(n=117)的女性被诊断出GDM,其特征是平均孕产妇年龄(MA)和孕前体重指数(BMI)较高。在评估的13种维生素中,生物素,叶酸,烟酸,在GDM组中发现泛酸明显更高,就像铁一样,镁,锰,磷,和10种矿物质中的锌。结果受评估时间的影响。重要的是,MAR在怀孕期间较高,发现GDM的风险增加1%(95CI:1,1.02)。敏感性分析显示,降低MAR显著使GDM风险增加68%(95CI:1.02,2.79)。坚持地中海饮食(MD)与GDM风险之间没有相关性。这些发现强调了进一步调查涉及这些特定微量营养素的饮食调整是否可以有效影响GDM结局的领域。
    Understanding how maternal micronutrient intake and dietary habits impact gestational diabetes mellitus (GDM) is crucial. Data from 797 pregnant women were prospectively analyzed to assess GDM status with the oral glucose tolerance test (OGTT). Nutritional intake was evaluated using a validated food frequency questionnaire (FFQ) across two periods: Period A, covering 6 months before pregnancy, and Period B, from pregnancy onset to mid-gestation (24 weeks). Micronutrient intakes were compared against the European Food Safety Authority (EFSA) dietary reference values (DRVs) and were used to estimate the mean adequacy ratio (MAR) to assess dietary adequacy. GDM was diagnosed in 14.7% (n = 117) of women with the characteristics of a higher mean maternal age (MA) and pre-pregnancy body mass index (BMI). Out of the 13 vitamins assessed, biotin, folate, niacin, and pantothenic acid were found significantly higher in the GDM group, as did iron, magnesium, manganese, phosphorus, and zinc from the 10 minerals. The results were influenced by the timing of the assessment. Importantly, MAR was higher during pregnancy and was found to increase the risk of GDM by 1% (95%CI: 1, 1.02). A sensitivity analysis revealed that reducing MAR significantly raised the GDM risk by 68% (95%CI: 1.02, 2.79). No association was revealed between adherence to the Mediterranean diet (MD) and GDM risk. These findings highlight areas for further investigation into whether dietary modifications involving these specific micronutrients could effectively influence GDM outcomes.
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  • 文章类型: Journal Article
    背景:绝经前女性的铁摄入量需求分布不对称,这使评估铁不足患病率的EAR(估计平均需求)切点方法无效。因此,必须使用比顿的全概率方法(PA)。虽然PA需要有关整个铁摄入量需求分布的信息,欧洲食品安全局(EFSA)仅提供了EAR(第50百分位数),第90,95(PRI)和97.5百分位数。
    目的:本研究旨在可靠地估计使用PA的绝经前女性铁不足的患病率,根据EFSA制定的摄入量要求,并将结果与EAR切点法获得的结果进行比较。
    方法:习惯性铁摄入量是使用统计计划来评估饮食暴露(SPADE)计算的,数据来自2012-2016年荷兰国家食物消费调查的484名女性(20-45岁)。应用了EFSA的铁要求(包括额外获得的信息)。将来自PA的结果与用EAR切点法获得的结果进行比较。敏感性分析检查了较低的铁摄入量分布对PA和EAR切点方法之间估计的不足摄入量差异的影响。
    结果:与EAR切点法相比,使用PA时,荷兰绝经前女性的铁不足患病率高出两倍。使用EFSA的参考值。敏感性分析表明,EAR切点方法也可能导致摄入量分布较低的人群的过度估计。
    结论:本研究通过使用有关EFSA参考值的全部需求分布的额外衍生信息,为使用PA方法提供了一个示例。结果再次显示EAR切点法不适合计算绝经前女性铁不足的患病率。因此,我们建议得出膳食参考值的机构提供使用正确方法确定人群摄入量不足所需的所有信息。
    The iron intake requirement distribution for premenopausal females is not symmetric, which invalidates the EAR cut-point approach for assessing the prevalence of iron inadequacy. Therefore, Beaton\'s Full Probability Approach (PA) must be used. Although the PA requires information on the entire iron intake requirement distribution, the European Food Safety Authority (EFSA) only provided the EAR (50th percentile), 90th, 95th (population reference intake), and 97.5th percentiles.
    This study aimed to reliably estimate the prevalence of iron inadequacy in premenopausal females using the PA, based on the intake requirements established by EFSA, and compare the results with those obtained from the EAR cut-point method.
    Habitual iron intakes were calculated using the statistical program to assess dietary exposure with data from 484 females (20-45 y) from the Dutch National Food Consumption Survey 2012-2016. Iron requirements of EFSA (including additionally obtained information) were applied. Results from the PA were compared to results obtained with the EAR cut-point method. Sensitivity analyses examined the impact of lower iron intake distributions on differences in estimated inadequate intakes between PA and EAR cut-point methods.
    A 2-fold higher prevalence of iron inadequacy among Dutch premenopausal females was observed when employing the PA compared to the EAR cut-point method, using EFSA\'s reference values. Sensitivity analysis showed that the EAR cut-point method could also result in large overestimations for populations with lower intake distributions.
    This study provided an example of using the PA method by using additionally derived information on the full requirement distribution underlying EFSA\'s reference values. Results showed once more the unsuitability of the EAR cut-point method to calculate the prevalence of iron inadequacy in premenopausal females. Hence, we recommend that institutions deriving dietary reference values provide all the information needed to use the correct method to determine inadequate intakes in the population.
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  • 文章类型: Journal Article
    DSHEA已有30年的历史,它通过相关机构的监督为公共卫生提供合法保护的地方创造了一系列法律和科学要求。相比之下,欧盟对补充剂和允许的成分有规定。鉴于全球食品配料供应链的背景,美国/欧盟之间配料合法性之间的任何冲突都可能抑制国际贸易的经济可行性。这次审查的目的是对比这些不同的立法监督制度。对这两个市场的分析表明,在全国范围的协调与州规则和相关解释之间,合法食品成分存在分歧。美国/欧盟之间在这方面有许多共同点,从边缘医学分类到最终排除食物使用。然而,欧盟内部现有的成文法律体系和过度的指导可以被视为耗时和僵化,特别是在市场上放置新的成分。相比之下,美国对NDI的立法解释持保留态度,GRAS和可能的药物排除法。在DSHEA周年之际,美国/欧盟中央政府最近的评论指出,在成分安全评估方面加强了国际合作,但这是否会导致市场之间的无摩擦准入尚待确定。
    The DSHEA is 30 years old and its place in providing legitimate protections for public health through relevant agency oversight has created a patchwork of legal and scientific requirements. In contrast, the European Union has rules on supplements and permitted ingredients. Given the context of a global supply chain for food ingredients any conflict between the legality of ingredients between the U.S/EU can inhibit the economic viability of international trade. The purpose of this review is to contrast these different systems of legislative oversight. The analysis of both markets demonstrates a fragmentation in what are considered legal food ingredients between country wide harmonization and state rules and related interpretation. There are many commonalities in this regard between the U.S/EU, from borderline medicinal classifications to their resultant preclusion from food use. However, the codified legal system existing within the EU and excessive guidance can be viewed as time consuming and inflexible, especially for placing new ingredients on the market. The US in contrast is in a holding pattern for legislative interpretation regarding NDIs, GRAS and possible drug preclusion laws. As we hit the anniversary of the DSHEA recent commentary from U.S./EU central authorities point to increased international co-operation in ingredient safety assessments but whether this results in friction-free access between markets is to be determined.
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  • 文章类型: Journal Article
    2011年,欧洲食品安全局(EFSA)对橄榄油多酚进行了健康声明,因为它们可以保护LDL颗粒免受氧化损伤。然而,迄今为止,有限的科学证据未能赋予维持正常脂质代谢的任何功能主张。我们对人类随机对照试验进行了系统评价和荟萃分析,评估橄榄油多酚给药对血脂的影响。直到2023年6月,以前的文献都是从六个电子数据库中获取的。共检索到75篇文章,筛选纳入标准,结果选择了10个RCT来评估每日接触橄榄油多酚对成人血脂的影响。荟萃分析是根据结果的三位数建立的,如下:低(0-68毫克/千克),培养基(68-320毫克/千克),和高(320-600毫克/千克)的多酚对HDL和LDL胆固醇(HDL-C和LDL-C,分别),和低(0-59.3毫克/千克),培养基(59.3-268毫克/千克),和高(268-600mg/kg)的多酚总胆固醇(TC)。研究方案在PROSPERO上注册(注册码:CRD42023403383)。研究设计主要是交叉的(n=8/10),但也包括平行的(n=2/10)。研究人群主要是欧洲人和健康人群。每日食用橄榄油多酚不会影响TC水平,仅略微显著降低LDL-C,仅在每日高食用橄榄油多酚(WMD-4.28,95CI-5.78至-2.77)时,WMD具有统计学意义。相反,我们的数据发现有统计学意义的HDL-C增强效应(WMD合并效应模型:1.13,95CI0.45;1.80,异质性38%,p=0.04),按每日暴露水平计算的大规模杀伤性武器对低(WMD0.66,95CI0.10-1.23)显示出统计学上显着的改善效果,中等(WMD1.36,95CI0.76-1.95),橄榄油多酚消费量高(WMD1.13,95CI0.45-1.80)。橄榄油多酚有助于维持脂质代谢。因此,食品标签法规应强调橄榄油的这种健康特征,据此,应在市场上的产品中添加橄榄油多酚含量的声明。消费者需要意识到他们消费的任何产品的质量和可能对健康的影响,营养标签的实施提供了提供这些信息的最佳方式。
    In 2011, the European Food Safety Authority (EFSA) accorded a health claim to olive oil polyphenols in that they protected LDL particles from oxidative damage. However, limited scientific evidence has so far failed to confer any claim of function on the maintenance of normal lipid metabolism. We performed a systematic review and meta-analysis of human RCTs, evaluating the effect of olive oil polyphenol administration on lipid profiles. Previous literature was acquired from six electronic databases until June 2023. A total of 75 articles were retrieved and screened for inclusion criteria, which resulted in the selection of 10 RCTs that evaluated the effect of daily exposure to olive oil polyphenols on serum lipids in adults. Meta-analyses were built by tertiles of outcomes, as follows: low (0-68 mg/kg), medium (68-320 mg/kg), and high (320-600 mg/kg) polyphenols for HDL and LDL cholesterol (HDL-C and LDL-C, respectively), and low (0-59.3 mg/kg), medium (59.3-268 mg/kg), and high (268-600 mg/kg) polyphenols for total cholesterol (TC). The study protocol was registered on PROSPERO (registration code: CRD42023403383). The study design was predominantly cross-over (n = 8 of 10) but also included parallel (n = 2 of 10). The study population was predominantly European and healthy. Daily consumption of olive oil polyphenols did not affect TC levels and only slightly significantly reduced LDL-C, with WMD statistically significant only for high daily consumption of olive oil polyphenols (WMD -4.28, 95%CI -5.78 to -2.77). Instead, our data found a statistically significant HDL-C enhancing effect (WMD pooled effect model: 1.13, 95%CI 0.45; 1.80, heterogeneity 38%, p = 0.04) with WMD by daily exposure level showing a statistically significant improvement effect for low (WMD 0.66, 95%CI 0.10-1.23), medium (WMD 1.36, 95%CI 0.76-1.95), and high (WMD 1.13, 95%CI 0.45-1.80) olive oil polyphenol consumptions. Olive oil polyphenols contribute toward maintaining lipid metabolism. Thus, food labeling regulations should stress this health feature of olive oil, whereby a declaration of the olive oil polyphenol content should be added to products on the market. Consumers need to be aware of the quality and possible health effects of any products they consume, and enforcement of nutrition labels offers the best way of providing this information.
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  • 文章类型: Journal Article
    异象病是由异象属的寄生线虫引起的一种重要的人畜共患疾病。人类可以通过食用被寄生虫污染的生鱼鱼或未煮熟的鱼来感染它,导致胃肠道和过敏症状。虽然anisakiosis在葡萄牙并不常见,西班牙对Anisakis的过敏反应的存在表明伊比利亚半岛的持续暴露。为了解决这一问题,波尔图海洋与环境研究跨学科中心,葡萄牙,与CeskeBudejovice的捷克科学院生物学中心合作,捷克共和国,根据欧洲食品风险评估研究金计划,提出了一个名为“评估葡萄牙健康风险:大西洋中的Anisakis寄生虫在葡萄牙市场出售”的项目。该项目的主要目标是收集有关宿主的有价值的流行病学数据,大西洋鲭鱼(S.大肠杆菌)和寄生线虫(Anisakisspp。),重点是评估污染水平并评估与葡萄牙人口的anisakiosis相关的潜在健康风险。通过进行这项研究,该项目旨在帮助了解葡萄牙的anisakiosis及其对公共卫生的影响。对在葡萄牙市场上出售的大西洋鲭鱼中存在异语寄生虫的调查将为食用生鱼或未煮熟的鱼相关风险提供重要见解。最终,我们的研究结果将有助于制定预防措施和指导方针,以确保葡萄牙人口的福祉.
    Anisakiosis is a significant zoonotic disease caused by parasitic nematodes of the Anisakis genus. It can be contracted by humans through the consumption of raw or undercooked fish contaminated with the parasite, leading to gastrointestinal and allergic symptoms. While anisakiosis is not frequently documented in Portugal, the presence of allergic reactions to Anisakis in Spain suggests ongoing exposure in the Iberian Peninsula. To address this concern, the Interdisciplinary Centre of Marine and Environmental Research in Porto, Portugal, in collaboration with the Biology Centre of Czech Academy of Sciences in Ceske Budejovice, Czech Republic, has proposed a project entitled \'Assessing Portuguese Health Risks: Anisakis Parasite in Atlantic Chub Mackerel (Scomber colias) Sold in Portuguese Markets\' under the European Food Risk Assessment Fellowship Programme. The primary objective of the project is to gather valuable epidemiological data on the host, Atlantic chub mackerel (S. colias) and the parasitic nematode (Anisakis spp.) with the focus on assessing contamination levels and evaluating potential health risks associated with anisakiosis in the Portuguese population. By conducting this research, the project aims to contribute to the understanding of anisakiosis and its impact on public health in Portugal. Investigation of the presence of the Anisakis parasite in Atlantic chub mackerel sold in Portuguese markets will provide crucial insights into the risks associated with consuming raw or undercooked fish. Ultimately, our findings will aid in the development of preventive measures and guidelines to ensure the well-being of the Portuguese population.
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  • 文章类型: Journal Article
    新型食品是一种新型的食品,受欧盟指令第2015/2283。后一种规范将食品定义为“新颖”,如果该食品在该法规生效之日前在联盟内没有在很大程度上用于人类消费,即1997年5月15日。“。最近,新型食品受到了全世界研究人员的越来越多的关注。在这个意义上,关注的关键领域是发现对人类健康的新益处以及在新的应用领域中利用这些新的材料来源。制药和医药领域的一个新兴领域是纳米技术,涉及纳米级新递送系统的开发。在这种情况下,这篇综述旨在总结基于属于新食品清单的材料的纳米递送系统的设计和表征的最新进展,以及用于递送衍生自新型食品的化合物的纳米食品产品。此外,在食品中使用纳米颗粒的安全隐患,即,食品补充剂,鉴于目前的欧洲法规,认为纳米材料是新型食品。
    Novel Food is a new category of food, regulated by the European Union Directive No. 2015/2283. This latter norm defines a food as \"Novel\" if it was not used \"for human consumption to a significant degree within the Union before the date of entry into force of that regulation, namely 15 May 1997\". Recently, Novel Foods have received increased interest from researchers worldwide. In this sense, the key areas of interest are the discovery of new benefits for human health and the exploitation of these novel sources of materials in new fields of application. An emerging area in the pharmaceutical and medicinal fields is nanotechnology, which deals with the development of new delivery systems at a nanometric scale. In this context, this review aims to summarize the recent advances on the design and characterization of nanodelivery systems based on materials belonging to the Novel Food list, as well as on nanoceutical products formulated for delivering compounds derived from Novel Foods. Additionally, the safety hazard of using nanoparticles in food products, i.e., food supplements, has been discussed in view of the current European regulation, which considers nanomaterials as Novel Foods.
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  • 文章类型: Journal Article
    农达是农业中使用最广泛的除草剂。它含有草甘膦作为“活性成分”,连同配方。有各种版本的农达,根据配方的不同,效果略有不同。大多数转基因作物都是为了耐受农达,因此,允许在作物生长季节喷洒杂草而不破坏杂草。被大量使用,这种除草剂现在在土壤中发现,水,空气,甚至在全世界的人类中。农达也可能在可食用作物上残留。许多研究发现了对环境和健康的危害,必须规范农达的使用,并确保其各种配方在长期使用时不会造成危险。不幸的是,监管机构只能评估“活性成分”,草甘膦,忽略配方的毒性,比活性成分毒性大得多.这一遗漏违反了欧洲联盟法院的一项裁决。监管机构和他们应该监管的行业之间有着密切的联系。令人反感的做法包括监管机构和行业之间的“旋转门”,严重依赖行业未发表的论文,同时驳回独立科学家发表的论文,以及对行业监管过程的强大秘密影响。尽管本文的重点是欧盟(EU),美国的情况大致相同。
    Roundup is the most widely used herbicide in agriculture. It contains glyphosate as the \'active ingredient\', together with formulants. There are various versions of Roundup, with somewhat different effects depending on the formulants. Most genetically-modified crops are designed to tolerate Roundup, thus allowing spraying against weeds during the growing season of the crop without destroying it. Having been so heavily used, this herbicide is now found in the soil, water, air, and even in humans worldwide. Roundup may also remain as a residue on edible crops. Many studies have found harm to the environment and to health, making it imperative to regulate the use of Roundup and to ensure that its various formulations pose no danger when used in the long-term. Unfortunately, regulators may only assess the \'active ingredient\', glyphosate, and ignore the toxicity of the formulants, which can be far more toxic than the active ingredient. This omission is in violation of a ruling by the Court of Justice of the European Union. There are close ties between the regulators and the industry they are supposed to regulate. Objectionable practices include \'revolving doors\' between the regulators and the industry, heavy reliance on unpublished papers produced by the industry while dismissing papers published by independent scientists, and strong covert influence on the regulatory process by industry. Although this paper focuses on the European Union (EU), the situation is much the same in the United States.
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  • 文章类型: Journal Article
    膳食补充剂是促进健康的产品。膳食补充剂作为食品的法律分类不会引起关注,但是对它们如何在人体中工作的一般理解似乎偏离了官方的定义。因此,有必要建立有效的膳食补充剂市场控制方法。这项研究旨在评估各种食品安全当局的建议对新注册产品中使用的成分的影响。它探讨了在欧洲食品安全局(EFSA)和波兰首席卫生检查员(GIS)发布建议后,如何修改所用产品成分的比例。关于产品成分的研究数据来自波兰国家膳食补充剂登记册,涵盖2012年至2021年11月28日。请注意,对103,102种产品进行了37种成分的分析,并应用连接点回归方法评估与成分使用相关的变化趋势。正如我们的研究指出的,大多数情况下,趋势的变化出现在产品成分中,欧洲食品安全局和波兰首席卫生检查员发布了具有最安全消费水平的建议。然而,这些变化似乎是随机出现的,不应毫无疑问地被认为是已发布建议的结果。
    Dietary supplements are health-promoting products. The legal categorization of dietary supplements as foods does not raise concerns, but a general understanding of how they work in the human body seems to deviate from the official definition. Thus, it is necessary to establish effective methods of market control related to dietary supplements. This research aims at assessing the impact of recommendations by various food safety authorities on ingredients used in newly registered products. It probes how the proportions of utilized product ingredients were modified after the European Food Safety Authority (EFSA) and Chief Sanitary Inspector in Poland (GIS) published their recommendations. Research data on the composition of products comes from the Polish national register of dietary supplements and covers the period from 2012 to 28 November 2021. Note that 103,102 products were analysed for the presence of thirty-seven ingredients, and the joinpoint regression method was applied to assess changing trends related to the use of ingredients. As our research points out, most often, changes in the trend appeared in product ingredients for which the European Food Safety Authority and Chief Sanitary Inspector in Poland issued the recommendation of having the safest level of consumption. However, these changes seem to emerge randomly and should not be unquestionably considered as the result of the published recommendations.
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  • 文章类型: Journal Article
    在食品中添加或发现的化学品的安全性评估传统上利用来自对实验动物进行的体内研究的数据。进行风险评估所需数据的性质和数量通常在不同的食品立法或部门指导文件中规定。然而,仍然存在法律没有或只有有限的实验数据或没有规定的情况,例如用于植物保护产品中的污染物或来自活性物质的一些次要代谢物。对于这种情况,可以应用毒理学关注阈值(TTC)。这篇综述探讨了TTC方法在欧盟食品安全中的应用,关于不同的食品行业,法律要求和未来的机会。
    The safety assessment of chemicals added or found in food has traditionally made use of data from in vivo studies performed on experimental animals. The nature and amount of data required to carry out a risk assessment is generally stipulated either in the different food legislations or in sectoral guidance documents. However, there are still cases where no or only limited experimental data are available or not specified by law, for example for contaminants or for some minor metabolites from active substances in plant protection products. For such cases, the Threshold of Toxicological Concern (TTC) can be applied. This review explores the use of the TTC approach in food safety in the European Union, in relation to the different food sectors, legal requirements and future opportunities.
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