进口保健食品在我国注册备案情况及发展趋势

目的分析申请进口保健食品的"瓶颈"及原因,并提出进口保健食品未来的发展管理趋势。方法通过对我国上市的进口保健食品注册和备案产品总数、保健功能、原料及申请国家情况的统计分析,梳理进口保健食品注册备案法规,并对已获得注册和备案的进口保健食品建立数据库,通过excel软件进行描述性分类统计分析。结果根据进口注册的保健食品总量分析,2003年以前批准的产品占65%,2003年以后批准的产品占35%;注册产品保健功能以增强免疫力最多,其次为辅助降血脂,申报的保健功能涉及18个;申请备案的保健食品中保健功能以补充钙最多,其次是维生素D,申报的营养素涉及17个;进口保健食品注册和备案申请最多的是美国,涉及国家达到15个。结论面对巨大的国内消费市场,在我国获得注册批准证书和备案凭证的进口保健食品数量却不足一千个,远低于国外上市健康产品种类。这与我国对进口保健食品法规要求较严,国外保健食品类似产品管理不同等有关。作为进口到中国的保健食品,必须确保产品长期食用的安全性。未来随着保健食品原料目录的调整及法规完善,更多符合我国法律法规要求的进口保健食品将给国人带来更多的健康选择。     

日本保健功能食品市场综合治理考察与经验借鉴

日本一直以来都是亚洲国家中食品安全治理的典范,在保健功能食品领域亦不例外。由于日本在保健功能食品领域起步较早,在对保健功能食品的市场治理方面已形成了一套从政府到行业协会、食品生产企业、消费者治理的综合治理框架体系,这为我国保健功能食品市场从传统机械性的单一政府治理走向社会治理提供了一种良好的范式。故本文旨在通过考察日本如何利用其政府、保健功能食品行业协会、食品生产企业、消费者对其保健食品市场进行多中心、多维度的综合治理,以期为我国保健食品市场整体治理水平的提升找到一条可借鉴之路。     

国外保健食品类似产品功能声称管理及对我国食品声称管理的启示

声称并具有特定保健功能或者以补充维生素、矿物质为目的的食品,在我国被定义为保健食品。全球范围内此类产品的定位、要求和名称不尽相同。我国《食品安全法》明确规定保健食品声称保健功能应当具有科学依据,不得对人体产生急性、亚急性或者慢性危害。《食品安全法实施条例》规定对保健食品之外的其它食品,不得声称具有保健功能。本文聚焦保健食品类似产品功能声称管理,在系统梳理美国、欧盟、加拿大、韩国等国家和地区做法的基础上,总结我国保健食品功能声称管理的现状和特点,提出完善我国普通食品和保健食品声称的建议。     

辅酶Q10等5 种原料的保健食品纳入备案制目录管理的情况分析及启示

目前我国保健食品行业正处于迅速发展阶段,然而相关制度的不完善以及产品定位等问题导致我国保健食品行业后续发展受阻。2015年保健食品“双轨制”管理的概念首次提出,次年正式落地,新政策的出台顺应了保健食品行业快速发展的趋势,促进了行业扩大生产,同时新增的审批备案程序也对保健食品的功效要求更加严格,强化了企业主体责任。2020年12月1日,辅酶Q10、破壁灵芝孢子粉、鱼油、褪黑素、螺旋藻5 种原料正式纳入保健食品原料目录,并于2021年3月1日起执行,以上5 种功能性原料纳入保健食品原料目录对后续其他保健食品原料纳入备案管理有着深远的意义,解决了“重前置审批,轻后市监管”的问题,促进了保健食品行业不断规范发展。本文聚焦5 种原料纳入目录前的审批情况并进行分析,旨在根据分析启发如何进一步推进保健食品原料纳入目录的制修订工作,为完善保健食品的监管提供建议。     

国内外保健食品管理法规标准比较研究(续完)

为给中国的保健食品管理提供借鉴 ,将中国大陆、澳大利亚、欧盟、日本、美国、中国台湾以及食品法典委员会 (CAC)有关保健 (功能 )食品或食品健康声称的法规、标准作为比较对象 ,重点分析和比较这些国家或地区在保健 (功能 )食品范畴、法律地位、产品成分、剂型、安全和功效要求等方面的异同 ,了解国外保健食品管理法规及标准建立的背景及科学依据。通过介绍各国或各地区针对保健 (功能 )食品或其标识、声称所建立的审批或审核机制 ,分析其管理模式的利弊 ,提出完善我国保健食品管理体系的意见和建议 ,为探讨今后进行国际协调的可能性提供技术依据。     

国内外保健食品管理法规、标准比较研究(待续)

将中国大陆、澳大利亚、欧盟、日本、美国、中国台湾以及食品法典委员会 (CAC)有关保健(功能 )食品或食品健康声称的法规、标准作为比较对象 ,重点分析和比较这些国家或地区在保健(功能 )食品范畴、法律地位、产品成分、剂型、安全和功效要求等方面的异同 ,了解国外保健食品管理法规及标准建立的背景及科学依据。通过介绍各国或各地区针对保健 (功能 )食品或其标识、声称所建立的审批或审核机制 ,分析其管理模式的利弊 ,提出完善我国保健食品管理体系的意见和建议 ,为今后进行国际协调提供技术依据。     

日本健康相关食品的分类与管理

在国家大健康战略背景下,我国保健食品产业将面临巨大的发展机遇,目前正在调整保健食品管理的相关政策与法规,而日本有相对成熟、先进的食品管理体系,值得我国借鉴与参考。因此,本文介绍了日本在推进健康相关食品分类发展方面的进展与措施,重点介绍健康辅助食品、特定保健用食品、营养素功能食品、功能性标识食品等健康相关食品及健康声称的管理,为今后我国在健康与健康声称食品的分类管理、保健食品健康声称的分类审批与管理等方面制定和完善相关政策与法规提供参考,更好地推进我国保健食品产业的持续稳定发展。     

保健食品功效成分测定方法现状及发展趋势

按照<保健食品管理办法>的要求,企业在申报保健食品时应提供产品的功效成分和功效成分的定性、定量测定方法,并说明功效成分在保健食品中所处地位.功效成分是保健食品保健功能的关键所在,也是产品质量的主要指标,国内外对保健食品(功能食品)的开发研究都十分重视功效成分的研究.1999年1月在北京举办的保健食品国际研讨会上,中外学者一致认为保健食品要长期稳定地健康发展,必须首先明确功效成分,解决功效成分的测定方法,特别是以草本植物为原料的保健食品,弄清其功效成分更有着极其重要的意义.我国传统的保健食品长期在低水平徘徊,没有确定功效成分及解决功效成分的测定方法是一个主要因素.     

我国保健食品的现状及存在的问题

保健食品系指表明具有特定保健功能的食品,即适宜于特定的人群食用,具有调节机体功能,不以治疗疾病为目的的食品。卫生部于1996年发布了《保健食品管理办法》及一系列与之相配套的技术标准和规定,使我国保健食品的审批、生产经营、标签、说明书、广告宣传及监督管理等纳入了法制化管理。通过这几年的实践,我国保健食品的监督管理     

具有免疫调节作用的保健食品

随着生活水平的提高,人们的食品消费观念发生了质的变化,逐渐由关注食物的风味转而重视食物的营养与保健功能,由此保健食品应运而生,它被专家誉为“二十一世纪的食品”,必将成为今后食品消费的热点.经过对保健食品市场两年多来的治理整顿,我国保健食品行业纳入了科学化、法制化管理的轨道.现在已有免疫调节作用,延缓衰老作用,抗疲劳作用等二十五种功能接近2000种产品通过了卫生部认证,取得了保健食品称号.为了帮助消费者认识,了解和选购保健食品,从本期开始,我们将按不同的保健功能,分期介绍一些已取得国家卫生部批准文号的保健品.     

Functional foods: An overview

A direct relationship between foods and health has led to various scientific studies to find the significance of foods or food ingredients on specific functions in the body. The term functional food refers to food with specific beneficial functions, is first coined in Japan. The present paper reviews the factors that have driven the functional food development, various definitions proposed by different authors and their classification. It also provides an overview on various functional ingredients in different food sources along with their potential health benefits, state of the art in commodity-based development and research on functional foods, the key factors required for their mass popularity, including some highlights on the increase in the global market share for such products. Mentions have also been made on the fact that framed rules for proving health claims of functional foods by conducting longitudinal studies before launching in the market are still lacking in many countries.     

Maximizing the value of milk through separation technologies.

Milk is the source of a wide range of proteins that deliver nutrition to the most promising new food products today. Isolated milk proteins are natural, trusted food ingredients with excellent functionality. Separation technologies provide the basis for adding value to milk through the production of proteins that provide the food industry with ingredients to meet specific needs, not possible with milk itself or with other ingredients. The major milk proteins, casein and whey protein, can be isolated by manipulating their compositional and physical properties and then by using various separation technologies to recover the proteins. Additionally, they can be processed in various ways to create a wide range of ingredients with diverse functional characteristics. These ingredients include milk protein concentrate, milk protein isolate, casein, caseinate, whey protein concentrate, whey protein isolate, hydrolysates, and various milk fractions. Within each of these ingredient categories, there is further differentiation according to the functional and nutritional requirements of the finished food. Adding value to milk by expanding from consumer products to ingredients often requires different technologies, marketing structure and distribution channels. The worldwide market for both consumer products and ingredients from milk continues to grow. Technology often precedes market demand. Methods for the commercial production of individual milk components now exist, and in the future as clinical evidence develops, the opportunity for adding value to dairy products as functional foods with health benefits may be achieved. The research and development of today will be the basis of those value-added milk products for tomorrow.     

Role of Fiber in Cardiovascular Diseases: A Review

ABSTRACT: Worldwide, cardiovascular disease is estimated to be the leading cause of death and loss of disability‐adjusted life‐years. Effective prevention needs a global strategy based on knowledge of the importance of risk factors, including diet. Recent years have seen increased interest on the part of consumers, researchers, and the food industry into how food products can help maintain the health of an individual. Extracts rich in dietary fiber obtained from plants could be used as functional ingredients because they provide numerous health benefits that go far beyond supporting bowel regularity. These benefits may include not only digestive health, but weight management, cardiovascular health, and general wellness. The objective of this review is to present an overview of the potential of different types of fiber as a technological tool for its application to functional foods to reduce the incidence of cardiovascular disease through diet.     

Nutrition and Health Claims as Marketing Tools

European regulations mandate that only substantiated and approved statements can be used as nutrition- and health-related claims in food marketing. A thorough understanding of consumer perceptions of these approved claims is needed to assess their impact on both the purchase intention of functional foods and the development of innovative functional food concepts. In this paper, a conceptual framework on the European consumers’ perception of nutrition and health claims on these functional foods is proposed. Through a literature review, common independent variables are structured, and an analysis of these variables shows that nutrition and health claims are mostly only perceived positive by specific target consumers (who need the product, accept the ingredient, understand the benefit, and trust the brand). These consumers indicate that the products with substantiated and approved claims help them in reaching overall health goals. This increased expectation in functional efficacy may mediate an increase in repurchase intent, overall liking, and the amount consumers are willing to spend. Other consumers, however, may have adverse reactions towards nutrition and health claims on functional foods. Implications for the consumer and the industry are discussed.     

韩国健康功能食品管理研究及对中国的启示

保健食品产业与文化背景密切相关,韩国与中国文化背景相似,为了完善中国保健食品的法律法规及管理措施,文章梳理了韩国健康功能食品管理的具体办法,指出借鉴韩国的管理经验很有必要。     

不溶性膳食纤维的提取、表征及改性研究进展

合理摄入膳食纤维对机体健康至关重要。为了开发兼顾营养、感官与健康的膳食纤维强化食品,不溶性膳食纤维的分离提取与改性研究广受关注。大量研究运用物理作用力、化学反应或酶解等手段,对样品组成、结构以及性质进行改造,以强化其在食品加工与营养健康方面功能特性。改性产物作为添加成分对于食品的加工过程、产品品质及健康功效方面具有积极影响,有利于各类膳食纤维强化产品的开发。本文对近年来国内外文献报道的不溶性膳食纤维的提取、改性及应用相关研究成果进行梳理总结,以期为调控膳食纤维功能特性、开发高品质健康功能食品提供参考。     

基于国际经验探究中国保健食品原料管理研究

随着人造肉等未来食品的出现,食品可使用的原料将不断增加,保健食品的品类也将不断丰富。保健食品原料管理是保健食品注册与备案工作的重点和难点,管活、管住、管优保健食品原料是保证保健食品安全、有效和质量可控的关键。本文在总结我国保健食品原料分类及使用情况,梳理国内外保健食品原料管理经验的基础上,分析了我国保健食品原料管理存在的问题并提出了相关建议和意见,旨在服务监管部门制定科学合理的监管政策。     

澳大利亚补充药品管理及对我国保健食品监管启示研究

澳大利亚将含有草药、维生素和矿物质、营养补充剂、顺势疗法和一些特定的芳香疗法制剂等治疗用途的产品称为补充药品，与我国保健食品的定位相似。澳大利亚补充药品分为备案制补充药品、评定备案制补充药品和注册制补充药品三类且健康声称与原料管理分开管理。本文总结归纳了澳大利亚补充药品的管理要求，同时结合我国保健食品的管理进行了分析，对我国保健食品的监管具有一定的借鉴意义     

Consumer perception of carriers of a satiating compound. Influence of front-of-package images and weight loss-related information

Nowadays it is common to find dietary supplements on the market with the same health promoting compounds as certain functional food products. However, there is a lack of research comparing these two categories of carriers (food and supplements) for the same functional ingredient. This work focuses on konjac glucomannan (KGM) due to its recognized body weight reduction-related effect: when it swells in the stomach in the presence of sufficient water, it produces a sensation of fullness. In this context, the objectives of the present work were to gain knowledge about consumer perception of KGM and its different carriers or forms of presentation (in a food item or in capsules). In addition, the relative importance of the carrier, front-of-package images and weight loss-related information were studied by different sensory techniques, such as word association, projective mapping and conjoint analysis. The results showed that consumers formed negative perceptions when the information was not sufficiently complete and that they considered a food product containing KGM better than KGM capsules. Regarding the front of the package, health benefit-related images were more attractive than verbal information.     

日本益生菌、益生元市场与应用概况

为了大力推广益生菌和益生元,介绍了日本益生菌制品、益生元、灭活细胞粉及对它们的管理情况。其中,日本厚生劳动省批准了65种特定保健食品,允许使用了近20种菌株．同时,各种功能性低聚糖已广泛使用在400多种食品、保健食品以及宠物饲料中,并说明了除益生菌活菌体外,益生菌或肠道正常菌群的灭活细胞,在大量存在下也可和活菌体一样具有免疫增强作用和发挥益生元的功能的作用。