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欧美营养标准概要第一篇：欧美营养标准概要欧美营养标准简要中国营养专业标准委员会已正式成立，为了更好的履行中国营养标准委员会的职责，发挥其作用，详细了解国外的营养标准十分必要。
他山之石，可以攻玉，通过了解并学习，我们可以从中取长补短、去芜存菁。
欧美营养标准的内容主要是两部分，一个是美国提出的DRIs系统和欧盟提出的膳食营养素参考值（DRVs），另一个是膳食指南和食品营养标签等。
DRIs系统和膳食营养素参考值 DRIs系统美国科学院医学研究所提出DRIs系统，即一系列的营养学建议，主要针对美国和加拿大人群使用，在原来RDA的基础上发展起来，主要供学校、监狱、医院和疗养院膳食、新食品的工业开发，医疗决策者和公共卫生相关官员使用。
为了扩大现有膳食指南中RDA的范围，从1997年开始使用DRIs，但目前没有应用于食物营养标签。
DRIs的组成部分包括EAR（估计平均需要量）、RNI（建议摄入量）、AI （适宜摄入量）和UL（可耐受最高摄入量）。
膳食营养素参考值欧盟提出的膳食营养素参考值（DRVs）为营养建议和参考值，如人群参考摄入量、平均摄入量、适宜摄入量和最低摄入量。
在欧盟层面上，1992年成立的欧洲能量摄入营养和食品科学委员会（SCF）为欧洲社会提供能量和营养素参考摄入量建议。
欧洲食品安全局提供了最先进、最新和全面的科学咨询意见，以支持欧盟政策制定者在营养领域的决策。
欧洲食品安全局营养摄入量的建议为营养政策提供了重要的证据基础，以确定与饮食有关的公共健康目标，建立消费者对健康饮食的教育方案。
膳食指南和食品营养标签膳食指南膳食指南与居民生活健康息息相关。
世界卫生组织和CINDI开发了膳食金字塔模型（见图1），以不同的颜色来标识食品及摄入需求。
红色提醒居民仅需要极少的摄入量；绿色为谷物蔬菜，可以较多地摄入；橙色包括奶制品、鱼、肉类和蛋类的。
世界卫生组织（WHO）膳食指南的总体要求是：营养教育的原则是以食物为主，适合人群中的每个个体使用；即使不能用具体实物表达，也应该尽量避免使用营养学专业术语；避免使用推荐摄入量等专业词汇，或是使用人群整体的概念，而是给每个人提供可行的膳食建议。
欧盟果蔬食品安全标准体系1.1欧洲食品安全法律法规的制定机构欧盟委员会和欧共体理事会是欧盟有关食品安全卫生的政府立法构构。
其对于食品安全控制方面的职权分得十分明确。
欧盟委员会负责起草与制左与食品质疑安全相应的法律法规，如有关食品化学污染和残留的32002R221—委员会法规No221/2002：还有食品安全卫生标准，如体现欧盟食品最髙标准的《欧共体食品安全白皮书》；以及各项委员会指令, 如关于农药残留立法相关的委员会指令2002/63/EC和2000/24/EC.而欧共体理事会同样也负责制立食品卫生规范要求，在欧盟的官方公报上以欧盟指令或决议的形式发布，如有关食品卫生的理事会指令93/43/EEC。
以上2个部门在控制食品链的安全方而只负责立法，而不介入具体的执行工作。
1.2欧洲食品标准的制定机构欧洲标准（EN）和欧共体各成员国国家标准是欧共体标准体系中的两级标准, 苴中欧洲标准是欧共体各成员国统一使用的区域级标准，对贸易有重要的作用。
欧洲标准由三个欧洲标准化组织制左，分别是欧洲标准化委员会（CEN）、欧洲电工标准化委员会（CENELEC）.欧洲电信标准协会（ETSI）o这3个组织都是被欧洲委员会（European Commission）按照83/189/EEC指令正式认可的标准化组织，他们分别负责不同领域的标准化工作。
CENELEC负责制豪电工、电子方面的标准：ETSI负责制泄电信方而的标准：而CEN负责制定除CENELEC和ETSI负责领域外所有领域的标准。
1.3 CEN的食品标准化概况自1998年以来，CEN致力于食品领域的分析方法，为工业、消费者和欧洲法规制左者提供了有价值的经验。
新的欧洲法规为CEN提供了更多的支持，ECN 致力于跟踪和实施这些改革方针。
截I匕到2002年12月底，CEN已经制左欧洲标准7650个，协调文件4个，暂行标准395个。
CEN的技术委员会（CEN/TC）具体负责标准的制、修订工作，各技术委员会的秘书处工作由CEN各成员国分别承担。
营养标签规范(食品营养成分标示准则)附件：1.食品营养成分标示准则2.中国食品标签营养素参考值3.食品营养声称和营养成分功能声称准则附件1食品营养成分标示准则依据《食品营养标签管理规范》中所涉及的内容要求，制定本准则。
本准则规定了能量和营养成分的定义、折算系数、营养成分分析和标示方法、数值表达、允许误差和推荐的营养标签格式等内容。
一、术语和定义1．预包装食品（prepackaged foods）经预先定量包装，或装入（灌入）容器中，向消费者直接提供的食品。
2．营养成分（nutritional components）指食品中具有的营养素和有益成分。
包括营养素、水分、膳食纤维等。
3. 营养素 (nutrients) 指食品中具有特定生理作用，能维持机体生长、发育、活动、繁殖以及正常代谢所需的物质,缺少这些物质，将导致机体发生相应的生化或生理学的不良变化。
包括蛋白质、脂肪、碳水化合物、矿物质、维生素五大类。
4. 能量（energy）指食品中的蛋白质、脂肪和碳水化合物等营养素在人体代谢中产生的能量。
推荐以千焦（kJ）或焦耳（J）标示，当以千卡（kcal）标示能量值时，应同时标示千焦（kJ）。
食品中产能营养素的能量折算系数如表1所示:表 1 食物中产能营养素的能量折算系数* 1千卡(kcal)的能量相当于4.184千焦(kJ)。
5. 蛋白质 (protein) 蛋白质是含氮的有机化合物，以氨基酸为基本单位组成。
食品中蛋白质含量可通过“总氮量”乘以“氮折算系数”，或食品中各氨基酸含量的总和来确定。
在测定出“总氮量”后，食品中蛋白质含量的计算公式如下：蛋白质（g/100g）=总氮量（g/100g）×氮折算系数不同食品的氮折算系数如表2所示，对于原料复杂的加工或配方食品，统一使用折算系数6.25。
表2 不同食品氮折算系数*来源：*《中国食物成分表2002》6. 脂肪和脂肪酸 (fat and fatty acid)由于检测方法的不同，脂肪有粗脂肪（crude fat）或总脂肪（total fat）之分，在营养标签上均可标示为“脂肪”。
食品营养标签一、有下列情况之一的包装食品，可以不标注营养成分：（一）食品每日食用量不足10克（g）或10毫升（二）包装的生肉、生鱼、生蔬菜和水果；（三）包装的总表面积小于100平方厘米（cm2）的食品；（四）现制现售的食品；（五）酒精含量大于等于0.5% 的产品；（六）其它法规标准规定可以不做标签的食品。
二、应首先标示能量及4种核心营养素—1+4：能量+蛋白质、脂肪、碳水化合物，钠三、鼓励标注的营养素6个饱和脂肪酸、Saturated fatty acids,胆固醇、Cholesterol,糖、Sugar,膳食纤维、Df,维生素A 、VitA,钙、Ca四、食品标签营养成分标示的绝对顺序1.能量2.蛋白质\脂肪\碳水化合物\钠脂肪：饱和脂肪酸、不饱和脂肪、反式脂肪酸、胆固醇碳水化合物：糖、膳食纤维、可溶性膳食纤维、不可溶性膳食纤维3.维生素：维生素A（β-胡萝卜素）。
若标示其他维生素，在维生素A下面划横线，横线下标示。
维生素D、维生素E、维生素K、维生素B1（硫胺素）、维生素B2（核黄素）、维生素B6、维生素B12、维生素C（抗坏血酸）、烟酸、叶酸、泛酸、生物素和胆碱4.矿物质：钙、磷、钾、钠、镁、铁、锌、碘、硒、铜、氟、铬、锰和钼。
2.4400 150 800 50 5 ug3014mg-TE80能量的计算通用方法：能量=蛋白质×17＋脂肪×37＋碳水化合物×17特殊食品:能量=蛋白质×17＋脂肪×37＋碳水化合物×17 ＋膳食纤维×8 ＋乙醇×29 ＋有机酸×13＋糖醇×10。
欧盟包材指令94/62/EC 及其他相关法规欧盟指令94/62/EC 及其他相关法规欧盟指令94/62/EC 是基于环境与生命安全，能源与资源合理利用的要求，对全部的包装和包装材料、包装的管理、设计、生产、流通、使用和消费等所有环节提出相应的要求和应达到的目标。
技术内容涉及包装与环境、包装与生命安全、包装与能源和资源的利用。
特别应关注的是，基于这些要求和目标，派生出具体的技术措施。
另外，具体的实施还有相关的指令、协调标准及合格评定制度。
指令94/62/EC 已于1997年付诸全面实施，但就其中的包装材料的回收率，欧盟某些成员国持有异议。
比如对饮料瓶的重复使用或一次性使用的环保性、经济性、可行性和安全性的评估等存在分歧。
2004 年2 月11 日欧盟颁布了对94/62/EC 的修正案2004/12/EC，其中规定整体回收率60%，再循环率55%。
另外规定具体的再循环率：玻璃60%、纸和纸板60%、金属50%、塑料25%、木材15%，重金属浓度指标未改变。
2005 年3 月9 日，欧盟再次颁布了94/62/EC 的修正案2005/20/EC，其中增加了一些成员国各自法规生效的具体日期。
指令94/62/EC 第十一款规定的有害重金属含量最大允许极限为100 mg/kg，目的在于保护地下水源和土壤。
实施范围涵盖全部的包装和包装材料。
金属回收冶炼形成的炉渣、玻璃回收熔化形成的废渣、复合材料和某些不易作为资源回收利用的纸和塑料、以能源回收的形式焚烧形成的残渣等最终填埋后，有害物质将通过渗滤对地下水源造成污染。
需氧或厌氧生物降解处理后得到的堆肥与土壤相关。
特别应注意的是，不要轻言使用的包装材料可降解，欧共体对土壤和土壤改良另有法规，在EN 13432 中引用了相关法规。
指令EN 13432 附录A（规范性附录）给出了包装材料和所有的包装允许的最大元素含量的规定（见表10.1），并且要求受检物质的重量按50%的残存无机矿物质（不可降解的）计量。
营养标签是指在包装或容器上贴有的描述产品营养成分的标签，它提供了关于食品所含有的营养成分的信息，消费者可以通过这些信息来做出明智的食品选择。
以下是一些关于营养标签的常见标准：
1. 美国标准：美国食品和药品管理局（FDA）规定了一系列的标准，要求在包装上贴有营养标签，标签必须列出食品所含的总脂肪、饱和脂肪、胆固醇、钠、总碳水化合物、膳食纤维、糖和蛋白质含量以及维生素、矿物质等。
2. 欧盟标准：欧洲联盟（EU）制定了一些标准，规定食品包装中必须包含营养标签。
标签要求列出食品的能量值、脂肪、饱和脂肪、糖、盐和蛋白质的含量。
3. 中国标准：中国制定的食品安全法要求食品包装上必须标明营养成分表。
标签应包含食品的总能量、蛋白质、脂肪、饱和脂肪、反式脂肪、碳水化合物、糖、钠和胆固醇等。
除上述营养标签的标准，不同国家和地区可能还有其他的要求，例如标明植物蛋白等。
总之，营养标签应该遵循相应的行业标准和法规，提供准确、全面和易于理解的营养成分信息，以便消费者做出明智的食品选择。
欧盟关于食品营养标签的规定一、一般规定欧盟理事会于1990年9月24日发布了有关食品营养标签的理事会指令90/496/EEC，并于同年开始实施。
2009年11月上旬，欧盟理事会又对上述指令做出了修订。
该指令详细规定了如何在食品标签上标示营养价值。
标签上所需的信息包含两类：第一类：能量值、蛋白质含量、碳水化合物含量以及脂肪含量。
第二类：能量值、蛋白质含量、碳水化合物含量、糖含量、脂肪含量、饱和脂肪酸含量、纤维素含量以及钠含量。
按规定凡声称提供营养的食品必须使用第二类标签。
指令中规定了计算能量值时所需的换算系数碳水化合物：4 kcal/g –17 kJ/g、蛋白质：4 kcal/g – 17 kJ/g、脂肪：9 kcal/g – 37 kJ/g、酒精：7 kcal/g – 29 kcal/g、有机酸：3 kcal/g – 13 kJ/g）。
该指令的一些修订已于2009年11月起开始实施。
除上述几种化合物外，又新确定了几种贡献能量的组分：. 膳食纤维：2 kcal/g – 8 kJ/g. 低能量脂肪：6 kcal/g – 25 kJ/g膳食纤维和低能量脂肪中的能量小于同等规格的碳水化合物和脂肪中的能量，因此在食物中使用它们可减少能量的摄入。
膳食纤维（饼干和婴儿食品中）和低能量脂肪在食品行业中已经得到越来越广泛的应用。
这种趋势也对其它商品产生了影响，即仅仅使用脂肪、蛋白质和化合物来计算能量值，已远远不够。
依照修订后的指令规定，有些没有必要分析，如膳食纤维不作为酸奶的配料使用时，便没有必要去分析膳食纤维。
另一方面，如面包或糖果制品中使用了低能量脂肪作为其配料时，则必须对其中的低能量脂肪含量进行分析。
欧盟于2006年12月30日公布关于食品营养及健康声明的第1924/2006号指令。
指令适用于在欧盟市场出售、供人食用的任何食品或饮品，旨在确保食品包装上向消费者提供的营养资料准确可靠。
为达到这个目的，指令列明对标签和广告宣传的要求。
国内外食品营养标签标准与法规比较情况(一)营养标签法规标准的适用范围和法律效力见表1。
从表1可以看出,以上各地区国家均以法规或标准的形式来规范营养标签。
除中国外，营养标签要求针对整个食品类别，一些是在任何情况下都是强制性，一些则指出“如产品进行营养宣传,则要求强制标注”的管理方针。
与此对照，中国只有一个针对特殊营养食品的标签标准(GB 13432)，它只强调了此类产品的标签要求，其它食品无论进行营养宣传与否均不在管理之列。
从上表还可看出，营养标签标准、法规是近十年来的产物，并且发展很快，这也是适应国民营养健康意识增强的趋势，而且随着实施进程中出现的问题和有关营养健康认识的提高，各国相关法规标准还在不断修订和完善。
（二）营养成分标识1、标识内容见表2。
从表2看出，大多数国家和地区要求标示的营养物质有热量、蛋白质、总脂肪、总糖类，一些国家为在标签中提供更多的营养健康信息,还要求对不饱和脂肪酸、胆固醇、食用纤维、钠等进行标识。
从上述比较中我们发现各国对于营养标签中必须标示的内容无论规定得具体还是笼统,都要求对几种基本营养物质的含量进行标示，对该产品营养宣传(声明)所涉及的营养素也规定标示其含量，而对其它营养物质则由厂商自行决定是否标示。
2、营养成分的表述方式见表3。
从表3可以看出大多数国家和地区都采用每100 g、100 mL或一份食品为单位标示营养成分含量，标示方式可以用含量数值或含量占营养素日需要量(RDA)的百分比表示,也可采用将营养素日推荐摄入量列出对照的方式。
在这一点上只有中国尚未将营养素日推荐摄入值应用于营养标签中(而美国是要求强制标注的)。
“每份餐量”和“营养素日需要量RDA”的引入对指导消费者科学合理地摄取能量和营养物质等具有极其重要的作用,越来越多的国家已注意到这个问题。
但对于食品管理和监督人员来说,这种标示方式又不便于产品的质量检测，因为首先“每份餐量”缺乏标准化，不容易控制个体间的差异；其次各国用于营养标签的RDA(Recommended Daily Value)、RDI(Reference Daily Intake),NRV(Nutrient Reference Value)的涵义又有不同(本文略)，现美国正着手对RDA进行改革,理由是对膳食中与慢性病相关的营养素及摄入量有新认识：一些营养素需标示上限,防止中毒危险,增加一般传统认为不是营养素但却与健康相关的物质等等。
REGULATION(EC)No1924/2006OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof20December2006on nutrition and health claims made on foodsTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-PEAN UNION,Having regard to the Treaty establishing the European Com-munity,and in particular Article95thereof,Having regard to the proposal from the Commission,Having regard to the opinion of the European Economic and Social Committee(1),Acting in accordance with the procedure laid down in Article 251of the Treaty(2),Whereas:(1)An increasing number of foods labelled and advertised inthe Community bear nutrition and health claims.Inorder to ensure a high level of protection for consumersand to facilitate their choice,products put on the marketmust be safe and adequately labelled.(2)Differences between national provisions relating to suchclaims may impede the free movement of foods andcreate unequal conditions of competition.They thus havea direct impact on the functioning of the internal market.It is therefore necessary to adopt Community rules onthe use of nutrition and health claims on foods.(3)General labelling provisions are contained in Directive2000/13/EC of the European Parliament and of theCouncil of20March2000on the approximation of thelaws of the Member States relating to the labelling,presentation and advertising of foodstuffs(3).Directive2000/13/EC generally prohibits the use of informationthat would mislead the purchaser or attribute medicinalproperties to food.This Regulation should complementthe general principles in Directive2000/13/EC and laydown specific provisions concerning the use of nutritionand health claims concerning foods to be delivered assuch to the consumer.(4)This Regulation should apply to all nutrition and healthclaims made in commercial communications,including,inter alia,generic advertising of food and promotionalcampaigns,such as those supported in whole or in partby public authorities.It should not apply to claims whichare made in non-commercial communications,such asdietary guidelines or advice issued by public health autho-rities and bodies,or non-commercial communicationsand information in the press and in scientific publica-tions.This Regulation should also apply to trade marksand other brand names which may be construed as nutri-tion or health claims.(5)Non-beneficial nutrition claims are not covered by thescope of this Regulation;Member States intending tointroduce national schemes relating to non-beneficialnutrition claims should notify such schemes to theCommission and to other Member States in accordancewith Directive98/34/EC of the European Parliament andof the Council of22June1998laying down a procedurefor the provision of information in the field of technicalstandards and regulations and of rules on InformationSociety services(4).(6)At international level the Codex Alimentarius hasadopted General Guidelines on claims in1991andGuidelines for the use of nutrition claims in1997.Anamendment to the latter has been adopted by the CodexAlimentarius Commission in2004.That amendmentconcerns the inclusion of health claims in the1997Guidelines.Due consideration is given to the definitionsand conditions set in the Codex Guidelines.(7)The possibility of using the claim‘low fat’for spreadablefats provided for in Council Regulation(EC)No2991/94of5December1994laying down standards for spread-able fats(5)should be adapted to the provisions of thisRegulation as soon as possible.In the meantime,Regu-lation(EC)No2991/94applies for the products itcovers.(1)OJ C110,30.4.2004,p.18.(2)Opinion of the European Parliament of26May2005(OJ C117E,18.5.2006,p.187),Council common position of8December2005(OJ C80E,4.4.2006,p.43)and Position of the European Parliament of16May2006(not yet published in the Official Journal).Council Deci-sion of12October2006.(3)OJ L109,6.5.2000,p.29.Directive as last amended by Directive2003/89/EC(OJ L308,25.11.2003,p.15).(4)OJ L204,21.7.1998,p.37.Directive as last amended by the2003Actof Accession.(5)OJ L316,9.12.1994,p.2.(8)There is a wide range of nutrients and other substancesincluding,but not limited to,vitamins,minerals includingtrace elements,amino acids,essential fatty acids,fibre,various plants and herbal extracts with a nutritional orphysiological effect that might be present in a food andbe the subject of a claim.Therefore,general principlesapplicable to all claims made on foods should be estab-lished in order to ensure a high level of consumer protec-tion,give the consumer the necessary information tomake choices in full knowledge of the facts,as well ascreating equal conditions of competition for the foodindustry.(9)Foods promoted with claims may be perceived by consu-mers as having a nutritional,physiological or otherhealth advantage over similar or other products to whichsuch nutrients and other substances are not added.Thismay encourage consumers to make choices whichdirectly influence their total intake of individual nutrientsor other substances in a way which would run counter toscientific advice.To address this potential undesirableeffect,it is appropriate to impose certain restrictions asregards the products bearing claims.In this context,factors such as the presence of certain substances,forexample the alcohol content of the product or thenutrient profile of the product,are appropriate criteriafor determining whether the product can bear claims.The use of such criteria at national level,whilst justifiedfor the purpose of allowing consumers to make informednutritional choices,is likely to result in barriers to intra-Community trade and should therefore be harmonised atCommunity level.(10)The application of nutrient profiles as a criterion wouldaim to avoid a situation where nutrition or health claimsmask the overall nutritional status of a food product,which could mislead consumers when trying to makehealthy choices in the context of a balanced diet.Nutrientprofiles as provided for in this Regulation would beintended for the sole purpose of governing the circum-stances in which claims may be made.They should bebased on generally accepted scientific data relative to therelationship between diet and health.However,profilesshould also allow for product innovation and should takeinto account the variability of dietary habits and tradi-tions,and the fact that individual products may have animportant role in the context of an overall diet.(11)The establishment of nutrient profiles should take intoaccount the content of different nutrients and substanceswith a nutritional or physiological effect,in particularthose such as fat,saturated fat,trans-fatty acids,salt/sodium and sugars,excessive intakes of which in theoverall diet are not recommended,as well as poly-andmono-unsaturated fats,available carbohydrates otherthan sugars,vitamins,minerals,protein and fibre.Whensetting the nutrient profiles,the different categories offoods and the place and role of these foods in the overalldiet should be taken into account.Exemptions from therequirement to respect established nutrient profiles maybe necessary for certain foods or categories of foodsdepending on their role and importance in the diet of thepopulation.These would be complex technical tasks andthe adoption of the relevant measures should beentrusted to the Commission,taking into account theadvice of the European Food Safety Authority.(12)Food supplements as defined in Directive2002/46/EC ofthe European Parliament and of the Council of10June2002on the approximation of the laws of the MemberStates relating to food supplements(1)presented in aliquid form and containing more than1,2%by volumeof alcohol are not considered as beverages under thisRegulation.(13)There is a wide variety of claims currently used in thelabelling and advertising of foods in some Member Statesrelating to substances that have not been shown to bebeneficial or for which at present there is not sufficientscientific agreement.It is necessary to ensure that thesubstances for which a claim is made have been shownto have a beneficial nutritional or physiological effect.(14)In order to ensure that the claims made are truthful,it isnecessary that the substance that is the subject of theclaim is present in the final product in quantities that aresufficient,or that the substance is absent or present insuitably reduced quantities,to produce the nutritional orphysiological effect claimed.The substance should also beavailable to be used by the body.In addition,and whereappropriate,a significant amount of the substance produ-cing the claimed nutritional or physiological effect shouldbe provided by a quantity of the food that can reasonablybe expected to be consumed.(1)OJ L183,12.7.2002,p.51.(15)It is important that claims on foods can be understoodby the consumer and it is appropriate to protect allconsumers from misleading claims.However,since theenactment of Council Directive84/450/EEC of10September1984concerning misleading and compara-tive advertising(1),the Court of Justice of the EuropeanCommunities has found it necessary in adjudicating onadvertising cases to examine the effect on a notional,typical consumer.In line with the principle of propor-tionality,and to enable the effective application of theprotective measures contained in it,this Regulation takesas a benchmark the average consumer,who is reasonablywell-informed and reasonably observant and circumspect,taking into account social,cultural and linguistic factors,as interpreted by the Court of Justice,but makes provi-sion to prevent the exploitation of consumers whosecharacteristics make them particularly vulnerable tomisleading claims.Where a claim is specifically aimed ata particular group of consumers,such as children,it isdesirable that the impact of the claim be assessed fromthe perspective of the average member of that group.Theaverage consumer test is not a statistical test.Nationalcourts and authorities will have to exercise their ownfaculty of judgment,having regard to the case-law of theCourt of Justice,to determine the typical reaction of theaverage consumer in a given case.(16)Scientific substantiation should be the main aspect to betaken into account for the use of nutrition and healthclaims and the food business operators using claimsshould justify them.(17)A nutrition or health claim should not be made if it isinconsistent with generally accepted nutrition and healthprinciples or if it encourages or condones excessiveconsumption of any food or disparages good dietarypractice.(18)Given the positive image conferred on foods bearingnutrition and health claims and the potential impactthese foods may have on dietary habits and overallnutrient intakes,the consumer should be able to evaluatetheir global nutritional quality.Therefore,nutrition label-ling should be compulsory and should be extensive onall foods bearing health claims.(19)General nutritional labelling provisions are contained inCouncil Directive90/496/EEC of24September1990onnutrition labelling for foodstuffs(2).According to thatDirective,where a nutrition claim appears on labelling,inpresentation or in advertising,with the exclusion ofgeneric advertising,nutrition labelling should be compul-sory.Where a nutrition claim is made for sugars,satu-rates,fibre or sodium,the information to be given shouldbe that of Group2as defined in Article4(1)of Directive90/496/EEC.In order to achieve a high level of consumerprotection,this obligation to provide the information ofGroup2should apply,mutatis mutandis,where any healthclaim is made,with the exception of generic advertising.(20)A list of permitted nutrition claims and their specificconditions of use should also be created based on theconditions for the use of such claims that have beenagreed at national or international level and laid down inCommunity legislation.Any claim considered to have thesame meaning for consumers as a nutrition claimincluded in the aforementioned list should be subject tothe same conditions of use indicated therein.Forexample,claims related to the addition of vitamins andminerals such as‘with…’,‘restored…’,‘added…’,or‘enriched…’should be subject to the conditions set forthe claim‘source of…’.The list should be regularlyupdated in order to take into account scientific and tech-nological developments.Furthermore,for comparativeclaims it is necessary that the products being comparedbe clearly identified to the final consumer.(21)Conditions for claims such as‘lactose-free’or‘gluten-free’,addressed to a group of consumers with specific disor-ders,should be dealt with in Council Directive89/398/EEC of3May1989on the approximation of thelaws of the Member States relating to foodstuffs intendedfor particular nutritional uses(3).In addition,that Direc-tive provides the possibility that foodstuffs for normalconsumption can indicate their suitability for use bythese groups of consumers if they fulfil the conditionsfor such statement.Until the conditions for such state-ments are set at Community level,Member States maymaintain or adopt relevant national measures.(22)Health claims should only be authorised for use in theCommunity after a scientific assessment of the highestpossible standard.In order to ensure harmonised scien-tific assessment of these claims,the European FoodSafety Authority should carry out such assessments.(1)OJ L250,19.9.1984,p.17.Directive as last amended by Directive2005/29/EC of the European Parliament and of the Council(OJ L149,11.6.2005,p.22).(2)OJ L276,6.10.1990,p.40.Directive as last amended by CommissionDirective2003/120/EC(OJ L333,20.12.2003,p.51).(3)OJ L186,30.6.1989,p.27.Directive as last amended by Regulation(EC)No1882/2003of the European Parliament and of the Council(OJ L284,31.10.2003,p.1).(23)There are many factors,other than dietary ones,that caninfluence psychological and behavioural functions.Communication on these functions is thus very complexand it is difficult to convey a comprehensive,truthful andmeaningful message in a short claim to be used in thelabelling and advertising of foods.Therefore,it is appro-priate,when using psychological and behavioural claims,to require scientific substantiation.(24)In the light of Commission Directive96/8/EC of26February1996on foods intended for use in energy-restricted diets for weight reduction(1)which prohibits,in the labelling,presentation and advertising of productscovered by that Directive,any reference to the rate oramount of weight loss which may result from their use,it is considered appropriate to extend this restriction toall foods.(25)Health claims other than those referring to the reductionof disease risk,based on generally accepted scientificdata,should undergo a different type of assessment andauthorisation.It is therefore necessary to adopt a Com-munity list of such permitted claims after consulting theEuropean Food Safety Authority.(26)In order to keep up with scientific and technologicaldevelopments,the list referred to above should be revisedpromptly whenever necessary.Such revisions are imple-menting measures of a technical nature and their adop-tion should be entrusted to the Commission in order tosimplify and expedite the procedure.(27)A varied and balanced diet is a prerequisite for goodhealth and single products have a relative importance inthe context of the total diet.Furthermore,diet is one ofthe many factors influencing the onset of certain humandiseases.Other factors such as age,genetic predisposition,the level of physical activity,the consumption of tobaccoand other drugs,environmental exposure and stress mayall influence the onset of human diseases.Specific label-ling requirements should therefore apply in respect ofclaims relating to the reduction of a disease risk.(28)In order to ensure that health claims are truthful,clear,reliable and useful to the consumer in choosing a healthydiet,the wording and the presentation of health claimsshould be taken into account in the opinion of the Euro-pean Food Safety Authority and in the subsequentauthorisation procedure.(29)In some cases,scientific risk assessment alone cannotprovide all the information on which a risk managementdecision should be based.Other legitimate factors rele-vant to the matter under consideration should thereforebe taken into account.(30)For the sake of transparency and in order to avoidmultiple applications in respect of claims which havealready been assessed,a public register containing thelists of such claims should be established and updated bythe Commission.(31)In order to stimulate research and development withinthe agri-food industry,it is appropriate to protect theinvestment made by innovators in gathering the informa-tion and data supporting an application pursuant to thisRegulation.This protection should however be limited intime in order to avoid the unnecessary repetition ofstudies and trials.(32)Given the particular nature of foods bearing claims,addi-tional means to those usually available to monitoringbodies should be available in order to facilitate efficientmonitoring of those products.(33)Adequate transitional measures are necessary to enablefood business operators to adapt to the requirements ofthis Regulation.(34)Since the objective of this Regulation,namely to ensurethe effective functioning of the internal market as regardsnutrition and health claims whilst providing a high levelof consumer protection,cannot be sufficiently achievedby the Member States and can therefore be betterachieved at Community level,the Community may adoptmeasures,in accordance with the principle of subsidiarityas set out in Article5of the Treaty.In accordance withthe principle of proportionality as set out in that Article,this Regulation does not go beyond what is necessary inorder to achieve that objective.(35)The measures necessary for the implementation of thisRegulation should be adopted in accordance withCouncil Decision1999/468/EC of28June1999layingdown the procedures for the exercise of implementingpowers conferred on the Commission(2),(1)OJ L55,6.3.1996,p.22.(2)OJ L184,17.7.1999,p.23.HAVE ADOPTED THIS REGULATION:CHAPTER ISUBJECT MATTER,SCOPE AND DEFINITIONSArticle1Subject matter and scope1.This Regulation harmonises the provisions laid down by law,regulation or administrative action in Member States which relate to nutrition and health claims in order to ensure the effec-tive functioning of the internal market whilst providing a high level of consumer protection.2.This Regulation shall apply to nutrition and health claims made in commercial communications,whether in the labelling, presentation or advertising of foods to be delivered as such to the final consumer,including foods which are placed on the market unpacked or supplied in bulk.It shall also apply in respect of foods intended for supply to restaurants,hospitals,schools,canteens and similar mass caterers.3.A trade mark,brand name or fancy name appearing in the labelling,presentation or advertising of a food which may be construed as a nutrition or health claim may be used without undergoing the authorisation procedures provided for in this Regulation,provided that it is accompanied by a related nutri-tion or health claim in that labelling,presentation or advertising which complies with the provisions of this Regulation.4.This Regulation shall apply without prejudice to the following Community provisions:(a)Directive89/398/EEC and Directives adopted on the basisthereof;(b)Council Directive80/777/EEC of15July1980on theapproximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters(1);(c)Council Directive98/83/EC of3November1998on thequality of water intended for human consumption(2).Article2Definitions1.For the purposes of this Regulation:(a)the definitions of‘food’,‘food business operator’,‘placing onthe market’and‘final consumer’,set out in Articles2,3(3), 3(8)and3(18)of Regulation(EC)No178/2002of the European Parliament and of the Council of 28January2002laying down the general principles and requirements of food law,establishing the European Food Safety Authority and laying down procedures in matters of food safety(3),shall apply;(b)the definition of‘food supplement’set out in Directive2002/46/EC shall apply;(c)the definitions of‘nutrition labelling’,‘protein’,‘carbohy-drate’,‘sugars’,‘fat’,‘saturates’,‘mono-unsaturates’,‘poly-unsaturates’and‘fibre’set out in Directive90/496/EEC shall apply;(d)the definition of‘labelling’set out in Article1(3)(a)of Direc-tive2000/13/EC shall apply.2.The following definitions shall also apply:1.‘claim’means any message or representation,which is notmandatory under Community or national legislation, including pictorial,graphic or symbolic representation,in any form,which states,suggests or implies that a food has particular characteristics;2.‘nutrient’means protein,carbohydrate,fat,fibre,sodium,vitamins and minerals listed in the Annex to Directive90/ 496/EEC,and substances which belong to or are components of one of those categories;3.‘other substance’means a substance other than a nutrientthat has a nutritional or physiological effect;(1)OJ L229,30.8.1980,p.1.Directive as last amended by Regulation(EC)No1882/2003.(2)OJ L330,5.12.1998,p.32.Directive as amended by Regulation(EC)No1882/2003.(3)OJ L31,1.2.2002,p.1.Regulation as amended by Regulation(EC)No1642/2003(OJ L245,29.9.2003,p.4).4.‘nutrition claim’means any claim which states,suggests orimplies that a food has particular beneficial nutritional prop-erties due to:(a)the energy(calorific value)it(i)provides,(ii)provides at a reduced or increased rate,or(iii)does not provide;and/or(b)the nutrients or other substances it(i)contains,(ii)contains in reduced or increased proportions,or(iii)does not contain;5.‘health claim’means any claim that states,suggests or impliesthat a relationship exists between a food category,a food or one of its constituents and health;6.‘reduction of disease risk claim’means any health claim thatstates,suggests or implies that the consumption of a food category,a food or one of its constituents significantly reduces a risk factor in the development of a human disease;7.‘Authority’means the European Food Safety Authority estab-lished by Regulation(EC)No178/2002.CHAPTER IIGENERAL PRINCIPLESArticle3General principles for all claimsNutrition and health claims may be used in the labelling,presen-tation and advertising of foods placed on the market in the Community only if they comply with the provisions of this Regulation.Without prejudice to Directives2000/13/EC and84/450/EEC, the use of nutrition and health claims shall not:(a)be false,ambiguous or misleading;(b)give rise to doubt about the safety and/or the nutritionaladequacy of other foods;(c)encourage or condone excess consumption of a food;(d)state,suggest or imply that a balanced and varied dietcannot provide appropriate quantities of nutrients in general.Derogations in the case of nutrients for which suffi-cient quantities cannot be provided by a balanced and varied diet,including the conditions for their application, may be adopted in accordance with the procedure referred to in Article24(2),taking into account the special condi-tions present in Member States;(e)refer to changes in bodily functions which could give rise toor exploit fear in the consumer,either textually or through pictorial,graphic or symbolic representations.Article4Conditions for the use of nutrition and health claims1.By19January2009,the Commission shall,in accordance with the procedure referred to in Article24(2),establish specific nutrient profiles and the conditions,including exemptions, which shall be respected for the use of nutrition and health claims on foods and/or categories of foods.These nutrient profiles established for food and/or certain cate-gories of food,and the conditions for the use of nutrition or health claims with respect to the nutrient profiles,shall be laid down taking into account in particular:(a)the quantities of certain nutrients and other substancescontained in the food,such as fat,saturated fatty acids, trans-fatty acids,sugars and salt/sodium;(b)the role and importance of the food(or of categories offoods)in the diet of the population in general or,as appro-priate,of certain risk groups including children;(c)the overall nutritional composition of the food and thepresence of nutrients that have been scientifically recognised as having an effect on health.The nutrient profiles shall be based on scientific knowledge about diet and nutrition,and their relation to health.In setting the nutrient profiles,the Commission shall request the Authority to provide,within12months,relevant scientific advice,focusing in particular on:(i)whether profiles should be set for food in general and/orcategories of food;(ii)the choice and balance of nutrients to be taken into account;(iii)the choice of reference quantity/basis for profiles;(iv)the approach to the calculation of the profiles,and(v)testing of a proposed system.In setting the nutrient profiles,the Commission shall carry out consultations with interested parties,in particular food business operators and consumer groups.Nutrient profiles and their conditions of use shall be updated to take into account relevant scientific developments in accordance with the procedure referred to in Article24(2).2.By way of derogation from paragraph1,nutrition claims referring to the reduction of fat,saturated fatty acids,trans-fatty acids,sugars and salt/sodium shall be allowed without reference to a profile for the specific nutrient/s for which the claim is made,provided they comply with the conditions laid down in this Regulation.3.Beverages containing more than1,2%by volume of alcohol shall not bear:(a)health claims;(b)nutrition claims,other than those which refer to a reductionin the alcohol or energy content.4.In the absence of specific Community rules regarding nutrition claims referring to the reduction or absence of alcohol or energy in beverages which normally contain alcohol,relevant national rules may apply in compliance with the provisions of the Treaty.5.Foods or categories of foods other than those referred to in paragraph3,for which nutrition or health claims are to be restricted or prohibited,may be determined in accordance with the procedure referred to in Article24(2)and in the light of scientific evidence.Article5General conditions1.The use of nutrition and health claims shall only be permitted if the following conditions are fulfilled:(a)the presence,absence or reduced content in a food or cate-gory of food of a nutrient or other substance in respect of which the claim is made has been shown to have a benefi-cial nutritional or physiological effect,as established by generally accepted scientific data;(b)the nutrient or other substance for which the claim is made:(i)is contained in the final product in a significant quantityas defined in Community legislation or,where suchrules do not exist,in a quantity that will produce thenutritional or physiological effect claimed as establishedby generally accepted scientific data;or(ii)is not present or is present in a reduced quantity that will produce the nutritional or physiological effectclaimed as established by generally accepted scientificdata;(c)where applicable,the nutrient or other substance for whichthe claim is made is in a form that is available to be used by the body;(d)the quantity of the product that can reasonably be expectedto be consumed provides a significant quantity of the nutrient or other substance to which the claim relates,as defined in Community legislation or,where such rules do not exist,a significant quantity that will produce the nutri-tional or physiological effect claimed as established by generally accepted scientific data;(e)compliance with the specific conditions set out in ChapterIII or Chapter IV as the case may be.2.The use of nutrition and health claims shall only be permitted if the average consumer can be expected to under-stand the beneficial effects as expressed in the claim.3.Nutrition and health claims shall refer to the food ready for consumption in accordance with the manufacturer's instruc-tions.。
