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加拿大的转基因

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发表于 2011-2-19 11:21 | 显示全部楼层 |阅读模式
加拿大卫生部 www.hc-sc.gc.ca www.hc - sc.gc.ca
信息:安全评估转基因玉米
经过仔细的评估,加拿大卫生部的结论是玉米已改变基因,使其对某些害虫抗药性没有比其他成分或市售玉米品种营养品质的不同,而且它是食品中使用。 Consequently, Health Canada has notified Ciba Seeds that it has no objection to the sale of this corn in Canada.因此,加拿大卫生部已通知汽巴种子,它已经没有这个在加拿大的玉米销售反对。

The corn has been genetically modified to protect it against insect pests, particularly the European Core Borer (ECB), a major insect pest in corn agriculture.玉米已被基因改造,以防止,害虫特别是欧洲的核心是玉米螟(ECB)的,一个重要的农业害虫玉米害虫。

Ciba Seeds has synthesized a gene, the Bt gene, that contains a truncated form of an insect-control protein from Bacillus thuringiensis subspecies kurstaki (Btk).汽巴种子已合成了一种基因,Bt基因,其中包含Btk制剂)截断形式苏云金芽孢杆菌亚种kurstaki(昆虫控制蛋白芽孢杆菌 。 When the gene is inserted into field corn, the corn produces the insect-control protein in its leaves and pollen, which ECB larvae feed upon.当基因插入到外地玉米,玉米生产在其叶子和花粉的昆虫控制蛋白,欧洲央行幼虫饲料后。 The insect gut processes the protein similarly to the insecticidal protein produced by Btk in nature and in pesticides based upon Btk, and the insect is killed.昆虫肠道处理杀虫蛋白类似的蛋白质Btk制剂生产的性质和对Btk制剂的杀虫剂,昆虫被杀死。 This development permits producers to reduce their use of pesticides, which can leave chemical residues in the environment and on the corn.这种发展允许生产者减少农药的使用,它可以留在环境和对玉米的化学残留物。

A second gene has also been inserted into the corn to express a protein, phosphinothricin acetyltransferase (PAT).第二个基因也被插入到玉米来表达的一种蛋白质,膦乙酰转移酶(八)。 This protein is an enzyme that acts as a biological marker to allow researchers to identify the modified plants.这种蛋白是一种酶作为一种生物标记,以使研究人员找出基因植物的行为。

The insect-control protein is produced in very small quantities in corn leaves and pollen; most other plant tissues, including kernels, have barely detectable levels of the protein.昆虫控制蛋白的产生,在玉米叶片和花粉的数量非常小,大多数其他植物组织,包括内核,具有蛋白质几乎检测不到的水平。 Both the insect-control protein and the PAT protein are expected to be destroyed during the processing of grain into food products.无论是昆虫控制蛋白和八蛋白质,预计将在粮食加工成食品销毁。 Digestibility studies have shown that, in the unlikely event that any proteins persist, they will be digested as conventional dietary protein.消化率的研究表明,在万一任何蛋白持续存在,他们将作为常规饲料蛋白质消化。 Acute oral toxicity studies in mice and birds indicated no effect from either the insect-control protein or the PAT protein.小鼠急性经口毒性和鸟类的研究表明没有任何昆虫控制的PAT蛋白或蛋白的作用。 Comparisons of the insect-resistant corn with other commercial corn varieties found no difference in the concentration and bioavailability of nutrients.与其他商业的玉米品种抗虫玉米比较没有发现营养成分的含量和生物利用度的差异。

Health Canada's assessment of the insect-resistant corn was conducted according to the Guidelines for Safety Assessment of Novel Foods (September 1994).加拿大卫生部的玉米评估的抗虫根据1994年进行)的指导方针的新食品安全性评价 (九月。 These guidelines are based on internationally accepted principles for establishing the safety of foods derived from genetically modified organisms, and were developed in consultation with other government agencies, consumers, and industry.这些准则是根据国际公认的原则,建立了转基因生物的食品安全,并与其他政府机构,消费者和业界协商。

This assessment relates only to the food use of the insect-resistant corn.这种评估只涉及到抗虫玉米食物中使用。 Issues related to growing this corn in Canada are being addressed separately through existing regulatory procedures in Agriculture and Agri-Food Canada.此有关的问题越来越多,加拿大玉米正在通过现有的农业和农业食品部的监管程序分开。
 楼主| 发表于 2011-2-19 11:22 | 显示全部楼层
信息:安全评估转基因大豆
经过仔细的评价和评估,加拿大卫生部已决定将草甘磷大豆的安全性和其他商用大豆品种营养丰富,并为食品中使用。 Health Canada has accordingly notified Monsanto Canada Inc. that it has no objection to the sale of these soybeans in Canada.加拿大卫生部已相应通知孟山都公司加拿大公司,该公司已经没有在加拿大的这些大豆销售异议。

Roundup Ready soybeans have been genetically modified to tolerate in-crop applications of Roundup herbicide.草甘磷转基因大豆已经被容忍的农达除草剂在作物中的应用。 A single gene derived from a common soil bacterium has been inserted into the soybean.从一个单一的基因产生一个共同的土壤细菌已被插入到大豆。 The gene produces a version of a plant enzyme that is normally blocked by glyphosate, the active ingredient in Roundup herbicide.该基因产生的一种植物酶,通常由草甘膦,农达除草剂中的活性成分阻止版本。 The bacterial version of the enzyme is naturally tolerant to glyphosate, allowing the soybeans to continue to grow after being sprayed with the herbicide, while other weeds are killed and offering producers a new tool for weed control.这种酶的细菌的版本是自然耐草甘膦,使大豆将继续增长,但已被喷洒除草剂,杂草被杀死,而其他生产者和提供杂草控制的新工具。 The bacterial enzyme is a protein that is easily digested by both humans and animals.该细菌酶是一种很容易被人类和动物消化蛋白质。

Health Canada conducted an extensive and thorough assessment of the soybeans according to the Guidelines for Safety加拿大卫生部的指导方针进行了广泛和彻底的安全黄豆根据评估

Assessment of Novel Foods (September 1994). 新型食品的评估 (1994年9月)。 These guidelines are based on internationally accepted principles for establishing the safety of foods derived from genetically modified organisms, and were developed in consultation with other government agencies, consumers, and industry.这些准则是根据国际公认的原则,建立了转基因生物的食品安全,并与其他政府机构,消费者和业界协商。

The assessment compared Roundup Ready soybeans with the commercial variety from which they were derived, as well as with other commercial varieties of soybeans.评估比商业品种从他们所得,与其他商业品种大豆以及草甘磷大豆。 It determined that, apart from minute levels of the introduced protein, there was no difference between the genetically altered soybeans and other commercial varieties.它决定,除了引进蛋白质分钟的水平,也没有转基因大豆之间的商业和其他品种的差异。 The insertion of genetic information into these soybeans to confer glyphosate tolerance caused no difference in the composition or nutritional quality of the soybeans.在这些大豆的遗传信息插入赋予草甘膦宽容没有造成成分或黄豆的营养品质差异。

This evaluation applies only to food use of these soybeans.这种评估只适用于食品,这些大豆的使用。 Issues related to growing these soybeans in Canada and to their use as animal feeds have been addressed separately through regulatory processes in Agriculture & Agri-Food Canada.成长有关的问题在加拿大和他们使用这些大豆作为动物饲料都已经解决,通过在农业与农业食品部的监管程序分开。
 楼主| 发表于 2011-2-19 11:24 | 显示全部楼层
马铃薯抗安全评估
to the Colorado Potato Beetle科罗拉多州的马铃薯甲虫
简介

Health Canada has notified Monsanto Canada Inc. that it has no objection to the food use of NewLeafTM potatoes developed by NatueMark, a unit of Monsanto Company.加拿大卫生部已通知加拿大公司孟山都,它已经没有了NewLeafTM土豆食品使用NatueMark,一个单位的孟山都公司研制异议。 This new variety of potatoes has been genetically modified to be protected against the Colorado Potato Beetle (CPB) which is the major insect pest in Canada's potato agriculture.这种马铃薯新品种已被基因改造要针对科罗拉多马铃薯甲虫(体外循环),这是加拿大的主要害虫的马铃薯农业有害生物的保护。

Health Canada conducted a thorough assessment of CPB-resistant potatoes according to its Guidelines for the Safety Assessment of Novel Foods (September, 1994).加拿大卫生部进行了一次彻底的评估抗马铃薯体外循环,根据1994年) 为评估指引的新型食品安全 (九月。 These guidelines are based on internationally accepted principles for establishing the safety of foods derived from genetically modified organisms.这些准则是根据国际公认的原则,建立了转基因生物的食品安全。 Other government agencies, consumers and industry played a major part in developing the guidelines.其他政府机构,消费者和行业发展的指导方针发挥了重要作用。

Four elements present in the CPB-resistant potatoes distinguish them from other potato varieties.体外循环的四大要素抗马铃薯目前区别于其他马铃薯品种它们。 These are two new genes (specific sequences of DNA which encode the traits of every living organism) isolated from bacteria, and the two proteins these new genes produce.这是两个(DNA的特定序列的编码,每一个生活生物体性状)由细菌分离,而这些新基因的两种蛋白质产生新的基因。

One gene produces a protein derived from Bacillus thuringiensis (Bt) subspecies tenebrionis which provides the protection一个基因制造蛋白质的保护提供了一个来自苏云金杆菌 (Bt)的亚种tenebrionis其中

from CPB to these potato plants.从体外循环这些马铃薯。 The Bt family of insecticidal proteins are naturally occurring proteins which are included as the active insecticidal agent in certain commercial pest control products.转Bt杀虫蛋白的家庭是天然的是作为活跃在某些商业害虫控制产品代理包括杀虫蛋白。 These have been used safely for more than 30 years to control insect pests by home gardeners, organic growers and other farmers.这些已经使用了超过30年来安全地控制家庭园艺,有机种植者和其他农民害虫。

A second gene produces an enzyme, a biological marker, that allows researchers to identify the modified plants.第二个基因产生一种酶,生物标志物,可以让研究人员确定修改后的植物。

Health Canada reviewed the comparision of the CPB - resistant potatoes to other commercial potatoes (Russet Burbank) and found no difference in composition except for the two introduced proteins.加拿大卫生部审查了该科的比较 - 马铃薯抗其他(拉塞特伯班克)商业土豆,发现在组成,除了引进的两个不同的蛋白质。 These results and a thorough review of the development and production of the CPB-resistant potatoes demonstrate that the introduction of genetic information (DNA) into these potatoes to make them resistant to CPB does not result in any differences in the composition or nutritional quality of the potatoes.这些结果和对发展有透彻的检讨,该科的抗马铃薯生产表明,在这些遗传信息的马铃薯(DNA)的引入,使它们抵抗体外循环不会导致任何成分的差异或营养品质土豆。 Health Canada has concluded that these potatoes are as safe and nutritious as other commercially available potato varieties.加拿大卫生部认为,这些土豆的安全性和其他市售马铃薯品种营养。

This Health Canada opinion deals only with the food use of CPB-resistant potatoes.这只能与加拿大卫生部体外循环耐土豆食品使用的意见处理。 Issues related to growing these potatoes in Canada are being addressed separately through existing regulatory processes in Agriculture and Agri-Food Canada.成长有关的问题在加拿大这些马铃薯正在通过现有的农业和农业食品部的监管程序分开。
 楼主| 发表于 2011-2-19 11:26 | 显示全部楼层
信息:安全评价的Flavr Savr™番茄
加拿大政府已完成了对转基因西红柿,将首次在加拿大销售的审查。 The Flavr Savr™ tomato, produced by the Calgene, Inc. has been genetically engineered to slow the rate at which it ripens.番茄的Flavr Savr™,由Calgene生产,公司已经经过基因工程改造的速度放慢,在它花成熟为一颗。 This means that the Flavr Savr™ tomato can ripen longer on the vine than other tomatoes in order to more fully develop its flavour.这意味着Flavr Savr™番茄可以比其他成熟的西红柿藤长,以便更充分发挥它的味道。 Health Canada indicated that as a result of its assessment, it has no objection to the sale of Flavr Savr™ tomatoes as food in Canada.加拿大卫生部表示,由于其评估的结果,它没有向Flavr Savr™西红柿在加拿大食品销售反对。

Three elements present in the Flavr Savr™ tomato distinguish it from other tomato varieties.三要素中的Flavr Savr™番茄目前区别于其他番茄品种它。 There is a gene, or specific DNA sequence that has been reversed within the plant, that retards the softening process.有一个基因,或特定的DNA序列,该工厂内已经扭转,这会阻碍软化过程。 There is also a second gene and its resulting product, a biological marker, that allow researchers to identify the modified plants.还有一个第二个基因,其最终产品,生物标志物,可以让研究人员确定修改后的植物。

Growers can harvest the tomato and ship it at a riper stage, but its end use will not differ from that of other tomato varieties.种植者可以收获的番茄,船舶处于比较成熟的阶段,但其最终的使用不会不同于其他番茄品种。

The federal government has put the Flavr Savr™ tomato through a thorough assessment before giving the go-ahead to import and sell the tomato in Canada.联邦政府已提出一个全面的评估,然后通过给反超进口和销售在加拿大番茄Flavr Savr™番茄。 The process began in June 1994 when Calgene, Inc. notified Health Canada of their intention to sell genetically modified, slower-ripening tomatoes in Canada.这一进程始于1994年6月时Calgene公司通知,他们打算在加拿大出售转基因,慢熟西红柿加拿大卫生部。 Calgene provided information required under Health Canada's Guidelines for the Safety Assessment of Novel Foods (September 1994). Calgene提供)1994年信息新型食品 (九月须根据指南加拿大卫生部的安全评价 。 These guidelines are based on internationally accepted principles for establishing the safety of foods derived from genetically modified organisms.这些准则是根据国际公认的原则,建立了转基因生物的食品安全。 Other government agencies, consumers and industry played a major part in developing the guidelines that were used to assess Calgene's data.其他政府机构,消费者和工业发展起到了被用来评估Calgene的数据指导方针的重要组成部分。

Health Canada compared the Flavr Savr™ to other commercial varieties and found no difference in composition or nutritional characteristics.加拿大卫生部比较Flavr Savr™其他商业品种,没有发现任何成分或营养特性的差异。 Based on Calgene's information, the Department found the Flavr Savr™ to be as safe and nutritious as other tomato varieties.关于Calgene的资料,该署发现Flavr Savr™被视为安全和其他番茄品种营养。

Agriculture and Agri-food Canada sets policy on food labelling and is responsible for compliance and enforcement.农业和农业食品加拿大食品标签上设置的政策,遵守和执法工作。 The Department also monitors the labelling of imported foods at the wholesale level and inspects imported food at the border.该部还监测在批发层面进口食品标签和在边境检查进口食品。 Agriculture and Agri-food Canada has reviewed information that Calgene, Inc. submitted for an importation permit for Flavr Savr™ tomatoes.农业和农业食品部已审查信息Calgene公司为进口许可证Flavr Savr™西红柿提交。 The Department has determined that the importation of the tomato fruit for food does not pose a potential plant pest problem in Canada.该部已确定了番茄果实的粮食进口不会构成潜在的植物害虫在加拿大的问题。

The Canadian government is at the preliminary stages of developing an appropriate federal approach to labelling novel foods derived from genetic engineering.加拿大政府正在制定一个适当的联邦新标签的方法从基因工程生产的食品的初级阶段。 Once this policy has been developed using an extensive consultation process, the Calgene tomato and other such products will be subject to this policy.一旦这一政策已经开发利用了广泛的磋商过程中,Calgene番茄和其他类似产品会受到这一政策。 In the meantime, existing policy on labelling is adequate to prevent false or misleading information on labels.在此期间,现行的政策是适当的标签,以防止虚假或误导性的标签的信息。

Health Canada has determined that there are no health or safety concerns that would warrant special labelling of the Flavr Savr™ tomato.加拿大卫生部已确定有没有健康或安全问题,将需要的Flavr Savr™番茄特殊标签。 Calgene, Inc. plans to provide point-of-sale information about the Flavr Savr™ and to market it as a distinct brand -- MacGregor -- to give consumers information they can use to make informed purchasing decisions. Calgene,公司计划提供点到点的销售有关Flavr Savr™信息和市场作为一个独特的品牌IT - 麦格雷戈 - 给消费者的信息,他们可以用它来作出明智的购买决策。 Existing provisions under the Food and Drugs Act ensure that such labelling is truthful and not misleading.根据现有规定, 食品和药品法案确保这种标签是真实的,而不是误导。
 楼主| 发表于 2011-2-19 11:26 | 显示全部楼层
食品安全的某些类别的评税通知书含有添加植物甾醇
简介

This document summarizes Health Canada's safety assessment of certain foods containing added phytosterols and invites manufacturers to seek authorization to sell and advertise these novel foods in Canada.这份文件总结了加拿大卫生部的某些食品含有添加植物甾醇的安全评估,并请厂商寻求授权在加拿大销售和宣传这些新的食品。

The term "phytosterols" is used in this document as a collective term for plant sterols, and their hydrogenated stanol forms, whether used in the free sterol form or esterified with fatty acids (also known as sterol esters or phytosterol esters).术语“植物固醇”,是本文档中使用的植物固醇作为一个集合名词,它们的氢化stanol形式,无论是在免费使用的形式或甾醇(也称为甾醇酯或植物甾醇酯已知)脂肪酸酯化。 There is a diversity in the composition of phytosterols and over 40 phytosterols have been identified in nature.有一个多样性的组成和植物甾醇已超过40植物甾醇的性质确定。 The safety assessment considered phytosterols and stanols as a group.植物甾醇的安全评估认为,作为一个群体stanols。

Phytosterols occur naturally in plants, and vegetable oils are the major source of phytosterols in Canadian diets.植物甾醇发生自然植物和植物油是在加拿大饮食植物甾醇的主要来源。 Phytosterols, when consumed at sufficiently high levels, have been shown to reduce serum total and LDL cholesterol levels.植物甾醇,当在足够高的消费水平,已被证明降低血清总胆固醇和 LDL胆固醇水平。

In Canada, the regulatory status of foods with added phytosterols has evolved over the past ten years.在加拿大,添加了植物甾醇的食品的管理状况,已经发展了近十年。 Phytosterols sold in isolated form have a history of sale and use as drugs and, later, when the Natural Health Product Regulations came into effect, as natural health products under the Food and Drugs Act to treat hypercholesterolemia.植物甾醇分离形式销售有销售历史和药物使用,后来,当这些自然健康产品法规生效高胆固醇血症, 法将其作为天然保健产品在食品和药品 。 When it was first proposed that a food containing added phytosterols be sold the product was considered a drug on the basis that it was manufactured for a therapeutic purpose, ie, interfering with the absorption of intestinal cholesterol (modifying an organic function) with the intent of reducing elevated serum cholesterol levels.当它首先提出一种食品含有添加植物甾醇被售出的产品被认为是在此基础上制造的药物,它是为治疗目的,即与肠道胆固醇(修改一个有机的功能)的吸收干扰的意图降低血清胆固醇水平。 As a result, no novel food review was completed.结果,没有发现新的食物审查已经完成。 At the time, data and information to support the safety of foods containing phytosterols, particularly long term studies, were lacking.当时,数据和信息,以支持含有植物固醇,特别是长期研究,食品安全的缺乏。

Health Canada has recently reconsidered the classification of such products in light of recently clarified principles for the classification of foods at the Food-Natural Health Product interface; and the developments in what is known about these products.加拿大卫生部最近已重新考虑在为在食品,天然保健品最近澄清接口食品分类原则,就这些产品的分类,以及事态发展是什么样的产品而闻名。 It was determined that where a substance with a food purpose or dietary origin is added to a product in controlled amounts to allow for safe consumption as a food and food has substantiated health effects, the product may be classified and regulated as a food.经测定,在一个有目的的食品或饮食起源物质添加到产品在控制量作为一个粮食和食品安全消费allow已经提供实质性内容健康的影响,该产品可分为和食品监管。 In these circumstances, the use of a disease risk reduction claim or therapeutic claim would not be sufficient to classify the food as a natural health product.在这种情况下,减少风险的一种疾病治疗要求索赔或使用将不足以归类为一种天然保健品食品。

Completion of this novel food class assessment has also become possible because, very importantly, data and information considered critical to the establishment of the safety of phytosterols for use as ingredients in foods has recently become available.这种新型食品级评估工作已完成,也成为可能,因为,很重要的,关键数据和信息考虑到植物甾醇作为原料使用的食品安全机构最近变得可用。

The safety of phytosterols was assessed according to Division 28 of the Food and Drug Regulations ( FDR ), because foods with added phytosterols were considered "a substance that does not have a history of safe use as a food."甾醇是安全的,按照部)28美国食品和药物法规 (FDR,因为添加了植物甾醇的食物被认为是“一种物质,没有食物的历史作为一个安全使用。” Health Canada has received several novel food submissions for a range of foods with added phytosterols.加拿大卫生部收到了添加了植物甾醇的食物的范围了一些新的食物意见书。 The Food Directorate ( FD ) has conducted the safety assessments according to its Guidelines for the Safety Assessment of Novel Foods .食物局(FD)的安全性进行了评估,根据其小说准则食品安全性评价 。 These Guidelines are based upon internationally accepted principles for establishing the safety of novel foods.这些准则是根据国际公认的原则建立的新型食品的安全。 The following summarizes the major elements of the assessment:下面总结,评估的主要内容:
Toxicological Assessment毒理学评价

The toxicological assessment considered data from reports of adverse effects of excessive plant sterol accumulation in humans, data from experimental animals, and well-documented and well-conducted human safety trials.毒理学评价认为,从植物的过度积累对人类固醇不良反应的报告数据,从动物实验数据和资料保存完好,有效地开展人类安全性试验。 In the toxicological assessment, critical consideration was given to the adverse effects observed in individuals with excessive plasma plant sterol concentrations (eg decreased red blood cell and platelet counts, increased serum alanine aminotransferase and aspartate aminotransferase activity, increased total serum bilirubin) because these effects would suggest the potential of plant sterols to interfere with the biological role of cholesterol (eg structure of cell membranes, and the production of bile acids, steroid hormones, and vitamin D).在毒性评估,重要的考虑因素给予了过多的不利影响与血浆植物甾醇浓度个人观察(如红血细胞减少和血小板计数,增加血清谷丙转氨酶和谷草转氨酶活性,增加血清总胆红素),因为这些影响将建议植物固醇可能干扰胆固醇(如细胞膜的结构,而胆汁酸,类固醇激素的生产,而维生素D)的生物学作用。

The available human trials that sufficiently reported haematology and clinical chemistry parameters provided evidence of a lack of adverse effects at doses as high as 6.6 g of free phytosterols/day for 12 weeks and 8.8 g of free phytostanols/day for 10 weeks.可用有充分报道血液学和临床化学参数提供人体试验剂量高达六点六克自由植物甾醇/日,12周和8.8自由phytostanols /日克10周高的不利影响,缺乏证据。 However, there is uncertainty regarding the potential for adverse effects with the consumption of levels higher than 3 g of free phytosterols per day for an extended period of time, specifically for a subset of the population who hyperabsorb phytosterols from the diet.然而,就存在不确定性与某一个较长时期的水平,每超过3天的免费植物甾醇克高消费产生不利影响的潜在专门为人口的一部分,谁从饮食hyperabsorb植物甾醇。 This subset cannot self-identify and therefore cannot know to avoid use of foods with added phytosterols.该子集不能自我确定,因此无法知道,以避免食品中使用添加了植物甾醇。 An upper limit of 3 g of free phytosterols per day provides a conservative approach which mitigates the potential for adverse effects from increased phytosterol consumption by those individuals who hyperabsorb plant sterols.每一个3天的免费植物甾醇克上限提供了一个保守的做法,减轻了从上升的个人谁hyperabsorb植物甾醇植物甾醇消费产生不利影响的潜力。

Based on its review of the available evidence, therefore, the Food Directorate has concluded that 3 g per day for adults and 1 g per day for children should be used as reference safe intakes.根据其对现有证据的审查,因此,食品局的结论是,每日3克为成人每日1克的儿童应被视为安全的摄入量参考使用。 The FD has no safety concerns regarding the consumption of plant sterol fortified products by the targeted population, (ie hypercholesterolemic adults who wish to lower their cholesterol levels), at levels lower than the reference safe intakes.没有安全的 FD关切固醇人口强化产品的目标消费植物(即高胆固醇血症的成年人谁希望降低他们的胆固醇水平)摄入量,在安全水平低于参考。 In addition, there are no safety concerns for the general population, including hyperabsorbers, children, and pregnant women, who may unintentionally consume plant sterol fortified food products.此外,还有不为一般民众的安全问题,包括hyperabsorbers,儿童,孕妇,谁可能无意中食用植物甾醇强化食品。
Nutritional Assessment营养评估

A potential nutritional safety issue raised in the literature is the lowering of serum carotenoids after consumption of phytosterols, particularly provitamin ß-carotene.一个潜在的营养安全问题在文献中提出的是消费后的植物甾醇降低血清中类胡萝卜素,尤其是维生素原β-胡萝卜素。 Carotenoids are important to humans in mainly two aspects: their provitamin A activity and their antioxidant capacity.类胡萝卜素对人类很重要的主要是两个方面:他们的维生素A活性,其抗氧化能力。 If consumed regularly in excessive amounts, it has been suggested that phytosterols may decrease serum ß-carotene.如服用过量,定期,有人认为它可能会降低血清植物甾醇β-胡萝卜素。 However, serum concentration of ß-carotene is highly variable and the variability can be attributed to a variety of life-style and physiological factors.然而,血清β-胡萝卜素浓度变化很大的变异性可以归结为一种生活方式和生理因素等。 According to the Institute of Medicine (2000), serum concentration of ß-carotene ranges from 2.2 to 122.7 g/dL.根据美国医学研究院(2000年),血清β-胡萝卜素的范围从2.2到122.7克/升的浓度。 In addition, the published studies overall demonstrate that at the consumption level of 3 g of phytosterols per day, there is no significant effect on serum levels of ß-carotene, or the effect disappears when the change in ß-carotene levels is adjusted for the change in serum total cholesterol level.此外,公布的研究表明,在整体的3植物甾醇克,每天的消费水平,不存在对β-胡萝卜素血清水平显着效果,或者效果消失时,在β-胡萝卜素水平的变化是调整改变血清总胆固醇水平。 Therefore it is concluded that the consumption of plant sterols up to the reference safe intake of 3 g per day is nutritionally safe for the general population with respect to ß-carotene.因此它的结论是,植物固醇消费高达参考每天3克的安全摄入量是营养方面的β-胡萝卜素一般人口的安全。
Dietary Exposure从食物摄取

Modelling studies were conducted by Health Canada to determine the appropriate food categories and level of addition of phytosterols in order to help ensure that potential exposure to the addition of phytosterols to foods would be below the safe reference levels in the general population, including children.进行了模拟研究由加拿大卫生部确定适当的食物种类和添加量的植物固醇,以帮助确保潜在的暴露在植物甾醇除了食品将低于一般人群中的安全参考水平,包括儿童。 In the modelling studies, various scenarios were examined using a broad range of foods and levels of addition, including those proposed by petitioners and those approved in other jurisdictions.在模拟研究,利用各种方案进行了研究范围广泛的食品和添加量,包括提出请愿,并在其他司法管辖区的批准的。 The distribution of potential intakes across the population relative to the reference safe intake was used to determine the appropriate food categories and level of addition of phytosterols.潜在的摄入量在人口相对参考的安全摄入量的分布来确定适当的食物种类和添加量的植物甾醇。 The studies estimated potential exposure by age and sex in the population including non-target populations, particularly children.该研究估计,包括潜在的非目标人群,特别是儿童人口按年龄和性别曝光。 The findings of the simulation studies suggested that the addition of phytosterols at up to 1 g (free phytosterols) per serving and per reference amount to unstandardized spreads, mayonnaise, margarine, calorie-reduced margarine, salad dressing and unstandardized salad dressings, yogurt and yogurt drinks and vegetable and fruit juices would not result in over exposure in the non-target population.仿真研究结果表明,高达每服1克(免费植物固醇)和每参考金额非标准利差此外植物甾醇,蛋黄酱,人造黄油,热量减少人造黄油,沙拉酱和非标准沙拉酱,酸奶和酸奶蔬菜和水果饮料和果汁不会导致多在非目标人群的接触。 Post-market studies conducted in Europe also support that over consumption of phytosterols, even in the target population, is very unlikely.在欧洲进行的邮政市场研究也支持了植物甾醇的消费,即使在目标人群,是不太可能。
Labelling标签

Health Canada and the Canadian Food Inspection Agency ( CFIA ) share responsibility in regard to labelling requirements for food.加拿大卫生部和加拿大食品检验局(CFIA)对于分担责任的食品标签要求。 Health Canada is responsible for policy and standard setting for matters related to health and safety under the FDR , whereas CFIA is responsible for enforcement of the Regulations. CFIA also administers and enforces those aspects of the Food and Drugs Act and Regulations and the Consumer Packaging and Labelling Act and Regulations to ensure that labelling is understandable, truthful and not misleading.加拿大卫生部负责制定政策和标准有关事项的罗斯福的健康和安全下,而加拿大食品检验局是负责规例的强制执行。CFIA还实施和执行方面的包装和食品和药品法 ,法规和消费标签法和条例,以确保标签是可以理解的,真实的和没有误导成分。

Phytosterols are not nutrients and under nutrition labelling regulations, the amount of phytosterols may not be included in the Nutrition Facts table ( NFT ).植物甾醇是不营养,根据营养标签法规,植物甾醇金额可能不包括在营养成分表(NFT的 )。 The total phytosterol content may be declared elsewhere on the label in g per serving, rounded to the nearest multiple of 0.1 g.总甾醇含量可能会在标签上宣布在其他地方每份克,四舍五入至最接近倍数为0.1克

It is recognized that the food industry would like to include a health claim on the label to position their products in the marketplace for consumers who wish to use a dietary approach to lower blood cholesterol.人们认识到,食品行业将要加入一个标签上的健康声明,以定位为消费者谁希望使用一种饮食的方法来降低血液中胆固醇的市场他们的产品。 For guidance on acceptable health claims please see Summary of Assessment - Plant Sterols and Blood Cholesterol Lowering索赔接受健康指导,请参阅总结评估-植物甾醇和血胆固醇降低

For additional information, please consult Plant Sterols Plant Sterols (phytosterols) .有关其他信息,请咨询植物甾醇植物甾醇(甾醇) 。
Conclusion结论

In light of these conclusions, manufacturers of the following types of foods containing added phytosterols at a maximum level of 1 g (free phytosterols) per serving and per reference amount are invited to file notifications of their intention to sell these foods as novel foods:鉴于这些结论,对以下类型的食品制造商含附加在每份1克(免费植物甾醇)的最高限额和参考用量每邀请文件,表示有意出售这些食品作为新型食品植物甾醇通知:

unstandardized spreads, mayonnaise, margarine, calorie-reduced margarine, salad dressing and unstandardized salad dressings, yogurt and yogurt drinks, and vegetable and fruit juices.非标准化的利差,蛋黄酱,人造黄油,热量减少人造黄油,沙拉酱和非标准沙拉酱,酸奶和酸奶饮料,蔬菜和果汁。

Petitioners are asked to notify the Food Directorate of each new product with added plant sterols by sending a letter or e-mail to the address below indicating the type of product, the level of addition of phytosterols, the name of the product, and the name and address of the manufacturer.上访者被要求通知每个新产品添加植物固醇通过发送以下说明的产品类型的信件或电子邮件地址的粮食局,对植物甾醇添加量,产品的名称,该名称生产厂家和地址。 In these cases, a record will be made of the intention to sell and a letter of no objection will be sent back to the petitioner, once it is confirmed that the product intended for sale fits the conditions of the current review of the use of phytosterols in food, as described in the current decision document.在这种情况下,记录将被出售的意图和作出的不反对通知书会发回给申诉人,一旦证实,拟出售的产品适合对目前使用的植物甾醇审查的条件在食品,所描述的当前决定文件。 Petitioners who wish to market foods not appearing on the list, or foods containing levels greater than 1 g phytosterols/serving are required to notify Health Canada in accordance with Division 28 of the Food and Drug Regulations .请愿谁不希望市场上出现的食品名单,或含有水平大于1克植物甾醇/服务都必须向加拿大卫生部药品法规并根据食品部28。

All notifications should be addressed to: Submission Management and Information Unit, Food Directorate, Health Products and Food Branch, Health Canada, Postal Locator 2201C, 251 Sir Frederick Banting Driveway, Ottawa, Ontario, Canada, K1A 0K9.所有通知应寄往:提交管理和信息股,粮食局,保健品和食品部,加拿大卫生部,邮政定位器2201C,251万津先生,冯检基车道,渥太华,安大略省,加拿大,K1A 0K9。 The e-mail address for the unit is: smiu-ugdi@hc-sc.gc.ca .该地址为单位的电子邮箱是: smiu-ugdi@hc-sc.gc.ca
 楼主| 发表于 2011-2-19 11:28 | 显示全部楼层
)使用多个周期高压处理(HPP的治疗准备吃(RTE)的肉类和家禽产品
新型食品信息

Health Canada has notified Gridpath Solutions Inc. that it has no objection to the use of Ready To Eat ( RTE ) meats and poultry that have been treated with up to three consecutive cycles of High Pressure Processing ( HPP ) treatment.加拿大卫生部已通知Gridpath解决方案公司,它没有任何异议处理和利用现成的吃(RTE)的肉类家禽有)被处理了(HPP的连续三个周期的高压处理。 The Department conducted a comprehensive assessment of these RTE meat and poultry according to its Guidelines for the Safety Assessment of Novel Foods .该部进行了全面的评估和家禽肉类,这些即食 食品 ,根据其指引到小说的安全评估 。 These Guidelines are based upon internationally accepted principles for establishing the safety of novel foods.这些准则是根据国际公认的原则建立的新型食品的安全。
Background背景

The following provides a summary of the notification from Gridpath Solutions Inc. and the evaluation by Heath Canada and contains no confidential business information.下面提供了从Gridpath解决方案公司的通知和加拿大的Heath评估总结,并包含任何机密的商业信息。
1. 1。 Introduction简介

This Novel Food Information document has been prepared to summerize the opinion regarding the subject product provided by the Food Directorate, Health Products and Food Branch, Health Canada.这种新颖的食品信息文件已经准备summerize认为就这一课题由食物局产品,保健品和食品部,加拿大卫生部提供。 This opinion is based upon the comprehensive review of information submitted by the petitioner according to the Guidelines for the Safety Assessment of Novel Foods.这个意见是根据所根据的新型食品安全评估指引请愿人提交的资料进行全面审查。

High Pressure Processing ( HPP ) consists of applying a high pressure to a packaged food product via compressed water.高压处理(HPP的 )由申请一经压缩包装食品的高压水。 Prior to pressurization, packaged Ready To Eat ( RTE ) meat and poultry products are loaded in a tray, which is itself loaded into the pressure vessel.在此之前加压,打包准备吃(RTE)的肉类和家禽产品装在一个托盘,它本身就是装入容器压力。 The vessel is sealed and then pressurized by injecting water into the vessel until a defined pressure specific for the food to be treated is reached.该船是密封,然后注射到血管的压力,直到定义为食品具体的水加压至处理为止。 The packaged RTE products are thus immersed in the pressurized water and subjected to high hydrostatic pressure. 即食产品的包装因此沉浸在压水,受到高静压力。 The proposed process is run in a batch mode for prepackaged foods; other units also exist which can run in a semi-continuous mode, for easily pumped liquid foods (eg juices, purees, sauces, etc.).建议的过程是运行在预先包装食品的批处理模式,其他单位也存在,可以运行在一个半连续模式,可方便地抽出液体食物(例如果汁,果泥,调味料等)。

The length of the HPP treatment determines the efficacy of inactivation of background microflora.治疗长度高压处理决定的微生物的灭活效果的背景。 The high hydrostatic pressure does not affect any of the structural components of the food itself (eg structural proteins, fibres, fats, etc.), nor does it affect the structural integrity of the package used, as the pressure is applied uniformly on the food and on the package.高静水压不影响食物的任何部件本身的结构(如结构蛋白,纤维,脂肪等),也不会影响使用的包结构完整,压力均匀地应用于食品在包装上。

The process is for use as a post-processing, post-packaging intervention step for the control of Listeria monocytogenes in RTE meats and poultry, and in some cases to extend the shelf life of these products.这个过程是家禽作为后处理,后肉类和即食包装干预步骤中单核细胞增生李斯特菌的控制,在某些情况下,延长这些产品的保质期。

For clarity, RTE meats and poultry means meat or poultry products which have already been subjected to a process sufficient to inactivate vegetative pathogenic microorganisms or their toxins and control spores of foodborne pathogenic bacteria so that the meat product does not require further preparation before consumption, except, in certain cases, washing, thawing or exposing to sufficient heat to warm the product without cooking it.为了明确起见, 即食肉类和家禽肉类或家禽除外手段的产品已经受到足够的进程灭活致病微生物的,或者其营养毒素和控制食源性致病细菌孢子,使肉类产品不前的准备工作还需要进一步的消耗,在某些情况下,清洗,解冻或暴露在没有足够的热量来温暖烹饪产品。 It excludes raw meats or meat products requiring further processing before being safely consumed,它不包括生肉,肉类产品安全食用之前,需要进一步处理, 下一个环节将带你到另一个网站 Meat Inspection Regulations, 1990, Section 2 . 肉类检验法规,1990年,第2节 。

The submission provided by Gridpath Solutions Inc. pertains to the acceptability of RTE meats and poultry that have been treated with up to three consecutive cycles of HPP treatment (87000 psi /600 MPa , from 3 min up to 9 min per cycle). HPP的处理解决方案的公司提交的意见书Gridpath涉及肉类的接受程度RTE和家禽的处理已连续三个周期最多(87000 磅 / 600 兆帕 ,从3分钟可达每分钟9周期)。 This petition is an expansion of the previous approval of RTE meats and poultry treated with a single cycle of HPP treatment (87000 psi /600 MPa , for 3 min), Decision Document for the Use of High Hydrostatic Pressure for the Control of L.这份请愿书是扩大治疗前批准的 HPP周期单用即食肉类和家禽处理(87000 磅 / 600 MPa时 ,3分钟), 高静压力决定文件的使用,为属控制 monocytogenes in Ready To Eat (RTE) Meats and Poultry . 李斯特菌在准备吃(RTE)的肉类和家禽 。

The purpose of this expansion is to make provision for food manufacturers to exercise a deviation procedure in the event of an incomplete HPP treatment cycle.此次扩建的目的是使这一规定的行使食品制造商HPP的治疗周期偏差不完整的程序,该事件的一个。 An incomplete HPP cycle can occur as a result of a mechanical error in the system equipment (eg failure to achieve the desired pressure within the vessel) or a technical error in the system's supervisory program (eg power outage).一个不完整的HPP的周期可能会出现一个)的结果停电机械误差在系统设备(如未能达到所需的压力容器内(例如)一个技术性错误或在系统的监管方案。 Gridpath Solutions Inc. has indicated that approximately 5% of all HPP cycles will result in an incomplete cycle, translating to a maximum of 2-3 incomplete cycles on average in a typical 8 h operational shift. Gridpath解决方案公司已表示,大约5%的HPP的周期会导致不完整的周期,平均转移转化的H业务典型的8至最高2-3不完整周期。 When the cycle is incomplete, and based on the design of the system, the pressure vessel (containing the partially treated product) will remain sealed until an approved systems operator manually restarts the treatment cycle or opens the vessel to remove the product.当周期是不完整的,并在系统,压力容器(含部分处理的产品)的设计将保持密封,直至经批准的系统操作员手动重新启动治疗周期或打开容器中删除该产品。 The commonly established deviation procedure entails restarting the process (ie 87000 psi /600 MPa for 3 min).在共同确定的偏差程序需要重新启动过程(即87000 磅 / 600分钟兆帕 3)。 The impact of this procedure on the food product is that it is subjected to a repeated, complete cycle(s) of high hydrostatic pressure exposure.这种对食品生产过程的影响是,它是遭受了多次,完整周期的高静水压曝光(s)。

The assessment conducted by the Food Directorate considered the physical properties (eg pH, water activity, etc.) of the treated RTE meat or poultry product, the impact of multiple-cycle HPP treatment on the nutritional composition and chemical safety of RTE meat and poultry products, and the impact of extending the treatment duration of a single HPP cycle from 3 min up to 9 min.粮食局的评估进行审议家禽产品的物理性质,影响多个周期(如pH,水分活度等),或经处理的肉类高压杀菌处理对即食的营养成分和化学安全和家禽肉类即食产品,影响最小的 HPP至9周期从3分钟延长治疗时间最多的一个。 Gridpath Solutions Inc. has provided data which demonstrates that RTE meat and poultry products subjected to three consecutive cycles of HPP treatment (87000 psi /600 MPa , from 3 min up to 9 min per cycle) are as safe as the equivalent products subjected to a single cycle of HPP treatment (87000 psi /600 MPa , for 3 min), the standard cycle presently used by the meat industry. Gridpath解决方案公司提供的数据,表明即食肉类和禽类产品受到高压杀菌处理,连续三个周期的(MPa时 ,从3分钟高达87000 磅 / 600至9周期每分钟),可作为安全的产品受到的等效单周期HPP 的治疗(87000 磅 / 600 兆帕分钟,3),标准周期目前所使用的肉类行业。

The Food Program has a legislated responsibility for pre-market assessment of novel foods and novel food ingredients as detailed in the Food and Drug Regulations (Part B, Division 28). HPP -treated meats and poultry are considered novel foods, as per B.28.001, as they have been manufactured by a process that has not previously to those foods, and causes the foods to undergo a major change, the major change being, in respect to these foods, a change that places the food outside the accepted limits of natural variations for that food, with regard to microbiological safety.粮食计划署已在28)法定责任预新型食品和新型食品配料市场的评估,详细的食品和药品法规 (B部分司。 高压杀菌处理过的肉类和家禽被视为新食品,按照二28.001,因为他们已经制造了一个过程,以前没有对这些食品,并导致食品经过重大改变,对于这些食品的主要变化是,这种变化的接受范围以外的地方的食物自然变化对粮食,对于微生物的安全。
2. 2。 Development of the novel food开发的新食品

Gridpath Solutions Inc. has provided information describing the methods and parameters used to compare the potential effects on RTE meat and poultry products treated by a single cycle or multiple consecutive cycles of HPP . Gridpath解决方案公司提供的资料描述的方法和 HPP参数用于连续循环的潜在影响的比较或多个周期的即食肉类和家禽由单一的产品对待。

Data were provided for samples of RTE meat and poultry products with higher (>0.9) water activity (ie sliced cooked chicken) and lower (<0.9) water activity (ie sliced dry prosciutto ham).数据的活动提供了即食肉类样本)水和家禽产品具有较高的(“0.9(即熟鸡肉切片)和较低的”(<0.9)水活性(即干火腿切片火腿)。 Samples were treated to both a single cycle of HPP treatment (87000 psi /600 MPa , with 2, 3, or 9 min per cycle) and three consecutive cycles of HPP treatment (87000 psi /600 MPa , with 2, 3, or 9 min per cycle).样品是经过高压处理的治疗既是一个单周期(87000 磅 / 600 兆帕 ,2,3或9分钟每循环)和三个连续,周期HPP 的治疗(87000 磅 / 600 兆帕 ,2,3或9每个周期分)。 All treatment conditions were tested in triplicate for each RTE meat and poultry product.所有的处理条件进行了测试,一式三份每个即食肉类和家禽产品。

Samples were treated to high hydrostatic pressure using a batch method.样品处理,以高静水压使用批处理的方法。 Prior to pressurization, the vacuum-packed samples were loaded unto a tray, which itself was loaded into the pressure vessel.在此之前加压,真空包装的样品装入托盘那里,这本身就进了压力容器装载。 The vessel was sealed and then pressurized by injecting water into the vessel until the defined pressure (ie 87000 psi /600 MPa ) was reached.该船密封,然后加压注入杯中的水,直到把压力定义(即87000 磅 / 600 兆帕 )的共识。 Treatment pressure was maintained for 2, 3, or 9 minutes per cycle respectively, followed by depressurization and release of the samples.治疗压力维持2,3或9分钟,每个周期分别由降压和随后公布的样本。 All samples were packaged in flexible films approved for HPP treatment.所有样品被包装在高压杀菌处理灵活薄膜批准。 The HPP -treated RTE meat and poultry products still required refrigeration. 认可区内处理即食肉类和家禽产品仍需要制冷。
3. 3。 Dietary Exposure从食物摄取

It is expected that RTE meat and poultry products treated with multiple cycles of HPP will be consumed comparatively to their non-treated counterparts. RTE meat and poultry products treated with multiple cycles of HPP can be expected to partially replace non-treated RTE meat and poultry products.预计即食肉类和家禽产品高压杀菌处理的周期与多个将被消耗相对其非治疗的同行。 即食肉类和家禽的 HPP周期多产品处理可望取代部分非治疗即食肉类和家禽产品。
4. 4。 Chemistry化学

The impact of the HPP treatment on the packaging materials used to package RTE meats and poultry has been performed independently of the novel food submission by the Food Packaging Materials & Incidental Additives Section of the Chemical Health Hazard Assessment Division, as per Division 23, Part B of the Food and Drug Regulations .家禽影响的HPP的处理即食肉类及包装材料,用于包装,目前已进行独立的危害评估司提交的新型食品包装材料和食品添加剂附带化学组的健康,每格23日,B部分美国食品和药品法规 。

It should be noted that the packaging material authorization process is independent from the novel food authorization process.应当指出,包装材料的授权过程是由独立的新型食品授权过程。 The packaging material companies direct any requests concerning the acceptability of packaging materials for HPP treatment to the Canadian Food Inspection Agency ( CFIA ) to obtain proper clearance. CFIA will contact the Food Packaging Materials & Incidental Additives Section, as necessary, to obtain an opinion on the safety of the packaging material used with a novel process.包装材料公司直接有关的任何要求接受治疗的高压处理的包装材料向加拿大食品检验局(CFIA),以获得正确的间隙。 加拿大食品检验署将联系食品包装材料及附带添加剂组,在必要时,获得一见对包装材料的安全使用一种新的进程。
5. 5。 Microbiology微生物

In the original Novel Food submission regarding the use of HPP for the control of L.在原来提交关于新食品的 HPP 属使用的控制 monocytogenes in RTE meats and poultry, Decision Document for the Use of High Hydrostatic Pressure for the Control of L. 李斯特菌在即食肉类和家禽, 决定文件的属采用高静压的控制 monocytogenes in Ready To Eat (RTE) Meats and Poultry , Health Canada reviewed the data provided regarding the microbiological safety of these HPP -treated products. 和单核细胞增生就绪吃(即食)肉类家禽 ,加拿大卫生部审查所提供的数据处理有关这些产品的微生物安全性高压处理 ,。 Based on this information, Health Canada has no objection to the use of RTE meats and poultry which have been subjected to a single cycle of HPP treatment (87000 psi /600 MPa , for 3 min).信息基于此,加拿大卫生部已没有)反对分钟的使用即食肉类和家禽已受到周期为一个高压杀菌处理(87000 磅 / 600 兆帕 ,3。

Considering that the conditions of a single cycle of HPP treatment (87000 psi /600 MPa , for 3 min) are sufficient to ensure the microbiological safety of treated RTE meats and poultry, it is understood that the microbiological safety of a RTE meat or poultry product treated with additional consecutive cycles is expected to be equivalent or even enhanced by such treatment.考虑到分)的条件周期单一高压杀菌处理(87000 磅 / 600 兆帕斯卡 ,3足以确保微生物安全和家禽肉类的处理即食 ,据了解,家禽产品的微生物安全的即食肉类或额外的连续循环处理预计将相当于或什至这种待遇提高。 From a microbiological standpoint, the Bureau of Microbial Hazards has no objection to the use of RTE meats and poultry which have been subjected to up to three consecutive cycles of HPP treatment (87000 psi /600 MPa , from 3 min up to 9 min per cycle).从微生物角度来看,微生物的危害局并没有按照循环反对使用即食肉类和家禽已受到向上/ 600连续三个周期HPP 的治疗(87000 磅兆帕 ,从3分钟至9分钟注册)。
6. 6。 Nutrition营养

The petitioner provided data pertaining to the impact of a multiple-cycle HPP treatment on the nutritional composition of RTE meats and poultry.申诉人提供的数据有关家禽影响多周期高压杀菌处理对肉类和即食的营养成分。 The study design included the measurement of vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), protein, moisture, calcium, iron, vitamin A, retinol, and beta-carotene, for samples of both sliced cooked chicken and sliced dry prosciutto ham subjected to either a single or three consecutive cycles of HPP treatment.研究设计包括维生素B1的测量(硫胺素),维生素B2(核黄素),维生素B3(烟碱酸),蛋白质,水分,钙,铁,维生素A,维生素A和β-胡萝卜素,为双方鸡肉切片样本火腿切片干燥和受单一或连续三年HPP的治疗周期中。

Samples subjected to three consecutive cycles of HPP treatment (87000 psi /600 MPa , from 3 min up to 9 min per cycle) were nutritionally comparable to those treated with a single cycle (87000 psi /600 MPa , 3 min per cycle).样品受到最多循环),每到9分/ 600 MPa时 ,连续三次周期从3 HPP 的治疗磅 (87000分的营养媲美)周期的治疗一个周期(87000 磅 / 600 兆帕分钟,3元。

Based on the assessment of the data provided in the submission and the probable risks associated with HPP , the Bureau of Nutritional Sciences has no objection to the use of RTE meats and poultry which have been subjected to up to three consecutive cycles of HPP treatment (87000 psi /600 MPa , from 3 min up to 9 min per cycle). HPP的基础上提供的数据与评估,并提交了相关的可能风险,营养科学局的异议没有87000(使用的即食肉类和家禽已受到最多连续三个周期HPP 的治疗磅 / 600 兆帕 ,从3分钟可达每分钟9周期)。
7. 7。 Toxicology毒理学

With respect to the possible generation of toxic compounds from the components of RTE meat and poultry products, the potential for repeated exposure to HPP treatment to cause the breakdown of protein and increase the concentration of nitrites and nitrates than already present in the food was investigated.关于肉类和家禽产品可能产生的有毒化合物的即食从组件,治疗潜在的反复暴露于高压处理引起蛋白质分解和亚硝酸盐浓度增加和硝酸盐比目前已在食品进行了调查。 An increase in the level of nitrites and nitrates would be a concern as nitrites can react with amines in foods to form nitrosamines which are genotoxic carcinogens, and nitrates can be converted to nitrites.在亚硝酸盐和硝酸盐的水平的提高将是一个关注,因为食物中的亚硝酸盐可与胺反应生成亚硝胺是遗传毒性致癌物质,硝酸盐和亚硝酸盐可转换为。

No significant increase in the level of nitrites and nitrates was observed for RTE meat and poultry products exposed to three consecutive cycles of HPP treatment (87000 psi /600 MPa , from 3 min up to 9 min per cycle) compared to those treated with a single cycle (87000 psi /600 MPa , for 3 min).无亚硝酸盐和硝酸盐明显增加,在观察水平为 RTE肉类和周期)家禽每分钟3分钟到9个产品连续循环HPP 的治疗(暴露在三87000 磅 / 600 兆帕一个由比较单一的治疗周期(87000 磅 / 600 兆帕分钟,3)。 These results support the conclusion that the multiple-cycle HPP treatment of RTE meat and poultry products does not increase the potential generation of toxic compounds.这些结果支持这样的结论: 即食肉类和家禽产品的多个周期HPP的治疗不会增加潜在的有毒化合物生成。

On this basis, the Bureau of Chemical Safety has no objection to the use of RTE meats and poultry which have been subjected to up to three consecutive cycles of HPP treatment (87000 psi /600 MPa , from 3 min up to 9 min per cycle).在此基础上,对化学安全局没有)反对周期的使用即食肉类和家禽的有,从3分钟每分钟高达9已连续三个周期的治疗受到的 HPP最多(600 磅 87000 / 兆帕 。
8. 8。 Labelling标签

Exposure to three consecutive cycles of HPP treatment (87000 psi /600 MPa , from 3 min up to 9 min per cycle) does not cause a significant compositional change in the food, nor has there been any safety concerns raised regarding the use of this process for RTE meats and poultry.接触到每9分钟周期)到HPP 的治疗(87000 磅连续三个周期/ 600 兆帕 3,从分不会导致食物中的重大结构的改变,也没有发生过任何安全上的使用过程中提出的关于本为 RTE肉类和家禽。 On this basis, mandatory labelling requirements are not necessary in this case.在此基础上,强制性标签要求,在这种情况下没有必要的。
Conclusion结论

Health Canada's review of the information presented in support of the food use of RTE meats and poultry which have been treated with up to three consecutive cycles of HPP treatment (87000 psi /600 MPa , from 3 min up to 9 min per cycle), concluded that this use does not raise concerns related to food safety.加拿大卫生部的资料审查)颁发周期支持即食肉类食品使用和家禽的有,从3分钟到9分钟,每已连续三个周期HPP 的治疗治疗达(87000 600 磅/ MPA的,得出的结论这种使用不提出有关食品安全的关注。 Health Canada is of the opinion that those treated RTE meats and poultry are as safe as other RTE counterparts on the market.加拿大卫生部认为,这些处理即食肉类和家禽的市场安全同行在与其他即食 。

This opinion is solely with respect to the suitability for sale of these RTE meats and poultry.这种观点完全是相对于家禽适宜性和销售这些即食肉类。 It is the continuing responsibility of the food manufacturer to ensure that their products are in compliance with all applicable statutory and regulatory requirements.它是食品生产商继续有责任确保其产品符合所有适用的法律和法规规定。 Any new information obtained in relation to these products which have potential health and safety implications should be forwarded to Health Canada for our consideration in order to ensure the continued safety and integrity of all foods available in the Canadian marketplace.任何新的信息获取有关这些产品有潜在的健康和安全问题应提交给我们考虑到加拿大卫生部,以确保持续安全和所有食品在加拿大市场上提供的完整性。 The sale of food which poses a hazard to the health of consumers would contravene the provisions of the Food and Drugs Act.售卖的食物构成了危害消费者的健康会违反美国食品和药品法的规定。

This Novel Food Information document has been prepared to summarize the opinion regarding the subject product provided by the Food Directorate, Health Products and Food Branch, Health Canada.这种新颖的食品信息文件的编写,总结意见就这一课题由食物局产品,保健品和食品部,加拿大卫生部提供。 This opinion is based upon the comprehensive review of information submitted by the petitioner according to the Guidelines for the Safety Assessment of Novel Foods .这种观点是基于全面的新型食品安全信息评估审查提交由申诉人根据该指引 。

For further information, please contact:如需进一步信息,请联系:

Novel Foods Section新食品节
Food Directorate粮食局
Health Products and Food Branch健康产品和食品司
Health Canada, PL2204E加拿大卫生部,PL2204E
251 Frederick Banting Driveway弗雷德里克班廷德莱夫韦251
Ottawa, Ontario K1A 0K9渥太华,安大略省K1A 0K9

Telephone: (613) 957-1742电话:(613)957-1742
Facsimile: (613) 952-6400传真:(613)952-6400
 楼主| 发表于 2011-2-19 11:29 | 显示全部楼层
水果和蔬菜汁添加了植物甾醇产品
简介

This document summarizes Health Canada's safety assessment of certain foods containing added phytosterols and invites manufacturers to seek authorization to sell and advertise these novel foods in Canada.这份文件总结了加拿大卫生部的某些食品含有添加植物甾醇的安全评估,并请厂商寻求授权在加拿大销售和宣传这些新的食品。

The term "phytosterols" is used in this document as a collective term for plant sterols, and their hydrogenated stanol forms, whether used in the free sterol form or esterified with fatty acids (also known as sterol esters or phytosterol esters).术语“植物固醇”,是本文档中使用的植物固醇作为一个集合名词,它们的氢化stanol形式,无论是在免费使用的形式或甾醇(也称为甾醇酯或植物甾醇酯已知)脂肪酸酯化。 There is a diversity in the composition of phytosterols and over 40 phytosterols have been identified in nature.有一个多样性的组成和植物甾醇已超过40植物甾醇的性质确定。 The safety assessment considered phytosterols and stanols as a group.植物甾醇的安全评估认为,作为一个群体stanols。

Phytosterols occur naturally in plants, and vegetable oils are the major source of phytosterols in Canadian diets.植物甾醇发生自然植物和植物油是在加拿大饮食植物甾醇的主要来源。 Phytosterols, when consumed at sufficiently high levels, have been shown to reduce serum total and LDL cholesterol levels.植物甾醇,当在足够高的消费水平,已被证明降低血清总胆固醇和 LDL胆固醇水平。

In Canada, the regulatory status of foods with added phytosterols has evolved over the past ten years.在加拿大,添加了植物甾醇的食品的管理状况,已经发展了近十年。 Phytosterols sold in isolated form have a history of sale and use as drugs and, later, when the Natural Health Product Regulations came into effect, as natural health products under the Food and Drugs Act to treat hypercholesterolemia.植物甾醇分离形式销售有销售历史和药物使用,后来,当这些自然健康产品法规生效高胆固醇血症, 法将其作为天然保健产品在食品和药品 。 When it was first proposed that a food containing added phytosterols be sold the product was considered a drug on the basis that it was manufactured for a therapeutic purpose, ie, interfering with the absorption of intestinal cholesterol (modifying an organic function) with the intent of reducing elevated serum cholesterol levels.当它首先提出一种食品含有添加植物甾醇被售出的产品被认为是在此基础上制造的药物,它是为治疗目的,即与肠道胆固醇(修改一个有机的功能)的吸收干扰的意图降低血清胆固醇水平。 As a result, no novel food review was completed.结果,没有发现新的食物审查已经完成。 At the time, data and information to support the safety of foods containing phytosterols, particularly long term studies, were lacking.当时,数据和信息,以支持含有植物固醇,特别是长期研究,食品安全的缺乏。

Health Canada has recently reconsidered the classification of such products in light of recently clarified principles for the classification of foods at the Food-Natural Health Product interface; and the developments in what is known about these products.加拿大卫生部最近已重新考虑在为在食品,天然保健品最近澄清接口食品分类原则,就这些产品的分类,以及事态发展是什么样的产品而闻名。 It was determined that where a substance with a food purpose or dietary origin is added to a product in controlled amounts to allow for safe consumption as a food and food has substantiated health effects, the product may be classified and regulated as a food.经测定,在一个有目的的食品或饮食起源物质添加到产品在控制量作为一个粮食和食品安全消费allow已经提供实质性内容健康的影响,该产品可分为和食品监管。 In these circumstances, the use of a disease risk reduction claim or therapeutic claim would not be sufficient to classify the food as a natural health product.在这种情况下,减少风险的一种疾病治疗要求索赔或使用将不足以归类为一种天然保健品食品。

Completion of this novel food class assessment has also become possible because, very importantly, data and information considered critical to the establishment of the safety of phytosterols for use as ingredients in foods has recently become available.这种新型食品级评估工作已完成,也成为可能,因为,很重要的,关键数据和信息考虑到植物甾醇作为原料使用的食品安全机构最近变得可用。

The safety of phytosterols was assessed according to Division 28 of the Food and Drug Regulations ( FDR ), because foods with added phytosterols were considered "a substance that does not have a history of safe use as a food."甾醇是安全的,按照部)28美国食品和药物法规 (FDR,因为添加了植物甾醇的食物被认为是“一种物质,没有食物的历史作为一个安全使用。” Health Canada has received several novel food submissions for a range of foods with added phytosterols.加拿大卫生部收到了添加了植物甾醇的食物的范围了一些新的食物意见书。 The Food Directorate ( FD ) has conducted the safety assessments according to its Guidelines for the Safety Assessment of Novel Foods .食物局(FD)的安全性进行了评估,根据其小说准则食品安全性评价 。 These Guidelines are based upon internationally accepted principles for establishing the safety of novel foods.这些准则是根据国际公认的原则建立的新型食品的安全。 The following summarizes the major elements of the assessment:下面总结,评估的主要内容:
Toxicological Assessment毒理学评价

The toxicological assessment considered data from reports of adverse effects of excessive plant sterol accumulation in humans, data from experimental animals, and well-documented and well-conducted human safety trials.毒理学评价认为,从植物的过度积累对人类固醇不良反应的报告数据,从动物实验数据和资料保存完好,有效地开展人类安全性试验。 In the toxicological assessment, critical consideration was given to the adverse effects observed in individuals with excessive plasma plant sterol concentrations (eg decreased red blood cell and platelet counts, increased serum alanine aminotransferase and aspartate aminotransferase activity, increased total serum bilirubin) because these effects would suggest the potential of plant sterols to interfere with the biological role of cholesterol (eg structure of cell membranes, and the production of bile acids, steroid hormones, and vitamin D).在毒性评估,重要的考虑因素给予了过多的不利影响与血浆植物甾醇浓度个人观察(如红血细胞减少和血小板计数,增加血清谷丙转氨酶和谷草转氨酶活性,增加血清总胆红素),因为这些影响将建议植物固醇可能干扰胆固醇(如细胞膜的结构,而胆汁酸,类固醇激素的生产,而维生素D)的生物学作用。

The available human trials that sufficiently reported haematology and clinical chemistry parameters provided evidence of a lack of adverse effects at doses as high as 6.6 g of free phytosterols/day for 12 weeks and 8.8 g of free phytostanols/day for 10 weeks.可用有充分报道血液学和临床化学参数提供人体试验剂量高达六点六克自由植物甾醇/日,12周和8.8自由phytostanols /日克10周高的不利影响,缺乏证据。 However, there is uncertainty regarding the potential for adverse effects with the consumption of levels higher than 3 g of free phytosterols per day for an extended period of time, specifically for a subset of the population who hyperabsorb phytosterols from the diet.然而,就存在不确定性与某一个较长时期的水平,每超过3天的免费植物甾醇克高消费产生不利影响的潜在专门为人口的一部分,谁从饮食hyperabsorb植物甾醇。 This subset cannot self-identify and therefore cannot know to avoid use of foods with added phytosterols.该子集不能自我确定,因此无法知道,以避免食品中使用添加了植物甾醇。 An upper limit of 3 g of free phytosterols per day provides a conservative approach which mitigates the potential for adverse effects from increased phytosterol consumption by those individuals who hyperabsorb plant sterols.每一个3天的免费植物甾醇克上限提供了一个保守的做法,减轻了从上升的个人谁hyperabsorb植物甾醇植物甾醇消费产生不利影响的潜力。

Based on its review of the available evidence, therefore, the Food Directorate has concluded that 3 g per day for adults and 1 g per day for children should be used as reference safe intakes.根据其对现有证据的审查,因此,食品局的结论是,每日3克为成人每日1克的儿童应被视为安全的摄入量参考使用。 The FD has no safety concerns regarding the consumption of plant sterol fortified products by the targeted population, (ie hypercholesterolemic adults who wish to lower their cholesterol levels), at levels lower than the reference safe intakes.没有安全的 FD关切固醇人口强化产品的目标消费植物(即高胆固醇血症的成年人谁希望降低他们的胆固醇水平)摄入量,在安全水平低于参考。 In addition, there are no safety concerns for the general population, including hyperabsorbers, children, and pregnant women, who may unintentionally consume plant sterol fortified food products.此外,还有不为一般民众的安全问题,包括hyperabsorbers,儿童,孕妇,谁可能无意中食用植物甾醇强化食品。
Nutritional Assessment营养评估

A potential nutritional safety issue raised in the literature is the lowering of serum carotenoids after consumption of phytosterols, particularly provitamin ß-carotene.一个潜在的营养安全问题在文献中提出的是消费后的植物甾醇降低血清中类胡萝卜素,尤其是维生素原β-胡萝卜素。 Carotenoids are important to humans in mainly two aspects: their provitamin A activity and their antioxidant capacity.类胡萝卜素对人类很重要的主要是两个方面:他们的维生素A活性,其抗氧化能力。 If consumed regularly in excessive amounts, it has been suggested that phytosterols may decrease serum ß-carotene.如服用过量,定期,有人认为它可能会降低血清植物甾醇β-胡萝卜素。 However, serum concentration of ß-carotene is highly variable and the variability can be attributed to a variety of life-style and physiological factors.然而,血清β-胡萝卜素浓度变化很大的变异性可以归结为一种生活方式和生理因素等。 According to the Institute of Medicine (2000), serum concentration of ß-carotene ranges from 2.2 to 122.7 g/dL.根据美国医学研究院(2000年),血清β-胡萝卜素的范围从2.2到122.7克/升的浓度。 In addition, the published studies overall demonstrate that at the consumption level of 3 g of phytosterols per day, there is no significant effect on serum levels of ß-carotene, or the effect disappears when the change in ß-carotene levels is adjusted for the change in serum total cholesterol level.此外,公布的研究表明,在整体的3植物甾醇克,每天的消费水平,不存在对β-胡萝卜素血清水平显着效果,或者效果消失时,在β-胡萝卜素水平的变化是调整改变血清总胆固醇水平。 Therefore it is concluded that the consumption of plant sterols up to the reference safe intake of 3 g per day is nutritionally safe for the general population with respect to ß-carotene.因此它的结论是,植物固醇消费高达参考每天3克的安全摄入量是营养方面的β-胡萝卜素一般人口的安全。
Dietary Exposure从食物摄取

Modelling studies were conducted by Health Canada to determine the appropriate food categories and level of addition of phytosterols in order to help ensure that potential exposure to the addition of phytosterols to foods would be below the safe reference levels in the general population, including children.进行了模拟研究由加拿大卫生部确定适当的食物种类和添加量的植物固醇,以帮助确保潜在的暴露在植物甾醇除了食品将低于一般人群中的安全参考水平,包括儿童。 In the modelling studies, various scenarios were examined using a broad range of foods and levels of addition, including those proposed by petitioners and those approved in other jurisdictions.在模拟研究,利用各种方案进行了研究范围广泛的食品和添加量,包括提出请愿,并在其他司法管辖区的批准的。 The distribution of potential intakes across the population relative to the reference safe intake was used to determine the appropriate food categories and level of addition of phytosterols.潜在的摄入量在人口相对参考的安全摄入量的分布来确定适当的食物种类和添加量的植物甾醇。 The studies estimated potential exposure by age and sex in the population including non-target populations, particularly children.该研究估计,包括潜在的非目标人群,特别是儿童人口按年龄和性别曝光。 The findings of the simulation studies suggested that the addition of phytosterols at up to 1 g (free phytosterols) per serving and per reference amount to unstandardized spreads, mayonnaise, margarine, calorie-reduced margarine, salad dressing and unstandardized salad dressings, yogurt and yogurt drinks and vegetable and fruit juices would not result in over exposure in the non-target population.仿真研究结果表明,高达每服1克(免费植物固醇)和每参考金额非标准利差此外植物甾醇,蛋黄酱,人造黄油,热量减少人造黄油,沙拉酱和非标准沙拉酱,酸奶和酸奶蔬菜和水果饮料和果汁不会导致多在非目标人群的接触。 Post-market studies conducted in Europe also support that over consumption of phytosterols, even in the target population, is very unlikely.在欧洲进行的邮政市场研究也支持了植物甾醇的消费,即使在目标人群,是不太可能。
Labelling标签

Health Canada and the Canadian Food Inspection Agency ( CFIA ) share responsibility in regard to labelling requirements for food.加拿大卫生部和加拿大食品检验局(CFIA)对于分担责任的食品标签要求。 Health Canada is responsible for policy and standard setting for matters related to health and safety under the FDR , whereas CFIA is responsible for enforcement of the Regulations. CFIA also administers and enforces those aspects of the Food and Drugs Act and Regulations and the Consumer Packaging and Labelling Act and Regulations to ensure that labelling is understandable, truthful and not misleading.加拿大卫生部负责制定政策和标准有关事项的罗斯福的健康和安全下,而加拿大食品检验局是负责规例的强制执行。CFIA还实施和执行方面的包装和食品和药品法 ,法规和消费标签法和条例,以确保标签是可以理解的,真实的和没有误导成分。

Phytosterols are not nutrients and under nutrition labelling regulations, the amount of phytosterols may not be included in the Nutrition Facts table ( NFT ).植物甾醇是不营养,根据营养标签法规,植物甾醇金额可能不包括在营养成分表(NFT的 )。 The total phytosterol content may be declared elsewhere on the label in g per serving, rounded to the nearest multiple of 0.1 g.总甾醇含量可能会在标签上宣布在其他地方每份克,四舍五入至最接近倍数为0.1克

It is recognized that the food industry would like to include a health claim on the label to position their products in the marketplace for consumers who wish to use a dietary approach to lower blood cholesterol.人们认识到,食品行业将要加入一个标签上的健康声明,以定位为消费者谁希望使用一种饮食的方法来降低血液中胆固醇的市场他们的产品。 For guidance on acceptable health claims please see Summary of Assessment - Plant Sterols and Blood Cholesterol Lowering索赔接受健康指导,请参阅总结评估-植物甾醇和血胆固醇降低

For additional information, please consult Plant Sterols Plant Sterols (phytosterols) .有关其他信息,请咨询植物甾醇植物甾醇(甾醇) 。
Conclusion结论

In light of these conclusions, manufacturers of the following types of foods containing added phytosterols at a maximum level of 1 g (free phytosterols) per serving and per reference amount are invited to file notifications of their intention to sell these foods as novel foods:鉴于这些结论,对以下类型的食品制造商含附加在每份1克(免费植物甾醇)的最高限额和参考用量每邀请文件,表示有意出售这些食品作为新型食品植物甾醇通知:

unstandardized spreads, mayonnaise, margarine, calorie-reduced margarine, salad dressing and unstandardized salad dressings, yogurt and yogurt drinks, and vegetable and fruit juices.非标准化的利差,蛋黄酱,人造黄油,热量减少人造黄油,沙拉酱和非标准沙拉酱,酸奶和酸奶饮料,蔬菜和果汁。

Petitioners are asked to notify the Food Directorate of each new product with added plant sterols by sending a letter or e-mail to the address below indicating the type of product, the level of addition of phytosterols, the name of the product, and the name and address of the manufacturer.上访者被要求通知每个新产品添加植物固醇通过发送以下说明的产品类型的信件或电子邮件地址的粮食局,对植物甾醇添加量,产品的名称,该名称生产厂家和地址。 In these cases, a record will be made of the intention to sell and a letter of no objection will be sent back to the petitioner, once it is confirmed that the product intended for sale fits the conditions of the current review of the use of phytosterols in food, as described in the current decision document.在这种情况下,记录将被出售的意图和作出的不反对通知书会发回给申诉人,一旦证实,拟出售的产品适合对目前使用的植物甾醇审查的条件在食品,所描述的当前决定文件。 Petitioners who wish to market foods not appearing on the list, or foods containing levels greater than 1 g phytosterols/serving are required to notify Health Canada in accordance with Division 28 of the Food and Drug Regulations .请愿谁不希望市场上出现的食品名单,或含有水平大于1克植物甾醇/服务都必须向加拿大卫生部药品法规并根据食品部28。

All notifications should be addressed to: Submission Management and Information Unit, Food Directorate, Health Products and Food Branch, Health Canada, Postal Locator 2201C, 251 Sir Frederick Banting Driveway, Ottawa, Ontario, Canada, K1A 0K9.所有通知应寄往:提交管理和信息股,粮食局,保健品和食品部,加拿大卫生部,邮政定位器2201C,251万津先生,冯检基车道,渥太华,安大略省,加拿大,K1A 0K9。 The e-mail address for the unit is: smiu-ugdi@hc-sc.gc.ca .该地址为单位的电子邮箱是: smiu-ugdi@hc-sc.gc.ca
 楼主| 发表于 2011-2-19 11:31 | 显示全部楼层
好多哟。
发表于 2011-2-19 17:05 | 显示全部楼层
谢谢楼主,我一定要仔细看一遍。
 楼主| 发表于 2011-2-20 02:05 | 显示全部楼层
 楼主| 发表于 2011-2-20 02:14 | 显示全部楼层
The retailers and non-profits listed here are committed to informed choice when it comes to GMOs, and endorse the Non-GMO Project’s approach to ensuring the sustained availability of non-GMO options.

Stores highlighted in pink have made financial donations to support the Non-GMO Project (for a list of all donors, please click here).

Stores with a Non-GMO Project logo are “Supporting Retailers.” For more information about what that means, please click here).
 楼主| 发表于 2011-2-20 02:15 | 显示全部楼层
加拿大有专卖非转基因的食品店。
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