食品法规培训及资源网介绍.ppt

Click to edit Master title,Click to edit Master text,Second level,Third level,Fourth level,Fifth level,*,www.jf-,Click to edit Master title,Click to edit Master text,Second level,Third level,Fourth level,Fifth level,*,食品法规培训及资源网介绍,一,.,国际通用法规,二,.,欧盟相关法规,三,.,美国相关法规,四,.,日本相关法规,五,.,韩国相关法规,六,.,检索工具总结,目录,一、国际通用法规,1.FDA,将强制实行保健品行业,cGMP,改造,2007,年,6,月,22,日美国,FDA,正式宣布，在美国境内所有膳食补充剂生产企业都应符合,cGMP,的要求才能继续生产和销售产品。,(,美国的保健品不同于我国,.,它们均被称之为“膳食补充剂”,-,dietary supplyment,）,FDA,后来又补充规定了新的期限即,500,人以上的膳食补充剂公司必需在,2008,年,6,月底前实施,cGMP,改造,500,人以下公司可放宽至,2009,年,6,月,，而少于,20,人的,小型膳食补充剂生产商可以进一步放宽至,2010,年,6,月,完成,cGMP,改造。,-FDA,将强制实行保健品行业,cGMP,改造,中国制药信息,2008,年第,24,卷第,6,期,25-26,一、国际通用法规,2.,食品添加剂通用法典标准,(,中文版,),CODEX STAN 192-1995,1995,年采纳，,1997,、,1999,、,2001,、,2003,、,2004,、,2005,、,2006,、,2007,、,2008,修订。,GB 2760-2007,前言“本标准参考了国际食品法典委员会（,CAC,）食品添加剂通用标准,GENERAL STANDARD FOR FOOD ADDITIVES,，,CODEX STAN 192-1995(Rev.6-2005)”,FAO(Food and Agriculture Organization of the United States),联合国食品与农业组织（亦称“联合国粮农组织”）,JECFA(The Joint FAO/WHO Expert Committee on Food,Additives,）食品添加剂专家联合委员会,一、国际通用法规,2.,食品添加剂通用法典标准,(,中文版,),在,FAO,的,JECFA,网页,-,www.fao.org/ag/agn/jecfa-additives/search.html?lang=en,有英,文版的食品添加剂规格标准数据库,-,提供了食品添加剂目前,ADI,状态、,JECFA,最新评估年代、,INS,编码等资料。,-,该数据库具有英、法、西班牙、阿拉伯以及中文版的查询页面和背景信息。,World Health Organization(,联合国,),世界卫生组织的,JECFA,网页,www.who.int/ipcs/food/jecfa/en,/,提供了,JECFA,的报告,一、国际通用法规,2.,食品添加剂国际手册,英文原版,food additives date book,2003,年 出版，,First published 2003 by Blackwell Science Ltd,For further information on Blackwell Science,Visit website:,www.blackwell-,二、欧盟法规,EC,与,EEC,的区别与联系,欧洲经济共同体,EEA(Europen Economic Area),里面的负责制定法规的最高行政部门是,欧洲经济委员会,Europen Economic,Commission,（简称,EEC,）,如,88/388/EEC,意思是,1988,年，欧洲经济委员会制定的,388,号指令。,1993,年，,EEA,上升为,EU,，就是,欧盟,(Europen Union),，欧盟里面制定法规指令的最高行政机构是,欧盟委员会,EC,（,European Commission,，如,2008,/,1334/EC,，,意思就是,2008,年欧盟委员会制定的,1334,号指令。,技术壁垒资源网，可以查询欧盟法规，免费下载：,86/362/EEC,86/363/EEC,90/642/EEC,90/642/EEC,2005/396,/EC,and,2008,/,149,/,EC,最大残留限量,maximum residue levels,（,MRLs,）中国,limites,定义：在生产或保护商品过程中，按照农药使用的良好农业规范（,GAP,）使用农药后，允许农药在各种食物中和动物饲料中或其表面残留的最大浓度,.,二、欧盟法规,1.,农残,(,pesticide residue,),法规：,2008,/,149,/,EC,通过建立附录,II,、,III,和,IV,设定附录,I,中涉及的产品的最大残留限量，修订欧洲议会和理事会条例,(EC)No 396/2005,最近欧盟关于农残法规，是对,2005/396,/EC,的修改和补充。,具体列出各种农药在附录,产品中,的残留限量 （多菌灵,28,页）,。,二、欧盟法规,2.,溶剂残留,(solvent residue),法规：,88/344/EEC modified by Dir.92/115/EEC,94/52/EC,97/60/EC,2009/32/CE,2009/32/CE,on the approximation of the laws of the Member,States on extraction solvents used in the production of,foodstuffs and food ingredients,二、欧盟法规,2.,溶剂残留,(solvent residue),法规：,88/344/EEC modified by Dir.92/115/EEC,94/52/EC,97/60/EC,2009/32/CE,最近法规,2009/32/CE,ANNEX-Part,Extraction solvents to be used in compliance with good,manufacturing practice,for all uses,.,丙烷，丁烷，乙酸乙酯，,乙醇,，二氧化碳，丙酮，一氧化氮,二、欧盟法规,2.,溶剂残留,(solvent residue),ANNEX-Part,Extract solvent for which condition of use are,specified,Name,Conditions of use,(summary description of extraction),Maximum residue limits in the extracted,foodstuff or food ingredient,正己烷,Production or fractionation of fats and oils and production of cocoa butter,1 mg/kg in the fat or oil or cocoa butter,Preparation of defatted protein products anddefatted flours,10 mg/kg in the food containing the defatted protein products and the defatted flours,30 mg/kg in the defatted soya products as sold to the final consumer,Preparation of defatted cereal germs,5 mg/kg in the defatted cereal germs,乙酸甲酯,Decaffeination of,or removal of irritants and bitterings from coffee and tea,20 mg/kg in the coffee or tea,Production of sugar from molasses,1 mg/kg in the sugar,二、欧盟法规,2.,溶剂残留,(solvent residue),ANNEX-Part,Extract solvent for which condition of use are specified,Name,Conditions of use,(summary description of extraction),Maximum residue limits in the extracted,foodstuff or food ingredient,丁酮,Fractionation of fats and oils,5 mg/kg in the fat or oil,Decaffeination of,or removal of irritants and bitterings from coffee and tea,20 mg/kg in the coffee or tea,二氯甲烷,Decaffeination of,or removal of irritants and bitterings from coffee and tea,2 mg/kg in the roasted coffee and 5 mg/kg in the tea,甲醇,For all uses,10 mg/kg,丙烷,-2-,醇,For all uses,10 mg/kg,二、欧盟法规,2.,溶剂残留,(solvent residue),ANNEX-Part,Extract solvent for which condition of use are specified,Name,Maximum residue limits in the foodstuff due to the use of extraction solvents in the preparation of,flavourings from natural flavouring materials,二乙醚,2 mg/kg,正己烷,1 mg/kg,乙酸甲酯,1 mg/kg,丁烷,-1-,醇,1 mg/kg,丁烷,-2-,醇,1 mg/kg,丁酮,1 mg/kg,二氯甲烷,0.02 mg/kg,丙烷,-1-,醇,1 mg/kg,四氯乙烷,0.02 mg/kg,二、欧盟法规,3.,污染物,(contaminants),法规：,2006/1881,/,EC,，修改法规,2008/565/EC,（但是具体项目未作修改）,设立每种污染物的限量，所包括的污染物见下表，具体残留限量见法规。,名称,备注,Nitrate(,硝酸盐）,Mycotoxins(,真菌霉素类）,包括,Aflatoxins(,黄曲霉素,),Ochratoxin A(,赭曲霉毒素,A),Patulin(,棒曲霉素），,Deoxynivalenol(,呕吐毒素,),Zearalenone(,玉米烯酮,Fumonisins,（烟曲霉毒素）,Metals,包括：铅，镉，汞，锡（,tin),3-MCPD,3-,单氯丙二醇,Dioxins and PCBs,二恶英 和多氯联苯,Polycyclic aromatic hydrocarbon,稠环芳烃；多环芳烃,包括：,benzopyrene(,苯并芘,),二、欧盟法规,4.,黄曲霉素,(Aflatoxins),法规：,98/53/EC,内容：,sampling methods and the methods of analysis,黄曲霉素类取样和分析方法,二、欧盟法规,5.,二恶英,(,dioxins,),法规：,2002/69/CE:,内容：,the sampling methods and the methods of analysis for the official control of dioxins and the determination of dioxin-like PCBs in foodstuffs,二恶英及其类似物的检测方法,二、欧盟法规,6.,重金属,(,metals),法规：,200,8,/6,2,9/CE:,内容：,amending Regulation(EC)No 1881/2006 setting maximum levels for certain contaminants in,foodstuffs,对,2006/1881/EC,的补充,增加了对膳食补充剂（,Food supplements,）中重金属的要求，如下：,-,铅,3.0mg/kg,-,镉,1.0mg/kg,-,汞,0.1 mg/kg,国内保健品标准是多少呢？,GB16740-1997,保健（功能）食品通用标准,.,铅，,0.5 mg,kg,砷，,0.3 mg,kg,汞，,mg,kg,二、欧盟法规,7.,辐射,(,I,onisation,),法规：,1999/2/EC,内容：,foods and food ingredients treated with ionising radiation,各成员国有关采用电离辐射处理食品和食品配料的法律,生效日期：,-permit the marketing and use of irradiated foodstuffs by 20 September 2000,-prohibit the marketing and use of irradiated foodstuffs not complying with this Directive by 20 March 2001.,二、欧盟法规,7.,辐射,(,I,onisation,),法规：,1999/2/EC,附录,I Conditions for authorising food irradiation,1.Food irradiation may be authorised only if:,授权食物进行辐射的前提条件,there is a reasonable technological need,合理的技术需要,it presents no health hazard and is carried out under the conditions proposed,无健康危害，同时按照给出的方法执行,it is of benefit to the consumer,对消费者有益,it is not used as a substitute for hygiene and health practices or for good manufacturing or agricultural practice,不能用来代替卫生和健康规范,二、欧盟法规,7.,辐射,(I,onisation,),法规：,1999/2/EC,附录,I Conditions for authorising food irradiation,2 Food irradiation may be used only for the following purposes:,只有为了达到下列目的的时候才可以辐射,to reduce the incidence of food-borne disease by destroying pathogenic organisms,通过消灭致病菌来降低经食物传播的疾病的几率,to reduce spoilage of foodstuffs by retarding or arresting decay processes and destroying spoilage organisms,to reduce loss of foodstuffs by premature ripening,germination or sprouting,to rid foodstuffs of organisms harmful to plant or plant products.,二、欧盟法规,7.,辐射,(,I,onisation,),法规：,1999/2/EC,ANNEX II,Foodstuffs may be treated only by the following sources of ionising radiation:,允许使用的辐射方法：,(a)gamma rays from radionuclides,60Co or 137Cs,;,(b)X-rays generated from machine sources operated at or below a nominal energy(maximum quantum energy)level of,5 MeV,;,(c)electrons generated from machine sources operated at or below a nominal energy(maximum quantum energy),level of 10 MeV,.,国内辐射标准是多少呢？,用钴,-60,、铯,-137,产生的,射线或电子加速器产生,的低于,10ME,电子束辐照加工处理的食品，包括,辐照处理的食品原料、半成品。,累积吸收剂量不得大于,10,GY,二、欧盟法规,8.,过敏原,(,Food Allergenicity,),法规：,2000/13/EC,2003/89/EC,2005/26/EC,2005/63/EC,2007/68/EC,2007/68/EC,附录过敏原内容：,将过敏物质一共分为,14,类,1.Cereals containing gluten(i.e.wheat,rye,barley,oats,spelt,kamut or their hybridised strains)and products thereof,except:,(a)wheat-based glucose syrups including dextrose(1);,(b)wheat-based maltodextrins(1);,(c)glucose syrups based on barley;,(d)cereals used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages.,二、欧盟法规,8.,过敏原,(,Food Allergenicity,),2007/68/EC,附录过敏原内容：,2.Crustaceans and products thereof.,3.Eggs and products thereof.,4.Fish and products thereof,except:,(a)fish gelatine used as carrier for vitamin or carotenoid preparations;,(b)fish gelatine or Isinglass used as fining agent in beer and wine.,5.Peanuts and products thereof.,二、欧盟法规,8.,过敏原,(,Food Allergenicity,),2007/68/EC,附录过敏原内容：,6.Soybeans and products thereof,except:,(a)fully refined soybean oil and fat(1);,(b)natural mixed tocopherols(E306),natural D-alpha tocopherol,natural D-alpha tocopherol acetate,natural D-alpha tocopherol succinate from soybean sources;,(c)vegetable oils derived phytosterols and phytosterol esters from soybean sources;,(d)plant stanol ester produced from vegetable oil sterols from soybean sources.,二、欧盟法规,8.,过敏原,(,Food Allergenicity,),2007/68/EC,附录过敏原内容：,7.Milk and products thereof(including lactose),except:,(a)whey used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages;,(b)lactitol.,8.Nuts,i.e.almonds(Amygdalus communis L.),hazelnuts(Corylus avellana),walnuts(Juglans regia),cashews(Anacardium,occidentale),pecan nuts(Carya illinoiesis(Wangenh.)K.Koch),Brazil nuts(Bertholletia excelsa),pistachio nuts(Pistacia,vera),macadamia nuts and Queensland nuts(Macadamia ternifolia),and products thereof,except:,(a)nuts used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages.,二、欧盟法规,8.,过敏原,(,Food Allergenicity,),2007/68/EC,附录过敏原内容：,9.Celery and products thereof.,10.Mustard and products thereof.,11.Sesame seeds and products thereof.,12.Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre expressed as SO2.,13.Lupin and products thereof.,14.Molluscs and products thereof.,二、欧盟法规,9.,转基因,(GMO),法规：,97,/,258,/,EC,2003/,1829/,EC,2003/,1830/,EC,一个常见的问题：,-Does this product need GMO declaration/labelling according EC 1829/2003 and 1830/2003?,回答为“,No,”,二、欧盟法规,9.,转基因,(GMO),法规：,97,/,258,/,EC,2003/,1829/,EC,2003/,1830/,EC,GMO,声明：,-does not contain genetically modified organisms(GMOs),-is not manufactured using genetically modified organisms(GMOs).,-is not produced with the aid of substances which contain or are manufact,ured using genetically modified organisms(GMOs),二、欧盟法规,9.,转基因,(GMO),2003/,1829/,EC,内容：,genetically modified food and feed,关于由,GMOs,制造或含有,GMOs,食品和饲料,上市及在市场上的管理,二、欧盟法规,9.,转基因,(GMO),2003/,18,30,/,EC,内容：,concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms,genetically modified food and feed,.,转基因生物体可追溯性和标签及由转基因生物体生产的食品和饲料,产品的可追溯性,.,二、欧盟法规,10.,Non BSE/TSE,法规,:2001/999/,EC,，后面有过很多次修改。,声明,Does not contain any substance or component of Bovine,Ovine or Caprine in its composition.,It is also stated that:,-Throughout the manufacturing process of this raw-material,no substance or reagent of Bovine,Ovine or Caprine origin have been used;,-The raw material concerned has not been exposed to risks of environmental contamination from substances of Bovine,Ovine and Caprine origin,during the said manufacturing process.,二、欧盟法规,11.,微生物（,microbiological,）,法规：,2007/1441/EC,内容：,amending Regulation(EC)No 2073/2005 on,microbiological,criteria for foodstuffs,。,Microbiological criteria for foodstuffs,Chapter 1.Food safety criteria.15,Chapter 2.Process hygiene criteria.20,2.1 Meat and products thereof.20,2.2 Milk and dairy products.23,2.3 Egg products.26,2.4 Fishery products.27,2.5 Vegetables,fruits and products thereof.28,Chapter 3.Rules for sampling and preparation of test samples.29,3.1 General rules for sampling and preparation of test samples.29,3.2 Bacteriological sampling in slaughterhouses and at premises producing minced meat and meat,preparations.,.29,项 目,限 量,液态产品,固态或半固态产品,蛋白质等于或大于,1.0,蛋白质小于,1.0,蛋白质等于或大于,4.0,蛋白质小于,4.0,菌落总数，,cfu,g,或,mL,1000,100,30000,1000,大肠菌群，,MPN,100g,或,100mL,40,6,90,40,霉菌，,cfu,g,或,mL,10,10,25,25,酵母，,cfu,g,或,mL,10,10,25,25,致病菌（指肠道致病菌和致病性球菌,),不 得 检 出,GB16740-1997,保健（功能）食品通用标准,.,二、欧盟法规,12.,新奇食品（,Novel food status,）,法规：,97/258/EC,内容：,novel foods and novel food ingredients,主要针对,新型食品、欧盟以外国家,来源的食品和食品添加剂。评估以营养价值为标准,范围：,(a)foods and food ingredients containing or consisting of,genetically modified organisms,within the meaning of Directive 90/220/EEC;,(b)foods and food ingredients produced from,but not containing,genetically modified organisms;,(c)foods and food ingredients with a new or intentionally,modified primary molecular structure;,二、欧盟法规,12.,新奇食品,法规：,97/258/EC,范围：,(d)foods and food ingredients consisting of or isolated from,micro-organisms,fungi or algae;,(e),foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals,except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use;,(f)foods and food ingredients to which has been,applied a production process not currently used,where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value,metabolism or level of undesirable substances.,二、欧盟法规,13.,食品添加剂,法规：,2002/46/EC,明确指出：“营养品或食品添加剂”是指具有营养价值的营养品，或是具有营养、生理作用的其它物质。,生产的目的是对正常饮食的补充。,产品剂型可以是胶囊、含片、片剂、丸剂、粉剂、口服液或滴剂。,二、欧盟法规,13.,食品添加剂,法规：,89/107/EEC,号指令,范围：是关于食品添加剂的,管理框架,，指令要求所有允许使用的食品添加剂都要经过欧盟食品科学委员会（,SCF,）根据该指令附件中的基准进行安全性评估。,1994,年,6,月欧洲议会和理事会,94/34/EC,指令对其进行了修正，,指出成员国可以提出禁止本国境内某些传统食品中使用某些添加剂,，如果得到允许，相关成员国可以继续在其境内禁止在这些食品中使用添加剂，并由此产生了,292/97/EC,号决定。,二、欧盟法规,13.,食品添加剂,食品添加剂的分类名称和国际编号系统,分类：,色素,甜味剂,除色素和甜味剂以外的食品添加剂,E 160a Carotenes,E 161b Lutein,E 160d Lycopene,E 162 Beetroot Red,（,betanin,）,E 163 Anthocyanins,（包括 花色素类，葡萄皮色素，黑加仑色素，紫玉米色素，红甘蓝色素）,二、欧盟法规,13.,食品添加剂,-,色素,法规：,94/36/EC,我现在的资源网无法下载全文，是否可以从客户要来，可以查阅一下叶黄素添加量,是关于色素使用方面的详细规定。,哪些色素可以应用到食品当中，具体添加量等,（相当于中国的,2760,）,迄今为止有没有修正法规,二、欧盟法规,13.,食品添加剂,-,色素,法规：,95/45/EC,叶黄素的欧洲标准,(34,页,),，溶剂残留可以参考,是针对色素的规格规定,定义了每种色素的规格标准，含量，鉴别，重金属，溶剂残留等。,迄今为止有过五个修正法规：,99/75/EC,2001/50/EC,2004/47/EC,2006/33/EC,二、欧盟法规,13.,食品添加剂,-,色素,法规：,95/45/EC,叶黄素的欧洲标准,(34,页,),，溶剂残留可以参考；花色苷（,36,页）,是针对色素的规格规定,定义了每种色素的规格标准，含量，鉴别，重金属，溶剂残留等。,迄今为止有过五个修正法规：,99/75/EC,2001/50/EC,2004/47/EC,2006/33/EC,二、欧盟法规,13.,食品添加剂,-,色素,法规：,95/45/EC,叶黄素的溶剂残留中国标准,着色剂,营养强化剂,溶剂残留：,正己烷,甲 醇,丙酮、异丙醇和丙二醇总量,50 mg/kg,10 mg/kg,1000 mg/kg,溶剂残留：,正己烷,甲 醇,50 mg/kg,10 mg/kg,二、欧盟法规,13.,食品添加剂,-,甜味剂,法规：,94/35/EC,，是关于甜味剂使用方面的详细规定,我现在的资源网无法下载全文,哪些甜味剂可以应用到食品当中，具体添加量是多少,迄今为止有过四个修正法规：,96/83/EC,2003/115/EC,2006/52/EC,2009/163/EC,二、欧盟法规,13.,食品添加剂,-,甜味剂,法规：,95/31/EC,我现在的资源网无法下载全文,是针对甜味剂的规格规定,定义了每种甜味剂的规格标准，含量，鉴别，水分，灰分，,pH,值，重金属等。,迄今为止有过五个修正法规：,98/66/EC,2000/51/EC,2001/52/EC,2004/46/EC,2006/28/EC,二、欧盟法规,13.,食品添加剂,-,除色素和甜味剂以外的食品添加剂,法规：,95/2/EC,相当于中国的,GB/T 2760-2007,食品添加剂卫生标准,是关于食品添加剂使用方面的详细规定,哪些添加剂可以应用到食品当中，具体添加量是多少,迄今为止有过六个修正法规：,96/85/EC,98/72/EC,2001/5/EC,2003/52/EC,2003/114/EC,2006/52/EC,这七个法规已经被官方做成一个,PDF,，方便查询,二、欧盟法规,13.,食品添加剂,-,除色素和甜味剂以外的食品添加剂,法规：,96/77/EC,是针对食品添加剂的规格规定,定义了每种食品添加剂的规格标准，含量，鉴别，水分，灰分，,pH,值，重金属，,微生物,等。,迄今为止有过七个修正法规：,98/86/EC,介绍编号,400-585,食品添加剂规格