GRAS Flavoring Substances 25

药品注册用英语现在做注册资料经常会涉及英语表达，为了使我们写注册资料时的英语更纯正，希望各位达人能积极勇跃提供经常涉及的英语表达，使我们的注册水平更上一层楼。

我先抛砖引玉CEP：欧洲药典适应性证书certificate of suitability to monograph of European Pharmacopoeia。

是欧洲药典所收载的原料药的一种认证程序，用以确定原料药的质量可以用欧洲药典的方法加以控制。

这一程序适用于生产的和提取的有机或无机物质以及发酵生产的非直接基因产品。

DMF：Drug master File美国药物主文件档案。

是指提交给FDA的用于提供关于人用药品的生产设备、工艺或生产、工艺处理、包装和储存中使用的物料的详细的和保密的信息。

分为五种类型：I：生产地点、设备、操作程序和人员II：原料药、原料药中间体、生产原料药和中间体使用的物料和药品III：包装材料IV：赋形剂、色素、调味剂、香料或生产这些物质所用的物料V：FDA接受的参考信息EDMF：European Drug Master File欧洲药物主文件档案。

是指欧洲制剂申请中有关原料药信息的文件，又称原料药主文件档案（ASMF）。

EDMF 只有在制剂申请的支持下才能提交。

EDMF分为两部分：1．申请人部分（AP）：供制剂申请人使用的非保密信息；2. 限制部分（RP）：EDMF持有人认为是保密的信息。

EDMF的使用范围：1. 新原料药2. 已知的但欧洲药典或其成员国药典没有收载的原料药3. 欧洲药典或成员国药典已收载的原料药ANDA：Abbreviated New Drug Application 美国简略新药申请。

是FDA规定的仿制药申请程序。

Generic：仿制的，非特殊的API：Active Pharmaceutical Ingredient 原料药Dossier：文档，档案。

TSE：Transmitting animal Spongiform Encephalopathy agent 传播性动物海绵状脑病体Q7A：ICH（国际协调会议）原料药GMP 指南。

一、1.国内外著名厂家：国际、奇华顿、爱普、曼氏、波顿、西湖、华宝、百花、绿晶……2.世界前五大香精香料企业：美国国际香料公司（IFF）；荷兰纳尔顿（Naarden）香料公司；瑞士奇华顿（Givaudan）香料公司；德国哈曼雷默（Haarrman&Reimer）香料公司；日本高砂香料株式会社.3. 与食用香精有关的法规和管理机构FCC(Food Chemical Codex)：食品化学品法典FDA(Food and Drug Administration)：美国食品和药品管理局FEMA(Flavor Extract Manufacturers Association)：美国食品香料与萃取物制造者协会GRAS(Generally Recognized as Safe)：一般认为安全COE(Council of Europe & Experts on Flavoring Substance)：欧洲理事会与食品香料专家委员会IOFI(International Organization of Flavor Industry)：食用香料香精工业国际组织。

二、香料专业术语1.香料（Perfume）：在一定浓度下具有香气或香味的、用于配制香精的物质。

“香精”(perfume compound)：由人工调配出来的或由发酵、酶解、热反应等方法制造的含有多种香成分的混合物。

2.天然香料（Nature Perfume）：从动物、植物、微生物中，通过发酵、压榨、蒸馏、萃取、吸附等方法获得的香料。

如麝香酊、橘子油、薄荷油。

3.合成香料（Synthetic Perfume）：通过化学合成的方法制得的香料。

4.日用香料（Fragrance）：用于调配日用香精的香料。

5.食用香料（Flavor）：用于调配食用香精的香料。

6.精油（Essential Oil）：从香料植物中提取出的挥发性油状液体。

7.酊剂（Tincture）：以乙醇为溶剂，在室温或加热条件下浸提天然香料原料，经冷却、澄清、过滤后得到的溶液。

食品专业英语化学品/农药残留物检测系统— Chemical/pesticide residue testing;外界污染源勘测仪器 - Detection of foreign contaminating objects;实验室设备和传感器 - Laboratory equipment and sensors;射线杀菌和巴氏杀菌消毒技术- Irradiation sterilization and pasteurization technology；超高温杀菌设备— Over-temperature sterilization equipment;冷冻速冻设备— Freezing and deep freezing equipment;超临界萃取设备 - Over-critical extraction equipment；膜分离设备— Velum seperation equipment;分子蒸馏设备 - Molecule distillation equipment;无菌（真空）包装设备 - Vacuum packaging equipment；化学品分析仪器 - Chemical analyzers;食品成分分析仪器— Constituent analyzers;过滤设备 - Filtration equipment;食品预处理设备 - Food preparation equipment;湿度控制仪器— Humidity control equipment；食品配料分析仪器— Ingredient analyzers;污染控制设备 - Pollution control equipment;离析器 - Separators；饮业清洁设备— Catering sanitizers；温度纪录仪器 - Temperature recording equipment;检测设备— Testing equipment；废物处理设备 - Waste disposal equipment；水质量分析和控制设备 - Water quality analysis and control equipment；气相／液相色谱仪 - Gas/Liquid chromatogram apparatus.溶剂— Solvents；餐饮业厨房用地板 - Kitchen flooring for catering；手套— Gloves；清洁剂— Cleanser;试纸、试剂 - Test paper and reagent.审核和认证服务— Auditing and certification;数据库和软件服务— Databanks and software on regulatory issues;实验室食品分析服务 - Food analysis laboratory services；咨询服务— Consulting services;食品质量控制管理服务— Food quality control management services;食品安全管理服务— Food safety management services；食品卫生管理服务 - Food hygiene management services;HACCP和BRC培训服务— HACCP & BRC training services；微生物检测和认证服务— Microbiology testing and identification services;专家咨询服务 - Regulatory experts services；食品安全保障技术 - Food safety guarantee technology；生物工程技术— Biology engineering technology食品安全 Food Safety食品防御安全 Food SecurityEEC serial No.欧共体（食品添加剂）顺序号EFEMA（European Food Emulsifer Manufacturers Association) 欧洲食品乳化剂制造者协会encapsulating agent for food additives and vitamins 食品添加剂和维生素用包囊剂engineering food 工程食品enrich （食品)增补（营养素），强化；富集，浓缩;加料enriched food 强化（营养素）食品Expert Committee on Food Additive 食品添加剂专家委员会extruded food 挤压食品Fabricated food 合成食品，组合食品FAC（Food Advisory Committee） (英国)食品咨询委员会fad food 应时食品FAO/WHO Joint Committee of Alimentary Codex（CA—C） FAO/WHO食品卫生法规联合委员会FAP(Food Additive Petition)(U.S。

SUBCHAP TER B—FOOD FOR HUMAN CONSUMP TIONPART 170—FOOD ADDITIVESSubpart A—General ProvisionsSec.170.3Definitions.170.6Opinion letters on food additive sta-tus.170.10Food additives in standardized foods. 170.15Adoption of regulation on initiative of Commissioner.170.17xemption for investigational use and procedure for obtaining authoriza-tion to market edible products from ex-perimental animals.170.18Tolerances for related food additives. 170.19Pesticide chemicals in processed foods.Subpart B—Food Additive Safety170.20General principles for evaluating the safety of food additives.170.22Safety factors to be considered.170.30E ligibility for classification as gen-erally recognized as safe (GRAS).170.35Affirmation of generally recognized as safe (GRAS) status.170.38Determination of food additive sta-tus.170.39Threshold of regulation for sub-stances used in food-contact articles. Subpart C—Specific Administrative Rulingsand Decisions170.45Fluorine-containing compounds.170.50Glycine (aminoacetic acid) in food for human consumption.170.60Nitrites and/or nitrates in curing pre-mixes.A UTHORITY: 21 U.S.C. 321, 341, 342, 346a, 348, 371.S OURCE: 42 FR 14483, Mar. 15, 1977, unless otherwise noted.E DITORIAL N OTE: Nomenclature changes to part 170 appear at 66 FR 56035, Nov. 6, 2001. Subpart A—General Provisions§170.3Definitions.For the purposes of this subchapter, the following definitions apply:(a) Secretary means the Secretary of Health and Human Services.(b) Department means the Department of Health and Human Services.(c) Commissioner means the Commis-sioner of Food and Drugs.(d) As used in this part, the term act means the Federal Food, Drug, and Cosmetic Act approved June 25, 1936, 52 Stat. 1040 et seq., as amended (21 U.S.C. 301–392).(e)(1) Food additives includes all sub-stances not exempted by section 201(s) of the act, the intended use of which results or may reasonably be expected to result, directly or indirectly, either in their becoming a component of food or otherwise affecting the characteris-tics of food. A material used in the pro-duction of containers and packages is subject to the definition if it may rea-sonably be expected to become a com-ponent, or to affect the characteristics, directly or indirectly, of food packed in the container. ‘‘Affecting the charac-teristics of food’’ does not include such physical effects, as protecting contents of packages, preserving shape, and pre-venting moisture loss. If there is no migration of a packaging component from the package to the food, it does not become a component of the food and thus is not a food additive. A sub-stance that does not become a compo-nent of food, but that is used, for exam-ple, in preparing an ingredient of the food to give a different flavor, texture, or other characteristic in the food, may be a food additive.(2) Uses of food additives not requiringa listing regulation. Substances used in food-contact articles (e.g., food-pack-aging and food-processing equipment) that migrate, or may be expected to migrate, into food at such negligible levels that they have been exempted from regulation as food additives under §170.39.(f) Common use in food means a sub-stantial history of consumption of a substance for food use by a significant number of consumers.(g) The word substance in the defini-tion of the term ‘‘food additive’’ in-cludes a food or food component con-sisting of one or more ingredients.(h) Scientific procedures include those human, animal, analytical, and other scientific studies, whether published or unpublished, appropriate to establish the safety of a substance.21 CFR Ch. I (4–1–02 Edition)§170.3(i) Safe or safety means that there is a reasonable certainty in the minds of competent scientists that the sub-stance is not harmful under the in-tended conditions of use. It is impos-sible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of the use of any substance. Safety may be determined by scientific procedures or by general recognition of safety. In determining safety, the following fac-tors shall be considered:(1) The probable consumption of the substance and of any substance formed in or on food because of its use.(2) The cumulative effect of the sub-stance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet.(3) Safety factors which, in the opin-ion of experts qualified by scientific training and experience to evaluate the safety of food and food ingredients, are generally recognized as appropriate.(j) The term nonperishable processed food means any processed food not sub-ject to rapid decay or deterioration that would render it unfit for consump-tion. E xamples are flour, sugar, cere-als, packaged cookies, and crackers. Not included are hermetically sealed foods or manufactured dairy products and other processed foods requiring re-frigeration.(k) General recognition of safety shall be determined in accordance with §170.30.(l) Prior sanction means an explicit approval granted with respect to use of a substance in food prior to September 6, 1958, by the Food and Drug Adminis-tration or the United States Depart-ment of Agriculture pursuant to the Federal Food, Drug, and Cosmetic Act, the Poultry Products Inspection Act, or the Meat Inspection Act.(m) Food includes human food, sub-stances migrating to food from food-contact articles, pet food, and animal feed.(n) The following general food cat-egories are established to group spe-cific related foods together for the pur-pose of establishing tolerances or limi-tations for the use of direct human food ingredients. Individual food prod-ucts will be included within these cat-egories according to the detailed clas-sifications lists contained in E xhibit 33B of the report of the National Acad-emy of Sciences/National Research Council report, ‘‘A Comprehensive Sur-vey of Industry on the Use of Food Chemicals Generally Recognized as Safe’’ (September 1972), which is incor-porated by reference. Copies are avail-able from the National Technical Infor-mation Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, or available for inspection at the Office of the Fed-eral Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408: (1) Baked goods and baking mixes, in-cluding all ready-to-eat and ready-to-bake products, flours, and mixes re-quiring preparation before serving.(2) Beverages, alcoholic, including malt beverages, wines, distilled liq-uors, and cocktail mix.(3) Beverages and beverage bases, nonalcoholic, including only special or spiced teas, soft drinks, coffee sub-stitutes, and fruit and vegetable fla-vored gelatin drinks.(4) Breakfast cereals, including ready-to-eat and instant and regular hot cereals.(5) Cheeses, including curd and whey cheeses, cream, natural, grating, proc-essed, spread, dip, and miscellaneous cheeses.(6) Chewing gum, including all forms.(7) Coffee and tea, including regular, decaffeinated, and instant types.(8) Condiments and relishes, includ-ing plain seasoning sauces and spreads, olives, pickles, and relishes, but not spices or herbs.(9) Confections and frostings, includ-ing candy and flavored frostings, marshmallows, baking chocolate, and brown, lump, rock, maple, powdered, and raw sugars.(10) Dairy product analogs, including nondairy milk, frozen or liquid cream-ers, coffee whiteners, toppings, and other nondairy products.(11) E gg products, including liquid, frozen, or dried eggs, and egg dishes made therefrom, i.e., egg roll, egg foo young, egg salad, and frozen multi-course egg meals, but not fresh eggs. (12) Fats and oils, including mar-garine, dressings for salads, butter, salad oils, shortenings and cooking oils.Food and Drug Administration, HHS§170.3(13) Fish products, including all pre-pared main dishes, salads, appetizers, frozen multicourse meals, and spreads containing fish, shellfish, and other aquatic animals, but not fresh fish. (14) Fresh eggs, including cooked eggs and egg dishes made only from fresh shell eggs.(15) Fresh fish, including only fresh and frozen fish, shellfish, and other aquatic animals.(16) Fresh fruits and fruit juices, in-cluding only raw fruits, citrus, melons, and berries, and home-prepared ‘‘ades’’and punches made therefrom.(17) Fresh meats, including only fresh or home-frozen beef or veal, pork, lamb or mutton and home-prepared fresh meat-containing dishes, salads, appe-tizers, or sandwich spreads made there-from.(18) Fresh poultry, including only fresh or home-frozen poultry and game birds and home-prepared fresh poultry-containing dishes, salads, appetizers, or sandwich spreads made therefrom.(19) Fresh vegetables, tomatoes, and potatoes, including only fresh and home-prepared vegetables.(20) Frozen dairy desserts and mixes, including ice cream, ice milks, sher-bets, and other frozen dairy desserts and specialties.(21) Fruit and water ices, including all frozen fruit and water ices.(22) Gelatins, puddings, and fillings, including flavored gelatin desserts, puddings, custards, parfaits, pie fill-ings, and gelatin base salads.(23) Grain products and pastas, in-cluding macaroni and noodle products, rice dishes, and frozen multicourse meals, without meat or vegetables. (24) Gravies and sauces, including all meat sauces and gravies, and tomato, milk, buttery, and specialty sauces. (25) Hard candy and cough drops, in-cluding all hard type candies.(26) Herbs, seeds, spices, seasonings, blends, extracts, and flavorings, includ-ing all natural and artificial spices, blends, and flavors.(27) Jams and jellies, home-prepared, including only home-prepared jams, jellies, fruit butters, preserves, and sweet spreads.(28) Jams and jellies, commercial, in-cluding only commercially processed jams, jellies, fruit butters, preserves, and sweet spreads.(29) Meat products, including all meats and meat containing dishes, sal-ads, appetizers, frozen multicourse meat meals, and sandwich ingredients prepared by commercial processing or using commercially processed meats with home preparation.(30) Milk, whole and skim, including only whole, lowfat, and skim fluid milks.(31) Milk products, including flavored milks and milk drinks, dry milks, top-pings, snack dips, spreads, weight con-trol milk beverages, and other milk or-igin products.(32) Nuts and nut products, including whole or shelled tree nuts, peanuts, co-conut, and nut and peanut spreads.(33) Plant protein products, including the National Academy of Sciences/Na-tional Research Council ‘‘reconstituted vegetable protein’’ category, and meat, poultry, and fish substitutes, analogs, and extender products made from plant proteins.(34) Poultry products, including all poultry and poultry-containing dishes, salads, appetizers, frozen multicourse poultry meals, and sandwich ingredi-ents prepared by commercial proc-essing or using commercially processed poultry with home preparation.(35) Processed fruits and fruit juices, including all commercially processed fruits, citrus, berries, and mixtures; salads, juices and juice punches, con-centrates, dilutions, ‘‘ades’’, and drink substitutes made therefrom.(36) Processed vegetables and vege-table juices, including all commer-cially processed vegetables, vegetable dishes, frozen multicourse vegetable meals, and vegetable juices and blends.(37) Snack foods, including chips, pretzels, and other novelty snacks.(38) Soft candy, including candy bars, chocolates, fudge, mints, and other chewy or nougat candies.(39) Soups, home-prepared, including meat, fish, poultry, vegetable, and combination home-prepared soups.(40) Soups and soup mixes, including commercially prepared meat, fish, poultry, vegetable, and combination soups and soup mixes.(41) Sugar, white, granulated, includ-ing only white granulated sugar.21 CFR Ch. I (4–1–02 Edition)§170.3(42) Sugar substitutes, including granulated, liquid, and tablet sugar substitutes.(43) Sweet sauces, toppings, and syr-ups, including chocolate, berry, fruit, corn syrup, and maple sweet sauces and toppings.(o) The following terms describe the physical or technical functional effects for which direct human food ingredi-ents may be added to foods. They are adopted from the National Academy of Sciences/National Research Council na-tional survey of food industries, re-ported to the Food and Drug Adminis-tration under the contract title ‘‘A Comprehensive Survey of Industry on the Use of Food Chemicals Generally Recognized as Safe’’ (September 1972), which is incorporated by reference. Copies are available from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408:(1) ‘‘Anticaking agents and free-flow agents’’: Substances added to finely powdered or crystalline food products to prevent caking, lumping, or agglom-eration.(2) ‘‘Antimicrobial agents’’: Sub-stances used to preserve food by pre-venting growth of microorganisms and subsequent spoilage, including fungi-stats, mold and rope inhibitors, and the effects listed by the National Academy of Sciences/National Research Council under ‘‘preservatives.’’(3) ‘‘Antioxidants’’: Substances used to preserve food by retarding deteriora-tion, rancidity, or discoloration due to oxidation.(4) ‘‘Colors and coloring adjuncts’’: Substances used to impart, preserve, or enhance the color or shading of a food, including color stabilizers, color fixa-tives, color-retention agents, etc.(5) ‘‘Curing and pickling agents’’: Substances imparting a unique flavor and/or color to a food, usually pro-ducing an increase in shelf life sta-bility.(6) ‘‘Dough strengtheners’’: Sub-stances used to modify starch and glu-ten, thereby producing a more stable dough, including the applicable effects listed by the National Academy of Sciences/National Research Council under ‘‘dough conditioner.’’(7) ‘‘Drying agents’’: Substances with moisture-absorbing ability, used to maintain an environment of low mois-ture.(8) ‘‘E mulsifiers and emulsifier salts’’: Substances which modify sur-face tension in the component phase of an emulsion to establish a uniform dis-persion or emulsion.(9) ‘‘Enzymes’’: E nzymes used to im-prove food processing and the quality of the finished food.(10) ‘‘Firming agents’’: Substances added to precipitate residual pectin, thus strengthening the supporting tis-sue and preventing its collapse during processing.(11) ‘‘Flavor enhancers’’: Substances added to supplement, enhance, or mod-ify the original taste and/or aroma of a food, without imparting a char-acteristic taste or aroma of its own. (12) ‘‘Flavoring agents and adju-vants’’: Substances added to impart or help impart a taste or aroma in food. (13) ‘‘Flour treating agents’’: Sub-stances added to milled flour, at the mill, to improve its color and/or baking qualities, including bleaching and ma-turing agents.(14) ‘‘Formulation aids’’: Substances used to promote or produce a desired physical state or texture in food, in-cluding carriers, binders, fillers, plasti-cizers, film-formers, and tableting aids, etc.(15) ‘‘Fumigants’’: Volatile sub-stances used for controlling insects or pests.(16) ‘‘Humectants’’: Hygroscopic sub-stances incorporated in food to pro-mote retention of moisture, including moisture-retention agents and anti-dusting agents.(17) ‘‘Leavening agents’’: Substances used to produce or stimulate produc-tion of carbon dioxide in baked goods to impart a light texture, including yeast, yeast foods, and calcium salts listed by the National Academy of Sciences/National Research Council under ‘‘dough conditioners.’’(18) ‘‘Lubricants and release agents’’: Substances added to food contact sur-faces to prevent ingredients and fin-ished products from sticking to them.Food and Drug Administration, HHS §170.6(19) ‘‘Non-nutritive sweeteners ’’: Sub-stances having less than 2 percent of the caloric value of sucrose per equiva-lent unit of sweetening capacity. (20) ‘‘Nutrient supplements ’’: Sub-stances which are necessary for the body ’s nutritional and metabolic proc-esses. (21) ‘‘Nutritive sweeteners ’’: Sub-stances having greater than 2 percent of the caloric value of sucrose per equivalent unit of sweetening capacity. (22) ‘‘Oxidizing and reducing agents ’’: Substances which chemically oxidize or reduce another food ingredient, thereby producing a more stable prod-uct, including the applicable effect list-ed by the National Academy of Sciences/National Research Council under ‘‘dough conditioners.’’(23) ‘‘pH control agents ’’: Substances added to change or maintain active acidity or basicity, including buffers,acids, alkalies, and neutralizing agents.(24) ‘‘Processing aids ’’: Substances used as manufacturing aids to enhance the appeal or utility of a food or food component, including clarifyingagents, clouding agents, catalysts, floc-culents, filter aids, and crystallization inhibitors, etc.(25) ‘‘Propellants, aerating agents, and gases ’’: Gases used to supply force to expel a product or used to reduce the amount of oxygen in contact with the food in packaging.(26) ‘‘Sequestrants ’’: Substanceswhich combine with polyvalent metal ions to form a soluble metal complex,to improve the quality and stability ofproducts.(27) ‘‘Solvents and vehicles ’’: Sub-stances used to extract or dissolve an-other substance.(28) ‘‘Stabilizers and thickeners ’’:Substances used to produce viscous so-lutions or dispersions, to impart body,improve consistency, or stabilize emul-sions, including suspending and body-ing agents, setting agents, jellying agents, and bulking agents, etc.(29) ‘‘Surface-active agents ’’: Sub-stances used to modify surface prop-erties of liquid food components for a variety of effects, other than emulsi-fiers, but including solubilizing agents, dispersants, detergents, wettingagents, rehydration enhancers, whip-ping agents, foaming agents, and de-foaming agents, etc. (30) ‘‘Surface-finishing agents ’’: Sub-stances used to increase palatability, preserve gloss, and inhibit discolora-tion of foods, including glazes, polishes, waxes, and protective coatings. (31) ‘‘Synergists ’’: Substances used to act or react with another food ingre-dient to produce a total effect different or greater than the sum of the effects produced by the individual ingredients. (32) ‘‘Texturizers ’’: Substances which affect the appearance or feel of the food. [42 FR 14483, Mar. 15, 1977, as amended at 47 FR 11835, Mar. 19, 1982; 53 FR 16546, May 10,1988; 54 FR 24896, June 12, 1989; 60 FR 36595,July 17, 1995]§170.6O pinion letters on food addi-tive status. (a) Over the years the Food and DrugAdministration has given informal written opinions to inquiries as to the safety of articles intended for use as components of, or in contact with,food. Prior to the enactment of the Food Additives Amendment of 1958 (Pub. L. 85–929; Sept. 6, 1958), theseopinions were given pursuant to sec-tion 402(a)(1) of the Federal Food, Drug, and Cosmetic Act, which reads in part: ‘‘A food shall be deemed to be adulterated if it bears or contains anypoisonous or deleterious substance which may render it injurious to health ’’.(b) Since enactment of the Food Ad-ditives Amendment, the Food and Drug Administration has advised such in-quirers that an article:(1) Is a food additive within the meaning of section 201(s) of the act; or (2) Is generally recognized as safe (GRAS); or (3) Has prior sanction or approval under that amendment; or (4) Is not a food additive under the conditions of intended use.(c) In the interest of the public health, such articles which have been considered in the past by the Food and Drug Administration to be safe under the provisions of section 402(a)(1), or to be generally recognized as safe fortheir intended use, or to have prior sanction or approval, or not to be food。