FCC 美国食品、化学品法典


一、 概述
   美国食品化学品法典(Food Chemicals Codex,简称FCC)是由美国国家科学院药品研究院(Institute of Medicine of the National Academy of Sciences)下属的食品与营养品委员会(Food and Nutrition Board)负责制订的关于食品化学品标准的综合性集成,是美国食品与药品管理局(Food and Drug Administration,简称FDA)以及许多国际食品检验权威机构用于鉴定食品化学品等级的重要依据。第一版FCC于1966年问世,在此之前FDA一直通过法规与非正式声明等形式公布其对食品化学品以及食品添加剂化学品的安全卫生要求,但是对于食品化学品的制造商与用户来讲,这些分散的法规与声明远远不能满足他们在推广、采购食品化学品时的特定要求。因此,FCC的问世使得加工食品制造商、食品技术人员、食品质量控制化学师、研究人员等各方在涉及到食品安全方面的问题时有了参考依据。
   FCC的最新版本提供:
   (1) 关于美国境内食品化学品的质量与纯度方面的标准;
   (2) 关于食品添加剂、GRAS物质、以及任何其他食品原材料方面的信息;
   (3) 915种食品化学品的标准专论。


   二、 适用范围
   FCC收录的规格与标准只针对经美国食品与药品管理局(FDA)认可的、通过GMP认证的、用于食品及食品加工过程中的食品物质。
In keeping with current practice, analytical methods for flavor chemicals have been revised from mostly wet-chemical procedures to gas chromatography.
Infrared spectra are provided for identification of essential oils, flavor chemicals, and a variety of other substances.
New lower limits on contaminants
New quantitative procedures to measure low lead levels.
Reorganization of material on general analytical and test procedures for easier access.
A new section for food specialists interested in suggesting analytical methods to the FCC committee.
The Fourth Edition reflects many of the changes in science and manufacturing since the publication of Third Edition.
Where feasible, FCC specifications are now harmonized with those of other standard setters, in particular the FAO/WHO Compendium of Food Additive Specifications.


   三、 结构
   全书共分5大部分:
   1. 关于FCC规格、检验与化验的总条款与要求。(GENERAL PROVISIONS AND REQUIREMENTS APPLYING TO SPECIFICATIONS, TESTS, AND ASSAYS OF THE FOOD CHEMICALS CODEX)
   2. 专论。(MONOGRAPHS)
The Fourth Edition updates the field, retaining 915 chemical monographs and adding 52 new monographs. Each monograph provides a physical description of the substance and its use in foods, lists its purity requirements, describes the appropriate tests to determine compliance, and provides packaging and storage guidelines.
   3. 调味品用化学制品。(FLAVOR CHEMICALS)
   4. 红外光谱。(INFRARED SPECTRA)
   The infrared absorption spectra contained in this section are provided in conjunction with the requirement for Identification as specified for a number of substances in this edition.
   This section contains reproductions of infrared spectra for three major groups of substances: essential oils, flavor chemicals, miscellaneous other substances. Most of the spectra were prepared especially for use in the Food Chemicals Codex by the Technical Committee of the Flavor and Extract Manufacturers Association. It was not feasible for them to be recorded in a single uniform format, however. Consequently, spectra of several shapes and sizes, contributed by different laboratories using various types of infrared spectro-photometers, will be found. Within each series, however, spectra of the same format have been grouped together in uniform subseries. An alphabetical listing ,with page references, is provided at the beginning of each series to aid the reader in locating the desired spectrum.
   5. 检验与化验。(GENERAL TESTS AND ASSAYS)

   四、 法律地位
   问世以来,FCC得到国际范围的广泛认可,食品化学品的制造商、销售商以及用户将FCC中的标准作为他们销售/购买合约的基础。1966年7月FDA专员James L. Goddard签署了一份文件,认可并赋予了FCC在美国”准法律”的地位。文件声明,”FDA将FCC中的标准视作是the FDA will regard the specifications in the Food Chemicals Codex as defining an “appropriate food grade” within the meaning of Sec.121.101(b)(3) and Sec. 121.1000(a)(2) of the food additive regulations, subject to the following qualification: this endorsement is not construed with requirements of Acts of Congress or with regulations and rulings issued by the Food and Drug Administration under authority of such Acts.”此外,FCC中的部分规格被美国联邦法规(Code of Federal Regulations,简称CFR)引用,以定义特定的安全成份。
   在加拿大,加拿大食品与药品法规(Canadian Food and Drug regualtions)中Section B.01.045(b)条款正式认可FCC及其补编作为其食品添加剂标准的参照。新西兰政府的食品法规中,也将符合FCC要求作为其食品添加剂标准的唯一参照。在澳大利亚,国家食品管理机构也经常以FCC标准作为其检验食品添加剂的唯一依据。

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