These General Notices provide in summary form, a commentary on how the specifications of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) are to be interpreted. Where, occasionally, exceptions to the General Notices are necessary, the language in the individual Specifications or in the General Methods of the Guide to JECFA Specifications, FAO Food and Nutrition Paper (FNP) 5, revision 2, 1991, takes precedence and specifically indicates the directions or intent. Otherwise, these General Notices apply.
Component Parts of Individual Specifications
1. Substances Other than Enzyme Preparations
The specifications for each food additive or group of additives other than enzyme preparations generally consist of the following major sections: Title, Synonyms, Definition, Description, Functional uses, Characteristics, Tests and Method of Assay. These sections are discussed below in the order in which they occur in the specifications.
TITLE |
The title selected for individual specifications is the name of the additive or group of additives which, in the view of JECFA, most appropriately identifies the substance or substances defined by the specifications. The name used for the title is not necessarily the chemical name of the additive, nor the name used by the International Union of Pure and Applied Chemistry (IUPAC). Furthermore, the titles of the specifications in this document may differ from the titles used in the toxicological monograph, which sometimes apply to large groups of additives (e.g. acetates, phosphates) for which specifications are established separately. See also the Guidelines for Designating Titles for Specifications Monographs, part 2.3.4, report of the 33rd meeting of JECFA, WHO Technical Report Series No. 776, 1989. |
TENTATIVE |
In cases where the specification has been designated incomplete, the status TENTATIVE is given in the upper left hand corner of the specification, and the reason, if known, given in this section. |
This section informs the user at which JECFA meeting and year the specification was prepared together with a reference to where it was published. In the case of older specifications, such as those published in various NMRS publications, which are out of print, the FNP 52 (1992), i.e. the Compendium is also referenced. If applicable, information is given of superseded specifications. | |
SYNONYMS |
Listed in this section are names, acronyms, and abbreviations under which a given additive is widely known, other than those used for the Title or Chemical name (see below). The International Numbering System (INS) number which was adopted by the Codex Alimentarius Commission and the USA FD & C number (for colours) are also listed here where applicable. Common or trivial names may be included. However, registered trade names are not used as titles or synonyms. |
DEFINITION |
This section defines the additive. The Chemical name, Chemical formula, Structural formula, Formula weight and Assay are usually given. Where appropriate, the Chemical Abstracts Service (C.A.S.) number is given. For some substances, such as those of natural origin or those with mixed components, detailed descriptions, are given as necessary to define the additives. |
CHEMICAL NAMES |
Where an IUPAC or IUB (the International Union of Biochemistry) name exists for an additive (whether systematic name or recommended common name), it is listed first among the chemical names. Other chemical names may also be provided. |
CHEMICAL FORMULA & STRUCTURAL FORMULA |
These are provided where known or where generally accepted, for the additive itself, or for the active component(s) of the additive. For technical reasons some structural formulae are provided in the anhydrous form, i.e. without molecules of crystal water; the chemical formulae include all hydrates. |
FORMULA WEIGHT |
The term "Formula weight" is used throughout in preference to Molecular weight and the IUPAC recommendation of Relative molecular mass, since the term will be applicable in general to any substance having a chemical formula - compound or element - regardless of the nature of its constituent particles -atoms, ions, molecules, or extended arrays of covalently linked atoms. Formula weights (as well as gravimetric factors specified in analytical procedures) are calculated from values given in the 1987 IUPAC Table of Standard Atomic Weights, which are based on the carbon-12 scale. |
ASSAY |
A quantitative assay requirement is provided where applicable to indicate the minimum acceptable content, or acceptable range, of the principal chemical component(s) of an additive. When an upper limit is not given, the assay should show the equivalent of not more than 100.5%. Sometimes the minimum acceptable content or the range of the constituent relating to the content of the component of the additive is given. |
DESCRIPTION |
Information pertaining to physical appearance and other properties such as stability and odour is provided in this section, as well as special conditions in usage and/or storage. Such information should not be interpreted as rigidly as measurable characteristics and does not constitute standards or tests of identity or purity. |
FUNCTIONAL USES |
Functional uses are provided to indicate the primary and secondary recognized technological application(s) of the additive in foods or in food processing. The statement, however, is not intended to indicate that the additive has no other utility than the functional uses listed. |
CHARACTERISTICS |
|
IDENTIFICATION |
Identification tests for a substance are not all-inclusive and do not, of themselves, establish absolute proof of identity. They serve, however, to generally identify the substance and if the substance fails these tests, it can be assumed that the substance is not what it purports to be. |
PURITY |
Tests for trace impurities as well as for other parameters, such as physical properties, are based on knowledge of the manufacturing process at the time the specifications are prepared. Limits for such constituents are provided at levels that are consistent with good manufacturing practice and are deemed to be safe and otherwise unobjectionable under conditions in which the additive is customarily used (including consideration of the Acceptable Daily Intake established for the additive by JECFA). |
TESTS |
Procedures and specific conditions of Identification Tests and Purity Tests are presented in detail in this subsection whenever there is no General Methods reference. Use of italics refer to the Guide to Specifications, Food and Nutrition Paper no. 5 Rev. 2 (1991). However, in cases where the procedure can be given in brief, it is presented in the section on Characteristics. |
METHOD OF ASSAY |
Assay methods which are given include detailing the principle involved, listing the apparatus and reagents, detailing the analytical procedure and the method of calculating results. Where possible, however, assay methods refer, in italics, to specific procedures in the General Methods. |
2.Enzyme Preparations
Enzyme preparations used in food processing whether from animal, vegetable or microbial sources have to meet the general specification, "General Specifications for Enzyme Preparations used in Food Processing" (see Annex 1). In addition, enzyme preparations have to meet individual specifications which generally consist of the following sections discussed below in the order in which they occur:
TITLE |
The name of the active principle(s) which most accurately characterizes the preparation defined by the specification. The name used for the title is not necessarily the systematic name recommended by the Nomenclature Committee of the IUB. Where appropriate, the sources appear as a component of the title. |
SYNONYMS |
Listed in this section are names and abbreviations under which the preparation is widely known, other than those used for the Title or Systematic Names (see below). The INS number is also listed where applicable. |
SOURCE |
Described in this section are animal tissues, plant material or microbial sources used. Also given are species, strains or variants, strain numbers and plasmid numbers if from recognized culture collections/depositories (e.g., ATCC) where appropriate. In the case where the source organism is derived from genetic manipulation, a description of the derivation is given. This includes the identity of the host organism and characterization of all introduced DNA. |
ACTIVE PRINCIPLES |
Listed in this section are principle enzyme activities demonstrated by the preparation. IUB's recommended names are generally listed first. Other names may also be provided. |
SYSTEMATIC NAMES AND NUMBERS |
Where IUB's systematic name and enzyme number exist, they are listed for each active principle. |
REACTIONS CATALYZED |
Listed in this section are the specific substrates acted upon, the reactions catalyzed and the products formed by the active principles. |
SECONDARY ENZYME |
Listed here are minor enzyme activities which may be present in the enzyme preparations and influence the applications. |
DESCRIPTION |
Information pertaining to physical appearance, solubility in water and in organic solvents and other information such as manufacturing process, diluents, carriers, stabilizers, preservatives, immobilization agents is presented here. |
FUNCTIONAL USES |
Listed in this section are principal and secondary technological applications of the enzyme preparation in food or in food processing. |
GENERAL SPECIFICATIONS |
A statement that all preparations have to conform to the "General Specifications for Enzyme Preparations used in Food Processing" is given here. |
CHARACTERISTICS |
Assay methods for enzyme activities are provided here as a means of identifying the active principles. Where applicable, assay methods will refer to General Methods. Also listed are tests for trace impurities resulting from, for example, leakage of carriers and immobilization agents other than those noted by the General Specifications. |
REFERENCES |
IUPAC, Nomenclature of Inorganic Chemistry (Recommendations 1990), 1990, Blackwell Scientific Publications. IUPAC, Nomenclature of Organic Chemistry (Sections A,B,C,D,E,F and H, 1979 Edition), 1979, Pergamon Press. IUB, Enzyme Nomenclature (Recommendations 1984), 1984, Academic Press. |
1. The term "Specifications" or "JECFA Specifications" refers to specifications of food additives prepared by JECFA.
2. The designation "TENTATIVE" on the upper left hand corner of the monographs means the Specifications presented are considered to be incomplete. At its 23rd Session in 1979, JECFA decided to use the qualifier "Tentative" to describe those instances where the technical data was insufficient to adequately characterize the purity of a substance, or its identity, assay method or the minimum acceptable content or acceptable range of the principal ingredient. Such technical deficiencies may be indicated immediately below the title of the monograph, or in the JECFA meeting report (WHO Technical Report Series). Previous to the 23rd Session, JECFA had applied this designation also to specifications of substances for which the toxicological evaluation had resulted in a "temporary ADI" or "no ADI". This is no longer done.
3. International Numbering System numbers ("INS No. XXX") were adopted by FAO/WHO at the 18th Session of CAC in July, 1989. Where these numbers are available, they are listed as synonyms to the title name of individual additives. The list of INS numbers is open and has been updated every two years by CAC. Therefore readers are expected to check the updated version of the list published by CAC when these numbers are used.
4. For the definition and comments of following terms, refer to the General Notices section of the General Methods (Guide to JECFA Specifications, FNP 5/Rev.2, 1991):
"Analytical Samples", "Analytical Standards", "Apparatus", "Blank Tests", "Constant Weight", "Desiccants and Desiccates", "Indicators", "Methods and Procedures", "Odourless", "Reagents", "Significant Figures", "Solubilities", "Solutions", "Temperatures", "Turbidity", "Vacuum", "Water", "Water-bath".
5. Weights and Measures
The metric system of weights and measures is used. The units and abbreviations commonly used are as follows:
m = meter |
µl = microliter (10-6 L) |
cm = centimeter (10-2 m) |
h = hour(s) |
mm = millimeter (10-3 m) |
min = minute(s) |
µm = micrometer (10-6 m), formerly µ (microns) |
sec = second(s) |
nm = nanometer (10-9 m), formerly mµ (millimicrons) |
o = degrees Celsius (centigrade) |
g = gram |
N = normality (gram equivalent per liter) |
kg = kilogram (103 g) |
M = molarity (mole per liter) |
mg = milligram (10-3 g) |
cm-1 = wave number |
µg = microgram (10-6 g) |
mmHg = mm of mercury, unit of pressure |
ng = nanogram (10-9 g) |
Rf = ratio distance spot moved/distance solvent moved |
L (or l) = liter |
rpm = revolution per minute |
ml = milliliter (10-3 L) |
bar = unit of pressure (kgm-1sec-2) |
6. Abbreviations commonly used in this publication are as follows:
ADI = Acceptable Daily Intake |
IUB = International Union of Biochemistry |
AOAC = AOAC INTERNATIONAL, formerly the Association of Official Analytical Chemists |
IUPAC = International Union of Pure and Applied Chemistry |
ASTM = American Society for Testing Materials |
JECFA = Joint FAO/WHO Expert Committee on Food Additives |
ATCC = American Type Culture Collection |
i.d. = internal diameter |
CAC = Codex Alimentarius Commission |
o.d. = outer diameter |
CAS = Chemical Abstracts System |
IR = Infrared |
C.I. = Colour Index |
G(L)C = Gas (liquid) chromatography |
EC = Enzyme Commission of IUB (for systematic nomenclature and numbering system of enzymes) |
(HP)LC = (High Performance) Liquid chromatography |
FD&C = Food, Drug and Cosmetic |
meq = milli equivalent |
FNP = FAO Food and Nutrition Paper |
MW = Molecular weight |
FNS = FAO Food and Nutrition Series |
soln = solution |
NMRS = FAO Nutrition Meeting Report Series |
TLC = Thin Layer Chromatography |
FCC = Food Chemicals Codex (USA) |
TRS = WHO Technical Report Series |
INS = International Numbering System (for food additives) |
UV = Ultraviolet |
ISO = International Organization of Standardization |