Food safety and quality
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ABOUT THE DATA

Contents 

  • Background 

  • About JECFA Specifications 

  • JECFA Specifications and the Codex System 

  • Format of Specifications 

  • Weights and Measures 

  • Abbreviations 

 

BACKGROUND 

 

The Joint FAO/WHO Expert Committee on Food Additives (JECFA) was established following the recommendation of the first Joint FAO/WHO Conference on Food Additives that the two organizations collect and disseminate information on food additives (Joint FAO/WHO Conference on Food Additives, Report. FAO Nutrition Meetings Report Series, No. 11; WHO Technical Report Series, No. 107, 1956).  JECFA was first convened in 1956, and has met annually, with a few exceptions, since that time.

As part of its work, JECFA establishes specifications of identity and purity for food additives.  These were originally published in FAO Nutrition Meetings Reports Series (NMRS), the WHO Technical Report Series (TRS) or as FAO Food and Nutrition Papers (FNP).  However many of these are now out of print, and the first edition of the Compendium of Food Additive Specifications (FNP 52) was published in 1992 in order to consolidate all of the then current JECFA specifications into a single publication.  Since 1992, thirteen separate Addenda to this Compendium have been published which contain both newly established specifications and revisions to earlier specifications.

A second edition of the Compendium has now been published to replace the earlier edition and it incorporates all the additions and revisions made since 1992, up to and including those contained in Addendum 13. Many additive specifications have been revised two or more times as new information or circumstances require. The specifications contained in the present database are the most recent revision for any given additive.

All specifications are, however, subject to future review and revision as part of JECFA’s continuing work. New and revised specifications are published as soon as practicable after the JECFA meetings when these were considered, and will be made available online on this website.

 

ABOUT JECFA SPECIFICATIONS 

 

The specifications of identity and purity established by JECFA are intended to ensure that the Committee’s safety evaluations apply, with a high degree of confidence, to all food additives  manufactured according to those specifications.  In setting specifications, the Committee also takes into account the need to encourage good manufacturing practice and to maintain the quality of additives on the market, noting that these considerations may add to the assurance of safety that the Committee is seeking as part of its risk assessment function.

JECFA’s specifications are also intended to set manufacturing standards for food additives traded in international commerce either as such, or incorporated in food products.  In some cases, JECFA specifications will differ from specifications developed by other national and international organizations. JECFA’s safety evaluations can, however, be taken to apply to additives complying with these other specifications, provided that the additives are of equal or higher purity than those required by the JECFA specifications, and provided that the test criteria in the JECFA specifications are met.

The formulation of satisfactory specifications requires detailed information to be made available to the Committee on the method of manufacture of the additive, including information on raw materials and on its chemical characterization.  

Specifications may be revised where there is new information available on methods of manufacture or on the characteristics of the product, or where changes or revisions in analytical methods are needed.  Such changes may also prompt a review of the safety evaluation.  Similarly, a review of the specifications may be needed if the safety evaluation is reconsidered.

In some cases, there may be insufficient information for the Committee to elaborate what it regards as fully acceptable specifications.   The Committee may then decide to publish the incomplete specifications, but with a designation of ‘Tentative’.  In such cases the Committee will also state what additional information is required, and set a date by which this must be provided.  The Committee will reconsider the specifications once the necessary information has been received, and if it considers that the information is sufficient, it will remove the ‘Tentative’ designation.  If, however, the information is still deficient, or if no information has been provided by the due date, the specifications will be withdrawn.

JECFA SPECIFICATIONS AND THE CODEX SYSTEM 

 

The respective roles of JECFA and the Codex Committee on Food Additives and Contaminants (CCFAC) have been extensively discussed in recent years in the context of the Codex risk analysis framework.  In this context, JECFA is regarded as the expert risk assessment body on additives, contaminants and natural toxicants in food, with CCFAC fulfilling the corresponding risk management role.  Thus, CCFAC endorses maximum use levels only for those additives for which JECFA (i) has established specifications of identity and purity and (ii) has completed a safety assessment or has performed a quantative risk assessment

 

CCFAC also makes recommendations to the Codex Alimentarius Commission on the possible adoption of JECFA specifications as Codex Advisory Specifications. National food control authorities use Codex Advisory Specifications for enforcement purposes, and for ensuring that additives in international commerce meet agreed standards. National governments may also draw on Codex Advisory Specifications when developing their own regulatory standards. 

FORMAT OF SPECIFICATIONS 

 

Additives other than enzyme preparations and flavouring agents 

JECFA specifications for food additives other than enzymes and flavouring agents normally include the headings listed below, which are given in the order in which they appear in the specifications.  Note also that aluminium lakes of colouring matters must comply with the Aluminium Lakes of Colouring Matters - General Specifications in this database.

 

TITLE 

 

The TITLE includes the name selected for the individual additive.  This is the name that, in the view of JECFA, most appropriately identifies the substance or substances specified. It will normally correspond with the name given to the substance that was subject to safety evaluation, although in some cases there may be discrepancies, as when the substance is a member of a group that has been evaluated collectively, e.g. the phosphates.

The TITLE also indicates those cases where the specifications have been designated as ‘Tentative’.  This designation is used when the Committee regards the information on the additive as insufficient to elaborate fully acceptable specifications, and in such cases the specifications will include an indication of the further information required.

 The TITLE further includes a statement referring to the JECFA meeting at which the specifications were prepared.  In cases where the specifications supersede earlier specifications, reference will also be made to these earlier specifications.  The statement also includes a reference to the Committee’s latest safety evaluation of the substance.

SYNONYMS 

Listed in this section are names, acronyms, and abbreviations under which the substance is widely known, other than those used in the TITLE or in the Chemical name(s) (see below).  The Codex Alimentarius International Numbering System (INS) number and the USA FD&C number (for colours) are also included here where applicable.  Common or trivial names may also be included as synonyms, but registered trade names are not used.

DEFINITION 

This section normally includes information on the raw materials used in the manufacture of the additive, together with a brief description of the salient points of the manufacturing method. Proprietary manufacturing information may be excluded provided that this has been agreed with the JECFA Secretariat. For some substances, for example those of natural origin or those containing a number of different components, more detailed information, including manufacturing and purification methods, is given as necessary.  The possible presence of other substances included in commercial additive preparations - for example anticaking agents and antioxidants – may also be noted.

Chemical name(s) 

Where an IUPAC or IUBMB name exists for an additive, this is generally included under this heading and listed first among the chemical names, whether or not it is the systematic name or the recommended common name.

CAS number(s) 

The Chemical Abstract Service registry number(s) (CAS number(s)) for the major component(s) of the substance is normally given here.  CAS numbers for substances that are encompassed by the specifications, e.g. specific isomeric forms of the main component(s), may also be included along with suitable descriptions.

Chemical formula(e) 

The chemical formula(e) of the major component(s) of the additive is given here.

Structural formula(e) 

The structural formula(e) corresponding to the major component(s) given under the previous heading is given here, as appropriate.

Formula weight 

Formula weights are quoted in JECFA specifications in preference to molecular weights in order to avoid the improper use of the latter form.  Formula weights are calculated from values quoted by IUPAC in its Table of Standard Atomic Weights.

Assay 

A quantitative assay requirement is provided here, where applicable, to indicate the minimum acceptable content, or maximum acceptable content range, of the principal functional component(s) of the additive. 

DESCRIPTION 

Information on physical appearance and other significant properties, e.g. stability and odour, is provided in this section, and will normally include any special conditions required for the storage and use of the additive.  Such information is by its nature descriptive and should not be interpreted as rigidly as, for example, the requirements under the DEFINITION section. For safety reasons, descriptions of the taste of a substance are not included.

FUNCTIONAL USES  

Functional uses are included in specifications to indicate the technological functions of the additive as used in foods or in food processing.  The stated functional uses are not necessarily an exhaustive list, however, and an additive may have uses other than those listed.  The functional uses are intended to conform as far as possible to the harmonized Codex Alimentarius International Numbering System (INS) list of functional uses.  Where this is not possible, an unlisted term may be used, and in these cases the new term will be referred for further discussion by the Codex Committee on Food Additivesand Contaminants (CCFAC) as part of its consideration of the possible adoption of the specifications as Codex Advisory Specifications.

CHARACTERISTICS 

IDENTIFICATION 

Identification criteria are generally qualitative and provide part of the means for defining the specified additive.  Such criteria typically include solubility in water, solubility in organic solvents, colour reactions, absorption spectra, and pH values.

Where possible, test methods refer to procedures detailed in Volume 4. If the test procedure is not included in the published tests given in Volume 4, it will be included here provided it can be described briefly.  Otherwise the details will be set out in the TESTS section under the heading IDENTIFICATION TESTS.

PURITY 

Items relating to the purity of the additive, such as limits on impurities and, where appropriate, criteria for microbiological purity, are included under this heading.  Limits for trace impurities and for other parameters relating to purity, for example physical properties, are based on the information available on the manufacturing process at the time the specifications were prepared.  Limits are set to be consistent with good manufacturing practice and to help provide an assurance of safety, taking into account the use of the additive.

Where possible, test methods refer to procedures detailed in Volume 4. If the test procedure is not included in the published tests given in Volume 4, it will be included here provided it can be described briefly.  Otherwise the details of the test will be set out in the TESTS section under the heading PURITY TESTS.

TESTS 

IDENTIFICATION TESTS 

This section describes in full those test procedures referenced in the CHARACTERISTICS section under the heading IDENTIFICATION. The basic principle behind the analytical method is normally included in the narrative, in addition to details of the apparatus and reagents, the analytical procedure, and the method for calculating results.

PURITY TESTS 

This section describes in full those test procedures referenced in the CHARACTERISTICS section under the heading PURITY. The basic principle behind the analytical method is normally included in the narrative, in addition to details of the apparatus and reagents, the analytical procedure, and the method for calculating results.  Suppliers of reference standards are named in the text.

METHOD OF ASSAY

The Method of Assay includes a description of the principle of the method, a list of the apparatus and reagents required, details of the analytical procedure, and the method for calculating results.  Where possible, these are described by reference to procedures listed in Volume 4.  Suppliers of reference standards are named in the text.

 

 

 

Enzyme preparations 

Enzyme preparations used in food processing, whether from animal, vegetable or microbial sources, must comply with the General Specifications and Considerations for Enzyme Preparations used in Food Processing.  In addition, enzyme preparations must meet the specifications criteria contained in the individual specifications monographs  These normally include the headings listed below, which are given in the order in which they appear in the specifications.

TITLE 

The TITLE of the specifications monograph includes the name given to the enzyme preparation.  This will normally correspond to the name of the enzyme activity or activities that most accurately characterize the preparation.  Where appropriate, the source material from which the preparation is derived is also included, so that the name will normally take the form [Principal enzyme activity/activities] from [Systematic IUBMB name of source organism][Description of genetic modification process where applicable]. The name may or may not be the same as the systematic name recommended by the IUBMB Enzyme Commission Nomenclature Committee.

The TITLE also indicates those cases where the specifications have been designated as ‘Tentative’.  This designation is used when the Committee regards the information on the enzyme preparation as insufficient to elaborate fully acceptable specifications, and in such cases the specifications will include an indication of the further information required and the date by which this must be submitted.

The TITLE further includes a statement referring to the JECFA meeting at which the specifications were prepared. In cases where the specifications supersede earlier specifications, reference will also be made to these earlier specifications. The statement also includes a reference  to the Committee’s latest safety evaluation of the substance defined by the specifications.

SYNONYMS 

This section includes names and abbreviations under which the preparation is widely known, other than those used in the TITLE.  The INS number is also listed where applicable.

SOURCES 

This section identifies the animal, plant or microbial sources used to derive the enzyme preparation.  The species, strains or variants, strain numbers and plasmid numbers, if from recognized culture collections/depositories (e.g. ATCC), are also given where appropriate.  In cases where the source organism has been derived using recombinant DNA technology, a description of this process, including the identity of the host organism, is included.

 Active principles

Listed in this section are the principal enzyme activities exhibited by the preparation.  IUBMB-recommended names are preferred and will generally be listed first, but other names may also be included.

Systematic names and  numbers

Where IUBMB systematic names and Enzyme Commission (EC) enzyme numbers exist, these are listed for each active principle.  CAS numbers are also given here where these exist.

Reactions catalysed

This section includes a description of the substrates acted on by the enzyme preparation, the reactions catalysed, and the resultant products. 

 

 

Secondary enzyme activities

Listed here, if appropriate, are minor enzyme activities that may be present in the enzyme preparation. 

DESCRIPTION 

Information on physical appearance is provided in this section, together with other information such as solubility in water, solubility in organic solvents, and relevant details of the manufacturing process. Information on the diluents, carriers, stabilisers, preservatives and immobilization agents that may be present in commercial products is also included in this section. 

FUNCTIONAL USES  

This section gives the principal and secondary technological function(s) of the enzyme preparation as used in foods or in food processing. 

GENERAL SPECIFICATIONS  

This gives a statement to the effect that all preparations have to conform to the General Specifications and Considerations for Enzyme Preparations used in Food Processing found in the next section to this Introduction.

CHARACTERISTICS 

IDENTIFICATION 

The enzyme activities of the active principles are listed here.  Also listed here are criteria for trace impurities resulting from, for example, the use of carriers and immobilization agents, other than those noted in the General Specifications and Considerations for Enzyme Preparations used in Food Processing  (see the next section of this Introduction).

Where possible, the assay methods refer to procedures detailed in Volume 4.  Otherwise the details of the test are set out in the section on TESTS.

TESTS 

Assay methods for the enzyme activities of the active principles listed in the CHARACTERISTICS section under the heading IDENTIFICATION are included here in cases where this cannot be done by reference to Volume 4.  These describe the principle of the method, apparatus and reagents required, and give details of the analytical procedure and  the method of calculating results.  Suppliers of standards for test materials are named in the text.

 

TESTS AND ASSAYS

 

Descriptions and terms applying to the tests and assays in JECFA specifications include the following:  

Analytical Samples 

The quantity of the analytical sample to be used is usually indicated in tests and assays.  Unless otherwise specified, the quantity used may deviate by 10% from that stated.  All quantitative determinations should be conducted on duplicate test portions and in these cases, the amount actually taken should be accurately weighed or measured and the result of the analysis calculated on this exact quantity. When substances are to be "accurately weighed" in a test or assay, the weighing is to be performed in such manner as to limit the error to ±0.1% or less.  Quantities smaller than 100 mg should be weighed to the nearest 0.1 mg.

Analytical Standards 

Certain procedures (e.g. chromatographic and spectrophotometric instrumental analyses, and antibiotic and enzyme assays) require the use of analytical reference standards.  Where suitable standards are available from recognized international bodies, these are specified.  In the absence of international standards, it has been necessary in some cases to specify the use of reference standards available from such organizations as the British Pharmacopoeia (BP), Food Chemicals Codex (FCC), National Formulary (NF) of the United States, or the United States Pharmacopeia (USP). The addresses of these organizations may be found in the individual monographs.

Apparatus 

With the exception of volumetric flasks and other exact measuring or weighing devices, directions to use a certain size or type of container or other laboratory apparatus are intended only as recommendations, unless otherwise specified.  In certain unavoidable cases, the Committee has found it necessary, for accurate description, to use a proprietary name to indicate a certain type of instrument (e.g. spectrophotometer or chromatograph) that is known to give satisfactory results in a particular analytical procedure.  However, such a listing in specifications does not necessarily constitute endorsement of the specified instrument by the Committee, nor does it imply that similar instruments from other sources cannot be used with equal or better satisfaction, or that they are of lesser quality or utility than the instrument named.

Blank Tests 

The instruction to "perform a blank determination", or similar instructions, indicates that a reagent blank determination should be conducted, in which the same quantities of the same reagents are used, and the same procedure is repeated in every detail, except that the substance being tested is omitted. 

Constant Weight 

A direction that a substance is to be "dried to constant weight" means that the drying should be continued until two consecutive weighings differ by not more than 0.5 mg per g of sample taken, the second weighing to follow an additional hour of drying time at the temperature specified.  The direction to "ignite to constant weight" means that the ignition should be continued at a temperature of 450°-550°, unless otherwise specified, until two consecutive weighings do not differ by more than 0.5 mg per g of sample taken, the second weighing to follow an additional 30 min ignition period, depending upon the nature of the sample tested.

Desiccants and Desiccators 

The expression "in a desiccator" means the use of a tightly closed container of appropriate size and design in which a low moisture content can be maintained by means of a suitable desiccant.  Preferred desiccants include, but are not limited to, anhydrous calcium chloride, magnesium perchlorate, phosphorus pentoxide, and silica gel.

Indicators 

The quantity of an indicator solution used should be 0.2 ml (approximately 3 drops), unless another quantity is specified. 

Odourless 

The term "odourless" applies to the examination, after exposure to air for 15 min, of between 1 and 25 g of the substance that has been transferred from the original container to an open evaporating dish of about 100 ml capacity. 

Reagents 

Reagents used in tests and assays should be of appropriate analytical grade and should contain no interfering impurities. 

Significant Figures 

Where tolerance limits are expressed numerically, the values are considered to be significant to the number of digits shown. Thus, "not less than 99.0%" means 99.0% but not 99.00%.  Values obtained in tests and assays should be rounded off to the nearest indicated digit according to the commonly used practice of rejecting or increasing numbers less than or greater than 5.  For example, a requirement of not less than 96.0% would be met by a result of 95.96% but not by a result of 95.94%.  When the digit to be dropped is exactly 5, the value should be rounded off to the closest even digit.  Thus, both 1.4755 and 1.4765 would be rounded off to 1.476. When a range is stated, the upper and lower limits are inclusive, so that the range consists of the two values themselves, properly rounded off, and all intermediate values between them.

Solubilities 

Solubilities, as specified in the CHARACTERISTICS sections of monographs, are to be interpreted according to the following descriptive terms:

Descriptive Term        Parts of Solvent required for 1 part of Solute

Very soluble        Less than 1

Freely soluble        From 1 to 10

Soluble        From 10 to 30

Sparingly soluble        From 30 to 100

Slightly soluble        From 100 to 1,000

Very slightly soluble        From 1,000 to 10,000

Practically insoluble or insoluble        More than 10,000

Unless otherwise specified, the solubility test is to be conducted after transferring a sample into the specified solvent and shaking for no less than 30 sec and no more than 5 min. 

Solutions 

All solutions, unless otherwise specified, are to be prepared with distilled or deionized water. Directions for the preparations of "TS" (test solutions), "TSC" (colorimetric solutions) and "PbT" (lead free solutions) are provided in Volume 4.  Where volumetric solutions of definite concentration are directed to be used in quantitative determinations, standardized solutions of other concentrations may be employed, unless otherwise specified, if allowance is made for the calculation factor and if the error of measurement is known not to be increased significantly thereby.  Unless otherwise specified, it should be understood that concentrations of solutions prepared from liquids only are expressed in terms of volume in volume (v/v), and solutions of solids in liquids are expressed in terms of weight in volume (w/v).  Thus, expressions such as "1 in 10" or "10%" mean that 1 part by volume of a liquid, or 1 part by weight of a solid, is to be dissolved in a volume of the diluent or solvent sufficient to make the finished solutions 10 parts by volume. For other types of solutions (e.g. gases in liquids), and where the above guidelines do not apply, the directions will specify the basis on which the concentration is determined (e.g. w/w, v/w).

Temperatures 

Unless otherwise specified, temperatures are expressed in degrees Celsius, and all measurements are to be made at 20°. Ordinary procedures not involving precise instrumental measurements may be conducted at ambient temperature (approximately 15°-30°) unless a particular temperature is specified in a test or assay.

Turbidity 

The terms "clear", "almost clear", "very slightly turbid", and "turbid", as specified in Purity Tests for "Clarity and colour of solution", are defined in the individual monographs.  The term "no turbidity is produced" means that the clarity of the solution does not change.

Vacuum 

The unqualified use of the term "in vacuum" or "in vacuo" means a pressure at least as low as that obtainable by an efficient aspirating water pump (i.e. not higher than about 20 mm of mercury). 

Water 

See "Solutions". 

 

 

Water-bath 

The term "water-bath" means a bath of boiling water, unless water at some other temperature is indicated.  An alternative form of heating may be employed, provided that the required temperature is approximately maintained and not exceeded.

 

 

WEIGHTS AND MEASURES 

 

JECFA uses SI units and units accepted for use with SI.  The units and abbreviations commonly used in specifications are as follows:

 

m = metre 

cm = centimetre (10-2 m)

mm = millimetre (10-3 m)

µm = micrometre (10-6 m)

nm = nanometre (10-9 m)

g = gram  

kg = kilogram (103 g)

mg = milligram (10-3 g)

µg = microgram (10-6 g)

ng = nanogram (10-9 g)

l = litre 

ml = millilitre (10-3 l)

µl = microlitre (10-6 l)

h = hour(s)* 

min = minute(s)* 

sec = second(s) 

º = degrees Celsius 

N = normality (gram equivalents per litre) 

M = molarity (moles per litre) 

cm-1 = wave number

bar = unit of pressure (kgm-1sec-2)*

mm Hg = mm of mercury, unit of pressure ** 

Rf = ratio of (distance of spot from point of application): (distance moved by solvent)

rpm = revolutions per minute 

 

*Time in minutes or hours, and volume in litres or decimals of litres, are outside the SI, but are accepted for use within it.  The term ‘bar’ is also outside the SI, but is subject to review.

** ‘mm Hg’ is outside the SI system, but is in common use and is retained: 760 mm Hg is equal to 1.013 bar. 

 

 

ABBREVIATIONS 

 

JECFA specifications include various abbreviations and acronyms, as set out below.

 

ADI = Acceptable Daily Intake (expressed in mg/kg bw) 

AOAC = AOAC INTERNATIONAL, formerly the Association of Official Analytical Chemists 

ASTM = ASTM INTERNATIONAL, formerly the American Society for Testing and Materials 

ATCC = American Type Culture Collection 

CAC = Codex Alimentarius Commission 

CAS = Chemical Abstracts System 

C.I. = Colour Index 

EC = Enzyme Commission of IUBMB (for systematic nomenclature and numbering system of enzymes) 

FD&C = Food, Drug and Cosmetic 

FCC = Food Chemicals Codex (USA) 

FEMA = Flavor and Extract Manufacturers Association of the United States 

FNP = FAO Food and Nutrition Paper 

FNS = FAO Food and Nutrition Series 

FW = Formula weight 

G(L)C = Gas (Liquid) chromatography 

(HP)LC = (High Performance) Liquid Chromatography 

INS = Codex Alimentarius International Numbering System (for food additives) 

ISO = International Organization for Standardization 

IUBMB = International Union of Biochemistry and Molecular Biology 

IUPAC = International Union of Pure and Applied Chemistry 

JECFA = Joint FAO/WHO Expert Committee on Food Additives 

i.d. = internal diameter 

o.d. = outer diameter 

IR = Infrared 

meq = milliequivalent 

MW = Molecular weight 

Mol. Wt = Molecular weight 

MTDI = Maximum Tolerable Daily Intake 

soln = solution 

NMRS = FAO Nutrition Meeting Report Series 

TLC = Thin Layer Chromatography 

TRS = WHO Technical Report Series 

UV = Ultraviolet 

VIS = Visible wavelength