Part I

Summary of evaluations performed
by the Joint FAO/WHO Expert Committee
on Food Additives

1.  Background

Beginning in 1956 and extending to the present time the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) have been engaged in collecting and evaluating scientific data on food additives and making recommendations on safe levels of use. This has been accomplished (a) by elaborating specifications for the identity and purity of individual food additives that have been toxicologically tested and are in commerce and (b) by evaluating the toxicological data on these food additives and estimating acceptable intakes by humans. This work has been accomplished by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

In 1972 the scope of the evaluations was extended to include contaminants in food, while in 1987 the scope was extended even further to include residues of veterinary drugs in food. When evaluating the latter compounds, maximum residue limits are recommended based upon acceptable intakes estimated by the Committee and data relating to good practice in the use of veterinary drugs.

This document summarizes the evaluations of food additives, contaminants, and residues of veterinary drugs in food that have been performed by JECFA since 1956. It supersedes the FAO/WHO food additives data system that was published as FAO Food and Nutrition Paper 30 Rev. 1 in 1985 with two later addenda and previous editions of this summary.

Because of the complexities involved in evaluating food additives, contaminants, and veterinary drug residues, it is difficult to describe the basis for the evaluations in the few words used in this summary. Therefore, users should consult the sections of the reports and evaluations, as listed in Annex 1, on specific substances on which they have an interest or responsibility rather than to rely solely on this summary.

2.  Functions of the Committee

As an expert committee sponsored jointly by FAO and WHO, JECFA is convened according to the regulations for expert advisory panels and committees of the two Organizations. In general terms, the purpose and functions of expert committees include: (a) reviewing the latest knowledge and expert information and making it available to the two Organizations; (b) formulating technical recommendations; and (c) making recommendations designed to initiate, stimulate, and coordinate the research necessary to fulfil their terms of reference.

Specialists invited to serve as members of JECFA are independent scientists who serve in their individual capacities as experts and not as representatives of their governments or employers.

During each meeting, the Committee members invited by WHO are primarily responsible for reviewing the toxicological and related data and for estimating, where possible, acceptable daily intakes (ADIs) or other endpoints of assessment (see Section 5.2) and for establishing principles for toxicological evaluation and testing. The members invited by FAO are primarily responsible for preparing and reviewing the specifications for the identity and purity of food additives that have undergone toxicological evaluation. When veterinary drugs are considered, the members invited by FAO are responsible for estimating maximum residue limits (MRLs) in foods of animal origin when drugs are used in accordance with good practice in the use of veterinary drugs.

A report summarizing the conclusions is published after each meeting. All of the latest reports have been published in the WHO Technical Report Series (TRS). Except for the reports of the third and fourth meetings, the early reports (meetings 1 through 19) were published jointly with FAO in the FAO Nutrition Meetings Report Series (NMRS).

Toxicological monographs, which summarize the safety data and provide full references to the literature and unpublished data on the food additives, contaminants, and veterinary drugs reviewed by the Committee, are also published after each meeting. In recent years they have been published in the WHO Food Additives Series (FAS).

Specifications for the identity and purity of food additives, and residues monographs summarizing the data used for recommending MRLs for veterinary drugs, are published by FAO. In recent years they have been published in the FAO Food and Nutrition Paper (FNP) series.

JECFA has, throughout its existence, developed and established principles for the safety assessment of chemicals in food. To improve the consistency and quality of its decision-making process, the International Programme on Chemical Safety (IPCS) sponsored the publication of Environmental Health Criteria No. 70 (Annex 1, reference 76), published in 1987, which consolidated and updated the principles for the safety assessment of food additives and contaminants in food. Because of scientific advances and developments in risk analysis made since that time, FAO and WHO have initiated a project to update and consolidate principles for the assessment of food additives, contaminants, and residues of veterinary drugs by JECFA and pesticide residues by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR).

For further information about the Joint FAO/WHO Expert Committee on Food Additives, please contact either of the Joint Secretaries:

    FAO Joint Secretary of JECFA
    Food Quality Liaison Group
    Food and Nutrition Division
    Food and Agriculture Organization of the United Nations
    Via delle Terme di Caracalla
    00100 Rome, Italy
    Telefax (+39 06)5705 4593
    jecfa@fao.org
    http://www.fao.org/ag/agn/agns/jecfa_index_en.asp

    WHO Joint Secretary of JECFA
    International Programme on Chemical Safety
    World Health Organization
    1211 Geneva 27, Switzerland
    Telefax: (+41 22)791 4848
    tritschera@who.int
    http://www.who.int/ipcs/food/jecfa/en/
 

The Joint Secretaries invite anyone who finds errors in this summary to bring such errors to their attention.

3.  Use of JECFA products

Regulatory control of chemicals in food, such as food additives, contaminants, and residues of veterinary drugs, is one of the essential components of food control systems. However, not all countries in the world have the means or resources to carry out the task of toxicologically evaluating the many chemicals that are used or are found adventitiously in food. International activities such as those of JECFA serve to fill this gap and to promote harmonization of assessment methods so that all governments have an opportunity to save resources and promote the health of consumers and international trade in food commodities.

JECFA serves as the scientific advisory body to the Codex Alimentarius Commission (CAC) on all matters relating to food additives, contaminants, and residues of veterinary drugs in food. Although JECFA is an independent FAO/WHO Expert Committee and is not part of the CAC, most priorities for assessment by JECFA originate with the CAC.

The CAC is an international intergovernmental body administered by the Joint FAO/WHO Food Standards Programme, which was established in the early 1960s. The primary aims of the CAC are to protect the health of the consumer and to facilitate international trade in food commodities. JECFA advises three general subject committees of the CAC: the Codex Committee on Food Additives (CCFA), the Codex Committee on Contaminants in Foods (CCCF) and the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF).

To obtain information on the Codex Alimentarius Commission, please contact:

    Chief, Joint FAO/WHO Food Standards Programme
    Food Quality and Standards Service
    Food and Nutrition Division (ESN)
    Food and Agriculture Organization of the United Nations
    via delle Terme di Caracalla
    00100 Rome, Italy
    Telefax: (+39 06)5705 4593
    Codex@fao.org
    http://www.codexalimentarius.net
 

4.  Organization of this summary

4.1  Introduction

This introduction provides information on the Committee, its products, and explanation of terms.

4.2  Database

Information is provided in three lists. "Primary Index" provides complete alphabetical list of substance name with links to the records. "Secondary Index" provides complete alphabetical list of synonym or cross-reference with links to their primary records. "Functional class list" provides list of functional class with links to primary record lists in each functional class. Part II also provides keyword search option.

The information was first put together by the International Life Sciences Institute (ILSI), a Non-Governmental Organization in official relations with FAO and WHO. After ILSI made the information available, the two Organizations updated and modified it, which was used for the preparation of the original published summary in 1994 and the first revision in 1996. Mr Durward Dodgen, Alexandria, VA, USA, updated and formatted the summary from 1996 through early 2004. Dr John Herrman, Placerville, CA, USA, updated the summary from 2004 through 2006. ILSI continues contribute by sponsoring the electronic publication and printing of the summary. FAO and WHO express their appreciation to Mr Dodgen and Dr Herrman for their intellectual contributions, dedication, and hard work in keeping the summary up-to-date and acknowledge the important contributions made by ILSI in its preparation of the original database and publication of the summary.

4.3  Annexes

Annex 1 contains a list of JECFA reports and monographs. This list should be consulted to obtain detailed information on the publications referenced in the summary. The abbreviations at the end indicate the availability of language editions: Ar = Arabic; E = English; F = French; R = Russian; S = Spanish. An asterisk (*) indicates a language edition in preparation. This annex provides links to the many documents that are available electronically.

Annex 2 contains information on how to order JECFA publications. Books published and distributed by FAO and WHO can be ordered by going to the respective web sites. A discount on the prices listed on these forms is given to individuals and organizations in developing countries.

5.  Explanation of terms used in this summary

The latest evaluation status of each substance is listed in the following manner:

   Year of latest evaluation:
   ADI:
   Comments:
   Report:
   Specifications (food additives) or residues (veterinary drugs):
   Tox Monograph:

For substances that have been reviewed more than once, their previous evaluation status is listed under Previous Status.

5.1  Reports and evaluations

The following abbreviations are used to identify reports and evaluations:

   FAS - WHO Food Additives Series
   FNP - FAO Food and Nutrition Paper
   FNS - FAO Food and Nutrition Series
   NMRS - FAO Nutrition Meeting Report Series
   TRS - WHO Technical Report Series

5.2  Toxicological terms

ADI (Acceptable Daily Intake)
An estimate of the amount of a substance in food or drinking-water, expressed on a body-weight basis, that can be ingested daily over a lifetime without appreciable risk (standard human = 60 kg) (Annex 1, reference 97 [1991, TRS 815-JECFA 38/61]). The ADI is listed in units of mg per kg of body weight.
 
Temporary ADI
Used by JECFA when data are sufficient to conclude that use of the substance is safe over the relatively short period of time required to generate and evaluate further safety data, but are insufficient to conclude that use of the substance is safe over a lifetime. A higher-than-normal safety factor is used when establishing a temporary ADI and an expiration date is established by which time appropriate data to resolve the safety issue should be submitted to JECFA (Annex 1, reference 76, page 114). The temporary ADI is listed in units of mg per kg of body weight.
 
ADI "not specified" - food additives
A term applicable to a food substance of very low toxicity which, on the basis of the available data (chemical, biochemical, toxicological, and other), the total dietary intake of the substance arising from its use at the levels necessary to achieve the desired effect and from its acceptable background in food does not, in the opinion of JECFA, represent a hazard to health. For that reason, and for reasons stated in individual evaluations, the establishment of an acceptable daily intake expressed in numerical form is not deemed necessary. An additive meeting this criterion must be used within the bounds of good manufacturing practice, i.e., it should be technologically efficacious and should be used at the lowest level necessary to achieve this effect, it should not conceal inferior food quality or adulteration, and it should not create a nutritional imbalance (Annex 1, reference 76, page 111).
 
ADI "not specified" - veterinary drugs
Available data on the toxicity and intake of the veterinary drug indicate a large margin of safety for consumption of residues in food when the drug is used according to good practice in the use of veterinary drugs. For that reason, and for the reasons stated in the individual evaluation, the Committee has concluded that use of the veterinary drug does not represent a dietary hazard to human health and that there is no need to specify a numerical ADI (Annex 1, reference 104 [1992, TRS 832-JECFA 40/5]).
 
ADI "not limited"
A term no longer used by JECFA that has the same meaning as ADI "not specified".
 
Conditional ADI
A term no longer used by JECFA to signify a range above the "unconditional ADI" which may signify an acceptable intake when special problems, different patterns of dietary intake, and special groups of the population that may require consideration are taken into account (Annex 1, reference 6 [1961, NMRS 31/TRS 228-JECFA 6/10]).
 
No ADI allocated
There are various reasons for not allocating an ADI, ranging from a lack of information to data on adverse effects that call for advice that a food additive or veterinary drug should not be used at all. The report should be consulted to learn the reasons that an ADI was not allocated (Annex 1, reference 101 [1992, TRS 828-JECFA39/5]).

Acceptable

Flavouring agents: Used to describe flavouring agents that are of no safety concern at current levels of intake (Annex 1, reference 122 [1996, TRS 868-JECFA 46] and subsequent reports of meetings on food additives). If an ADI has been allocated to the agent, it is maintained unless otherwise indicated.

Enzyme preparations: Used to describe enzymes that are obtained from edible tissues of animals or plants commonly used as foods or are derived from microorganisms that are traditionally accepted as constituents of foods or are normally used in the preparation of foods. Such enzyme preparations are considered to be acceptable provided that satisfactory chemical and microbiological specifications can be established (Annex 1, reference 76, Annex III).

Food additives: Used on some occasions when present uses are not of toxicological concern or when intake is self-limiting for technological or organoleptic reasons.

Acceptable level of treatment
ADIs are expressed in terms of mg per kg of body weight per day. In certain cases, however, food additives are more appropriately limited by their levels of treatment. This situation occurs most frequently with flour treatment agents. It should be noted that the acceptable level of treatment is expressed as mg/kg of the commodity. This should not be confused with an ADI.
 
LGMP (Limited by Good Manufacturing Practice)
This statement refers to the limitation of a food additive in specified foods. It means that the additive in question is self-limiting in food for technological, organoleptic, or other reasons.
 
MTDI (Maximum Tolerable Daily Intake)
See PMTDI.
 
PMTDI (Provisional Maximum Tolerable Daily Intake)
The endpoint used for contaminants with no cumulative properties. Its value represents permissible human exposure as a result of the natural occurrence of the substance in food and in drinking-water. In the case of trace elements that are both essential nutrients and unavoidable constituents of food, a range is expressed, the lower value representing the level of essentiality and the upper value the PMTDI (Annex 1, reference 76, page 113).
 
PTMI (Provisional Tolerable Monthly Intake)
An endpoint used for a food contaminant with cumulative properties that has a very long half-life in the human body. Its value represents permissible human monthly exposure to a contaminant unavoidably associated with otherwise wholesome and nutritious foods (Annex 1, reference 154 [2002, TRS 909-JECFA 57/143]).
 
PTWI (Provisional Tolerable Weekly Intake)
An endpoint used for food contaminants such as heavy metals with cumulative properties. Its value represents permissible human weekly exposure to those contaminants unavoidably associated with the consumption of otherwise wholesome and nutritious foods (Annex 1, reference 76, page 114).

5.3  Other terms

INS (International Numbering System)
The International Numbering System for food additives (INS) has been prepared by the Codex Committee for Food Additives and Contaminants (CCFAC) for the purpose of providing an agreed international numerical system for identifying food additives in ingredient lists as an alternative to the declaration of the specific name (Codex Alimentarius, Volume 1A, General requirements, Revision 6, 2001).
 
JECFA numbers for flavouring agents
Flavouring agents evaluated by JECFA have been numbered consecutively for administrative purposes since the forty-ninth meeting by the FAO Joint Secretariat. The flavouring agents evaluated at the forty-sixth meeting have been numbered retroactively.
 
"Tentative" specifications
The Committee agreed at the twenty-third meeting that the term "tentative" should be used only in cases where data on the purity and identity of the substance are required. The assignment "tentative" will require submission and re-evaluation within a specified period of time (usually two years).
 
MRL (Maximum Residue Limit)
The maximum concentration of residue resulting from the use of a veterinary drug (expressed in mg/kg or mg/kg on a fresh weight basis) that is acceptable in or on a food. It is based on the type and amount of residue considered to be without toxicological hazard for human health as expressed by the Acceptable Daily Intake (ADI), or on the basis of a temporary ADI that utilizes an additional safety factor. It also takes into account other relevant public health risks as well as food technological aspects and estimated food intakes.

When establishing an MRL, consideration is also given to residues that occur in food of plant origin and/or the environment. Furthermore, the MRL may be reduced to be consistent with good practices in the use of veterinary drugs and to the extent that practical analytical methods are available.

The MRLs elaborated by JECFA are "recommended MRLs" that are forwarded to the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) for consideration (Annex 1, reference 85 [1989, TRS 788-JECFA 34/10]). In this summary MRLs are expressed in terms of mg/kg tissue or mg/L milk.

 
Temporary MRL
Used by JECFA when a temporary ADI has been established and/or when it has been found necessary to provide time to generate and evaluate further data on the nature and quantitation of residues (Annex 1, reference 91 [1990, TRS 799-JECFA 36/17]). In this summary temporary MRLs are expressed in terms of mg/kg tissue or mg/l milk.
 
MRL "not specified"
Available data on the identity and concentration of residues of the veterinary drug in animal tissues indicate a large margin of safety for consumption of residues in food when the drug is used according to good practice in the use of veterinary drugs. For that reason, and for the reasons stated in the individual evaluation, the Committee has concluded that the presence of drug residues in the named animal product does not present a health concern and that there is no need to specify a numerical MRL (Annex 1, reference 104 [1992, TRS 832-JECFA 40/5]).
 
% T.O.S. (total organic solids)
% T.O.S. = 100 - (A + W + D) where
A = % ash,
W = % water, and
D = % diluent and carrier.

The ADI is expressed in terms of mg T.O.S. per kg of body weight (Annex 1, reference 77[1987, TRS 759-JECFA 31/16].

5.4  Codes

Certain codes have been incorporated into the electronic database to facilitate searching. For the most part these codes have not been reproduced in the hard-copy summary. However, they are included in the Previous Status fields, so they are defined here:

5.5  Sample entry

WHO Technical Report Series No. 759 Thirty-first meeting of JECFA, page 29



 

[Table of Contents] [Part I] [Part II]
[Annex 1] [Annex 2]