Safety evaluation of certain food additives and contaminants

Prepared by the Sixtyfirst meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA)

World Health Organization, Geneva, 2004

IPCS—International Programme on Chemical Safety

Safety evaluation of certain food additives and contaminants/ prepared by the sixtyfirst meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

(WHO food additives series ; 52)

1. Food additives—toxicity 2. Flavoring agents—toxicity

3. Food coloring agents—toxicity 4. Food contamination

5. Risk assessment I. Joint FAO/WHO Expert Committee on Food Additives. Meeting (61st : 2003 : Rome, Italy) II. Series

ISBN 92 4 166052 X         (NLM classification: WA 712) ISSN 03000923

This publication is a contribution to the International Programme on Chemical Safety.

The International Programme on Chemical Safety (IPCS), established in 1980, is a joint venture of the United Nations Environment Programme (UNEP), the International Labour Organisation (ILO), and the World Health Organization (WHO). The overall objectives of the IPCS are to establish the scientific basis for assessing the risk to human health and the environment to exposure from chemicals, through international peerreview processes as a prerequisite for the promotion of chemical safety, and to provide technical assistance in strengthening national capacities for the sound management of chemicals.

The InterOrganization Programme for the Sound Management of Chemicals (IOMC) was established in 1995 by UNEP, the Food and Agriculture Organization of the United Nations, WHO, the United Nations Industrial Development Organization, and the Organisation for Economic Cooperation and Development (Participating Organizations), following recommendations made by the 1992 United Nations Conference on the Environment and Development to strengthen cooperation and increase coordination in the field of chemical safety. The purpose of the IOMC is to promote coordination of the policies and activities pursued by the Participating Organizations, jointly or separately, to achieve the sound management of chemicals in relation to human health and the environment.



Specific food additives (other than flavouring agents)

alpha-Amylase from Bacillus licheniformis containing a genetically engineered alpha-amylase gene from B. licheniformis

Annatto extracts


Diacetyltartaric and fatty acid esters of glycerol

Laccase from Myceliophthora thermophila expressed in Aspergillus oryzae

Mixed xylanase, beta-glucanase enzyme preparation, produced by a strain of Humicola insolens


Polyvinyl alcohol


Xylanase from Thermomyces lanuginosus expressed in Fusarium venenatum


Safety evaluations of groups of related flavouring agents


Alicyclic, alicyclicfused and aromaticfused ring lactones

Aliphatic, alicyclic, linear, alpha,beta-unsaturated, di and trienals and related alcohols, acids and esters

Aliphatic branched-chain saturated and unsaturated alcohols, aldehydes, acids, and related esters

Aliphatic and aromatic ethers


Simple aliphatic and aromatic sulfides and thiols: additional compounds

The safety evaluation of natural flavouring complexes

Nutritional source of iron: ferrous glycinate (processed with citric acid)

Disinfectant for drinking-water: sodium dichloroisocyanurate






Annex 1 Reports and other documents resulting from previous meetings of the Joint FAO/WHO Expert Committee on Food Additives

Annex 2 Abbreviations used in the monographs

Annex 3 Participants in the sixtyfirst meeting of the Joint FAO/WHO Expert Committee on Food Additives

Annex 4 Recommendations on compounds on the agenda and further toxicological studies and information required

Annex 6 Summary of the safety evaluation of secondary components of flavouring agents with minimum assay values of less than 95%


The monographs contained in this volume were prepared at the sixtyfirst meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), which met at FAO Headquarters in Rome, Italy, 10–19 June 2003. These monographs summarize the safety data on selected food additives reviewed by the Committee.

The sixty-first report of JECFA has been published by the World Health Organization as WHO Technical Report No. 922. Reports and other documents resulting from previous meetings of JECFA are listed in Annex 1. The participants in the meeting are listed in Annex 3 of the present publication; a summary of the conclusions of the Committee is given in Annex 4. Some of the substances listed in Annex 4 were evaluated at the meeting only for specifications.

Specifications that were developed at the sixtyfirst meeting of JECFA have been issued separately by FAO as Food and Nutrition Paper No. 52, Addendum 11. The toxicological monographs in the present publication should be read in conjunction with the specifications and the report.

JECFA serves as a scientific advisory body to FAO, WHO, their Member States, and the Codex Alimentarius Commission, primarily through the Codex Committee on Food Additives and Contaminants and the Codex Committee on Residues of Veterinary Drugs in Foods, regarding the safety of food additives, residues of veterinary drugs, naturally occurring toxicants and contaminants in food. Committees accomplish this task by preparing reports of their meetings and publishing specifications or residue monographs and toxicological monographs, such as those contained in this volume, on substances that they have considered.

The toxicological monographs contained in the volume are based on working papers that were prepared by Temporary Advisers. A special acknowledgement is given at the beginning of each monograph to those who prepared these working papers.

Many proprietary unpublished reports are unreferenced. These were voluntarily submitted to the Committee by various producers of the food additives under review, and in many cases represent the only data available on those substances. The Temporary Advisers based the working papers they developed on all the data that were submitted, and all of these reports were available to the Committee when it made its evaluation. The monographs were edited by H. Mattock, St Jean d’Ardières, France.

The preparation and editing of the monographs included in this volume were made possible through the technical and financial contributions of the Participating Organizations of the International Programme on Chemical Safety (IPCS), which supports the activities of JECFA.

The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the organizations participating in the IPCS concerning the legal status of any country, territory, city, or area or its authorities, or concerning the delimitation of its frontiers or boundaries. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the organizations in preference to others of a similar nature that are not mentioned.

Any comments or new information on the biological or toxicological properties of the compounds evaluated in this publication should be addressed to: Joint WHO Secretary of the Joint FAO/WHO Expert Committee on Food Additives, International Programme on Chemical Safety, World Health Organization, Avenue Appia, 1211 Geneva 27, Switzerland.

    See Also:
       Toxicological Abbreviations