JECFA safety evaluation

The process of evaluation starts at a meeting of the Codex Alimentarius Committee on Food Additives and Contaminants (CCFAC). The Committee, 

Category Total number With numerical ADI ADI Not specified  

If the CCFAC agrees with the proposal, the additive is included on a future JECFA agenda. Prior to the next JECFA meeting, a call for data is published, and any item put forward for inclusion will be in that data call, requesting all available toxicological, specification and consumption data. 

The toxicological data will be sent to a WHO expert for evaluation, with a second expert appointed to comment on the report prepared for submission to the Expert Committee. The specification will be written based on information submitted by an FAO expert, and another FAO expert will consider the likely consumption. When the Expert Committee meets, these three groups of people discuss the aspects of the toxicology, specification and likely consumption before an additive is approved and an ADI is allocated. 

This chapter concludes with three appendices summarising regulations covering additives both at EU and international level. These appendices cover  

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The JECFA safety evaluation procedure for flavoring substances leads the evaluator through a decision tree with two branches, one for substances that are metabolized to innocuous end products and the second for substances that are not metabolized to innocuous end products (Fig. 9.1). The decision tree is applied using a series of questions ... 

Since the introduction of the JECFA safety evaluation procedure, over 900 flavoring substances have been evaluated by JECFA using this procedure. This procedure provides a practical and efficient scientific means to evaluate flavoring substances by integrating knowledge of toxicity, stmcture-activity relationships, structural class, metabolic fate and exposure. 

In conclusion, the JECFA evaluation process for food additives is a thorough, comprehensive review of safety, intake, and specifications resulting in an assignment of an ADI. An evaluation by JECFA could serve as a credible review of the safety of a new excipient. Likewise, the safety evaluation by FDA or the EFSA of an ingredient for use as a food additive could also be very useful to support the potential use of a new excipient for the oral route of administration. 

Joint FAO/WHO Expert Committee on Food Additives (JECFA), 2000. Safety evaluation of certain food additives and contaminants. Zearale-none. WHO Food Additives Series 44. http //www.inchem.org/documents/ jecfa/jecmono/v44jecl4.htm... 

JECFA (Joint FAOAVHO Expert Committee of Food Additives) (2001). Ochratoxin A. In Safety Evaluation of Certain Mycotoxins in Food. Prepared by the Fifty-sixth meeting of the JECFA. FAO Food and Nutrition Paper 74, Food and Agriculture Organization of the United Nations, Rome, Italy. 

WHO Food Additives Series 40, Safety evaluation of certain food additives and contaminants, prepared by the 49th Meeting of JECFA, Annex 5 1. C. Munro and R. Kroes Application of a threshold of toxicological concern in the safety evaluation of certain flavouring substances, WHO, Geneva, 1998, 499-532. 

JECFA (2000) Safety Evaluation of Certain Food Additives and Contaminants WHO Food Additives Series 44 Methylmercury. Prep, by 53rd Joint FAOAVHO Expert Committee on Eood Additives (JECEA), World Health Organization, Geneva, Switzerland, available at http // WWW. inchem. org/documents/jecfa/jecmono/v44jecl3.htm... 

Toxicological databases and the concept of thresholds of toxicological concern as used by the JECFA for the safety evaluation of flavouring agents - A. G. Renwick - Toxicology Letters 149(1-... 

The TTC concept was adopted by the Joint FAOAVHO Expert Committee on Food Additives (JECFA) to evaluate flavoring agents in food, and it is also now used by the European Food Safety Authority. In the TTC decision-tree approach of Kroes et al. (2004), proteins, heavy metals, and dioxins were excluded because the database used to derive TTC values did not include proteins and heavy metals, and the extreme species-dependence of the dioxins and related compounds made it less useful for this category (compared to the existing toxicity equivalence factor method). This approach could be much more widely used to categorize trace chemicals in the environment as well as help prioritize the thousands of untested chemicals for further evaluation. 

JECFA (1974) Joint FAO/WHO Expert Committee on Food Additives. Evaluation of safety of synthetic beta-carotene. Evaluation 18/68. 

In the 1992 edition, flavoring substances are classified into Category A or B based on the information currently available (i.e., Category A - flavoring substances which may be used in foodstuffs, or Category B - flavoring substances for which further information is required before an opinion on their safety-in-use can be determined) (CE, 1992). In addition, where available, an ADI is specified by the Committee of Experts. The ADI is typically the one recommended by JECFA, and, in cases where the substance has not been evaluated by JECFA and where toxicological data are insufficient to establish an ADI, acceptable upper use levels in food (i.e., those that would be considered to result in no risk to health) are specified. 

An important step and for some countries even a prerequisite before food additive approval is endorsement for food use by international scientific bodies like the JECFA or the European SCF. These committees evaluate the safety data, identify a no-observed-effect level and allocate an ADI, usually by applying a safety factor of 100 to the ADI. While numerical values have been allocated for all intense sweeteners, the ADIs for bulk sweeteners are normally not specified as any numerical limitation would not be reasonable for these substances. 

The Joint FAO/WHO Expert Committee on Food Addihves (JECFA) is an international expert scientihc committee that is administered jointly by FAO and WHO. It has been meeting regularly since 1956, inihally to evaluate the safety of food addihves. Its work now also includes the evaluation of contaminants, naturally occurring toxicants, and residues of veterinary drugs in food. These evaluations are collected in a report published after each JECFA meeting (Section 3.6.1.3) (JECFA 2006). 

The stmcmre-based, tiered TTC approach as outlined by Munro et al. (1996, 1999) is used by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in a procedure for the evaluation of flavoring substances in food, including an acceptance of the general TTC of 1.5 pg/person/day, i.e., the US-FDA Threshold of Regulation (Section 4.13.1). The European Food Safety Authority (EFSA) also uses this approach for evaluation of flavoring substances, except that the general TTC of 1.5 pg/person/day is not accepted (Larsen 2006). 

The evaluation of the safety of a new excipient as a food additive could be accomplished by the submission of a food additive petition to the United Nations expert panel operating under the auspices of the FAO and the World Health Organization known as the JECFA. A JECFA review could serve as a separate independent safety review to support the new excipient for potential use in drug products. Alternatively, the safety of a new excipient could be evaluated through the food additive petition processes, as currently in practice both in the United States and the EU, assuming that the new excipient can be demonstrated to have a technological function as a food additive. 

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