Food Additive Risk Assessment “Annatto extract”

Food Additive Risk Assessment “Annatto extract”

Please follow the instructions carefully

Conduct a safety evaluation and risk analysis of a selected food additive permitted in Australia. Gather a wide range of literature, including the publications of Joint FAO/WHO Expert Committee on Food Additives (JECFA), Food Standards Code and Australian Bureau of Statistics (ABS). Calculate the TMDI and EDI. And use critical thinking to assess the toxicological safety of the food additive.


The objective of this report is to familiarise yourself with:
? Information on which the safety evaluation of food additives are based
? Methods of risk analysis ? including hazard characterisation and exposure assessment to reach a decision on safety of a food ingredient.

? Beginning with the JECFA reports, find your food additive and collect information regarding it?s manufacture, toxicology & feeding trials, dose related effects and ADI.
? Background on dietary exposure risk assessment can be found in the FSANZ publication ?Principles and Practices of Dietary Exposure Assessment for Food Regulatory Purposes?
? Collect information on permitted usage of the food additive in foods/beverages from FSANZ Food Standards Code PART 1.3 Substances Added to Food
? Calculate the amount consumed in food based on the amount permitted and the composition of diets (for normal and vulnerable persons) using Australian Bureau of Statistics data
? Finally conduct a risk analysis on the likelihood of the persons exceeding the ADI, as discussed in the lectures and provided in the references given in class.
Attend the Tutorial workshop in week 5 for guidance on obtaining the material for

Outline of report requirements
1. Introduction (5 marks)
Briefly introduce your topic for investigation; ie. your food additive and planned toxicological evaluation study, and state your objectives for this study. Maybe about a paragraph.

2. Name/ structure (5 marks)
Name, Synonyms, Classification numbers, Chemical structure
Laid out clearly

3. Manufacture & Specifications (10 marks)
a) Describe method of manufacture or purification of additive, appropriately summarised from literature;
b) Chemical and physical specifications for additive;
Clearly laid out, table format if needed.

4. Food use, applications (10 marks)
Describe the function of the additive in food and provide some typical food applications of the additive. Also discuss whether the activity of the additive is affected by the composition of the food or the treatment processes the food receives, (eg. effect of pH, heat, oxygen exposure).

5. Food Standards Information (5 marks)
Summarise the relevant information from the Food Standards Code; list which schedules the additive is regulated under; provide a table listing the permitted levels of the additive in different foods (cross ref with table used in TMDI calc).

6. Toxicological studies and ADI (20 marks)
Summarise some of the toxicological studies available on your additive, what are the findings; comment on relationship between these studies on animals and human effects.
Describe how the ADI was calculated for the additive, and what is the ADI for this additive.

7. TMDI calculation (10 marks)
Calculate the Theoretical Maximum Daily Intake, based on mean intake using ABS data. The methods for this calculation are covered in the lectures.
Provide spreadsheet showing your calculation

8. EDI calculation (10 marks)
Calculate the Estimated Daily Intake for a high risk individual, eating a typical diet at the high end of consumption patterns. The methods for this calculation are covered in the lectures.
Provide spreadsheet showing your calculation

9. Risk analysis and conclusion (20 marks)
Discuss your TMDI and EDI results and compare to the ADI. Assess the risk of your additive in the context of your calculations, the assumptions made in these calculations. Who are the high risk groups? Which are the high risk foods? Reflect on the findings of the toxicological studies, what are the likely implications on the health and safety of the consumers of this additive.
Provide recommendations and conclusions.