Nutrition Meets Food Science

Exploring Safety & Market Potential of Food Additives

The market and consumption of packaged or processed foods is growing because of the changing lifestyle of people. This in turn leads to more consumption of Food additives with these foods. Food additives are substances added in small quantities to food during processing. They are very important tools in food product manufacturing and have specific functions in food processing which include improving the safety, quality, texture, taste, visual appeal, nutritional value, or shelf life of the final product. Different additives could be colors, preservatives, enzymes, artificial sweeteners & flavour enhancers. Since they are part of the product, their safety for human health is of utmost importance. With the globalization of Food Trade, the safety of Food Additives has become of enormous importance. This is because different countries have different regulations and there is a possibility that unsafe food may get exported to a country with no strict regulations. These additives must undergo a risk assessment to be safe for human consumption. Risk assessment is a scientific process, that needs toxicologists and nutritionists to work together.

Joint FAO/ WHO Expert Committee on Food Additives (JECFA) evaluates the safety of Food additives. JECFA and the Scientific Committee on Foods (SCF) decide Acceptable Daily Intake (ADI) values. ADI (1) is the value of an additive if consumed at that dosage daily throughout life, there would not be an “appreciable health risk.” The ADI is normally derived from the lowest no observed adverse effect level (NOAEL) obtained from long-term animal studies. ADI is then calculated by applying a safety or uncertainty factor, generally 100 to the NOAEL obtained from the most sensitive species. This can be further explained by taking an example of a particular additive. Suppose in a long-term toxicity study of the additive, NOAEL of carcinogenicity in mice is 10mg/Kg. Then ADI will be 10mg/ Kg divided by 100, which means ADI will be 0.1 mg per Kg body weight per day. In such a case, a 60 Kg body weight person will be at no risk if he consumes less than 6mg (60*0.1) daily of this particular additive for a lifetime. Any food additive used in the food package has either an E-number given by the European Union (EU) or by an International Numbering System (INS-No.) signifying the approval by JECFA.

Risk assessment is part of the risk analysis process. (2) Before approval of any food additive, a vigorous Scientific evaluation of associated hazards is carried out during Risk assessment. This exercise is carried out before approval of an additive and also repeated, as the environment changes. Risk assessment of Food Additives is a science-based approval process having four steps.

The first step is Hazard identification (Step 1): This finds the intrinsic properties of an additive that can affect health. A review of appropriate published scientific databases is done for human and animal toxicological studies. Epidemiological data is given more importance than lab-based data. This approach is also termed the “weight of evidence approach”.

The second step is Hazard characterization (step 2): The safety of food additives is decided based on toxicity data. This step involves both “dose-response extrapolation” and “dose scaling”. The toxicity levels estimated in animals should be extrapolated both qualitatively and quantitatively to much lower levels for comparison to human exposure levels. In dose scaling JECFA uses mg/ Kg body weight for “inter-species” scaling. Many approaches including Mathematical models can be used to characterize dose-response relationships.

Exposure assessment (Step 3): Once the dose is decided, it is necessary to ascertain the exposure of the additive to the consumer. This step requires the help of experts in the field of Nutrition to estimate the actual consumption of food additives. Food Frequency Questionnaire (FFQ) or twenty-four-hour dietary records are generally used to estimate the intake of Foods likely to contain additives. The concentration of additives in the foods is analyzed to find out the dietary exposure of the additive to the food.

Risk Characterisation (Step 4): In this step, the probability of occurrence of adverse effects on humans because of exposure to Food Additives is assessed. This is generally done by comparing ADI values of additives with exposure levels in humans. Risk can be characterized by different exposure scenarios. Hazard Index (HI) is also the term for characterizing risk and is calculated by the average daily intake dose (ADD) for the additive from the diet expressed as a percentage of ADI. If HI is less than 100% indicating that there is no harm to exposure of that additive.

The Food additives market in India was valued at US$600 in 2020 and is expected to grow to US$1247 by 2027 at a CAGR of 11%. (3) Different additives like Preservatives, Sweeteners, Hydrocolloids, and Colorants go into segments like Dairy, Frozen, Bakery, Meat, Beverages, and Confectionary products and have scope to grow. Demand for Food Additives is driven by rising penetration of ready-to-eat products and low-calorie sweeteners. Food preservatives and colors that extend the shelf life and make processed foods attractive will also grow. With high growth in Confectionary products, the additives demand in the segment will increase. The overall demand is also increasing because the per capita disposable income of the urban middle class is rising.

With a growing economy and an increase in consumption of all kinds of processed foods, we are seeing a range of new products manufactured with many new technologies. These kinds of innovations will call for the use of more food additives leading to a further rise in their demand. Sometimes concerns are raised about the safety of some of the food additives making normal consumers confused. However, any food additive that is approved for food use by the regulatory authorities undergoes a scientific approval process which considers ADI and the consumers should rest assured that they will not have any health issues because of approved Food additives.


Dr. Shashank Bhalkar

Executive Director, PFNDAI

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