The International Numbering System (INS) for food additives does not mention nutrient or health additive as technical function of food additives. Carotenes and Ascorbic Acid (L-), for example, are not designated as vitamins or nutrients under the column “technical functions”.

These are designated as colour and antioxidant respectively. Similarly mineral supplement, say magnesium chloride, is not designated as supplement salt. It is designated as firming agent as per functionality of additive in food processing.

Lysozyme, the important enzyme present in mother’s milk, is designated as preservative in INS food additives identification system. It is required to be present in infant formula in quantity not less than 0.8 grammes/ litres [FSSR (Food Products Standards and Food Additives) 2011, 2.1.9(2)] along with many nutrients proteins, fats, vitamins and minerals – all within prescribed limits – if the product is set in order to provide nutrients ordinarily found in human milk. But Lysozyme, the most distinguished human milk enzyme, too is not designated as nutrient in INS list of food additives.

It seems the food law does not intend to decisively declare that which compounds are nutrition and health food additives. The word “health” is used in the law to define the terms “hazard” and “risk”. The law states that “hazard” means a biological, chemical or physical agent in or condition of food with the potential to cause an adverse health effect (FSSA 2006, chapter 1 Preliminary 3 Definitions, u).

 The law also states that “risk”, in the relation to any article of food, means the probability of an adverse effect on the health of consumers of such food and the severity of that effect, consequential to a food hazard (FSSA 2006 : 1, 3, zm). The law accepts that a relationship exists between a foods or a constituent of that food and health and any food article can make a claim for it. According to FSSR 2011 (Packing and Labelling) 2.2.2.(3) –

(i) “Health claims” means any representation that states, suggests or implies that a relationship exists between a food or a constituent of that food and health and includes nutrition claims which describe the physiological role of the nutrient in growth, development and normal functions of the body, other functional claims concerning specific beneficial effect of the consumption of food or its constituents, in the context of the total diet, on normal functions or biological activities of the body and such claims relate to a positive contribution to health or to the improvement of function or to modifying or preserving health, or disease risk reduction claim relating to the consumption of a food or food constituents, in the context of the total diet, to the reduced risk of developing a disease or health related condition;

(ii) “Nutrition claim” means any representation which states, suggests or implies that a food has particular nutritional properties which are not limited to the energy value but include protein, fat, carbohydrates, vitamins and minerals.

(iii) “Risk reduction” in context of health claims means significantly altering a major risk factor for a disease or disease-related condition.
 The food-health relationship in context of total diet is perhaps important for evaluation of risk reduction due to an additive or food supplement, on the basis of which a health or nutrition claim is made. A clinical trail, even following “good clinical practices” (GCP), might lead to anomalous results if total diet is not conceptualized. Indian agricultural produce, in general is non-organic in nature grown with artificial fertilizers in soil and spray of pesticides and
insecticides.

Any diet in India – cereals, pulses, milk etc. – can be legally claimed as safe if pesticide-insecticide residue in those is within is tolerance limit as per FSSR 2011 (contaminants, toxins and residues) : 2.3.1(2). But it can’t be said, without conducting a clinical trial that any additive - well known for its nutrition and health property like vitamins – consumed with diet containing upper pesticide-insecticide tolerance limit would surely lead to health preservation or risk reduction. This might be the rationale for not designating additives like vitamins as nutrients, under the column ‘technical function’, in the INS table. In other words the hypothesis “Additives like Vitamins preserve health or reduce risk” may be or may not be verified. Further both the hypothesis and null hypothesis may appear equally consistent as the outcome of a clinical trail.

The law-makers, perhaps like to link health and nutrition claims for food supplements or its additives with clinical trails in context of total diet and not with the well known nutritional properties of additives. There seem to be two reasons behind this ideology of law-makers. First, as discussed above, is concerned with total diet of consumers. Second is concerned with purity of nutritional ingredient itself, on the basis of which claim is made.

The health and nutrition aspects of “turmeric” and “amla”, as mentioned in Ayurveda; are well known. But these are grown in farms and so can’t be considered to behave as “curcumin” and “ascorbic acid” added to pure carbohydrates, proteins, fibres etc. The presence of pesticide-insecticide residues in these Ayurvedic medicinal plants might tend to alter their properties. Therefore health and nutrition claims can not only depend on additives but also may do on outcome of clinical trails on claim hypothesis in context of total diet.

However, the adverse effects of pesticides and insecticides have appeared on Indian macro-scenario. For example a train running between Bathinda and Bikaner is now popularly called Cancer Train, whatsoever is its real name. It is so named by people for peasants of Punjab, who don’t consume tobacco products, suffering from cancer travel via this train for treatment at Tulsi Cancer Ward, PBM Hospital in Bikaner. The carcinogenic effect of pesticides and insecticides is self-evident on a macro-scenario so micro clinical trials on nutrition or health claim in context of total diet do not seem to be favourable to claim hypothesis. The null hypothesis might, probably, gain more clinical support in comparison to hypothesis.

There is a difference between drug and food. A drug is a pure compound or composition. Similarly addition of a nutrient to a pure organic food results in formation of a dietary supplement. There however is interrogation mark on purity of food. The “infant formula”, for example as the law states, means the product prepared by spray drying of the milk of cow or buffalo or mixture thereof.

The milk may be modified by partial removal/substitution of milk fat with vegetable oils rich in polyunsaturated fatty acids and/or by different milk solids, carbohydrates such as sucrose, dextrose and dextrins/ moltodextrins maltose and lactose; salts such as phosphates and citrates, vitamins A, D, E, B and C group and other vitamins; minerals such as iron, copper, zinc and iodine and others. Needless to say the purity or organic nature of food plays the role in preparation of food supplement for which health claim is made and in total diet of populace for which clinical trails are to be conducted in context of health claim.

Not only of health claim the organic food, is also the demand of public health in India. The cost - effective organic farming demands soil conservation and so dense forestation in country. The FSSAI is expected to do the needful towards co-ordination with forest and agriculture departments to promote organic farming practices so that condition regarding regulatory aspects of nutritional food additives and ingredients is reasonably met.