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Food Ingredients and additives- Legal aspects and GMP
Friday, 02 April, 2021, 12 : 00 PM [IST]
Sanjay Indani & Khushbu Shah
For centuries, ingredients have served useful functions in a variety of foods. Our ancestors used salt to preserve meats and fish, added herbs and spices to improve the flavour of foods, preserved fruit with sugar, and pickled cucumbers in a vinegar solution. Today, consumers demand and enjoy a food supply that is flavourful, nutritious, safe, convenient, colourful and affordable. Food additives and advances in technology help make that possible.

Some consumers have concerns about additives because they may see the long, unfamiliar names and think of them as complex chemical compounds. In fact, every food we eat - whether a just-picked strawberry or a homemade cookie - is made up of chemical compounds that determine flavour, colour, texture and nutrient value.

Why are food additives and colour ingredients added to food?
Additives perform a variety of useful functions in foods. Some additives could be eliminated if we were willing to grow our own food, harvest and grind it, spend many hours cooking and canning, or accept increased risks of food spoilage.
Here is some reasons why ingredients are added to foods:
1.    Maintains the food safety and freshness.
2.    To improve or maintain the nutritional value.
3.    Improve taste texture and appearance.

What is a food additive?
A food additive is any substance added to food. Legally, the term refers to ‘any substance the intended use of which results or may reasonably be expected to result -- directly or indirectly -- in its becoming a component or otherwise affecting the characteristics of any food'.   This definition includes any substance used in the production, processing, treatment, packaging, transportation or storage of food. However the definition excludes the ingredients which are safe for consumption recognised by USFDA.

Direct Food Additives: Direct food additives are those that are added to a food for a specific purpose in that food. For example, xanthan gum -- used in salad dressings, chocolate milk, bakery fillings, puddings and other foods to add texture -- is a direct additive. Most direct additives are identified on the ingredient label of foods.

Indirect food additives are those that become part of the food in trace amounts due to its packaging, storage or other handling. For instance, minute amounts of packaging substances may find their way into foods during storage. Food packaging manufacturers must prove to the U.S. Food and Drug Administration (FDA) that all materials coming in contact with food are safe before they are permitted for use in such a manner.

Colour Additive is any dye, pigment or substance which when added or applied to a food, drug or cosmetic, or to the human body, is capable (alone or through reactions with other substances) of imparting colour. FDA's permitted colours are classified as subject to certification or exempt from certification, both of which are subject to rigorous safety standards prior to their approval and listing for use in foods.
 
Approval of additives for use in the food
Today, food and colour additives are more strictly studied, regulated and monitored than at any other time in history. FDA has the primary legal responsibility for determining their safe use. A manufacturer or other sponsor must first petition FDA for its approval and In India Additive petition through questionnaire  is approved by food additives subcommittee or food additive scientific panel then its sent to CCFS (certified in comprehensive food safety ) or food authority and then they draft the notification further drafting the final notification. It is then passed to JEFCA (Joint FAO/WHO Expert Committee) and codex approval status. It is then approved by the other regulatory authorities. Further questionnaire to include on:
1.    technical information such as chemical name, CAS no, chemical formula and structural formula.
2.    Specification for identify and purity of the substance
3.    Chemical and physical properties
4.    Method of analysis.

Approach to Harmonisation
Basic criteria for harmonisation are:
•    JEFCA Assessments are done
•    Additives historically used by Indian food industry
•    Codex preparations
•    OIV standards for alcoholic beverages
•    Standards of identity and purity – JEFCAS/BIS

The food category system
 An additive is specified for use in the main category, it is recognised for use in all its sub-categories, unless otherwise stated. Or if an additive is recognised for use in a sub-category, its use is recognised in further sub categories or individual foodstuffs mentioned in a sub-category. These regulations also provide indicative examples for each category. They also recommend maximum use level of additive in different categories.

Provisions for carry-over additive
Carry-over additive is the additive which is present in the food, other than by direct addition, as a result of carry-over from a raw material or ingredient used to produce the food.

Such additives are allowed in food as per these regulations
•    The amount of the additives in these does not exceed the specified maximum use level.
•    The food itself does not contain the carry over additive in a quantity greater than that shall be introduced by the use of raw material, or ingredients under proper. technological conditions or manufacturing practice, consistent with the provisions of these regulations.

Preservatives can keep food fresher for longer  periods of time, extending its shelf life.

Food preservatives also are used to slow or prevent changes in colour, flavour or texture and delay rancidity.
Difference between natural & artificial preservative
Preservatives are classified as  :
1.    Class I (natural preservatives)  -  such as salt, sugar, vinegar, syrup, spices, honey and edible oil. Natural preservatives made from natural sources such as fruit, plant, animal lard and insect.
Class I preservatives can be used without restriction - salt, sugar, spices, vinegar.
Their chemical composition is not altered and they are not mixed with any synthetic items either. These also have, in most cases, anti-oxidant properties. We know that Anti-oxidants delay the process of oxidation or ageing  as it were.
Pickles can last for years because of a potent combination of salt and oil – that acts like a natural preservative for the vegetable chunks.
                                                                                                       
2.    Class II (chemical or synthetic preservatives) such as benzoates, sorbets, nitrites and nitrates of sodium or potassium, sulfites, glutamates and glycerides. Artificial preservatives are made from synthetically.
These preservatives are also used to delay spoilage and contamination in foods, but these are artificially produced or synthetic in nature.  Ketchups, packed juices, baked goodies and spreads and jams could contain artificial preservatives.
Class II preservative use is restricted to only certain foods and the amount of the preservative which can be added to these foods is also specified under FSSAI rules. The presence of a Class II preservative has to be declared on the packaging/ label- sulphites, nitrates and nitrites, benzoic acid, sorbic acid.

GMP status:
All food additives subject to the provisions of this standard shall be used under conditions of good manufacturing practice, which include the following:
a.    The quantity of the additive added to food shall be limited to the lowest possible level necessary to accomplish its desired effect;
b.    The quantity of the additive that becomes a component of food as a result of its use in the manufacturing, processing or packaging of a food and which is not intended to accomplish any physical, or other technical effect in the food itself, is reduced to the extent reasonably possible; and,
c.    The additive is prepared and handled in the same way as a food ingredient.

(Sanjay Indani is food safety-regulatory advisor-trainer at SafeFoodz Solutions. Khusbu Shah is food safety advisor-trainer. They can be reached at safefoodz@gmail.com)
 
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