Nov 9, 2015

FSSAI issues draft regulations on additives for horizontal food category

FSSAI, in a recent development, has issued draft regulations to amend the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, regarding harmonisation of horizontal food. These regulations are termed as Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2015. They talk about horizontal food category that includes a defined food category system, which is also prescribed in the proposed draft.
The amendments shall come into force with effect from ensuing January 1 or July 1 of the year, as the case may be, subject to a minimum of 180 days from the date of final notification of these regulations in the Official Gazette, says the draft of the amendment.
According to sources, this regulation is part of the process of harmonisation that was completed by the apex food regulator for harmonisation of standards in accordance with the Codex.
This amendment is regarding food additives which are included in these regulations having been assigned as Acceptable Daily Intake (ADI) or determined on the basis of other criteria like food safety. The use of additives in conformance with these regulations is considered to be technologically justified, says the draft.
According to the draft, food additive means any substance not normally consumed as a food by itself and not normally used as a typical ingredient of the food, whether or not it has nutritive value, the intentional addition of which to food for a technological (including organoleptic) purpose in the manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food results, or may be reasonably expected to result (directly or indirectly), in it or its by-products becoming a component of or otherwise affecting the characteristics of such foods. The term does not include contaminants or substances added to food for maintaining or improving nutritional qualities.
While ADI means the amount of food expressed on a body weight basis that can be ingested daily over a lifetime without appreciable health risk. An additive meeting this criterion must be used within the bounds of good manufacturing practice as defined in Section3.1.1 (8) of the draft.
Further, these regulations set forth the conditions under which food additives may be used in all foods, whether or not they have previously been permitted by the Food Safety and Standards (Food Standards and Food Additives) Regulations, 2011.
Besides, the draft also talks about the foods in which additives may not be used. “Food categories or individual food items in which the use of food additives is not acceptable, or where use should be restricted, are defined by this regulation,” says the draft.
The other definition includes Maximum Use Level of an additive, which is the highest concentration of the additive determined to be functionally effective in a food or food category and agreed to be safe. It is generally expressed as mg additive/kg of food. The maximum use level will not usually correspond to the optimum, recommended, or typical level of use. Under GMP, the optimum, recommended, or typical use level will differ for each application of an additive and is dependent on the intended technical effect and the specific food in which the additive would be used, taking into account the type of raw material, food processing and post-manufacture storage, transport and handling by distributors, retailers, and consumers, says the draft.
Further according to the draft, justification is required for addition of additives.
The use of food additives is justified only when such use has an advantage, does not present an appreciable health risk to consumers, does not mislead the consumer, and serves one or more of the technological functions as specified in these regulations and the needs set out from (a) to (d) below, and only where these objectives cannot be achieved by other means that are economically and technologically practicable:
a) To preserve the nutritional quality of the food; an intentional reduction in the nutritional quality of a food would be justified in the circumstances dealt with in sub-paragraph (b) and also in other circumstances where the food does not constitute a significant item in a normal diet;
b) To provide necessary ingredients or constituents for foods manufactured for groups of consumers having special dietary needs;
c) To enhance the keeping quality or stability of a food or to improve its organoleptic properties, provided that this does not change the nature, substance or quality of the food so as to deceive the consumer;
d) To aid in the manufacture, processing, preparation, treatment, packing, transport or storage of food, provided that the additive is not used to disguise the effects of the use of faulty raw materials or of undesirable (including unhygienic) practices or techniques during the course of any of these activities.
Also, food additives used in accordance with this standard shall be of appropriate food grade quality and should at all times conform with the applicable specifications of identity and purity recommended by these regulations. In terms of safety, food grade quality is achieved by conformance of additives to their specifications as a whole (not merely with individual criteria) and through their production, storage, transport, and handling in accordance with GMP, says the draft.
Food Category System
The food category system is a tool for assigning food additive uses in these regulations. The food category system applies to all foodstuffs. The food category descriptors are not to be legal product designations nor are they intended for labelling purposes. The food category system is based on the following principles:
(a) The food category system is hierarchical, meaning that when an additive is recognised for use in a general category, it is recognised for use in all its sub-categories, unless otherwise stated. Similarly, when an additive is recognised for use in a sub-category, its use is recognised in any further subcategories or individual foodstuffs mentioned in a sub-category.
(b) The food category system is based on product descriptors of foodstuffs as marketed, unless otherwise stated.
(c) The food category system takes into consideration the carry-over principle. By doing so, the food category system does not need to specifically mention compound foodstuffs (e.g. prepared meals, such as pizza, because they may contain, pro rata, all the additives endorsed for use in their components), unless the compound foodstuff needs an additive that is not endorsed for use in any of its components.
(d) The food category system is used to simplify the reporting of food additive uses for assembling and constructing these regulations.

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