Law relating to establish Food Safety and Standards Authority of India (FSSAI) for science based standards for articles of food, etc., to ensure availability of safe and wholesome food for human consumption.
Food Safety and Standards Act, 2006
Act No. 34 of 2006
[23rd August, 2006]
An Act to consolidate the laws relating to food and to establish the Food Safety and Standards Authority of India for laying down science based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption and for matters connected therewith or incidental thereto
Be it enacted by Parliament in the Fifty-seventh Year of the Republic of India as follows:—
Statement of Objects and Reasons.—Multiplicity of food laws, standard setting and enforcement agencies pervades different sectors of food, which creates confusion in the minds of consumers, traders, manufacturers and investors. Detailed provisions under various laws regarding admissibility and levels of food additives, contaminants, food colours, preservatives, etc., and other related requirements have varied standards under these laws. The standards are often rigid and non-responsive to scientific advancements and modernisation. In view of multiplicity of laws, their enforcement and standard setting as well as various implementing agencies are detrimental to the growth of the nascent food processing industry and is not conducive to effective fixation of food standards and their enforcement.
2. In as early as in the year 1998, the Prime Minister’s Council on Trade and Industry appointed a Subject Group on Food and Agro Industries, which had recommended for one comprehensive legislation on Food with a Food Regulatory Authority concerning both domestic and export markets. Joint Parliamentary Committee on Pesticide Residues in its report in 2004 emphasized the need to coverage all present food laws and to have a single regulatory body. The Committee expressed its concern on public health and food safety in India. The Standing Committee of Parliament on Agriculture in its 12th Report submitted in April, 2005 desired that the much needed legislation on Integrated Food Law should be expedited.
3. As an on going process, the then Member-Secretary, Law Commission of India, was asked to make a comprehensive review of Food Laws of various developing and developed countries and other relevant international agreements and instruments on the subject. After making an in depth survey of the international scenario, the then Member-Secretary recommended that the new Food Law be seen in the overall perspective of promoting nascent food processing industry given its income, employment and export potential. It has been suggested that all acts and orders relating to food be subsumed within the proposed Integrated Food Law as the international trend is towards modernisation and convergence of regulations of Food Standards with the elimination of multi-level and multi-departmental control. Presently, the emphasis is on (a) responsibility with manufacturers, (b) recall, (c) Genetically Modified and Functional Foods, (d) emergency control, (e) risk analysis and communication and (f) food safety and good Manufacturing Practices and process control viz., Hazard Analysis and Critical Control Point.
4. In this background, the Group of Ministers constituted by the Government of India, held extensive deliberations and approved the proposed Integrated Food Law with certain modifications. The Integrated Food Law has been named as ‘The Food Safety and Standards Bill, 2005’. The main objective of the Bill is to bring out a single statute relating to food and to provide for a systematic and scientific development of Food Processing Industries. It is proposed to establish the Food Safety and Standards Authority of India, which will fix food standards and regulate/monitor the manufacturing, import, processing, distribution and sale of food, so as to ensure safe and wholesome food for the people. The Food Authority will be assisted by Scientific Committees and Panels in fixing standards and by a Central Advisory Committee in prioritization of the work. The enforcement of the legislation will be through the State Commissioner for Food Safety, his officers and Panchayati Raj/Municipal bodies.
5. The Bill, inter alia, incorporates the salient provisions of the Prevention of Food Adulteration Act, 1954 (37 of 1954), and is based on international legislations, instrumentalities and Codex Alimentaries Commission (which related to food safety norms). In a nutshell, the Bill takes care of International practices and envisages on overarching policy framework and provision of single window to guide and regulate persons engaged in manufacture, marketing, processing, handling, transportation, import and sale of food. The main features of the Bill are:
(a) movement from multi-level and multi-departmental control to integrated line of command;
(b) integrated response to strategic issues like novel/genetically modified foods, international trade;
(c) licensing for manufacture of food products, which is presently granted by the Central Agencies under various Acts and Orders, would stand decentralized to the Commissioner of Food Safety and his officer;
(d) single reference point for all matters relating to Food Safety and Standards, regulations and enforcement;
(e) shift from mere regulatory regime to self-compliance through Food Safety Management Systems;
(f) responsibility on food business operators to ensure that food processed, manufactured, imported or distributed is in compliance with the domestic food laws; and
(g) provision for graded penalties depending on the gravity of offence and accordingly, civil penalties for minor offences and punishment for serious violations.
6. The abovesaid Bill is contemporary, comprehensive and intends to ensure better consumer safety through Food Safety Management System and setting standards based on science and transparency as also to meet the dynamic requirements of Indian Food Trade and Industry and International trade.
The Bill seeks to achieve the aforesaid objectives.
Chapter I
PRELIMINARY
1. Short title, extent and commencement.
1. Short title, extent and commencement.—(1) This Act may be called the Food Safety and Standards Act, 2006.
(2) It extends to the whole of India.
(3) It shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint, and different dates[i] may be appointed for different provisions of this Act and any reference in any such provision to the commencement of this Act shall be construed as a reference to the coming into force of that provision.
2. Declaration as to expediency of control by the Union.
2. Declaration as to expediency of control by the Union.—It is hereby declared that it is expedient in the public interest that the Union should take under its control the food industry.
3. Definitions.
3. Definitions.—(1) In this Act, unless the context otherwise requires,—
(a) “adulterant” means any material which is or could be employed for making the food unsafe or sub-standard or mis-branded or containing extraneous matter;
(b) “advertisement” means any audio or visual publicity, representation or pronouncement made by means of any light, sound, smoke, gas, print, electronic media, internet or website and includes through any notice, circular, label, wrapper, invoice or other documents;
(c) “Chairperson” means the Chairperson of the Food Authority;
(d) “claim” means any representation which states, suggests or implies that a food has particular qualities relating to its origin, nutritional properties, nature, processing, composition or otherwise;
(e) “Commissioner of Food Safety” means the Commissioner of Food Safety appointed under Section 30;
(f) “consumer” means persons and families purchasing and receiving food in order to meet their personal needs;
(g) “contaminant” means any substance, whether or not added to food, but which is present in such food as a result of the production (including operations carried out in crop husbandry, animal husbandry or veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food or as a result of environmental contamination and does not include insect fragments, rodent hairs and other extraneous matter;
(h) “Designated Officer” means the officer appointed under Section 36;
(i) “extraneous matter” means any matter contained in an article of food which may be carried from the raw materials, packaging materials or process systems used for its manufacture or which is added to it, but such matter does not render such article of food unsafe;
(j) “food” means any substance, whether processed, partially processed or unprocessed, which is intended for human consumption and includes primary food to the extent defined in clause (zk), genetically modified or engineered food or food containing such ingredients, infant food, packaged drinking water, alcoholic drink, chewing gum, and any substance, including water used into the food during its manufacture, preparation or treatment but does not include any animal feed, live animals unless they are prepared or processed for placing on the market for human consumption, plants prior to harvesting, drugs and medicinal products, cosmetics, narcotic or psychotropic substances:
Provided that the Central Government may declare, by notification in the Official Gazette, any other article as food for the purposes of this Act having regards to its use, nature, substance or quality;
(k) “food additive” means any substance not normally consumed as a food by itself or 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 food but does not include “contaminants” or substances added to food for maintaining or improving nutritional qualities;
(l) “Food Analyst” means an analyst appointed under Section 45;
(m) “Food Authority” means the Food Safety and Standards Authority of India established under Section 4;
(n) “food business” means any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of manufacture, processing, packaging, storage, transportation, distribution of food, import and includes food services, catering services, sale of food or food ingredients;
(o) “food business operator” in relation to food business means a person by whom the business is carried on or owned and is responsible for ensuring the compliance of this Act, rules and regulations made thereunder;
(p) “food laboratory” means any food laboratory or institute established by the Central or a State Government or any other agency and accredited by National Accreditation Board for Testing and Calibration Laboratories or an equivalent accreditation agency and recognised by the Food Authority under Section 43;
(q) “food safety” means assurance that food is acceptable for human consumption according to its intended use;
(r) “food safety audit” means a systematic and functionally independent examination of food safety measures adopted by manufacturing units to determine whether such measures and related results meet with objectives of food safety and the claims made in that behalf;
(s) “Food Safety Management System” means the adoption of Good Manufacturing Practices, Good Hygienic Practices, Hazard Analysis and Critical Control Point and such other practices as may be specified by regulation, for the food business;
(t) “Food Safety Officer” means an officer appointed under Section 37;
(u) “hazard” means a biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect;
(v) “import” means bringing into India any article of food by land, sea or air;
(w) “improvement notice” means a notice issued under Section 32 of this Act;
(x) “infant food” and “infant milk substitute” shall have the meanings assigned to them in clauses (f) and (g) of sub-section (1) of Section 2 of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 (41 of 1992), respectively;
(y) “ingredient” means any substance, including a food additive used in the manufacture or preparation of food and present in the final product, possibly in a modified form;
(z) “label” means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stencilled, marked, embossed, graphic, perforated, stamped or impressed on or attached to container, cover, lid or crown of any food package and includes a product insert;
(za) “licence” means a licence granted under Section 31;
(zb) “local area” means any area, whether urban or rural, notified by the Commissioner of Food Safety, to be a local area for the purposes of this Act;
(zc) “manufacture” means a process or adoption or any treatment for conversion of ingredients into an article of food, which includes any sub-process, incidental or ancillary to the manufacture of an article of food;
(zd) “manufacturer” means a person engaged in the business of manufacturing any article of food for sale and includes any person who obtains such article from another person and packs and labels it for sale or only labels it for such purposes;
[ii][(ze) “Member” includes a part-time Member and the Chairperson of the Food Authority;]
(zf) “misbranded food” means an article of food—
(A) if it is purported, or is represented to be, or is being—
(i) offered or promoted for sale with false, misleading or deceptive claims either—
(a) upon the label of the package, or
(b) through advertisement, or
(ii) sold by a name which belongs to another article of food; or
(iii) offered or promoted for sale under the name of a fictitious individual or company as the manufacturer or producer of the article as borne on the package or containing the article or the label on such package; or
(B) if the article is sold in packages which have been sealed or prepared by or at the instance of the manufacturer or producer bearing his name and address but—
(i) the article is an imitation of, or is a substitute for, or resembles in a manner likely to deceive, another article of food under the name of which it is sold, and is not plainly and conspicuously labelled so as to indicate its true character; or
(ii) the package containing the article or the label on the package bears any statement, design or device regarding the ingredients or the substances contained therein, which is false or misleading in any material particular, or if the package is otherwise deceptive with respect to its contents; or
(iii) the article is offered for sale as the product of any place or country which is false; or
(C) if the article contained in the package—
(i) contains any artificial flavouring, colouring or chemical preservative and the package is without a declaratory label stating that fact is not labelled in accordance with the requirements of this Act or regulations made thereunder or is in contravention thereof; or
(ii) is offered for sale for special dietary uses, unless its label bears such information as may be specified by regulation, concerning its vitamins, minerals or other dietary properties in order sufficiently to inform its purchaser as to its value for such use; or
(iii) is not conspicuously or correctly stated on the outside thereof within the limits of variability laid down under this Act.
(zg) “notification” means a notification published in the Official Gazette;
(zh) “package” means a pre-packed box, bottle, casket, tin, barrel, case, pouch, receptacle, sack, bag, wrapper or such other things in which an article of food is packed;
(zi) “premises” include any shop, stall, hotel, restaurant, airline services and food canteens, place or vehicle or vessel where any article of food is sold or manufactured or stored for sale;
(zj) “prescribed” means prescribed by rules made by the Central Government or the State Government, as the case may be under this Act;
(zk) “primary food” means an article of food, being a produce of agriculture or horticulture or animal husbandry and dairying or acquaculture in its natural form, resulting from the growing, raising, cultivation, picking, harvesting, collection or catching in the hands of a person other than a farmer or fisherman;
(zl) “prohibition order” means an order issued under Section 33 of this Act;
(zm) “risk”, in 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;
(zn) “risk analysis”, in relation to any article of food, means a process consisting of three components, i.e., risk assessment, risk management and risk communication;
(zo) “risk assessment” means a scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterisation, (iii) exposure assessment, and (iv) risk characterisation;
(zp) “risk communication” means the interactive exchange of information and opinions throughout the risk analysis process concerning risks, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions;
(zq) “risk management” means the process, distinct from risk assessment, of evaluating policy alternatives, in consultation with all interested parties considering risk assessment and other factors relevant for the protection of health of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options;
(zr) “sale” with its grammatical variations and cognate expressions, means the sale of any article of food, whether for cash or on credit or by way of exchange and whether by wholesale or retail, for human consumption or use, or for analysis, and includes an agreement for sale, an offer for sale, the exposing for sale or having in possession for sale of any such article, and includes also an attempt to sell any such article;
(zs) “sample” means a sample of any article of food taken under the provisions of this Act or any rules and regulations made thereunder;
(zt) “specified by regulations” means specified by regulations made by the Food Authority;
(zu) “standard”, in relation to any article of food, means the standards notified by the Food Authority;
(zv) “State Government” in relation to a Union territory means the Administrator of that Union territory appointed by the President under Article 239 of the Constitution;
(zw) “substance” includes any natural or artificial substance or other matter, whether it is in a solid state or in liquid form or in the form of gas or vapour;
(zx) “sub-standard”, an article of food shall be deemed to be sub-standard if it does not meet the specified standards but not so as to render the article of food unsafe;
(zy) “Tribunal” means the Food Safety Appellate Tribunal established under Section 70;
(zz) “unsafe food” means an article of food whose name, substance or quality is so affected as to render it injurious to health:—
(i) by the article itself, or its package thereof, which is composed, whether wholly or in part, of poisonous or deleterious substances; or
(ii) by the article consisting, wholly or in part, of any filthy, putrid, rotten, decomposed or diseased animal substance or vegetable substance; or
(iii) by virtue of its unhygienic processing or the presence in that article of any harmful substance; or
(iv) by the substitution of any inferior or cheaper substance whether wholly or in part; or
(v) by addition of a substance directly or as an ingredient which it not permitted; or
(vi) by the abstraction, wholly or in part, of any of its constituents; or
(vii) by the article being so coloured, flavoured or coated, powdered or polished, as to damage or conceal the article or to make it appear better or of greater value than it really is; or
(viii) by the presence of any colouring matter or preservatives other than that specified in respect thereof; or
(ix) by the article having been infected or infested with worms, weevils or insects; or
(x) by virtue of its being prepared, packed or kept under insanitary conditions; or
(xi) by virtue of its being misbranded or substandard or food containing extraneous matter; or
(xii) by virtue of containing pesticides and other contaminants in excess of quantities specified by regulations.
(2) Any reference in this Act to a law which is not in force in the State of Jammu and Kashmir shall, in relation to that State, be construed as a reference to the corresponding law, if any, in force in that State.
References
[i] Sections 4 to 10, 87, 88, 91 and 101, came into force, w.e.f. October 15, 2007 [Vide S.O. 1758(E), dated 15-10-2007].
Sections 3 and 30, came into force, w.e.f. May 28, 2008 [Vide S.O. 1246(E), dated 28-5-2008].
Section 90, came into force, w.e.f. August 28, 2008 [Vide S.O. 2127(E), dated 28-8-2008].
Sections 16 to 18, 81 to 86, 92 and 93, came into force, w.e.f. November 18, 2008 [Vide S.O. 2678(E), dated 18-11-2008].
Sections 11 to 15, came into force, w.e.f. March 9, 2009 [Vide S.O. 650(E), dated 9-3-2009].
Section 99, came into force, w.e.f. June 29, 2009 [Vide S.O. 1575(E), dated 29-6-2009].
Sections 36 to 47, came into force, w.e.f. July 31, 2009 [Vide S.O. 1868(E), dated 31-7-2009].
Sections 19 to 21 (both inclusive), Sections 23 to 29 (both inclusive), Sections 31 to 35 (both inclusive), Section 48 to 80 (both inclusive), Section 89, Sections 94 to 98 (both inclusive) and Section 100, come into force, w.e.f. July 29, 2010 [Vide S.O. 1855(E), dated 29-7-2010].
Section 22 [except in respect of matters relating to the genetically engineered or modified food as explained in clause (2) of the Explanation], came into force, w.e.f. August 18, 2010 [Vide S.O. 2038(E), dated 18-8-2010].
[ii] Subs. by Act 13 of 2008, S. 2 (w.e.f. 7-2-2008).
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