Jf ISS CAL 000 ssecry ao stannanos "itnist oF a Inspiring Trust, Assuring Safe & Nutritious Food Ministry of Health and Family Welfare, Government of Inia ' MANUAL FOR FOOD SAFETY OFFICERS One Nation One Food LawTABLE OF CONTENTS PREFACE on ‘ACRONYMS 02 IMPORTANT WEB LINKS 03 General Instructions for Food Safety Officers 04 Food Safety, the FSS Act, Rules and Regulations 05 FSSAI, Food Safety Enforcement and State Food Authorities 4 Food Standards 2 Food Safety Officer 38 Licensing and Registrations of Food Businesses 3 “chapter Inspections of Various Food Establishments 54 [ERREA sompting and snatyss 89 “chapter 8 Food Safety Surveillance 104 Food Recall 107 Prohibition & Restriction on Sales 4 ‘Adjudication, Prosecution, Offences and Penalties ai Connect to Citizens 128 Social and behavioural change 137 ‘Third Party Food Safety Audits 143 BIS and AGMARK 148 Common adulterants and Quick Tests for detection of these adulterants 152 Suggestive Annual Surveillance Plan 158 Glossary 164 FEEDBACK FORM 169MANUAL FOR FOOD SAFETY OFFICERS PREFACE “Manual for Food Safety Officers” is for guidance of Food Safety Officers (FSOs) to ‘ensure food regulatory compliance under the Food Safety and Standards Act, 2006 and Rules and Regulations made thereunder. Umbrella Food Safety law enacted in 2006 envisaged a unified food safety law in the spirit of “One Nation One Food Law” to ensure food safety is maintained in a consistent and effective manner across the country. However, there is lack of uniform approach in implementation of the food safety law in the States/UTs. FSO being the field level officer vested with regulatory functions and powers is responsible for uniform and consistent application of regulatory provisions. FSSAI has come out with this Manual to ensure transparency, objectivity and consistency in implementation and application of food law throughout the country. This Manual takes into account the role of FSO in particular and. covers the regulatory provisions, regulations, inspections, sampling, surveillance and procedures to be followed by FSOs in discharging their duties. All stakeholders including States regulators and food business are requested to give their feedback and make suggestions in the “Feedback Form” provided in this Manual. This manual will be updated from time to time so as to make it more relevant and useful inthe years tocome. Pawan Agarwal CEO, FSSAI on(02 | MANUAL FOR FOOD SAFETY OFFICERS ACRONYMS oo Adjusting Officer co Chief Executive Officer [mo Designated Officer a (Ho Food Business Operator | oscons Food Safety Compliance through Regular Inspections and Sampling. “sme Food Safety Training And Certification saa Food Safety and Standards Act, 2006 sa Food Safety and Standards Authority of India Pee ster otter [as Food Licensing registration system Cintower Indian Food Laboratory Network ce Prevention of Food Adulteration Act, 1954 vas Risk Based Inspection System ce Safe and Nutritious FoodMANUAL FOR FOOD SAFETY OFFICERS | 03 IMPORTANT WEB LINKS 1 10. 11 12, 2B. 4. 15. 16. v7. 18, 19. 20. 21. 22, FSSAI Food Safety and Standards Act, 2006 FSSAI Rules FSSA Regulations FLRS (Food Licensing and Registration System) FICS (Food Import Clearance System) INFOLNET (Indian Food Laboratory Network) Food Safety Connect Android Food Safety Connect ~ Online portal Water Portal Food Safety Training and Certification (FoSTaC) Food Safety on Wheels. (Mobile Labs) National Milk Quality Survey Food Safety Display Boards Food Fortification SNF Portal(Safe & Nutritious Food) FSSAI Books (Pink book, DART, Yellow book) Food Smart Consumer website FSKAN (Food Safety Knowledge Assimilation Network Portal FSSAI Facebook page FSSAI Twitter FSSAI Youtube Web Link: wwwfssai.gou.in http://www.fssai.gov.in/home/fss-legislation/food-safety- and-standards-act. html hittp://www.fssai.gov.in/home/fss-legislation/food-safety- and-standards-rule. html http://www.fssai.gov.in/home/fss-legislation/fss- regulations.html https://foodlicensing fssai.gov.in/index.aspx https: //ics.fssai.gov.in/AOLogin.aspx?ReqlD=99887766 https://infolnet fssai.gov.in/#t Apphttps://play.google.com/store/apps/details?id= com fssai-fssai&hi=en https://foodlicensing fssai.gov.in/cmsweb/ https://safewaterfssai.gov.in/CleanWater/home hittps://fostac.fssai.gov.in/ http://www.fssai.gow.in/home/food-testing/Food-Safety- on-Wheels.htm! https://fssai.gov.in/MilkSurvey/ http://www.fssai.gov.in/home/safe-food-practices/food- safety-display-boards.html httpi//ffre-fssai.gov.in/ffre/home http://snfportal.in/ http://www.fssai.gov.in/home/capacity-building/FSSAI- Books.htm! http://foodsmart fssai.gov.in/ https://fssai.gowin/fskan hnttps://www.facebook.com/fssai htpsi//twitter-com/fssaiindia https://www.youtube.com/user/Foodsafetyinindia(04 | MANUAL FOR FOOD SAFETY OFFICERS General Instructions for Food Safety O' Tey 1. This manual has been prepared with a view to help Food Safety Officers in discharge of their duties efficiently. This manual serves as a quick reference book and covers subjects like the Food Safety and Standards Act, 2006, Rules, Regulations, inspections, surveillance, regulatory authorities, functions and duties, common adulterants etc which are expected to be in good knowledge of Food Safety Officers. FSOs are advised to study the documents ‘covered in this manual for thorough knowledge, Most of the documents including the Food Safety and Standards Act, Rules and Regulations discussed in the Manual are available on the website of FSSAI (http://www.fssai.gov.in). A list of important web links is given in this manual for ready reference. 2, The FSO should stay up to date with all the regulations, amendments, advisories etc. that are Issued and notified under the FSS Act. FSSAI, from time to time, issues instructions, uidelines and clarifications and takes initiatives and policy interventions which are placed ‘on the FSSAI website for information. FSO may regularly visit FSSAI website to keep themselves updated with latest developments. FSSAI also conducts induction, refresher and focused training for regulatory officers. 3. The Food Safety and Standards Act, 2006 focuses on self-compliance by Food Business Operators rather than a pure regulatory regime. Food Safety Officer, being the field level officer in direct line of contact with FBOs, should play the important role of facilitator in helping the food business operators comply with food regulatory provisions. 4, F50s should at all times maintain absolute integrity, devotion to duty and do nothing which is unbecomi ‘of a public servant. They should, in the performance of official d the exercise of powers conferred on them, actin their best judgement as per guidelines and provisions of the Act, Rules and Regulations. 5. The whole process of inspection and sampling should be transparent and Impartial. The food safety officers should act in an impartial, transparent and objective manner during the entire process of Inspection and Sampling. 6. They should also take immediate action on complaints received from consumers duly informing and getting directions from their senior officer. ‘A feedback form is given in the Manual. FSOs are requested to give their invaluable suggestions in the feedback form to further improve and enrich this manual.eA Ana Food Safety, the FSS Act, Rules and Regulations(06 | MANUAL FOR FOOD SAFETY OFFICERS A. Food Safety 1 Food Safety is important for maintaining overall health and well being.The Food Safety & Standards Act, 2006 defines Food Safety as an “assurance that food is acceptable for human consumption according toits intended use.” Food Safety ensures that food is safe for human consumption and involves handling, preparation, and storage of food in ways that prevent food borne illness. Food safety considerations include the origins of food including the practices relating to food labelling, food hygiene, food additives and contaminants, as well as policies on biotechnology and food and guidelines for the management of import and export, inspection and certification systems for foods. Food Safety is important to prevent microbes and contaminants from getting into foods and water. Microbes ‘or contaminants not only cause diseases to human beings, but theyalso destroy valuable nutrientsin the food, Millions of people fall ill every year and may die as a result of consuming unsafe food. Proper food preparation can prevent most of the food borne diseases. Infections caused due to consumption of unsafe food have a bigger impact on populations with poor & fragile health, infants, elderly etc., and are usually more severe & maybefatal. There are various opportunities for food contamination to take place. Food supply chain involves a range of stages including on farm production, harvesting, processing, storage, transportation, distribution, etc. before itreaches the consumers and hence opportunities for food contamination increase. Further, Globalization of food business is making the food supply chain longer and complicates food-borne disease outbreak investigation and product recallin case of emergency. Food contamination has far reaching effects beyond direct public health consequences - it undermines food exports, tourism, 100ds of food handlers and economic development, both in developed and develoy countries. Food safety is multi- sectoral and multidisciplinary. To improve food safety, a multitude of different professionals need to work together, making use of the best available science and technologies. Different governmental departments and agencies, encompassing public health, agriculture, education and trade, collaborate and communicate with each other and engage with civil society including consumer groups. Food safety is a shared responsibility between governments, industry, producers, academia, and consumers. Everyone has a role to play. Achieving food safety is a multi-sectoral effort requiring expertise from a range of different disciplines - toxicology, microbiology, parasitology, nutrition, health economics, and human and veterinary medicine. Local communities, women's groups and school education also play an important role. Consumers must be well informed on food safety practices. People should make informed and wise food choices and adopt adequate behaviours. They should know common food hazards and how to handle food safely, using the information provided in food labelling.FOOD SAFETY, THE FSS ACT, RULES AND REGULATIONS | 07 B. Unsafe Food (a) The Food Safety & Standards Act, 2006 defines Unsafe Food as an article of food whose nature, substance or ualityis so affected as to render it injurious to health:- (i) by the article itself, or its package, which is composed, whether wholly or in part, of poisonous or deleterious substance; or (ii). by the article consisting, wholly or in part, of any filthy, putrid, rotten, decomposed or diseased animal substance or vegetable substance; or by virtue ofits unhygienic processing or the presence in that article of any harmful substance; or by the substitution of any inferior or cheaper substance whether wholly orin part; or byaddition ofa substance directly or as an ingredient which is not permitted; or by the abstraction, wholly or in part, of any ofits constituents; or by the food article being so coloured, flavoured or coated, powdered or polished, as to damage or conceal the article or tomake it appear better or of greater value thanitreally is; or by the presence of any colouring matter or preservatives other than that specified for that article of food; (ix) bythe article having been infected or infested with worms, weevils, or insects; or (x) bythe foodarticle being prepared, packed or kept under insanitary conditions; or (xi) by the article being misbranded or sub-standard or food containing extraneous matter; or (xii) by the food article containing pesticides and other contaminants in excess of quantities specified by regulations. C. The Food Safety & Standards Act 2006 (i) Background ey Prior to Food Safety and Standards Act, 2006, there was multiplicity of food laws, food related legislation was fragmented and there was lack of uniformity in approach and effect. Moreover, there were various Ministries/ organizations/ agencies for standard setting and enforcement of different sectors of food. Asa result, there were varied quality/safety standards with rigidness. The existing laws on food failed to match the rapid evolution of food related technologies and advancement in production, storage, distribution, sale, etc. There were few laboratories with poor laboratory infrastructure coupled with thin spread of manpower, and other resources non-conducive to effective fixation of standards. There was poor information dissemination to consumer level It is in this background that the need for a single law with single regulatory body at national level on all food safety and related matters was felt to ensure holistic approach, uniformity and effective implementation. The Central Government declared its intention in this behalf in the Budget Speech in 2002. The work pertaining to consolidation of various Acts/ Orders governing food was entrusted to the Ministry of Food Processing Industries, who piloted the Food Safety and Standards Bill, 2005 which was finally enacted as the Food Safety and Standards Act, 2006 by the Parliament and the same was published in the Gazette of India (Extraordinary) Part ll, Section 1 on 24th August, 2006 after receiving assent of the President on 23rd August, 2006. The Food Safety and Standards Act, 2006 was enacted as a consolidated Act and the following food acts and orders were(08 | MANUAL FOR FOOD SAFETY OFFICERS (a) Prevention of Food Adulteration Act, 1954 (b) Fruit Products Order, 1955 (c) Meat Food Products Order, 1973 (d) Vegetable Oil Products (Control) Order, 1947 (e) Edible Oils Packaging (Regulation) Order, 1998 (f) Solvent Extracted Ol, De-oiled Meal, and Edible Flour (Control) Order, 1967 (g) Milkand Milk Products Order, 1992 (h)Anyotherorder under Essential Commodities Act, 1955 relating tofood 3. The FSS Act was a result of extensive consultations with various stakeholders and series of discussions/ deliberations in the Inter-Ministerial Group and Standing Parliamentary Committee meetings and its clearance from the Group of Ministries. The Ministry of Health and Family Welfare was finally designated as the ‘Administrative Ministry for the purposes ofthe FSS Act, 2008. (ii) Salient Features of the FSS Act, 2006 1. The Food Safety and Standards Act, 2006 marks a shift from a multi-level toa single line of control with focus on self-compliance rather than a pure regulatory regime. It envisages regulation of manufacture, storage, distribution, sale and import of food to ensure availability of safe and wholesome food for human consumption ‘and for consumers connected therewith. It provides for establishment of FSSAI as. single reference point forall matters relating to food safety, standards and wholesome/ nutri 1us foods, regulations and enforcement. 2. The Act extends to the whole of India and provides for uniform licensing/ registration regime across the Centre ‘and the States. It also offers Integrated response to strategic issues like Novel foods, genetically modified foods, international trade etc. The some of salient features the Act may be summarized as under:- (2) Decentralisation of licensing for food products. It empowers States to issue Registration and State License, (b) Effective, transparent and accountable regulatory framework. It has well defined functions, powers and responsibilities of various food authorities, bodies and committees. (c) Emphasises on gradual shift from regulatory regime to self compliance (d) Regulation of food imported inthe country (€) Provision for food recall. (f) Surveillance (e) Envisages large network of food laboratories. (h) New justice dispensation system for fast track disposal of cases. (1) Provision for graded penalties. (i) Consistency between domestic and international food policy measures without reducing safeguards to publichealth and consumer protectio.FOOD SAFETY, THE FSS ACT, RULES AND REGULATIONS | 09 (k) The act emphasizes on training and awareness program regarding food safety for business operators, consumersand regulators. (iii) Parts ofthe FSS Act, 2006 ‘The FSS Act, 2006 is organised through a total of 12 Chapters. A brief description of these chaptersis given below: Chapter-I: Preliminary This section consists of the Short Title, extent and commencement, Declaration as to expediency of control by the Union, and Definitions. Chapter-lI: Food Safety and Standards Authority of India This Chapter, containing Sections 4 to 17, provides for establishment of the Food Safety and Standards Authority of India, terms and conditions of appointment and removal of Chairman and the members and their terms of office and other conditions, Officers and other employees of the Food Authority, Functions of the Chief Executive Officer, establishment of the Central Advisory Committee and its functions, establishment of Scientific Panels and the Scientific Committee and the procedure for the Scientific Committee and the Scientific Panels. The chapter further details the duties and functions of the Food Authority to regulate and monitor the manufacture, processing, distribution, sale and import of food. It also provides for the procedures for conduct of meetings of the Food Authority, transaction of business at its meetings and procedure of voting by Members, etc. Chapter -II!: General Principles of Food Safety Comprising only Section 18, this chapter contains provisions on the general principles of Food Safety, factors to be taken into account while framing regulations or specifying the Standards under the Act, and the principles to be observed in administration of the Act by the Central Government, the Food Authority, the State Government and other agencies, while enforcing or implementing the provisions of the Act. The said authorities shall be guided by the general principles of Food Safety such as risk analysis, risk assessment, risk management, risk communication, transparent public consultation, protection of consumer interests, etc. It empowers the Food Authority to notify other general principles fromtime to timeas per the requirements. Further, it stipulates that the provisions of this Act shall not apply to any farmer, or fisherman or farming operations or crops or livestock or aquaculture, and supplies used or produced in farming or products of crops produced by a farmer at farm level ra fisherman in his operations. Chapter /: General provisions as to articles of food Comprising of Sections 19 to 24, this chapter stipulates that no article of food shall contain contaminants, naturally occurring toxic substances or toxins or hormone or heavy metals, insecticides, pesticides, veterinary drugs residues, antibiotic residues, solvent residues, pharmacological active substances and micro-biological counts in excess of such quantities as may be specified by the regulations. Section 19 prohibits use of food additives or processing aids other than, those prescribed under the Standards/ regulations. Section 22 places a restriction on various categories of food, which arent in accordance with the standards prescribed under the regulations. Section 23 deals with the subject of packaging and labelling requirements of food. Section 24 places restrictions on10 | MANUAL FOR FOOD SAFETY OFFICERS. misleading advertisements and prohibits use of unfair trade practices. It also provides that packaged food product shall be marked and labelled as specified. It prohibits deceptive practices to mislead the public regarding the standards, quality, quantity, usefulness or giving of any guarantee of the efficacy that is not based on an adequate or scientific justification thereof. Chapter- V: Provisions Relating to Import Containing only Section 25, this chapter mandates that all imports of articles of food are subject to the provisions of the Act. It provides that no person shall import into India any article of food in contravention of the Act or any rules and regulations made thereunder. It also provides that the Central Government shall, while prohibiting, restricting or otherwise regulating import of articles of food under the Foreign Trade (Development and Regulation) Act, 1992 follows the standards laid down by the Food Authority under the provisions of this Act. Chapter -VI: Special Responsibilities as to Food Safety This chapter, containing Sections 26 to 28, provides for the responsibilities of the food business operator to ensure that. the articles of food satisfy the requirements of the Act and the rules and regulations made thereunder at all stages of production, processing, import, distribution and sale within the businesses under his control. Section 27 deals with the liabilities of the manufacturers, distributors and sellers of articles of food if they do not conform to the food safety requirements of the Act and the rules and regulations made thereunder. Section 28 spells out the Food Recall procedures and the responsibilities of a Food Business Operator to withdraw the Food from market in case the same is, ‘non-compliant with the provisions of the Act and the regulations framed thereunder. Chapter -Vil: Enforcement of the Act Sections 29 to 42 of the Act comprised in this Chapter deal with the enforcement related provisions including the responsibilities of the Food Authority and the State Food Authorities. Provisions for appointment of Commissioner of Food Safety of the State, licensing and registration of food business, improvement notices, prohibition orders, emergency prohibition notices and orders, notification of food poisoning, appointment of the Designated Officer, Food Safety Officer and their powers, liabilities, powers of search, seizure, prosecution and procedure thereof, and the provision for a purchaser to have the food analysed are contained in these sections. Chapter - Vill: Analysis of Food Sections 43 to 47 included in this chapter contain the provisions relating to recognition and accreditation of laboratories, research institutions and referral food laboratories, food analyst, functions of the food analyst and the provisions for sampling and analysis of food. Chapter - IX: Offences and Penalties This chapter, consisting of Sections 48 to 67, deals with various offences and penalties for selling food not of thenature or substance or quality demanded, sub-standard food, misbranded food, misleading advertisements, for food containing extraneous matter, for unhygienic or unsanitary processing, for possessing adulterant. The chapter contains provisions for punishment for unsafe food, for interfering with seized items, for false information, for obstructing or impersonating, a Food Safety Officer, for carrying out a business without license and compensation in case of injury or death of a consumer.FOOD SAFETY, THE FSS ACT, RULES AND REGULATIONS | 11 Chapter - X: Adjudication and Food Safety Appellate Tribunal Comprising of Sections 68 to 80, this chapter authorises the state governments to notify the adjudicating officer in the district. It defines the powers to compound offences, the powers of the designated officers, establishment of the Food Safety Appellate Tribunals and the procedures and powers of the Tribunal. The chapter bars the jurisdiction of courts in the mattersin which the adjudicating officer or Tribunal is empowered by the act. The act provides that the courts can try, the cases summarily. The Act also provides for the special courts and public prosecutors for the offences related to the food. Chapter -XI: Finance, Accounts, Audit and Reports The Chapter contains Sections 81 to 84 requiring the Food Authority to prepare an Annual Budget showing the estimated receipts and expenditure of the Food Authority. The Central Government shall make grants of such some of money as it, deems fit. It provides that the Food Authority shall maintain proper accounts and an annual statements of accounts. The Food Authority s required to prepare an Annual Report, which isto be laid before each House of Parliament. Chapter -XIl: Miscellaneous This chapter, containing Sections 85 to 101, empowers the Central Government to issue directions to Food Authority, State Governments and obtain reports and returns. The chapter gives over riding effect of this Act over all other food related laws. It empowers the Central Government to make rules and the Food Authority to make regulations. The chapter also gives State Governments powers to make rules and the procedure for rewards and the procedure for recovery of penaltiesimposed. Schedules: There are two Schedules given at the end of the Act. While the First Schedule contains the five zones into which all the States and UTs have been grouped, the Second Schedule contains the Act and various orders which stand repealed with the coming into force ofthis Act. ‘There are other laws like BIS and AGMARK relating to Food. These laws are covered at Annexure-I. D. Food Safety and Standards Rules, 2011 The Food Safety and Standards Act, 2006 under Section $1 empowers the Central Government to make rules by notification the Official Gazette, for carrying out the provisions of the FSS Act. Such rules may provide for all or any ofthe following matters, namely: (a) salary, terms and conditions of service of Chairperson and Members other than ex officio Members under subsection (2) and the manner of subscribing to an oath of office and secrecy under sub-section (3) of section 7; (b) qualifications of Food Safety Officer under sub-section (1) of section 37; (c)_themanneroftaking the extract of documents seized under sub-clause (8) of section 38; (a) determination of cases for referring to appropriate courts and time-frame for such determination under sub- section (4) of section 42; (e) qualifications of Food Analysts under section 45; 6112 | MANUAL FOR FOOD SAFETY OFFICERS. (f) the manner of sending sample for anal subsection (1) of section 47; and details of the procedure to be followe this regard under (g) the procedure to be followed in adjudication of cases under sub-section (1) of section 68; (h) qualifications, terms of office, resignation and removal of Presiding Officer under sub-section (4), the procedure of appeal and powers of Tribunal under sub-section (5) of section 70; (I) anyother matter relating to procedure and powers of Tribunal under clause (g) of sub-section (2) of section 71; (i) the fee to be paid for preferring an appeal tothe High Court under subsection (1) of section 76; (k) form andtime of preparing budget under sub-section (1) of section 81; (i) formand statement of accounts under sub-section (1) of section 83; (m) he form and time for preparing annual report by Food Authority under sub-section (1) of section 84) and (n) any other matter which is required to be, or may be, prescribed or in respect of which provision is to be made by rulesby the Central Government. Inexercise of the powers conferred by the Act, the Central Government notified the Food Safety and Standards Rules in 2008 regulating the salaries, allowances and other services of Chairperson and Members other than ex officio Members of Food Authority. Subsequently Central Government came up with comprehensive Food Safety and Standards Rules 2011 to regulate various subject given under Section 91 of the Act. E. The Food Safety and Standards Regulations, 2011 (a) The Food Safety and Standards Act, 2006 under Section 92 provides that the Food Authority may, with the previous approval of the Central Government and after previous publication, by notification, make regulations consistent with this Act and the rules made thereunder to carry out the provisions of this Act.Such regulations may provide for all or any of the following matters, namely:~ (i)_ salaries and other conditions of service of officers and other employees of the Food Authority under sub- section (3) of section 9; rules of procedure for transaction of business under subsection (5) of section 11; other functions of the Central Advisory Committee under sub-section (2) of section 12, 62 procedure of Scientific Committee and Panels under subsection (4) of section 15; (v) notifying standards and guid sub-section (2) of section 16; es in relation to articles of food meant for human consumption under (vi)_ procedure to be followed by Food Authority for transaction of business atts me (2)ofsection 17; igs under sub-section making or amending regulations in view of urgency concerning food safety or public health under clause (d) of sub-section (2) of section 18; (vii) limits of additives under section 19; (ix) limits of quantities of contaminants, toxic substance and heavy metals, etc., under section 20;FOOD SAFETY, THE FSS ACT, RULES AND REGULATIONS | 13, (9) tolerance limit of pesticides, veterinary drugs residues, etc, under section 21; (xi) the manner of marking and labelling of foods under section 23; (xii) form in which guarantee shall be given under sub-section (4) of section 26; (xiii) conditions and guidelines relating to food recall procedures under subsection (4) of section 28; (xiv) regulations relating to functioning of Food Safety Officer under subsection (5) of section 29; (xv) notifying the registering authority and the manner of registration; the manner of making application for obtaining license, the fees payable therefore and the circumstances under which such license may be cancelled or forfeited under section 31; (xvi) the respective areas of which the Designated Officer shall be in-charge for food safety administration under subsection (1) of section 36; procedure in getting food analysed, details of fees etc., under sub-section (1) of section 40;63, functions, procedure to be followed by food laboratories under sub-section (3) of section 43; procedure to be followed by officials under sub-section (6) of section 47; financial regulations to be adopted by the Food Authority in drawing up its budget under sub-section (2) ofsection 81; (xxi). issue guidelines or directions for participation in Codex Meetings and preparation of response to Codex matters; and (xxii) any other matter which is required to be, or may be, specified by regulations or in respect of which provision is to be made by regulations. (b) In exercise of the powers conferred by the Act, the Food Authority has from time to time brought out a number of Regulations to regulate the subjects mentioned in Section 92 of the FSS Act. Some important Regulations are given below: (i) Food Safety and Standards Authority of india Business Transaction Regulations, 2010 (ii) Food Safety and Standards (Licensing and Registration of Food Businesses) Regulation, 2011 (iii) Food Safety and Standards (Food Product Standards and Food Additives) Regulation, 2011 (iv) Food Safety and Standards (Prohibition and Restriction on Sales) Regulation, 2011 (v) Food Safety and Standards (Packaging and Labelling) Regulation, 2011 (vi) Food Safety and Standards (Laboratory and Sampling Analysis) Regulation, 2011 (vii) Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical Purpose, Functional Foods and Novel Food) Regulations, 2016 (viii) Food Safety and Standards (Food Recall Procedure) Regulation, 2017 (ix) Food Safety and Standards (Import) Regulation, 2017eA An 4 FSSAI, Food Safety Enforcement and State Food AuthoritiesFSSAl, FOOD SAFETY ENFORCEMENT AND STATE FOOD AUTHORITIES | 15 A. Food Safety and Standards Authority of India (FSSAI) ‘The Food Safety and Standards Authority of India (FSSAl) was established in 2008 under the aegis of the Ministry of Health and Family Welfare with the mandate 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 to enforce the provisions of the FSSAct. ‘At the Apex level there is Food Authority which is a single reference point for all matters related to food safety and standards in the country. The Food Authority is assisted by Scientific Committees and Panels in setting standards and. the Central Advisory Committee in coordinating with enforcement agencies. The Food Authority guides and regulates all persons engaged in manufacturing, processing, import transportation, storage, distribution and retail of food, on issues of food safety and nutrition with primary responsibility for enforcement largely with the State Food Safety Commissioners. The Chairperson and Chief Executive Officer of FSSAI are appointed by the Central Government. The Head office of the Authority is located at FDA Bhawan, Kotla Road, New Delhi-110002 1. Role of FSSAI The main role of Authority isto regulate and monitor, manufacture, processing, distribution, sale and import of food while ensuring safe and wholesome food to the consumers. The Act lays down the following main function for discharge by the Authority. (2) Prescribing the Standards & Guidelines in relation to food and specified appropriate system for enforcement. (b) Specifying limits for Additives, Contaminants, Pesticides & Veterinary Drug Residues, Heavy Metals, Processing Aids, Mycotoxins, Antibiotics and Pharmacological active substances and Irradiated Foods. (6) Lay down food labelling standards including claims on health, nutrition, special dietary uses and food category system for foods. (a) Lay down methods of sampling, analysis and exchange of information among enforcement agencies prescribing procedures and guidelines for accreditation of certification bodies and laboratories. (@) Taking up, summarizing and analyzing relevant scientific and technical data on incidence and prevalence of biological or emerging risk, residues of various contaminants, introduction of rapid alert system ‘among others. (f}_ Prescribing the procedure, and the enforcement of quality control in relation to any imported article of food in to india (6) Creating an information network across the country to disseminate rapid reliable and objective information about food safety and issues of concern. (h) Providing Training Programs for persons who are involved or intent to get involved in food businesses ())_ Promoting general awareness about food safety and food standards and promoting coordination of work ‘on food standards undertaken by International Governmental and Non-Governmental Organization,16 | MANUAL FOR FOOD SAFETY OFFICERS 2. The Governing Structure of FSSAI is given below: Food Authority Chairperson and 22 members -—— —} Food Standards Compliance and Inspections o o Scientific Committee Central Advisory Committee Chairperson of scientific panels and 6 independent members I State Level Steering Committee 17 Scientific Panels District Level Advisory Committees 3. FSSAI works through 11 Divisions fa mors Don Regulation / Codex Division Risk Assessment and R & D Division Regulatory Compliance / Surveillance FSMS Division Division Quality Assurance / Surveillance Division General Administration Division Human Resource, Vigilance and Training Division poe Finance DivisionFSSAl, FOOD SAFETY ENFORCEMENT AND STATE FOOD AUTHORITIES | 17 4. Food Authority The Food Authority is the apex body and a single reference point for all matters related to food safety and standards in the country. It comprises of 22members representing various Ministries and Departments such as Agriculture, Commerce, Consumer Affairs, Food Processing, Health, Legislative Affairs and other stake holders representing farmers, scientists& technologists, small scale Industries and retail organizations, with a minimum composition of one third of the members being women. The foremost responsibility of FSSAI include the development of 'Science-based Food Standards for articles of food and food products and to regulate their manufacture, storage, distribution, sale and import to ensure availability of safe and wholesome food for human consumption. To further its mandate the Authority is assisted and advised by the Scientific Panels, Scientific Committee and the Central Advisory Committee. The Food Authority from time to time brings out regulations to regulate food activities. The Food Authority may from time to time give such directions, on matters relating to food safety and standards, to the Commissioner of Food Safety of State, who shall be bound by such directions while exer \ghis powers under this Act; 5. Central Advisory Committee The Food Authority is responsible for framing of policies for food and state food regulators have a active role to play in enforcement of the law and ensuring food safety and quality. The Central Advisory Committee is an interface between the central and the state authorities. The Food Authority, by notification, establishes the Central Advisory Committee which ensures close cooperation between the Food Authority and the enforcement agencies and organizations operating in the field of food. All Commissioners of Food Safety are membersof this committee The CAC, comprises of representatives of concerned Central Ministries/Departments, State/Union Territory Governments and other stakeholders, provides the connecting bridge among the FSSAI, the enforcement agencies (States) and organisations operating in the field of food through a consultative approach. The primary ‘mandate of CAC s advising the Authority on work programme, prioritisation of work, identifying potential risks ‘and pooling of knowledge. 6. Scientific Committee This Committee comprises of Chairpersons of all Scientific Panels and six independent scientific experts, responsible for providing consistent scientific opinion to the Authority while harmonizing working methods of the Scientific Panels. The Committee provides opinions on cross industry and sectoral issues and covers areas which are unique and not covered within the competence of the Scientific Panels. 7. Scientific Panels Scientific Panels provide their expert advice on specific fields such as biological hazards, contaminants, food testing & sampling, water, meats, dairy, cereals, oil, nutraceuticalsetc. 8. Chief Executive Officer: The Chief Executive Officer of the Food Authority is an Officer not below the rank of Additional Secretary to the Government of india appointed by the Government of india as the executive head of FSSAI. The Chief Executive18 | MANUAL FOR FOOD SAFETY OFFICERS Officer is responsible for the day-to-day administration of the Food Authority. CEO draws up of proposal for the Food Authority's work programmes in consultation with the Central Advisory Committee and is responsible for implementing the work programmes and the decisions adopted by the Food Authority. The Chief Executive Officer has administrative control over the officers and other employees of the Food Authority. The Chief Executive Officer exercises the powers of the Commissioner of Food Safety while dealing with matters relating to food safety of such articles. The Chief Executive Officer is Member Secretary of Food Authority. B. Food Safety Enforcement and State Food Authorities India is a vast country with over 1.25 billion population and sheer magnitude of food safety enforcement is a challenging task. The Food Authority and the State Food Safety Authorities jointly share this responsibility. While Food Authority provides policy intervention, direction and coordination at national level, States/UTs conduct food safety enforcement at the field level. The responsibility of compliance of food standards as per Food Safety and Standards Act, 2006 and Rules and Regulations framed there under rests primarily with the States and UT Governments. The States/UTs are responsible for creation and filling up of necessary posts required for the purpose. The Food Safety and Standards Authority of India provides support in the form of imparting necessary training and capacity building of enforcement staff of States/ UTs. The huge differentiation among States/ UTs in terms of size, population, food culture, languages, industry penetration, manufacturing capability and location has its own level of maturity in terms of enforcement capability which is consistently growing and improving. Food Safety Authorities in States/UTs The framework for food safety enforcement machinery provided under Food Safety and Standards Act, 2006 and Rules and Regulations has the following officers:- Designated Food Safety Officers Officers Commissioner of Food Safety EY Food AnalystFSSAl, FOOD SAFETY ENFORCEMENT AND STATE FOOD AUTHORITIES | 19 1. Commissioner of Food Safety of the State ‘As per the Food Safety & Standards Act, 2006, the State Food Safety machinery is headed by the Commissioner of Food Safety of State, for efficient implementation of food safety and standards and other requirements laid down under this Act and the rules and regulations made there under. The Commissioner of Food Safety performs all or any of the following functions, namely:- {a) prohibit in the interest of public health, the manufacture, storage, distribution or sale of any article of food, either in the whole of the State or any area or part thereof for such period, not exceeding one year, as maybe specified in the order notified in this behalf inthe Official Gazette; (b) carry out survey of the industrial units engaged in the manufacture or processing of food in the State to find ‘out compliance by such units of the standards notified by the Food Authority for variousarticles of food; (@)_ conductor organise training programmes for the personnel of the office of the Commissioner of Food Safety and, ona wider scale, for different segments of food chain for generating awareness on food safety; (d) ensure an efficient and uniform implementation of the standards and other requirements as specified and also ensurea high standard of objectivity, accountability, practicability, transparency and credibility; {e) sanction prosecution for offences punishable with imprisonment under this Act; (f)_ such other functions as the State Government may, in consultation with the Food Authority, prescribe. (g) The Commissioner of Food Safety may delegate, such of his powers and functions under this Act (except the power to appoint Designated Officer, Food Safety Officer and Food Analyst) to any officer subordinate to him. 2. Designated Officer (a) The Commissioner of Food Safety, by order, appoints the Designated Officer, who is not below the rank of a ‘Sub-Divisional Officer, to be in-charge of food safety administration in such area as may be specified by regulations. (b) There hasto be a Designated Officer for each district of astate. (€)_ Chief Executive Officer of the Food Authority appoints Central Designated Officers by order in his capacity as ‘a Commissioner of Food Safety of the country, while dealing with matters relating to food safety. (a) A Central Designated Officer is a Central Licensing Authority and a State Designated Officer is a State Licensing Authority. 3. Functions of the Designated Officer (Section36 of the Food Safety and Standards Act, 2006): (2) Shallbea whole time officer, not below the rank of Sub divisional Officer or Equivalent. (b) Appointment shall be done by Commissioner of Food Safety and each district will have at least one Designated Officer who has the power to issue or cancel license. (c) Prohibit sale of any article of foodin contravention with the provisions of The Act and the rules. (d) Receive report and samples of articles from Food Safety Officer under his jurisdiction and get them20 | MANUAL FOR FOOD SAFETY OFFICERS (e) Recommended cases to Commissioner for sanction to launch prosecution, in case the contravention is punishable with imprisonment. (f) Sanction or launch prosecution in case of contravention punishable with fine or recommended the case to ‘Commissioner for punishment with imprisonment. (g) Maintain record of all inspections made by Food Safety Officer and the Actions taken by them, etc. Adjudicating Officer (a) The role of adjudicating office is important for looking into offences committed/ contravention of the provisions of the Act and Rules and Regulations made there under by the food business operators at any stage, and provide legal conclusionsin these matters. (b) The Adjudicating Officer, after giving the person a reasonable opportunity for mal ‘matter, and if, on such inquiry, he is satisfied that the person has committed the contravention of provisions of this Act or the Rules or the Regulations made there under, impose such penalty as he thinks fit in accordance with the provisions relating to that offence. (c) The State Government will notify adjudicating officer for adjudication of food related cases. (d) He will perform all or any of the following functions: (i) The Adjudicating Officer will have the powers of a civil court and all the proceedings before him shall be deemed to be judicial proceedings within the meaning of sections 193 and 228 of the indian Penal Code. (ii) The Adjudicating Officer while adjudging the quantum of penalty shall have due regard to the following, (aa) the amount of gain or unfair advantage (wherever possible to quantify) due to contravention (ab) the amount of loss caused or likely to cause to any person due to contravention (ac) the repetitive nature of contravention (ad) whether contravention is knowingly or unknowingly (e) mayissue direction to person found guilty of an offence, for taking corrective action to rectify the mistake or destruction of such article of food. (f)_ may direct offender to pay compensation to victim or representative of victim in case of injury or death of consumer. (@)_ mayorderfor cancellation of license, re-call of food from market, forfeiture of establishment ad property (h) issue prohibition orders Food Safety Officer Food Safety Officers are appointed by the Commissioner of Food Safety, through notification, for such local areas ‘as he may assign to them for the purpose of performing functions under this Act and the rules and regulations made there under. The State Government may authorise any officer of the State Government having the qualifications prescribed to perform the functions of a Food Safety Officer within a specified jurisdiction, The role powers and duties of Food Safety Officer is discussed in detailin Chapter S.FSSAl, FOOD SAFETY ENFORCEMENT AND STATE FOOD AUTHORITIES | 21 6. Food Analysts Food Analysts have a major role to play in analysis of food samples in the food laboratories. The analysis reports of food articles are of immense importance to know about the status of safety and food quality. The Food ‘Analysts having the qualifications as prescribed by the Central Government are appointed by the Commissioner of Food Safety, by notification, for such local areas as may be assigned to them. Different Food Analysts may be appointed for different articles of food. Functions of the Food Analyst (Section 45) He would be responsible for carrying out the required analysis of the sample as instructed by the Food Safety Officer along with the test method. The various steps to be taken areas follows: (a) Compare and note down the conditions of the seal of the container and the outer cover containing the sample (b) He may ask for the second sample if the first sample is found to be in broken condition or unfit for analysis and inform the DO about the same within seven days time and also send a requisition for the second part of the sample retained by DO. (c) He will then analyze, prepare report and send to DO for copies of report indicating the method of sampling and analysis within 14 days time. (d) Where the purchaser wants the food to be analyzed, then the report shall be sent to that purchaser with a copy to the DO.Vat a) Food StandardsFOOD STANDARDS | 23, Under the Food Safety and Standards Act, 2006 FSSA is responsible for framing standards for food products and for food safety. The scientific risk assessment and setting of standards is carried out on the basis of latest developments in food science along with various factors including emergence of new additives, changes in processing technology, identification of new risks associated with a food or an additives in respect of metallic contaminants, toxins, residues of pesticides and veterinary drugs, microbiological contaminants, food consumption pattern, nutritional aspects, advancement in analytical methods, and regulatory impact. This entire process is carried out in a transparent manner involvis all stakeholders. For this purpose, FSSAI has constituted scientific bodies, namely, a Scientific Committee and 17 Scientific Panels under the provisions of Food Safety and Standards Act for development of standards. 17 Scientific Panels and a Scientific Committee comprising of more than220subjectindependent experts/scientists of eminence. Formulation of standards of any article of food involves several stages. After recommendation by the Scientific Panel, following the due process laid down including validation by the Scientific Committee a standard is then approved by the Food Authority. After which draft notification is issued for inviting public comments and finally notified as standards. Further, considering the needs of the Indian population, for promoting innovation by the Industry and to bridge the gap between National and International best practices, FSSAI has constituted eight Standard Review Groups for various vertical group of commodities viz. Oils & Fats; Milk & Milk Products; Cereals & Cereals Products; Fruits, Vegetables & their Products; Sweets & Confectionery; Meat & Fish Products; Beverages including Alcoholic Beverages; and Nutraceuticals. These groups, which consist of representatives from the Industry associations, would review the existing standards, identify gaps and propose development of new standards taking into account the Indian and international scenario, for minimizing the regulatory burden, while reflecting advancement in scientific knowledge in areas of food processing and technology, nutrition, toxicology and prepare and forward note justifying revision of existing standards or development of new standards for food commodities. Category of Standards Standards can be broadly categorized into Horizontal Standards and Vertical Standards. Horizontal standards cut across foods or categories of foods like Food Safety and Standards (Contaminants, Toxins and Residues) Regulations-2011 and Food Safety and Standards (Packaging and Labelling) Regulations-2011. Vertical Standards mainly include identity and compositional standards of specific food products like Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011 and Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 Important Food Standards Contaminants, Toxins, Residues & Biological Hazards: The Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011 relates to safety of food products with respect to Contaminants, Toxins and Residues. The limits for microbiological contaminants have been prescribed at Appendix-B of Food Safety and Standards (Food Products standards and Food Additives) Regulations, 2011. These Regulations prescribe the maximum permissible limits ofthe following contaminants: i) Metal Contaminants: Such as Lead, Copper, Arsenic, Tin, Cadmium, Mercury, Methyl Mercury, Chromium and Nickel. The requirement of heavy metalshas been prescribed for all food categories.24 | MANUAL FOR FOOD SAFETY OFFICERS ii) Insecticide/Pesticide Residues: Maximum residue level of about 149 insecticides/pesticides. Maximum residue evel of nearly 70 new pesticides are at various stages of notification. iil) Antibiotic and other Pharmacologically Active Substances: Such as Tetracycline, Oxytetracycline, Trimethoprim and Oxolinic acid for fish and fish products and 10 antibiotics for honey have been prescribed. Maximum residue level of nearly 119 antibiotics and veterinary drugs are at various stages of notification, iv) Crop Contaminants: Such as Afiatoxins, Ochratoxin A, Patulin and Deoxynivalenol.. v) Naturally Occurring Toxic Substances: Such as Agaricacid, Hydrocyanicacid, Hypericine and Saffrole. vi) Other Contaminants: Such as Melamine in Powdered infant formula, Liquid infant formula and for other foods, Histamine in fish and fishery products. vii) Microbiological Contaminants: Safety and hygiene requirements have been specified for majority of food categories. More standards in this area are at various stages of notification. Labelling, Packaging & Claims: The link between food packaging, labelling and consumer protection is of high significance. To safeguard the interests of the consumer and the society at large, Food Safety and Standards Authority of India has notified Food Safety and Standards (Packaging and Labelling) Regulations, 2011. These Regulations are now being split into three parts, namely: 1. FoodSafety and Standards (Packaging) Regulations; 2. Food Safety and Standards (Labelling) Regulations; 3. Food Safety and Standards (Advertisement and Claims) Regulations. The proposed packaging Regulations deal with the various types of packaging standards such as plastics, metal & metal alloys, paper, paper board and glass. For the sake of innovation with different types of packaging material available Blobally, the list of safe packaging materials has also been broadened in the proposed regulation. These Regulations prescribe the general requirements for containers used in the preparation, packaging & storing of food and product specific packaging requirements to be followed by the FBOs. It also provides a suggestive list of packaging materials for different food categories. The proposed labelling Regulations prescribes the general and specific labelling requirements for pre-packaged food articles. The information required to every FBOs to declare on the label of pre-packaged food has also been specified. Labelling regulations further prescribe the mandatory provisions, developed based on WHO model, for Front of Pack ‘nutritional labelling for energy, total fat, trans fat, added sugar and sodium along with their per serve % contribution to RDA. The same would also be applicable to Foods containing high fat, sugar and salt (HFSS). The proposed Regulations also provides for labelling of Genetically Engineered (GE) foods. While framing the Labelling Regulations overlapping provisions with Legal Metrology (Packaged Commodities) Rules, 2011 have been removed. Legal Metrology (Packaged Commodities) Rules, 2011 has given exemption in respect of packages containing food articles wherever appropriate and in such cases, the requirements of Food Safety and Standards Act would apply. Food Safety and Standards (Advertisement and Claims) Regulations prescribes general principles for claims and provides conditions for specific claims like nutritional claims, non-addition claims, health claims, claims related to dietary Buidelines or healthy diets, conditional claims and prohibited claims. Further, it includes the schedules for approved Nutrition claims, Health claims for disease risk & fortified foods, claims regarding use of words like natural, fresh, pure,FOOD STANDARDS | 25 Provision has also been made for restricting the advertisements and/or claims for food articles that undermines the products of any other manufacturer for the purpose of promoting their products or influencing consumer behavior. ‘+ Food Additives: The provisions for use of food additives is given under the Food Safety and Standards (Food Products standards and Food Additives) Regulations, 2011. These Regulations specify an updated/expanded list of food additives, largely harmonized with Codex standards, and their criteria for use in foods, including specifications for the identity and purity of food additives. The revised regulation also provides hierarchical food category system with 16 major categories and subcategories inline with the codex food categorization system, The updated/expanded food additive provisions provide a wide choice of additives to food manufacturers for improving the quality of food products by use of food additives that are technologically best suitable forthe product. ‘+ Food Category System: In compliance with the guiding principles specified in the Food Safety and Standards Act, 2006 and India's commitments towards WTO, FSAI created a Food Category System (FCS), in harmony with the Food. Categorization System adopted in Codex General Standard for Food Additives (GSFA). There are 16 Main categories of food. One more category numbered '99' is included for substances added to food which are not for direct consumption as food' under the Food Categorization Code. These are: 01. Dairy products and analogues 02. Fatsandoils, and fat emulsions 03. Edible ices, including sorbet 04. Fruits and vegetables (including mushrooms and fungi, roots and tubers, fresh pulses and legumes, and aloe vera), seaweeds, and nutsand seeds 05. Confectionery 06. Cereals and cereal products, derived from cereal grains, from roots and tubers, pulses, legumes (fresh pulses and. legumes are covered in category 4.2) and pith or soft core of palm tree, excluding bakery wares of food category 07.0 07. Bakery products 08. Meatand meat products, including poultry 09. Fishand fish products, including molluscs, crustaceans, and echinoderms 10. Eggsandegg products 11. Sweeteners, including honey 12. Salts, spices, soups, sauces, salads and protein products 13. Foodstuffs intended for particular nutritional uses 14. Beverages, excluding dairy products 15, Ready-to-eat savouries 16. Prepared foods 17. Substancesadded to food which are ‘not fordirect consumption as food’ Most of the standards for food products under categories such as milk and milk products, oils and fats, and fruits and vegetable products have already been established. However, a few remaining products under Cereal, Fish, Meat & Egg26 | MANUAL FOR FOOD SAFETY OFFICERS and their products are at various stages of development. The Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011 initially prescribed standards for 377 products/product categories. Since, then additionally standards for 134 products have been finalized and notified and an equal number of the product standards are inthe process of being finalized. ‘+ Health Supplements and Nutraceuticals: Standards for Health supplements and Nutraceuticals are specified under Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food, and Novel Food) Regulations, 2016. The enforcement of these regulations shall ‘commence with effect from January 1, 2018. The regulations cover eight categories of Functional foods, namely, Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Specialty food containing plant or botanicals, Foods containing Probiotics, Foods containing Prebiotics and Novel Foods. It provides for the general conditions for manufacture and sale of these foods, requirements related to claims, besides providing details of each type of above foods individually regarding its essential composition, specific labeling requirements and permitted use of additives. The regulations do not allow the use of hormones or steroids or psychotropic ingredients in any of the articles of food. Furthermore, these regulations provide various Schedules containing list of vitamins and minerals, amino acids, schedule for minimum and maximum values for vitamins and minerals for FSDU and FSMP category, list of ingredients of plants or botanical origin, nutraceuticals, probiotics and prebiotics. A comprehensive schedule of additives, dividedinto various sub-categories for useiin different foodsisalso included. For ingredients which are in use for a number of years with history of safe consumption in India and/or abroad, which have not been included in said regulations, as well as novel foods, FBOs will have to apply to FSSAI for approval as per Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017. ‘+ Fruits & Vegetable Products: Standards for Fruit & Vegetable Products’, and those of ‘Salt, spices, condiments and related products’ are prescribed under sub-regulation 2.3 and 2.9 respectively of Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011. These regulations covers more than 50 products such as Thermally Processed Fruits, Thermally Processed Vegetables, Thermally Processed Fruits Juices, Thermally Processed Vegetable Juices, Soup Powders, Tamarind Pulp/Puree and Concentrate, Fruit Bar/ Toffee, Fruit/Vegetable, Canned Tomatoes, Tomato Juice, Jams, Fruit Jellies & Marmalades, Table Olives, Inclusion of Ethylene gas for ripening (revision), Cinnamon whole and powder, Pickles, Nuts and Raisins, and spices such as caraway, cardamom, chillies and capsicum (Lal Mirchi), Cinnamon, mustard, nutmeg, pepper black, poppy, saffron, turmeric, curry powder, iodized salt, iron fortified iodized salt (double fortified salt), and many more. ‘These regulations prescribed the quality parameters for the product. The safety parameters have been separately prescribed under The Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011, ‘Some new standards which are under the process of development are Date Paste, Fermented Soybean Paste, Harrisa (Red Hot Pepper Paste), Quick frozen French fried potatoes, Vegetable Protein Products, Cocoa mass/cocoa cake, Canned Chestnut and Chestnut Puree, Edible Fungus Products, Mixed Spices(Powder) , Oleoresins, Almond Kernels, Coconut Milk Powder, Tejpat, Star Anise, Water Chestnuts Flour, Dried Oregano - Whole and Powder, Pimento (Allspice) - Whole and Powder, Laurel (Bay Leaf) - Whole and Powder.FOOD STANDARDS | 27 ‘+ Milk and Milk Products: With the large-scale development and changing needs of the dairy industry in the country, and to bring in consistency with the globally recognized standards, the standards for milk and milk products have recently been revised in a comprehensive manner, The revised regulations include a general standard for milk and milk products which provides comprehensive definitions of milk/milk products and heat treatments used in dairy ns for use of dairy terms in the nomenclature of food products etc. The Regulations also include revised individual identity standards for various products, namely, milk; flavoured milk; evaporated or concentrated Milk; sweetened condensed milk; khoa; cream and malai; fermented milks; milk powders; partially dehydrated milks (condensed milks); cheeses; indigenous dairy products; milkfat products (butter, ghee etc.); whey powder; ice ‘cream; frozen desserts etc. New standards for edible lactose, dairy whitener, flavoured dahi fermented milk drinks ‘and camel milk have also been included therein. ‘+ Infant Food Products: The standards for different infant products are specified under 2.1.9 of Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. These Regulation contains standards for mainly two categories of products that is infant milk substitute and infant foods. They prescribe the limits of various nutrients such as protein, fat, vitamins and minerals etc. along with the source of mineral salts and vitamin ‘compounds to be used, and list of additives with their permissible limit. Further, as per Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011 no person shall manufacture, sell, store or exhibit for sale, an infant milk food, infant formula and milk cereal based weaning food, processed cereal based weaning food and follow up formula except under Bureau of Indian Standards certification mark. + Cereal & Cereal Products: Standards for Cereals and Cereals Products are prescribed under Regulation 2.4 of FSS (Food Product Standards and Food Additives) Regulations, 2011. These regulation covers products like Atta, Maida, Semolina, Besan, Pearl Barley, Foodgrains, Cornflour, Corn flakes, Custard Powder, Macaroni products, Malted and Malt Based Foods, Rolled Oats, Solvent Extracted Flours, Starchy Foods, Bakery Products, Instant Noodles, Oats, Pasta and many more. ‘Some new standards which are under the process of development are Sago, Durum wheat, Durum Wheat Semolina and Whole durum wheat semolina, Durum Wheat Maida, Pearl Millet Flour, Sorghum Flour, Soybean, Soy Protein Products, Quinoa, Finger Millet, Amaranth, Wheat Protein Products Including Wheat Gluten, Whole Maize (Corn) Flour, Degermed Maize (Corn) Flour and Maize (Corn) Grits, Couscous, Tempe, Textured Vegetable Protein (Soya Bari), Tofu, Edible Sago Flour, Decorticated Pear! Millet Grains (Bajra), Basmati Rice, Chia seeds, Gari, Edible Cassava Flour, Chana Sattu, RagiFlour, Wheat bran etc. ‘+ Alcoholic Beverages: Regulations on Alcoholic beverages is in the final stage of notification. It covers all alcoholic beverage containing more than 0.5 per cent alcohol. These Regulations includes following types of alcoholic beverages: i) Distilled alcoholic beverages: Brandy (grape, blended), Country Liquors (Plain, Fenny, Blended), Gin, Pot distilled spirits, Rum (rum, white rum), Liqueur or cordials, Vodka, Whisky (single malt, blended) ii) Wine and other Fermented Beverages: Table/grape wine (white and red), Fortified Wine, Wine with carbon dioxide, Fruit Wine (fruit wine, cider, Perry), Wine from other agricultural and plant sources. ii) Beer: Beer (strong and regular), Draught Beer (strong and regular). FSSA\ is also in the process of notifying a list of additives which would be allowed to be used in manufacturing of above alcoholic beverages. Thislist is aligned with the OIV lst of food additives.28 | MANUAL FOR FOOD SAFETY OFFICERS Packaged Drinking Water: Standards for packaged drinking water have been prescribed under sub regulation “2.10.8 of Food Safety and Standards (Food Products standards and Food Additives) Regulations, 2011. It provides for manufacture of packaged drinking water from various sources such as surface water or civic water supply or underground water or sea water or any other consistent source of water. Various types of treatments such as decantation, filtration, combination of filtration, aerations, filtration with membrane filter depth filter, cartridge filter, activated carbon filtration, demineralization, remineralization, reverse osmosis etc. has also been specified. The regulation also provides for the types of packaging. Proprietary Food: The regulation on proprietary food covers those foods which are not standardized in any of the Regulations notified by FSSAI. This regulation provides for ingredient based concept as against the recipe based approval of food products followed earlier by FSAI. As per this regulation any food product prepared using those ingredients which are either standardized or permitted to be used in standardized products does not require any product approval. Further, FSSAI is in the process of extending the scope of this provision by considering the food or ingredients included in Indian Food Composition Tables by National institute of Nutrition thereby allowing food 528 key food ingredients representing all major food groups that could be utilized by the F8Os manufacturing proprietary food which would also not require any separate product approval. Relevant FSSR and their amendments including the definition for proprietary food has covered a majority of food products for which NOC/product approvals were required earlier (http://www.fssai.gov.in/home/fss-legislation/ss-regulations.htm)) Non-Specified Food Products Approval Mechanism: For the FBOs whose product which have not been standardized in any of the Regulations, FSSAI has recently Notified Food Safety and Standards (Approval for Non Specified Food and Food ingredients) Regulations, 2017. These regulations lay down the procedure for grant of prior approval of non-specified food and food ingredients whereby FBOs are required to submit application as prescribed along with necessary documents such as the safety data, history of safe use, a certificate of analysis in respect of the ‘chemical, physical, microbiological and nutritional parameters etc. along with a fee of Rs. 50000/-. The approval for these products are granted by the Authority after the risk analysis carried out by the Scientific Panels. Food Fortification: Regulations on fortification of foods namely Food Safety and Standards (Fortification of Foods) Regulation have been operationalized since October, 2016. These regulation provides for fortification of staples such ‘as Wheat flour, Rice, Edible oil & Vanaspati, Milk and salt with micronutrients like Vitamin A, Vitamin D, Iron, Folic Acid, Vitamin B12, Zinc, Thiamine, Riboflavin, Niacin and Pyridoxine and their salts with the permitted levels as specified under the regulation. Further, the regulation prescribes the '+F" logo that may be used by FBOs for Fortified Food Products Procedure for use of + logo is also available on website. (http://ffre.fssai.gov.in/ffrc/licence_registration). ‘+ Organic Food Products: Standards to regulate manufacture, distribution, sale or import organic foods have been prescribed under Food Safety and Standards (Organic Foods) Regulations, 2017. These Regulations recognizes two systems of certification i.e. Participatory Guarantee System (PGS) implemented by Ministry of Agriculture and Farmers Welfare and National Programme for Organic Production {NPOP) implemented by Ministry of Commerce and Industry. As such FSSAI will be regulating transport, storage, processing, distribution, retail and imports of all organicproducts. The Regulation which is at the final stage of notification will be able to provide the integrity of the Organic food products and control the unscrupulous practices of Organic Foods in the market. The Regulation will also ensure credibility of Organic Products amongst the consumers thus benefitting the farmers by way of increasing their income.FOOD STANDARDS | 29 FSSA is also in the process of developing online database having details of Organic Food Business Operators with their products and geographical areas in which such products are available for the benefit of the other Food Business Operatorsand Consumers. ‘+ Irradiated Foods: Irradiated foods are food and agricultural commodities preserved by radiation processing, Radiation processing of food or food irradiation, is a physical process in which food and agricultural commodities in pre-packaged form or in bulk, are exposed to a controlled amount of radiant energy froma gamma, X-ray or electron beam source, to achieve desirable technological objectives such as inhibition of sprouting, delay in ripening, killing of insect pests, parasites, pathogenic and spoilage microorganisms. FSSAI has published Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2016, on the use of irradiation for sanitary and phyto-sanitary purposes. The regulations provide for radiation processing of different classes of food products ‘and the limits of radiation dose. The regulations also provide for the dose limits recommended for radiation processing of allied products such as packaging materials, food additives, health foods, dietary supplements and nutraceuticals, incorporating the relevant provisions of Atomic Energy (Radiation Processing of Food & al Products) Rules, 2012. In conjunction with Plant Quarantine (Regulation of Import into India) Order, 2003, these regulations enable use of irradiation as a phyto-sanitary or quarantine measure for import or export of produce for ‘overcoming quarantine barriers and getting market access. For sanitary applications, the technology has been used in India for microbial decontamination of exportable spices since 2000. Since 2007 Indian mangoes have found market access in USA by using irradiation asa phyto-sanitary measure. Nutrition and health portfolio ‘+ Food Fortification Resource Centre (FFRC): The Food Fortification Resource Centre has been set up as a Resource and Support Centre, in collaboration with Tata Trusts, to promote large-scale fortification of food across India. This centre works closely with government departments at the Centre and States, development partners, food businesses, premix suppliers, equipment manufacturers and consumer representative organisations to address any issuein the effective implementation of food fortification programme. ‘The objectives of FERC isto Sensitize states about fortification of food and promote fortified foods in state nutrition programmes, to provide technical support especially to small scale food manufacturers to enable them to produce fortified foods; to educate people about the benefits of fortification and consume fortified foods; to train and build capacity for large-scale fortification of foods and provide tools for monitoring and evaluation of fortification programmes, to provide communication material, technical, scientific and financial support to promote large-scale fortification of foods. ‘An online portal of the Food Fortification Resource Centre has been set up to aid in realisation of these objectives. The portal provides all information pertaining to fortification of food such as scientific evidence, latest fortification technology, national andinternational experience and best practices. ‘+ IFSQuick Access: FSSAI has developed a system integrating all Food Safety Standards and Regulations for providing a quick access to the vertical as well as the horizontal standards. This is aimed at minimizing ambiguity in the interpretation of regulations and facilitating FBOs in smooth operations of their business. Quick Access would provide all relevant information about a food product at a single glance. It would facilitate a user to access the information relating to all permitted food additives; HS Code; Food Category Code; contaminants, pesticide residues, metallic contaminant, product-specific quality standards; licensing and imports related requirements. (http://117.239.180.188:8080/IFSquickaccess/)30 | MANUAL FOR FOOD SAFETY OFFICERS Packaging and Labelling of Foods The Food Safety and Standards (Packaging and labelling) Regulations, 2011 provides the manner in which food products are to be packed and labelled. Section 24 of the Food Safety & Standards Act, 2006 talks about restrictions of advertisement and prohibition as to unfair trade practices and Regulation 2.5 of Food Safety & Standards (Packaging and Labelling) Regulations, 2011 alsorelatestorest ion on advertisement. All packaged food products has to be labelled in the manner as may be specified by the regulations. The labels should not contain any statement, claim, design or device which is false or misleading in any pai cular concerning the food products contained in the package or concerning the quantity or the nutritive value implying medicinal or therapeutic claims orin relation to the place of origin of the said food products. Every food business operator has to ensure that the labelling and presentation of food, including their shape, appearance or packaging, the packaging materials used, the manner in which they are arranged and the setting in which they are displayed, and the information which is made available about them through whatever medium, does not mislead consumers. A. Important Definitions — 1 “Best before” means the date which signifies the end of the period under any stated storage conditions during Which the food shall remain fully marketable and shall retain any specific qualities for which tacit or express claims have been made and beyond that date, the food may still be perfectly safe to consume, though its quality ‘may have diminished. However the food shall not be sold ifat any stage the product becomes unsafe. “Date of manufacture” means the date on which the food becomes the product as described; “Date of packaging” means the date on which the food is placed in the immediate containerin which it wll be ultimately sold; “Infant” meansa child not more than twelve months of age; “Lot number” or “code number” or “batch number” means the number either in num Is or alphabets or in combination thereof, representing the lot number or code number or batch number, being preceded by the words “Lot No” or “Lot” or “code number” or “Code” or Batch No” or “Batch” or any distinguishing prefix by which the food can be traced in manufacture and identified in distribution. “"Multi-piece package” means a package containing two or more individually packaged or labelled pieces of the ‘same commodity of identical quantity, intended for retail either in individual pieces or packages asa whole. ‘Non- Vegetarian Food” means an article of food which contains whole or part of any animal including birds, fresh water or marine animals or eggs or products of any animal origin, but excluding milk or milk products, as an ingredient; “re-packaged!” or “Pre-packed food”, means food, which is placed in a package of any nature, in such a manner thatthe contents cannotbe changed without tampering ttand whichis ready forsale tothe consumer. Note: The expression “package” wherever it occurs in these Regulations, shall be construed as package containing pre-packed food articles. “Principal Display Panel” means that part ofthe container/package which is intended or likely to be displayed or presented or shown or examined by the customer under normal and customary conditions of display, sale or purchase of the commodity contained therein.FOOD STANDARDS | 31 10. “Use ~by date” or “Recommended last consumption date” or “Expiry date” means the date which si end of the estimated period under any stated storage conditions, after which the food probably will not have the quality and safety attributes normally expected by the consumers and the food shall not be sold; 11. “Vegetarian Food” means any article of Food other than Non- Vegetarian Food as defined in regulation 1.2.1(7). 12. “Wholesale package” means a package containing — (a) a number of retail packages, where such first mentioned package is intended for sale, distribution or delivery toan intermediary and is not intended for sale direct to asingle consumer; or (b) acommodity of food sold to an intermec such commodity of food to the consumer ry in bulkto enable such intermediary to sell, distribute or deliver ‘smaller quantities. B. Packaging General Requirements (a) Utensil or container made of following material or metal used in the preparation, packaging and storing of food shall be deemed to render it unfit for human consumption if: {i) containers which are rusty; (ii) enamelied containers which have become chipped and rusty; (iil) copper or brass containers which are not properly tinned {iv) containers made of aluminium not conforming in chemical composition to 1S:20 specification for Cast ‘Aluminium & Aluminium Alloy for utensils or 1S:21 specification for Wrought Aluminium and Aluminium Alloy for utensils. (b) Containers made of plastic materials should conform to the Indian Standards Specification, used as appliances or receptacles for packingorstoring. (c)_ General packaging requirements for Canned products (i) Allcontainers shall be securely packed and sealed. (li) The exterior of the cans shall be free from major dents, rust, perforations and seam distortions. (ii) Cans shall be free fromleaks. Product Specific Requirements (a) Packaging requirements for Milk and Milk Products (i) Bottling or filling of containers with heat-treated milk and milk product shall be carried out mechanically and the sealing of the containers shall be carried out automatically. (ii) Wrapping or packaging may not be re-used for dairy products, except where the containers are of a type which may be re-used after thorough cleaning and disinfecting. (ii) Seating shall be carried out in the establishment in which the last heat-treatment of drinking milk or liquid milk-base products has been carried out, immediately after filling, by means of a sealing device which ensures that the milk is protected from any adverse effects of external origin on its characteristic, The32 | MANUAL FOR FOOD SAFETY OFFICERS sealing device shall be so designed that once the container has been opened, the evidence of opening. remains clear and easy to check. {iv) Immediately after packaging, the dairy products shall be placed in the rooms provided for storage. {b) Packaging requirements for Edible oil/ fat:v Tin Plate used for the manufacture of tin containers for packaging edible oils and fats shall conform to the standards of prime grade quality contained in B..S. Standards No, 1993 or 13955 or 9025 or 13954 as amended from time to time and in respect of Tin containers for packaging edible oils and fats shalll conform to IS No. 10325 0 10339 as amended from timetotime. v (©) Packaging requirements for Fruits and Vegetables Products (i) Every bottle in which any fruit product is packed shall be so sealed that it cannot be opened without destroying the licensing number and the special identification mark of the manufacture to be displayed on the top orneck of the bottle. (ii) For Canned fruits, juices and vegetables, sanitary top cans made up of suitable kind of tin plates shall be used. (ii) For Bottled fruits, juices and vegetables, only bottles/jars capable of giving hermetic seal shall be used. (iv) Juices, squashes, crush, cordials, syrups, barley waters and other beverages shall be packed in clean bottles securely sealed. These products when frozen and sold in the form of ice shall be packed in suitable cartons. Juices and Pulps may be packed in wooden barrels when sulphited. (v) For packing Preserves, Jams, Jellies, and Marmalades, new cans, clean jars, new canisters, bottles, chinaware jars, aluminium containers may be used and it shall be securely sealed. (vi) For Pickles, clean bottles, jars, wooden casks, tin containers covered from inside with polythene lining of 250 gauge or suitable lacquered cans shall be used. For Tomato Ketchups and Sauces, clean bottles shall be used. Ifacidity doesnot exceed 0.5% as aceticacid, open top sanitary cans may also be used. (vil) Candied fruits and peels and dried fruits and vegetables can be packed in paper bags, cardboard or wooden boxes, new tins, bottles, jars, aluminium and other suitable approved containers. (ix)_ Fruits and Vegetable products can also be packed in aseptic and flexible packaging material having food ‘grade quality conforming to the standards laid down by BIS. (4) Packaging requirements for Canned Meat Products (i) New sanitary top cans made from suitable kind of tin plate shall be used. The cans shall be lacquered internally; they shall be sealed hermetically after filling. The lacquer used shall be sulphur resistant and shallnot be soluble in fat orbrine. (ii). Cans used for filling pork luncheon meat shall be coated internally with edible gelatin, ard or lined with vegetable parchment paper before being filled. (iii) Meat products packed in hermetically sealed containers shall be processed to withstand spoilage under commercial conditions of storage and transportFOOD STANDARDS | 33, (e) Packaging requirements for Drinking Water (Both Packaged and Mineral Water) tt shall be packed in clean, hygienic, colourless, transparent and tamperproof bottles/containers made of polyethylene (PE) (conforming to 1S:10146 or polyvinyl chloride (PVC) conforming to IS : 10151 or polyalkylene terephthalate (PET and PBT) conforming to IS: 12252 or polypropylene conforming to IS : 10910 or food grade polycarbonate or sterile glass bottles suitable for preventing possible adulteration or contamination of the water. All packaging materials of plastic origin shall pass the prescribed overall migration and colour migration limits C. Labelling (a) General Requirements (i) Every pre-packaged food shall carry a label containing information as required here under unless otherwise provided, namely, The particulars of declaration required under these Regulations to be specified on the label shall be in English or Hindiin Devnagri script: Provided that nothing herein contained shall prevent the use of any other language in addition to the language required under this regulation. (iil) Pre-packaged food shall not be described or presented on any label or in any labelling manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character in any {iv) Label in pre-packaged foods shall be applied in such a manner that they will not become separated from the container; (v) Contents on the label shall be clear, prominent, indi le and readily legible by the consumer under normal conditions of purchase and use; (vi) Where the container is covered by a wrapper, the wrapper shall carry the necessary information or the labelon the container shall be readily legible through the outer wrapper and not obscured byt; (vii) License number shall be displayed on the principal display panel in the following format, namely:- SSAL FSSL 1000000000000 Provided that the existing products ofa unit shall comply with the requirement of this clause on and after the six months of commencement of the Food Safety and Standards (packaging and labeling ) ‘Amendment Regulation 2013. }34 | MANUAL FOR FOOD SAFETY OFFICERS (b) Labelling of Pre-packaged Foods In addition to the General Labelling requirements specified above every package of food shall carry the following information on the label, namely, (i) The Name of Food: The name of the food shall include trade name or description of food contained in the package. (ii) List of ngredients Nutritional information (iv) Declaration regarding Veg or Non veg (v) Declaration regarding Food Additives i) Name and complete address of the manufacturer ( (vill) Lot/Code/Batch identification Net quantity (ix) Date of manufacture or packing. (x) Best Before and Use By Date (xi) Country of origin forimported food: (xi) instructions foruse (c) Manner of declaration (I) Any information or pictorial device written, printed, or graphic matter may be displayed in the label provided that tis notin conflict with the requirements of the Regulations. (ii) Every declaration which is required to be made on package under the regulations shall be: (aa) Legible and prominent, definite, plain and unambiguous (ab) Conspicuousas to size number and colour, (ac) as far as practicable, in such style or type of lettering as to be boldly, clearly and conspicuously present in distinct contrast to the other type, lettering or graphic material used on the package, and shall be printed or inscribed on the package in a colour that contrasts conspicuously with the background of the label. Provided that — (i) Where any label information is blown, formed or moulded on a glass or plastic surface or where such information is embossed or perforated on a package, that information shall not be required to be presented in contrasting colours: (i) Where any declaration on a package is printed either in the form of a handwriting or hand script, such declaration shall be clear, unambiguous and legible. (iii) | No declaration shall be made so as to require it to be read through any liquid commodity contained in the package.FOOD STANDARDS | 35 (iv) Where a package is provided with an outside container or wrapper, such container or wrapper shall also contain all the declarations which are required to appear on the package except where such container or wrapper itselfis transparent and the declarations on the package are easily readable through such outside container or wrapper. (v) Labels not to contain false or misleading statements: A label shall not contain any statement, claim, design, device, fancy name or abbreviation which is false or misleading in any particular concerning the food contained in the package, or concerning the quantity or the nutritive value or in relation to the place of origin of the said food: Provided that this regulation shall not apply in respect of established trade or fancy names of confectionery, waters, such as, Ginger Beer or Gold-Spot or any other name in existence in international trade practice. iscuits and sweets, such as, barley, sugar, bull's eye, cream cracker or in respect of aerated (d) Principal display panel: (2) The information required under these Regulations shall be given on the principal display panel of the package or container and such information may be givenin the following manner. (i) Allinformation should be grouped together and given at one place. OR (ii) The pre-printed information be grouped together and given in one place and (b) Online information or those not pre-printed be grouped together in another place. (c) Area of the principal display panel and the height of numeral in the declars Regulations. ion shalll be as prescribed in the (€) Specificrestrictions on Product labels (i) Labelsnot to contain reference to Act or rules or regulations contradictory to required particulars (ii) Labels not to use words implying recommendations by medical profession (ili) Unauthorized use of words showingimitation prohibited (iv) Any fruit syrup, fruit juice, fruit squash, fruit beverages, cordial, crush or any other fruit products standardised under Food Safety and Standards (Food Products standards and Food Additives) Regulations, 2011 which does not contain the prescribed amount of fruit juice or fruit pulp or fruit content shall not be described as a fruit syrup, fruit juice, fruit squash, fruit beverages, cordial, crush or any other fruit product as the case maybe. ) ‘Any food product which does not contain the specified amount of fruit and is likely to deceive or mislead or give a false impression to the consumer that the product contains fruit, whether by use of words or pictorial representation, shall be clearly and conspicuously marked on the label as “ADDED” (NAME OF THE FRUIT) FLAVOURED’. (vi) Any food product which contains only fruit flavours, whether natural flavours and natural flavouring substances or nature identical flavouring substances, artifical flavouring substances as single or in combination thereof, shall not be described asa fruit product and the word "ADDED" (NAME OF FRUIT) FLAVOUR shall be used in desc ing such a product;36 | MANUAL FOR FOOD SAFETY OFFICERS (vil) Carbonated water containing no fruit juice or fruit pulp shall not have a label which may lead the consumer into believing that tis afruit product. (viii) Any fruit and vegetable product alleged to be fortified with vitamin C shall contain not less than 40 mg, of ascorbic acid per 100 gm. ofthe product. (ix) imitations not to be marked "pure" (x) Labelling prohibitions for Drinking Water (Both Packaged and Mineral Water) (aa) No claims concerning medicinal (preventative, alleviative or curative) effects shall be made in respect of the properties of the product covered by the standard Claims of other beneficial effects related to the health of the consumer shall not be made. (ab) The name of the locality, hamlet or specified place may not form part of the trade name unless it refers to.a packaged water collected at the place designated by that tradename. (ac) The use of any statement or of any pictorial device which may create confusion in the mind of the Public or in any way mislead the public about the nature, origin, composition, and properties of such waters put on sale's prohibited. (f) Restriction on advertisement There shall be no advertisement of any food which is misleading or contravening the provisions of Food Safety and Standards Act, 2006 (34 of 2006) or the rules/regulations made thereunder. (g) Exemptions from labelling requirements- (i) Where the surface area of the package is not more than 100 square centimeters, the label of such package shall be exempted from the requirements of list of ingredients, Lot Number or Batch Number ‘or Code Number, nutritional information and instructions for use, but these information shall be given ‘onthe wholesale packages or multi piece packages, as the case may be. (ii)_ the ‘date of manufacture’ or best before date’ or ‘expiry date’ may not be required to be mentioned on the package having surface area of less than 30 square centimeters but these information shall be sivenon the wholesale packages or multipiece packages, asthe case may be; (il) in case of liquid products marketed in bottles, if such bottle is intended to be reused for refilling, the requirement of list of ingredients shall be exempted, but the nutritional information specified in regulation 2.2.2 (4) these regulations shall be given on the label. Provided that in case of such glass bottles manufactured after March 19, 2008, the list of ingredients ‘and nutritional information shall be given on the bottle. (iv)_ in case of food with shelf-life of not more than seven days, the ‘date of manufacture’ may not be required to be mentioned on the label of packaged food articles, but the ‘use by date’ shall be mentioned on the label by the manufacturer or packer. (v)_ Incase of whole sale packages the particulars regarding list of ingredients, nutritional information , Date of manufacture/ packing, best before, expiry date labelling of irradiated food and , veget: logo/non vegetarian logo, may not be specified.FOOD STANDARDS | 37 (h) Restrictions of Advertisement and Prohibition as to Unfair Trade Practices (Section 24 of FSS Act) (i) The advertisement of any food made should not be misleading or deceiving or contravening the provisions of this Act, the rules and regulations made there under. No person shall engage himself in any unfair trade practice for purpose of promoting the sale, supply, use and consumption of articles of food or adopt any unfair or deceptive practice including the practice of making any statement, whether orally or in writing orby visible representation which - (aa) falsely represents that the foods are of a particular standard, quality, quantity or grade- ‘composition; (ab) makes a false or misleading representation concerning the need for, or the usefulness; (ac) gives to the public any guarantee of the efficacy that is not based on an adequate or scientific justification thereof: Provided that where a defence is raised to the effect that such guarantee is based on adequate or scientific justification, the burden of proof of such defence shall lie on the person raising such defence.OA Ane! Food Safety OfficerFOOD SAFETY OFFICER | 39 A. Food Safety Officer Food Safety Officers are the field officers and the backbone of entire food safety compliance structure. Food Safety Officers are appointed by the Commissioner of Food Safety, through notification, for such local areas as he may assign to them for the purpose of performing functions under this Act and the rules and regulations made there under. The State Government may authorise any officer of the State Government having the qualifications prescribed to perform the functions of a Food Safety Officer within a specified jurisdiction. For effective discharge of its functions, the Food Safety Officer is required to have adequate knowledge of the FSS Act, Rule and Regulations and their application in discharge of their duties, proper procedure for inspection and sampling and various other aspects of food safety. B. Powers & Duties of Food Safety Officer: A Food Safety Officer has a very important role to play as an enforcement officer and in ensuring food safety and quality. The powers and duties of a Food Safety Officer include the following: (i) To issue registration for small and petty food business operators in their capacity as a Registering Authority within the area assigned to him. {ii) Toinspect the premises of small and petty food business operators and ensure compliance as per Schedule 4 (Part |) of Food Safety and Standards (Licensing and Registration of Food Businesses), Regulations, 2011, Within the area assigned to him. {ii) To inspect, as frequently as may be prescribed by the Designated Officer, all food establishments licensed for manufacturing, handling, packingor selling of an article of food within the areaassigned to him, {iv) To satisfy himself that the conditions of licenses are being complied with by each of the Food Business Operators carrying on business within the area assigned to him and report to the Designated Officer. {(v) Torecommend Designated Officer to issue of improvement notices to the Food Business Operator whenever necessary giving the food business operators an opportunity in order to comply with the conditions of license within a prescribed time limit, (vi) To make such inquiries and inspections as may be necessary to detect the manufacture, storage or sale of articles of food in contravention of the Act or rules framed there under. (vii) To investigate any complaint which may be made to him in writing in respect of any contravention of the provisions of the Act, or rules framed there under. (vill) To stop and inspect any vehicle suspected to contain any unsafe food or food which does not comply with the provisions of this Act and rules, intended for sale or delivery for human consumption. (ix) To recommend to the Designated Officer giving specific grounds, suitable action in regard to licenses issued tony Food Business Operator, if on inspection the Food Safety Officer finds that the Food Business Operator had violated the conditions for grant oflicense.. (x) Take a sample of any food, or any substance, which appears to him to be intended for sale, or to have been sold for human consumption. (xi) Take a sample of any article of food or substance which is found by him on or in any such premises; which he has reason to believe that it may be required as evidence in proceedings under any of the provisions of this ‘Actor of the Regulations or orders made there under.40 | MANUAL FOR FOOD SAFETY OFFICERS le of food after taking a sample; and in both cases send the same for analysis to a Food Analyst for the local area within which such sample has been taken. Where the Food Safety Officer keeps such article in the safe custody of the food business operator, he may require the food business operator to execute a bond for a sum of money equal to (xii) Take a sample and keep it in the safe custody of the food business operator such a the value of such article with one or more sureties as the Food Safety Officer deems fit and the food bi ‘operator shall execute the bond accordingly. (xii) To procure and send for analysis if necessary, samples of any article of food which he has reason to believe or ‘on the basis of information received including from a purchaser are being manufactured, stocked or sold or exhibited for sale in contravention of the provisions of the Act, or rules and regulations framed there under. (xiv) To draw samples for purposes of surveillance, survey and research, which shall not be used for prosecution. (xv) Where any sample is taken, its cost calculated at the rate at which the article is usually sold to the public shall be paid to the person from whomitistaken. (xvi) To carry out food safety surveillance toidentify and address the safety hazards. (xvii) To seize any article of food which appears to the Food Safety Officer to be in contravention of this Act or the regulations made there under. («vii) Where any article of food seized is of a perishable nature and the Food Safety Officer is satisfied that such article of food is so deteriorated that itis unfit for human consumption, the Food Safety Officer may, after giving notice in writing to the food business operator, cause the same tobe destroyed. (xix) Any adulterant found in the possession of a manufacturer or distributor of, or dealer in, any article of food or in any of the premises occupied by him as such and for the possession of which he is unable to account to the satisfaction of the Food Safety Officer and any books of account or other documents found in his possession ‘or control and which would be useful for, or relevant to, any investigation or proceeding under this Act, may be seized by the Food Safety Officer and a sample of such adulterant submitted for analysis to a Food Analyst. No such books of account or other documents shall be seized by the Food Safety Officer except with the previous approval of the authority to which he is subordinate. (1) Where any books of account or other documents are seized, the Food Safety Officer shall, within period not exceeding thirty days from the date of seizure, return the same to the person from whom they were seized after copies thereof or extracts there from as certified by that person. Where such person refuses to socertify and a prosecution has been instituted against him under this Act, such books of account or other documents shall be returned to him only after copies thereof and extracts there from as certified by the court have been taken. (oxi), Where the Food Safety Officer i ofthe opinion or he has reason(s) tobe recorded in writing that in the given situation its not possible to comply with the provision of Section 38 (1) (c) or the proviso to section 38(1) for reasons like non availabilty of the Food Business Operator, the Food Safety Officer may seize the adulterant ‘or food which is unsafe or sub-standard or misbranded or containing extraneous matter, may seal the premises for investigation after takinga sample of such adulterant or food for analysis. (xxi) Where the Food Safety Officer is of the opinion or he has reason(s) to believe that any person engaged in selling, handling or manufacturing any article of food is suffering from or harbouring the germs of any infectious disease/ contagious disease, he may cause such person to be examined by a qualified medical professional duly authorized by the Designated Officer, Provided that where such person isa female, she shall be examined by 2 qualified lady medical professional duly authorized by the Designated Officer. If on suchFOOD SAFETY OFFICER | 41 examination the qualified medical professional certifies that such person is suffering from any such disease, the Food Safety Officer may by order in writing under intimation to the Designated Officer direct such person not to take partin selling or manufacturingany article of food. (bail) To respond to incidents of food poisoning in his area and to send report to and assist the Designated Officer to ‘enable him to initiate corrective action, (xxiv) To maintain data base of all Food Business within the area assigned to him. (xvi) To maintain a record of all inspections made and action taken by him in the performance of his duties, including the taking of samples and seizure of stocks, and to submit copies of such records to the Designated Officer as directed in this regard. (xvii) When any adulterantis seized under, the burden of proving that such adulterant is not meant for purposes of ‘adulteration shall be on the person from whose possession such adulterant was seized. (vii) To facilitate preparation of Food safety plans for Panchayat and Municipalities in accordance with the parameters and guidelines given in schedule 1Vof Chapter 3 of Regulations. (xxix) To detain imported packages which are suspected to contain articles of food, the import or sale of which is. prohibited. (100%) To coordinate with the Food Business Operators within his area of operation and facilitate the introduction of food safety systems by the Food Business Operator. (oxi) To perform such other duties, as may be entrusted to him by the Designated Officer or Food Safety ‘Commissioner having jurisdiction in the local area concerned. (oxi) Food Safety Officer shall launch prosecution before courts of ordinary jurisdiction or Special Court, as the ‘case may be; and such communication shall also be sent to the purchaser if the sample was taken under section 40, legal sample. C. Liability of Food Safety Officer in certain cases ‘Any Food Safety Officer while exercising powers under this Act or the rules and regulations made there under, seizes any article of food or adulterant without any reasonable ground or with intention to harass or commits any other act to the injury of any person without having reason to believe that such act is necessary for the execution of his duty, willbe guilty of an offence under this Act and is liable toa penalty which may extend to one Lacrupees. However incase any false complaint is made against a Food Safety Officer anditis proved so, the complainant will be guilty of an offence under this Act and will be punishable with fine which should not be less than fifty thousand rupees but may extend to one Lacrupees. Note: The Commissioner of Food Safety and Designated Officer can exercise the same powers as are conferred on the Food Safety Officer and follow the same procedure specified in this Act. D. Various Important Regulations under the Act. The Food Safety Officer should be well acquainted with following Regulations notified by the Food Safety and Standards Authority of India under the FSS Act. (i) Food Safety and Standards (Licensing and Registration of Food Businesses), Regulations 2011 (ii) Food Safety and Standards (Food Product Standards and Food Additives), Regulations 201142 MANUAL FOR FOOD SAFETY OFFICERS. (iil) Food Safety and Standards (Pro! {iv) Food Safety and Standards (Packaging and Labelling), Regulations 2011 (v) Food Safety and Standards (Contaminants, Toxins and Residues), Regulations 2011 (vi) Food Safety and Standards (Laboratory and Sampling Analysis), Regulations 2011 (vil) Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Food for Special Dietary Uses, Foods for Special Medical Purpose, Functional Foods and Novel Foods), Regulations 2016 ion and Restriction on Sales), Regulations 2011 (viii) Food Safety and Standards (Food Recall Procedure), Regulations 2017 (ix) Food Safety and Standards (Import), Regulations 2017,CHAPTER 5 ATM Melody of Food Businesses44 | MANUAL FOR FOOD SAFETY OFFICERS ‘A. As per Section 31 of Food Safety & Standards Act, 2006 and Regulation 2.1 of all Food Business Operators in the country have to be registered or licensed in accordance with the procedures laid down. Salient Features: 1. Noperson shall commence or carry on any food business except under alicense. 2. Inaddition to the Designated Officer, Registering authority can alsoissue registration certificate. 3. Unified Licensing procedures for both centre and state and through the country-Single Window 4. Categorised into Central License, State License and Registration. 5. Introduction of exhaustive Safety, Sanitary and Hygienic conditions mandatory for registration/licensing 6. Lessinspections, more audit of system 7. Emphasis on Monitoring, Self-compliance and Surveillance. Authorities responsible for Licensing & Registration of Food Business Peed Food safety officer or any official in panchayat, municipal Corporations or any reg ‘other local body or panchayat Area notified by the state Food Commissioner for the purpose of registration Recent Designated officer appointed under section 36 (1) of FSS Act by the Food Safety Commissioner of the state or UT for the purpose of Licensing and Monitoring Coy Coote eS) Designated officer appointed by the chief Executive officer of the Food Uy ‘Authority of India in his capacity as food Safety Commissioner. Food Licen: ig and Registration System (FLRS) Under the Food Safety and Standards Act, 2006, every Food Business Operator has to take License/Certificate to commence business. Food Licensing & Registration System (FLRS) has been developed under the guidelines laid down under Food Safety and Standards (Licensing & Registration of Food Businesses) Regulation, 2011, FLRS is a web based system to facilitate Food Business Operators across the country to apply for License/Registration Certificate online and track their application status through the various stages of processing. FLRS is being used by FSSAI Regional and Sub-Regional Offices and State Governments to process applications online. Itis hosted on a secure data centre at NIC and available 24X7 to all stakeholders. FLRS allows ‘ieee sibel Sieeie venetian vials tee tie tiaras ane: wailiatiies Vines veasaiieaiiiail eet cade titiLICENSING AND REGISTRATIONS OF FOOD BUSINESSES | 45 sends automatic alerts on email and sms to the FBOs at different intervals to facilitate faster processing of applications and allowing the FBOs to maintain continuity of their license/registration certificates. The Designated Officers and FSOs are provided with user ID and password to access FLRS. Once Registration/License is applied on FLRS, the applications is pushed to the bin of DO. DO confirm the receipts of fee to FBO and scrutinises the documents uploaded with the Application. 00 may send back application to the bin of F80 in FLRSin case of incompleteness or for clarification. On the receipt of a complete application including the additional information if asked for, the Licensing Authority shall issue an Application 1D number to each applicant that will be referred to in all future correspondence between the Licensing Authority and the applicant. After the issue of Application ID number the Licensing Authority may direct the Food Safety Officer or any other person or agency specially designated for such functions to inspect the premises in the manner prescribed by the Food Safety and Standard Authority of India in accordance with these Regulations, Such Inspecting Officer or person may issue anotice tothe applicant, iit deems fit, guiding food business operator on necessary steps to be taken or changes or alteration to be made in the premises in order to ensure general sanitary and hygienic conditions as specified in Schedule 4. The applicant shall carry out the required steps, changes or alterations and intimate the Licensing Authority within 30 days or such period as may be allowed by the Licensing Authority. Within a period of 30 days from receipt of an inspection report excluding the time taken by the applicant in complying with the advice, ifany given in the inspection report and verification thereof, the concerned Licensing Authority shall consider the application and may either grant license or reject the application. Provided that before refusing license an applicant shall be given an opportunity of being heard and the reasons for refusal shall berecordedin writing. Live URL- http://foodlicensing.fssai.gov.in/ FAQs-https://foodlicensing fssai.gov.in/PDF/FAQN.pdf How toapply--https://foodlicensing fssai.govin/how_to_apply. html Help Desk— Toll free Number 1800112100, email-licensing@fssai.gov.in B. Petty Food Business Operator "Petty Food Operator” means any food business operator, who fa) (b) () (a) } manufactures or sells any article of food himself or a petty retailer, hawker, itinerant vendor or temporary stall holder; or distributes foods including in any religious or social gathering except a caterer; or such other food businesses including small scale or cottage or such other industries relating to food business or tiny food businesses with an annual turnover not exceeding Rs 12 lakhs and/or whose production capacity of food (other than milk and milk products and meat and meat products) does not exceed 100kg/Itrper day or procurement or handling and collection of milkis up to SOOlitres of milk per day or slaughtering capacity is 2large animalsor 10 small animals or SO poultry birds per day orless.46 | MANUAL FOR FOOD SAFETY OFFICERS é Process of Registration of Petty Food Business 1. Every petty Food Business Operator will register themselves with the Registering Authority by submitting an application for registration in Form A along witha fee of Rs. 100/-. 2. The petty food manufacturer has to follow the basic hygiene and safety requirements provided in Part | of Schedule 4 of these Regulations and providea self attested declaration of adherence to these requirements with the application in the format provided in Annexure-1. 3. The Registering Authority will consider the application and may either grant registration or rejectiit with reasons tobe recorded in writing orissue notice for inspection, within 7 days of receipt of an application for registration, 4, Inthe event of an inspection being ordered, the registration will be granted by the Registering Authority after being satisfied with the safety, hygiene and sanitary conditions of the premises as containedin Part lof Schedule 4withina period of 30 days. Ifregistration is not granted, or denied, or inspection not ordered within 7 days or no decisionis communicated within 30 days the petty food manufacturer may start its business, provided that it will be incumbent on the Food Business Operator to comply with any improvement suggested by the Registering Authority even later. The registration cannot be refused without giving the applicant an opportunity of being heard and for reasons to be recorded in writing. 5. The Registering Authority will issue a registration certificate and a photo identity card, which hasbe displayed at a prominent place at all times within the premises or vehicle or cart or any other place where the person carries on sale/manufacture of food in case of Petty Food Business. 6. The Registering Authority or any officer or agency specifically authorized for this purpose carries out food safety inspection of the registered establishments at least once in a year. Provided that a producer of milk who is a registered member of a dairy Cooperative Society registered under Cooperative Societies Act and supplies or sells the entire milk to the Society shall be exempted from this provision for registration. List of documents required for a Registration Certificate 1. Photo of Food Business Operator 2. Document for Identity Proof like Ration Card, Voter 1D Card, PAN Card, Driving License, Passport, Aadhar Card, Senior Citizen Card, Department Issued ID Supporting Documents (if any):- NOC by Municipality/Panchayat, Health NOC Online System of Registration Food Safety & Standards Authority of India has launched a online system for registration and licensing via Food Licensing & Registration System (FLRS), in order to facilitate the Food Business Operators to apply for registration or license and track their status from any corner of the world. This system sends alerts/ emails to the Food Business Operators for timely processing of the application and also to maintain continuity of the certificate Mode of payment: All fees and charges payable is to be paid vide pay order, challan or demand draft or any online mode of payment as may be prescribed in this regard, by the concerned Food Safety Commissioner, . Validity and Renewal of Registration Regulation 2.1.7 mentions the provisions for validity and renewal of a registration certificate issued to a food business operator.LICENSING AND REGISTRATIONS OF FOOD BUSINESSES | 47 (a) A Registration granted may be valid and subsisting, for a period of 1 to 5 years as chosen by the Food Business Operator, from the date of issue of registration subject to remittance of fee applicable for the period and ‘compliance with all conditions of registration. The renewal fee for one year is equivalent to one year registration fee. (b) Any application for the renewal of a registration granted will be made in Form A not later than 30 days prior to the expiry date indicatedin the license (c)_ The Registration will continue to be in force till such time that the orders are passed on the renewal application which inno case shall be beyond 30 days from the date of expiry of registration. (d) Any Registration for which renewal has not been applied for within the period above shall expire and the Food Business Operator will have to stop all business activity at the premises. The Food Business Operator will have to apply for fresh Registration ifhe wantsto restart the business. Suspension or Cancellation of Registration Certificate Section 32 of the Food safety & Standards Act, 2006 and the Regulations 2.1.8 of Licensing & Registration of Food Businesses, 2011 details the reasons and process to be followed by the Registering Authority in suspension or cancellation of a registration certificate. (a) The Registering Authority in accordance with the provisions of Section 32 of the Act may, after giving the concerned Food Business Operator a reasonable opportunity of being heard, suspend any registration in respect of all or any of the activities for which the registration has been granted under these Regulations after recording a brief statement of the reasons for such suspension, if there is reason to believe that the Food Business Operator has failed to comply with the conditions within the period mentioned in any Improvement Notice served under Section 32 of the Act. A copy of such statement shall be furnished to the concerned Food Business Operator whose Registration has been suspended. (b) The registering, may direct an inspection of the Food Business Operator's premise(s) within a reasonable period which shall not be less than 14 days from the date of order of suspension. (c) Inthe event that the Registering is of the opinion, on a review of the inspection report, that the Food Business Operator has still failed to rectify the defects or omissions or comply with the conditions of the improvement notice causing the suspension, such authority may cancel the registration of the Food Business Operator after givinghim an opportunity to show cause as provided under Section 32(3) of the Act. (d) Notwithstanding anything contained in these Regulations, the Registering Authority may suspend or cancel any registration or license forthwith in the interest of public health for reasons to be recorded in writing. (e) Asuspension or cancellation of registration shall not entitle the Food Business Operator for any compensation or refund of fee(s) paid in respect ofthe registration certificate or renewal thereof. (f) After a period of 3 months from the date of cancellation above the Food Business Operator may make fresh application for Registration to the concerned authority fall observations made in the improvement notice have been complied with. Modifications, Expansion or Changes in premise(s) after grant of Registration (a) The Food Business Operators can take modifications, expansion or changes in the existing premise after grant of stration certificate, only after necessary approval from the Registering Authority. In such cases the Food48 | MANUAL FOR FOOD SAFETY OFFICERS J (b) Food Business Operators has to ensure that the Registering Authority always has up-to-date information on their food business establishments and will inform the relevant Authority of any modifications or additions or ‘changes in product category, layout, expansion, closure, or any other material information based on which the certificate was granted and such information will be conveyed before the changes occur. (c) Provided that any change that alters the information contained in the registration certificate will require an approval or endorsement in registration prior to start of business with such changes. The Food Business Operator will submit the original license to the Registering Authority along with a fee equivalent to one year license fee for effecting necessary changes. The Registering Authority may approve and issue an amended license incorporating such changes in activities within 30 days from the date of receipt of such information. While approving the afore mentioned changes the concerned Registering Authority takes into account the feasibility of carrying on the business and the legal and other relevant aspects of the desired modifications or additions or changes in activities and, if required, may order an inspection of the premises before granting the approval. Transfer of Registration Certificate in case of Death (a) Inthe event of death of the holder of a Registration certificate, such certificate will subsist for the benefit of the legal representative or any family member of the deceased or untilthe expiry of: — (b) the period of 90 days from the date of death of the holder of a Registration certificate or license; or (c)_ such longer period as the Designated Officer may allow, for reasons to be recordedin writing. (4) The legal representative or family member of the deceased holder of the registration certificate will apply to the concerned Authority for transfer of such certificate in his favour. (e) The registering Authority, may, after making such enquiry as it may deem fit, either approve the transfer of the Registration certificate if satisfied that the applicantis the legal representative, or refuse the request. (f)_ The Registering Authority cannot not refuse the request without giving the applicant an opportunity of b heard and or reasons tobe recordedin writing. (g) Upon filing of application for transfer and pending the decision of the authority, the registration will continue to beinforce. Duplicate Registration Certificate The Food Business may apply for a duplicate registration certificate to the Registering Authority in lieu of the original lost, destroyed, torn, defaced or mutilated. In this condition he has to pay a fee equivalent to one tenth of the fees payable for one year, which is equal to Rs. 10/-only. Appeal ‘AFood Business Operator aggrieved by an order of the Registering Authority can prefer an appeal to the concerned Designated Officer or the Food Safety Commissioner, as per provisions laid down under Section 31(8) and 32 (4)of the Act.