Food safety and standards (Food product standards and Food Additives) regulation, 2011

Food safety and standards (Food product standards and Food Additives) regulation, 2011

LAWS & REGULATIONS GOVERNING THE FOOD INDUSTRY IN INDIA WITH SPECIAL REF. TO FSSAI

Post no-1086 Dt-08 /02/2019
Compiled & shared by-DR RAJESH KUMAR SINGH , LIVESTOCK & POULTRY CONSULTANT,,JAMSHEDPUR, JHARKHAND,INDIA 9431309542,rajeshsinghvet@gmail.com

To meet a country’s sanitary and phytosanitary requirements, food must comply with the local laws and regulations to gain market access. These laws ensure the safety and suitability of food for consumers. In some countries food laws also govern food quality and composition standards 
The requirement of food regulation may be based on several factors such as whether a country adopts international norms developed by the Codex Alimentarius Commission of the Food and Agriculture Organization of the United Nations and the World Health Organization or a country may also has its own suite of food regulations. Each country regulates food differently and has its own food regulatory framework

Food laws in our country ———-

The Indian Parliament has recently passed the Food Safety and Standards Act, 2006 that overrides all other food related laws.
Such as;
1.Prevention of Food Adulteration Act, 1954 
2.Fruit Products Order,1955 
3.Meat Food Products Order ,1973; 
4.Vegetable Oil Products (Control) Order, 1947 
5.Edible Oils Packaging (Regulation) Order 1988 
6.Solvent Extracted Oil, De- Oiled Meal and Edible Flour (Control) Order, 1967, 
7.Milk and Milk Products Order, 1992 etc are repealed after commencement of FSS Act, 2006

Food Safety and Standards Authority of India (FSSAI)————-

The Food Safety and Standards Authority of India (FSSAI) has been established under Food Safety and Standards Act, 2006 which consolidates various acts & orders that have hitherto handled food related issues in various Ministries and Departments. FSSAI has been created 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.

Food Safety and Standards Authority of India 
Food Safety and Standards Act, 2006 was passed by Indian Parliament and notified in the gazette of India on 24th August, 2006 
Gazette Notified Licensing/Registration – FSS Regulations 5th August, 2011
All Food Business Operators in India MUST get Licensed/Registered with Food Safety Authority as per the procedures laid down in under Section 31, FSS Regulations, 2011

What is covered under the FSS Act, 2006? ————–

FOOD means any substance, whether processed, partially processed or unprocessed, which is intended for human consumption and includes primary food, genetically modified or engineered food or food containing such ingredients, infant food, packaged drinking water, alcoholic drink, chewing gum, and any substance, including water used into the food during its manufacture, preparation or treatment but does not include any animal feed, live animals unless they are prepared or processed for placing on the market for human consumption, plants prior to harvesting.

Bureau of Indian Standards (BIS) ————-

The Bureau of Indian Standards (BIS), the National Standards Body of India, resolves to be the leader in all matters concerning Standardization, Certification and Quality

Main Activities——–
Harmonious development of standardization, marking and quality certification 
To provide new thrust to standardization and quality control
To evolve a national strategy for according recognition to standards and integrating them with growth and development of production and exports.

Bureau of Indian Standards (BIS) ——————

Main Activities
Certification
To Product ——-
Hallmarking of Gold Jewellery.
Quality Management System 
Environmental Management Systems 
Occupational Health and Safety Management System
Food Safety Management System 
Hazard Analysis and Critical Control Points
Imported Products
Laboratory Management
International Activities
Training Services

AGMARK —————–

The Directorate of Marketing and Inspection enforces the Agricultural Produce (Grading and Marketing) Act, 1937. Under this Act Grade standards are prescribed for agricultural and allied
AGMARK is a Quality Certification Mark . It ensures quality and purity of a product. It acts as a Third Party Guarantee to Quality Certified Quality standards for agricultural commodities are framed based on their intrinsic quality. Food safety factors are being incorporated in the standards to complete in World Trade.

Standards are being harmonized with international standards keeping in view the WTO requirements. Certification of agricultural commodities is carried out for the benefit of producer/manufacturer and consumer.

Products available under AGMARK are as follows:-
Pulses
Whole spices & ground spices
Vegetable oils
Wheat Products
Milk products.
Other products such as Honey, Compounded asafetida, Rice, Tapioca Sago, Seedless tamarind, Besan (Gram flour)

Fruit Product Order (FPO), 1955——————

The main objective is lay down quality standards to manufacture fruit & vegetable products maintaining sanitary and hygienic conditions in the premises. It is mandatory for all manufacturers of fruit and vegetable products including some non fruit products like non fruit vinegar, syrup and sweetened aerated water to obtain a license under this Order
Following minimum requirements are laid down in the Fruit Product Order for hygienic production and quality standards:

• Location and surroundings of the factory
• Sanitary and hygienic conditions of premises
• Personnel hygiene
• Portability of water
• Machinery & Equipment with installed capacity
• Quality control facility & Technical staff
• Product Standards
Limits for preservatives & other additives

Fruit Product Order (FPO), 1955————

• Fruit product means any of the following articles, namely
• Non fruit beverages, syrups and sherbets
• Vinegar, whether brewed or non-fruit
• Pickles
• Dehydrated fruits and vegetables
• Squashes, crushes cordials, barley water, barreled juice, and ready to serve beverages, fruit nectars or any other beverages containing fruit juices or fruit pulp
• Jams, jellies and marmalades
• Tomato products, ketchup and sauces
• Preserves, candied and crystallized fruit and peel
• Chutneys
• Canned and bottled fruits, juices and pulps
• Canned and bottled vegetables
• Frozen fruits and vegetables
• Sweetened aerated water and without fruit juice pr fruit pulp
• Fruit cereal flakes
• All unspecified fruit and vegetable products which are considered microbiologically safe and contains only permitted additives within permissible limits.
Each container in which any fruit product is packed shall specify a code number indicating the lot or the date of manufacture of such fruit product.
No person can carry on the business of a manufacturer except under and in accordance with the terms of an effective license granted to him under this Order in Form B and shall not use the License number on labels of non-fruit products.FPO mark should be printed on the label with license number.
The labels shall not contain any statement, claim, design or device which is false or misleading in any particular concerning the fruit products contained n the package or concerning the quantity or the nutritive value or in relation to the place of origin of the said fruit products.

Meat Food Products Order (MFPO)———————–

The main objective is to regulate production and sale of meat food products through licensing of manufacturers, enforce sanitary and hygienic conditions prescribed for production of wholesome meat food products, exercise strict quality control at all stages of production of meat food products, fish products including chilled poultry etc. Meat & Meat Products are highly perishable in nature and can transmit diseases from animals to human-beings. Processing of meat products is licensed under Meat Food Products Order,(MFPO) 1973 which was hitherto being implemented by Ministry of food Processing industries . Under the provision of MFPO all manufacturers of meat food products engaged in the business of manufacturing, packing, repacking, relabeling meat food products meant for sale are licensed but excluding those manufacturers who manufactures such products for consumption on the spot like a restaurant, hotel, boarding house, snack bar, eating house or any other similar establishment

Milk and Milk Product order (MMPO) ——————-

The objective of the order is to maintain and increase the supply of liquid milk of desired quality in the interest of the general public and also for regulating the production, processing and distribution of milk and milk products. As per the provisions of this order, any person/dairy plant handling more than 10,000 liters per day of milk or 500 MT of milk solids per annum needs to be registered with the Registering Authority appointed by the Central Government. In every case where the milk or milk product is packed by the holder of a registration certificate in a tin, barrel, carton or any other container, the registration number shall either be exhibited prominently on the side label of such container or be embossed, punched or printed prominently thereon.

Prevention of Food Adulteration Act, 1954 ———–

• The Act was promulgated by Parliament in 1954 to make provision for the prevention of adulteration of food. Broadly, the PFA Act covers food standards, general procedures for sampling, analysis of food, powers of authorized officers, nature of penalties and other parameters related to food. It deals with parameters relating to food additives, preservative, colouring matters, packing & labelling of foods, prohibition & regulations of sales etc. The provisions of PFA Act and Rules are implemented by State Government and local bodies as provided in the rules. 
• In every case where the milk or milk product is packed Prevention of Food Adulteration Act, 1954 is repealed from 05.08.2011by the Central Government as per the Food Safety and Standards Act,2006
• The act clearly defines “What is meant by Food Adulteration and what is the punishment given to person/manufacturer involved in the crime? 
• The food is considered adulterated if it fulfills any of the below

If food is sub-standard rotten, decomposed or obtained from diseased animal or is insect- infested or is otherwise unfit for human consumption. If food contains any other substance which affects, or if the article is so processed as to affect, injuriously the nature, substance or quality thereof
if the article has been prepared, packed or kept under insanitary conditions whereby it has become contaminated or injurious to health;
if any constituent of the article has been wholly or in part abstracted so as to affect injuriously the nature, substance or quality thereof. if the article contains any poisonous or other ingredient which renders it injurious to health . if any colouring matter other than that prescribed in respect thereof is present in the article, or if the amounts of the prescribed colouring matter which is present in the article are not within the prescribed limits of variability. if the article contains any prohibited preservative or permitted preservative in excess of the prescribed limits. if the quality or purity of the article fall. below the prescribed standard or its constituents are present in.

Registration required for the Food Business Operator, who is a———–

 manufactures or sells any article of food himself or a petty retailer, hawker, itinerant vendor or temporary stall holder; or
 such food business including small scale or cottage 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 100 kg/ltr per day or
 Production or procurement or collection of milk is up to 100 litres of milk per day or
 Slaughtering capacity is 2 large animals or 10 small animals or 50 poultry birds per day or less than that

Central License required for the Food Business Operator, who: ————

 Dairy units including milk chilling units process more than 50 thousand litres of liquid milk/day or 2500 MT of milk solid per annum.
 Vegetable oil processing units having installed capacity more than 2 MT per day.
 All slaughter houses equipped to slaughter more than 50 large animals or 150 or more small animals or 1000 or more poultry birds per day
 Meat processing units equipped to handle or process more than 500 kg of meat per day or 150 MT per annum
 All food processing units other than mentioned above having installed capacity more than 2 MT/day.

Food Licensing & Registration————–

Rule as per Food Safety and Standards (Licensing and Registration of Food businesses) Regulation, 2011 As per 2. 1 of Registration and Licensing of Food Business. All Food Business Operators in the country will be registered or licensed in accordance with the procedures laid down And as per 2.1.2 of this regulations No person shall commence any food business unless he possesses a valid license Existing Operator holding valid license/registration shall convert their license within one year of notification of this Regulation (Deadline of 4 February, 2016)

License———

1. Application in Form B 
2. Existing license to be converted within one year (Extended) 
3. 60 days for date of application ID Application accepted- ID issued
4. Inspection- Notice for changes(Improvements) 
5. Time to be given 30 days or more ( This time to be excluded) 
6. Within 30 days of inspection report , Designated Officer to consider 
7. License in Format C (Schedule 2) 
8. Business can be started if no response from FSSAI in 60 days.

Renewal —————-

1. 1-5 year validity (FBO choice) 
2. Renewal of the license have to apply at least 30 days prior to the expiry date of the license 
3. Late fee of Rs. 100/day 
4. Old Licenses with validity- one year time to change over to get new number

General Compliance Requirements of FBO’s———————-

• FBO should display license at all the times at a prominent place in the premises • FBO should have an operational FSMS plan in place • Inform authority of any changes / modifications in activities/content of license • Employ at-least one technical person to supervise • Deal with No product other than the product indicated on license (Annexure) • Ensure source and standard of raw material are as per standards • The manufacturer/importer/distributor shall buy and sell food products only from, or to, licensed/registered vendors and maintain record thereof • Proprietors of hotels, restaurants and other food stalls who sell or expose for sale savouries, sweets or other articles of food must display list of articles cooked in ghee, oil etc for the info of consumer • Take away packages should have following written on the package- “ for immediate consumption”

Safety guidelines for all types of food outlets——————
• Raw material ———–

• Obtain raw material from reliable and known dealers (authorized dealers with a valid license) • Look for temperature abuse especially for frozen foods, like signs of thawing (water droplets n the product and texture changes) • Examine for physical hazard and foreign body contamination • Packaged food products must be checked for expiry date/ best before/ use by date, packaging integrity and storage conditions • Proper rotation of all the raw materials and finished materials should be undertaken on FIFO (First in First out), FEFO (First Expire First out) and FMFO (First manufactured First out) • Receiving and storage temp. of potentially high risk food should be at or below 5 deg cel. and frozen food below -18 deg cel

Safety guidelines for all types of food outlets———–
• Formulations—
Keep the consumer informed by displaying the ingredients, indicative of possible allergen (milk, egg, fish, crustaceans, shell fish, nuts, wheat gluten, peanuts and soy proteins), high sugar etc. for health reasons
•Preparation and Processing —
Adequate to eliminate and reduce hazards to an acceptable levels which might have been introduced at the start level ƒ Cooked preparation should not be re-contaminated ƒ Veg, Non-veg foods should be segregated
• Transportation, handling and storage of prepared foods —
• Dedicated vehicle for transport of food which should not carry anything else • Time requirement should be minimum- in case of foods prepared at long distances, which require transportation for longer period should be chilled to less than 5 deg cel and transported and re-heated at the time of service ƒ Coked food, served hot should be kept at a temperature atleast 60 deg cel to prevent microbial growth, cold food should be kept below 5 deg cel to prevent growth of pathogens
• Personnel Hygiene —–
The hygiene and the health of all food handlers are essential to keep safe e.g. should wear clean and proper clothing, cover their hair, wear hand gloves while handling food 
• Vending/ selling units, equipments, utensils ——–
Design, construction & maintenance of all food related equipments, utensils and units should be such that they can be cleaned and sanitized totally, they should be made of safe materials and stored properly after drying
• Environment and surroundings ——
Should be ensured that the food procured and prepared hygienically do not get contaminated due to any uncleaned and unhygienic environment, hence all areas used for preparation and display and sale of food should have clean surroundings 
• Cleaning and sanitizing ——–
Cleaning and sanitizing at every point of the preparation chain has to be ensured by using proper cleaning agents, methods & cleaning schedules
• Waste disposal and pest control ——-
Waste disposal is critical to keep F&B safe at every point of the chain, waste at no point should come in contact with the food directly or indirectly (through flies, insects etc. )

Regulatory Prosecution——–
Prosecution is specified under section 48 of FSS Act, 2006: ™ 
Substandard food: Upto Rs. 2.00 lakhs ™ 
Misbranded: Upto Rs. 3.00 lakhs ™ 
Misleading advertisement : Upto Rs. 10.00 lakhs ™ 
Food with extraneous matter: Upto Rs. 1.00 lakhs ™ 
Fail to meet the requirements as directed by FSO: Upto Rs. 2.00 lakhs ™ 
Unhygienic / unsanitary preparations: Upto Rs. 1.00 lakhs ™ 
Adulterant not injurious to health: Upto Rs. 2.00 lakhs ™ 
Adulterant injurious to health: Upto Rs. 10.00 lakhs ™
Unsafe food – but does not cause immediate injury : 6 months imprisonment with fine of Rs.1.0 lakh

Food Safety and Standards (Import) Regulations, 2017 –

FSSAI has integrated its Food Import Clearance System (FICS) with the ICEGATE System (Indian Customs and Central Excise Electronic Commerce/Electronic Data Interchange (EC/EDI) Gateway) of Customs under the Single Window Clearance Interface to Facilitate Trade (SWIFT) at Delhi, Mumbai, Kolkata, Chennai, Cochin and Tuticorin Ports. To minimise the sampling size and time thus expediting the imports clearance process in line with Ease of Doing Business initiative, a risk based sampling system called Risk Management System (RMS) has been introduced by the Department of Customs under the Single Window Interface for Facilitating Trade (SWIFT). Due to electronic process clearance, the time for clearance of imported food consignments has been reduced from about 12 days to nearly 8 days.
Some broad level import regulations that may be relevant for new investors in India, who may choose to begin operations by first importing their signature products, are listed below:
• No imports of food articles are permitted into India without an import license from the Central Licensing Authority. A remaining shelf life of minimum 60 per cent at the time of import is a must
• These regulations shall not apply to any person bringing a food article for personal consumption, provided that the value of such food articles does not exceed the amount allowed by customs, from time to time
• In case of imported packaged food consignments, the following special dispensation on labeling shall be allowed for rectification at the custom bound warehouse, by affixing a single non detachable sticker or by any other no detachable method next to the principle display panel namely: ―
o Name and address of the importer
o Food Safety and Standards Authority of India’s Logo and license number,
o Non-Veg or Veg Logo
o Category or sub category along with generic name, nature and composition for proprietary food
• FSSAI NOC is exempted for imported food on following conditions, by submitting an undertaking:
o Articles of food imported for personal consumption
o Imported food consignments meant for display purpose in trade fairs/exhibitions
o Imported food consignments meant for research & development purposes
o Imported food consignments meant for sports events
o Imported food consignments meant for 100 per cent export and re-export
• Imported consignments of food items having a shelf life of less than 7 days and the food that requires special storage conditions shall be issued Provisional NOC, without waiting for the analysis report from the lab, on the basis of an undertaking from the Importer as prescribed by FSSAI
• An importer can apply for retest if the primary laboratory finds a sample non-conforming to the FSS Standards
• From time to time the Food Authority may review risks associated with imports of articles of food and adopt a risk-based framework and risk based inspection process for clearance of imported articles of food or even include them in the prohibited items list

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