India Food Licensing & Registration: Impact to Industry

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Information about India Food Licensing & Registration: Impact to Industry

Published on February 24, 2014

Author: Adrienna


FSSAI and impact to industry: Licensing and Registration

     Multiplicity of food laws, standard setting and enforcement agencies for different sectors of food Varied Quality/Safety standards restricting innovation in food products Thin spread of manpower, poor laboratories infrastructure and other resources non-conducive to effective fixation of standards Standards rigid and non-responsive to scientific advancements and modernization Poor Information dissemination to consumer level

Prevention of Food Adulteration Act, 1954 Fruit Products Order, 1955 Meat Food Products Order, 1973 Vegetable Oil Products (Control) Order, 1947 Edible Oils Packaging (Regulation) Order, 1988, Solvent Extracted Oil, De-oiled Meal and Edible Flour (Control) Order, 1967 Milk and Milk Products Order, 1992 Any order under Essential Commodities Act, 1955 relating to food. 3

FSS Act – New Features • Covering Health Foods, supplements, nutraceuticals • Issuing Licenses within a time frame of 2 months • Provision of Improvement Notice by Designated Officers • Compounding and Adjudication of cases – to reduce Court’s workload and expedite the disposal of cases • Prosecution, if to be launched, should be within 1 year time frame 4

FSS Act – New Features • Constitution of Special Courts for summary trials • Special Tribunals • Compensation to Victims (for any case of Injury/ Grievous injury/ Death) • Reward to informer (informing about the violators – adulteration etc.) by State Govt. • One composite license for unit(s) falling under one area 5

FSS Act – New Features • Training and Awareness programmes for Food Business Operators as well as Regulators; • Ensuring representation in the Authority from different regions by grouping States into 5 Zones; • Recognition of Food Safety Audit Agencies to verify the compliance of Food Safety and Management systems; • Encouraging Self regulation through introduction of Food Recall Procedures; and, • No License for small food business operators; only registration is mandatory; 6

     Section 91- provides for Central Government to make Rules for carrying out provisions of the Act. Section 92 (1)- provides Food Authority with the previous approval of Central Government and after previous publication, by notification, make regulations consistent with this Act and Rules made thereunder. FSSAI drafted Rules and Regulations through extensive consultation and deliberations/meetings with various stakeholders. Final Rules have been notified in the gazette of India on 5th May, 2011. Final Regulations have been notified in the gazette of India on 1st August, 2011.

     Describe the qualification and duties of Food Safety commissioner, Designated Officer and Food Safety Officer. Sampling procedure, manner of taking samples Function of Food analyst and the analysis report Adjudication procedure, appeal Food Safety Appellate Tribunal, Special courts

COMMISSIONER OF FOOD SAFETY OF THE STATE FUNCTIONS        Prohibit the manufacture, storage, distribution or sale of any article of food. Survey of the Industrial Units. Conduct or organise training programmes. Uniform implementation of the standards and other requirements as specified. Ensure a high standard of objectivity, accountability, practicability, transparency and credibility. Sanction of prosecution for offences punishable with imprisonment under this Act. Other functions.

DESIGNATED OFFICER Issue or cancel licence.  Prohibit the sale of any article of food.  Receive report and samples of article of foods.  Recommend to the Commissioner of Food Safety for sanction to launch prosecutions.  Sanction or launch prosecutions.  Maintain record of all inspections made by Food Safety Officers and action taken by them in the performance of their duties;  Investigate any complaint.  Other duties. 

FOOD SAFETY OFFICER Powers  Take sample.  Seize any article of food.  Can enter and inspect any place.  May destroy, deteriorated, perishable product after giving notice in writing.  May seize any article of food and books of account or other documents found in position of manufacturer, distributor and dealer where position of adulterant found.  In case of non availability of the FBO, the FSO may seize the adulterant food and seal the premises for investigation after taking a sample of such adulterant or food for analysis.  May cause a person to be examined by a qualified medical professional duly authorized by the Designated Officer.

MANNER OF DISPATCHING CONTAINERS OF SAMPLE To analyst 1 Two parts to Designated Officer 2 3 4 Remaining part, if FBO Request send to accredited Lab

Fourth part First part On request FBO Send to food analyst Send to accredited laboratory Analysis report Analysis report 2 &3rd part DO Send to Referral Laboratory Report shall be final If at variance Analysis report fails FBO can Appeal Analysis report fails (form VIII) Punishment with fine or imprisonment

Prosecution Designated Officer Sample Pass Punishable with imprisonment with/without fine Sample Fail Punishable with Fine

Prosecution Punishable with Fine Other FBO’s Petty Manufacturer Compounding u/s. 69 Order by Adjudication Officer Enforcement Appeal to Appellate Tribunal

Prosecution Punishable with imprisonment with/without fine Commissioner Appeal to High Court Case filed Court order Enforcement

     Integrates the erstwhile acts/rules/orders, no new standards being introduced. New chapter scheme to facilitate scientific approach in regulatory framework, & scientific developments, provide specificity and traceability of content, easy to digitalized. Unified Licensing Procedures and application forms Clear line of distinction between licensing and registration Standards have been systematically arranged taking into consideration Codex classification

      Food Safety and standards (Licensing and registration)Regulations, 2011 Food Safety and standards (packaging and labeling)Regulations, 2011 Food Safety and standards (Food products standards and Food Additives) Regulations, 2011. Food Safety and standards (Prohibition and restriction for sale) Regulations, 2011 Food Safety and standards (contaminants, toxins and Residues )Regulations, 2011. Food Safety and standards (Referral laboratories and sampling) Regulations, 2011

The present Regulation integrates the Licensing provisions in the following Orders relating to food products :       Fruit Products Order, 1955 Prevention of Food Adulteration Act, 1954 Milk and Milk Products Order, 1992 Vegetable Oil Products (Control) Order, 1947 Edible Oils Packaging (regulation ) Orders, 1998 The Solvent Extracted Oil, De oiled Meal and Edible flour (Control) Order, 1967 Meat Food Products Orders, 1973

      Unified Licensing procedures. Common application forms and procedures. Registration of food Businesses to cover all petty food businesses. Distinction between ‘registration’ and ‘licensing’. Cut off limits for registration and licensing. Sectors which have high Installed Capacity are covered under central licensing. Safety, Sanitary and Hygienic conditions.

Registering Authority State Licensing Authority Central Licensing Authority Designated Officer Food Safety Officer or any official in Panchayat,Municipal Corporation or any other local body in an area, notified as such by the State Food Safety Commissioner for the purpose of registration Designated Officers appointed under Section 36(1) of the Act by the Food Safety Commissioner of a State or UT for the purpose of licensing and monitoring. appointed by the Chief Executive Officer of the Food Authority of India in his capacity of Food Safety Commissioner


 means any Food manufacturer, who  Manufactures or sells any article of food himself or a petty retailer, hawker, itinerant vendor or temporary stall holder; or

 such other industries including small scale or cottage or tiny food businesses with an annual turnover not exceeding 12 lakhs and 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  procurement or collection of milk is up to 500 litres of milk per day or  slaughtering capacity is 2 large animals or 10 small animals or 50 poultry birds per day or less

Procedure of Registration Filing of Application Application Form A Fees Rs 100/- Processing of Application Either grant or reject Registration Certificate, Issue notice for inspection After the Inspection grant the registration Within 7 days of receipt of application If no response Within a period of 30 days Food Business operator may start business

Registration Procedure •Registration shall not be refused without giving the applicant an opportunity of being heard. •A registration certificate and a photo identity card shall be issued which shall be displayed at a prominent place. •The Registering Authority or any officer or agency specifically authorized for this purpose shall carry out inspection.

No person (other than petty food businesses) shall commence any food business without obtaining a valid license.  Existing Operator holding valid license/registration shall CONVERT their license within one year of notification of this Regulation  No license fee for the remaining period of the validity.  License for businesses mentioned under Schedule 1, shall be granted by the Central Licensing Authority and all others by State licensing Authority  Licensing Authority shall ensure periodical food safety audit and inspections of the licensed establishments. 

More than 50,000 thousand lrs of liquid milk/day or 2,500 MT of milk solid per annum

Installed capacity more than 2 MT per day

50 large animals 150 or more small animals, 1000 or more poultry birds per day.

More than 500 kg of meat/day or 150 MT per annum

2 MT/day except grains, cereals and pulses milling units.

 100 % Export Oriented Units  All Importers importing food items    Any article of Food which does not fall under any of the food categories or deviates from the prescribed specification for additives. FBO s operating in two or more states Food catering services in establishments and units under Central government Agencies like Railways, Airlines and airport, Seaport, Defense etc.

Photo I.D and address proof. (optional)  List of food category desired to be manufactured. (In case of manufacturers)  Authority letter with name and address of responsible person nominated by the manufacturer along with alternative responsible person. (wherever applicable)  Analysis report (Chemical & Bacteriological) of water to be used as ingredient in food from a recognised/ public health laboratory to confirm the potability. (mandatory only for manufacturing and processing units only) 

     Proof of possession of premises. (optional) Partnership Deed/Affidavit/Memorandum & Articles of Association towards the constitution of the firm. (optional) Copy of certificate obtained under Coop Act - 1861/Multi State Coop Act - 2002 in case of Cooperatives. (optional; wherever applicable) NOC from manufacturer in case of Re-labellers (mandatory) Food safety management system plan or certificate ( if any)

     Source of raw material for meat and meat processing plants (wherever applicable) Pesticide residues report of water in case of units manufacturing Packaged drinking water, packaged Mineral water and/or carbonated water. (only for packaged drinking water and mineral/ carbonated water) Recall plan, if any (optional) NOCs from Municipality or local body and from State Pollution Control Board (optional) Source of milk or procurement plan for milk including location of milk collection centers etc in case of Milk and Milk Products processing units. (wherever applicable)

Procedure of Licensing Filing of an Application Application Form B Documents + Fees unique application number Require additional information on incomplete Application Inspection of premises after receiving completed No inspection application & issue inspection report Grant or reject within a period of 30 days from receipt of inspection report excluding the time taken by FBO. Improvement Notice FBO may start the business after 60 days No improvement Suspension No improvement Cancelation Fresh application After 90 days

Modifications, Expansion or Changes Food Business Operators Shall inform the Authority Any modifications or additions or changes in product category, layout, expansion, closure, or any other material information based. Any change that alters the information contained in the license certificate shall require an approval or endorsement in license prior to start of business with such changes. Submit the original license along with a fee. The Authority may approve and issue an amended license within 30 days from the date of receipt of such information.

Return Submit a return in Form ’D’ on or before 31st May of each year, in respect of each class of food products handled by FBO during the previous financial year. 1. Form D1 – Annual Return for businesses other than Dairy 2. Form D2 – half yearly returns for businesses engaged in manufacturing milk products for the period of 1st April to 30th September and 1st October to 31st March of every financial year. Any delay in filing return beyond 31st May of each year shall attract a penalty of Rs 100 per day of delay.

Validity and Renewal of Registration and License i. For a period of 1 to 5 years as desired by the FBO, from the date of issue of registration or license ii. apply in Form A or B, not later than 30 days prior to the expiry date indicated in the license. iii. The Registration or License shall continue to be in force till such time that the orders are passed on the renewal application which in no case shall be beyond 30 days from the date of expiry of registration or license. iv. Any renewal application filed beyond the period mentioned above but before the expiry date, shall be accompanied by a late fee of Rs 100 per day of delay

1. Fees for Registration Rs 100 2. Fees for License issued by Central Licensing Authority: Rs 7500 3. Fees for License issued by State Licensing Authority: Manufacturer /Miller Above 1MT per day Production or 10,001 to 50,000 LPD of milk or 501 to 2500 MT of milk solids per annum Rs. 5000/Below 1 MT of Production or 501 to 10,000 LPD of milk or 51 MT to 500 MT of milk solids per annum Rs.3000/Hotels – 3 Star and above Rs. 5000/All Food Service providers including restaurants/boarding houses, hotels below 3 star, clubs etc. serving food, Canteens (Schools, Colleges, Office, Institutions), Caterers, Banquet halls with food catering arrangements, food vendors like dabba wallas etc. Rs. 2000/Any other Food Business Operator Rs. 2000/- The fees paid not refundable under any circumstances. License lost, destroyed, torn, defaced or mutilated, licensee to apply for a duplicate copy of the registration certificate or license during the validity period, accompanied with a fee amounting to 10% of the applicable License fee. Duplicate license to have word “Duplicate” word on it.

Liability for Compliance Section 27 Manufacturer shall be liable for meeting all requirements under this Act Wholesaler/distributor shall be liable only for Sale after expiry stored or supplied in violation of the safety instruction Unsafe or misbranded Manufacturer unidentifiable Received with knowledge of being unsafe Seller shall be liable only for Sale after expiry Handled or kept in unhygienic conditions misbranded Manufacturer unidentifiable

Inspection for New applicant/ Routine Inspection On receiving the completed application licensing authority directs Food Safety Officer or any other person specially designated for such functions to inspect the premises. A prescribed inspection procedure being laid down in Chapter Inspection of food establishments and Inspection of Special Establishments. A detailed Inspection Report to be prepared by the officer as per the format A. Copy of the same has to be handed to the applicant suggesting compliance for improvements if any. After confirming that all requirements have been complied with the requirements a licence to be issued by the Licensing Authority in format C provided under Schedule 2 of the Regulations 2010.

FSSAI National Licensing & Registration portal

Improvement Notices Designated officer Suspension Improvement Notice state the grounds specify the matters cancellation specify the measures which require the food business operator to take those measures Appeal to the commissioner

       Single Window Less inspections, more audit of system Preventive rather than after the event Independent regulator of safety Transparent science based standards and Procedures Pooling of regulatory resources Responsibility of Food Business Operator

       Recall of unsafe food. Small vendors exempted from licensing. 60 days time limit for processing of license. Adjudication and compounding offences. Quicker justice. Penalty for harassment by Food safety Officer. Less inspector Raj.


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