FSSAI and impact to industry: Licensing and

Registration

Multiplicity of food laws, standard setting andenforcement agencies for different sectors of food

Varied Quality/Safety standards restricting innovationin food products

Thin spread of manpower, poor laboratoriesinfrastructure and other resources non-conducive toeffective fixation of standards

Standards rigid and non-responsive to scientificadvancements and modernization

Poor Information dissemination to consumer level

3

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.

4

• Covering Health Foods, supplements, nutraceuticals

• Issuing Licenses within a time frame of 2 months

• Provision of Improvement Notice by DesignatedOfficers

• 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

FSS Act – New Features

5

• 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

FSS Act – New Features

6

• Training and Awareness programmes for FoodBusiness Operators as well as Regulators;

• Ensuring representation in the Authority fromdifferent regions by grouping States into 5 Zones;

• Recognition of Food Safety Audit Agencies to verifythe compliance of Food Safety and Managementsystems;

• Encouraging Self regulation through introduction ofFood Recall Procedures; and,

• No License for small food business operators; onlyregistration is mandatory;

FSS Act – New Features

Section 91- provides for Central Government tomake Rules for carrying out provisions of the Act.

Section 92 (1)- provides Food Authority with theprevious approval of Central Government and afterprevious publication, by notification, makeregulations consistent with this Act and Rules madethereunder.

FSSAI drafted Rules and Regulations throughextensive consultation and deliberations/meetingswith various stakeholders.

Final Rules have been notified in the gazette ofIndia on 5th May, 2011.

Final Regulations have been notified in the gazetteof 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 saleof any article of food.

Survey of the Industrial Units.

Conduct or organise training programmes.

Uniform implementation of the standards and otherrequirements as specified.

Ensure a high standard of objectivity, accountability,practicability, transparency and credibility.

Sanction of prosecution for offences punishable withimprisonment 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 FoodSafety for sanction to launch prosecutions.

Sanction or launch prosecutions.

Maintain record of all inspections made byFood Safety Officers and action taken by themin the performance of their duties;

Investigate any complaint.

Other duties.

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.

FOOD SAFETY OFFICER

MANNER OF DISPATCHING CONTAINERS OF SAMPLE

1

2 3

4

To analyst

Two parts to

Designated Officer

Remaining part, if FBO

Request send to accredited Lab

First part

Send to food analyst

Analysis report

Fourth part

Send to accredited laboratory

Analysis report

If at variance

Send to Referral

Laboratory

Report shall be final

2 &3rd

part DO

Analysis report fails

On request FBO

FBO can Appeal

(form VIII)

Analysis report fails

Punishment with fine or imprisonment

Prosecution

Designated

Officer

Sample Pass

Sample Fail Punishable with

imprisonment

with/without fine

Punishable with

Fine

Prosecution

Order by

Adjudication

Officer

Petty

Manufacturer

Other FBO’s

Punishable with

Fine

Compounding u/s.

69

Enforcement

Appeal to

Appellate

Tribunal

Prosecution

Commissioner

Enforcement

Appeal to High

Court

Punishable with

imprisonment

with/without fine

Case filed

Court order

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.

Central Licensing Authority

State Licensing AuthorityRegistering

Authority

Designated Officer

appointed by the Chief

Executive Officer of the

Food Authority of India

in his capacity of Food

Safety Commissioner

Food Safety Officer or any official in

Panchayat,MunicipalCorporation 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.

CENTRAL

FOOD

AUTHORITY

FSSAI Head Quarters

(Licensing)

ZONAL DIRECTORS & OTHER OFFICERS(for inspections &

Monitoring)

FRAMEWORK FOR REGISTRATION/ LICENSING/MONITORING OF FOOD BUSINESS

ESTABLISHMENTS

CHIEF EXECUTIVE OFFICER, FSSAI

STATE FOOD SAFETYCOMMISSIONER

34 STATES/UT

LICENSINGAUTHORITY

FOOD SAFETY OFFICER(for Inspection and

Monitoring Food Business operators)

REGISTRATION AUTHORITY

DESIGNATED OFFICERLICENSING AUTHORITY

• City Municipal Corporation,

• Town Panchayat,• Gram Panchayat

means any Food manufacturer, who

Manufactures or sells any article of food himself or apetty retailer, hawker, itinerant vendor ortemporary stall holder; or

such other industries including small scale orcottage or tiny food businesses with anannual turnover not exceeding 12 lakhs andwhose

production capacity of food (other than milk andmilk products and meat and meat products) doesnot exceed 100 kg/ltr per day or

procurement or collection of milk is up to 500 litresof milk per day or

slaughtering capacity is 2 large animals or 10 smallanimals or 50 poultry birds per day or less

Procedure of Registration

Filing of Application

Processing of Application

Either grant or reject Registration Certificate,

Issue notice for inspection

After the Inspection grant the registration

ApplicationForm A

Fees Rs 100/-

Within 7 days of receipt of

application

Within a period of

30 days

Food Business operator may start business

If no response

•Registration shall not be refused withoutgiving the applicant an opportunity of beingheard.

•A registration certificate and a photoidentity card shall be issued which shall bedisplayed at a prominent place.

•The Registering Authority or any officer oragency specifically authorized for thispurpose shall carry out inspection.

Registration Procedure

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 underany of the food categories or deviates fromthe prescribed specification for additives.

FBO s operating in two or more states

Food catering services in establishments andunits under Central government Agencies likeRailways, 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)

Filing of an Application

unique application number

Require additional information on incomplete

Application

Procedure of Licensing

ApplicationForm B

Documents + Fees

Inspection of premises after receiving completed

application & issue inspection report

Grant or reject within a period of 30 days from

receipt of inspectionreport excluding the time

taken by FBO.

FBO may

start the business after 60

days

Suspension

Improvement Notice

Cancelation

No inspection

No improvement

No improvement

Fresh applicationAfter 90 days

Food Business Operators Shall inform the Authority

Any modifications or additions or changes in productcategory, layout, expansion, closure, or any other materialinformation based.

Any change that alters the information contained in the licensecertificate shall require an approval or endorsement in licenseprior to start of business with such changes.

Submit the original license along with a fee.

The Authority may approve and issue an amended licensewithin 30 days from the date of receipt of such information.

Modifications, Expansion or Changes

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.

Return

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

Validity and Renewal of Registration and License

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.

Section 27Manufacturer shall be liable for meeting all requirements under this ActWholesaler/distributor shall be liable only for

Sale after expirystored or supplied in violation of the safety instruction Unsafe or misbrandedManufacturer unidentifiableReceived with knowledge of being unsafe

Seller shall be liable only for Sale after expiryHandled or kept in unhygienic conditions misbrandedManufacturer unidentifiable

Liability for Compliance

On receiving the completed application licensingauthority directs Food Safety Officer or any other personspecially designated for such functions to inspect thepremises.

A prescribed inspection procedure being laid down inChapter Inspection of food establishments andInspection 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 applicantsuggesting compliance for improvements if any.

After confirming that all requirements have beencomplied with the requirements a licence to be issued bythe Licensing Authority in format C provided underSchedule 2 of the Regulations 2010.

Inspection for New applicant/ Routine Inspection

FSSAI National Licensing & Registration

portal

Designated officer

Improvement Notice

state the grounds

specify the matters

specify the measures which

require the food business operator to take those

measures

cancellation

Suspension

Appeal to the commissioner

Improvement Notices

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.

THANK YOU

THANK YOU