Prabodh Halde, Chetana Bhandari / FnBnews
Food Safety & Standards Regulations – Impact on industry
Introduction
The Food Safety and Standards Act, 2006, was born out of the need for an integrated food law, prioritising consumer safety and harmonisation of food standards with international regulations. The Food Safety and Standards Act, 2006, is a new legislation that integrates eight different existing food laws and is a comprehensive enactment aimed at ensuring public health and safety. The implementation of this Act will be a major transformation that ensures to bring paradigm shift in the food regulatory scenario of India. The Food Safety and Standards Regulations, 2011, have been released now in seven chapters and are effective from August 5, 2011. This analysis presents the highlights of the regulations and discusses the impact of the regulations for the industry.
Impact on industry
The FSS Act 2006 compels the licensing / registration of every single entity in the food business. The entities have been categorised as petty food manufacturers and food business operators depending upon their manufacturing capacities. Petty food manufacturers, e.g. street food vendors or small food business operators (FBOs) with annual turnover less than Rs 12 lakh will, fall under the purview of registration and it is mandated that these petty food manufacturers must register with the registering authority. The petty food manufacturer must follow the basic hygiene and safety requirements provided in Part I of Schedule 4 of the Regulations. On application, a registration certificate and a photo identity card will be granted by the authority, which the petty food manufacturer shall display at a prominent place at all times within the premises or his place of business. Licensing is applicable to food business operators which include big and medium scale manufacturers, warehouses, distributors, importers, etc. The licensing system has been laid down as a two-tier system comprising Central & state licensing. The list of businesses which fall under the purview of Central Licensing Authority are enlisted in Schedule 1 of the Food Safety and Standards (Licensing & Registration) Regulations, 2011.
SCHEDULE 1 : FBOS Under Central Licensing
Dairy units including milk chilling units equipped to handle or process more than 50,000 litres of liquid milk / day or 2,500 MT of milk solid per annum
Vegetable oil processing units and units producing vegetable oil by the process of solvent extraction and refineries including oil expeller unit 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 including sheep and goats or 1,000 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 under (I) to (IV) including relabellers and repackers having installed capacity more than 2 MT / day except grains, cereals and pulses milling units
100 % Export Oriented Units
All Importers importing food items including food ingredients and additives for commercial use
All food business operators manufacturing any article of food containing ingredients or substances or using technologies or processes or combination thereof whose safety has not been established through these regulations or which do not have a history of safe use or food containing ingredients which are being introduced for the first time into the country
Food Business Operator operating in two or more states
Food catering services in establishments and units under Central government agencies like railways, air and airport, seaport, defence etc.
The following officers have been appointed as Designated Officers under Central Licensing for the respective jurisdiction / area provided against the names.
The medium-scale manufacturers, depots / warehouses, distributors will have to attain a licence from the State Licensing Authority.
Licencing
The licence will be granted by Licencing Authority based on compliance to the conditions of licence and it may be obtained for a period of 1 to 5 years. The licenced establishments will be subject to periodical inspections and food safety audits by licencing authority or certain agencies authorised for the purpose. The following section enlists the conditions of licence that are mandatory for compliance at all times of business.
Licensing Requirements
● A true copy of the FSSA licence is displayed at a prominent place in the premises at all times
● Information with respect to any change or modifications in activities / licence content is communicated to the authorities
● The production process is supervised by at least one technical person, who possesses at least a degree in science with chemistry / biochemistry / food and nutrition / microbiology or a degree or diploma in food technology or any degree or diploma related to the specific requirements of the business from a recognised university or institute or equivalent
● The periodic annual return from April 1 to March 31 is furnished within May 31 of each year
● No product other than the product(s) indicated in the licence / registration is produced in the facility
● The sanitary and hygienic standards and worker’s hygiene is followed and implemented as specified in the Schedule – 4
● The daily records of production, raw materials utilisation and sales are maintained in a separate register
● The source and standards of raw material used are of optimum quality
Premises for manufacture, storage, exposure for sale of food are well separated from any urinal, drain, storage area for foul / waste matter
● Clean-in-place systems (wherever necessary) for regular cleaning of the machine & equipments are maintained and followed
● The testing of all relevant chemical and microbiological contaminants in food products is carried out through own or NABL / FSSA recognised labs at least once in six months
● Required temperature / conditions are maintained throughout the supply chain from the place of procurement / sourcing till the consumer end including transportation, storage, etc
● The food products are bought / sold by the manufacturer / importer / distributor only from or to licensed / registered vendors and records are maintained
A register is maintained for edible oils and solvent extracted oil, showing the quantity of oil manufactured, received, nature of oil used as applicable and the destination of each consignment of the substances sent out from the factory. Such register is furnished for inspection when required by the Licencing Authority
● Well equipped laboratory facility for analytical testing of samples is available in the premises
● No edible oil is sold / distributed / offered for sale / dispatched or delivered for purpose of sale unless it is packed, marked and labelled in the manner specified in the regulations
Labelling
There are not many changes in labelling requirements for other products. However with some of the orders merging into FSSA, the registration numbers issued under such orders may not be valid. This may imply labelling revisions for labels of certain products. However, the Legal Metrology Act & Rules and Agmark regulations are still operative. Also elaborate legislation for regulating label claims and claim substantiation are being framed and may be made available soon.
Product standards
For the product standards chapter, the Food Safety & Standards Act includes a section (Section 22) providing for new categorisation of foods namely health supplements, foods for special dietary uses, novel foods, etc. The categories are defined broadly in the Act and a more detailed regulation on this front is expected. This feature which was absent in the existing food laws was anticipated to facilitate and promote the development of new products thus enabling innovation opportunities and the growth of the industry.
Sampling procedure
Sampling procedures have also been changed in the new food legislation. The Food Safety Officer (FSO) will now draw four samples, instead of three as was the case in Prevention of Food Adulteration Act. The product sample will be divided into four parts, sealed and signature of the person from whom sample is drawn shall be taken. One or more witnesses will be called upon and their signatures taken at the time of drawing samples. One part of the drawn sample will be sent to the food analyst and the two parts of the sample will be sent to the Designated Officer by suitable means. The Food Safety Officer must serve a notice in form VA to the FBO right at the time of sample pick up. There is a provision that the FBO may request for analysis of the remaining fourth sample by NABL-accredited laboratory. However, if the reports of food analyst and accredited laboratory are at variance, the sample may be sent to a referral laboratory the results of which shall be considered final. The following schematic representation depicts the process following the sample pickup by the Food Safety Officer
Adjudication
The Food Safety & Standards Act also provides for a new judicial process of adjudication. When the sample picked by FSO fails in the analysis, the non-compliance may be punishable with fine or imprisonment. Prosecution will be launched in the court in case of the offences to be penalised with imprisonment. For offences punishable with fine, the FSO must file for adjudication of the alleged offence. An adjudicating officer, appointed by the state, would preside on such cases. Anybody unsatisfied with the decision may appeal to the food safety appellate tribunal. The tribunal enjoys the same powers as a civil court and decides the penalty in case of non-compliance with the provisions of the Act. Thus only the severe cases of unsafe food will go to court. This system will help in the reduction of number of litigations and facilitate quick disposal of cases.
Unlike the Prevention of Food Adulteration Act, a graded penalty structure is proposed based on the severity of offences. The punishment imposed will be a fine for offences like manufacturing, selling, storing, or importing sub-standard or misbranded food. Severe offences of manufacturing, selling, importing unsafe food may be punished with imprisonment along with a fine. However, the penalties for non-compliances are very high and this only emphasises the need for total compliance to the regulations in all respects.
Penalties and punishment 
Import of food
An additional chapter is expected to be incorporated in the Food Safety & Standards Regulations on food imports. The Authority has uploaded the draft regulations for Food Safety and Standards (Food Import) Regulations, 2011, and comments had been invited for the same. The draft regulations include various chapters on licencing of food imports, their prohibition and regulation, the risk categorisation, sampling and analysis and disposal of rejected food products. The imported food clearance process has already been operationalised by the authority since August-September, 2010, through appointment of authorised officers at 14 major ports of entries.
Food recall
There are some other requirements which have been introduced with the implementation of these regulations. With a view to address the issues of food traceability under the FSSA, 2006, establishment of food recall procedures have been made compulsory and it has been laid down that a recall plan must be submitted where applicable, along with the licence application. The nominations are present under the PFA Act. The companies will need to file the nominations under the new law to inform the licencing authority of the nominees for their establishments.
Way forward
Considering the size of the food industry, it will take time to penetrate the new food law and lots of awareness needs to be created by FSSAI authorities. Features such as single-window for licences and special courts to settle disputes have been welcomed. The companies expect the lead time to settle litigations and implement their expansion plans to decrease drastically if the FSSA policies are implemented. Industry anticipates that stronger implementation, involvement of stakeholders in rule framing, single authority and law, sound scientific standards aligned with international regulations are many of the important benefits of FSSA implementation. The Indian food industry appreciates the new law and looks forward to its implementation. The most important thing is consumer safety which is prime motto of FSSA. For more details you can log in to http://www.fssai.gov.in/.
(The authors deal with regulatory issues at Marico Ltd. They can be contacted at prabodh@maricoindia.net or 9820278746)
