Jan 7, 2012
Licensing and Registration of Food Businesses under FSSR, 2011
With effect from August 5, 2011, the Food Safety and Standard (Licensing and Registration of Food Business) Regulations, 2011, have come into force and all the food business operators have to comply with these requirements.
Henceforth, all food business operators in the country will be registered or licensed in accordance with the procedures laid down hereunder, the summary of which is presented below for awareness:
Registration of petty food business
" All petty food business operators shall register themselves with the registering authority by submitting an application for registration as prescribed in these rules.
" The petty food manufacturer shall follow the basic hygiene and safety requirements provided in Part I of Schedule 4 of these regulations and provide a self-attested declaration of adherence to these requirements with the application.
" The registering authority shall consider the application and may either grant registration or reject it with reasons to be recorded in writing or issue notice for inspection, within 7 days of receipt of an application for registration.
" The registering authority shall issue a registration certificate and a photo identity card, after completing the process and which shall be 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.
" The registering authority or any officer or agency specifically authorised for this purpose shall carry out safety inspection of the registered establishments at least once in a year.
License for food business
No person shall commence any food business unless he possesses a valid license.
" Provided that any person or food business operator carrying on food business on the date of notification of these regulations, under a license, registration or permission, as the case may be, under the Acts or Orders mentioned in the Second Schedule of the Act shall get their existing license converted into the license / registration under these regulations by making an application to the licensing / registering authority after complying with the safety requirements mentioned in the Schedule 4 contained under different parts dependent on nature of business, within one year of notification of these regulations.
" In case of difficulty, the licensing authority with the approval of the food safety commissioner in the state will determine the advisability of applying any specific condition keeping in view the need to ensure safety of food and public interest.
" No license fee will have to be paid for the remaining period of the validity of the earlier license or registration granted under any of the said Acts or Orders.
" Non-compliance with this provision by a food business operator will attract penalty under Section 55 of the Act.
" License for commencing or carrying on food business, which falls under Schedule 1, shall be granted by the Central Licensing Authority, provided that food authority may through notification make such changes or modify the list given in the Schedule I as considered necessary.
" License for commencing or carrying on food business, which are not covered under Schedule 1, shall be granted by the concerned state / UTs licensing authority.
" Further no person shall manufacture, import, sell, stock, exhibit for distribution or sale any article of food which has been subjected to the treatment of irradiation, except under a license obtained from Department of Atomic Energy under the Atomic Energy (Control of Irradiation of Food) Regulations, 1996.
List of food business falling under the purview of Central Licensing Authority
" I. 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.
" II. 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.
" III. 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.
" IV. Meat processing units equipped to handle or process more than 500 kg of meat per day or 150 MT per annum.
" V. 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.
" VI. 100% Export Oriented Units.
" VII. All importers importing food items including food ingredients and additives for commercial use.
" VIII. 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 in the country.
" IX. Food business operator operating in two or more states.
" X. Food catering services in establishments and units under Central government agencies like railways, air and airport, seaport, defence etc.
General requirements on hygienic and sanitary practices to be followed by all FBOs applying for Registration and License
" For those applying for registrations, the requirements are very basic and primarily to ensure safe and hygienic sourcing, handling, storing, serving and prevention of contamination of food. These are applicable to the street food vendors as well as to the units other than manufacturing and processing.
" Further, the elaborate licensing requirements are applicable to the food establishments, other than those who apply for registration, in which food is being handled, processed, manufactured, packed, stored, and distributed by the food business operator and the persons handling them should conform to the sanitary and hygienic requirement, food safety measures and other standards as specified below.
" It shall also be deemed to be the responsibility of the food business operator to ensure adherence to necessary requirements.
" In addition to the requirements specified, the food business operator shall identify steps in the activities of food business, which are critical to ensure food safety, and ensure that safety procedures are identified, implemented, maintained and reviewed periodically.
" These requirements are explained under 12 main heads and in general based on the generally acceptable guidelines of the good manufacturing practices and good hygiene practices. The compliance to these requirements is one of the pre-requisite to get a new license by way of submission of food safety plan adopted or certificate. It may be noted that in case of units falling under Central licensing it has to be a certificate from accredited agency.
1 Location and surroundings
2 Layout and design of food establishment premises
3 Equipment & containers
4 Facilities
4.1 Water Supply
4.2 Cleaning utensils and equipments
4.3 Washing of raw materials
4.4 Ice and steam
4.5 Drainage and waste disposal
4.6 Personnel facilities and toilets
4.7 Air quality and ventilation
4.8 Lighting
5 Food operations and controls
5.1 Procurement of raw materials
5.2 Storage of raw materials and food
5.3 Food processing / preparation, packaging and distribution / service
5.4 Food packaging
5.5 Food distribution and service
6 Management and supervision
7 Food testing facilities
8 Audit, documentation and records
9 Sanitation and maintenance of establishment premises
9.1 Cleaning and maintenance
9.2 Pest control systems
9.3
10 Personal hygiene
10.1 Health status
10.2 Personnel cleanliness
10.3 Visitors
11 Product information and consumer awareness
12 Training
Apart from these requirements there are certain specific requirements for those manufacturing, processing, storing and selling of milk and milk products, meat and catering and food service establishments.
Henceforth, all food business operators in the country will be registered or licensed in accordance with the procedures laid down hereunder, the summary of which is presented below for awareness:
Registration of petty food business
" All petty food business operators shall register themselves with the registering authority by submitting an application for registration as prescribed in these rules.
" The petty food manufacturer shall follow the basic hygiene and safety requirements provided in Part I of Schedule 4 of these regulations and provide a self-attested declaration of adherence to these requirements with the application.
" The registering authority shall consider the application and may either grant registration or reject it with reasons to be recorded in writing or issue notice for inspection, within 7 days of receipt of an application for registration.
" The registering authority shall issue a registration certificate and a photo identity card, after completing the process and which shall be 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.
" The registering authority or any officer or agency specifically authorised for this purpose shall carry out safety inspection of the registered establishments at least once in a year.
License for food business
No person shall commence any food business unless he possesses a valid license.
" Provided that any person or food business operator carrying on food business on the date of notification of these regulations, under a license, registration or permission, as the case may be, under the Acts or Orders mentioned in the Second Schedule of the Act shall get their existing license converted into the license / registration under these regulations by making an application to the licensing / registering authority after complying with the safety requirements mentioned in the Schedule 4 contained under different parts dependent on nature of business, within one year of notification of these regulations.
" In case of difficulty, the licensing authority with the approval of the food safety commissioner in the state will determine the advisability of applying any specific condition keeping in view the need to ensure safety of food and public interest.
" No license fee will have to be paid for the remaining period of the validity of the earlier license or registration granted under any of the said Acts or Orders.
" Non-compliance with this provision by a food business operator will attract penalty under Section 55 of the Act.
" License for commencing or carrying on food business, which falls under Schedule 1, shall be granted by the Central Licensing Authority, provided that food authority may through notification make such changes or modify the list given in the Schedule I as considered necessary.
" License for commencing or carrying on food business, which are not covered under Schedule 1, shall be granted by the concerned state / UTs licensing authority.
" Further no person shall manufacture, import, sell, stock, exhibit for distribution or sale any article of food which has been subjected to the treatment of irradiation, except under a license obtained from Department of Atomic Energy under the Atomic Energy (Control of Irradiation of Food) Regulations, 1996.
List of food business falling under the purview of Central Licensing Authority
" I. 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.
" II. 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.
" III. 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.
" IV. Meat processing units equipped to handle or process more than 500 kg of meat per day or 150 MT per annum.
" V. 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.
" VI. 100% Export Oriented Units.
" VII. All importers importing food items including food ingredients and additives for commercial use.
" VIII. 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 in the country.
" IX. Food business operator operating in two or more states.
" X. Food catering services in establishments and units under Central government agencies like railways, air and airport, seaport, defence etc.
General requirements on hygienic and sanitary practices to be followed by all FBOs applying for Registration and License
" For those applying for registrations, the requirements are very basic and primarily to ensure safe and hygienic sourcing, handling, storing, serving and prevention of contamination of food. These are applicable to the street food vendors as well as to the units other than manufacturing and processing.
" Further, the elaborate licensing requirements are applicable to the food establishments, other than those who apply for registration, in which food is being handled, processed, manufactured, packed, stored, and distributed by the food business operator and the persons handling them should conform to the sanitary and hygienic requirement, food safety measures and other standards as specified below.
" It shall also be deemed to be the responsibility of the food business operator to ensure adherence to necessary requirements.
" In addition to the requirements specified, the food business operator shall identify steps in the activities of food business, which are critical to ensure food safety, and ensure that safety procedures are identified, implemented, maintained and reviewed periodically.
" These requirements are explained under 12 main heads and in general based on the generally acceptable guidelines of the good manufacturing practices and good hygiene practices. The compliance to these requirements is one of the pre-requisite to get a new license by way of submission of food safety plan adopted or certificate. It may be noted that in case of units falling under Central licensing it has to be a certificate from accredited agency.
1 Location and surroundings
2 Layout and design of food establishment premises
3 Equipment & containers
4 Facilities
4.1 Water Supply
4.2 Cleaning utensils and equipments
4.3 Washing of raw materials
4.4 Ice and steam
4.5 Drainage and waste disposal
4.6 Personnel facilities and toilets
4.7 Air quality and ventilation
4.8 Lighting
5 Food operations and controls
5.1 Procurement of raw materials
5.2 Storage of raw materials and food
5.3 Food processing / preparation, packaging and distribution / service
5.4 Food packaging
5.5 Food distribution and service
6 Management and supervision
7 Food testing facilities
8 Audit, documentation and records
9 Sanitation and maintenance of establishment premises
9.1 Cleaning and maintenance
9.2 Pest control systems
9.3
10 Personal hygiene
10.1 Health status
10.2 Personnel cleanliness
10.3 Visitors
11 Product information and consumer awareness
12 Training
Apart from these requirements there are certain specific requirements for those manufacturing, processing, storing and selling of milk and milk products, meat and catering and food service establishments.
Food and Safety Authority of India to invite suggestions
The Food And Safety Authority of India is issuing shortly a notification inviting suggestions from the public and trade bodies regarding 400 standards fixed for various food items,a top official said today.
The present Act had been brought amalgamating seven different acts concerned with the food industry,V.N.Gaur, Chief Executive Officer of the Authority, said. "We have taken the old standards into consideration during the framing of the act.We are not happy with the present standards and there is scope for improvement and polishing". he said participating in an awareness programme on Food Safety Standards Act. The suggestions will be examined by a scientific committee,under which a panel of 120 scientists are working.
The CEO rejected the argument that the Act would come in the way of feeding people,starving in the country. He said the issue(setting standards will come in the way of feeding poor people)was discussed even at the World Food summit where a resolve was made to bring down number of people suffering from chronic hunger from a billion to 50 per cent by 2015.
While Government's philosophy was not to hang wrongdoers,it wanted punishment to be deterrent for violators, he said. "We want the stake holders to come along with us.The act is yet to be implemented in some states,while in other states people have been prosecuted under the act." "We have to see what happens in the months to come.The problems in implementing the act..we will take it to the notice of the Government,and it should consider it.But any penalty should not be convenient,it should be deterrent.We are strong on that," he said.
The Primary food produce from the farm had been exempted from the ambit of the act.But at the same time the Government was launching a major programme for the farmers so that they used less fertilsers and harmful pesticides following certain practices.
There will be a massive awareness programme for the farmers also."It is being taken up in a big manner." The programme was organised by the Madurai District Tiny and Small Industries Association.
Jan 6, 2012
Pollution-hit Tuticorin salt manufacturers worried by food safety act being implemented
A salt pan in front of the Tuticorin Thermal Power Station
The salt manufacturers in Tuticorin, one of the major salt-producing centre in the country, are upset with the stringent Food Safety and Standards Act, 2006 (FSSA) being implemented. They claim there is too much pollution due to thermal power plants in the area, which makes it difficult to maintain quality in their products as envisaged by the Act. They say that pollution needs to be controlled before the authorities start cracking down on them.
Currently, there are about three thermal power plants, with a capacity of about 1,500 MW, operating in the district. Many more plants are in the pipeline. Fly ash from these plants settles on the salt. The Act says that salt has to be manufactured in such a way that it contains 96 per cent sodium chloride.
“My salt pan lies very close to one of the state-owned thermal power stations. During peak season (May–September), fly ash settles on the salt, which has to be left in the open for evaporation,” says AS Dhanabalan, a salt manufacturer. He adds that he loses 50 bags of salt for every 1,000 bags produced because of the fly ash. “I cannot always assure that the other 1,000 bags are clear of pollutants,” he adds. “Why does the government not ensure a cleaner environment if they demand better quality and high standards for the finished product?” he asks.
Small players cannot go hi-tech
P K Raman, another salt manufacturer, says small scale manufactures who make up 95 per cent of the salt industry in the district will be the worst hit as they cannot afford high-end technology to refine salt. “The Tuticorin salt industry has many small players and it should be the government's responsibility to protect them,” he adds.
The FSSA passed in 2006 was implemented last year. Under it, every district in the country has a designated officer who will be in-charge of implementation. Jagadish Chandra Bose, the designated officer for Tuticorin district, convened a meeting on December 27 last year to create awareness among the food business operators in the district with regard to the new laws superseding all the previous acts and regulations.
“All food business operators are required to register under the FSSA from street vendors to food processors to manufacturers,” says Bose. In case the annual turnover of an operator is more than Rs 12 lakh, the operator will have to apply for a license under the FSSA, he adds. Bose says that the business operators should not worry about the new policy as there is scope for two warnings before being penalised.
Jan 5, 2012
Red-faced Ministry issues corrigenda
Dozens of lapses in grammar, punctuation and spelling besides factual mistakes in the notification of the country’s top food watchdog for Food and Safety and Standards Regulations 2011 issued four months ago has left the Health Ministry red-faced. Not to talk about the utter confusion it created for the stakeholders, particularly the food processing sector.
Two days ago, the embarrassed Ministry issued corrigenda in this regard, correcting slew of bloomers in the text of the gazette. But the case reflects the stark negligence at various levels in the Food Safety and Standards Authority of India (FSSAI).
FSSAI CEO VN Gaur acknowledged the error but said that the notification bombed spectacularly in the printing department. “It’s the printer’s devil.” Talking to The Pioneer, Gaur explained: “Mistakes happened due to the last minute rush after the Law Ministry asked us to split the regulation in seven parts. Despite our best efforts and last minutes changes aiming to accommodate the Law Ministry’s views, there remained technical flaws.”
At the instance of the Law Ministry, the regulation was split into seven parts. However, the blatant errors in gazette have become a fodder of ridicule among the stakeholders. “The case speaks volumes about the casual way of the government. Also, many in the industry have already purchased the copies of the regulations full with errors from private publishers. Who will foot their bill for such copies?” said a representative from the industry.
For instance, line 37, pg 322 in FSS(food product standards and food additives) regulation, 2011, “Safflower oil” should have been read as “Imported safflower oil” while in pg 315, line 37 and 38 for “Milk protein (on dry basis) percent by weight (for fruit shrikhand-not less than..6.0)” should be read as milk protein (on dry basis) per cent by weight” and not less than …7” should read “not less than..7 (for fruit shrikhand-not less than..06.”
Similarly “barrey ka tel” has been written as “berry ka tel” while in page 337, line 37 and 38, instead of “it may contain food additives permitted in these regulations and appendices” it is written “no anti-oxidant, synergist, emulsifier or any other substances shall be added except with prior sanction of the Authority.”
Spelling and factual errors are in aplenty in FSS (licensing and registration of food business) regulation, 2011, FSS (packaging and labelling) regulation, 2011, FSS(prohibition and restriction on sales) regulation, 2011, FSS(contaminants, toxins and residues) regulations 2011 and FSS(laboratory and sampling analysis) regulation, 2011.
The notification was delayed for many months due to one or another reason and finally put in effect from August 5, 2011. However, the final outcome has been utterly poor, the representative commented.
In fact, if the FSSAI has left the Ministry embarrassed, the later too has failed to give due attention to the former. For the staff starved Authority has no Chairperson for the last few months while Gaur is to retire by February end this year.
Two days ago, the embarrassed Ministry issued corrigenda in this regard, correcting slew of bloomers in the text of the gazette. But the case reflects the stark negligence at various levels in the Food Safety and Standards Authority of India (FSSAI).
FSSAI CEO VN Gaur acknowledged the error but said that the notification bombed spectacularly in the printing department. “It’s the printer’s devil.” Talking to The Pioneer, Gaur explained: “Mistakes happened due to the last minute rush after the Law Ministry asked us to split the regulation in seven parts. Despite our best efforts and last minutes changes aiming to accommodate the Law Ministry’s views, there remained technical flaws.”
At the instance of the Law Ministry, the regulation was split into seven parts. However, the blatant errors in gazette have become a fodder of ridicule among the stakeholders. “The case speaks volumes about the casual way of the government. Also, many in the industry have already purchased the copies of the regulations full with errors from private publishers. Who will foot their bill for such copies?” said a representative from the industry.
For instance, line 37, pg 322 in FSS(food product standards and food additives) regulation, 2011, “Safflower oil” should have been read as “Imported safflower oil” while in pg 315, line 37 and 38 for “Milk protein (on dry basis) percent by weight (for fruit shrikhand-not less than..6.0)” should be read as milk protein (on dry basis) per cent by weight” and not less than …7” should read “not less than..7 (for fruit shrikhand-not less than..06.”
Similarly “barrey ka tel” has been written as “berry ka tel” while in page 337, line 37 and 38, instead of “it may contain food additives permitted in these regulations and appendices” it is written “no anti-oxidant, synergist, emulsifier or any other substances shall be added except with prior sanction of the Authority.”
Spelling and factual errors are in aplenty in FSS (licensing and registration of food business) regulation, 2011, FSS (packaging and labelling) regulation, 2011, FSS(prohibition and restriction on sales) regulation, 2011, FSS(contaminants, toxins and residues) regulations 2011 and FSS(laboratory and sampling analysis) regulation, 2011.
The notification was delayed for many months due to one or another reason and finally put in effect from August 5, 2011. However, the final outcome has been utterly poor, the representative commented.
In fact, if the FSSAI has left the Ministry embarrassed, the later too has failed to give due attention to the former. For the staff starved Authority has no Chairperson for the last few months while Gaur is to retire by February end this year.
Jan 3, 2012
Centre picks state for pilot e-project on food licensing
Impressed by its use of technology to ban spurious drugs, the Food Safety and Standards Authority of India has chosen Gujarat to launch project for online registration and licensing of food stalls.
The local panipuri larri or the sandwich stall that serves you mouth-watering snacks will no longer be able to get away if it dishes out substandard food. The Food Safety and Standards Authority of India (FSSAI) has chosen Gujarat to implement the pilot project for online registration and licensing of food establishments and vendors. This, because the food and drugs administration has already been successful in using technology to seize and ban spurious drugs across the state.
Which means, the state is ready to replicate the same in creating a database for registration and licensing of unlicensed food business operators and clearing the backlog of pending licences. The project is scheduled to begin by the end of February.
Under this project, all the shops selling food items will be registered and issued a licence.
Raghu Gudal and S Murthy, senior officials of the National Institute for Smart Government — a Hyderabad-based central government agency has developed a software for online registration and licensing of food vendors and establishments — met officials of the Food and Drugs Department on December 30 at Gandhinagar. They also met health minister Jaynarayan Vyas.
Last week, the food and drugs control department commissioner Hemant Koshia had been called to New Delhi by the FSSAI to intimate him about their decision to launch the pilot project in Gujarat.
Vyas told Mirror, “Gujarat is ahead of other states in developing an online system to check sale of spurious drugs. The food and drug administration department, through its online system, can locate the medical shop where the spurious drug is available and also record its batch number. The administration can block and seize the drugs by sending an SMS to all medical stores and even issue instructions online. The effective use of technology has prompted the Centre to choose Gujarat for implementation of the pilot project.”
Speaking to Mirror, Koshia said Gujarat was selected for the pilot project because of its computer network and infrastructure. Besides, the state has a ready online database of food establishments. Gujarat also has complete list of food laboratories online and a GSWAN connectivity which is considered the best in the country.
TWO-DAY TRAINING
The implementation of Centre’s pilot project in Gujarat is scheduled to begin by the end of February
As many as 200 food safety officers from across the state will be trained on online registration and licensing of food establishments and vendors during a two-day workshop. In the last week of January, the food and drugs control department will start accumulation and assimilation of data to prepare a database.
The central government has also asked the food and drugs administration to clear the backlog of pending licences by August 5.
The state administration has presently issued 70,000 licences to food business operators that have a turnover of more than Rs 12 lakh annually. There are roughly about two lakh vendors across the state who earn less than Rs 12 lakh annually. These vendors will also be covered under the ambit of registration and licensing.
Koshia said , “The biggest benefit of online registration is that it will speed up the licensing process. The online data will also help keep quality of food provided by vendors under check. Moreover, it will have details like the location and contact numbers of the vendors. Unknown hawkers who are presently not quality conscious will also be registered. The consumer stands to benefit a lot from this new system.”
The local panipuri larri or the sandwich stall that serves you mouth-watering snacks will no longer be able to get away if it dishes out substandard food. The Food Safety and Standards Authority of India (FSSAI) has chosen Gujarat to implement the pilot project for online registration and licensing of food establishments and vendors. This, because the food and drugs administration has already been successful in using technology to seize and ban spurious drugs across the state.
Which means, the state is ready to replicate the same in creating a database for registration and licensing of unlicensed food business operators and clearing the backlog of pending licences. The project is scheduled to begin by the end of February.
Under this project, all the shops selling food items will be registered and issued a licence.
Raghu Gudal and S Murthy, senior officials of the National Institute for Smart Government — a Hyderabad-based central government agency has developed a software for online registration and licensing of food vendors and establishments — met officials of the Food and Drugs Department on December 30 at Gandhinagar. They also met health minister Jaynarayan Vyas.
Last week, the food and drugs control department commissioner Hemant Koshia had been called to New Delhi by the FSSAI to intimate him about their decision to launch the pilot project in Gujarat.
Vyas told Mirror, “Gujarat is ahead of other states in developing an online system to check sale of spurious drugs. The food and drug administration department, through its online system, can locate the medical shop where the spurious drug is available and also record its batch number. The administration can block and seize the drugs by sending an SMS to all medical stores and even issue instructions online. The effective use of technology has prompted the Centre to choose Gujarat for implementation of the pilot project.”
Speaking to Mirror, Koshia said Gujarat was selected for the pilot project because of its computer network and infrastructure. Besides, the state has a ready online database of food establishments. Gujarat also has complete list of food laboratories online and a GSWAN connectivity which is considered the best in the country.
TWO-DAY TRAINING
The implementation of Centre’s pilot project in Gujarat is scheduled to begin by the end of February
As many as 200 food safety officers from across the state will be trained on online registration and licensing of food establishments and vendors during a two-day workshop. In the last week of January, the food and drugs control department will start accumulation and assimilation of data to prepare a database.
The central government has also asked the food and drugs administration to clear the backlog of pending licences by August 5.
The state administration has presently issued 70,000 licences to food business operators that have a turnover of more than Rs 12 lakh annually. There are roughly about two lakh vendors across the state who earn less than Rs 12 lakh annually. These vendors will also be covered under the ambit of registration and licensing.
Koshia said , “The biggest benefit of online registration is that it will speed up the licensing process. The online data will also help keep quality of food provided by vendors under check. Moreover, it will have details like the location and contact numbers of the vendors. Unknown hawkers who are presently not quality conscious will also be registered. The consumer stands to benefit a lot from this new system.”
Executive Summary on National Survey on Milk Adulteration
The National Survey on Milk Adulteration 2011 (snap shot survey) was conducted by the Food Safety and Standards Authority of India to ascertain the quality of milk and identify different type of adulteration in the liquid milk throughout the country. The survey was carried out by the Regional Offices of the FSSAI located at Chennai (Southern Region), Mumbai (Western Region), Delhi (Northern Region) , Guwahati, (North Eastern Region) and Kolkata (Eastern Region) with the following objectives:
1. To identify the common adulterants in milk in rural and urban areas of different states.
2. To find out the non conforming samples in loose and packed milk.
The samples were collected randomly and analysed from 33 states namely Andhra Pradesh (75), Arunachal Pradesh (25), Assam (109), Bihar (75), Chhattisgarh (19), Chandigarh (25), Delhi (71), Dadra & Nagar Haveli (12), Daman & Diu (25), Goa (24), Gujarat (100), Haryana (109), Himachal Pradesh (27), Jammu & Kashmir (18), Jharkhand (25), Karnataka (51), Kerala (50), Madhya Pradesh (61), Maharashtra (126), Manipur (25), Mizoram (25), Meghalaya (26), Nagaland (22), Orissa (50), Puducherry (25), Punjab (109), Rajasthan (103), Sikkim (18), Tamil Nadu (74), Tripura (25), Uttarakhand (26), Uttar Pradesh (136), West Bengal (100) totalling to a sample size of 1791.
The samples were sent to the govt. laboratories namely, Department of Food and Drug testing Government of Puducherry, Central Food Laboratory Pune, Food Reasearch and Standardisation Laboratory Ghaziabad, State Public Health Laboratory, Guwahati and Central Food Laboratory Kolkata for testing of samples for the presence of common adulterants such as Fat (%), SNF (%), Neutralizers, Acidity, Hydrogen Peroxide, Sugar, Starch, Glucose, Urea, Salt, Detergent, Skimmed milk powder, Formalin and Vegetable fat .
The total conforming samples to the FSSA standards were 565 (31.5%). The total non-conforming samples were found to be 1226 (68.4%) .
The non-conformity of samples in rural areas were 381(31%) out of which 64 (16.7%) were packet samples and 317 (83.2%) were loose samples respectively and in urban area the total non confirming samples were 845 (68.9%) out of which 282 (33.3%) were packed and 563 (66.6%) were loose samples.
The deviation were found highest for fat (%) and SNF (%) in 574 samples (46.8%) of the total non –conformity . Perhaps the reason may be dilution of milk with water. The second highest parameter of non conformity was the Skim Milk Powder (SMP) in 548 samples (44.69%) which includes presence of glucose in 477 samples. Glucose would have been added to milk probably to enhance SNF. The presence of Skim Milk Powder indicates the reconstitution of milk powder. Detergent was also found in 103 samples (8.4%).
The non-conforming sample in the descending order of percentage with respect to the total sample collected in different states were as follows: Bihar (100%), Chhattisgarh (100%), Daman and Diu (100%), Jharkhand (100%), Orissa (100%), West Bengal (100%), Mizoram (!00%), Manipur (96%), Meghalaya (96%), Tripura (92%), Gujarat (89%), Sikkim (89%), Uttrakhand (88%), Uttar Pradesh (88%), Nagaland (86%), Jammu & Kashmir (83%), Punjab (81%), Rajasthan (76%) Delhi (70%), Haryana (70%), Arunachal Pradesh (68%), Maharashtra (65%), Himachal (59%), Dadra and Nagar Haveli (58%), Assam (55%), Chandigarh (48%), Madhya Pradesh (48%), Kerala (28%), Karnataka (22%), Tamil Nadu (12%), and Andhra Pradesh (6.7%).
All the sample in Goa and Puducherry conformed to the standards.
Conclusion
(1) The study indicates that addition of water to milk is most common adulterant. Addition of water not only reduces the nutritional value of milk but contaminated water may also pose health risk to the consumers.
(2) It also shows that powdered milk is reconstituted to meet the demand of milk supply. All state /UT enforcement authorities may specifically check whether the declaration of new FSSAI rules are being complied to.
(3) The study also indicated the presence of detergent in some cases. Consumption of milk with detergent may cause health hazards and indicates lack of hygiene and sanitation in the milk handling.
1. To identify the common adulterants in milk in rural and urban areas of different states.
2. To find out the non conforming samples in loose and packed milk.
The samples were collected randomly and analysed from 33 states namely Andhra Pradesh (75), Arunachal Pradesh (25), Assam (109), Bihar (75), Chhattisgarh (19), Chandigarh (25), Delhi (71), Dadra & Nagar Haveli (12), Daman & Diu (25), Goa (24), Gujarat (100), Haryana (109), Himachal Pradesh (27), Jammu & Kashmir (18), Jharkhand (25), Karnataka (51), Kerala (50), Madhya Pradesh (61), Maharashtra (126), Manipur (25), Mizoram (25), Meghalaya (26), Nagaland (22), Orissa (50), Puducherry (25), Punjab (109), Rajasthan (103), Sikkim (18), Tamil Nadu (74), Tripura (25), Uttarakhand (26), Uttar Pradesh (136), West Bengal (100) totalling to a sample size of 1791.
The samples were sent to the govt. laboratories namely, Department of Food and Drug testing Government of Puducherry, Central Food Laboratory Pune, Food Reasearch and Standardisation Laboratory Ghaziabad, State Public Health Laboratory, Guwahati and Central Food Laboratory Kolkata for testing of samples for the presence of common adulterants such as Fat (%), SNF (%), Neutralizers, Acidity, Hydrogen Peroxide, Sugar, Starch, Glucose, Urea, Salt, Detergent, Skimmed milk powder, Formalin and Vegetable fat .
The total conforming samples to the FSSA standards were 565 (31.5%). The total non-conforming samples were found to be 1226 (68.4%) .
The non-conformity of samples in rural areas were 381(31%) out of which 64 (16.7%) were packet samples and 317 (83.2%) were loose samples respectively and in urban area the total non confirming samples were 845 (68.9%) out of which 282 (33.3%) were packed and 563 (66.6%) were loose samples.
The deviation were found highest for fat (%) and SNF (%) in 574 samples (46.8%) of the total non –conformity . Perhaps the reason may be dilution of milk with water. The second highest parameter of non conformity was the Skim Milk Powder (SMP) in 548 samples (44.69%) which includes presence of glucose in 477 samples. Glucose would have been added to milk probably to enhance SNF. The presence of Skim Milk Powder indicates the reconstitution of milk powder. Detergent was also found in 103 samples (8.4%).
The non-conforming sample in the descending order of percentage with respect to the total sample collected in different states were as follows: Bihar (100%), Chhattisgarh (100%), Daman and Diu (100%), Jharkhand (100%), Orissa (100%), West Bengal (100%), Mizoram (!00%), Manipur (96%), Meghalaya (96%), Tripura (92%), Gujarat (89%), Sikkim (89%), Uttrakhand (88%), Uttar Pradesh (88%), Nagaland (86%), Jammu & Kashmir (83%), Punjab (81%), Rajasthan (76%) Delhi (70%), Haryana (70%), Arunachal Pradesh (68%), Maharashtra (65%), Himachal (59%), Dadra and Nagar Haveli (58%), Assam (55%), Chandigarh (48%), Madhya Pradesh (48%), Kerala (28%), Karnataka (22%), Tamil Nadu (12%), and Andhra Pradesh (6.7%).
All the sample in Goa and Puducherry conformed to the standards.
Conclusion
(1) The study indicates that addition of water to milk is most common adulterant. Addition of water not only reduces the nutritional value of milk but contaminated water may also pose health risk to the consumers.
(2) It also shows that powdered milk is reconstituted to meet the demand of milk supply. All state /UT enforcement authorities may specifically check whether the declaration of new FSSAI rules are being complied to.
(3) The study also indicated the presence of detergent in some cases. Consumption of milk with detergent may cause health hazards and indicates lack of hygiene and sanitation in the milk handling.
Consumption of Kesari dal results in paralysis: Study
HYDERABAD: Consumption of Kesari dal does result in paralysis. This has been found in large animal experiments conducted by the National Institute of Nutrition (NIN) here. Consumption of Kesari dal has been practically banned all over the country since 1961. However, with demands for lifting the ban on Kesari dal being raised, the study was undertaken last year.
The experiments conducted on goats have shown that consumption of Kesari dal can result in lathyrism, a form of paralysis that affects the lower limbs. With such findings, the Indian Council of Medical Research (ICMR) has now constituted a committee that will formulate a plan to undertake human studies. The committee will meet in New Delhi on January 11.
"We have carried out the experiments on goats and in one of the kid goats, there has been a `frank' case of lathyrism," Dr Arjun L Khandare, deputy director, National Institute of Nutrition (NIN) said. The experiments were carried out in association with Osmania University and the Acharya N G Ranga Agricultural University (Angrau) at the instance of the Food Safety Standards Authority of India (FSSAI). The findings of the experiments are important as one Dr Shantilal Kothari, president, Academy of Nutrition Improvement, has been spearheading a movement to get the ban lifted on Kesari dal consumption.
With strong evidence emerging about the affects of consuming Kesari dal, the ICMR has decided that human studies should be done to further verify the findings. The experiments would be conducted in Maharashtra, Chattisgarh and West Bengal where farmers cultivate Kesari dal.
The experiments conducted on goats have shown that consumption of Kesari dal can result in lathyrism, a form of paralysis that affects the lower limbs. With such findings, the Indian Council of Medical Research (ICMR) has now constituted a committee that will formulate a plan to undertake human studies. The committee will meet in New Delhi on January 11.
"We have carried out the experiments on goats and in one of the kid goats, there has been a `frank' case of lathyrism," Dr Arjun L Khandare, deputy director, National Institute of Nutrition (NIN) said. The experiments were carried out in association with Osmania University and the Acharya N G Ranga Agricultural University (Angrau) at the instance of the Food Safety Standards Authority of India (FSSAI). The findings of the experiments are important as one Dr Shantilal Kothari, president, Academy of Nutrition Improvement, has been spearheading a movement to get the ban lifted on Kesari dal consumption.
With strong evidence emerging about the affects of consuming Kesari dal, the ICMR has decided that human studies should be done to further verify the findings. The experiments would be conducted in Maharashtra, Chattisgarh and West Bengal where farmers cultivate Kesari dal.
Jan 2, 2012
Delving deeper into understanding food toxins and contaminants like Patulin
Introduction
Nowadays, food safety is of major concern since more and more chemicals are becoming a part of our environment.
Actually, food is an important route of exposure to contaminants such as dioxins, mycotoxins, heavy metals, pesticides, polycyclic aromatic hydrocarbons, drugs and hormones. Mycotoxins are a class of highly toxic compounds, secondary metabolites, produced under particular environmental conditions by certain fungi or moulds, developing in many foodstuffs. Despite concerted efforts in prevention, mycotoxins remain a problem of human health concern in several parts of the world including developed countries.
Many foods contain their own toxins. If these are ingested in large quantities or repetitively problems can arise. Toxins involved in food processing and storage include carcinogens such as nitrosamines, bleaching agents like methionine sulphoximine, solvent extraction by trichloroethylene and fumigation with ethylene oxide.
Natural toxins from plants may be both endogenous and exogenous. Cabbage and related vegetables contain glucosinolates which have goitrogenic activity although clinical symptoms are unlikely. Sweet potatoes or legumes may produce cyanogens thus producing neuropathy and mental confusion. Datura stramonium may produce atropine with resultant hallucinations. Bananas may produce pressor amines thus causing headache and hypertension. Solanin may be found in potatoes, especially when badly stored, which may result in headaches, incoherence, hallucination and dizziness.
Exogenous sources include peanuts and grains which may contain aflatoxins if contaminated with certain moulds. Aflatoxins can cause encephalopathy, hallucinations, and hepatic disease. Nitrites originating from endogenous nitrates may be present in some green vegetables including spinach with potential risk of headache, hepatic disease and methaemoglobinaemia. Conversion to nitrosamines results in potential risk of carcinogenic activity. Naturally occurring toxins from animals occur. Endogenous examples include fish which contain certain lipoproteins that may result in symptoms of vomiting, headache, and dizziness. Other examples include cheese which contains tyramine and can give headache and elevated blood pressure in susceptible individuals. Saxitoxin originating from dinoflagellates may be found in fish or shellfish possibly giving symptoms of dyspnoea, paralysis, or haemorrhage.
Patulin
Like other toxins, patulin is also one, which is present in many foods. Patulin is a mycotoxin that is produced by certain species of Penicillium, Aspergillus and Byssochylamys moulds that may grow on a variety of foods including fruits, grains, and cheese. Patulin is having molar mass 154.12 g mol-1, molecular formula C7H6O4 (Fig. 2) and is soluble in water. Patulin has been found to occur in a number of foods including apple juice, apples and pears with brown rot (Harwig, 1973, Brain, 1956), flour (Hasseltine and Graves, 1966), and malt feed (Ukai, 1954). However, given the nature of the food, the manufacturing processes, or consumption practices for many foods, patulin does not appear to pose a safety concern, with the exception of apple juice (Fritz and Engst, 1981). For instance, the rotten portions of most fruits and grains typically are removed prior to consumption. In foods such as cheese, the high cysteine content of the food interacts with patulin to render it inactive (Ciegler, 1977). Patulin is reported to be destroyed by fermentation and thus, is not found in either alcoholic fruit beverages or vinegars produced from fruit juices. Thermal processing appears to cause only moderate reductions in patulin levels, thus patulin present in apple juice will survive the pasteurisation processes (IARC, 1986, WHO, 1990, Harrison, 1989, McKinley and Carlton, 1991).
Fig1. An apple contaminated by Penicillium expansum
Fig2. 4-hydroxy-4H-furo[3,2-c]pyran-
History
Patulin was first isolated by Birkinshaw et al. in 1943 from Penicillium griseofulvum and Penicillium expansum. This was a part of the screening effort to find new fungal molecules with antibiotic properties, in the general enthusiasm following the discovery of penicillin by Fleming. Patulin fits well with Paracelces definition in his treatise -Von der besucht. "Every substance is a poison; only dose distinguishes a poison from drug." This compound was tested in clinical trials by a British company under the brand name - tercinin (Chalmers et al., 2004), however, the interest in this potential antibiotic soon waned due its toxicity to humans and animals. Today, patulin belongs to a short list of mycotoxins (aflatoxins, ochratoxin A, zearalenone, fumonisins and trichothecenes).
Microorganisms producing patulin
Patulin is isolated from several species belonging to Penicillium, Aspergillus, Paecilomyces and Byssochlamys. Among the Aspergillus species, the number of patulin producing species is limited to three of the Clavati group: Aspergillus clavatus, A. giganteus and A. longivesica (Varga et al., 2007). For the Penicillium genus, after checking a significant number of isolates from each species and re-identification of certain isolates, an overview determined 13 patulin producing species: P. carneum, P. clavigerum, P. concentricum, P. coprobium, P. dipodomyicola, P. expansum, P. glandicola, P. gladioli, P. griseofulvum, P. marinum, P. paneum, P. sclerotigenum, P. vulpinum (Frisvad et al., 2004). Among these species, P. expansum is responsible for the decay in pomaceous fruits (apples and pears) characterised by rapid soft rot and eventually by blue pustules (Fig 1). This species is considered as the main source of patulin in these fruits and consequently in apple derived products (McKinley and Carlton, 1991).
Occurrence
Occurrence of patulin in different fruit products had been determined and summarised here in table 1.
Table 1: Patulin concentrations in fruit products quantified in stable isotope dilution assays using GC/HRMS
Toxicology of patulin
During the last 60 years, several adverse health effects resulting from exposure to patulin have been described. Briefly, patulin is reported to be acutely toxic (McKinley & Carlton, 1991), genotoxic (Alves et al., 2000), cytotoxic, immunosuppressive, teratogenic and possible neurotoxic (Devaraj et al., 1982). Patulin has a strong affinity for sulphydryl groups, which causes the inactivation of enzymes. Although no specific studies on the mode of action of patulin have been performed, it is becoming clear that this ability of patulin to react with sulphydryl groups would explain the cytotoxic and some of the genotoxic effects (Speijers, 2004). However, it is unlikely that the toxicity is systemic since patulin is degraded quickly after penetrating the gastric wall. This degradation is caused partly by the reaction with glutathione and probably also by the reaction with proteins. However, the significant depletion of glutathione in gastric tissue can lead to local toxic effects (Rychlik et al., 2004). For many years patulin was believed to be carcinogenic, however the International Agency for Research on Cancer (IARC) concluded that there is inadequate evidence for carcinogenicity of patulin in experimental animals (IARC, 1986). A study on the combined effects of patulin on reproduction and long-term toxicity pointed to a safe intake of 43 g/kg body weight/day.
Safety assessment, risk management for patulin
FDA employed the "safety assessment" method as the risk assessment approach for considering the available safety data on patulin. FDA used the outcome of the safety assessment to evaluate whether processors should implement controls for patulin in apple juice, and to identify a level, (i.e., an "action level") at which FDA would consider taking legal action against apple juice products bearing patulin under Federal Food Drug and Cosmetic Act, which states that a food is "adulterated" if it bears or contains an added poisonous or deleterious substance which may render it injurious to health.
The safety assessment method (Lehman and Fitzhugh, 1954), introduced the use of 10-fold safety factors, which later also became known as "uncertainty factors," in assessing the safety of substances, e.g. contaminants, in food. Lehman and Fitzhugh described the application of the 10-fold safety/uncertainty factors as useful for establishing a "target" margin of safety. However, they concluded there were no scientific or mathematical means by which absolute values for these factors could be derived. Over the years these factors have been used routinely both in the US and internationally to ensure an adequate margin of safety (WHO, 1987).
Typically, for a contaminant in a food such as apple juice, where there is a potential for chronic exposure to the contaminant, FDA would determine the exposure level that would ensure an adequate safety margin from known adverse effects by applying two 10-fold safety factors (equating to a 100-fold safety factor) to the "no observed adverse effect level" (NOAEL) from lifetime animal feeding studies. One safety factor accounts for the extrapolation from animal data to humans (i.e., interspecies variation), and the second accounts for variation in sensitivity to the contaminant's effects within humans (i.e., intraspecies variation). This calculation yields a provisional tolerable daily intake (PTDI) or provisional tolerable weekly intake (PTWI) for the contaminant. An action level may be identified by calculating a maximum level for the contaminant in the food that will ensure that exposure to the contaminant results in an acceptable margin of safety, considering the PTDI or PTWI.
In deriving the action level for patulin, FDA considered consumption of apple juice by consumers of all ages who drink apple juice, and by consumers who drink apple juice among small children in two age categories, children less than one-year-old and children 1-2 years old. FDA considered the two age categories for children because they consume higher amounts of apple juice relative to their body weight than other age groups. Older children, e.g., 2-10 year olds, were not included as a separate group in FDA's assessment because consumption of apple juice on a "relative to body weight" basis declines substantially after age two. Therefore, there are no special risk considerations affecting older children that would need to be taken into account in a safety assessment.
Fig3. Illustration of how food safety control at a country level can link into food safety management at the operational level through a food safety objective set by a governmental competent authority on the basis of a public health goal (ALOP) established following the risk analysis framework
Source: Gorris (2005)
The Food Safety and Standards Authority of India (FSSAI) has been established under the Food Safety and Standards Act, 2006, as a statutory body for laying down science-based standards for articles of food and regulating manufacturing, processing, distribution, sale and import of food so as to ensure safe and wholesome food for human consumption. Various Central Acts like 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; etc. will be repealed after commencement of FSS Act, 2006. The Act also aims to establish a single reference point for all matters relating to food safety and standards, by moving from multi-level, multi-departmental control to a single line of command. To this effect, the Act establishes an independent statutory authority the FSSAI with head office at Delhi. FSSAI and the state food safety authorities shall enforce various provisions of the Act.
Several countries have set limits for patulin concentrations in apple products. The World Health Organisation (WHO) recommended a maximum concentration of 50g/L in apple juice. In European Union, the limit is set to 50 micrograms per kilogram (g/kg) in both apple juice and cider, and to half of that concentration, 25g/kg in solid apple products and 10g/kg in products for infants and children. The Joint FAO/WHO Expert Committee on Food Additives set a provisional maximum tolerable daily intake of 0.4 g/kg body weight (JECFA, 1995). These limits came into force on November 1, 2003.
According to the FSSAI following are the proposed limits for crop contaminants and naturally occurring toxic substances including patulin
Conclusion
Toxin-producing microbial species are extremely common, and they can grow on a wide range of substrates under a wide range of environmental conditions. For agricultural commodities, the severity of crop contamination tends to vary from year to year based on weather and other environmental factors. Aflatoxin, for example, is usually worst during drought years; the plants are weakened and become more susceptible to insect damage. Toxins occur, with varying severity, in agricultural products all around the world. The estimate usually given is that one quarter of the world's crops are contaminated to some extent with toxins. Toxins can enter the food chain in the field, during storage, or at later points. Toxin problems are exacerbated whenever shipping, handling, and storage practices are conducive to mould growth. The end result is that toxins are commonly found in foods.
Nowadays, food safety is of major concern since more and more chemicals are becoming a part of our environment.
Actually, food is an important route of exposure to contaminants such as dioxins, mycotoxins, heavy metals, pesticides, polycyclic aromatic hydrocarbons, drugs and hormones. Mycotoxins are a class of highly toxic compounds, secondary metabolites, produced under particular environmental conditions by certain fungi or moulds, developing in many foodstuffs. Despite concerted efforts in prevention, mycotoxins remain a problem of human health concern in several parts of the world including developed countries.
Many foods contain their own toxins. If these are ingested in large quantities or repetitively problems can arise. Toxins involved in food processing and storage include carcinogens such as nitrosamines, bleaching agents like methionine sulphoximine, solvent extraction by trichloroethylene and fumigation with ethylene oxide.
Natural toxins from plants may be both endogenous and exogenous. Cabbage and related vegetables contain glucosinolates which have goitrogenic activity although clinical symptoms are unlikely. Sweet potatoes or legumes may produce cyanogens thus producing neuropathy and mental confusion. Datura stramonium may produce atropine with resultant hallucinations. Bananas may produce pressor amines thus causing headache and hypertension. Solanin may be found in potatoes, especially when badly stored, which may result in headaches, incoherence, hallucination and dizziness.
Exogenous sources include peanuts and grains which may contain aflatoxins if contaminated with certain moulds. Aflatoxins can cause encephalopathy, hallucinations, and hepatic disease. Nitrites originating from endogenous nitrates may be present in some green vegetables including spinach with potential risk of headache, hepatic disease and methaemoglobinaemia. Conversion to nitrosamines results in potential risk of carcinogenic activity. Naturally occurring toxins from animals occur. Endogenous examples include fish which contain certain lipoproteins that may result in symptoms of vomiting, headache, and dizziness. Other examples include cheese which contains tyramine and can give headache and elevated blood pressure in susceptible individuals. Saxitoxin originating from dinoflagellates may be found in fish or shellfish possibly giving symptoms of dyspnoea, paralysis, or haemorrhage.
Patulin
Like other toxins, patulin is also one, which is present in many foods. Patulin is a mycotoxin that is produced by certain species of Penicillium, Aspergillus and Byssochylamys moulds that may grow on a variety of foods including fruits, grains, and cheese. Patulin is having molar mass 154.12 g mol-1, molecular formula C7H6O4 (Fig. 2) and is soluble in water. Patulin has been found to occur in a number of foods including apple juice, apples and pears with brown rot (Harwig, 1973, Brain, 1956), flour (Hasseltine and Graves, 1966), and malt feed (Ukai, 1954). However, given the nature of the food, the manufacturing processes, or consumption practices for many foods, patulin does not appear to pose a safety concern, with the exception of apple juice (Fritz and Engst, 1981). For instance, the rotten portions of most fruits and grains typically are removed prior to consumption. In foods such as cheese, the high cysteine content of the food interacts with patulin to render it inactive (Ciegler, 1977). Patulin is reported to be destroyed by fermentation and thus, is not found in either alcoholic fruit beverages or vinegars produced from fruit juices. Thermal processing appears to cause only moderate reductions in patulin levels, thus patulin present in apple juice will survive the pasteurisation processes (IARC, 1986, WHO, 1990, Harrison, 1989, McKinley and Carlton, 1991).
Fig1. An apple contaminated by Penicillium expansum
Fig2. 4-hydroxy-4H-furo[3,2-c]pyran-
History
Patulin was first isolated by Birkinshaw et al. in 1943 from Penicillium griseofulvum and Penicillium expansum. This was a part of the screening effort to find new fungal molecules with antibiotic properties, in the general enthusiasm following the discovery of penicillin by Fleming. Patulin fits well with Paracelces definition in his treatise -Von der besucht. "Every substance is a poison; only dose distinguishes a poison from drug." This compound was tested in clinical trials by a British company under the brand name - tercinin (Chalmers et al., 2004), however, the interest in this potential antibiotic soon waned due its toxicity to humans and animals. Today, patulin belongs to a short list of mycotoxins (aflatoxins, ochratoxin A, zearalenone, fumonisins and trichothecenes).
Microorganisms producing patulin
Patulin is isolated from several species belonging to Penicillium, Aspergillus, Paecilomyces and Byssochlamys. Among the Aspergillus species, the number of patulin producing species is limited to three of the Clavati group: Aspergillus clavatus, A. giganteus and A. longivesica (Varga et al., 2007). For the Penicillium genus, after checking a significant number of isolates from each species and re-identification of certain isolates, an overview determined 13 patulin producing species: P. carneum, P. clavigerum, P. concentricum, P. coprobium, P. dipodomyicola, P. expansum, P. glandicola, P. gladioli, P. griseofulvum, P. marinum, P. paneum, P. sclerotigenum, P. vulpinum (Frisvad et al., 2004). Among these species, P. expansum is responsible for the decay in pomaceous fruits (apples and pears) characterised by rapid soft rot and eventually by blue pustules (Fig 1). This species is considered as the main source of patulin in these fruits and consequently in apple derived products (McKinley and Carlton, 1991).
Occurrence
Occurrence of patulin in different fruit products had been determined and summarised here in table 1.
Table 1: Patulin concentrations in fruit products quantified in stable isotope dilution assays using GC/HRMS
Toxicology of patulin
During the last 60 years, several adverse health effects resulting from exposure to patulin have been described. Briefly, patulin is reported to be acutely toxic (McKinley & Carlton, 1991), genotoxic (Alves et al., 2000), cytotoxic, immunosuppressive, teratogenic and possible neurotoxic (Devaraj et al., 1982). Patulin has a strong affinity for sulphydryl groups, which causes the inactivation of enzymes. Although no specific studies on the mode of action of patulin have been performed, it is becoming clear that this ability of patulin to react with sulphydryl groups would explain the cytotoxic and some of the genotoxic effects (Speijers, 2004). However, it is unlikely that the toxicity is systemic since patulin is degraded quickly after penetrating the gastric wall. This degradation is caused partly by the reaction with glutathione and probably also by the reaction with proteins. However, the significant depletion of glutathione in gastric tissue can lead to local toxic effects (Rychlik et al., 2004). For many years patulin was believed to be carcinogenic, however the International Agency for Research on Cancer (IARC) concluded that there is inadequate evidence for carcinogenicity of patulin in experimental animals (IARC, 1986). A study on the combined effects of patulin on reproduction and long-term toxicity pointed to a safe intake of 43 g/kg body weight/day.
Safety assessment, risk management for patulin
FDA employed the "safety assessment" method as the risk assessment approach for considering the available safety data on patulin. FDA used the outcome of the safety assessment to evaluate whether processors should implement controls for patulin in apple juice, and to identify a level, (i.e., an "action level") at which FDA would consider taking legal action against apple juice products bearing patulin under Federal Food Drug and Cosmetic Act, which states that a food is "adulterated" if it bears or contains an added poisonous or deleterious substance which may render it injurious to health.
The safety assessment method (Lehman and Fitzhugh, 1954), introduced the use of 10-fold safety factors, which later also became known as "uncertainty factors," in assessing the safety of substances, e.g. contaminants, in food. Lehman and Fitzhugh described the application of the 10-fold safety/uncertainty factors as useful for establishing a "target" margin of safety. However, they concluded there were no scientific or mathematical means by which absolute values for these factors could be derived. Over the years these factors have been used routinely both in the US and internationally to ensure an adequate margin of safety (WHO, 1987).
Typically, for a contaminant in a food such as apple juice, where there is a potential for chronic exposure to the contaminant, FDA would determine the exposure level that would ensure an adequate safety margin from known adverse effects by applying two 10-fold safety factors (equating to a 100-fold safety factor) to the "no observed adverse effect level" (NOAEL) from lifetime animal feeding studies. One safety factor accounts for the extrapolation from animal data to humans (i.e., interspecies variation), and the second accounts for variation in sensitivity to the contaminant's effects within humans (i.e., intraspecies variation). This calculation yields a provisional tolerable daily intake (PTDI) or provisional tolerable weekly intake (PTWI) for the contaminant. An action level may be identified by calculating a maximum level for the contaminant in the food that will ensure that exposure to the contaminant results in an acceptable margin of safety, considering the PTDI or PTWI.
In deriving the action level for patulin, FDA considered consumption of apple juice by consumers of all ages who drink apple juice, and by consumers who drink apple juice among small children in two age categories, children less than one-year-old and children 1-2 years old. FDA considered the two age categories for children because they consume higher amounts of apple juice relative to their body weight than other age groups. Older children, e.g., 2-10 year olds, were not included as a separate group in FDA's assessment because consumption of apple juice on a "relative to body weight" basis declines substantially after age two. Therefore, there are no special risk considerations affecting older children that would need to be taken into account in a safety assessment.
Fig3. Illustration of how food safety control at a country level can link into food safety management at the operational level through a food safety objective set by a governmental competent authority on the basis of a public health goal (ALOP) established following the risk analysis framework
Source: Gorris (2005)
The Food Safety and Standards Authority of India (FSSAI) has been established under the Food Safety and Standards Act, 2006, as a statutory body for laying down science-based standards for articles of food and regulating manufacturing, processing, distribution, sale and import of food so as to ensure safe and wholesome food for human consumption. Various Central Acts like 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; etc. will be repealed after commencement of FSS Act, 2006. The Act also aims to establish a single reference point for all matters relating to food safety and standards, by moving from multi-level, multi-departmental control to a single line of command. To this effect, the Act establishes an independent statutory authority the FSSAI with head office at Delhi. FSSAI and the state food safety authorities shall enforce various provisions of the Act.
Several countries have set limits for patulin concentrations in apple products. The World Health Organisation (WHO) recommended a maximum concentration of 50g/L in apple juice. In European Union, the limit is set to 50 micrograms per kilogram (g/kg) in both apple juice and cider, and to half of that concentration, 25g/kg in solid apple products and 10g/kg in products for infants and children. The Joint FAO/WHO Expert Committee on Food Additives set a provisional maximum tolerable daily intake of 0.4 g/kg body weight (JECFA, 1995). These limits came into force on November 1, 2003.
According to the FSSAI following are the proposed limits for crop contaminants and naturally occurring toxic substances including patulin
Conclusion
Toxin-producing microbial species are extremely common, and they can grow on a wide range of substrates under a wide range of environmental conditions. For agricultural commodities, the severity of crop contamination tends to vary from year to year based on weather and other environmental factors. Aflatoxin, for example, is usually worst during drought years; the plants are weakened and become more susceptible to insect damage. Toxins occur, with varying severity, in agricultural products all around the world. The estimate usually given is that one quarter of the world's crops are contaminated to some extent with toxins. Toxins can enter the food chain in the field, during storage, or at later points. Toxin problems are exacerbated whenever shipping, handling, and storage practices are conducive to mould growth. The end result is that toxins are commonly found in foods.
Despite SC order, FSSAI's scientific panel has 3 members from industry
The Food Safety and Standards Authority of India (FSSAI) is yet to take out three industry members from its scientific panel.
This has been discovered in spite of the fact that earlier in February 2011, the Supreme Court in its order sought the removal of industry members from the scientific panels and scientific committee of the FSSAI and instead have independent members.
The Authority had re-constituted the panels which had 20 industry members. Out of these 20 members, the FSSAI excluded few members and reabsorbed others after completion/termination of their services to the industries by taking them into the panels as industry consultants.
However, the status of the three members remained unchanged till today. These members who are still on board belong to private organisations. They are Dr Deepa Bhajekar, proprietor and chief executive officer, Micro Chem Laboratory, Mumbai; Dr Mridul Salagme, managing director, IADFAC Laboratories, Bangalore; and Rashmi Kulshrestha, expert in pesticides residues and contaminants, food and pharma regulatory consultant, Regulatory Wisdom.
While Bhajekar is a member of the sampling and analysis panel, Salagme is a panel member for labelling and claims/advertisements and Kulshrestha is serving on the panel for contaminants in the food chain.
Bhajekar and Salagme belong to private laboratories and Kulshrestha works in a consultancy firm.
When FnB News approached the Authority, an official said, These two members (Bhajekar and Salagme) came from the laboratory background and do not belong to an industry but scientific bodies.
However, private laboratories have clients from allied industries like hotels & restaurants, retail chains, shopping malls & foods courts, corporate offices and industrial cafeterias, food & beverage retail franchisees and food importers/ exporters. Not only this, Micro Chem Laboratory is also empanelled for testing of imported food items. McDonald's, Domino's Pizza, Sodexo and Modern Bread are some of its clients for domestic testing.
Bhajekar responded, I am not governed by the Act because I am not a manufacturer. The specifications mentioned in the Food Safety and Standards Act, 2006, are more relevant to a manufacturer of raw material and finished food products. As a laboratory, we test and certify the quality of food products based on the Act.
Last year, the Supreme Court, had asked the FSSAI to exclude all members from the industry to comply with Section 13 (1) of the FSSA, which states, The Food Authority shall establish scientific panels, which shall consist of independent scientific experts.
Scientific panels, according to the SC, provided an open ground for lobbying for the big industrial names.
The FSSAI officer, caught in confusion, said, We have already filed an affidavit in the Supreme Court giving a new list, so if the Supreme Court thinks no members from private organisations should be included we shall do so. In any case we are going to reconstitute these panels and committees by May 2012 and an EoI has already been floated in this regard.
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