Monday 23 January 2012

Honey safety norms in place soon

January, 23, 2012

The government is putting in place safety standards for honey after it has been found that lots, even those sold by top brands, had traces of antibiotics and pesticides in them.

The Food And Safety Standards of India (FSSAI) will soon make it mandatory that honey samples conform to these regulatory measures before they can be declared safe for consumption.

The new standards have been approved by the scientific committee of the experts and are likely to be notified soon by the government. While the new standards specify that there “should not be any residue of antibiotics in honey”, the FSSAI will also list down antibiotics that should remain absent from honey before it is made available for the consumers.

The standards for honey prescribed under prevention of food adulteration rules only specify the maximum limits of heavy metal etc. So far, there are no standards for antibiotics in honey in India. In last few years, there have been reports of antibiotic contamination in honey exported from India and also in honey available in the domestic market.

Earlier, the food and feed control authorities of the member states of the EU had also found Indian honey contaminated with prohibited antibiotics, like nitrofuran and chloramphenicol, tetracycline and streptomycin.
Experts say even that recently the samples picked up by FSSAI too found antibiotic residue in honey. “The laboratories will have a clear mandate. The list of antibiotics will be given based on limit of quantification,” FSSAI CEO V.N. Gaur said.

Those manufacturers which are found not conforming to the standards and thereby making it “unsafe” will face imprisonment and severe punishment that may include closing down of manufacturing unit.

Experts say that move gains significance keeping in view the recent reports of drug resistant bugs present in India. “The presence of antibiotics unnecessarily enhances immunity which could harm the body in the long run. The problem of presence of drug resistance bugs can also not be ignored,” said a senior official.

Source: The Asian Age

Karnataka plans new food lab, hires staff for better FSSA implementation

January 23, 2012

Karnataka has now speeded up efforts to ensure preparedness in terms of infrastructure and personnel to help the industry adhere to the Food Safety & Standards Act (FSSA), 2006.

The state, which has four food labs, is now looking to have a fifth facility in Bangalore, under the Karnataka Health Systems Development Project, which is funded by the World Bank.

The state is also contemplating on setting up mobile vans to simplify the surveillance of food units at a faster pace. Further efforts are on to offer online issue of licences and renewal. In this regard, the Union government has now software to network the state food commissionerates across the country. Karnataka is hoping to be among the first to install the same.

Further the state will also set up helplines and a website to solve the issues of the industry in terms of comprehending and consulting the finer points of the Act.

In this regard, the state has identified four food safety labs for which NABL (National Accreditation Board for Testing and Calibration Laboratories) certification is being sought and currently a Gap Analysis is on to help compare the actual performance with potential performance, according to B S Ramaprasad, Karnataka commissioner for food, directorate of health and family welfare.

The four labs present in the state are being upgraded with the help of state health department and national rural health mission scheme. Also the notification pertaining to food safety officers is complete. Training to food safety officers has been imparted, recruitment of adjudicating officer is complete and constitution of special courts in the 30 districts of the state is also through.

“The cog in the wheel is the required staff, laboratories and related infrastructure. While we have 104 FSO, there is a shortfall of 130 personnel. We have designated district surveillance officers to oversee the inspection of food joints at all levels,” he added.

He further stated, “Going hand in hand with the required labs and FSOs, we are now on an aggressive drive to implement information, education and communication (IEC) which combines strategies, approaches and methods that enable individuals to correctly understand the FSSA.”

On a concluding note, he said, “The key task for the food industry is to remain self- compliant, implement recall and improve tasks which will help it to easily adhere to the FSSA. For the government it is the challenge of taking the stakeholders into confidence.”       

Monday 16 January 2012

Govt draws up mega plan to ensure food safety

NEW DELHI: The government, it seems, has finally woken up to the threat of adulteration and contamination in food products and is planning a slew of measure to shore up food safety.

It plans to set up cluster laboratories of accredited standards for every 4-5 districts to carry out basic tests and zonal food laboratories (1 in 10 districts) to perform tests for residues and heavy metals and 10 referral laboratories considering that a network of efficient laboratories is the backbone of a credible food safety initiative.

In addition, mobile laboratory facilities will also be started to cater to large public congregations, natural calamities, disease outbreak and inaccessible areas.

Under the ambitious plan, the government will spend around Rs 6,548 crore on food safety measures during the 12th Five Year Plan (2012-17) that include strengthening of Food Safety and Standards Authority of India (FSSAI).

For the first time, the government plans to establish food safety offices in every district at the cost of around Rs 2,200 crore to tighten the food safety enforcement system.

There is also a plan to set up a National Food Science and Risk Assessment Centre costing Rs 155 crore. The dedicated institution under the direct control of FSSAI will conduct regulatory research and risk assessment, as well as oversee surveillance on the lines of international institutions like Centre for Food Safety and Applied Nutrition in the US and other countries. The institute is also envisaged to carry out a food safety risk analysis training programmes.

The Centre will be the repository of all food standards and will carry out all risk assessment related work and analyze food surveillance data received from labs and other surveillance organizations.

Along with networking of all food testing labs working, Planning Commission's working group on food safety has also recommended upgradation of Central Food Laboratories in Mumbai and Kolkata which will cost Rs 40 crore.

The group recommended that bio-safety should be an integral part of any risk assessment being undertaken by FSSAI. It is of the view that sufficient focus on food safety issues is lacking in the curriculum of MBBS and an appropriate module on food safety and bio-safety needs to be introduced at the earliest.

It also talked of spending Rs 50 crore for nation-wide food safety surveillance network and data collection on regular basis, along with a budget of Rs 669 crore to be spent on creating awareness of food safety related issues in the country.

The government will strengthen national food safety helpline, along with reward scheme to encourage public and employees to give information regarding unsafe food and malpractices within or outside the system.

The helpline will be strengthened to ensure direct communication with all stakeholders in an interactive manner. It will be linked to the emergency response centres in the states.

A National Food Safety Training Institute at FSSAI will be set up which will provide regular training programmes for trainers of food safety personnel and also other stakeholders. A fund of Rs 15 crore is proposed for conducting training programmes during the plan period.

Tuesday 10 January 2012

70% of milk in Delhi, country is adulterated Spiked with Detergent, Fat, Urea & Water


New Delhi: Beware, your daily glass of good health could actually be doing you harm. As much as 70% of milk samples picked up from the capital by a government agency failed to conform to standards. 

Of the 71 samples randomly taken from Delhi for testing by the Food Safety Standards Authority of India (FSSAI), 50 were found to be contaminated with glucose and skim milk powder SMP), which is usually add
ed to milk in the lean season to enhance volumes. 

Elsewhere in the 33 states and UTs study, milk was found adulterated with detergent, fat and even urea, besides the age-old dilution with water. Across the country, 68.4% of the samples were found contaminated.
Only in Goa and Puducherry did 100% of the samples tested conform to required standards. At the other end were West Bengal, Bihar, Chhattisgarh, Jharkhand, Orissa and Mizoram, where not a single sample tested met the norms. 

Other prominent states fared just a shade better. Around 89% of the samples tested from Gujarat, 83%
from Jammu & Kashmir, 81% from Punjab, 76% from Rajasthan, 70% from Delhi and Haryana and 65% from Maharashtra failed the test. Around half of the samples from Madhya Pradesh (48%) also met a similar fate. 

States with comparatively better results included Kerala where 28% of samples did not conform to the FSSAI standards, Karnataka (22%), Tamil Nadu (12%) and Andhra Pradesh (6.7%). 

The samples were collected randomly and analysed from 33 states totaling a sample size of 1,791. Just 31.5% of the samples tested (565) conformed to the FSSAI standards while the rest 1,226 (68.4%) failed the test.
Detergent found in over 8% of tested milk 

 A study conducted by Food Safety Standards Authority of India (FSSAI) across 33 states has found that milk was adulterated with detergent, fat and even urea, besides the age-old practice of diluting it with water. Across the country, 68.4% of the samples were found contaminated. 

These were sent to government laboratories like Department of Food and Drug Testing of Puducherry, Central Food Laboratory in Pune, Food Reasearch and Standardization Laboratory in Ghaziabad, State Public Health Laboratory in Guwahati and Central Food Laboratory, Kolkata, for testing against presence of adulterants like fat, neutralizers, hydrogen peroxide, sugar, starch, glucose, urea, detergent, formalin and vegetable fat. 

Detergent was found in 103
samples (8.4%). “This was because milk tanks were not properly washed. Detergents in milk can cause health problems,” FSSAI official told TOI. The non-conforming samples in rural areas numbered 381 (31%) out of which 64 (16.7%) were packet milk and 317 (83.2%) were loose samples. 

In urban areas, the number of non-confirming samples were 845 (68.9%) out of
which 282 (33.3%) were packed and 563 (66.6%) were loose. 

The most common adulteration was that of fat and solid not food (SNF), found in 574 (46.8%) of the non-conforming samples. This, scientists say, is because of dilution of milk with water. The second highest parameter of non-conformity was skim milk powder in 548 samples (44.69%) which includes presence of glucose in
477 samples. Glucose could have been added to milk probably to enhance SNF. 

The report asked state enforcement authorities to check whether the new FSSAI rules are being complied with. An earlier first-of-its-kind study of milk boiling habits that involved 2,400 women across eight major cities had found that Chandigarh leads the pack in boiling milk, doing it more than three times a day. While 84% women in Kolkata boiled milk for more than five minutes, about 46% of women in Pune preferred to boil milk in high temperatures. The study, by the Indian Medical Academy, said, “About 49% boil milk more than thrice before consumption. Around 56% boil it for more than 5 minutes, and 73% don’t stir while boiling,” said Dr Pawan Gupta, IMA. 

TNN Times View This only confirms that food adulteration is common in India. Even milk, consumed primarily by children, isn’t spared. What’s particularly worrying is the kind of substances used to adulterate, including toxic chemicals. This shows the trade off between the risk of getting caught and the ‘reward’ of huge profits is skewed heavily in favour of the latter. The government must focus on raising the risks to the adulterator. One way of doing this is by hiking the penalty, including making it analogous to attempt to murder in extreme cases. It’s equally important to regularly check foodstuff for adulteration and ensure speedy trials.

Source: The Times of India

Friday 6 January 2012

Food safety issues – residues, contaminants: Scenario in India

January 06, 2012

Food security has always been a topic of major focus for policy-makers all over the world. To be able to provide food for all is a challenge even today for many of the under-developed and developing countries. A large number of countries still depend upon the import of food. Among those importers of food, the ones from the developed countries have started making the quality criteria of foods more stringent with time. The emphasis on the quality parameters pertaining to safety of food, has taken the centre stage in the global food trade. With time, the allowed limits for various parameters are being made stringent especially in the countries of the developed world. Examples are members of EU, USA, and Japan. All this has brought food safety as the major area of concern, if not bigger then at least as much as food security.

The countries from the developing world would find it difficult to meet the food safety requirements of the regulators in the developed countries. This is so, in spite of the fact that the developed countries almost depend upon the imports from developing countries. There are several developing countries which have been exporting their food products to the developed countries till the other day, will be competing with each other for their market share in the developed countries.

Advantage developed countries
The overall outcome of making the quality norms more stringent is turning out to be of an advantage for the developed countries rather than for the exporting developing countries. The exporters even though are the real source of food for the developed world, will find it hard to get the approval of regulatory authorities in spite of the fact that they will be undertaking several programmes of capability building. In the end, as a result, the developing countries would have to cut down the prices of their produce, while bringing drastic improvements in food quality in terms of safety. To be able to capture the share of the global food trade, all the exporting countries would therefore have to build capabilities to meet the requirements of the regulators. In India, the scenario has already started changing at a rate much faster than perhaps envisaged a few years ago. In order to ensure that the exports of food from India do not get rejected by the importing countries, several capability building and capacity building projects need to be implemented across the country without loss of any further time. Here, it may be mentioned that the rejections of various consignments of different food products have yet to be brought down, even though there has been a considerable improvement as far as the quality assurance measures for food safety are concerned. The fact is that by the time the norms are met for a given parameter in certain category of products, new quality criteria are introduced by the importing countries. This is bound to continue till such time that quality standards in India are harmonised as per Codex with the backup of analytical research in areas like method development and method validation in the country. To achieve all this it should become a must for the regulators in India that the quality of the food products produced in India is monitored and controlled using the latest quality standards as per Codex. This will also have to be done even for the products being made available for the local population and not just for exports.

Key requirements
There exists a lot of gap areas in different fields of food production and processing in India. Some of the issues related to regulatory aspects of food have been taken care of; thanks to the setting up of Food Safety Standards Authority of India (FSSAI). In times to come, concerted efforts would have to be made to fill the gap areas. At all steps and stages in different sectors, projects will have to be initiated. While the consumers are regularly being updated by the local as well as international media, the regulators are also kept appraised about the safety related issues by the R&D organisations. In such a situation, the manufacturers will have to build capabilities to be able to supply food of desired quality to the consumers. Linkages will have to be developed such that the requirements of the emerging needs of food safety at global level are understood and accordingly R&D interventions are planned by the R&D organisations. Continuous policy research studies would have to be conducted to provide support to the regulators so that the products in the market can be ensured of the desired quality. The most important stakeholder in whole process would be the manufacturer who would be the driving force for programmes being envisaged by the policy-makers. Linkages where R&D, regulators, manufacturers and policy-makers work together in tandem and with complete coordination would be the key in the whole process.

Existing situation
The present article describes existing situation of food safety, specially focussing on residues and contaminants in foods in India. The emerging scenario of food safety in India would be discussed for the benefit of all the stakeholders for the purpose of preparation of path forward so that India and the Indian food industry remain in leading position at the global level. The subject has been covered with the following outline:
i. Residues and contaminants in foods and key issues associated with them.
ii. Evolutionary aspects of food safety standards.
iii. Existing situation and emerging scenario of residue and contaminants in foods in India.
iv. Gap areas for which R&D interventions are imminent.
v. Path forward.

(i) Residues & contaminants in foods - Key issues
a. Residues & contaminants in foods
The terms residues & contaminants are often used intermittently without giving a thought about the different meanings they present. It will be worthwhile defining both these terms before proceeding further on this subject.

Basically, residues as the term suggests are the remnants of various inputs (with degrading nature) used during the production process. For example, agrochemicals like pesticides when used during agriculture are supposed to get degraded after their application on the crops but that does not happen in all the cases. When small amounts (traces) of pesticides remain mixed with the food, it is called as residues of pesticide. Similarly, antibiotics used for apiculture would leave residues of antibiotics in honey. Likewise, the veterinary drugs used for animal husbandry may be ending as the residues of animal origin. In other words, the residues are the contaminants due to inputs used during the process of production of foods.

The contaminants, meanwhile, are the impurities picked from the surroundings, environment and packaging due to one reason or the other. Contaminants therefore are not due to the inputs used during manufacturing etc. Heavy metals in food, for example would fall in the category of contaminants because they get into the food chain from surroundings etc. In nutshell, all residues are contaminants but all contaminants are not residues.

With the increase in synthesis and manufacturing of new organic molecules everyday and their increased applications for various purposes, there is a major concern for these organic compounds coming into the food chain as residues and contaminants and contaminating the food products thereby, causing issues for food safety and health safety. Besides the possibility of presence of various chemical contaminants and residues in the food products, the food is also susceptible to the presence of various physical, radiological and biological contaminants such as different types of microbes including the deadly pathogens, different kinds of mycotoxins etc. which may get introduced into the food chain if proper hygienic practices are not followed. Various techniques of food processing such as preservation, emulsification, hydrogenation, distillation, esterification etc. have resulted into reduced spoilage and value addition of various types of foods. By adopting food processing technologies it has also been possible to bring down the incidents of food-borne illnesses. Here, it must be noted that all processing technologies suffer from one drawback or the other due to which there always remains some risks of contamination in foods. The processing should therefore be so well controlled and monitored that the conditions causing contamination are completely eliminated to ensure processed foods of desired quality.

The table below shows the vulnerability of different categories of food products to different types of toxic residues and contaminants.

Understanding vulnerability
From the details presented in Table I, it may be noted that almost all types of food are vulnerable to residues and contaminants of one kind or the other. The vulnerability is largely due to a) shelf-life of the product b) processes involved c) the conditions of storage, handling, transportation and on the shelf before the product is consumed. A thorough understanding of each step involved in delivering the food to the consumer, starting from the production to the stage where the product is picked up from the shelf by the consumer, is necessary to eliminate different possibilities of residues and contaminants in food. That one can provide food absolutely free from all sorts of residues and contaminants to the consumers all the time and every time, is something that is easier said than done. This is true, in spite of the fact that, one adopts the best of the practices and techniques for the purpose. In other words, what is most feasible and viable is to contain the residues and contaminants within the safe limits for all the food products. The question now is what are the safe limits for different residues and contaminants? To be able to answer this question right, one must remember that given the choice, the consumer would prefer to have foods completely free from all sorts of residues and contaminants irrespective of their economic background. Even then also if the consumers are still consuming foods with residues and contaminants beyond the desired limits, it can only be either due to their vulnerability or due to lack of awareness.

b) Key issues of food safety
The subject of residues and contaminants in various types of foods has been getting complex day-by-day. The complexities are attributed to
a) A large number of studies related to toxicity of all sorts of agrochemicals and the findings of toxic effects getting into wide circulation. Even on an isolated basis the toxicity data are taken with high degree of seriousness. As a result, a lot of new agrochemicals are being introduced. The fact that the pests and insects develop resistance to the existing ones also demands for development of new agrochemicals.
b) Excessive media coverage and exposure have resulted in making the consumers concerned, sometimes to an extent not really necessary.
c) Regulators being more strict and vigilant for monitoring of food processing for various types of residues and contaminants.
d) Trade related issues when it comes to the global trade of various food products. Often, developing countries complain of trade barriers created by way of reducing the residue limits to very low levels.

Onus on manufacturers
As a result of all this, the consumers are getting more aware and demanding while the regulators are becoming wiser and prudent. As a result, the manufacturer will have to work backward to meet the specified limits of residues and contaminants to fulfil the requirements set by the regulators. It is the responsibility of the manufacturer to deliver the foods of desired quality to the consumers; as per the new laws being implemented under the aegis of FSSAI. This is a daunting task for the food processing sector because they hardly have any control on the quality of input material. The ideal situation would be that, the raw food was produced without the use of any of the agrochemicals. But, that is not going to be the case in spite of the fact that the so called organic food fetches a higher value simply because the volume are more important than the quality for the countries that are heavily populated. The other possible option could then be to opt for safe agrochemicals that do not leave any residues or contaminants. It is also not going to be a possibility in the near future to replace the existing range of agrochemicals by the new generation safe agrochemicals, and hence, other measures will have to be adopted to keep the residues and contaminants under check as per the specified limits by Codex.

Stringent norms
The biggest concern in this situation, full of complexities, is the fact that the quality norms for residues and contaminants is getting more and more stringent with time; MRLs being revised downward by the developed countries led by the EU. The scientific basis should be the criteria for fixing MRLs has always been the topic of debate between the developing and developed countries. Look at the data presented in Table II and Table III to understand and appreciate the reasoning given by the two groups of countries against each other.

MRL values
From the data presented in Table II, it is evident that, it is difficult to justify the basis for keeping relatively higher MRL values for a given pesticide for leafy vegetables than it is for the others. It is a fact that the leafy vegetables are generally consumed in bulk as the main food item and tomato is consumed in small amounts as an additive to various food items. How can then one justify the lower MRL values for tomato and leafy vegetable like spinach. One can give a logic that leafy vegetables are highly vulnerable to attack of pests and insects and hence the usage of pesticide in leafy vegetable is supposed to be much higher than in the case of others. By this logic, one is able to explain the background for high MRL values from the point of view of food security but this explanation falls short of the desired purpose i.e. the food safety. One may also note that for certain pesticides MRL values for all the vegetables are exactly the same; example given is chlordane. There are also cases where the MRL values for leafy vegetables are much less than the values for other vegetables. If food safety is the concern, then, all the existing MRL values need to be reviewed scientifically rather than justifying them on other reasons.

The data presented in Table III clearly shows that the MRL values set for various food products are much lower as per Codex standards than they are as per PFA. Till the other day, products were being evaluated as per PFA. At the global level, the existing scenario of food safety ensured through specifications as per PFA cannot be considered as a happy situation for the Indian food industry. The emerging scenario, therefore, is highly challenging in all respects.

Herculean task
From the above discussion, it is clear that the food processing industry in India is supposed to deliver the products of highest quality from the raw materials which may not always be of desired standards. It is a Herculean task no matter, how justified the food processing industry is in opposing the implementation of the Codex standards; the reality of the day is that for their survival and also for their growth they will have to adopt methodologies and practices to keep the residues and contaminants under control. This is just like a situation where the raw material supplier is left untouched but the processor is caught for no fault at the latter’s end. Here the case of the quality standards for soft drinks would be handy to appreciate the anomaly. Before the parliamentary committee was set up to look into the standards of quality of soft drinks in India, the limits for residue of pesticides in carbonated drinks were very high. Overnight the limits were drastically brought down without bringing down the limits for various inputs. If the processed foods are to satisfy the desired quality standards, there has to be strict regulations for the raw materials for the processed food. Can we justify the differences in residue limits of various pesticides in different types of water meant for the same purpose? The limits for ordinary drinking water are highly lenient in comparison with those for the mineral and packaged drinking water. The food processing industry is justified in asking for the supply of drinking water (an important raw material for food processing industry) of the highest standards (same as that of mineral water) so that processed foods meet the desired standards. Such issues are to be given the topmost priority by the policy- makers.

No one denies the fact that consumers must get the food free from residues but that is absolutely impossible is also true. The question therefore is to what extent one can allow the amount of residues. The bone of contention is the methodology adopted in fixing those limits. Further, fixing limits for certain pesticides, for example, even for the produce from a country where such pesticides have never been in use is another matter of concern. The amount of efforts necessary to prove by way of conducting residue-monitoring plans for the residue levels in different foods is really huge for countries like India.

Moreover, what to do with the food already produced which is not meeting the specified limits of residues and contaminants. The notable example here is that of honey being exported from India to the EU. The experience of residue-monitoring plan suggests that only 40 per cent of the honey produced is meeting the EU norms. This means that the rest i.e. 60 per cent of the produce is consumed locally. How one can justify this anomalous situation! Akin to this is the case where the honey produced by certain countries is already banned for imports by the importers, e.g. the EU. The honey not being exported by those countries is therefore being consumed by local consumers. Like this, there are several products which are either already banned or are under scan for banning by the importers of developed world. Groundnut, milk powder, egg powder, marine products, fruits and vegetables etc. are the notable ones as far as India is concerned.

Rigorous measures
If India plans to export these products to countries like the EU, rigorous measures will have to be adopted to ensure that the quality of exports is as per the limits specified by the regulators of the importing countries. This would require extensive residue-monitoring plans across the country to establish the current status of residues and contaminants in these products at the outset. After this, each of the consignment should be checked for the quality norms set by the importers. In the process it may be possible that a percentage of the products may qualify the quality criteria for exports, which means that the local consumers will only get to consume the products of quality that is substandard with respect to the exported quality. This is something that would not be acceptable by the local consumers in times to come.

ii) Evolutionary aspects - FS standards & regulations in different countries
In order to provide safe products to the consumers, the governments and the regulators of various countries have been promulgating and enforcing certain regulations and policies. Food safety regulations and standards evolved differently around the world, as countries responded in their own ways to food safety crisis and prepared themselves for perceived exposure to emerging food safety risks. Looking at the sequence of developments, it can be said that the regulations and standards for quality of various products but especially for those to which the consumers are directly exposed across the world are shaped by
Experiences of countries with food safety;
Inherent food safety risk level in the food supply of each country;
Ability and willingness of the industries to allocate resources to control the risks in each country and;
Differences in food safety perceptions of consumers & hence preferences for targeting risk reduction efforts.
The main aim of the regulators has always been to protect consumer’s interests by setting the standards for all materials including the packaging and the labelling of ingredients of the processed foods. Regulatory regimes continue to respond to different foods and food processing methods or chemical or microbiological contamination risks. The new ways of growing and producing foods such as use of genetic engineering techniques and an array of new technologies for preserving foods such as food irradiation, ultra high pressure, ultraviolet light, sterilisation, freezing and cook, chill methods, use of smart packaging materials etc. have always been a concern for the regulatory authorities. Food handling risks are also managed by food standards and food regulations.

Developed, developing – differences
While on the one hand, the food laws and regulations and food standards in the developed countries are highly developed, more stringent, most of the time science-based involving various components of risk analysis and getting strengthened with timely introduction of new regulatory standards for previously unknown or unregulated hazards; on the other hand, the underdeveloped countries have yet not been able to pay much attention to food regulations and standards mainly due to food security or, the food regulations are not well defined or there is a lacunae in enforcement or implementation of these regulations. As a result, the differences in regulations and standards among the countries can have a major impact on the economy of the country and can lead to international trade conflicts or disputes, thereby, ultimately affecting the global patterns of food demand and reducing the trade. In order to understand this better, let us look at the food regulations existing in different parts of the world.

European Union food regulation
The regulation establishes the rights of consumers to safe food and to provide accurate and honest information from which they can choose their diet. The food law both at the national and community level not only provides health protection but also protects consumer interests in relation to prevention of deceptive practices including adulteration of food and ensures accurate information being provided to the consumers. This regulation broadens the more specific provisions in commodity labelling and advertising legislation by providing an overall principle that consumers must not be mislead. The European Union Food Regulations encompasses the following components:
i) Scientific basis to food laws involving systems which are science-based and integrating science and risk analysis at all its levels.
ii) The precautionary principle is relevant in those specific circumstances where risk managers have identified reasonable grounds for concern about existence of unacceptable level of risk to health but the supporting data or information is insufficient for a comprehensive risk assessment to be made. In such cases, decision-makers may take measures to protect health-based upon precautionary principle while seeking complete scientific and other data.
iii) Traceability of the origin of feed, food, ingredients and food sources to facilitate withdrawal of foods in case of any eventuality.
iv) Roles and responsibilities of the numerous and diverse stakeholders in the food chain so as to enable building up participative, co-ordinate and cohesive framework for action for ensuring compliance with food laws.
v) Food safety requirements which comprise two elements: a) food should not be injurious to health or b) unfit for human consumption. Only one of these elements has to be in place for the food to be considered as unsafe.
vi) Principle of transparency to increase consumer confidence in food law.

Physical significance
While the above discussion provides a bird’s eye view of the fundamentals based on which the regulations are framed in EU countries, it does not really present the physical significance of various steps involved in evolving the quality standards for food. For this it will be better to examine certain cases as examples; the antibiotics. Initially EU standards for the presence of residues of various antibiotics in different foods were not that stringent but during the recent past especially during the last decade things have undergone a sea change. Till the other day, the residue limits for various antibiotics was set based on the criteria of detectable limits of analytical instruments. It means that there were MRL values for antibiotics. At present it is not so. The MRL values for most of the antibiotics have been brought down to zero limit. Further, the list of antibiotics has been increasing. The products which are of high significance for Indian exporters are honey, meat and poultry, cheese, egg powder etc.

In similar manner, the limits for various veterinary drugs, pesticides, heavy metals etc. have also been brought down significantly. Here, again the number of veterinary drugs and there metabolites for which the products are to be checked have been increasing with time. The scenario about the biological contaminants is perhaps more complex than the chemical ones. The list of pathogens has been increasing and new types of microbes being added every time. The limits for various types of mycotoxins have also been made stringent with time. The regulations related to labelling on the containers of processed foods are something that is very important criteria for approval and rejection. In the past, there have been instances where many of the famous brands of processed foods from India have been rejected on the basis of being termed as filth in EU countries just because of the reason that the necessary information for the consumers was not provided on the label. Incidentally, labelling information on the container is something which has still to be taken seriously by the manufacturers in India. The Indian exporters must take necessary precautions keeping the evolutionary events of food quality in Europe in mind while exporting their products.

US food safety regulations
The United States food safety system is based on strong, flexible and science-based federal and state laws and industry’s legal responsibility to produce safe food.
The system is guided by the following principle:
1. Only safe and wholesome foods may be marketed;
2. Regulatory decision-making in food safety is science-based;
3. The government has enforcement responsibility;
4. Manufacturers, distributors, importers and others are expected to comply and are liable if they do not; and
5. The regulatory process is transparent and accessible to the public. As a result, the US system has high levels of public confidence.

The agencies’ well-qualified science and public health experts work cooperatively to ensure the safety of US food. Principal federal regulatory organisations responsible for providing consumer protection are the Department of Health and Human Services (DHHS); Food and Drug Administration (FDA); the US Department of Agriculture (USDA); Food Safety and Inspection Service (FSIS), and Animal and Plant Inspection Service (APHIS); and the Environmental Protection Agency (EPA). The Department of Treasury’s Customs Service assists the regulatory authorities by checking and occasionally detaining imports based on guidance provided.

Comparing US and Europe
It may be mentioned here that it is easier to export food products to the US than it is to Europe. The food safety systems in the US are considered to be more towards being practical and true to the real life situation, in comparison to Europe where the focus is on making the norms more and more stringent. The systems in the US rely more on scientific evidence for every decision made. While setting the standards of food safety, the US authorities adopt a 360 degree approach to an issue. The emphasis in the US is very high on compliance of both regulations as well as administration of the food safety systems. There have been cases where the exporters from the US find it difficult to export their produce to Europe. Therefore, it is in the interest of all that the standards are harmonised as early as possible.

Food safety regulations in India
Till the year 2005, there were different laws that dealt with different food products and standards such as i) Agricultural Produce Act ii) Agmark specifications iii) Prevention of Food Adulteration Act, 1954 iv) Meat Food Products Order MFPO, 1973 v) Bureau of Indian Standards Act, 1986 vi) Environmental Protection Act, 1986 vii) Milk Products Order, 1992 viii) Food Products Order FPO, 1995 ix) Essential Commodities Act, 1995 and x) Vegetable Oil Products Order, 1998.

All these multiple laws and regulations prescribed various standards regarding food additives, contaminants, food colours, preservatives and labelling, thereby, leading to a system which was over regulated and under-administered. Therefore, in order to rationalise the multiplicity of food laws and bring out a single reference point in relation to regulation of food products, a group of ministries was set up to suggest legislative and other changes to formulate an integrated food law that could protect the consumers and provide a regulatory environment conducive to industry in general as well as consumers’ protection. Based on the recommendations of the group of ministries, the ministry of food processing industries enacted the Food Safety and Standards Act (FSSA) 2006 with two main objectives i.e. i) To introduce a single statutory body relating to food and ii) To provide for a scientific development of the food processing industry.

Principle of harmonisation
The FSSA 2006 incorporates the salient provision of the Prevention of Food Adulteration Act, 1954, and is based on the international legislation, imbibed in CODEX Alimentarius Commission.

The principle of harmonisation is also enshrined in the Food Safety and Standards Act. The Act clearly specifies that
FSSA will be aided by several scientific panels and a Central Advisory Committee to lay down standards for food safety. These standards will include specifications for ingredients, contaminants, pesticide residues, biological hazards and labels.
The law will be enforced through State Commissioners of Food Safety and local level officials.
Everyone in the food sector is required to get a licence or a registration which would be issued by local authorities.
System of traceability of food articles given by the sellers to the distributors and the distributors to the manufacturers so as to enable to initiate the recalled procedures if the food sold is found to have violated the specified standards.
The Act provides a graded penalty structure where the punishment depends upon the severity of the violation.
The major benefits of the implementation of the new integrated food law would be
i) Bringing in steps and measure leading to harmonisation of food standards.
ii) Building of science-based standards.
iii) Alignment to international regulations.
iv) Certain amount of clarity on novel food areas.
v) Help in removing corruption and malpractices.

Evolutionary phases
From the above discussions it is evident that the evolutionary phases of food safety before the establishment of FSSAI in India were driven largely due to incidents and developments taking place elsewhere. The specifications were made stringent either because the importers made the requirements more stringent or there were outbreaks of serious nature due to contamination or residues in food products. In future, the driving force will necessarily have to be proactive approach for quality rather than remaining reactive. The objective set for FSSAI should be achieved in practical terms rather than theoretical. All the salient features mentioned above therefore will have to be translated in the form of concrete actions with quantifiable deliverables by the concerned agencies. The role of R&D both public and private, will become highly crucial. The food processing industries will have to start building their own R&D capabilities in order to be able to comply with the desired standards. Setting up of R&D centres and incubators will have to be considered seriously while planning to establish each of the mega food parks in the country. The emerging scenario would bring a lot of disputes related to a) quality of raw materials available and used, b) methods adopted to analyse residues and contaminants, c) validation of processes employed for various food products, d) food packaging interactions and leachables, e) nutritional and labelling information on the packet, f) shelf-life of the products.

Food regulations in Third World
Food-borne diseases are a serious threat to people in third world countries. Most of the food is imported in order to meet the food requirements of the local population. Because there is no effective food safety regime in place in most of these countries, the safety of the food cannot always be assured, adding to the risk of widespread food contamination.

There is a lack of adequate food safety policies and programmes capable of addressing current food safety challenges. National food safety systems are often characterised by the existence of multiple agencies with overlapping mandates and with little amount of collaboration among themselves, which ends up in inefficient use of resources due to duplication and gaps in the coverage of important food safety issues. Food legislations in most of these countries are either outdated or incomplete and do not provide the basic legal foundation for efficient food safety control. In addition, enforcement agencies do not have the necessary means to carry out their responsibilities for food control. This includes lack of adequately trained human resources as well as poor infrastructure facilities. Therefore, at the moment there is a strong need to draw out a strategic plan for food safety, specially tailored to the need of third world countries. Appropriate food safety legislation need to be introduced involving all those involved in the food production, processing, and catering sectors, which could respond to both global and domestic challenges.

India as example
In times to come the third world countries would follow the similar path already traversed by countries like India. The only difference would be the fact that they do not have to reinvent the wheel of food safety as they already have the reference data as the background for shaping their legislations and systems for their implementation. The point to be noted here is that the Indian food processing industry stands to gain a lot from the scenario in these countries. There exist an opportunity for the Indian food industry to create avenues of cooperation and collaboration which will be mutually beneficial. Already there are signals indicating that the food safety would be an appropriate plank for putting India in leading position at the global level. The large-scale agriculture being done by Indian farmers in countries like Ethiopia is something which deserves a mention here as a bright spot for food security and food safety for both the countries. Under the aegis of IAFS-II, Government of India has planned a series of capability building and capacity building projects based on food safety for different countries of Africa. The outcome of such initiatives will have far reaching consequences both for the growth in Africa in general and for upgrading food safety standards in India. In nutshell, food safety would be one of those key factors which will create cooperation and collaborations amongst different countries divided, based on their economic situations.

Safety, nutrition
In order to assure the consumer that the food consumed is safe and nutritious, it is important to develop a comprehensive and effective food system, which ensures both safety and nutrition. The objective of a comprehensive food system should be to ensure that foods meet science-based safety characteristics. A comprehensive food system has number of attributes:
Dynamic interdependence of all players through the development of strong networking between all stakeholders in the decision-making process.
Food safety consideration to be built into the food chain from farm to fork.
System should be science-based and integrate science and risk analysis at all levels.
Effective control and containment of food safety hazards along with the ability of the system to respond to crisis.
System should be responsive to everyday issues but also at the same time be able to meet the future challenges.
Food safety measures must also take into consideration the general regulatory framework governing human and animal health.

Consumer confidence
In developed countries, food systems possess many of the attributes of comprehensive and effective systems. The main priority is to make substantial improvements that will help regain or enhance consumer confidence. This includes increasing the resilience of the source systems along the food chain, enhancing the scientific basis for decision-making and providing organisational support for effective participation of all parties in the institutional debate.

On the contrary, the extremely diverse food systems in the developing countries suffer from a number of drawbacks. They are not always as organised, developed, comprehensive or effective as in the developed countries. They are faced by several challenges which adversely affect the security, safety and quality of food supplies. People in the developing countries, most of the time are exposed to a wide range of potential food safety risks. More often than not, there always exists a lacuna in awareness of consumers about food safety matters associated with lack of organised mobilisation of consumer groups and interests. In order to build a comprehensive and effective food safety system in developing countries, as well as those countries in transition, implies basically both capability and capacity-building approach.

Today, tomorrow
(iii) Existing situation and emerging scenario of residue and contaminants in foods in India.
In India, the situation of food and processed food is completely different from what exists elsewhere in the world, even in developing world. The reasons for this unique scenario are as follows:
a) The production of raw food is widespread across the country with very small land holdings. Quality monitoring at the farm level and maintaining the traceability of the food articles is one of the major concerns for the regulators from the point of view of food safety.
b) The raw produce passes through the traders etc. at various levels and as a result, it is subjected to the extreme conditions of storage and handling presenting the risk of introduction of contaminants.
c) Before the raw food reaches to the processors, there are various stages through which it passes, resulting in deterioration of its quality. There are possibilities of contaminating the foods with degradation products.
d) The awareness about the measure and precautions to be taken to avoid contamination is not upto the desired level. Even the public hygiene remains a major area of concern for food safety authorities.
e) Lack of infrastructure facilities especially in the unorganised sector is the major hurdle in the way of achieving desired standards of food safety in the country. Although the manufacturers from the organised sector may be adequately equipped for their products to be complying as per the latest requirements of food safety standards but they have to rely upon the raw materials coming from the unorganised sector which might be contaminated with various toxic contaminants. The post-harvest management technology needs to be overhauled without further delays. To appreciate this, it will be worthwhile looking at certain practices, which are rampant and pose high risk of contamination.
1) Use of chemicals and pesticides etc. for delaying the ripening of fruits & vegetables which results into leaving residues in the product.
2) Use of chemicals like calcium carbide for ripening of fruits like mango & banana.
f) Adulteration of foods with different types of additives (lookalike) which may cause health risks, is yet another matter of great concern. The methodologies being developed to check the adulterants have also not been serving the purpose. Imagine, menthol being adulterated with additives that remain undetected even by GC technique is prevalent.
g) Incidence of camouflaging foods by addition of banned substances like dyes & colours has yet to be eliminated. Widespread use of banned dyes in spices is quite common across the country.
h) Because of the socio-economic conditions of the majority of the Indian population, street- vended foods form a significant part of rural as well as the urban food supply. Most of the street food vendors are often poor and uneducated and lack appreciation for safe food-handling. Consequently, street foods are perceived to be a major public health risk.

Gap area - R&D interventions are imminent
Although the introduction of the modern integrated food law i.e. Food Safety and Standards Act, 2006, incorporates all the elements to ensure food safety and protect the consumers against all odds of food safety risks in future times to come, but as on today there exist several gap areas which need to be fulfilled and require R&D interventions. Following gap areas related to food safety in India are of major concern:
Availability of appropriate validated method for large number of toxic contaminants in various types of food matrices especially the indigenous processed and ready-to-eat food products.
Capabilities need to be built for setting up of MRL values in a scientific way so as to counter the attempts targeted to create Technical Barrier for Trade (TBT) by importing countries.
Availability of appropriate infrastructure for hygienic processing of food products especially the street-vended foods or the foods supplied by small restaurants.
Availability of systems to trace out the sources for food-borne illnesses.
Availability of technologies for ensuring good agricultural practices and post-harvest management of crops.
Availability of expertise for determination of residues and adulterants of toxic chemicals which might get introduced into the food products during processing or from different kinds of packaging materials.
Availability of data to support risk assessments including the identification of emerging hazards and contaminants.
Risk management and control in food safety.

As on today, there is an urgent need for bringing in improvements in the existing food safety scenario in India. If India wants to seize the opportunity for being amongst the top countries in the global food trade by making best utilisation of its produce, it has to match by the quality standards of food with those of the other countries of the world. There is an urgent need for setting up of the state-of-the-art advanced centres of excellence to undertake the analytical research work to cater to the requirements of industries, policy-makers, regulators and consumers. Residue-monitoring plans for determining the presence of existing toxic contaminants would have to be put in place for all kinds of products meant not only for exports but also for the domestic market. There is absolutely no doubt that during the 12th Five Year Plan, adequate facilities with the desired state-of-the-art equipment would come up in different parts of the country which would help in development of skills and capabilities in the country required to cater to the needs of the food industry.

While there are opportunities both at local and global level for the food processing industries of India, the challenges are also substantially enormous. It will only be through the indigenous R&D support that the Indian industry would be able to over come many of the challenges. It will only be through the R&D that the post-harvest losses of the perishable products to the tune of over 25 per cent can be avoided for the benefit of the economy and society. It will also be with the support of R&D that the traditional knowledge about the functionalities of various types of exotic foods of India, several functional foods will become the reality in times to come. With the advantage of strong R&D base, India would be able to play a leading role at the global level cooperating with the countries of the third world. The silver lining, thanks to certain developments like establishment of FSSAI, implementation of the integrated food law, comprehensive plans for creating knowledgeable human resource, setting up of mega food parks, setting up of food safety laboratories in different parts of the country etc., would serve as motivation for overall scenario of food safety in the country. Of course, the government support in terms of infrastructure, industry- friendly policies and financial support would serve as an inspirational tonic for the stakeholders of food safety in India.

Source: FnB News       

NIN for use of tech innovations for better nutrients in bakery products

January 06, 2012

The National Institute of Nutrition, a part of the Indian Council of Medical Research (ICMR), is now recommending the bakery sector to focus on technological innovations and better ingredients like zero trans fat, high fibre besides micro nutrient fortification to replace calorie-dense, high glycemic and relatively low nutrient value products. These baked foods are led by bread and biscuits and followed by cake, muffins, bun, pav and pizza.

“Bakery products are increasingly becoming popular in our country. The range and variety which exists these days make them an attractive food option. Apprehension however exists in the wake of the decreased activity and modern lifestyles that these products tend to be calorie-dense. There is need for research and development for novel and healthier bakery products relevant to the diverse needs of the country,” stated Dr B Sesikeran, director, National Institute of Nutrition, Hyderabad.

Consumers are increasingly becoming concerned about their health and are well aware of the relationship between nutritious food and optimal health. Various concerns have caused consumers to demand for healthier bakery products, according to Sesikeran.

Some popular trends in the market are light functional, natural organic products. In addition to the healthier products consumers are also purchasing products that satisfy their taste buds. Keeping this in perspective, future area of research at the NIN includes an in-depth study in the role of different macro and micronutrients. There is need to develop low-cost but healthy bakery products using locally available nutritious ingredients such as millets, full bran wheat, honey and greens. Once such products are standardised then the technology can be traversed to small bakery entrepreneurs in the rural and urban areas.

To ensure that the consumers get the best of the nutrients, NIN has generated database on nutritive values of over 650 Indian foods, which is used by various national organisations, planners and academic research institutions. It has also formulated Recommended Dietary Allowances (RDA) for Indians. Further, it has developed food- based dietary guidelines. As part of the food-based approach to combat micronutrient deficiencies, the NIN has also gone ahead to develop fortification methods with iron and iodine for prevention of related deficiency diseases. It has also demonstrated its beneficial effects in preventing the reduction in haemoglobin levels and devised simple kits to check the content of iron and iodine in fortified salt. The Indian bakery industry now needs to ensure developing bakery products comprising vitamins, whole grains and fibres, according to NIN.    

Source: FnB News

Wednesday 4 January 2012

Milk sold in AP safe, unadulterated: Survey

HYDERABAD: Here is some good news for milk consumers in Andhra Pradesh. According to a survey conducted on adulteration of milk in various parts of the country, the milk sold in Andhra Pradesh has been found to be 'mostly safe' but that is not the case with many parts of the country.

Tuesday 3 January 2012

Food and Nutraceutical Regulations - Global Snapshot

 January 03, 2012

The regulatory framework governing foods in major jurisdictions is evolving. Food research, product and process innovation and change in consumer behaviour facilitate adaptation of food regulations. Increasingly, the awareness is manifested through consumption of particular foods and dietary supplements believed to contribute to good health and in some cases, to hold therapeutic value in the treatment or prevention of specific diseases. Many of these food products are becoming commonly known as nutraceuticals or "functional foods."

Nutraceuticals are products that have the characteristics of both a nutrient and a pharmaceutical. Taken as dietary supplements, they can modulate the symptoms of various disease conditions by providing the additional nutrients our bodies may need to maintain well being. Food laws in every country is the basis of regulations of all kinds of food including health food, dietary supplement, functional food and nutraceuticals as specific guidelines / regulations are framed to regulate health food.

Stephen DeFelice, defined 'nutraceutical' as 'a food or part of food that provides medical or health benefits including the prevention and treatment of disease.'

Overview - US, EU, Japan, Canada, China, India - Regulations
The United States of America introduced the Dietary Supplement and Health Education Act (DSHEA) in 1994, which allowed considerable flexibility between foods and medicines found in other parts of the world. Under DSHEA a dietary supplement may contain 'a herb or other botanical' or 'a concentrate, metabolite, constituent, extract or combination of any ingredient from the other categories.'

The American food safety regulatory system is far more centralised than the European system. The issue of adulteration became a national issue in 1848 when Congress passed the Drug Importation Act, requiring inspection by the US Customs Service to prevent the entry of adulterated drugs from abroad. In 1862, in order to address the issue of adulterated food, the chemical division of the United States Department of Agriculture (USDA) was established and then renamed the Bureau of Chemistry (now FDA).

The genesis of US food legislation goes back to 1906 when a major piece of legislation was passed. The Food and Drugs Act was enacted in June 1906 and prohibited interstate commerce of misbranded and adulterated foods, drinks, and drugs. In 1938, the Food and Drugs Act was preempted by the Federal Food, Drug, and Cosmetic Act (FDCA). This Act focusses on food misbranding and adulteration and serves as the basic framework for food regulation by the FDA and the USDA. This legislation created food standards, mandated inspections of factories, and provided for the issuance of court injunctions in addition to the already existing seizure and prosecution remedies. Since 1938, the FDCA has been amended a number of times and additional supporting laws have been enacted relating to food safety, security threats, and nutrition. Additionally, this federal framework is supplemented by state laws.

The USDA and the FDA are the main authorities in food regulation in the United States. These two federal agencies encompass all phases of the food regulatory system: They evaluate, investigate, regulate, inspect, and sanction. However, even in a centralised system like the United States, some argue that the USDA and the FDA should consolidate into one single food agency. FDA regulates both finished dietary supplement products and dietary ingredients under a different set of regulations than those covering "conventional" foods and drug products.

Under the DSHEA, the dietary supplement or dietary ingredient manufacturer is responsible for ensuring that a dietary supplement or ingredient is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. All domestic and foreign companies that manufacture, package, label or hold dietary supplement, including those involved with testing, quality control, and dietary supplement distribution in the US, must comply with the Dietary Supplement Current Good Manufacturing Practices (cGMPS) for quality control.

In addition, the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is required to submit to FDA all serious adverse event reports. Further, FDA's other responsibilities include product information, such as labelling, claims, package inserts, and accompanying literature.

European Regulation
A wide variety of botanicals and other substances have been sold as dietary supplement ingredients, including many that are considered to be medicinal substances under most regulatory regimes in EU countries. The report published by the European Association of Self-Medication Industry, titled 'Herbal Medicinal Products in the European Union' has found that there was no consistency between the member states in the interpretation of the medicines Directive with respect to herbs. The criteria used to differentiate between medicinal and food herbs varied widely.

The EU food safety regulatory system needed a centralised regulatory power that would bring a more homogeneous type of regulation where member states would let European institutions oversee both risk assessment and risk management. Recognising the need to harmonise laws, the EC issued compositional directives in the 1970s. These directives created standards of composition for certain foodstuffs. The standards allowed some ingredients and prohibited others that did not meet the requirements set by the commission. Pertinently, the goal of those directives at that time was to guarantee the free movement of food within the European Common Market, rather than to advance consumer health. The directives applied only to particular ingredients, including sugars, jams, chocolate products, and preserved milks. Ultimately, however, this formula failed because the differing culinary cultures of the member states prevented them from agreeing on the adoption of those ingredients' requirements. In 1985, the EU came up with a new approach. Instead of trying to harmonise all of the food regulations, it decided to use labelling to indicate the differences in composition and production methods, allowing consumers to make an informed decision. It adopted the principle of mutual recognition, requiring a member state to allow the free circulation of goods produced in conformity to equivalent standards of other member states.

In 2002, the Council of the EU and the European Parliament adopted regulation and created the principles of food law and creating the European Food Safety Authority (EFSA). Each member state had regulated its own foodstuffs. In contrast, the EFSA is an independent agency that provides scientific advice to member states and EU institutions. It gathers data to help anticipate risks and issues opinions on matters and provides scientific assessments but does not handle any of the risk management.

Instead, the EU institutions and the member states themselves are responsible for risk management, a division of authority that poses an obstacle to greater centralisation. Under the European system the authority is not only divided among various countries, but those countries also have flexibility both in the way they control their food safety regulations and in the way they implement EU regulations and directives. Traceability and labelling are probably the biggest part of the harmonisation of standards and principles that the EU has undertaken in the realm of food safety regulation.

The Japanese government enacted a regulatory system called 'Foods with health claims' in April 2001, which consists of Foods for Specified Health Use (FOSHU) and Foods with Nutrient Function Claims (FNFC). The FOSHU was set up by the ministry of health and welfare in 1991 to approve descriptions on a label regarding an effect of food on the human body. It was enacted as a part of 'food for specified dietary use' under the Nutrition Improvement Law.

There are three important requirements for FOSHU approval. The first is scientific evidence of the efficacy, including clinical testing. The second is safety for consumption. The third is analytical determination of the effective component. Most of the descriptions of foods under the FOSHU system are similar to the category of enhanced function claims of Codex. Under FNFC, 12 vitamins and two minerals (calcium and iron) are standardised. These claims are similar to the nutrient function claims approved by Codex in 1997. The FOSHU certification is not easily obtained. There is a 3-stage approval process and in the case of domestic manufacturers (applicant) there is a process which amounts to a self-regulatory peer review by the Japan Health Food Association (JHFA). FOSHU can be applied to foods only and not isolated nutrients or manufactured nutritional supplements and only those foods which have identifiable health benefits based on sound scientific research. This marks the opportunity for the marketing and promotion of a wide range of foodstuffs which already have a significant degree of consumer acceptance.

In Canada, the Food and Drugs Act and Regulations is the primary statute which governs the sale of foods, drugs, cosmetics and medical devices. This statute which is remarkably simple in concept, can trace its origins to an 1860 British law entitled A Bill for Preventing the Adulteration of Articles of Food and Drink. The Canadian law evolved from an 1874 statute to the current Act which was passed in 1953.

In Canada there are no specific regulations dealing with functional foods and such foods are governed by the existing legislative and regulatory framework; The Food and Drugs Act and Regulations.

Under Canadian food and drug law, ingestible products must be either sold as a "food" or "drug." The term "Health Food," though widely used by industry and the consumer, is problematic for the Health Protection Branch (HPB).

The definition of "food" in the Food and Drugs Act makes no differentiation about types of food and states in another section that food must be free from poisonous or harmful substances. Thus, in legal terms, any food in compliance with the Food and Drugs Act and Regulations should assist in sustaining good health and should not present any appreciable hazard to the consumer. "Health Foods" should not be confused with "organically produced" foods which represent, by international consensus, foods derived from organic agriculture and are part of the broad spectrum of methodologies supportive of the environment.
The State Food and Drug Administration (SFDA) was founded on the basis of its former counterpart, SDA, and got its current name on April 16, 2003. SFDA is responsible for protecting the public health by assuring the safety, efficacy, and security of drugs, biological products, medical devices, food supply and cosmetics. As a direct part of the State Council, SFDA has regulatory and legal enforcement functions.

The National Institute of Nutrition and Food Safety (NINFS) is a research agency for nutrition and food hygiene. The institute facilitates improvement of nutritional status, preventing food-borne diseases, and strengthening the physical fitness of the people. The institute was formerly known as the Nutrition Division of the National Institute of Health of the Public Health Administration, which was established in 1941. After the founding of the People's Republic of China, the institute was affiliated with the following leading bodies under the title of the Department of Nutrition or the Department of Nutrition and Food Hygiene:

The first such national law, the Food Hygiene Law of the People's Republic of China, was adopted on October 30, 1995, and it defined food as "any finished product or raw material intended for people to eat or drink, as well as any product that has traditionally served as both food and medication, with the exception of products used solely for medical purposes.

In June 2003, SFDA took over the responsibility of health food registration approval from the Ministry of Health (MoH). The SFDA's Department of Drug Registration is completely responsible for the approval of health food, including nutrition supplements. In accordance with the Food Hygiene Law of the People's Republic of China and the Administrative Licensing Law of the People's Republic of China, the Interim Administrative Measures for Health Food Registration were promulgated by the SFDA and went into effect on July 1, 2005. With these provisions, the responsibility for the assessment and review of food safety, effectiveness, quality control, and labelling content was assigned formally to SFDA and its subsidiaries.

In contrast to the well-substantiated scientific evidence collected according to strict scientific procedures employed by many countries, Chinese regulations rely more on long established and accepted practice and experience developed in Traditional Chinese Medicine. Health claims are allowed on health foods provided requirements for public health are met and the claim in question does not employ medical jargon or terms likely to be confused with pharmaceuticals. Since August 1, 2005, no health food advertisements have been allowed to be released in the media prior to examination and approval by food and drug administration departments at the provincial level.

China is fast becoming a global powerhouse, and its impact has certainly been felt in the nutraceuticals industry, especially in ingredient segments. So while the evolution for China was being a net supplier to the global nutraceuticals industry, now China is entering the next phase of its evolution where it eventually becomes a net consumer of nutraceuticals.

There were multiple laws and regulations covering the foods in India, but there was no single law that could have significantly regulated the functional foods or dietary supplement or nutraceuticals.

In 2006, the Indian government passed Food Safety and Standard Act, 2006, to integrate and streamline the many regulations covering nutraceuticals, foods and dietary supplements. The Act calls for the creation of the Food Safety and Standards Authority (FSSA). The FSSA is responsible for drafting rules and regulations for companies in the food sector to be licensed by local authorities, a system of checks and balances, including product-recall procedures enforcements and penalties, and to develop science-based standards for food and to regulate and monitor the manufacture, processing, and storage. All food imports will therefore be subject to the provisions of the Act and any rules and regulations made under the Act. Further, it incorporates the salient provisions of the Prevention of Food Adulteration Act, 1954, and is based on international legislations, Instrumentalities and Codex Alimentarius Commission. Unlike the US, where the DSHEA is in place to regulate health-related products, in India, the government is in the process of drafting a law to regulate manufacturing, importing and marketing of health foods, dietary supplements and other nutraceuticals.

The concept of "nutraceuticals" is still developing in India. It has been defined in the FSSA but it is yet to be implemented as the rules are not completely framed.

However, FSSA lays down the suggestive structure of the regulation for Foods for Special Purpose and Nutritional Uses FSSA Act based on the learning from international best practices; the Food Safety and Standards (Packaging and Labelling) Regulation, 2011, deals with nutrition and health claims.

Final Comments
Every system of regulation has its pros and cons. The labelling of health-related foods should be based on scientific evidence, always bearing in mind harmonisation with global international standards. There should be a harmonisation of food regulations around the world. Economic growth and urbanisation are not enough evidence of the future growth of nutraceuticals, health demographic trends also support these growth forecasts. Consumers are deeply concerned about how their health care is managed, administered and priced. As health care cost has become high the consumers are frustrated with the expensive disease-treatment approach predominant in modern medicine; the consumer is now seeking alternative beneficial products like dietary supplement, functional food and nutraceuticals.

With innovative delivery mechanism to facilitate the use of nutraceuticals amongst its target groups, the world market is expected to witness a gradual shift toward natural ingredients. Further, EU focussing on the food safety regulation system by centralising of food regulatory powers, which would protect the public health as well as the future of the EU in a more general sense

Globally, the US and Japan are the most developed markets for nutraceuticals, due to the consumer acceptability achieved in these regions. India, China and Brazil are developing nations which show huge potential for the nutraceuticals market, India and China have emerged as a key sourcing destination for natural ingredients.

(The writer is partner, Corporate Law Group, New Delhi)       

Monday 2 January 2012

Effect of FSS Regulations on food product standards and food additives

January 02, 2012

The Food Safety and Standards Act, 2006
The food processing industry is widely recognised as the 'sunrise industry' in India and is of enormous significance for India’s development because it is a vital linkage between the industry and agriculture.

Earlier the food processing industry in India was governed or regulated by several Acts and orders to safeguard food safety and the health of the consumer. But due to variation in the specifications / standards in different Acts / Orders, and administration by different departments and ministries, there were implementation problems and less importance was given to safety standards over a period of time. The food industry was facing problems as different products were governed by different orders and ministries and the rules and regulations in the country needed consolidation.

The Food Safety and Standards Act 2006 was introduced to overcome these shortcomings and to give more importance to safety standards. This Act consolidates the laws relating to food and establishes the FSSA for laying down science-based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption. The Act integrates eight different food related statutes. 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.

Standards and additives prior to FSSA
Food laws and product standards prior to FSSA were often inconsistent and overlapping e.g., there were ambiguities and overlap between the standards laid down in PFA and FPO. The PFA laid emphasis on the prevention of adulteration of foods; PFA was prescriptive and recipe-based (PFA laid down over 300 recipes of products), which restricted product innovation and choice to the consumers. Proprietary formulations were not permitted for standard conventional products. PFA specified a list of additives that can be used in food products. Use of any other additive would render the product as adulterated even if the additive is safe. Under PFA, the Central Committee for Food Standards (CCFS) was the expert body that recommended mandatory national food standards. It had representation from the Central government, state governments, consumer organisations, research institutions, laboratories, and industry. There were various sub-committees under CCFS, which make recommendations on food standards in the respective sector.

Present status of standards, additives under FSSA
The Food Safety and Standards Rules have been notified on May 5, 2011, and FSSA has been notified on August 5, 2011. The food authority while drawing up the regulations has tried to integrate erstwhile Acts, Rules, Orders, in line with the mandate of the FSSA. The Authority has not introduced new standards at this stage since it would require detailed risk assessment, examination of risk management options, consideration by the scientific panels / committee and final approval by the food authority and Central government as the Act mandates for legislation to be based primarily on scientific evidence and risk assessment. To do this task, several scientific panels and an overseeing scientific committee have been constituted.

The food authority has constituted the following 8 scientific panels in terms of Section 13 of the Act, consisting of independent scientific experts:
1. Functional foods, nutraceuticals, dietetic products and other similar products;
2. Method of sampling and analysis;
3. Food additives, flavourings, processing aids and materials in contact with food;
4. Contaminants in food chain;
5. Biological hazards;
6. Pesticides and antibiotic residues;
7. Labelling and claims / advertisements;
8. Genetically-modified organisms and foods

FSSAI approach for drawing up / revision of standards
The new regulations / amendments will be made in the FSSAI standards / regulations from time to time and is an ongoing process. As per a draft paper shared by FSSAI for discussion on approach for drawing up / revision of standards; some of the objectives of developing food standards are – (1)To provide more effective food safety regulations and reduce the level of food-borne illnesses in India. (2) To continuously review and update the standards of food in line with progress of science and its capability to understand and prevent food-borne illnesses. (3) To develop regulations that are less prescriptive and easier to comply, which are more effectively monitored and implemented. (4) To encourage growth of the food sector by providing regulatory windows for innovative products to meet consumer choice and health, while providing highest level of protection to the consumer. While establishing standards, FSSAI will endeavour to (a) Develop standards which are easier to understand and make amendment more straightforward. (b) Replace standards which regulate individual foods with standards that apply across all foods or a range of foods. (c) Remove inconsistent / redundant regulations where new regulations are in conflict or superseded. (d) Resolve interface issues across various pieces of regulatory actions that arise with relation to foods. (e) Promote industry codes of practice to supplement regulation. (f) Promote consumer education as a cost-effective regulatory option to labelling requirements. (g) Facilitate harmonisation of standards with India’s trading partners and the international community-based on best practice.

New food categorisation system and food additives
FSSA is working on developing new food categorisation system for regulation of food additives with an objective of replacing standards for individual food and harmonisation with Codex food categorisation system and to remove difficulties like ambiguities arising due to the complicated current structure, practice of allowing additives on basis of individual product instead of product categories, absence of a comprehensive list of additives which are proven to be safe and would be allowed, to be used in most foods in general on GMP basis practice of listing additives according to their functional classes.

The main problem with the current system is the practice of allowing additives according to specific products and not categories. This is the main issue that needs to be corrected immediately in the new FSS Regulations. There are 15 tables under Appendix A which together list about 186 products / product categories. Some of them are specific products while some are categories. In many cases, the same product / category appears in 2/3 different tables and separate set of additives are mentioned against the same product in each of these.

Description of food categories and their coverage
While developing the new food categorisation system (product standards and additives) the authority is working on broad category numbering system that has been based on the Codex structure and this is also being followed in most modern laws across the world. It will bring in a harmonised structure and will also make it easy to relate to specific discussions on products and additives in Codex meetings. As far as the subcategories are concerned, efforts are being made to broad base the system so that each and every product currently listed in appendix finds a subcategory. Also new subcategories have been added to include products which are widely available in the Indian market but are not categorised under any standard or additive listing.

As per the FSS Act new regulations are also being made for the manufacture, distribution or trade of any novel foods, GM foods, irradiated foods, organic foods, foods for special dietary uses, functional foods, nutraceuticals, health supplements, proprietary foods, etc.

Food additives
FSSA has suggested 27 functional classes of food additives along with their technological purpose and as a single additive can be used for different technological purposes, the manufacturer shall declare the most appropriate functional class of additive. In the new categorisation system, products have been put under broad generic categories and subcategories so that the additives currently allowed to be used in one single product may also be allowed in similar products or proprietary foods falling under same categories. All food additives subject to the provisions of GMP Standard shall be used under conditions of GMP, which include the following; a) the quantity of the additive added to food shall be limited to the lowest possible level necessary to accomplish its desired effect; b) the quantity of the additive that becomes a component of food as a result of its use in the manufacturing, processing or packaging of a food and which is not intended to accomplish any physical, or other technical effect in the food itself, is reduced to the extent reasonably possible; and, c) the additive is of appropriate food grade quality and is prepared and handled in the same way as a food ingredient.

While we are developing food standards and additives based on scientific knowledge, risk assessment and harmonisation with Codex, adequate care should be take to cover indigenous products and new standards should focus on food safety and promote innovative and better offerings to the consumer. By the time new food product standards and categorisation systems are being worked out, the additives and standards approvals pending after shift from PFA to FSSA should be notified after due consideration so that the industry continues to innovate during this transition period.

(The author is principal scientist, foods, Dabur Reasearch & Development Centre: