Jan 2, 2012

THANE STORM - DISASTROUS PUDUCHERRY - Photos by ME


























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-2(6H)-one

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.

Effect of FSS Regulations on food product standards and food additives

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.

Conclusion
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. He can be contacted at hemchandra.joshi@dabur.com)

Challenge for implementation of FSSA is time needed to get approval of new food additive


The new law lays considerable emphasis on food product standard and additives. Dr H N Mishra, professor, food technology, agricultural and food engineering department, Indian Institute of Technology, Kharagpur, shares details on these and more with Anurag More in an email interaction.

Tell us more about food product standards and food additives.
The Food Safety and Standards Authority of India (FSSAI) has been established under the Food Safety and Standards Act (FSSA), 2006. This Act not only replaces the Prevention of Food Adulteration Act, 1954, but also consolidates the other food acts like the Fruits Product Order (FPO), Meat Food Products Order, Vegetable Oil Products (Control) Order, and the Milk and Milk Products Order. These Acts, earlier handled by different ministries, will now fall under the ambit of the FSSAI. The authority is a statutory body with the ministry of health and family welfare being the administrative head.

The FSSAI has notified the Food Safety and Standards Regulations, 2011, in the Gazette of India dated August 1, 2011. It has been divided into six parts & one of them which deals with food additives is known as Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, (Part I, Part II) which covers everything about the various food additives, ranging from the list of permitted food additives to their maximum limit allowed to their specific technical function. There are some changes being made in it from the previous list. The scientific panel on food additives is looking into the matter in detail.

What will be the changes that food product manufacturers will have to bring about for food product and additives in wake of the implementation of FSSA in the country?
In the pre- FSSAI era prior to 2006, only fortified and proprietary foods existed but no regulation was there for functional foods. But now foods for special nutrition or dietary uses must indicate validated labels which provide distinct composition differing from normal foods, if it exists. It should also specify supplements to regular diet or address certain diseases / physiological conditions.

In the wake of increased use of Ayurveda, the Section 22 of the FSSA has specified the contents which need to be followed by manufacturers. Therefore, the challenge for food manufacturers in the post- FSSAI era covers selection of right ingredients, correct labelling, proper science-based research / results and composition.

How important it is to formulate a negative list for additives?
Indeed it is very important to formulate a list of negative food additives since one may argue that if a chemical is not mentioned in the list of food additives, it doesn�t mean that it is harmful. However, negative listing will include even all those materials whose health implications are not known. And hence this list will clear the ambiguity on usage of food additives.

How important is upgrading food labs for newer methodologies in method validations in the additives industry?
There are around 72 food testing labs in the country but most of them don�t have either the equipments or technical persons who can conduct the validation of food additives in the food industry. In view of the requirement to meet standards of FSSAI, there is a great need to develop and / or upgrade food testing laboratories and few steps have been taken towards the same. At least, 125 NABL-accredited food testing laboratories for chemical and microbial testing have been proposed in the FSSAI meeting. Each lab will cater to five districts. In addition to setting up the new labs, the FSSAI will focus on upgrading these existing labs to capacitate them to testing all parameters. These labs would be brought up to a level where they were able to obtain the NABL certification.

Can help be taken from academicians in policy-making for food additives?
Of course, we should utilise their knowledge in making standards because they are the one who actually do the research-related to food additives, their use in food & long-term implications on health. They continuously upgrade their knowledge by way of reading scientific papers & conducting research on the same. Hence, their viewpoint must be taken into consideration while making food policies.

What are the technological advancements happening in the area of additive?
Many new techniques are being researched that will allow the production of additives in ways not previously possible. One approach is the use of biotechnology, which can use simple organisms to produce food additives. These additives are the same as food components found in nature. For example, enzyme, rennin, which traditionally had been extracted from calves' stomachs for use in making cheese is now bioengineered. Regulations need to be included in FSSA for same.
Do you find the new regulation more industry-friendly or is it consumer-friendly? Why?
The design of the new FSS Act is consumer-friendly and the emphasis is on consumer safety since the focus has shifted to scientific research. The new system is more transparent & open to consumer complaints. The labelling requirements have also got stricter which will be very helpful to consumers.

What are the challenges with the upcoming food law for the ingredient industry?
The major challenge for the ingredient industry with the implementation of FSSA is the time needed to get approval of any new food additive to be used. Since the process is time consuming, the time gap between invention of any new ingredient and its launch in market may take long. Also now, in-detail laws are being made under FSSA for functional foods & nutraceuticals which manufacturers have to follow. The labelling requirements have also got stricter, thereby, restricting the use of ingredients used in food preparations.

What are the shortcomings in the previous law, which you want the new Act to overcome?
The new regulations have been designed to make food safer and the main features of the Act includes licensing for manufacture of food products, which was granted by the central agencies under various Acts & Orders, is decentralised to the commissioner of food safety and his officer. Shift from mere regulatory regime to scientifically-based self-compliance through food safety management systems.

Some of the shortcomings of the previous regulatory system are

Varied quality / safety standards restricting innovation in food products
Thin spread of manpower, poor laboratories infrastructure and other resources restricting fixation of effective standards
Standards are rigid and non-responsive to scientific advancements and modernisation
Poor information dissemination level to consumer level

Do you have any suggestions for inclusion or exclusion of specific standards to help in the growth of the industry?
There should be a proper mechanism in place for the implementation of the Act and surveillances.

Will the new regulation help to curb fraudulent practices in food additives, in what way?
There is a plan to introduce negative food additives list and as mentioned earlier, this will help both food manufacturers as well as consumers in achieving food safety.

What is your take on the penalties imposed?
Though there is no lower limit to the amount of penalty being levied on an offence committed by the FBO (Food Business Operators), leaving him vulnerable to higher penalties, his past conduct on safety may be taken into consideration while imposing a penalty on him.

I think this system will be helpful in creating a safer food system for consumers as everybody is afraid of penalties & food manufacturers / distributors will avoid the illegal practices to gain profit.

Understanding Food Safety & Standards Act for processed & packaged food

Changing lifestyles, growing income of the middle-class and rising production of fruits, vegetables and milk, are turning north India, comprising Punjab, Haryana and Himachal Pradesh and parts of Jammu & Kashmir, into hub of the food processing industry.

Financial incentives from Himachal Pradesh and Haryana and liberal policies of the Punjab Government have helped attract big players to this region. In addition, a large number of local brands have also strengthened their hold over the market. The Indian food market is set to more than double by 2025. The market size for the food consumption category in India is expected to grow from US$155 billion in 2005 to US$344 billion in 2025 at a compounded annual growth rate (CAGR) of 4.1 per cent.

Investment target
In India, the food processing industry is one of the largest in terms of production, consumption and export prospects. The government has set an investment target of Rs 1,00,000 crore for the food processing sector by 2015. This is expected to almost double the country’s presence in the global food trade to three per cent. The investments of one lakh crore, as estimated by the government will, undoubtedly, catapult the growth of this sector, and put it at the higher growth trajectory.

Among the emerging business avenues and growth options in the diverse Indian agribusiness sector, the food-processing sector is particularly promising and is undoubtedly one of the largest potential markets for processed foods. The segments with the largest growth potential for processing are dairy, fruits and vegetables, wine, confectionery, poultry, convenience food and drinks and milk products. Products that have growing demand in the export market are pickles, chutneys, fruit pulp, canned fruits and vegetables, concentrated pulps and juices, dehydrated vegetables and frozen fruits and vegetables along with processed animal-based products.

As India is world's third-largest producer of agricultural products and large production base for a variety of raw materials covering food crops, commercial crops and fibres. Due to India’s diverse agro-climatic conditions, it has a wide-ranging and large raw material base suitable for food processing industries. Presently a very small percentage of these are processed into value-added products. And demand for processed / convenience food / ready-to-cook / ready- to-eat is constantly on the rise. Moreover, urbanisation and nuclear families are becoming the norm.

Market size
The market size for the processed foods is bound to increase from Rs 4,600 bn ($102 bn) to Rs 13,500 bn (US$330 bn) by 2014-15, assumed to grow at 10%, and the share of the value-added products in processed foods will grow from Rs 2,800 bn (US$44 bn) to Rs 5,700 bn, growing at the rate of 15%. The growth witnessed by the sector in the last decade and further improvement in growth rate expected in the years to come, presents innumerable opportunities for investment.

Keeping all these developments and market growth in view, it is of grave importance that there should be necessary steps undertaken for the safety of these packaged & processed foods. The government has already taken a step by increasing the quality level & standards / parameters for this category of food (Regulation Act for 2011 duly attached). But the major issue is implementing these standards. However, there are a couple of important things that we could keep in our minds while purchasing / using any packaged / processed food. All packaged foods with a shelf life of less than two years must have a use-by or 'best before' date stamped on the box, wrapper or bottle. This date gives you an idea of how long the food will last before it loses quality. A product will remain fresh and of good quality right up to the 'best before' date (and sometimes beyond) if it is properly stored, both at home and at the supermarket.

Foods with a shelf life of less than two years must have a 'best before' date. It may still be safe to eat those foods after the 'best before' date, but they may have lost quality and some nutritional value.

Foods that should not be consumed after a certain date for health and safety reasons, such as a ready-to-eat chilled lasagne, must have a 'use-by' date. An exception is bread, which can be labelled with a 'baked on' or 'baked for' date if its shelf life is less than seven days.

Manufacturers err on the side of caution
Manufacturers usually choose a 'best before' date well before the time when the food would be expected to deteriorate and spoil. A conservative 'best before' date is designed to encourage you to eat the product while it is fresh and at its best, so you should consider 'best before' dates as a guide only. Frozen and canned products, in particular, tend to keep their quality for some time after the 'best before' date has expired. Within reason, provided the food looks and smells as you would expect, it should be safe to eat, even if the 'best before' date had passed.

Foods need proper storage
Whether or not a product keeps fresh and edible right up to the use-by or 'best before' date depends on how it is stored. Many foods need to be kept at certain temperatures, either in the fridge or freezer. For instance, fresh milk needs to be refrigerated. If a carton of milk is left out on the kitchen bench, it will quickly sour, regardless of its 'best before' date.

Check the packaging
Foods can become spoiled well before their use-by or 'best before' date, either because their packaging has been damaged or they were not stored properly at the supermarket. When buying foods, check for dents, leaks and tears in the packaging. If you can see any sign of damage, do not buy the product, as it might be contaminated with bacteria. Many products, such as dairy foods, need to be kept at a low temperature to avoid spoilage. Do not buy any foods that need to be chilled or frozen if they are sitting on unrefrigerated shelves, or stacked in overfilled fridges.

Collect cold and frozen foods last
When shopping, collect your cold and frozen foods last of all. These foods could spoil before their 'best before' date if they are allowed to get warm. It is often best to keep them in a cooler bag while travelling home. As soon as you arrive home with your groceries, put away your cold and frozen foods first.

Things to remember
'Best before' dates give you an idea of how long foods will last before they lose quality.
Most products will last beyond their 'best before' date if they are stored properly.

(The author is founder, chairman & CEO, Himalya International Ltd)