Jun 26, 2015

Legal opinion: The sleeping FSSAI giant awakes from its slumber as Maggi tumbles

Kunal Kishore talks food

As the Indian food safety regulator has just announced that it would finally draft new norms for maximum lead and other heavy-metal content in foods, Advocate Kunal Kishore explains why food regulation has been neglected for far too long.
The whole controversy surrounding Maggi has caught everyone’s attention on two issues. First, Nestle and second the Food Safety and Standards Authority of India (FSSAI). People now realise that a government organisation exists that is supposed to ensure the safety of the food we consume. FSSAI has been in the news for quite some time now in relation to imported food items, but its name has now reached the common man with the Maggi controversy.
FSSAI was established under section 4 of the Food Safety and Standards Act, 2006 (FSS Act). It consists of a chairperson and 22 members. Members are appointed from various ministries related to food and also include representatives from the food industry, consumer organisations, food scientists/technologists, farmer’s organisations and retailer’s organisations. FSS Act also provides for the appointment of a Chief Executive Officer who is the legal representative of FSSAI, responsible for day-to-day administration and various other works. There is also a central advisory committee, scientific panels and a scientific committee.
The duty of FSSAI is to regulate and monitor the manufacture, processing, distribution, sale and import of food so as to ensure safe and wholesome food for public consumption. Under the FSS Act, FSSAI is, inter alia, empowered to make regulations prescribing standards for food items including limits on food additives, crop contaminants and pesticide residue. However, FSSAI can only come out with these regulations after receiving the approval of the Central Government and each house of parliament.
The mandate of the FSS Act is enforced by both FSSAI and state food safety authorities. State food safety authorities consist of food safety officers, designated officers and commissioners of food safety.
Food Product Standards and Food Additives Regulations
FSSAI came out with various regulations including the Food Safety and Standards (Food Product Standards and Food Additives) Regulations (the regulations). These regulations provide standards for different kinds of food articles and additives that are allowed to be used in food products. It also provides tables wherein different kinds of food items are mentioned, along with the additives that are allowed to be used.
This suggests that only those food items and additives that are specifically mentioned under the regulations are allowed. However, interestingly under the regulations an entry of “Proprietary Food” is defined to mean a food that has not been standardized under the regulation. Further, it provides that in addition to the labelling requirements provided under these regulations, a proprietary food shall also conform to the following:-
Conform to the labelling requirements specified under these regulations (it appears that the expression “these regulations” refers only to Food Product Standards and Food Additives Regulations” and it does not refer to labelling regulation) Name of the describing shall be as clearly as possible Nature or composition of the food shall be mentioned on the label The food shall comply with all other regulatory provisions specified in these regulations and appendices A and B (Appendix A provides tables wherein permissible usage of food additives are mentioned and Appendix B specifies micro-biological requirements) 
But why are only 377 food items standardised? Are 377 food items sufficient to cover all categories of food items? What happens to those food items that are not mentioned under Appendices A and B? How will the additives used therein be regulated? How are food items that existed at the time of the implementation of the regulations, and fall within the definition of “Proprietary Food”, regulated? How are food items that are standardised food but use extra additives treated?
To date most of the legal issues and disputes have arisen due to the term“Proprietary Food”. From the definition one cannot conclude that non-standardised foods are not allowed to be manufactured, imported or sold. However, at the same time it also cannot be concluded that all the non-standardised food items are allowed to be manufactured, imported or sold. Only 377 food items are standardised, with all remaining food items falling under the term “Proprietary Food”. Given this background, the following questions arise:-
There are many questions like these that leaves us to wonder how they can be allowed to crop up in the first place and where does the answer lie. These questions arose because, at the time of transition from the Prevention of Food Adulteration Act (PFA) to FSS Act, the regulations were imported without serious review.
So today what we have are old regulations which were adopted some 40 to 50 years ago. Different countries across the world have included at a minimum 5000 to 10,000 standards in their food safety laws, yet we are stuck with only 377. Now, if FSSAI wanted to correct this mistake they would have to go to parliament for their approval as per section 93. So instead they came out with a short-cut called product approval scheme (the scheme) .
Product approval scheme
The scheme was launched through an advisory process not through regulation which ideally should have been the case. Through the scheme, FSSAI have tried to achieve three objectives.
First, they improved their financial situation by fixing the fee for each product approval to Rs 25,000. As only 377 products were standardised, FSSAI was soon flooded with product approval applications and much needed money.
Second, they started collecting data on different kinds of foods through the applications. India had probably never had this information before and it didn’t cost them anything. In fact, they were getting money for it.
Third, they tried correcting their gravest mistake of not updating the standards at the time of transition from PFA to FSS Act.
The scheme also suited the industry as it allowed them to continue their business, which otherwise might have shut down or would have been highly susceptible to corruption. This arrangement suited both the regulator and the regulated until Vital Neutraceuticals decided this before the Bombay high court. Bombay high court held the scheme as ultra vires because the procedure laid out in section 92 and 93 was not followed, because it was not placed before the parliament and approval was not obtained.
In appeal, FSSAI approached the Supreme Court and the judgment of the Bombay high court was stayed and the matter is pending final hearing. So, to date, the product approval scheme is running and FSSAI does not allow anyone to manufacture, import or sell non-standardised food products without product approval.
It is because of this stand that Nestle was forced to withdraw Maggi Oats Masala Noodles with Tastemaker. But one very important thing went unnoticed, being the nature of the product approval scheme.
Analysing product approval systems existing in different countries, such a system generally exists only for novel food items or ingredients. Meaning from a particular date, FSSAI notifies the list of food articles, ingredients and additives that are known to have been used in food and are considered safe.
If a food business operator seeks to include any food item, ingredient or additive they will have to apply for product approval and pay a fee. The fee would be utilised to analyse the safety of the particular food item. However, our FSSAI did not bother to come out with any such updated list of known food items, ingredients and additives. Instead they asked everyone to apply for product approval, even for those food items, ingredients and additive that were already in use at the time of implementation of the regulations.
The purpose of doing this could have been to create a database at the cost of manufacturers, importers and sellers of food items. However, through this scheme, FSSAI is unduly enriching themselves at the cost of food business operators.
Under Appendix A of the regulations, the usage of additives has been specified by food category. In the same manner, FSSAI should update the list of accepted additives. However, they are not doing so and instead are asking every manufacturer and importer to obtain approval separately for the same additive used in similar products. The reasoning given is that the food product is said to be exclusive to the applicant and the food authority is restrained from sharing information.
Prima facie, it might look convincing but the logic is incorrect. The job of FSSAI is to specify whether a particular ingredient or additive is allowed to be used in a particular kind of food or not. And if yes then in what quantity.
Here, first, FSSAI is not specifying to food business operators what ingredients and additives are allowed. Rather they are taking advantage and must be earning money for approving the same ingredient or additive for possibly 10 or even 100 different food business operators.
Maggi Fiasco
Given this background, we will now look at the much discussed case of the present day, Nestle’s Maggi case. Here, we analyse some of the issues which went unnoticed:-
Effect of registration/licensing
Each packet of Maggi contained the FSSAI license number along with its logo. Does this not give an impression to the consumer that this food business operator is under the purview of the food safety authorities? Can consumers not assume that food safety authorities would have taken due inspection to ensure the quality?
During the whole Maggi episode, not even once did the FSSAI come out with a statement explaining how violations were allowed to take place at such a large scale. Forget about the explanation, even a future course of action has not yet been announced. This may mean that FSSAI is going to cancel Nestle’s license or it may mean that after a few months everyone will forget about it and Nestle will carry out its business as usual or with some improvement.
Non-identification of the source
Nestle never came out with a list of particular units where violations took place. Such a declaration would have helped them in restricting food recall to the Maggi manufactured in only such units and saved them to a great extent. At the same time, in the absence of any such declaration, inference can be drawn against them that violations took place at all units.
Food recall procedure
In the past weeks, print and electronic media has been flooded with news of the recall and it is being projected as one of the largest recalls ever. It may surprise readers to know that FSSAI has not implemented any food recall procedure to date.
The draft regulations in this regard were circulated for public discussion only 2-3 days prior to this Maggi fiasco. In the absence of these regulations how will FSSAI ensure the proper recall of the sub-standard Maggi packets? They might have to rely solely upon the declaration made by Nestle, which has already been widely published. Let’s hope they do not rely solely on media reports, and instead try and verify the data themselves.
Labelling violations
One of the reasons for banning Maggi was because “No Added MSG” was mentioned on the packet label. As per the FSSAI, this is mis-leading and they have relied upon a document of the US Food and Drug Administration to support their argument.
We appreciate the hard work that the FSSAI officials have put in to make a case against Nestle. However, it would have been appreciated more, had the guidelines been issued by FSSAI in advance. On the one hand, FSSAI maintains a view that what is permitted under Codex Alimentarius and other countries cannot be ipso facto regarded allowed in India, and on the other hand they themselves rely on foreign literature to make a case against a food business operator working in India.
Conclusion
FSSAI has been lethargic and inefficient in the past and it can be for many reasons including financial constraints and untrained manpower. Now they have started to pick up, however, they first need to put their house in order and then can expect everyone to follow them.
In their overenthusiasm, they might harm the industry and may jeopardise the jobs of many. In the last 2 to 3 months, one can definitely see a change in the workings of FSSAI. Its website appears more active and seems to be giving more clarity to the industry and consumers.
Despite this, there is lot more to improve. We hope that FSSAI soon starts quoting their own advisories in their orders rather than relying upon that of another country. 

1 comment:

  1. A science based law in implemented in the most unscientific manner by untrained team without taking into consideration various partners in the link has made the issues taken to court.

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