Product Approval - Should it be adopted or not?

The food industry was happy when government enacted the new integrated Food Safety & Standards Act in 2006 which was given to be known as a progressive, transparent, easily understandable and implementable law.

With this law in place, it was felt that doing a food business would be easy, hassle-free and transparent as the regulator would be friendly with the food industry while regulating the food business keeping in view the safety of food products.

But it appears that the objectives of the Act have been lost sight of and perhaps it is in the knowledge of all that how much hardship is being faced by food business operators (FBOs) in obtaining licence/registration and in implementing the food regulations especially in the era of so called “Product Approval” system being thrust on the food industry.

Complexity

The FSSAI has been implementing the Product Approval system for the last 2-3 years which has caused a lot of hardship to everyone. Any subsequent clarification by FSSAI in the form of amendment or guidelines by issue of advisories from time to time (more than a dozen advisories have been issued by FSSAI in this regard) created more complexity & confusion in the matter. The “Product Approval” system appears to be as per law, not based on science, non-transparent and could be termed as short of a commercial activity. Collection of hefty fee may also be violating the provisions of FSS Act, 2006, and FSS Regulations,2011, putting the food business at the backseat thus forfeiting the very objectives of the Act.

n The country had been producing, selling, exporting / importing food items and food ingredients / additives for the past several years as per the provisions of the old PFA Act 1954/PFA Rules 1955. There had been no provision of “Product Approval” therein. There was, however, an established procedure for seeking and providing approvals for new “food ingredients/additives” except proprietary foods.

n The new legislation i.e. FSS Act,2006, has imbibed the same product standards, ingredients / additives as were provided under the repealed PFA Act,1954 / PFA Rules, 1955 and other orders like FPO / MFPO / MMPO / SEO / VOPO etc. which have been integrated into FSSA 2006. The standards of around 377 food products which were existing under PFA Rules and other orders have been taken over as it is under FSSA Regulations, 2011.

Example: The provision of "Proprietary Foods" was available under Rule 37-A in the repealed PFA and the same was carried forward to the Regulation 2.12 under FSS (Food Product Standards and Food Additives) Regulations, 2011. As such for any approval of any new ingredient / additive or “Proprietary Food,” the same procedure as was prevalent in the country from 1955 till the FSSA Regulations came into force could have been adopted in 2011.

n It is very logical to think that no new reasons have arisen to go beyond the concept of approval of food ingredients / additives used in proprietary foods. The introduction of “Product Approval” System was totally unnecessary.

n (a) Apparently, confusion appears to have arisen because FSS Act, 2006, specifies under Section 22, approval of GM foods, functional foods, novel foods, organic foods and so on. It is natural that approval of such foods may be advisable because these are new innovative food products which require risk assessment and field trials before being manufactured / sold / consumed.

(b) It is strongly felt that by reasons of default, Section 22 of FSSA, 2006, also included the word “Proprietary Food” which covers most of the traditional / ethnic Indian foods being sold in the country for centuries where no Product Approval is required for the same unless a totally new ingredient / additive is being used in such a product.

To give an example: It is evident that Roti, Chapati, Dosa, Idli, Vada, Khakra, Rice Pulav, Rasogulla, sweets such as Gulab Jamun, Kheer, Halwa and Sattu do not require any product approval unless somebody proposes to use food additive(s) which is / are not provided / under the FSS Regulations.

(a)Considering the above description, it is neither logical nor required to ask for approval of all such traditional / ethnic Indian foods unless a new food ingredient / additive which is not provided or restricted under FSSA is to be used. In fact, it will not be scientific or humanly possible to provide approvals to millions of varieties of such traditional & ethnic foods.

(b) The purpose of introducing ‘Product Approval’ system is not understandable because there are around 377 food standards under FSS Regulations. Probably no Risk Assessment of these 377 Food Products appears to have been carried out during the last more than 60 years, because these are being produced and consumed in this country for a long period and can be assumed or presumed to be safe. Is this sufficient proof of their safety?

(c) One of the objectives of introduction of ‘Product Approval’ system in the country could be to establish the safety of such new foods not falling under the category of 377 food standards. Risk Assessment for the new foods has to be carried out by FSSAI on the basis of not only the documents submitted by the concerned FBO but, if needed, also get toxicity trails conducted on animal studies.

But the mute question is whether these risk assessment studies of some other country mandated to be submitted by FBO along with Product Approval application will hold good for this country or not? Moreover hundreds of food additives permitted to be used in processing of foods under food regulations, now whether safety studies of such permitted food additives have been conducted by the authorities in this country or validated so far or not? 

It is understood that whatever risk assessment study conducted at one location/place may be safe at that location/place only but may not necessarily be safe at another location/place.

(a) Under the existing provision(s) of the FSS Act or Regulations, an initial fee of Rs 25,000 is to be paid along with the application of ‘Product Approval’ and further additional amounts of Rs 25,000 to be paid if further toxicity and field trials as per documents submitted by them are required to be carried out to establish the safety of the new product.

In this connection it is felt that the regulatory body of the government is not a commercial organisation but a Scientific Regulatory Body constituted under the Act with clear objectives to lay down science-based standards for food products. Imposition of Rs 25,000 initially and further amounts if required should not become a burden on FBOs. The cost of such trials should be borne by the FA / government in the larger interest of society.

(b) It is appropriate to mention here that Government of India allocates around 3% of the GDP for the health care sector in the country for its citizens. On the same analogy either FSSAI or the administrative ministry could have requested the government to allocate, may be, around 1% of the GDP for ascertaining and laying down science-based standards for food products based upon valid risk assessment in the country rather than copying these or relying upon the risk assessments carried out by other countries.

Collection of Rs 25,000 from the concerned FBOs may work out to be a huge amount which is again a debatable issue.

n In case the Product Approval Procedure now in vogue or regulations are made for the same, then perhaps, the country will be heading towards a regime of Trade Mark/Copyright or Intellectual Property Rights in the food/processed food sector after which the availability of food for the poor may be a matter of serious concern especially when the government is committed to food security in the country and the food may not be available to the already starving, malnourished /undernourished needy society.

n The system of “Product Approval” will kill innovation in food sector as it is not scientific in the present form and hence provisions of the FSS Act and Regulations thereunder are need to be changed.

n As most are aware there are a large number of court cases going on in the country in this respect and some courts have ruled that the “Product Approval” and/or procedure adopted by FSSAI is unconstitutional. In fact, all advisories issued by FSSAI regarding 'Product Approval' may be considered a violation of the provisions of FSS Act / Regulations and hence the relevant provisions of the Constitution of India.

n According to Food Safety & Standards Authority of India (FSSAI) there are over 5.5 crore FBOs in the country. 

(a) As most of the FBOs (around 80%) fall under the category of micro, small & medium sectors and in case ‘Product Approval’ system is pressed forward by FSSAI, it will slowly kill their initiative to innovate & develop new products. It may be appreciated that these segments comprise 80% of the total FBOs having a number of around 5.5 crore in the country, which are playing a vital role of serving the common man in the country, hence food industry.

(b) According to the food regulator, so far state governments/UTs could grant around 5.6 lakh licence and could register around 23.80 lakh FBOs. Whereas, around 20,000 Central licences could be issued by the Central Designated Officers under the FSS Act, 2006.

(c) By applying “Pareto’s Principle” of 80:20, there could be around 80% (5.5 crore X 80%) i.e. 4.4 crore FBOs who may fall under the category of micro, small & medium sectors whereas 20% (5.5 crore X 20%) i.e. 1.1 crore of FBOs may fall under the category of state/Central licence in the ratio of 88 lakh and 22 lakh. It is not clear that how much time it will take to obtain or grant licences/registration to such a huge number. 

Following table will amply clarify the position:

Estimated no. of FBOs granted/obtained registration and licence out of 5.5 crore S. No. Description No. of FBOs required to obtain/grant registration or licence (No. in Lakh) Registered/Licenced FBOs from 2011 till April 2015 (No. in lakh) FBOs yet to be granted/obtain registration and licence

PS: (i) In a period of around four years 29.6 lakh FBOs could either obtain/granted registration & licence. At the present speed of registration/licensing how much time period will be required to either obtain or grant registration & licence to the remaining FBOs (around 520.4 lakh) is a matter of imagination.

(ii) In my next write-up, I will try give the procedure by which the process of Registration/Licensing could be completed in a time-bound period of say four to five years. 

n Again the big question arises whether the country/ regulator is equipped /prepared to enforce/implement the Act/Regulations or the FBO is prepared to comply with the provisions of the Act/Regulations?

It is felt that decisions with broader vision are required to be taken very coolly/ calmly in a transparent manner with timeframe in mind for implementing/enforcing the Act/Regulations including empowering the huge untrained enforcement field staff (most of which is yet to be placed in position) besides helping/enabling the FBOs in the country to comply with the Act/Regulations. It if felt that the onus of the entire matter rests with the government by taking all the stockholders into confidence rather than simply enforcing/thrusting the regulations.

n Status of Product Approval System in Developed Countries 

In most of the countries there is no such provision for “Product Approval” systems.

The system or procedures are available for pre-approval/registration for some of the foods/ingredients like “specially controlled foods,” “novel foods,” “dietary foods,” “food for special medical purposes” in some of the countries.

The brief position of ‘Product Approval’ system in most countries, as also under Codex, is as follows:

i. USA: We could not find any such term like ‘Product Approval’ system/procedure in the food regulations of USA. 

ii. European Union: No ‘Product Approval’ system/ procedure could be found under EU food regulations.

However, pre-market notification in respect of certain foods like ‘foods for special medical purposes’(FSMPs) has been stipulated for labelling purposes and for dietary foods.

It may be noted that if the member states (of EU) can demonstrate that such notification is not necessary, the concerned member state may not impose that obligation on FBOs.

iii. Australia & New Zealand: No ‘Product Approval’ system/procedure could be found under the Food Regulations of these two countries.

However they do have standards for these:

a. Standards for chemical contaminants and residues

b. Standards for additives or other substances

c. Standards for processing and manufacturing

d. Standards for imported food

e. Standards for Labelling

iv. China: No ‘Product Approval’ system/procedure could be found under the food regulations of China.

v. Thailand: There are three broad categories:

Standardised Foods – Standard foods do not require any registration but their quality and labelling have to meet the standard requirements as specified in the notification of ministry of public health.

Specially Controlled Foods – Registrations are required for foods in this category. Legal provisions are related to food standard quality, specifications, packaging, and labelling requirements, as well as other aspects of Good Manufacturing Practices. 

Other Foods – Foods, raw or cooked, preserved or non-preserved, processed or non-processed, if not listed under category (a) or (b) (there is a list) will be considered as general foods. Although registrations are not required, general food products are controlled and monitored with regard to Hygiene, Safety, Labelling and Advertisement. Foods in this category may be subdivided into (a) foods that must bear standard labels and (b) other general foods.

However pre-marketing controls are in position. These are like on (a) Labelling (b) Manufacturing Licence (c) Good Manufacturing Practices (GMP)(d) Manufacturing Licence (d) Advertisements and (e)Importation Licence

CODEX:

vi. There is no word/procedure like "Product Approval" laid down under Codex. India is going to align our food standards with Codex, hence there should be no word system like "Product Approval."

13. In conclusion, it is clear that the system of “Product Approval” is non-scientific, non-transparent, & a costly procedure (recently struck down by Mumbai High Court), which should not be pushed forward. If the government pushes the agenda of “Product Approval,” it will imply that Indian food industry may have to shut business sooner or later.

The food industry may consider the above and ponder to decide whether the ‘Product Approval’ system should be adopted by the regulator /country or not?

(The writer is a veteran food industry expert)

Disclaimer:

Opinions/suggestions in this write-up are exclusively of the author and may not be of any other individual or institution including AIFPA (All India Food Processors Association)