Food Product Approval System

This is a video recording of the webinar on ‘Food Product Approval – Regulatory Requirements & Procedures’. The web-conference was held on November 28, 2014. The video recording will help the food business operators who are involved in the manufacture, distribution, sale & Import of Nutraceuticals & Health Supplements in India.

Video

Our experts discussed the following agenda items:

• Who all are covered under the Licensing & Registration in compliance with Food Safety & Standards Act?
• What is Section 22 of the FSS Act, 2006?
• What is the latest advisory with regard to the contents of Section 22 of FSS Act, 2006?
• What is Food Product Approval?
• What are standardized food products?
• What are the non-standardized food products?
• What are the products, ingredients and compositions that have to be sent for the consent of the scientific panel?
• What are the food products, ingredients and compositions that do not require approval?
• What are the documents that are required for getting food product approval?
• What is the procedure for applying for food product approval?

Brief Profile of our experts Dr. Pawan Vats

• Vice President (Food Safety) at Auriga Research Ltd
• Ph.D in Chemistry, Post Graduate in Foods & Drugs Analysis
• Previously with Department of Food Safety, Government of NCT of Delhi
• Training of Food Safety Officers, Designated Officers, Adjudicating Officers, PGDFSQM for IGNOU
• Review of Food Safety Act & rules, Delhi PFA rules
• Food Safety and Standards Act, Rules & Regulations with different industry bodies
• Third Party Auditor-BRC Global Standard for Food Safety

Dr. Khalid Khan 

• Head: Fermish Clinical Technologies Pvt. Ltd., and Kleward Consulting Pvt. Ltd.
• Ph.D in Pharmaceutical Sciences
• Regulatory Consultant: since 1993
• Experience: Handling of approvals and clinical trial applications for nutra & health supplements, drugs, medical devices, biological and cosmetic products
• GMP & GCP audits, imparting training on regulations
• Specialization: Regulatory affairs, clinical research and strategic alliance 

Dr. Saurabh Arora 

• Ph.D in Pharmaceutics
• Founder: FoodSafetyHelpline.Com
• Director: Auriga Research Ltd
• Director: Arbro Pharmaceuticals Ltd (Arbro Analytical Division being one of the largest food testing laboratories in India)
• Leading the services business of Arbro and Auriga for over 9 Yrs
• Managing 4 food testing labs and a team of over 250 people

Hope you will find this informative and useful. We will welcome your queries and suggestions.

Transcript of this webinar

Dr. Saurabh: All right, we have the confirmation on the sound so we will start with the presentation. First of all, a very warm welcome to everyone and thank you for taking out time on Friday afternoon for the session, we’ve got a very good response; more than 250 people have registered and I see lot of people have already joined in. So, formal welcome from our side at Food Safety helpline. I will start quickly with the presentation now. So I am starting with a brief introduction about us at Food Safety Helpline and what are we doing here. By establishing FOOD SAFETY HELPLINE we really help you all to stay updated, keep on learning the latest requirements which are coming through this rapidly developing Act and law which is being imposed. So we share all these updates on-line and we also have a mobile application now and e-mail and newsletter which go out. So, we have a dedicated web site and very regular newsletter where we put together articles, trainings, FAQ and also any new changes in the Act that are happening in the Industry news.

We have a discussion forum which is very lively because of participation from all of you. So we have answered hundreds of questions and we take up the questions and try to answer them as soon as possible so even after this webinar if you have some questions left you can always contact us using the discussion forums. And I suggest you stay in touch with the blogs as we have been regularly publishing new articles every week and all these webinars are available online, even the recording of today’s webinar will be available online so that you can share it with your friends or access online or later at any time you want, so I think within a week time it would be uploaded. So you can always refer back to it. We have e-courses on labeling and registration to search the Act online on the website and ask questions and comment there.

We also have now the mobile application live on the play store. You can download mobile application and access the FOOD SAFETY HELPLINE in your pocket anytime you want. We have also added supplier directories to help you so that we have got lot of people asking us questions about common suppliers like labs and other things , so we have a directory which we are regularly updating , you can find all your suppliers in one place. Now starting with the base work, I will quickly introduce the speakers for today. First of all we have with us Dr. Pawan Vats. Dr Vats is the Vice President Food Safety at Auriga at Arbro. He is Phd in Chemistry with post graduation in Foods and drugs analysis. Previously, he was with the department of food safety, govt of Delhi as a licensing authority, he was involved in training of food safety officers, designated officers, adjucating officers and is also the counselor for the Post Graduate Diploma in food safety and quality management with IGNOU. He’s consulting with lot of bodies on the Food Safety Standard Act and the regulations. And also conducts third party audits under BRC Global standards and HSCPPE. So I welcome Dr. Vats.

Dr. Vats: Thank you Dr. Saurabh

Dr. Saurabh: I will quickly introduce myself also. I am Saurabh and I am Phd in Pharmaceutics and I am the Director at Arbro, Auriga heading the lab business here. We have more than 4 labs and more than 250 people are involved in food and pharmaceutical testing. Also with us is Dr. Khalid Khan, He is the head of Fermish Clinical Technologies and Kleward Consulting. He is Phd in Pharmaceutical Sciences. He has been regulatory consultant since 1993 and he has got vast experience in handling approvals and clinical trial applications for nutri-health supplements, medical devices, biological ,so basically the entire gambit of healthcare activities and also conducts GMP, GCP audits and conducts training programs. His specialization is in regulatory affairs, clinical research and strategic alliances. So I will welcome Dr. Khan and ask him to, you know, say a few words about today’s program.

Dr. Khan: Thank you Dr. Saurabh. The objective of today’s webinar and the topic of today’s webinar is food product approval and regulatory requirements and procedures. The main objective of the webinar is to really understand, what is the exact requirement and procedure of various kinds of approvals of the Food from FSSI head office, which is based at FDA Bhawan, New Delhi and as we all of us know that FSS Act, 2006 is very new Act and the new rules which were introduced in 2011 and ever since it had been evolving and we had seen very rapid changes in terms of procedure, in terms of requirements, in terms of the expectation and in terms of infrastructure, I mean people who were working earlier, they had been shifted, there have been lot of changes. So all these…the environment, there are various challenges being faced by the Industry, especially who are the.. company and the people who diligently work on filing the applications for NOC, filing the application for the product approval and filing the application for report licenses or notifying their businesses for operating their food businesses under FSSAI, so the various stake holders face a lot of problems.

So there had been a lot of confusion also as to when to apply, how to apply and whether we can apply for two products together in one application, there have been so many things, but, with due course of time, you know, the understanding of all the stake holders came in between and we are now at this stage where at least we understand what the exact requirement of the applications, how to simplify. Because of the court’s proceedings and judgment, the work at FSSAI had been stalled for some time. So, there had been no work virtually going on in FSSAI but now recently, all of us also know that lot of people know that they have started again at least accepting the new applications for the product approval and also they have started the online mechanism for filing the applications and that also. But how and what would be their standard operating procedures or work practice document for review of those applications and what would be the time milestones and the timelines for disposing of such applications that is not really spelt out very-very clearly by FSSI and because of that there had been a huge hue and cry in the Industry, lot of people do come to FSSI office but they are unable to find the suitable answers.

What we are going to learn today is basically focus would be on the food approval and the regulatory requirement and the procedures to the various kinds of applications and before that we will also learn a little bit about what the food license is and section 31 of food and the definition of food and what the food business means and food safety standard, the regulation 2011, category of the business defined under the license, then the section 22 of the food safety and the standard Act 2006, section 22, then we will also learn the details mentioned in the section 22 for example food for special dietary usage or functional food or nutraceutical or health supplements or the food for special dietary usage or nutraceutical food for health supplement….so I mean, these are the details in the section 22 which will be focused and then after that we will come on ..we will understand the difference between the standardized food and the non-standardized food also and then after that we will come and discuss about the food approval process, the various categories which are mentioned in the Act, which are basically the four categories they have spelt out and what is the documentary requirement and then how the licensing authority approves such products and what is the procedure for the product approval so this is what we will discuss it in the last and then these sections will be taken up both by Dr. Saurabh as well as by

Dr. Vats and at the end, Dr. Saurabh will spell out what do Arbro and Auriga do in terms of; how they are helping the industries for meeting the requirement, regulatory requirement or the approval procedures for the food industry or the food products.

Dr. Saurabh: Thank you Dr. Khalid for the introduction. So, I am just summarizing in one line-that FSSAI has started taking applications and it is good time to put in your applications because there is no fixed time line but what we understand is, it’s going to be processed in first-in-first-out so we will be understanding the procedure from Dr. Vats, Thank you.

Dr. Khalid: And I would like to add another thing here , which I just forgot, in the last if you have the question, any kind of question, whether it is very easy or very tough, don’t hesitate to ask, please do that because if you raise the question, it will increase our understanding and learning also. It’s not possible that we give answer to all of your questions, we will try to do that but you may ask some questions which we may find difficult to answer. In that case, we will find out the answer and learn ourselves also. So, in the case where we don’t find, you won’t get the answer right here, we will post it to you later on but please do send your questions, please ask the questions whether it is small, big or highly technical or non-technical but be clear in your mind you ask whatever you want to ask. Please Doctor Saab.

Dr. Saurabh: Thank you, we now request Dr Vats to please start with the presentation, Dr. Vats please.

Dr. Vats: Actually this food safety Act 2006 that came into effect from 5th August 2011 and to give effect to various provisions of this Act, rules and regulations were made in respect of implementation of the Act. There are so many provisions in the Act and each provision is very important but the licensing of food products is very important and we will be focusing mainly on this issue, the section 31 of the Food Safety and Standard Act provides that “No person shall commence or carry on any food business except under a license or a registration” so to do any food business you need to have license or the registration. Now we have to understand what is food?

In common man language food, what is eaten to satisfy your appetite that is food but in terms of legal or Food Safety Act, Food means any substance whether processed, partially processed or unprocessed which is intended for human consumption and it includes genetically modified food, engineered food and all ingredients which are being used for the manufacture of the food product which is for consumption whether the additives are there, preservatives are there, colours, flavours, they are also considered to be food and even the packaged drinking water that is a food but the water being used for washing purpose or any cleaning purpose that is not a food but the water which is used for preparation of any food, which comes as an ingredient in the food, then it is a food. So all this includes food but the drugs, they are not food, psychotropic drugs, they are not food and any food before harvesting that is not considered as a food.

They are, you can see there in the picture this syrup, these are food, this chips that is food, vegetables which are ready for sale for human consumption is food, ice-cream is food. So all this comes under the definition of food. Now the question is as I have discussed no food business can be carried out without obtaining a license or registration. Now what is the food business? Under the Act, the food business is defined as any undertaking, whether for profit or not and whether public or private, carrying out any of these activities related to any stage of manufacturing, processing, packaging, storage, transportation, distribution of food, import and includes food services, catering , sale of food or any food ingredient. So any activity, concerned with these activities that is a food business and whether it is being carried out for the charity purpose or for earning any profit that comes under food business. So to carry out any of these activities, we have to obtain either a license or a registration.

Now the question is who needs a license and who needs a registration certificate? If your annual turnover is less than 12 lakh rupees p.a. then you need to have a registration certificate, If your annual turnover is more than 12 lakh rupees then you need to have a license. Again there is a categorization of licensing, whether you have to obtain the license from the central licensing authority or from the state licensing authority. That depends on your product ion capacity so for that we have already discussed this who is supposed to take license from central authority and who has to take license from state authority, we have already discussed in our previous webinar and you can go and see that on our website.

Now there are certain categories of food which are defined for getting the license, whether you have to obtain the license for dairy units or vegetable or slaughter units or this and that. If all these categories are defined their standards are already there then you need to have applied for licensing straight away. There are certain food products for which standards are not prescribed. They are called non-standardized products and for which standards are prescribed under the Act rules and regulation they are called the standardized food product.

In nutshell there are around 377 food products for which standards are prescribed under the regulations and all these food products are categorized in 13, 14, 15 categories. For example Dairy products and analogous, under this category all milk products, curd, ghee all this falls. Another category is oil and fats, ground nut oil, mustard oil, any oil or this thing, then again fruit and vegetable, sauces ketchup all these things fall under this, Cereals and Cereal products – wheat, rice, aata, maida, wheat flour all these things are made of cereals , fall under this category. Similarly all the food products they are divided into 13 categories for which standards are prescribed. Another category is that for which standards are not prescribed and that category is called the proprietary foods.

Proprietary foods are those for which standards are not prescribed but they contain all the ingredients which are safe that means they are not unsafe to be used and they do not contain any prohibited food substances into that. Then for food products, for which standards are prescribed or the food products, for which standards are not prescribed but they are in use, which have been used in our country since ages for the last 100 years or 10 years or 15 years without any challenge of the safety that means standards are not there but they are very safe to be used and such types of foods are called here under the Act as Traditional and Ethnic food products. All the sweets, idli, jalebi, ghewar whatever, these depend on state to state, so many food products which are being used since ages but are known by different names in different states, so for all such type of foods also you can apply straight away for the license but there are certain food products for which you cannot apply directly for a license for which standards are not prescribed and the ingredients which have been used in that food products, the safety has not been assessed for any of the ingredients used in that , for that food product.

You need to get prior approval from the Food Safety Authority of India and that is called product approval. So what is product approval? Product approval is the process of getting your food products, which is not standardized but does not contain any harmful substance approved by the Food Safety Authority of India and such food products are defined under section 22. Section 22 of the Food Safety and standards say that, ”no person shall manufacture, distribute, sell or import any novel food, genetically modified food, irradiated food, organic food, food for special dietary uses, functional foods, nutraceutical, health supplements or any proprietary foods and such other articles of food except under prior approval from central government of India.

So for nutritional foods, food supplements, health foods or such types of foods for which standards are not there and you want to manufacture it or you want to import it, for such types of foods, you need to have taken product approval from the Food Safety Authority of India. Now the question is how this product approval is obtained and when it is to be obtained. This product approval has to be obtained before applying for the license and that you have to apply with the Food Safety Authority of India. Now earlier you could apply, you can submit your application in hard copies but now they have started online filing of applications for product approval.

Generally all the food products for which you need to have a product approval they are categorized in four categories. A, B, C or D these are four categories and these categories and procedures that have been defined in the latest advisory issued by the Govt of India and that advisory is that is dated , yes, it was issued on 11th May, 2013 and the main issue is product approval for the products which are generally used like this jalebi, rasgulla, this and that, you need not to have any product approval but nowadays the food for special requirements or dietary foods or nutraceuticals or health supplements, now so many such types of foods are coming in the market, the products full of vitamins, energy foods, certain type of foods used by the sports so that they need more energy, more muscular power, such type of food for that you need to have product approval and these food for special dietary uses or functional foods or nutraceutical foods or health supplements they have been defined very clearly under the Act.

This is section 22, which says, this food for special dietary uses or functional foods or nutraceutical foods or health supplements, these are the foods which are specially processed or formulated to specify or satisfy a particular dietary requirements which exists because of a particular physical or physiological condition or specific diseases and disorders and which are present as such where in the composition of these food stuffs must differ significantly from the composition of ordinary foods of comparable nature if such ordinary food exist and may contain one or more of the following may contain ..in nut shell what do you mean by special dietary foods or functional foods or nutraceuticals that means they are special type of foods which fulfills your requirements of vitamins, proteins, minerals, your requirements is because either you have suffered with some disease or some mal nutritional, that means these problems have created either because of the physiological functions and due to which you need more amount of vitamins, minerals, proteins or any special dietary foods which fulfills your requirement and they contain all these ingredients which is going to help you and these are special type of foods, not the ordinary ones, because if you say pulses contain lot of proteins but the pulses powder , that is not a food supplement.

If you have added this to some food product where you have already added some vitamins or minerals and then it will become the food supplement . That may fulfill your extra requirements of your minerals, vitamins, proteins but that should not be claimed that it will treat some particular disease. This is the other condition and your nutraceuticals, health foods they may contain proteins, vitamins, minerals, plants or botanicals but the plants or botanicals, if they are used, either they should be in powder form or in liquid form which can be taken orally. These minerals and vitamins or proteins or metals whatever added in the nutraceutical or health foods or supplements they should not exceed the recommended daily allowance that is called RDA and that has been specifically mentioned by the ICMR, in that case we have to follow ICMR data statistics mentioned for each vitamins or minerals on that. The other thing is, that should not fall under the category of any drug.

The drug is defined under Food Drugs Cosmetics Act 1940, in that the ayurvedic medicine or allopathic medicine or homoeopathic or normal food supplement, health supplement, that should not fall under the definition of food defined there and this food supplement that may be either in the form of powder, granules, tablets, capsules, liquids, jelly and any other dosage form but oral, in oral . That should not be in parental form. That means your health food supplement or health product that should not be for injectable purpose, that cannot be injected, that can be taken only orally. So this is about the health foods, nutraceuticals and I tell you about the genetically modified food, because it’s a genetically modified food, are still under controversy, so no product approval application is accepted in respect of genetically modified food.

As far as organic food is concerned, organic food is just like another. For example, if you say sugar or organic sugar, for the purpose of food safety, both are same. They are treated at par so all standards are applicable. Whatever applicable for ordinary sugar is applicable for organic sugar also. Now what is Proprietary and Novel food? For Proprietary and Novel food, for that you need to have a product approval. Proprietary and Novel food means article of food for which standards have not been specified under this Act and regulations made there under. So in nutshell the food products which are new, which are novel, which have not been used for the last many years, whose safety is not well established, the foods which are not standardized, for such type of food, you need to apply for product approval before getting a license.

Now, about the procedure of obtaining the food product approval. This is as per the advisory issued on 11th May 2013, yes, under this, all the food products are categorized in four categories and there are two types of application forms there. One is a and the other is b, there are two types of forms. But the category of food are four type of categories. The first category food products where the safety of its ingredients present are known and are permitted under FSS regulation Codex or European or Australian and New Zealand USFDA food safety standards regulations and not contain plants or botanical or substances from animal origin. So one category is that which contains only chemical ingredients which are neither plants nor botanicals not from animal origin and which are either allowed as per our Indian regulations or as per Codex regulations or as the other countries’ regulations so this but the combination of which or for that purpose the food products standards are not prescribed but their safety is known and they are allowed either here or somewhere in other countries i.e. 1 category.

The category 1(b) i.e. Food products where the safety of its ingredients present are known and are permitted under FSS regulation or codex or EU or in other countries and contain ingredients including plants or botanicals or substances from animal origin, that means in this category that contains plants and botanicals or substance from animal origin.

The other category is 1 (c) – this is almost like 1(b) but here the food safety, the assessment of food safety a little bit not properly established. So 1(c) means food products where the safety of its ingredients is insufficient to make a safety determination would be, that is the category where the food safety assessment is insufficient to make any conclusion whether it is safe or not, that product is forwarded to scientific panel but that is again Form 1(b) is used for 1 (c) also and for 1(b) also.

Form b is 1(b) is used for the products falling under 1 (b) and 1 (c). In 1 (b) safety is assured, in 1 (c), safety assessment is doubtful and that is to be forwarded to scientific panel. The other category is d. 1(d), the products for which the safety of its ingredients and their conditions of use are allowed in our regulations, Food Safety regulations 2011 or about which the product approval has already been given in such types of ingredients i.e. fall under 1(d) and for obtaining product approval for such types of foods, you need to apply again in 1(a). So for the products falling under 1(a) and 1(d) you have to use the application form 1(a) and for food products falling under category under 1(b) and 1(c) you need to apply in Form 1(b).

What are the important points for consideration of product approval is that, safety data wherever required should be provided for all the ingredients. So while applying for the product approval, safety data has to be provided. The use of minerals/vitamins/proteins or any enzymes, that should not exceed the RDA limits. In case of rejection of application under the approval procedure, if you have applied for the product approval and product approval is not granted. In that case you have to be, you have to get yourself prepared to recall the food product back. So you should proceed in such a manner if product approval is not granted, your product that can be recalled from the market immediately.

This procedure shall not be applicable if the food products or its ingredients are from the prohibited or banned source. If your product contains any substance which is prohibited under these regulations which is harmful for that purpose, no product approval is granted, take it, granted. So these points have to be taken in mind while applying for product approval. Now I have discussed which form has to be used for which type of food category product. For first, where the ingredients’ food safety is known, for that you need to. Now I will be discussing the list of documents and other things to be submitted along with your application.

Now the application fee: Application fee is 25,000/- Rupees and this fee is not refundable. For separate product, you have to file separate application form but the product and ingredients are same, only the different variants are there, for eg, one is orange flavoured, the other one is vanilla flavored, in that case 5 types of variants can be submitted in one application with application fee of Rs. 25,000/-But if there is even a small difference in the ingredients then you have to file separate application forms for that. So your application + 25,000 fee then again affidavit on 100 Rs. stamp paper in that you will mention that in case product approval is not granted the food shall be recalled, the proforma for this affidavit has been given along with the application form.

Now the application is filed online and this product approval process is carried out in the Head office of the FSSI at FDA Bhawan, Kotla Road, New Delhi and you have to submit the demand draft of 25,000 Rs in favour of Sr. Accounts Officer, FSSAI” at New Delhi. So the other documents required to be submitted along with the application is Certificate of analysis, Certificate of analysis from any NABL Lab of the food products, shelf life stability, datasheet of the product, copy of original label of the product if existing in the market or if you are going to put in the market in future, then copy of proto-type label, then detailed composition of the product with quantity of ingredients, additives added in the food product, then again the analysis report regarding the nutrient profile studies, risk assessment reports, toxicological studies, clinical trial reports of the product in human beings.

If you are claiming that this food product is good for such and such type of deformities or deficiencies, then in that case you need to have a clinical trial report in that regard, so this is also very important document for that and then safety evaluation data on proposed product ingredients regarding WHO, National or International agencies or USA or FDA whatever the safety evaluation data is to be produced, again if you are importing such type of food then you have to submit a proof of import like IEAC certificate, Bill entry, custom invoice, copy of agreement between marketeer and manufacturer, if brand owner, he has to obtain the product approval and if he want to get it manufactured through some other party then the copy of that agreement and copy of previous license if he have already a license under PFA Act or you have FPO license or other license then a copy of that license has to be submitted. These are the documents which are required to be submitted along with your application forms.

So this is regarding the process, then your application is processed in the product approval department there and if there is any deficiency in your application, then you will be intimated by speed post and as per the advisory or FAQs furnished by the FSSAI within 10 days time if there is any short coming in your application that will be intimated to you and you have to remove that, this short coming of your application. So this is all, what are the documents required, I again tell you, the analysis report from NABL that is very important, the analysis report regarding nutritional information, that is very important, the study, the shelf life study that is very important, then clinical trial study, that is very important and that has to be carried out through some well established food laboratory. And Dr. Saurabh, I am not wrong; we are doing all these things here also.

Dr. Saurabh: Yes sir, in fact I will now be taking briefly what all we are doing and how we can help and I will jump through few slides because we are short on time and you want to take some questions also. So we will be quickly, not taking too much time, just talk a bit about our services and then move on to questions-answers session, in the mean while please put in any questions you have you can use the questions pane on your right must be seen, there is a menu, so go there, type the questions, we will try and answer as many as possible right now and others we will answer even after we get through the webinar. So I will just talk about us a little bit. We are here at Arbro, Auriga and we are basically a food testing lab and contact research organization. Our diverse areas of analytical techniques here covering all your needs and backed by a team of over 250 professionals now in 4 labs NABL accredited and FSSAI authorized. So we are actually have NABL 2003 and are among the first labs to get FSSAI. We also have approvals from the other regulatory bodies, one can see on the slide. So basically related to product approval, we can help you with whole lot of things like labels and compliance related to labels regulations.

Dr. Vats: Yes, you know along with the list of documents, they are supposed to submit copy of label also. If labeling is not correct then again, it will create a problem.

Dr. Saurabh: In our experience, labeling is the most common question coming up and in fact it is easy to take care of also but it’s most common, 75% queries, I would say, would be coming out on the labels. Then we do analysis report of the product and one very common query which is coming out nowadays is that entire nutritional testing from a NABL lab and also the ingredients, so say, you are adding for eg say, white Minnie to your products so you need to test that also for compliance for the requirement. So the ingredients reports as well as the product reports. We also carry out shelf life studies. We have done stability study for a number of products and we can help you with that, we even have a clinical trial team and the centre where we do clinical studies to establish the claims, training your team, development of plans at manufacturing site and even conducting inspections for compliance to the regulations. So now I will go into the most important part of the webinar which is the questions and we have a whole lot of questions here, so starting with the questions, first question that we have is the what, if we have multiple brand names? So the same product, is going to the market but there are different brand names for the same composition. So do we need to make separate applications or the same application? Dr. Vats.

Dr. Vats: No, if the name of the product is different, here brand name is different , you are claiming, you are going to make different claims, for example I give you one example. If you are branding a flavored water. Then the other brand name is Herbal water. Then herbal water and the flavored water both are treated separately and you have to apply separately and you need separate product approval for this type of product.

Dr. Saurabh: However fees is only for one composition?

Dr. Vats: No, separate applications, separate fees. But if you are claiming flavored water, and in that one flavor is orange the other flavor is vanilla one flavor is apricot then you can club such 5 type of variants in one application. But the name, that has to be flavored water. If you are naming it as herbal water then it becomes a different brand.

Dr. Saurabh: Ok, we’ve got another question, it’s from some Chaghanti, I hope I am pronouncing the name properly. Do we need product approval for a cereal and pulse mixed powder?

Dr. Vats: Cereal and pulse. Which powder? If it falls under the traditional food, already that depends upon cereal to cereal , so there is a mixture of wheat and gram, that is being used since ages for that you do not need. If you are going to add some another cereal, which is not very common and novel product is coming up then it will be a new product or novel product for the users for that you need a product approval.

Dr. Saurabh: Another question from , how can we submit the composition product analysis and shelf life study reports?

Dr. Vats: Yes, they are submitted in the form of analysis report, proper analysis has to be carried out and in that regard, you know better …

Dr. Saurabh: You will send us the sample and we will give you the reports that you need to submit.

Dr. Vats: Yes.

Dr. Saurabh: That’s what we are here for.

Dr. Saurabh: Ok. Another question is that if we do not have the exact FSSAR code for which product approval is being sought, then how do we proceed with the application?

Dr. Vats: Actually, Indian food category is defined and I think there is one column which mentions “other than” the above mentioned category, that will fall in that category and most probably, you know, that Indian food category has been defined very well and in one or the other category, it will definitely fall.

Dr. Saurabh: So this question is from Prabhawati, can micro crystalline cellulose powder GMS be used in flavors and seasoning, if yes, to what percentage can it be used?

Dr. Vats: In fact, this is out of scope of this webinar. This is a particular question about the use of additives in food product. And for that purpose, appendix a and all the tables have to be consulted and then we can conclude, so right now, if we go through the tables and appendix, perhaps it will consume the whole time.

Dr. Saurabh: So Prabhawati, I suggest you go to our website and you search the Food Act for these names and you will get the labels and permitted labels in the tables. And you can proceed with it.

Dr. Vats: Ask her to furnish the labels and then we will scrutinize the labels and we will inform her about this.

Dr. Saurabh: Ok, another question from Prabhawati, how can we have clear understanding about FSSAI standards and new amendments as it looks confusing for the industry application. Ok. It’s not related to the product approval but you can keep attending our webinars and subscribe to our..

Dr. Vats: That’s why we are here to remove your confusion. You have any confusion, you give your specific query and we will come out with some solution for it.

Dr. Saurabh: So, then we have a question from Mr. Saurabh. He is asking as we are marketing our nutraceutical product in more than one state and having warehouse in two states, do we need to register as FPO and under which category?

Dr. Vats: For warehouse categories, there is a separate category. If you have warehouses in more than one state then you have to go for central registration as well as state registration or license depending on the capacity of your warehouse.

Dr. Saurabh: So you will need to have for manufacturing, for warehousing and also central license if you have some marketing corporate office, even that needs to be licensed.

Dr. Vats: Even if they have their own premises there. If they are supplying to their distributor and distributor has his own license there then in that case they don’t need to have license.

Dr. Saurabh: So another question from Saurabh is that if product approval has already been taken by the actual manufacturer without brand name can we market our product manufactured by actual manufacturer without taking approval with the brand name? Manufacturer has taken an approval say for multi-vitamins, as a general name and now he wants to sell it with another name, that product with a new brand name. Will this be a new application?

Dr. Vats: Yes, this will be a new application.

Dr. Saurabh: That’s not the case. You will have to take reapply because product approval is with the brand owner. In fact it is the other way round. Once a brand owner has the product approval for a brand, that approval he can use to get manufacturing licenses at different sites but it’s not that a manufacturer can have the product approved and give it to multiple brands. It clearly states that brands you have to apply separately for product approval. So lots of questions from Saurabh. We will take someone else’s question also. When is the next hearing of the Supreme Court? From Mr. Gomez. So

Dr. Vats: Dr. Khalid, he has already explained ..February. Exact date is not known but month of February it is there.

Dr. Saurabh: So, a question from Rukmani, if a product approval is obtained and later on a new ingredient has been included. Again product approval has to be sought?

Dr. Vats: Yes, Yes, now it is a different product.

Dr. Saurabh: So you will have to take a new product approval because you have another ingredient.

Dr. Saurabh: Ok, another common question that everybody is asking and has been asking is that what are the timelines for the product approval? How long does it take? Is it faster now? and all this. Sir, with your permission, I will answer this. If you see, last approvals were given some time in August this year and after this when it went sub-judice, when the court case everything started, everything stopped. And even they were not taking new applications. So then it was really a bad situation, as far as our knowledge goes, even now no approval has been given out but applications are being accepted and what we know is that first-in-first-out will be followed, so basically you do not have any firm timelines, yet but as it is an online process, and government and even the team at FSSAI is working very hard trying to streamline it. We hope next year, things will be moving much faster here and product approvals will be coming out. So definitely it makes sense to apply and hope that next year it will be faster.

Dr. Vats: Yes

Dr. Saurabh: with the online system, it is getting streamlined and it will be better. So simple answer, no fixed timeline yet, but expected to be much faster. Applications are going in so do apply and it will definitely happen quickly in the coming year. Ok. Another question is Delhi the only place for contacting regarding product approval? Is there any office down south for dealing the same?

Dr. Vats: No, now you have to file your application online, so you can file your application sitting in your office and that online application that will be processed in FSSAI Head Quarter.

Dr. Saurabh: Ok. So the question related to the definition of food again. Pooja is asking that packaged drinking water in huge cans, if it is not used for drinking will it be considered to come under food?

Dr. Vats: Packaged drinking water is a food. That is very clearly defined. Packaged drinking water is a food.

Dr. Saurabh: But if it is water being used for washing or something, that is not food.

Dr. Vats: But the other condition is non-packaged.

Dr. Vats: But you know in that case, if municipality water is being used in the manufacture then it is a food whether it is non-packed or packaged, it doesn’t matter.

Dr. Saurabh: Ok, another question from Mr. Naidu, why non GMO certificate is required? If required, how to verify it?

Dr. Saurabh: Ok I will answer that. GM products are not allowed in India and generally there is no consensus on its fate as to how it is going to move forward. So currently no product with GM content are being approved for food. So you have to have a non-GM certificate and this can be tested in a laboratory. Our lab is accredited for Non-GM certification as well and we are routinely doing this for a number of products. This is especially important when you are importing the products from outside of India. What happens for example if you look at American market so 90% of the corn or maize used is genetically modified. If you are using starch from that origin, that amounts to your product being genetically modified product. So that needs to be tested and certified GM free. So this can be done. It’s a DNA based test. It can be done in our laboratory and we can help you with that.

Dr. Saurabh: Ok moving through the questions, we have lot of questions, so I am going to skip down to some other recent questions. We will try to answer questions later on all of them. So this is question from Sudip Bhattacharya, if the ingredient is the same but the grammage is different, then are we required to file different application?

Dr. Vats: Ingredient is same but, quantity. Quantity, yes different quantity, different product, so separate application.

Dr. Saurabh: So Misbah is pointing out something that we had mentioned in our slide that the additional fees for scientific panel, yes that is very true, after 5th September it is not required to submit the fees.

Dr. Vats: Yes, from 5th September 2013 this scientific panel fee has been exempted.

Dr. Saurabh: But the old advisory still mentions it so that’s why we took it in the slide, note to mention that it is not applicable. So thank you Misbah for pointing that out.

Dr. Saurabh: So lot of questions on time lines, is wine considered as traditional item or does it need product approval?

Dr. Vats: Wine is a food and if it contains all the permitted additives then you need not to have a product approval. If it contain something which is not allowed in our regulations and you want to add it which is being used in foreign countries and you want to use it for our country then for this purpose you need a product approval.

Dr. Saurabh: So lot of questions on time line again. I think most of them are on time line. Ok. There is a question on clinical trial, do we have to register on CPRI? If we want to do PMS do we have to get IEC approval?

Dr. Saurabh: Ok, so CPRI submission is a good idea, it is not a requirement for foods but as a general practice we do this whenever we are conducting a clinical trial and we also go for IEC approvals. You can go to independent ethics committee and do it. These are good practices. See, right now there are no clear laws exactly on how to do the trials for foods but these are good practices and they make sense, they keep you and keep the participants safe so we recommend that you should go for ethic committee approval and also do a CPRI registration.

Dr. Saurabh: Ok, I have question from Abhay. If a firm is importing dietary supplement and wants to conduct clinical study on the product what license is required for the same and what is the procedure?

Dr. Saurabh: So I think that’s answered pretty much in the earlier question. They would be the same. Additionally they would require an import license.

Dr. Vats: Import license, that is, but approval is not required for that actually if he is importing it for scientific research purpose. It is treated differently. It is treated differently.

Dr. Saurabh: But I don’t think there is a separate procedure.

Dr. Vats: Separate procedure for that, the import procedure is there in the web site. That procedure is not allowed for the products which are only for scientific and research purposes. If it is not going to be used by the consumers at all but for that purpose definite evidence is required it is only for scientific purposes.

Dr. Saurabh: So question on shelf life studies. So Mrs. Sarkar, Jai Sarkar is asking while submitting the product approval application, shelf life study report is to be submitted. Can it be accelerated study or should it be real time?

Dr. Vats: For that purpose, the FSSAI requirement is you have to submit the shelf life study report and if you have sufficient time you go for real time, if you do not have the sufficient time, you have shortage of time, then you can go for expedited.

Dr. Saurabh: Most of the cases that we are seeing applications are filed with accelerated but these protocols need to be science based, we have see some of our people come to us that we have submitted one month accelerated report for shelf time claiming for three years. So they got up very back. Clearly they are observing and understanding it, so you need to have a scientific basis for it , so either the RENS principals or when people are saying ok lets follow the ICH principal and apply so both are valid so it should be scientifically based and you can apply with accelerated data but supplemented with real time data as you progress.

Dr. Vats: Yes, you know the documents that are submitted along with the application, all the documents are scrutinized thoroughly and scientifically, you cannot just submit a document just for the sake of submitting it.

Dr. Saurabh: Ok , so again lot of questions on time line. I am just going through them quickly. So what is the procedure for registration if my product contains an un-approved ingredient?

Dr. Vats: He has to file for product approval from 1 (b)

Dr. Saurabh: Ok. I have question from Usha Ma’m, Usha Ma’m is asking can you brief for food supplement with herbal extract? What kind of documents are required?

Dr. Vats: So they will fall in category 1(b) because botanical product is that the documents whatever we have be discussed, all the documents have to be submitted along with the application in 1 (b)

Dr. Saurabh: I hope that answers your question Ma’m and one question from Mr. Bindra, which bank the demand draft be submitted to?

Dr. Vats: The demand draft should be addressed to Accounts Officer, FSSAI, Delhi and bank, this is , left to your choice and payable at New Delhi.

Dr. Saurabh: Another interesting point relating to these demand drafts is

Dr. Vats: You know this amount is as per the choice of FSSAI and bank is as per your choice.

Dr. Saurabh: So, if you are trying to trace your old applications, what is the status, whether the product application is under process or not, so please remember to refer with your payment details. If you will put your demand draft no. all the payment details in it you will be more likely to get a response because in our experience they will be able to trace the applications much faster when the payment detail is there. So when you are tracking always remember to mention demand draft no.

Dr. Vats: Mention your demand draft no along with it.

Dr. Saurabh: Challan no whatever you have deposited with it.

Dr. Saurabh: Ok, I literally have 100 more questions and we have already 10 minutes over, my team will be going through all the questions and try to answer all of them in the coming week, so please be patient. We have your email address, phone nos. everything so we will be trying to reply and Manoj is here with us , he is sitting patiently and looking at all the questions he will be answering that. So thank you so much for joining in and we will answer the other questions in the forums and also by email and we look forward to your participation and feel free to contact us for any help you need. Dr. Vats! thank you so much for your time and always you are so keen to share your experience. It’s so nice that we have people like you with us who are sharing their knowledge. So thank you Dr. Vats, thank you so much and we will be in touch.

Dr. Vats: Yes, thank you very much Dr. Saurabh and really I must thank all the participants who took a keen interest, who asked very good questions and there are certain questions left which have not been answered. We will do our homework and we will do reply for their questions.

Thank you all.