With Nestle's Maggi in the cross-hairs of the regulatory watchdog, the issue of food safety has acquired a new urgency. While Maggi is in the dock for containing higher than the permissible limits of monosodium glutamate, new products from several top food companies regularly fail to pass the regulatory muster, bringing to the fore concerns about whether our safety standards and guidelines are clear and fair enough for food business operators to understand and comply with. In an analytical piece, Dr. Saurabh Arora suggests ways to make the regulatory framework more streamlined and how food operators can avoid tripping up on safety guidelines
There are various types of food products but they essentially fall within two categories - standardised and non-standardised. The standardised food products are those for which safety data is available and for which standards are prescribed in the Food Safety & Standards Act, 2006 (FSS Act), under its various rules & regulations. These products do not require product approval. Non-standardised food products are those for which safety data is not available, and standards are not prescribed They, therefore require product approval. In a nutshell, there are about 380 articles of food, for which standards are prescribed under the regulations of the FSS Act, and these are divided into 13 categories. Foods for which standards are not prescribed fall under the category of proprietary foods.
Then there are foods for which standards are not prescribed but which have been used for centuries in India without any health issues. These are called traditional and ethnic foods under the FSS Act. These food items can apply for license straightaway, without the need for product approval.
In brief, food products (ingredient, including additives) for which standards are not prescribed, will require prior approval from FSSAI under the Food Safety and Standards Regulations in India.
What is product approval?
Product approval is the process of getting approval for non-standardised food products (where no guidelines are available) as defined under Section 22 of the Food Safety and Standards Act, 2006. Section 22 of the FSS Act specifies 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, nutraceuticals, health supplements or any proprietary foods and such other articles of food except under prior approval from central government. This product approval has to be obtained before applying for the license, and which needs to be applied through FSSAI.
Nowadays, paperwork for product approval is less time taking as online filing has started. Section 22 specifies that food for special dietary uses, or functional foods or nutraceuticals or health supplements, are foods that are specially processed or formulated to specify or satisfy particular dietary requirements, which exist because of a particular physical or physiological condition or because of specific diseases and disorders and which are present as such wherein the composition of these food stuff s must differ significantly from the composition of ordinary foods of comparable nature. Moreover, novel foods for which new additives are being proposed, which either have no standards or cannot be used in a specific combination, need to be evaluated and a product approval may have to be obtained. Nutraceuticals and health foods may contain proteins, vitamins and minerals from plants/botanicals and animals sources. The proteins, vitamins and minerals should not exceed the recommended dietary allowance (RDA) as specified by the Indian Council of Medical Research. Moreover, these health supplements should not fall under the category of drugs (treatment of diseases).
Recent controversy on product approvals
The issue of product approval has come under the spotlight because of the recent spate of rejections by FSSAI involving big names like Tata Starbucks, Ferrero, Kellogg, McCain and FieldFresh Foods (a venture between Del Monte and Bharti Enterprises) to name just a few in a long list. There seems to be a lack of understanding and comprehension of the requirements of the FSSAI while applying for product approvals. These include requirements for ingredients, including the additives. Moreover, the food business operators (FBOs) appear to be in the dark when standards are not available. A thorough understanding of all the nitty-gritty of the product approval process, is a pre-requirement for gaining insight, identifying the gaps, and alleviating the problems. This will help the FBOs to get their products approved by the FSSAI without any hassles and delays in the processing time.
The Bombay High Court's stay on the FSSAI Advisory on product approval had brought a halt on the product approval process where the FBOs were the eventual sufferers as PA applications were not processed for couple of months. However, I must mention here that the Supreme Court intervened and asked the food regulator to resume the process of product approval pending the final judgement on the statutory power of FSSAI for issuing advisories.
The product approval process
Generally all the food products for which approval is required are categorised in four categories - 1(a), 1(b), 1(c) or 1(d) - as per the procedures that have been defined in the latest advisory issued by the Govt. of India. Food products, where the safety of its ingredients present are known and are permitted under FSS Act, Codex Alimentarius (CODEX), European Food Safety Authority (EFSA), Food Standards Australia New Zealand (FSANZ), or USFDA food safety standards regulations and which do not contain plants or botanical substances or substances from animal origin fall under category 1(a). 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, fall under the category 1(b). The third category is 1(c), which includes food products, where the safety of its ingredients is insufficient to make a safety determination or to come to a clear conclusion, whether it is safe or not. These food products are forwarded to the Scientific Panel for evaluation, but here again Form 1(b) is used. The last category is 1(d), where the products for which the safety of its ingredients and their conditions of use are allowed in our regulations (FSSR) or for those products/ingredients for which the product approval has already been given.
For obtaining product approval for such types of foods, application is given again in Form 1(a). Therefore, 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).
Harmonisation with global standards
Globally, standards are available for various types of regulations pertaining to food product approval. These global standards need to be accessed and their plus points harnessed in order to develop our own set of robust standards. Therefore, the FSSAI should coordinate with various globally renowned agencies like CODEX, EFSA, FSANZ, USFDA and others to harmonise its own regulations with the best regulations around the globe. This will help it to come up with a robust and streamlined set of regulations suitable for the Indian scenario. Importantly, we should take advantage of and learn from other countries' experiences.
Challenges and the way forward
The time has come to expedite the process of review of applications submitted for product approvals. The recently proposed 30 day - 30 day - 30 day time cycle for review of applications right from receipt of application till the final conclusion whether to award/reject PA or to further refer for scientific panel. This time line is due to be implemented from 1st July 2015.
Recently, all the information regarding the product approval process has been uploaded on the net for the benefit of all FBOs. On the part of the central government, there is a need to appoint more staff in order to augment the manpower to FSSAI, for smooth and streamlined implementation of the product approval process.
The regulations should also be streamlined, so that the approval process for any new product entering the market should be addressed expeditiously. The FSSAI should share data of approved products along with data on ingredients and compositions, so that new FBOs can benefit from this. Moreover, there should be a system within the regulatory framework, which allows all stakeholders to work upon on making information more transparent - from the ingredients up to the finished product - so that a good product development system comes into existence.
Copyright 2015 Images Multimedia Pvt. Ltd., distributed by Contify.com
There are various types of food products but they essentially fall within two categories - standardised and non-standardised. The standardised food products are those for which safety data is available and for which standards are prescribed in the Food Safety & Standards Act, 2006 (FSS Act), under its various rules & regulations. These products do not require product approval. Non-standardised food products are those for which safety data is not available, and standards are not prescribed They, therefore require product approval. In a nutshell, there are about 380 articles of food, for which standards are prescribed under the regulations of the FSS Act, and these are divided into 13 categories. Foods for which standards are not prescribed fall under the category of proprietary foods.
Then there are foods for which standards are not prescribed but which have been used for centuries in India without any health issues. These are called traditional and ethnic foods under the FSS Act. These food items can apply for license straightaway, without the need for product approval.
In brief, food products (ingredient, including additives) for which standards are not prescribed, will require prior approval from FSSAI under the Food Safety and Standards Regulations in India.
What is product approval?
Product approval is the process of getting approval for non-standardised food products (where no guidelines are available) as defined under Section 22 of the Food Safety and Standards Act, 2006. Section 22 of the FSS Act specifies 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, nutraceuticals, health supplements or any proprietary foods and such other articles of food except under prior approval from central government. This product approval has to be obtained before applying for the license, and which needs to be applied through FSSAI.
Nowadays, paperwork for product approval is less time taking as online filing has started. Section 22 specifies that food for special dietary uses, or functional foods or nutraceuticals or health supplements, are foods that are specially processed or formulated to specify or satisfy particular dietary requirements, which exist because of a particular physical or physiological condition or because of specific diseases and disorders and which are present as such wherein the composition of these food stuff s must differ significantly from the composition of ordinary foods of comparable nature. Moreover, novel foods for which new additives are being proposed, which either have no standards or cannot be used in a specific combination, need to be evaluated and a product approval may have to be obtained. Nutraceuticals and health foods may contain proteins, vitamins and minerals from plants/botanicals and animals sources. The proteins, vitamins and minerals should not exceed the recommended dietary allowance (RDA) as specified by the Indian Council of Medical Research. Moreover, these health supplements should not fall under the category of drugs (treatment of diseases).
Recent controversy on product approvals
The issue of product approval has come under the spotlight because of the recent spate of rejections by FSSAI involving big names like Tata Starbucks, Ferrero, Kellogg, McCain and FieldFresh Foods (a venture between Del Monte and Bharti Enterprises) to name just a few in a long list. There seems to be a lack of understanding and comprehension of the requirements of the FSSAI while applying for product approvals. These include requirements for ingredients, including the additives. Moreover, the food business operators (FBOs) appear to be in the dark when standards are not available. A thorough understanding of all the nitty-gritty of the product approval process, is a pre-requirement for gaining insight, identifying the gaps, and alleviating the problems. This will help the FBOs to get their products approved by the FSSAI without any hassles and delays in the processing time.
The Bombay High Court's stay on the FSSAI Advisory on product approval had brought a halt on the product approval process where the FBOs were the eventual sufferers as PA applications were not processed for couple of months. However, I must mention here that the Supreme Court intervened and asked the food regulator to resume the process of product approval pending the final judgement on the statutory power of FSSAI for issuing advisories.
The product approval process
Generally all the food products for which approval is required are categorised in four categories - 1(a), 1(b), 1(c) or 1(d) - as per the procedures that have been defined in the latest advisory issued by the Govt. of India. Food products, where the safety of its ingredients present are known and are permitted under FSS Act, Codex Alimentarius (CODEX), European Food Safety Authority (EFSA), Food Standards Australia New Zealand (FSANZ), or USFDA food safety standards regulations and which do not contain plants or botanical substances or substances from animal origin fall under category 1(a). 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, fall under the category 1(b). The third category is 1(c), which includes food products, where the safety of its ingredients is insufficient to make a safety determination or to come to a clear conclusion, whether it is safe or not. These food products are forwarded to the Scientific Panel for evaluation, but here again Form 1(b) is used. The last category is 1(d), where the products for which the safety of its ingredients and their conditions of use are allowed in our regulations (FSSR) or for those products/ingredients for which the product approval has already been given.
For obtaining product approval for such types of foods, application is given again in Form 1(a). Therefore, 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).
Harmonisation with global standards
Globally, standards are available for various types of regulations pertaining to food product approval. These global standards need to be accessed and their plus points harnessed in order to develop our own set of robust standards. Therefore, the FSSAI should coordinate with various globally renowned agencies like CODEX, EFSA, FSANZ, USFDA and others to harmonise its own regulations with the best regulations around the globe. This will help it to come up with a robust and streamlined set of regulations suitable for the Indian scenario. Importantly, we should take advantage of and learn from other countries' experiences.
Challenges and the way forward
The time has come to expedite the process of review of applications submitted for product approvals. The recently proposed 30 day - 30 day - 30 day time cycle for review of applications right from receipt of application till the final conclusion whether to award/reject PA or to further refer for scientific panel. This time line is due to be implemented from 1st July 2015.
Recently, all the information regarding the product approval process has been uploaded on the net for the benefit of all FBOs. On the part of the central government, there is a need to appoint more staff in order to augment the manpower to FSSAI, for smooth and streamlined implementation of the product approval process.
The regulations should also be streamlined, so that the approval process for any new product entering the market should be addressed expeditiously. The FSSAI should share data of approved products along with data on ingredients and compositions, so that new FBOs can benefit from this. Moreover, there should be a system within the regulatory framework, which allows all stakeholders to work upon on making information more transparent - from the ingredients up to the finished product - so that a good product development system comes into existence.
Copyright 2015 Images Multimedia Pvt. Ltd., distributed by Contify.com
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