Approval yoke on proprietary foods goes, but ensuring safety is now food industry’s burden
Last year, the Food Safety and Standards Authority of India (FSSAI) hit the headlines for being at loggerheads with the food industry. The ‘product approval’ system of the FSSAI attracted the maximum criticism, till it was struck down by the Courts. As per the system, food business operators (FBOs) had to obtain prior approval for all non-standardised food products (only 377 food items were standardised) before dealing in them. FSSAI had also not spared those ‘proprietary foods’ which had a history of being consumed for a long time.
Although the Supreme Court struck down the FSSAI product approval system, the industry’s doubt that it could return persisted because it had been struck down primarily for not following the correct procedural route before promulgation. The provisions under the system had not been tested in the courts. So, industry feared that FSSAI might bring it back after following due procedural formalities. However, to the great relief of the food industry, FSSAI has now taken a more pragmatic approach. Two recent developments show that the food regulator has decided to adopt a more sensible and practical manner.
First, FSSAI notified the operationalisation of standards for food additives for use in various food categories. Earlier, under the Food Products (Standards and Additives) Regulation, 2011, a very limited number of additives were allowed to be used against certain categories of food items. This posed significant problems to the food industry as they were required to obtain product approval for almost all kinds of processed food items. Now, FSSAI has come up with a detailed list of additives allowed for different categories of food items. This automatically reduces the need for obtaining any product approval for a vast majority of food items.
Second, departing from its earlier stand, FSSAI has now specifically allowed the manufacture and sale of ‘proprietary food’. Section 22 of the FSS Act defines proprietary food to mean an article of food which is non-standardised, but safe. Section 22 prohibits the manufacture, distribution, sale or import of proprietary foods unless it is specifically provided for under the Act and the Regulations made thereunder. Till now , such foods were being manufactured and sold by virtue of Regulation 2.12 of the Food Products (Standards and Food Additives), which described proprietary food as non-standardised food which needed to conform to certain requirements. However, FSSAI had taken a view in the past that such foods were not to be allowed without product approval. Even after the product approval system was struck down, industry remained doubtful.
Now, Regulation 2.12 has been changed so as to allow the manufacture, sale, distribution or import of proprietary foods without product approval. As per the changed description of proprietary foods, it will be permissible to use all standardised ingredients as well as ingredients allowed to be used in standardised food items. Through this change, FSSAI has now allowed manufacturing and sale of a vast majority of proprietary foods without the requirement of any approval.
However, while doing so, FSSAI has also introduced two very important changes which a FBO has to bear in mind. First, FSSAI has shifted the burden of ensuring safety of proprietary foods on the FBOs. Until now, the approach of FSSAI was to first check the safety of the proprietary food item and allow its usage after it passed all tests. From now onwards, though the FBO is allowed to use different kinds of ingredients and additives, it will be responsible for checking and ensuring that the final food item is safe for consumption and does not have any adverse effect on the consumer. The second change is that the scope of proprietary food has been restricted by specifically excluding certain categories of food products like neutraceuticals, health supplements, food for special dietary uses, functional food and novel food. Therefore, a food item falling under any of these categories cannot be manufactured, sold, distributed or imported because of the bar imposed under Section 22. Therefore, the food industry units need to cross-check whether their products fall under any of the excluded categories.
There is no doubt that the changes brought by FSSAI, i.e., putting a detailed list of food additives allowed to be used and allowing usage of different kinds of ingredients for proprietary foods without product approval, are welcome steps and the industry would cheer for it. At the same time, the exclusion of certain food products from the category of proprietary foods must have been disappointing for certain sections of the food industry. However, a draft regulation dealing with these categories of food items was put in public domain a few months back for public consultation and it is expected that the concerns of the industry would be definitely taken care of when the final regulation is brought into force. Nevertheless, the food industry now needs to be very careful while dealing with proprietary food items, and must check whether the additional conditions put under the changed description are met or not.
The author is joint partner, Lakshmikumaran & Sridharan. Views are personal
Last year, the Food Safety and Standards Authority of India (FSSAI) hit the headlines for being at loggerheads with the food industry. The ‘product approval’ system of the FSSAI attracted the maximum criticism, till it was struck down by the Courts. As per the system, food business operators (FBOs) had to obtain prior approval for all non-standardised food products (only 377 food items were standardised) before dealing in them. FSSAI had also not spared those ‘proprietary foods’ which had a history of being consumed for a long time.
Although the Supreme Court struck down the FSSAI product approval system, the industry’s doubt that it could return persisted because it had been struck down primarily for not following the correct procedural route before promulgation. The provisions under the system had not been tested in the courts. So, industry feared that FSSAI might bring it back after following due procedural formalities. However, to the great relief of the food industry, FSSAI has now taken a more pragmatic approach. Two recent developments show that the food regulator has decided to adopt a more sensible and practical manner.
First, FSSAI notified the operationalisation of standards for food additives for use in various food categories. Earlier, under the Food Products (Standards and Additives) Regulation, 2011, a very limited number of additives were allowed to be used against certain categories of food items. This posed significant problems to the food industry as they were required to obtain product approval for almost all kinds of processed food items. Now, FSSAI has come up with a detailed list of additives allowed for different categories of food items. This automatically reduces the need for obtaining any product approval for a vast majority of food items.
Second, departing from its earlier stand, FSSAI has now specifically allowed the manufacture and sale of ‘proprietary food’. Section 22 of the FSS Act defines proprietary food to mean an article of food which is non-standardised, but safe. Section 22 prohibits the manufacture, distribution, sale or import of proprietary foods unless it is specifically provided for under the Act and the Regulations made thereunder. Till now , such foods were being manufactured and sold by virtue of Regulation 2.12 of the Food Products (Standards and Food Additives), which described proprietary food as non-standardised food which needed to conform to certain requirements. However, FSSAI had taken a view in the past that such foods were not to be allowed without product approval. Even after the product approval system was struck down, industry remained doubtful.
Now, Regulation 2.12 has been changed so as to allow the manufacture, sale, distribution or import of proprietary foods without product approval. As per the changed description of proprietary foods, it will be permissible to use all standardised ingredients as well as ingredients allowed to be used in standardised food items. Through this change, FSSAI has now allowed manufacturing and sale of a vast majority of proprietary foods without the requirement of any approval.
However, while doing so, FSSAI has also introduced two very important changes which a FBO has to bear in mind. First, FSSAI has shifted the burden of ensuring safety of proprietary foods on the FBOs. Until now, the approach of FSSAI was to first check the safety of the proprietary food item and allow its usage after it passed all tests. From now onwards, though the FBO is allowed to use different kinds of ingredients and additives, it will be responsible for checking and ensuring that the final food item is safe for consumption and does not have any adverse effect on the consumer. The second change is that the scope of proprietary food has been restricted by specifically excluding certain categories of food products like neutraceuticals, health supplements, food for special dietary uses, functional food and novel food. Therefore, a food item falling under any of these categories cannot be manufactured, sold, distributed or imported because of the bar imposed under Section 22. Therefore, the food industry units need to cross-check whether their products fall under any of the excluded categories.
There is no doubt that the changes brought by FSSAI, i.e., putting a detailed list of food additives allowed to be used and allowing usage of different kinds of ingredients for proprietary foods without product approval, are welcome steps and the industry would cheer for it. At the same time, the exclusion of certain food products from the category of proprietary foods must have been disappointing for certain sections of the food industry. However, a draft regulation dealing with these categories of food items was put in public domain a few months back for public consultation and it is expected that the concerns of the industry would be definitely taken care of when the final regulation is brought into force. Nevertheless, the food industry now needs to be very careful while dealing with proprietary food items, and must check whether the additional conditions put under the changed description are met or not.
The author is joint partner, Lakshmikumaran & Sridharan. Views are personal
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