It should draft product recall guidelines as a supplement to the product approval regime it needs to set anew
The Supreme Court order in the matter of Vital Nutraceuticals & others vs the Union of India and the consequent notification issued by the Food Safety Standards Authority of India (FSSAI) that scraps the product-approval advisory have created a lot of confusion in the Indian food processing and packaging industry. It is a foregone conclusion that serving a population of over 1.2 billion people makes the industry an extremely vital one. From the perspective of the FSSAI, the past few months have been rocky, starting with the controversy surrounding its banning of Nestle’s popular insta-noodles brand, Maggi, and culminating in its product-approval regime being consigned to the dustbin by the Supreme Court. This column tries to explore the way forward for the FSSAI, especially with respect to setting a product-approval regime.
India’s product-approval mechanism stems from the Food Product Standards Regulations (FPSR) issued by the FSSAI in 2011. The regulations specify a list of food products (including their ingredients) and food product additives, which are considered as ‘standardised’ food products. Any product (or additive or ingredients, in relation to a product) not falling within the purview of the FPSR, is considered as ‘non-standardised’ food product, for which product-approval advisories were issued by the FSSAI. As per the product-approval advisories, in numerous instances, the
FSSAI initially granted a provisional ‘no-objection’ certificate to a non-standardised food product, and then, after the completion of various tests and analyses, the decision regarding the final product approval was made. Further, it was the norm that any non-standard food product would get to have a better case before FSSAI for receiving product approval if it was already approved by food regulators in the US, the UK or the EU.
The Supreme Court order held that product-approval advisories are invalid and has called for the FSSAI to regulate food product-approval by the way of full-fledged regulations. While the order allows the FSSAI to get its house in order, what remains to be seen is the fate of the new product launches in the near future by FMCG majors into India. It is also pertinent to note that uncertainty also looms regarding the import of non-standard food products, which hitherto required ‘product approval’ from the FSSAI, before crossing Indian shores.
In order to render absolute certainty to the food product-approval regime, the FSSAI should undertake a careful and well thought-out review of the existing food product standard regulations. This is to ensure that more food products are included within the category of ‘standardised food products’. Further, from the procedural perspective, the FSSAI should clearly lay down the time period for the granting of product-approvals as well as the time period for conducting laboratory tests, etc, in order to weed out any uncertainty around product-approvals. As a supplement to the product approval regulations that will be put in place, the FSSAI could formulate regulations concerning food product recall, in case of violation of product-approval standards by a food business operator. In fact, the FSSAI had issued a draft of the regulations earlier this year and sought public comments on the same.
Another important matter concerning the product-approval issue is the manner of governing import of food products. At present, the FSSAI has only instituted an online food import clearance system, which does not offer clarity on many counts. It would be pertinent for the FSSAI to put in place full-fledged regulations for food product imports as well. Since the import of various products is regulated by the Directorate General of Foreign Trade (DGFT), from the perspective of food products, it would be important for the FSSAI to co-ordinate with the DGFT while formulating the import regulations.
In a bid to recalibrate its position, the FSSAI has invited applications from legal advisors/law firms to assist it in formulating regulations for product approval and product imports. This move appears to be a step in the right direction. However, what remains unanswered is what will happen to the products needing approval till the time the FSSAI notified the regulations.
With contributions from CV Srikant
The Supreme Court order in the matter of Vital Nutraceuticals & others vs the Union of India and the consequent notification issued by the Food Safety Standards Authority of India (FSSAI) that scraps the product-approval advisory have created a lot of confusion in the Indian food processing and packaging industry. It is a foregone conclusion that serving a population of over 1.2 billion people makes the industry an extremely vital one. From the perspective of the FSSAI, the past few months have been rocky, starting with the controversy surrounding its banning of Nestle’s popular insta-noodles brand, Maggi, and culminating in its product-approval regime being consigned to the dustbin by the Supreme Court. This column tries to explore the way forward for the FSSAI, especially with respect to setting a product-approval regime.
India’s product-approval mechanism stems from the Food Product Standards Regulations (FPSR) issued by the FSSAI in 2011. The regulations specify a list of food products (including their ingredients) and food product additives, which are considered as ‘standardised’ food products. Any product (or additive or ingredients, in relation to a product) not falling within the purview of the FPSR, is considered as ‘non-standardised’ food product, for which product-approval advisories were issued by the FSSAI. As per the product-approval advisories, in numerous instances, the
FSSAI initially granted a provisional ‘no-objection’ certificate to a non-standardised food product, and then, after the completion of various tests and analyses, the decision regarding the final product approval was made. Further, it was the norm that any non-standard food product would get to have a better case before FSSAI for receiving product approval if it was already approved by food regulators in the US, the UK or the EU.
The Supreme Court order held that product-approval advisories are invalid and has called for the FSSAI to regulate food product-approval by the way of full-fledged regulations. While the order allows the FSSAI to get its house in order, what remains to be seen is the fate of the new product launches in the near future by FMCG majors into India. It is also pertinent to note that uncertainty also looms regarding the import of non-standard food products, which hitherto required ‘product approval’ from the FSSAI, before crossing Indian shores.
In order to render absolute certainty to the food product-approval regime, the FSSAI should undertake a careful and well thought-out review of the existing food product standard regulations. This is to ensure that more food products are included within the category of ‘standardised food products’. Further, from the procedural perspective, the FSSAI should clearly lay down the time period for the granting of product-approvals as well as the time period for conducting laboratory tests, etc, in order to weed out any uncertainty around product-approvals. As a supplement to the product approval regulations that will be put in place, the FSSAI could formulate regulations concerning food product recall, in case of violation of product-approval standards by a food business operator. In fact, the FSSAI had issued a draft of the regulations earlier this year and sought public comments on the same.
Another important matter concerning the product-approval issue is the manner of governing import of food products. At present, the FSSAI has only instituted an online food import clearance system, which does not offer clarity on many counts. It would be pertinent for the FSSAI to put in place full-fledged regulations for food product imports as well. Since the import of various products is regulated by the Directorate General of Foreign Trade (DGFT), from the perspective of food products, it would be important for the FSSAI to co-ordinate with the DGFT while formulating the import regulations.
In a bid to recalibrate its position, the FSSAI has invited applications from legal advisors/law firms to assist it in formulating regulations for product approval and product imports. This move appears to be a step in the right direction. However, what remains unanswered is what will happen to the products needing approval till the time the FSSAI notified the regulations.
With contributions from CV Srikant
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