In recently published document dated 26th August 2015, the Food Safety & Standards Authority of India has stated that it is no longer possible for them to continue with the existing Food Product Approval System as was facilitated through their advisory of 11 May 2013. The FSSAI has published this information in view of the Supreme Court Order dated 19 August 2015. The Apex court has upheld the order of Bombay High Court decision on quashing the advisory that FSSAI had issued on the procedure for product approvals.
FSSAI had introduced the advisory on product approval to streamline the entire process of approving the non-standardized food articles keeping in mind safety of food and public health. This advisory was applicable to those food products for which standards were not specified under Food Safety Standards Act, Rules and Regulations. Since the advisory came into force, all food manufacturers & importers were required to get product approval for the additives/ingredients in all products that were to be introduced in the Indian market for the first time. Since FSSAI had standards for only approx. 380 articles of food, almost all food manufacturers & importers of nutra & noval foods had to apply for product approval.
The news that the advisory on the product approval is quashed by apex court has evoked mixed reactions from food manufacturers and raised new questions about product approval. If the product approval system operating since May 2013 is scrapped then will there now a need for product approval? One thing is clear that advisories cannot be issued by FSSAI unless it has become an Act of Parliament.
FSSAI had stated only last month that setting standards is not easy as food products have different testing parameters and to bring a non-standardised product into the food chain is difficult and long process. Food products have additives, flavours and colours which have to be within the safe limit as salt and sugar can also pose health issues. So till foods standards are notified will no new foods be manufactured?
However, Union ministry of health has indicated that they are planning to approve a list of around 12,000 standards for additives and ingredients. The standards were formulated by the scientific panels and committees of FSSAI and this was seen as a move to ease product approval. FSSAI has recently proposed new draft regulations for Food Additives. The new document on the draft regulations has defined food categories according to a Food Category Code, the restrictions of additives to be imposed in foods, the Acceptable Daily Intake (ADI), maximum level, justification for the use of food additives, Good Manufacturing Practices (GMP). The 2015 draft regulations on Food Products Standards and Food Additives have also stated that carry-over of food additive from raw material or ingredient will not be acceptable in certain categories of foods especially infant formula and children’s foods.
Regulations on Food Articles mentioned under Section 22
In the latest notification of 26 August 2015, the FSSAI has also spoken about its endeavour to make regulations for foods under Section 22. The nutraceutical industry has been asking the FSSAI for regulatory standards under Section 22 for quite some time as the market for nutraceuticals is growing exponentially. Therefore FSSAI’s endeavours have come as welcome news by the nutraceutical manufacturers. These draft regulations will be finalized as soon as all the comments are received by FSSAI from all stakeholders within the stipulated time limit of 60 days from the date of the notification. The regulations are likely to be notified either by 1st January or 1st July of the year subject to a minimum 180 days from the date of final notification.
Food Safety experts say; around the globe product approval is not required to launch products. If FSSAI still feels the need for a product approval system it can only be possible by an Act of Parliament and not through an advisory. However, experts are still awaiting clarifications as right now there is no way to ascertain if food companies are free to launch new products or not. Some experts opine that perhaps new product launches may not be permitted until regulations are in place. Some companies feel that perhaps product approvals could be delayed further. All in all there is still confusion about what is the next step to be taken for new product launches. Those who are in the line for launching novel products are waiting before making any moves. So, now we all should wait for the final notification on the new regulations on the food articles which are governed under Section 22 of FSS Act.