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FSSAI grants industry one year to comply with functional food regulation
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Monday, 28 November, 2016, 08 : 00 AM [IST]
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Ashwani Maindola,New Delhi and Pushkar Oak,Mumbai
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fiogf49gjkf0d A period of one year was permitted by the Food Safety and Standards Authority of India (FSSAI) to the industry for effective compliance with the regulation on food and health supplements, nutraceuticals, food for special dietary uses, foods for special medical purposes, functional foods and novel food.
This will help in smooth transition to the new regulations. The industry appreciated the decision but laid emphasis on fast-tracking the deliberation of missing ingredients which will have a larger impact on the industry. They have been missed out, despite being safely consumed in the Indian population with no safety concerns reported.
In the deliberations, the facts and evidences over usage of the ingredients or ingredients in the products in India which are missed out from this direction will be displayed before FSSAI’s scientific panel.
This will include stating the usage of ingredients or ingredients in products, relative global standards where it is allowed and reports from all over the globe to support the safety of the ingredients or ingredients in the products.
It took FSSAI seven years to launch the new directive. Prior to its launch, an extensive study and scrutiny of other nations’ laws and regulations was undertaken. Work in this regard commenced in 2009.
Sandeep Gupta, national healthcare spokesperson, healthcare and food industry, and a leading strategist and expert on leading industry bodies like the Indian Drug Manufacturers' Association (IDMA), the Council of Soft Gelatin Manufacturers, the Federation of Indian Chambers of Commerce and Industry (FICCI) and the Confederation of Indian Industry (CII) for nutraceuticals, health and dietary supplements clarified that nutraceuticals will fall under category 13.6 and all food business operators (FBOs) should get their licenses renewed appropriately under the relevant category.
He said that the regulation had opened up avenues for start-ups who can now apply following the requirements of licensing and regulations.
This is great encouragement for new businesses to be set up and small and medium enterprises (SMEs) will be the biggest beneficiaries of such a decision to spearhead the economic growth of this new sector. The already restructured goods and service tax (GST) was another reform by this government, creating a level playing field for FBOs.
After several rounds of meetings by the industry stakeholders, led by the Indian Drug Manufacturers Association (IDMA) team, with the ministry of health and family welfare and FSSAI over the last 3-4 weeks, a milestone decision was taken by them to operationalise the Food Safety and Standards Regulations (FSSR), 2016, which will be shortly accompanied by an order setting guidelines for enforcement officers. This was expressed by Pawan Kumar Agarwal, chief executive officer, to industry stakeholders, who were present in large numbers in the FSSAI office recently.
Gupta said, “For the first time, the industry witnessed the handholding of all major stakeholders, including IDMA, CII, FICCI, OPPI, FOPE, CIPI, NAC, COSGM and others in public interest, to enable this critical decision of FSSAI.”
He added that the delay in operationalising this order was mainly due to the trimming of the permitted list of ingredients which have already been marketed in India for over two or three decades, causing grave concerns about major implications on this sunrise sector.
“The Indian population would have equally suffered a lack of access to such ingredients,” Gupta said, adding that the industry, in an integrated manner with all stakeholders, approached FSSAI to discuss in a transparent and consultative manner and represented this major issue, which was well received by Ashish Bahuguna, the regulator’s chairman, and Agarwal and facilitated subsequent deliberations with the Standards Division, where IDMA, OPPI, FOPE and CIPI submitted extensive details and evidence for consideration. It was decided that the list would be taken up immediately with FSSAI’s Scientific Panel for their advice and inclusion.
He added, “The industry and FSSAI decided to operationalise the regulations. This would benefit a large section of the sector and help foster the operations of FBOs. In the interim, to bridge the gaps, FSSAI took a decision to release an office order to direct the food safety officers (FSOs) and enforcement officers with clarity in implementing the regulations.”
Gupta stated that IDMA acknowledged and welcomed this initiative of the apex regulator, which will resolve more than 90 per cent of the sector’s issues. It acknowledged and understood that the regulations are evolving and dynamic. Amendments will be carried out in an appropriate manner and with the provisions of Food Safety and Standards Act, 2006, under Sections 18 2a(i), 18 2a(ii) and18 2d which shall help FSSAI achieve its objective and the industry meet its goals.
R K Sanghavi, chairman, nutraceutical committee, IDMA, who has pioneering expertise in handling nutraceuticals for over three decades and introduced many beneficial and innovative nutraceuticals to human health since the early 1990s (such as Glucosamine, Chondroitin, Co-enzyme Q10, Evening Primrose Oil, Omega-3), appreciated the efforts and decision taken by FSSAI.
He felt valued for his work through this regulation. However, he mentioned on a cautionary note that the industry would need to work extensively for innovative ingredients with FSSAI, helping to fine-tune the regulations.
At the same time, Sanghavi expressed that this step of FSSAI would boost the sector’s development and growth in near future. He mentioned that after five years, the nutraceutical sector has seen the decision coming to fruition, and this would open up new avenues of innovation for the sector and would create a level playing field at the global level.
He stated that it was not just the United States and Europe, but even countries like Thailand and Malaysia that have been quite ahead of India uptil now.
Sanghavi said that the industry should frequently and closely work with FSSAI for the inclusion of new ingredients, which are still a far reach for Indian consumers, but are highly beneficial to human health and available in global markets.
Such ingredients internationally are helping arresting future health complications and diseases in human population, for which India would need to wait. He added that FSSAI must consider in its evolving regulations and reconsider its clause of nutraceutical introduction in India which is contradictory in nature.
Sanjay Mariwala, managing director, Omni Actives (a global nutraceutical Ingredient player) and chairman, nutraceutical task force, FICCI (which has lead experts in its committee), congratulated Pawan Kumar Agarwal, chief executive officer, FSSAI, and expressed that this was a positive move by FSSAI for enabling the sector to see a bigger picture.
He added that operationalising regulations would restart the sector to get set and introduce more and higher standards for industry with quality supplements benefiting Indian consumers. He expressed that the industry needed to reach out to FSSAI to hand-hold and enable self-regulated programmes and modules for effective awareness building amongst the consumers about the needs and benefits of nutrition and nutraceuticals.
The industry expressed that nutraceutical regulations has set the positive momentum. However, the office order, which is yet to be released, will decide its implementation for smooth transition over a period of one year.
Meanwhile, Gupta stated that he looked forward to hand-holding between this important sector and the regulator for growth, development and innovation. He emphasised that their coming together facilitated the operationalisation of the nutraceutical regulation and looked forward to its effective compliance from the industry too.
He added, “Significant gains come in business operations with some pains and the nutraceutical, health and dietary supplement sectors heave a sigh of relief.”
Meanwhile, CII stated that this was indeed another remarkable initiative of FSSAI after the harmonisation of the food additives regulation. “The operationalisation of this regulation will help greatly in resolving the issues confronting this sector and in creating a conducive regulatory environment for the industry to operate,” it added.
As per the regulation, a period of a year was provided to FBOs to comply with the provisions of the regulation. The enforcement shall commence in January 2018. In the interim period, the industry will need to work closely with FSSAI to ensure a smooth transition to the new regime.
Piruz Khambatta, co-chair, CII national committee on food processing industry, and chairman and managing director, Rasna Ltd, said, “The industry appreciates the efforts undertaken by FSSAI in undertaking this massive task.”
“An enormous amount of work is being done by the food regulatory set-up in India. The most important aspect is that this work is being carried out in consultation with all stakeholders and it is a great beginning towards developing science-based globally-compatible regulations for this sector.”
Geetu Verma, chairman, CII task force on food regulatory affairs, executive director, foods, Hindustan Unilever Ltd, and vice-president, foods, Unilever South Asia, congratulated FSSAI on operationalising the regulation on nutraceuticals.
She added, “This move will go a long way in creating an enabling regulatory environment and alleviate the issues that exist in the current system.”
Anshu Budhraja, managing director, Amway India Enterprises Pvt Ltd, also welcomed the operationalisation of nutraceutical regulations.
He stated, “This is an enabling step taken by FSSAI to further improve the regulatory environment. The regulations will provide clarity to the food supplement industry by establishing standards for new food categories and create a level playing field for the industry.”
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