Stepping into the food industry isn’t just about offering great food products; it’s also about staying aligned with the essential food laws and regulations in India. In the competitive food market, regulatory compliance isn’t merely a requirement—it is a legislative necessity for successful market access. It ensures food safety, adherence to standards, and the delivery of quality products that support consumer health and well-being. Leveraging food regulatory consulting in India can significantly aid businesses in navigating these complex requirements, facilitating smoother processes like licensing, e-inspections, and overall technical preparedness.
Food Regulation in India
In India, the primary legislation pertaining to food regulation in India is the Food Safety and Standards Act of 2006. The Act authorises the Food Safety and Standards Authority of India (FSSAI), which was established with the aim to streamline guidelines, distribution, retail, and consumption of food production in India. Prior to the Food Safety and Standards Act of 2006, several food laws worked in a fragmented manner, which often lead to issues like lack of uniformity.
Here are key food regulatory bodies in India:
1. Food Safety and Standards Authority of India (FSSAI)
Established under the Food Safety and Standards Act 2006, the Ministry of Health and Family Welfare, Government of India, the FSSAI is an autonomous body that safeguards public health with a set of science-backed guidelines and supervision. FSSAI has been mandated by the FSS Act, 2006 for laying down the regulatory standards for food articles, creating guidelines for accreditation of certification bodies engaged in certification of food safety management system for food businesses, and regulating the manufacture, storage, distribution, sale and import to ensure availability of safe and wholesome food for human consumption.
In India, the main legislation governing food safety is the Food Safety and Standards Act of 2006, followed by several food safety and standards regulations introduced in 2011. On the basis of the power granted by the Act, the food authority has implemented various rules and regulations to oversee the subjects outlined in Section 92 of the Food Safety and Standards Act of 2006. Below are some key regulations in India.
From the Food Safety and Standards Act to guidelines for organic foods, India has a robust legal framework. CliniExperts can help expertly streamline FSSAI compliance by guiding businesses through the complexities of FSSAI Regulations, so that the food products meet the highest level of safety and efficacy for the intended use.
2. The Bureau of Indian Standards (BIS)
The Bureau of Indian Standards (BIS) serves as India’s National Standard Body, established under the BIS Act 2016, to ensure the consistent development of certification, standardization, and quality assurance of products, along with related matters. BIS is responsible for providing safe quality goods, consumer affairs services, product certification, creating Indian Standards for the processed food sector, encouraging exports and substitutes for imports, ultimately reducing health risks for consumers through the processes of standardization, certification, and testing. Manufacturers that clear the BIS standards can get the ISI Mark to display on their product packages. The quality requirements of BIS standards are comparatively stringent than those set forth by FSSAI and AGMARK.
BIS is the regulatory authority overseeing the production of packaged drinking water and mineral water in India, and it has established criteria for both. The IS requirements also apply to animal products, processed foods, spices, sauces, as well as fruits and vegetables. The BIS evaluates product quality through a network of testing laboratories, alongside various public and private labs recognized by the body. Numerous standards are derived from ISO (International Organisation for Standardisation) guidelines, which represent a global coalition of national standard organizations.
- IS 1165: Milk powder
- IS 1166: Condensed milk, partly skimmed and skimmed condensed milk
- IS 1656: Milk-cereal based weaning foods
- IS 11536: Processed cereal based complementary foods for infants
- IS 12176: Sweetened ultra-high temperature treated condensed milk
- IS 13334(Part 1): Skimmed milk powder, standard grade
- IS 13334(Part 2): Skimmed milk powder, extra grade
- IS 14542: Partly skimmed milk powder
- IS 14433: Infant milk substitute, Milk protein based
- IS 13428: Packaged Natural Mineral Water
- IS 14543: Packaged Drinking Water (Other than Packaged Natural Mineral Water)
- IS IS757: Follow -up- formula- Complimentary Food-Specification
Streamline regulatory compliance with CliniExperts. Our services include BIS certification, CRS, and license modification. Our personalised solutions, streamlined process, and timely results ensure hassle-free BIS Registration compliances.
3. APEDA
The Agricultural and Processed Food Products Export Development Authority (APEDA) is a statutory body, established under the Agricultural and Processed Food Products Export Development Authority Act, is responsible for export promotion and development of scheduled products, including fruits, vegetables and their products, meat and its processed forms, and poultry and poultry products.
From the Food Safety and Standards Act to stringent guidelines laid down for organic foods, India has a robust legal framework. Understanding which regulation applies to your product is half the battle won.
What Is Food Regulatory Consulting?
Food regulatory consulting is a specialised service aimed at assisting food businesses comply with the legal and safety regulations established by government entities. Food regulatory consultants manage all food-related regulatory matters from licensing to labelling, ensuring your food products meet legal requirements for sale and distribution.
Since the Indian food regulatory landscape is dynamic, overlooking minute details can result in fines, product recalls, or outright bans. A food consultant helps you navigate the complexities with breeze.
Common Challenges Faced by Food Businesses
Food businesses face a multitude of challenges, including food safety concerns, the need to accommodate changing consumer demands, food standards, and more:
- Compliance With the FSSAI Regulations: Navigating the complex and dynamic FSSAI regulatory landscape can be challenging for food operators.
- Product Approval Delays: New food products, especially imported goods and supplements, can face delays due to complex and stringent approval processes.
- Documentation Errors: Incomplete or incorrect documentation is often the most common reason for license rejection.
- Dynamic Consumer Preferences: Adapting to evolving consumer preferences, including health concerns, dietary preferences, is important for staying relevant in the industry.
- Food Quality and Safety: A slight mishap or downgrade in the quality and safety of a food product, either through improper handling, storage, or preparation, can jeopardise food business operators’ (FBO’s) goodwill.
- Supply Chain Management: Supply chains, either domestic or global, requiring transportation, storage, or sourcing ingredients can be complex and often present a challenge to new or small food business operators. Any disruption in the supply chain due to weather, labour shortages, or geographical conditions can bring challenges.
- Sustainability: Adapting to the increasing consumer preference for sustainable and ethical practices—such as waste reduction, sourcing ingredients locally, and lessening environmental impact—necessitates a shift in business operations and may require considerable investment.
- Technology Adoption: Integrating new technologies like online ordering platforms, inventory tracking software, and point-of-sale (POS) systems can boost operational efficiency and improve customer satisfaction. However, it also requires financial investment and staff training.
- Financial Management: Effectively managing cash flow, monitoring profitability, adapting to fluctuating energy prices, and making prudent financial choices require expert insights, which are significant challenges for the industry.
How Do Food Regulatory Consultants Help
A food regulatory consultant is a professional who provides specialised guidance and advice on meeting regulatory standards in the food industry. They support food businesses, including manufacturers, distributors, retailers, and restaurants, navigating complex food regulations and ensuring their products comply with legal obligations set by the government. Food regulatory consultants stay well versed with the latest food safety laws, labelling criteria, ingredient specifications, and other industry standards to help their clients adhere to the necessary regulations.
Following are the responsibilities of a food regulatory consultant:
1. Compliance and Strategy Planning
Food regulatory consultants evaluate the business model and create plans to resolve compliance deficiencies for end-to-end regulatory compliance. They also perform evaluations and audits to pinpoint non-compliance issues.
2. Licensing and Registration Support
From obtaining FSSAI registration to state licenses and FSSAI Authorised Agent Support to registration of foreign food manufacturing facilities, food regulatory consultants handle guide clients in completing regulatory applications and claims, ensuring accurate and compliant information is available to consumers.
3. Labelling and Packaging Compliance
They ensure the food product labels meet the necessary standards for nutritional information, allergens, and other mandatory disclosures.
4. Product Testing and Approvals
Food regulatory consultants provide recommendations on best practices for quality assurance, risk assessments, and food safety management systems, aiding businesses in building and sustaining a robust compliance framework in the constantly changing food regulatory environment. They also assist in coordinating with NABL-accredited labs to ensure the test results match the regulatory requirements.
5. Import/Export Regulatory Help
For food business operators planning to go global, consultants provide end-to-end product management services so that the products meet both domestic and global food safety standards,
How to Choose the Right Consultant
Here are some checks through which you can choose the right food consultant:
- Experience and Industry-specific Expertise: The consultant should have a deep understanding of the industry and its regulations and experience in your specific industry (e.g., manufacturing, importing, retail). Check how long the consultancy has been in business and what industries they have served.
- Technical Expertise: Look for technical expertise, including strong understanding of food safety regulations, HACCP, and other relevant standards.
- Client Testimonials and Case Studies: Proof of performance goes a long way in determining the quality of work provided by consultants, thus making an informed decision.
- Successful Approvals and Regulatory Network: Look for consultants that have robust connections with regulatory bodies and have proven track record of successfully obtaining market authorisations for similar businesses.
How Can CliniExperts Help You
CliniExperts can help food businesses navigate complex regulatory requirements by providing expert consultation on FSSAI registration, license renewal and modifications, and import assistance with strategic planning and technical acumen. Our dedicated team smoothly handles documentation and approvals for imported food items, closely coordinates with certified labs for product and ingredient testing, offers tailor-made packages for early-stage businesses. We also offer guidance on clinical trials, premarket and postmarket requirements, and post-market surveillance, making it easier for food businesses to meet regulatory standards and bring their products to market efficiently.
Conclusion
Although food business proposes enormous opportunities, the complexity of rules and regulations, dynamic guidelines, and multiple authorities can make navigating through food regulatory landscape slightly challenging. By collaborating with successful industry regulatory experts like CliniExperts, food businesses can level-head compliance strategies, save unnecessary time on licensing and approvals, and accelerate time-to-market, turning compliance from a headache into a competitive advantage.