FSSAI
FSSAI Regulatory Affairs Services
Streamline FSSAI compliance effortlessly with CliniExperts. From product compliance and licensing to market operations and import services, we've got you covered.
At CliniExperts, we take great pride in being the frontrunner for providing end to end FSSAI Regulatory Affairs Services. Whether it is the launch of a new product, Renewal of licenses, or aiding with Regulatory Audits, CliniExperts has a proven track record of guiding businesses through the complexities of FSSAI Regulations, so that your products meet the highest level of safety and efficacy for the intended use. We offer a wide range of services tailored to meet your requirements, including:
Partner with CliniExperts and get the advantage of Experience, Expertise, and Efficiency!
Food Safety – Food for Thought
Access to safe and nutritious food for people plays a significant role in building a strong nation. To ensure the availability of safe and wholesome food for human consumption, the Ministry of Health and Family Welfare, under the Food Safety and Standards Act 2006, established the Food Safety and Standards Authority of India (FSSAI) as the parent regulatory body, with outreach in states and union territories through regional offices.
With a vision to protect public health and promote confidence between suppliers and consumers in the food supply chain, FSSAI introduced sweeping reforms to enhance regulatory framework across products, packaging, and raw material categories. From manufacture to storage, distribution, sale, and import, FSSAI handles oversees food-related laws. These reforms give more teeth to the law and empower it to further safeguard citizens' food safety and security, while enhancing the punitive mechanism against erring parties.
Proper order in the ecosystem requires compliance with the regulations. In such ordered and stringent regulatory landscape, navigating the complexities seamlessly requires thorough knowledge and expertise. A regulatory affairs consultancy acts like a lifeboat for several manufacturers, importers, and distributors in food businesses to stay buoyant and navigate the regulatory landscape with ease and compliant solutions. CliniExperts, with in-house experts and years of experience, is an agile, competent regulatory partner guaranteeing regulatory solutions from start to finish. From documentation and submission to implementing quality assurance systems to gaining easy market access, CliniExperts proves to be a reliable and trustworthy beacon in the food compliance sector.
About FSSAI?
The Food Safety and Standards Authority of India (FSSAI), established under the Food Safety and Standards Act, 2006, is an autonomous statutory body responsible for regulating and overseeing food safety and standards in India. It lays down "science based" standards for food items across categories and regulates their manufacture, storage, distribution, sale and import. Thus, FSSAI acts as the main enforcer of the Food Safety and Standards Act, 2006 and its amendments, and acts as a single referencing body for all food safety and standards, mitigating confusion among producers, distributors, consumers, and investors
Who Can Apply?
Any "Food Business Operator" (FBO), who manufacturers, stores, distributes, and sells food items in India, can apply or register for the FSSAI license. These include small-scale food businesses, hawkers, retailers, itinerant vendors, temporary food stall owners, and even pharmacies selling supplements can apply for an FSSAI license on FoSCoS (Food Safety Compliance System) website.
Registration and Licensing
As per the FSSAI standards, all small to big-scale merchants and traders, hawkers, and other sundry sellers/resellers of food products with annual turnover below Rs. 12 Lakh are required to be registered with FSSAI. All other parties, including manufacturers, distributors, retailers, and large sales outlets are required to obtain an FSSAI license.
Why Choose CliniExperts?
The lengthy and cumbersome food regulatory process involves over 320 steps, and at each step, a high degree of factual accuracy and error-free reporting is required. Such a complex, detail-oriented, and knowledge-based regulatory function is best left to domain experts. Attempts at self-fulfilling this requirement may result in loss of valuable time and effort, and in cases of delay and penalties, loss of business and income. Navigating the regulatory landscape requires thorough understanding of rules and regulations and meticulous preparation. For such delicate and complex matters, having a trusted regulatory partner to handle your regulatory matters is wise for the business and its growth.
With over 15 years of hands-on experience and expertise, CliniExperts ensures compliance, streamlining applications and submissions for timely approvals, and helping important stakeholders, including manufacturers, importers, and sponsors navigate the complexities of regulatory affairs. Rest assured, CliniExperts is your best bet for a long-term, mutually rewarding regulatory partnership!
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FosCos FSSAI Food License & Registration in India License is obtained in Form C INR 100 per year is the registration fee for taking the FSSAI license to begin any food business on any premises whereas INR 2000/3000/5000 per year are the fees prescribed for obtaining a State License for the food business activities and INR 7500 per year for obtaining Central License. |
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Non Specified Product/Ingredient Approval in India – Form I & II Non specifed food approval is obtained in Form II To obtain non-specified food approval by FSSAI, the applicant is required to pay INR 50,000 per application. |
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Manufacturer License FSSAI Compliance (Food Regulation) - Food Safety & Standards -CliniExperts FSSAI Food Product compliance is a procedure where the applied food product meets all the requirements in the form of directives, regulations, and standards stated by FSSAI. There are 320+ checkpoints to be kept in mind for obtaining food product compliance in the fastest timeframe with minimal hindrance. |
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FSSAI Authorized Agent Support for Food
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FSSAI Food Claim Approval in India
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Approval of Non-Specified Ingredients/Products - Food Supplements & Nutraceuticals
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Approval of Non Specified Ingredients/ Products - For Food Supplements & Nutraceuticals
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FSSAI License for Food Supplements and Nutraceuticals in India – Form B & Form C
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FSSAI Advertisement & Claims Approval - For Food Supplements & Nutraceuticals in India
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Recent Food Posts
Different Types of FSSAI Licenses in Delhi
Explore the various types of FSSAI licenses available in Delhi. Learn which license is right for your food business and how to apply. Get a clear understanding of the different FSSAI licenses in Delhi and step-by-step guidance on the application process.
Safety and Efficacy Assessment in Non-Specified Food Approval: Focus on Functional Foods
The Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017, initially established by the FSSAI, served as a framework for regulating non-specified food products and ingredients.
Registration of Foreign Food Manufacturing Facilities (ReFoM)
Registration of Foreign Food Manufacturing Facilities (ReFoM) intending to export Egg powder; Nutraceuticals; Meat & meat items, including fish, poultry & their products; Infant food
Testimonials
The Brand That Promises To Turn, Your Business Around!
Atomy India Pvt ltd
We have been associated with CliniExperts for about a year now for our food products related services for FSSAI compliances and licenses from CliniExperts and are completely satisfied with their performance. Quick turnaround time in responding to queries, meticulous planning in completing the task, alongside the extensive knowledge of the regulations of the entire team is highly appreciable and marks the professionalism and quality driven ethics of the organization. We highly recommend their services as we believe it is best in the industry so far.
Rajeev Rattava
Finance Manager
Morepen Laboratories Ltd.
The team at CliniExperts is proficient in the subject matter and provide prompt services . We are satisfied with our engagement and would recommend their services.
Anubhav Suri
Business Head
Proficon Medisol Pvt. Ltd.
We have been professionally associated with Cliniexperts for more than 5 years now. They have smoothly sailed us all these years in different projects & this has been possible because of the knowledge & dedication cliniexpert team has in their portfolio. All the best Cliniexpert. Keep going.
Ajitesh Trehan
Director
Unity Enterprises
We appointed Cliniexperts for our Cosmetic registration project for one of our critical products for which we received the registration certificate much before the timelines committed by the company. The entire project was handled efficiently with sheer professionalism and in our comfort zone . We are very happy with the overall working experience with CliniExperts and will highly recommend their services to everyone.
Faiyaz
Founder, Unity Enterprises
Frequently Asked Questions
What sales model do you offer?
CliniExperts focus on all regulatory affairs matters related to food compliance, including registration, import and seamless logistics support around the clock, so that you can focus on your business and build the market reach.
What is the date of enforcement for the Food Safety and Standards (Labelling and Display) Regulation, 2020?
The timeline for mandatory compliance with labelling display regulation as per the Food Safety and Standards (labelling and Display) Regulation, 2020 has been extended to the 1st of July 2022.
What happens if the product is non-compliant?
There are provisions relating to offences and penalties specified in the Food Act if the product is non-compliant. Here is a list of a few of them: - A penalty of 5 lakhs on the manufacturer, seller, storage, distributor, and importer for sub-standard food. - A penalty of 3 lakhs on the manufacturer, seller, storage, distributor, and importer for misbranded food. - A penalty of 10 lakhs on the publisher or any person involved in publishing for a misleading advertisement describing false description, nature, or quality of substance.
Is the FSSAI License under Importer KoB sufficient to carry out further food Business activities of Imported Food Products?
No, FSSAI License under Importer KoB is only for importing food Items into the Country. Therefore, for carrying out further food business activities of that imported food products, as defined under clause 3(n) of the Food Safety and Standards Act, 2006, FBOs need to endorse all such relevant Kind of Business categories in the issued license by applying modification of license.
Do the importer and manufacturer require separate licenses for carrying different food businesses within the same premises?
No, the applicant must fill out all the details in one form for obtaining an FSSAI license for more than one food product.
What types of food products or ingredients are covered under these regulations?
The following food products or ingredients are covered under these regulations: - Novel food or novel food ingredients. - New additives or new processing aids (including enzymes). - Articles/papers of food products or ingredients that contain or are isolated from microorganisms, bacteria, yeast, fungi, or algae. - Other non-specified food.
What is a new additive as per the FSSAI?
A new additive can be defined as an ingredient that has not been included in any specific food category per the Food Safety and Standards Regulations (FSSR). The products listed under this category also include the additive assessed for safety by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). The food additive is included in Codex and approved by other regulatory authorities.
How many claim statements can be addressed per application?
A maximum of three claim statements can be addressed in one application.