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FSMP products are often prescribed or recommended by healthcare professionals to help manage conditions such as malabsorption, lactose intolerance, or other metabolic disorders. This product is meticulously produced under stringent safety and quality standards to ensure optimal nutrition and safety for infants requiring specialized care.

Introduction

BIS certification for Food for Special Medical Purpose intended for infants is essential to ensure these sensitive products adhere to the highest standards of safety, quality, and nutritional adequacy as per Indian Standard IS 17945: 2022. The Food Safety and Standards Authority of India (FSSAI), through a notification on August 31, 2022, mandated BIS certification via the Food Safety and Standards (Prohibition and Restrictions on Sales) First Amendment Regulations, 2022. This regulation requires that FSMP products carry the ISI Mark before being sold in the Indian market, ensuring compliance with critical health and safety standards. Certification provides assurance to parents, caregivers, and healthcare providers that the product meets strict quality and regulatory requirements.

Why is BIS Certification Necessary for Food for Special Medical Purpose Intended for Infants?

BIS certification for FSMP products intended for infants is crucial because these items are often used to address specific health issues and must meet strict safety and nutritional standards. Given the vulnerable consumer base, BIS certification ensures that products adhere to IS 17945: 2022, reducing risks related to contamination and inadequate nutrition. The 2022 amendment to the Food Safety and Standards Regulations requires manufacturers to obtain BIS certification before marketing these products. This mandate, enforced by FSSAI, protects infant health and holds manufacturers accountable to ensure all FSMP products meet high standards, with severe penalties for non-compliance as per the Food Safety and Standards Act, 2006.

BIS QCO for Food for Special Medical Purpose intended for Infants

Overview of Indian Standard IS 17945: 2022

Indian Standard IS 17945: 2022 outlines the specific nutritional, safety, and quality parameters for Food for Special Medical Purpose intended for infants. The standard ensures that these products meet the dietary requirements and medical needs of infants with particular health conditions, covering essential nutrient levels, microbial safety, and labeling specifications. The guidelines aim to ensure that FSMP products provide balanced, safe nutrition tailored for infants with restricted dietary needs. The 2022 FSSAI amendment to the Food Safety and Standards Regulations mandates compliance with IS 17945: 2022, enforcing high-quality standards to protect vulnerable infants and ensure regulatory accountability in the Indian market.

Process for BIS Certification

The BIS certification process for Food for Special Medical Purpose intended for Infants involves multiple steps, designed to thoroughly evaluate a product's compliance with the required standards. Here is a general overview of the certification process:

1. Application Submission: Manufacturers must submit an application form along with required documentation to BIS.

2. Documentation Review: BIS reviews the submitted documents to ensure completeness and correctness.

3. Factory Inspection: BIS officials conduct an on-site inspection of the manufacturing facility to assess the production process and quality control measures.

4. Sample Testing: Product samples are taken and tested in BIS-approved laboratories to verify compliance with Indian standards.

5. Certification Grant: Upon successful completion of the inspection and testing, BIS grants certification, allowing the manufacturer to use the BIS mark on their products.

Documents Required for BIS Certification

To apply for BIS certification, manufacturers need to submit the following documents:

● Application form

● Manufacturing process details

● Quality control plan

● Test reports from BIS-approved laboratories

● Factory layout and equipment details

● Proof of business registration

● Product specifications and technical details

● Declaration of conformity to Indian standards

Additionally, manufacturers may be required to provide proof of compliance with environmental and safety regulations, depending on the specific type of product being certified.

BIS Documents For Domenstic and Foreign Manufacturer Check

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Conclusion

BIS certification for Food for Special Medical Purpose intended for Infants is essential to ensure adherence to quality and safety standards as per IS 17945: 2022. By complying with the mentioned Quality control order, certified products provide reliable performance, enhance consumer safety, and reinforce the credibility of manufacturers in the Indian market.

Navigating the BIS certification process can be challenging, especially for small and medium-sized enterprises. EVTL India is a leading consultancy firm dedicated to assisting manufacturers in obtaining BIS certification (ISI Mark) efficiently. With expertise in managing BIS portal submissions, documentation, and regulatory fees, EVTL India ensures a smooth and successful certification process. By choosing EVTL India, manufacturers can enhance their product's marketability both in India and internationally, securing a competitive edge. Additionally, EVTL India provides ongoing support post-certification, helping manufacturers maintain compliance with BIS standards and renew their licenses as needed.