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FSSAI Manufacturers
Get a clear outline of FSSAI food safety standards for producers.
Read about FSSAI manufacturing regulations and safety guidelines.
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Overview of FSSAI Manufacturers
- The Food Safety and Standards Authority of India (FSSAI) plays a major role in setting standards and creating awareness among food manufacturers. According to FSSAI, any person or organization involved in the food manufacturing is considered a manufacturer.
- An FSSAI license is essential for any entity engaged in food manufacturing in India. This license authorizes manufacturers to produce and market their food products legally. Food business operators (FBOs) must apply for this license by submitting Form A or B through the FoSCoS portal.
- Ensuring compliance with FSSAI’s guidelines for food manufacturers, completing the FSSAI manufacturing checklist, and fulfilling all licensing requirements are crucial. Manufacturers must follow these regulations to guarantee safety and quality in food manufacturing. To achieve regulatory compliance, manufacturers must incorporate best practices in food production, adhere to regulatory audit procedures, maintain thorough documentation and record-keeping, and implement robust quality control measures. Moreover, aligning operations with environmental health and safety standards protects consumer health and supports sustainable manufacturing practices.
Introduction to FSSAI's Manufacturing Regulations
Role of FSSAI in Food Manufacturing Regulation
The Food Safety and Standards Authority (FSSAI) creates and implements rules that oversee multiple facets of food production, such as cleanliness, labelling, packing, and quality assurance. Ensuring that only enterprises that comply with regulations operate in the market is one of its main responsibilities, which involves licensing and registering food makers.
To ensure adherence to set guidelines and spot any possible threats to food safety, FSSAI regularly inspects and audits food manufacturing plants. These inspections look at factors like equipment, cleanliness, sanitation procedures, and compliance with Hazard Analysis and Critical Control Points (HACCP) and Good Manufacturing Practices (GMP) guidelines.
Additionally, FSSAI offers direction and assistance to food producers via training courses, capacity-building projects, and the sharing of best practice knowledge. Additionally, it works in conjunction with regulatory agencies, academic institutions, and industry players to stay abreast of new developments in the field and to continuously enhance food safety laws. FSSAI's proactive strategy and extensive regulatory framework are crucial in protecting public health and maintaining the integrity of the food supply chain in India.
FSSAI Licensing for Manufacturers
Manufacturers can apply for an FSSAI license online through the FSSAI website or offline at the nearest FSSAI office. Along with the application, manufacturers must submit necessary documents, including:
- Business details such as name, address, and type of business entity
- Food safety management plan outlining procedures for ensuring food safety
- Details of food products to be manufactured.
Manufacturers must demonstrate compliance with hygiene and sanitation standards set by FSSAI. Once the application is received, FSSAI conducts inspections and verifies the information provided. This includes assessing manufacturing processes, hygiene practices, labelling, and storage conditions.
Upon successful verification, FSSAI issues the license indicating compliance with food safety regulations. The license is granted for a specific period and must be renewed as per the FSSAI guidelines. After obtaining the license, manufacturers are subject to regular inspections and monitoring by FSSAI to ensure ongoing compliance with food safety standards. Adhering to FSSAI licensing requirements ensures that manufacturers maintain high standards of food safety, safeguarding consumer health and well-being.
Compliance Requirements for Domestic Food Manufacturers
The Food Safety and Standards Authority of India (FSSAI) has established standards and rules for food safety, and compliance with these regulations is required for domestic food manufacturers in India. Here are some of the prerequisites:
Key Compliance Aspects for Manufacturers
- Develop a Supplier Quality Development Programme outlining selection, approval, review, and ongoing approval criteria for suppliers
- Procure raw materials, process aids, and ingredients only from internally approved suppliers holding FSSAI/FDA/Ayush licenses or registration from other regulatory authorities. Evaluate suppliers based on quality, compliance, and other relevant factors
- Ensure raw materials received align with the storage and processing capacity of the manufacturing plant
- All raw materials and ingredients must comply with relevant regulations' standards
- Inspect and sort all raw materials, ingredients, packing materials, and process aids before processing. Confirm compliance with documented specifications through various methods such as certificate of analysis, visual inspection, and laboratory testing
- Maintain records of raw materials, ingredients, and procurement sources for traceability purposes
- Obtain food grade certificates for applicable food processing aids from suppliers
- Check bulk tankers/containers for seal integrity, previous cargo, and inspection checklist adherence upon receipt
- Inspect packaged raw materials for expiry date, packaging integrity, and storage conditions compliance
- Ensure incoming vehicles transporting raw materials adhere to cleanliness and hygiene standards, including absence of pests, dirt, and odours other than the raw material's natural scent.
Regular Inspections and Compliance Audits
FSSAI facilitates compliance culture by enabling auditing agencies to inspect and audit food businesses, emphasising self-compliance. The Food Safety and Standards (Food Safety Auditing) Regulations, 2018 outline procedures for recognition, renewal, and suspension of auditing agencies, auditing terms, and reporting standards.
Certain food categories, based on risk classification, necessitate mandatory food safety auditing. Businesses falling into these categories must undergo timely audits by recognised agencies, while others can opt for voluntary auditing. Businesses with satisfactory audits undergo less frequent inspections by licensing authorities, reducing regulatory burdens and promoting efficient self-compliance.
These regulations become effective upon publication in the Gazette of India. Foreign food manufacturing facilities may undergo inspection as required, with costs borne by the facility if prescribed by FSSAI. Inspections involve nominated officials from FSSAI or relevant ministries and recognised auditing agencies.
FSSAI and Foreign Food Manufacturers
Registration of Foreign Food
The Food Authority categorises food products intended for export to India based on risk, subjecting them to specific regulations. Foreign food manufacturing facilities falling under these categorised products must register with the Food Authority before exporting to India Facilities, either directly or through authorised representatives, can apply for registration using ‘Form 16’ provided in the regulations. They must submit requisite documents as outlined in Annexure-1 and pay the specified fee determined by the Food Authority.
Importing Food Products to India
If the Food Authority finds any deficiencies or incompleteness in the application for registration of manufacturing facilities, it notifies the applicant to provide the necessary information within thirty days. Failure to comply within this period leads to rejection of the application.
Upon receiving a complete application, including any requested additional information, the Food Authority may proceed with inspection, if necessary, or decide on the issuance or rejection of the registration.
Ensuring Quality and Safety in Food Manufacturing
FSSAI has initiated a portal for Registration of Foreign Food Manufacturing Facilities (ReFoM). It helps in overseeing registration and licensing of documents granted by the concerned authority of the country. In India an authorised representative should apply for registration through form 16 along with all the relevant documents and the registration fee as specified by the FSSAI. Upon screaming of the application form the FSSAI provides any additional details on the application to complete the registration. If the applicant fails to provide the required details within the required time the certificate will be cancelled food safety and Standards licence and registration of food businesses regulation of 2011 schedule for outlines that there will be no inspection required if food categories are covered under the mandatory BIS certificate.
Did you know? There are upto 48 countries listed in the FSSAI (ReFoM) where they can easily register their food manufacturing units of products.
FSSAI Standards for Food Safety and Hygiene
FSSAI guidelines emphasise locating food establishments away from sources of environmental pollution and industrial activities to prevent contamination from odours, fumes, and chemicals. Here are some of the FSSAI standards for food safety and hygiene:
- Proximity to residential areas should be avoided to mitigate the risk of contamination, especially for food processing involving meat products
- Maintain hygienic conditions by ensuring floors, ceilings, and walls are in good condition, preventing entry of insects and rodents
- Ensure separation between areas where food is sold and areas containing waste, urinals, or drainage systems
- Use containers made of corrosion-resistant materials to protect food from contamination by dust, dirt, and insects
- Regular cleaning and disinfection of equipment are essential to meet food safety and hygiene standards
- Adequate water supply using potable water for cooking and processing is crucial
- Develop facilities for washing raw materials, cleaning utensils, waste disposal, personal hygiene, ventilation, and lighting to obtain FSSAI licensing
- Implement a food hygiene system ensuring careful procurement of raw materials and checking expiration/use-by dates
- Maintain proper temperatures for high-risk foods to ensure safe storage and processing
- Establish cleaning and maintenance programs with specific frequencies and procedures to ensure food hygiene
- Promptly address pest infestations without compromising food quality
- Provide food handlers with protective clothing, head coverings, face masks, gloves, and appropriate footwear to maintain personal hygiene
- Mandate regular health check-ups for food handlers to prevent the transmission of diseases through food.
Innovations and Best Practices in Food Manufacturing
- Innovations in food processing technology maintain sensory attributes, nutritional value, and overall quality, improving taste, texture, and appearance
- Advanced techniques like HPP, microwave processing, and UV light treatment eliminate pathogens and contaminants, lowering the risk of foodborne illnesses and ensuring consumer safety
- Innovative methods control microbial growth, enzymatic activity, and oxidative degradation, extending the shelf life of food products and reducing food waste for enhanced sustainability
- Consumer preferences for clean label products drive the adoption of cleaner processing technologies, preserving the authenticity of food products with minimal processing and natural ingredients
- Latest innovations in food processing align with sustainability objectives by reducing energy consumption, water usage, and waste generation, contributing to a more environmentally friendly food system.
Frequently Asked Questions
What is the role of FSSAI in regulating food manufacturers?
How can food manufacturers obtain an FSSAI license?
What are the key compliance requirements for domestic food manufacturers under FSSAI?
How does FSSAI conduct inspections and audits for food manufacturers?
What process must foreign food manufacturers follow to register with FSSAI?
What regulations apply to foreign manufacturers exporting food products to India?
What are the FSSAI standards for food safety and hygiene in manufacturing?
How can innovations and best practices improve food safety in manufacturing?
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