Through a notification dated 31 January 2017 the FSSAI has asked for comments, views and suggestions related to regulations on approval of non-specified food and food ingredients. Earlier in October 2016 the FSSAI had proposed this regulation and has now prepared the draft. These regulations will be called the ‘Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017. The important highlights have been outlined below:
Detailed procedure for grant of approval
The FSSAI has specified the procedure for grant of approval. Manufacturers or importers of non-specified food and food ingredients will need to submit an application in the formats that have been given in the regulations. The formats are numbered and consist of six types of forms, FORM I, FORM II, FORM III, FORM IV, FORM V, FORM VI. The FBO will need to fill in the forms that are applicable to their product as part of the application process and also provide the requisite documents and fee to the Food Authority. The FSSAI will either grant approval or reject the application in FORM VII on the basis of safety assessment.
After the approval has been granted the FBO will need to
- Submit certificates of analysis of the production parameters relating to chemical, nutritional, microbiological, heavy metals, pesticide residues and naturally occurring toxicants to the Food Authority.
- If the FBO has reason to believe that there is any risk to consumer health from the approved food then the FBO must immediately suspend the import, manufacture, sale or distribution of such articles of food and take steps for recall of the same as per the provisions of the Food Safety and Standards (Food Recall) Regulation, 2016.
- If an approval has been rejected the FBO is permitted to file a review petition for the consideration of the Food Authority.
According to these regulations Prior Approval is required for the following articles of food
- novel food or food containing novel ingredients not having a history of human consumption in the country
- food ingredients with a history of human consumption in the country but not specified in any other regulations made under the Act
- new additives and processing aids
- food manufactured or processed with the use of novel technology
FORM I consists of the application format for approval of non-specified food and food ingredient. The applicant will need to fill out their name, address, email ID, phone number, name of organisation, License no. if any etc. (to be filled in by all FBOs seeking approval for the above mentioned food articles)
FORM II is for applicants applying for approval of novel food or food containing novel ingredients or processed with the use of novel technology. FBO will need to provide the following information
- Target group of the proposed food
- Name of the proposed food/ingredient and justification of the name
- Details on composition including quantity of ingredients and additives
- Source of the ingredient-animal botanical, chemical etc.
- Documents providing regulatory status of the food/ingredient
- Functional status of the product and justification
- Intended use of the product
- Certificate of analysis from NABL approved or International Laboratories Accreditation Cooperation recognised laboratories
- Proposed label
Similarly the FSSAI has provided formats for other articles of food and food ingredients and additives. The concerned FBO will have to fill out only that form which is applicable for their product or ingredient as each form contains specific information that the FSSAI seeks for the different kinds of foods and ingredients.
- FORM III Application for food ingredients with a history of human consumption in the country but not specified in any regulation under the Act
- FORM IV is the application format for new additives
- FORM V Application format for processing aids and enzymes
- FORM VI is the application format for articles of food and food ingredients consisting of or isolated from microorganisms, fungi or algae
FORM VII is the approval format which contains the application number, date of application, name and address of FBO, ingredients, food additives etc. All FBOs seeking approval will need to provide information in this form as it also contains
- Conditions of approval
- Reasons for rejection if any