Understanding FSSAI's Regulations For "Non Specified" Foods

Innovations in the form of new products, new methods of processing, and functional foods brought from abroad have taken place in the Indian food industry. But all innovations may not find a space within the food regulations specified by the Food Safety and Standards Authority of India (FSSAI). In order to take care of such innovations while taking the public health safety aspect into consideration, FSSAI framed the Food Safety and Standards (Approval for Non Specified Food and Food Ingredients) Regulations, 2017. Referred to as NSF Regulations, it gives a formal way of approving products that come under a non specified category.

What Are Non Specified Foods Or Ingredients?

• Non specified foods or food ingredients refer to those products which are not governed by the existing food safety and standards authority of India (FSSAI) regulations like:

• Food Product Standards and Food Additives Regulations (FPSFA),

• Nutraceutical Regulations,

• Contaminants and Toxins Regulations,

• Packaging and Labeling Regulations.

They might be:

• New compounds or extracts (such as monk fruit concentrate juice),

• Bioactives or microbial strains (such as probiotics that haven’t been approved),

• Nanomaterials and enzymes mix,

• New combination of approved substances,

• Proteins from fermentation, syntheses of natural substances, or new innovations of plants.

In other words, if your product hasn’t been specified by FSSAI, then your product will be considered as “non specified” and require regulation approval to be marketed in India.

Why Were The NSF Regulations Introduced?

Prior to 2017, FSSAI functioned with the Product Approval System that was declared invalid by the Supreme Court as there was no law supporting it. As a result, there was no regulation for food products not mentioned in the present laws.

In order to regulate this problem, FSSAI has introduced the Non Specified Food Regulations dated 11th September 2017 with the aim to:

• ensures scientific assessment of novel foods and food ingredients,

• provides a legal framework for the grant of approval,

• fosters innovation and international business while protecting consumer safety, and

• offers certainty and predictability for food industry operators.

The regulation has led to a systematic procedure for assessing such foods using scientific evidence from around the world and safety norms in India.

Who Needs To Apply Under NSF Regulations?

An FBO manufacturer, importer, brand owner, or distributor should request NSF approval if the product:

• Has an ingredient that is not mentioned in any existing regulation of India, 

• Uses a combination of ingredients in a new composition or concentration,

• Has new food processing aids or packaging technologies,

• Was manufactured in a country that allows it and there is no such regulatory precedence in India, 

• Has new claims, delivery forms, or strains.

Even if the product is allowed in the United States, European Union, Australia, or Japan, an additional FSSAI approval will be required for its import into India.

Approval Process for Non Specified Foodstuffs (NSFs)

The FSSAI has formulated a systematic procedure for securing the approval of non specified foods and foodstuffs.

Step 1: Filing of the Application Application form I should be filled up and sent together with the following documents to FSSAI through the online platform of FSSAI or at FSSAI headquarters. Details regarding the product and its applications

• Ingredients and concentrations

• Analysis certificates of purity

• Production process with flow charts

• Scientific information about the safety (toxicology, allergenicity, ADI/NOAEL)

• Country of origin

• Sample label of the product

Step 2: Payment of Application Fee

Filing of the Application Fee Non refundable fee of ₹50,000 for each product application.

Step 3: Technical Assessment by FSSAI

Application is assigned by FSSAI to a Scientific Panel/Expert Committee who conducts review based on:

• Scientific evidence and technical dossier

• Exposure of safety to human health

• Approval history in Codex, EFSA, FDA, and/or JECFA

• Dietary habits in India and risk assessment

Step 4: Approval/Rejection/Queries

After review, the authority may:

• Approve the product subject to conditions of use (such as dosage, type of product),

• Request clarifications or ask for further information,

• Reject the application giving reasons for rejection, and

• Close the file if no response is received from the applicant.

Compliance After Approval

• After approval, the product must comply with:

• Labels: The claims made must tally with the approved ones; no misleading claims can be made.

• Conditions of usage: Dosage, mode of usage, and consumer segment must comply with FSSAI conditions.

• Monitoring: FSSAI can do post market monitoring, particularly in the case of imported or risky ingredients.

• Notification of Changes: Change in formulation, source, and claims must be notified in advance and sometimes re approved.

Rejected Application Examples

• The products may not conform to the standards regarding safety or documentation.

Rejection is due to:

• Inadequate safety information

• Formulation issues

• Conflict with Indian dietary practices

• Use of prohibited ingredients

Rejections:

Example 1: Lactogen 2 with L. Reuteri rejected because of problems with the strain

Example 2: Capsules with Cordyceps extract – because of lack of information

Example 3: Ganoderma lucidum (Reishi mushroom extract) – because of inadequate safety information

Ingredients, which are used around the globe, can be rejected too if India feels that there

Common Mistakes To Avoid

Many applications face the problem of being postponed, denied, or even terminated because of the avoidable errors:

• Providing insufficient documents

• Using either absent or obsolete research

• Inconsistency between labeling and dossier claims

• Disregarding the regulations and dosages set by FSSAI

Conclusion 

Non Specified Food Regulations give an excellent approval process for any food item or ingredient not covered by FSSAI guidelines.

How Can Morulaa Help?

Morulaa is there to assist in all processes related to Non Specified Food approvals by FSSAI, including dossier preparation and submission. Morulaa assists both domestic and international food manufactures with the difficult process of gaining approval from FSSAI without binding you to any specific distributors.