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Novel Food Product: Regulatory Insights And Processes In India
The Food Safety and Standards Authority of India (FSSAI) has amended regulations to fix loopholes in the regulations of novel food. These regulations are called the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016. It came into force on the date of their publication in the Official Gazette and Food Business Operator shall comply with all the provisions of these regulations by 1st January, 2018.
As per the regulations, novel foods are the foods that do not have a history of human consumption or has any other ingredient used in it before which or the source from which it comes, does not have a history of human consumption. Novel Food can be newly developed, innovative food, and food produced using new technologies and production processes. The process may give rise to a significant change in the composition or structure, or size of the food or food ingredients that may alter the nutritional value, metabolism, or level of undesirable substances. The regulations stated that no novel food shall be manufactured or imported for commercial purpose without the prior approval of the Food Authority by filing an application of Non-specified food approval along with all relevant documents and details as specified by the Food Authority from time to time.
Examples of Novel Food include new sources of vitamin K (menaquinone) or extracts from existing food (Antarctic Krill oil rich in phospholipids from Euphausia superba), agricultural products from third countries ( Chaga Mushroom, Acai berries juice, etc), or food derived from new production processes (enzymes produced through novel fermentation technologies, etc. ), food consisting of engineered nanomaterials affecting absorption and assimilation in the human gut.
Regulatory Approval for Novel Food
Food products or ingredients that are neither standardized nor fall under the proprietary food category under Food Safety and Standards Regulations are called NSF (Non-specified food). Novel food manufacturer or importer needs prior approval under NSF before applying for FSSAI licence.
Criteria for Novel Food
The regulations specified for Novel Food are made so that they are:
- Properly labelled, and not misleading to consumers in every possible way
- As per evidence, novel food is safe for consumers and not pose a safety risk to humans.
- If novel food is intended to replace another food, it must not differ in a way that the consumption of the Novel Food is nutritionally disadvantageous for the consumer.
Labelling requirements of novel food
In addition to the general labelling requirements specified under the Food Safety and Standards (Labelling and Display) Regulations, 2020, novel foods need to comply with some specific labelling requirements. Few labelling requirements of novel food are mentioned in the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 while the others are granted in the approval letter (in case any specific labelling is required). They may be as follows:
- As per the specific labelling requirements, if any; or
- specific to claims relating to the novel product; or
- as per the category notified by the Food Authority in the specific regulations.
Safety Assessment of Novel Food
Various safety assessment for novel food and ingredients by organizations include
Assessment approaches –
Deterministic -single point, usually worst case e.g. 95th percentile intake for food consumption & highest level of addition.
Probabilistic – Models intake across the full distribution of intakes. Usually used when considering intake from multiple food sources
Risk assessment tools for novel food are:
- Risk characterization
- Hazard identification
- History of use
- Toxicological measurement
- Post launch monitoring
Food Business Operators must verify whether the food falls under the scope and must follow the regulations before introducing the food product in the Indian market. Still, you have confusion-Is my product or ingredient present in my product Novel? You may find the solution with us at CliniExperts Services Pvt. Ltd.
Novel food approval is a rigorous procedure in India. Our food regulatory consultants can help you understand the regulations related to Novel Food in India and fast-tracking the approval process.
- The Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical Purpose, Functional Foods, and Novel Food) Regulations, 2015. Available at: https://fssai.gov.in/upload/uploadfiles/files/Nutraceuticals_Regulations.pdf.Accessed on 18th February, 2021.
- Frequently Asked Questions (FAQs) on the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016(herein after referred as Nutraceutical Regulations) dated 24.08.2020.Available https://fssai.gov.in/upload/uploadfiles/files/FAQs_Nutraceutical_Regulations_25_08_2020.pdf. Accessed on 18th February, 2021.
- Frequently Asked Questions (FAQs) on Food Safety and Standards(Approval of non-specified food and food ingredients)Regulations, 2017.Available at: https://www.fssai.gov.in/upload/uploadfiles/files/FAQs_FSS_Approval_NonSpecified_Ingredients_06_05_2020.pdf. Accessed on 18th February, 2021.