The FSSAI has clarified all aspects regarding proprietary food regulations through an FAQ notification which the Food Business Operators can consult to clarify any doubts about the standards, definition, ingredients and additives used, licensing, labelling requirements in proprietary foods. The provisions of this notification have been enforced from 15 January 2016 and are required to be followed by the Central and State Authorities and all Food Business Operators (FBOs).
At the outset FSSAI has stated that it understands the need for a specific framework to manufacture and market proprietary foods. While they understand, that stakeholders require flexibility to innovate but there is also a need to adhere to global best practices. FSSAI has stated that it has issued a notice on 23 December 2015 for the “Operationalization of standards for Food Additives for use in various Food Categories” for expanded list of food additives in different food and food categories. The Apex Food Regulator has at the same time emphasised that use of the expanded list of food additives in proprietary foods puts the onus of food safety squarely on the shoulders of the Food Business Operators.
The earlier regulation that defined proprietary foods as foods that have not been standardised under the FSSAI regulations has been amended. Under the new operationalized amendment the scope of proprietary foods is as follows
- In this notification proprietary foods cover all non-standardised foods for which no identifiable standards have been prescribed in the FSSAI regulations. However, the category of novel foods, foods for special dietary uses, functional foods, nutraceuticals and health supplements are not included as proprietary foods.
- If there is any deviation or change in the specific quality parameters (such as TSS, ash content etc.) of any standardised food then the resultant product cannot qualify as proprietary food.
To the question of seeking approval from FSSAI for any proprietary food complying with the provisions as laid down in this notice the FSSAI said that any proprietary foods complying with the provisions of this notification will not require any pre-approval from the FSSAI. Again the FSSAI has emphasised that even though the FBO might not require product approval but the FBO will be fully responsible for the safety of the proprietary food that is in compliance with provisions of this notice.
Which ingredients besides additives can be used in proprietary foods?
- Ingredients which are standardised or are permitted to be used in standardised products under the Food Safety and Standards (Food Products Standards and Additives) Regulations 2011 can be also used in proprietary foods
- Any ingredient besides those mentioned above and which are already approved under the erstwhile product approval process can be used
- Added vitamins and minerals should not exceed 30 per cent of recommended Daily Allowance (RDA) for Indians when used in proprietary foods.
Which food additive can be used in proprietary foods?
The following additives can be used in proprietary foods
- Food additives that are permitted in Chapter 3 and Appendix A of the Food Safety and Standards (Food Product Standards and Additives) Regulation 2011, for that food, food category or sub-category as amended from time to time can be used in proprietary foods.
- All Food additives permitted in specific food or food category or subcategory that have become operational as per the FSSAI “Notice for operationalization of standards of Food Additive” for use in the various categories of food dated 23 December 2015 can be used.
- Besides those additives mentioned above, if FBOs have received approval for any additives under the previous product approval process then they may continue to use them.
Is there any change in licensing requirement and what documents are required?
- Licensing for proprietary foods will be granted for the specific foods or food category or sub category when the FBO requests for it in the application form and in accordance with the licensing regulation but there will be no requirement for any product approval.
- FBOs can also get new proprietary food incorporated into the existing license.
- Any proprietary foods already included in the existing licences will remain valid.
- Documents that are required to be deposited with the State/Central Licensing Agency are as per Annexure 2 of the Food Safety and Standards (Licensing and registration of Food Business) Regulations 2011
How will an intermediate product to be used by another industry be governed under this regulation?
Intermediate products (food/ food additive premixes) can contain ingredients permitted in this regulation and can contain additives as per Food Safety and Standards (Food Product Standards and Food Additives ) Regulation 2011 and /or Standards for food additives that have been operational through the notice of 23 December 2015 issued by FSSAI. FBO’s have the responsibility to ensure that the finished product prepared using such premixes/ intermediate products contain only those additives that are permitted under the regulations.
FSSAI has also clarified how the FBOs will comply with provisions of the notice to mention category on the label along with its name, nature and composition
- “Category” means category of the food as per the category and sub-category system provided in the Food Safety and Standards (Food Product Standards and Food Additives ) Regulation 2011 and permitted by the “notice for operationalization of standards for Food Additives for use in various food categories dated 23 December 2015 issued by FSSAI
For labelling purpose, the FBO can use the product name along with the category number.
- Name, nature and composition are as provided in the Food Safety and Standards (Packaging and Labelling ) Regulation 2011 where
- Name –means the generic name
- Nature- means the description of the food contained in the package
- Composition means list of ingredients in descending order
- The FBOs that have got product approval under the previous product approval process can comply with the provisions of the new labelling regulations within a period of six months from the 23 March 2016.
To ensure safety standards the proprietary foods should comply with contaminants (chemical and microbiological) specifications prescribed for ingredients as applicable. In case of final product FBO should ensure that the food does not contain any pathogen organisms at a level that could render it unsafe.
Regulations for special purpose foods
FSSAI says that since novel foods, foods for special dietary use, functional food, nutraceuticals, health supplements and such other articles of food which the central government may notify in this behalf are excluded from definition of proprietary foods in these regulations so these special purpose foods will be governed by their own regulations as and when notified. If any FBO is manufacturing or selling foods under this special category, and if they have product approval. Then they can continue to be manufacture/ sell such products till such time as the specific regulations in this regard are notified.