Through its recent notification the FSSAI has invited suggestions, comments and objections on its proposed regulations on ‘Approval for Non-Specified Food and Food Ingredients’ within a period of 60 days beginning 4 October 2016. Once notified in the Official Gazette these regulations will be called the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2016.
The following is a gist of the main points of the proposed regulation
Only those articles of food or food ingredients which have not been permitted to be manufactured, stored, sold, distributed or imported under Regulations of the FSS Act and will require approval prior to being manufactured, stored, sold, distributed or imported. The articles of foods and food ingredients that fall in this category are:
- Novel foods or foods 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 Regulation under the Act
- New additives and processing aids
- Foods manufactured or processed with the use of novel technology
Procedure for grant of approval
The manufacturer or importer needs to submit an application as per the Annexure I & II along with relevant documents and fee to the FSSAI (FSSAI may specify the amount of application fee and also review it from time to time). If required, after scrutiny the FSSAI could ask the FBO for additional supporting documents, data or clarifications. After making a safety assessment the product could be granted or refused approval by the FSSAI. If approval is granted then the FBO must submit to the FSSAI analysis certificates of the product for parameters relating to chemical, nutritional, microbiological, heavy metals, pesticide residues and naturally occurring toxins.
Rejection of application
If the approval is rejected the FBO can take recourse to appeal to the Chairperson FSSAI against the rejection. The FBO may also file review petition before the Central Government against the decision of the Chairperson, FSSAI. In such a case the decision of the Government then shall be final. The FSSAI can also revoke or suspend any approval granted to any FBO provided the reasons for doing so are recorded in writing and which will be binding on the FBO.
Food health risk
In case the FBO learns of a health risk after the approval of the product has been given the approval, then the FBO must immediately suspend the import, manufacture, sale, or distribution of the said article of food and take steps to recall the same as per the procedure laid down in the Food Safety and Standards (Food Recall) Regulation, 2016 and immediately intimate the FSSAI.
All the Food Safety Officers or Designated Officers will also immediately inform the FSSAI if any complaint is received regarding safety of the food approved by the FSSAI under these Regulations.
The FSSAI has also provided the application formats for
- approval of non-specified food and food ingredients in Annexure I
Annexure II provides
- Application details for Novel foods or foods containing novel Ingredients or processed with the use of Novel technology
- Application for Food ingredients with a history of human consumption in the country but not specified in any Regulation under the Act
- Application format for New Additives
- Application format for Processing Aids & Enzymes.
- Application format for Foods and food ingredients consisting of or isolated from microorganisms, fungi or algae
Some of the important details FBO must provide to the FSSAI as mentioned in the application formats are as follows
- Specify the target group the food is aimed at
- Name of the product /ingredient and justification for the same
- Detailed composition of the product (with quantity of the ingredients and additives added in the product )
- Source of ingredient whether animal, chemical, botanical or micro-biological including source genus and species where required
- Any new ingredient or ingredients which on date are not listed in FSSR, or an ingredient which has been introduced for the first time in India along with evidence to prove that the product / ingredient is safe
- Documentary evidence regarding regulatory status of the ingredients.
- Indicate the ICMR, RDA levels for vitamins, minerals and such other nutrients where RDAs are specified
Functional use of ingredient/product
- FBO must specify the functional use of the proposed product in the target group
- Provide evidence of human consumption use and documentary evidence for the justification for the quantity used along with data
- Provide intended use of the product, along with specific benefit, advantages and disadvantages to the consumers or food manufacturers, if the proposed food product/ingredient is allowed supported by documentary evidence.
- Provide Certificate of analysis (COA) from third party NABL/ILAC recognized laboratories which demonstrates the compliance of the Ingredients/Products to the specifications as claimed by the applicant. Such COAs should include chemical parameters, nutrient levels, calorific value, metals contaminants (Pb,Cd,As, Cr, Cu, Sn, Hg, Ni), naturally occurring toxic substances, aflatoxins, pesticide residues, TPC,Y&M, E-Coli, Coli Form and freedom from Pathogenic organisms etc.
- Provide validated test methods as needed for the analysis as a reference of FSSAI.
- Attach PROPOSED LABEL FOR APPROVAL in compliance with Section 23 of the FSS Act, 2006 and Food Safety and Standards (Packaging and Labelling) Regulations, 2011 to be attached
Method of Manufacture
FBO must also provide
- process used for manufacture of the product in detail
- real time or accelerated Shelf Life/Stability of product (shelf life studies)
- Specific storage conditions along with detailed directions for use and expected negative effects of failure to store the product under optimal conditions.
- history of consumption of product along with supporting documents, geographical area of use and established history of safe use in at least two countries that have food regulations as prevalent in EU, USA, Canada, Australia, Japan and China
- average quantity of consumption and its positive and negative effects
- Provide documents on risk assessment/toxicity studies
- Safety or risk assessment review can be provided from published studies or from safety studies conducted on the ingredient and food product by the applicant
- Information on human studies and toxicological studies, if any
- Provide evidence to demonstrate that the proposed product or the ingredient will not adversely affect any specific population groups i.e. Pregnant women, lactating mothers, children, elderly or any other vulnerable group
- History of use of new ingredient/product in other countries
- Allergenicity or other adverse effects in humans associated with the consumption of new foods/ ingredients. This may be reports prepared by WHO or by other national or international agencies responsible for food safety or public health like Codex, USFDA, EU, FSANZ etc.
- Mention countries where the product/ingredient is permitted for direct and/or indirect human consumption as food. If so, provide the level and purpose of consumption by the consumers with the relevant documentation
For regulatory requirements attach
- Copy of agreement of relationship of applicant and manufacturer and other entities involved in the food business of the proposed product (e.g. Marketer, importer, re-packer).
- Indexed list of documents in support of the application and identify these in relation to the information code herein.
NOTE: All data documentary evidence provided by the applicant must be from international peer reviewed journals, international bodies including WHO and FAO. Only complete records/studies shall be provided