Whereas the draft of the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017 were published as required under Section 92 of the Food Safety and Standards Act, 2006 (34 of 2006), vide notification of the Food Safety and Standards Authority of India, number F. No. 12/PA Regulation/Dir (PA)/FSSAI-2016, dated the 31st January, 2017, in the Gazette of India, Extraordinary, Part III, Section 4, inviting objections and suggestions from the persons likely to be affected thereby, before the expiry of the period of thirty days from the date on which the copies of the Gazette containing the said notification were made available to the public;
And whereas copies of the said Gazette were made available to the public on 9th February, 2017;
And whereas objections and suggestions received from the public in respect of the said draft regulations have been considered by the Food Safety and Standards Authority of India;
Now, therefore, in exercise of the powers conferred by clause (v) of sub-section (2) of Section 92 of the said Act, the Food Safety and Standards Authority of India hereby makes the following regulations, namely
(1) These regulations may be called the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017 .
(2) They shall come into force on the date of their publication in the Official Gazette.
(1) In these regulations, unless the context otherwise requires
(a) Act means the Food Safety and Standards Act, 2006 (34 of 2006);
(b) Approval means a permission to manufacture or import any article of food or food ingredients, intended directly or indirectly for human consumption, that has not been specified under any other regulations made under the Act;
(c) Food Authority means the Food Safety and Standards Authority of India established under Section 4 of the Act;
(d) Non-specified food means any food other than proprietary food or food ingredients, including additives, processing aids and enzymes for which standards have not been specified in any regulation made under the Act.
(2) The words and expressions used herein and not defined, but defined in the Act or rules or regulations made thereunder, shall have the meaning as assigned to them in the Act, rules or regulations.
(1) No person shall manufacture or import any non-specified food or food ingredient, as the case may be, except with the prior approval of the Food Authority.
(2) The provisions of these regulations are in addition to, and not in derogation of, any other rules or regulations made under the Act.
(1) The manufacturer or importer of non-specified food shall submit an application in Form I of these regulations along with necessary documents and fee to the Food Authority.
(2) The Food Authority shall scrutinize the application and information provided by the applicant.
(3) The Food Authority may direct the applicant to submit additional supporting documents, data or clarifications, if required.
(4) The Food Authority may either grant approval or reject the application, as per Form II, on the basis of the safety assessment of the article of food.
(5) Where approval is granted, the food business operator shall submit to the Food Authority, a certificate of analysis in respect of the chemical, physical, microbiological and nutritional parameters of the food manufactured or imported.
(6) The food business operator may file an appeal before the Chairperson, Food Authority against any decision of rejection of his application.
(7) A food business operator, who is aggrieved by the decision of the Chairperson, Food Authority may file review petition to be placed for consideration in the meeting of the Food Authority.
(8) The Food Authority may, for reasons to be recorded in writing, suspend or revoke any approval granted to any food business operator.
(9) The Food Authority may review from time to time, the amount of fee for filing an application.
(10) If a food business operator has reason to believe that the food for which the approval has been granted poses any risk to health, he shall immediately suspend the manufacture, import, sale, or distribution of such article of food and take steps to recall the same under intimation to Food Authority in accordance with the provisions of the Food Safety and Standards (Food Recall) Regulations, 2017.
(11) Food Safety Officers and Designated Officers shall immediately inform the Food Authority of any complaint received regarding safety of any product approved by the Food Authority under these regulations.
(12) The food business operator shall, after grant of approval apply for license as per the procedure specified in the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011.
[See sub-regulation (1) of Regulation 4]
(Application for approval of non-specified food and food ingredient)
1. Application for (Please tick )
Novel food or novel food Ingredients or processed with the use of novel technology
New additives
New processing aids including enzymes
Articles of food and food ingredients consisting of or isolated from micro-organisms, bacteria, yeast, fungi or algae
Any other non-specified food, please specify
2. General information
(1) Name of the applicant
(2) Name of the authorised person
(3) Mobile No./Phone No.
(4) E-mail
(All communications will only be made through the above email and phone number)
(5) Name of the organisation
(6) Address of the organisation/registered office
(7) Licence number, if any
(8) Nature of business
(9) Name of the food product/ingredient/additive/enzyme/processing aid, and proprietary name, if any
(10) Justification of the name
(11) Proposed product category
(12) Source of food ingredient(s) (animal, chemical, botanical or micro-biological)
(13) In case of animal, botanical or micro-biological source, genus and species of the organism shall be mentioned
(14) Functional use
(15) Intended use
(16) Certificate of analysis from third party National Accredited Board of Laboratories (NABL) or International Laboratories Accreditation Cooperation (ILAC) recognised laboratories shall be provided. The certificate of analysis shall include physical, chemical and microbiological parameters relevant to the product along with the validated test method and other test methods, if any with references wherever applicable
(17) Manufacturing process in brief
(18) Regulatory Status
(Mention the countries where the product is permitted for direct or indirect human consumption as food. If so, provide the level and purpose of consumption by the consumers with the relevant regulations along with the documentary evidence.)
(19) Copy of agreement of relationship of applicant and manufacturer and other entities involved in the food business of the proposed product, namely, marketer, importer, re-packer
(20) Safety Information(Documents on risk assessment or toxicity studies)
(a) The information shall be based on safety or risk assessment review from published studies and safety studies conducted on the ingredient and food product by the applicant
(b) Provide evidence to demonstrate that the proposed product or the ingredient will not adversely affect any specific population groups that is pregnant women, lactating mothers, children, elderly or any other vulnerable group
3. Additional specific information
(a) Novel food or novel food Ingredients or food processed with the use of novel technology
(1) The target group for the said proposed food, if any
(2) Detailed composition of the product (with quantity of the ingredients and additives added in the product)
Any new ingredient(s) (Please specify if the product has one or more new ingredients which as on date is not listed in Food Safety and Standards Regulation, or an ingredient which has been introduced for the first time in India)
(3) Details of new technology
(4) Safety Information (Documents on risk assessment or toxicity studies to be attached)
(a) Information on human studies including dietary exposure, nutritional impact and potential impact on the consumer if any
(b) Toxicological studies including results of Ame's tests to test mutagenecity, chromosomal aberration tests, studies for reproductive toxicity, prenatal developmental toxicity studies
(c) Allergenicity (published or unpublished reports of allergenicity or other adverse effects in humans associated with the food consumption; may include reports prepared by World Health Organisation or by other national or international agencies responsible for food safety or public health)
(5) History of consumption of food product/food ingredient, (attach supporting documents)
(a) Geographical area of use (with established history of safe use in at least two countries, with well-established regulatory status)
(b) Quantity of consumption
(c) Duration of consumption (in years)
(b) New additives
(1) Chemical name and INS No.
(2) Purity (food grade or equivalent)
(3) Acceptable Daily Intake (ADI) specified by JECFA or any other risk assessment body
(4) Proposed level of use in food category
(5) In case of colouring agent provide (Colour Index) colour number, where applicable
(c) New processing aids including enzymes
(1) Specification
(2) Enzyme activity
(3) Purity
(4) Residual limit in the final product (in case of processing aid)
(d) Articles of food and food ingredients consisting of or isolated from micro-organisms, bacteria, yeast, fungi or algae
| Sl. No. |
Data required for micro-organisms used as Food (Directly Fed) or used as a source of food ingredients |
|||
| (1) |
Nature of microbe |
Bacterium/Yeast/Fungus/Algae |
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| (2) |
Name of microbe |
Genus |
Species |
Strain |
| (3) |
Source |
Indigenous |
Imported |
|
| (4) |
If locally isolated |
Isolated |
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| Deposited in the national culture collection centre (eg-Microbial Type Culture Collection and Gene Bank, (MTCC), National Collection of Dairy Cultures (NCDC) Indian Type Culture Collection (ITCC)) |
Yes |
No |
||
| (5) |
If deposited in a national culture collection centre |
Name and address of Culture collection centre |
Reference No. |
Receipt (Copy) |
| (6) |
If bought from national culture collection centre |
Name and address of Culture collection centre |
Reference No. |
Receipt (Copy) |
| (7) |
If imported and privately Isolated |
Country of origin |
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| Name and address of the Foreign organization/Industry |
Reference No. |
Receipt Copy |
||
| (8) |
If bought from an international culture collection centre [e.g. American Type Culture Collection centre (ATCC), European Culture Collections Organisation (ECCO)] |
Name and address of International Culture Collection Centre |
Reference No. |
Receipt (Copy) |
| (9) |
Material Transfer Agreement between exporter/foreign entity and importer/manufacturer in India |
Yes (Copy) |
No |
|
| (10) |
If the organism has been genetically manipulated. |
Yes |
No |
|
| (11) |
Any institutional bio safety mechanism in place |
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| (12) |
Safety/Generally Recognised as Safe status (GRAS) of the microbe |
Copy |
||
| (13) |
Declaration by the manufacturer or importer regarding safety and end use |
The undersigned verifies that all ingredients are approved for use by the Export Country National Regulator or appear on their Generally Recognised as Safe list (Name of the Regulatory Agency), and each product is intended for human consumption and is available for sale in the country of origin without restriction. |
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Note: (1) Mention not applicable (NA) wherever necessary.
(2) All data documentary evidence provided by the applicant shall be from international peer reviewed journals, international bodies including World Health Organization (WHO) and Food and Agricultural Organization (FAO). Only complete records or studies shall be provided.
[See sub-regulation (4) of Regulation 4]
| Application No: |
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| Date of application: |
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| Name of organisation: |
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| Name of the applicant: |
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| Registered office address: |
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| Authorised person: |
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| Name of the food product: |
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| Product category: |
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| Composition: |
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| Ingredients |
Food Additives |
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| Name |
INS No |
Limits (GMP or mg/Kg) |
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| Application status: |
Approved/Rejected |
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1. Conditions for approval:
2. Reasons for rejection, if any:
(Authorised Signatory)
1. Ministry of Health and Family Welfare (Food Safety and Standards Authority of India), Noti. No. F. No. 12/PA Regulation/Dir (PA)/FSSAI-2016, dated September 11, 2017, published in the Gazette of India, Extra., Part III, Section 4, dated 13th September, 2017, pp. 7-12, No. 354