Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients)) Regulation, 2017

The Food Safety and Standards Act, 2006

Official text

MINISTRY OF HEALTH AND FAMILY WELFARE

(Food Safety and Standards Authority of India)

NOTIFICATION

New Delhi, the 1 1 th September , 2017

F. No. 12/PA Regulation/Dir (PA)/FSSAI-2016. — 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 31

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 9

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: —

Regulations

1 Short title and commencem ent.― (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.

2. Definitions. ― (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;

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.

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3. Prior approval for manufacture, storage, sale, distribution, import, etc.― (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.

4. Procedure for grant of prior approval. ― (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.

FORM – I

( See sub-regulation (1) of regulation 4)

(Application for approval of non-specified food and food ingredient)

1. Application for (Please tick √): -

o Novel food or novel food Ingredients or processed with the use of novel technology

o New additives

o New processing aids including enzymes

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o Articles of food and food ingredients consisting of or isolated from microorgan isms,

bacteria, yeast, fungi or algae

o 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 ma de 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

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(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

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

(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

(1) Specification

(2) Enzyme activity

(3) Purity

(4) Residual limit in the final product (in case of processing aid)

(d) A rticles of food and food ingredients consisting of or isolated from microorganisms, bacteria, yeast,

fungi or algae: -

No.

Data required for microorganisms used as Food (Directly Fed) or used as a s ource of food ingredients

(1) Nature of microbe Bacterium/Yeast/Fungus/Algae

(2) Name of microbe Genus Species Strain

(3) Source Indigenous Imported

(4) If locally isolated Isolated

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

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(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

Name and address of

Referenc e 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

(9) Material Transfer

Agreement between

and

India

Yes (Copy) No

(10) If the organism has been

genetically manipulated.

Yes No

(11) Any institutional bio

safety mechanism in place

(12) Safety / Ge nerally

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 Regulato r 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.

Note: (1) Mention “not applicable” (NA) wher ever 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.

FORM-II

( See sub-regulation (4) of regulation 4)

(Approval/Rejection)

Application No:

Date of application:

Name of organisation:

Name of the applicant:

Registered office address:

Authorised person:

Name of the food product:

Product category:

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Composition:

Ingredients Food Additives

Name INS No Limits (GMP or

mg/Kg)

1. Conditions for approval:

2. Reasons for rejection, if any:

(Authorised Signatory)

[ADVT.-III/Exty./223/17]

PAWAN AGARWAL, Chief Executive Officer