Are you claiming your product as 'Proprietary Food'? You need to comply this

On 10 Oct 2016, FSSAI published a gazzete notification which provided the much awaited specifications for proprietary food product. This notification exempted proprietary foods from requirement of product approval (from FSSAI )and introduced self regulatory mechanism for ensuring safety of proprietary foods.

For claiming your product as proprietary food, following conditions has be complied by Food Business Operator which are as follows:

Condition -1:Definition of Proprietary Food

Proprietary food means an article of food that has not been standardised under FSS(Food Product Standards and Additives) Regulation,2011.

It does not include:
1.Novel foods
2.Foods for special dietary uses,
3.Foods for special medical purposes, 4.Functional foods,
5.Nutraceuticals
6.Health supplements
(These type of foods are defined in section 22 of FSS Act, 2006)
7. Such other food articles which the Central Government may notify in this behalf.

It is interesting to note that , any deviation in quality parameters of a standardised food, as specified in the Food Safety and Standards Regulations made under the Food Safety and Standards Act, 2006 cannot qualify the resultant product as a proprietary food.

Eg.FSSAI specification for Fruit Jelly are as follows
1. Fruit Juice : Not less than 45%
2.TSS: Not less than 65%

And

If anyone manufactures Fruit Jelly with following specification
1.Fruit Juice:40%
2.TSS: 65%
One cannot claim it as 'Proprietary Food'.

Condition-2:Use Specified Ingredient Only

Proprietary food should be prepared from only those ingredients (other than additives)which are either standardised or permitted for use in the preparation of other standardised foods under FSS(Food Product Standards and Additives) Regulation,2011.

It may also contain vitamins and minerals in quantities not exceeding one RDA of the respective micronutrients.

Condition-3:Use Additives permitted to be used in specific category of food only
One should use only such additives and at such levels, as specified for the Category or Sub-category under Appendix A of FSS(Food Product Standards and Additives) Regulation,2011 to which your food belongs.

It is important to note that,
Such Category or Sub-category should be clearly mentioned on the label along with the generic name, nature and composition of the proprietary food.

Condition-4:Microbial Standards for Proprietary Foods
Proprietary food should comply with the microbiological requirements as specified in Appendix B of FSS(Food Product Standards and Additives) Regulation,2011.
If no microbiological standards are specified for any foods or food categories in Appendix B of these regulations, proprietary foods falling under such food categories should not contain any pathogenic microorganism at a
level that may render the food product unsafe.

Points to be noted:
1. Proprietary food has comply with the provisions, as applicable, of all other Regulations made under the Food
Safety and Standards Act 2006.

2. No health claims should be made in respect of proprietary foods either on the product label or otherwise, unless it is substantiated by adequate and scientific evidence.

3. Be aware that, the Food Business Operator is fully responsible for safety of the proprietary food in respect of human consumption.

References:
1.http://old.fssai.gov.in/Portals/0/Pdf/Gazette_Notification_Proprietary_Foods_19_10_2016.pdf

2.Clause no 2.12.1. of FSS(Food Product Standards and Additives) Regulation,2011.

Do you know the food exempted from FSSAI's Labeling requirements?

As per clause no. 2.6.1 of FSS (Packaging & Labeling) Regulation,2011 food products belonging to following cases are
exempted from labelling requirements:

Case-1. Where the surface area of the package is not more than 100 square centimeters.

Label of such package is exempted from the requirements of:

1.List of ingredients
2.Lot Number or Batch Number or Code Number,
3.Nutritional information and
4.Instructions for use

but these information should be given on the wholesale packages or multi piece packages, as the case may be.

Case-2. Packages having surface area of less than 30 square centimeters.

Label of such package is exempted from the requirements of:

1.List of ingredients
2.Lot Number or Batch Number or Code Number
3.Nutritional information
4.Instructions for use
5.The 'date of manufacture' or 'best before date' or 'expiry date'

but these information shall be given
on the wholesale packages or multipiece packages, as the case may be.

Eg. Candy in pillow pack , candies in Jar

Case- 3.Liquid products marketed in bottles, if such bottle is intended to be reused for refilling.

Requirement of list of ingredients is exempted, but the nutritional information specified in regulation 2.2.2 (4) of FSS (Packaging & Labeling) Regulation,2011  need to be given on the label.

Provided that in case of such glass bottles manufactured after March 19, 2009, the list of ingredients and nutritional information need to be given on the bottle.

Eg. Beverages in glass bottles

Case-4. Food with shelf-life of not more than seven days.

The 'date of manufacture' is not required to be mentioned on the label of packaged food articles, but the 'use by date' must be mentioned on the label by the manufacturer or packer.

Eg. Milk packets, bread etc.

Case-5. Multi piece packages containing packages having surface area more than 100  centimeters square.

Label of such package is exempted from the requirements of:

1.List of ingredients,
2.Nutritional information ,
3.Date of manufacture/ packing,
4.Best before
5.Expiry date
6.Labelling of irradiated food
7.Vegetarian logo/non vegetarian logo.

The Food Recall Regulation of FSSAI, India: In Short

On 18 Jan 2017, FSSAI implemented FSS (Food Recall) regulation,2017 which mandates FBOs to have their own Food Recall Plan and follow a specific procedure for recalling the food whose safety is at risk which is as follows:

Introduction: 

The concept of recall actually originated from recall of vehicles in automobile industry which later extended to various manufacturing sectors including food. Food recall is nothing but the process of removing food product under question from all places where it had been distributed. It also includes consumers, which may have purchased it. This regulation is specifically  applicable to food having safety at risk. It is interesting to note that, the food recalled for any other reason does not fall under the purview of this regulation and hence FBO need not to follow the recall procedure as mentioned in the regulation.So as to make this process of food recall more effective, efficient and quick the regulation mandates FBOs to have their own strategy/emergency plan in a documented form. The Food Recall Plan is document which contains an action plan when there is an urgent need to remove the food product from market at any stage of food chain.Usually this plan is made as a part of Food Safety Management System Plan which is an another mandatory document required for obtaining Food License in India. This regulation have not provided any model food recall plan, but given guidelines on mandatory information that need to be present in a typical food recall plan as follows:

1.Names & address of Raw material Suppliers.

2.Name & address of Customers(B2B) which includes Wholesale distributors, retailers down the line.

3.Nature of food

4.Date of purchased

5.Date of delhi very

6.Lot number

7.batch code

8.Pack size

9.brand name

10.Date of Manufacture

11.Best before date/ Date of expiry

(1- 11 As applicable depending upon type of product.)

For the product like alcoholic beverages where date of expiry is not applicable, but FBO has to preserve the record of purchase at least for two years.

FOOD RECALL PROCEDURE:

The recall regulation of India mandates FBOs to follow the specific procedure so as to ensure the rapid and complete recall of product.The regulation basically gives standard protocol which is need to be followed for effective & efficient recall of food. The recall procedure is basically divided into three steps which is as follows:

1. Initiation of recall

In this step, FBO has to intimate concerned food authority about his intention to recall food. This intimation has to be made in the format as specified in Schedule-I of the regulation, within 24 hrs of realization of need for recall.FBO also needs to prepare a Food Recall Notice and circulate it throughout the distribution chain immediately.

This food recall Notice require to have following information:

(a) Name of the Food Business Operator recalling the food;

(b) Name of the food, brand name, pack size, batch and code number, date of manufacture, used by date or best before date;

(c) The contamination or violation in the food or reason for such recall;

(d) “do not consume message”;

(e) Health warning and action;

(f) The places or outlets where the food is found;

(g) The action to be taken by the consumer;

(h) Contact number for queries.

Decision to stop production is totally up to the discretion of FBO, till it is specifically ordered by Food Authority. If FBO realize that there is a need to stop the production, he should voluntarily do so without waiting for orders from food authority. But during the process of recall, FBO need to respond to every query raised by Food Authority within 24 hrs of receipt of query.

2. Reporting Recall Status:

In this step, progress report about effectiveness of recall is to be submitted to food authority in the format as specified in shedule-II of regulation. Normally, FBO needs to submit this status report once in a weak, but frequency of submission can be decided by food authority. It is important to note that , FBO needs to keep submitting the status report till food authority issues a termination letter for that perticular recall.

3. Termination of recall:

In this step the FBO needs to write a letter to food authority requesting termination of recall, only if FBO is confidant about effectiveness of recall. This request letter has to be made in the format as specified in Schedule-III of regulation. The request letter must be sent along with the Status report (Schedule-II) demonstrating the the effectiveness of recall. If Food Authority is convinced with effectiveness of recall and believes that food under recall has been removed and/or disposed appropriately, the recall can be terminated. FBO also has to show the evidences that the necessary corrective actions have been taken to ensure to avoid such incidents again.

On receipt of such request, Food Authority needs to reply FBO within two weeks of receipt. If Food Authority is not convinced about effectiveness of recall, a legal action can be is initiated against FBO.

FBOs Exempted from having recall plan:
1.The food retailers are not required to have a food recall plan, unless they are also engaged in the manufacture or importation or wholesale supply of food.
2.Food service sector such as restaurants, caterers and takeaway joints are exempted from having a recall plan unless they are running multi-outlet food business chains with integrated manufacturing and distribution network.


References:
www.fssai.gov.in
http://www.fssai.gov.in/home/fss-legislation/fss-regulations.html

Information mandatarily present in nutritional facts of label as per FSSAI.

1.Nutritional Information or nutritional facts should be given per 100 gm or 100ml or per serving of the product.

2.Information mandatarily present in nutritional facts is as follows:—

(i) Energy value in kcal.

(ii) The amounts of protein, carbohydrate (specify quantity of sugar) and fat in gram (g) or ml.

(iii) The amount of any other nutrient for which a nutrition or health claim is made.

(Where a claim is made regarding the amount or type of fatty acids or the amount of cholesterol,the amount of saturated fatty acids, monounsaturated fatty acids and polyunsaturated fatty acids in gram (g) andcholesterol in milligram (mg) shall be declared, and the amount of trans fatty acid in gram (g) shall be declared inaddition to the other requirement given above.)

(iv) Wherever, numerical information on vitamins and minerals is declared, it shall be expressed in metricunits(mg/ug).

(v) Where the nutrition declaration is made per serving, the amount in gram (g) or milliliter (ml) shall beincluded for reference beside the serving measure.

3. It is important to note that FSSAI checks the compliance to quantity of declared nutrients on the label according to the established practices. Hence, at the time of analysis due consideration is given, based on shelf-life, storage, and inherent nature of the food shall be kept in view in case of quantity declared nutrients. But there is no clear cut guideline on amount of fluctuations acceptable in quantities of declared nutrients.

Reference
www.fssai.gov.in
2.2.2.3 of FSS (Packaging & Labeling) regulation,2011.

Do you know the food products exempted from mentioning nutritional facts on label?

As per clause no. 2.2.2.3(v).i  of FSS (Packaging & Labeling) Regulation,2011 following articles of food are exempted from mentioning nutritional information on label and can be sold without nutritional facts.

1.Raw agricultural commodities like,   wheat, rice, cereals.
2.Spices and spice mixes.
3.Herbs & condiments.
4.Table salt
5.Sugar & Jaggery
6.Non –nutritive products like, soluble tea, coffee, soluble coffee, coffee-chicory mixture
7.Packaged drinking water
8.Packaged mineral water
9.Alcoholic beverages
10.Fruit and vegetables, processed and pre- packaged assorted vegetables,
fruits, vegetables.
11.Products that comprise of single ingredient
12.Pickles
13.Papad
14. Foods served for immediate consumption such as served in hospitals, hotels or by food services vendors or halwais.
15.Food shipped inbulk which is not for sale in that form to consumers.

References
www.fssai.gov.in
2.2.2.3(v).i  of FSS (Packaging & Labeling) Regulation,2011.

How to put FSSAI logo and license number on label?

COLORED LOGO NOT REQUIRED
As per the recent order dated 10 Feb 2017 by FSSAI regarding FSSAI logo and license number, it is mandatory for every food business operator to put FSSAI logo and 14 digit license number on principle display part of label in following manner.

Lic. No.XXXXXXXXXXXXX

                                                         
It is interesting to note that, FSSAI didn't asked to put their logo in particular color combination. It just needs to be in contrast with background color of  the package/label so that it is clearly visible to consumers. Eg. If your package/label is of WHITE color then FSSAI logo and license number can be put in BLACK color.

MULTIPLE LOGOS NOT REQUIRED
Secondly, if you have multiple manufacturing units, then it is not required to put FSSAI logo beside the address of every manufacturing unit.You just need to put the 14 digit license number of that manufacturing unit beside its address in following manner. In this case also you need to put atleast one FSSAI logo and licence number in the manner as mentioned above.

Manufactured by:
ABC,
Ashok Vihar,
Plot no 276,MIDC,XYZ
Lic. No.XXXXXXXXXXXXXX

EFG,
Plot no 987, MIDC,
PUNE
Lic. No.XXXXXXXXXXXXXX

EXEMPTION FOR PACKAGES HAVING SMALL SURFACE AREA
As per notification dated 23 Jun 2014, clause no 2.6.1 of FSS (Packaging and labeling) regulation ,2011 made applicable to display of logo and license number. Hence packages having surface area below 100 centimeter square need not to put logo and license number on their label/package but whole packages/multi piece package need to display them.




References:
1.www.fssai.gov.in
2.http://fssai.gov.in/dam/jcr:6235bb65-782f-4792-a0f9-3e07539f7402/Order_FSSAI_Logo_10_02_2017.pdf
3.http://old.fssai.gov.in/Portals/0/Pdf/Notification%2824.06.14%29.pdf

List of food ingredient approved as prebiotic by FSSAI, Indian food sector regulating authority.

FSSAI recognised following food ingredient as prebiotic in the schedule VIII ofFSS(Health Supplements,Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food)Regulation,2016.

1. Polydextrose
2. Soybean oligosaccharides
3. Isomalto-oligosaccharides
4. Fructo-oligosaccharides
5. Gluco-oligosaccharides
6. Xylo-oligosaccharides
7. Inulin
8. Isomaltulose
9. Gentio-ologsaccharides
10. Lactulose
11. Lactoferrin
12. Sugar alcohols such as lactitol, sorbitol, maltitol, inositol, isomalt
13. Galacto-oligosaccharides

Now using these ingredient , food R & D person can easily design specific product having established health effect, which ultimately help in justifying the health claims on label.