Health claims approved by FSSAI for foods complying FSS(Fortification of Foods) Regulation, 2016.

On 16.10.2016 FSSAI operationalized the FSS(Fortification of foods) Regulation,2016 which were later amended and re-operationalized on 18.10.2017.

The said regulation provides the  standards for Wheat flour, Rice, Milk, Salt and edible oils which may be fortified with micronutrients like Vitamin A, Vitamin D, Iron, Folic acid, Vitamin B12, Zinc, Thiamine, Riboflavin, Niacin, and Pyridoxine.

As per directions given by FSSAI on 22-11-2017, the approved health claims for foods under FSS(Fortification of foods) Regulation, 2016 are as follows:

Nutrient : Approved Health claim

1.Vitamin A : Help against night blindness.
2.Vitamin D : Support strong bones.
3.Vitamin B12 : Important for maintaining normal functioning of nervous system and blood formation.
4.Foliate & Folic acid : Important for foetal development and blood formation.
5.Iron : Fights anaemia.
6.Iodine : Required for normal growth, thyroid and brain function.
7.Zinc : Support a healthy immune system.
8.Thiamine: Required for normal nerve and heart function.
9.Riboflavin: Necessary to release energy from food.
10.Niacin: Necessary to release energy from food.
11.Pyridoxin : Necessary to release energy from food.

References:
1.  Direction regarding 'Health Claims' permitted under FSS (Fortification of Foods) Regulations, 2016. (Uploaded on: 02.01.2018)

Wax coatings on fresh fruits as permitted by FSSAI.

As per 2.3.6 of FSS(Prohibition and Restrictions on sale ) Regulation,2011

The Fresh Fruits and Vegetables cannot be sold if they have coatings of waxes, mineral oil and colours.

Exception:

Fresh fruits may be coated with
1.Bees wax (white and yellow)
2.Carnauba wax
3.Shellac wax

Permitted level of addition:

Fresh fruits may be coated with these waxes at level not exceeding Good Manufacturing Practices (GMP)

Mandatory lebelling requirement:

If fresh fruits are coated with wax, then they have be mandarily declare name of wax on its package in following manner:

Coated with wax (give name of wax)

References

As per 2.3.6 of FSS(Prohibition and Restrictions on sale ) Regulation,2011

Foods which needs AGMARK along with FSSAI.

Following is the list of articles of foods which requires AGMARK certification besides FSSAI.

1.Carbia Callosa
2.Honey
3.Ghee ( having less Reichert value and a different standard for Butyro-refractometer reading at 40 C than that specified for the area in which it is imported for sale or storage shall not be sold or stored in that area)
4.Til Oil (produced in Tripura, Assam and West Bengal)
5.The Blended Edible Vegetable Oils
6.Fat spread

Note:
No person can manufacture, sell or exhibit for sale above mentioned foods except under the AGMARK certification mark on label.

References:
FSS(Prohibition and Restrictions on Sale ) Regulation,2011.

Foods which needs BIS certification along with FSSAI.

Following is the list of articles of food which requires BIS certification besides FSSAI.

1.Infant milk food
2.Infant formula
3.Milk cereal based weaning food 4.Processed cereal based weaning food 5.Follow up formula
6.Condensed milk sweetened,
7.Condensed skimmed milk sweetened
8.Milk powder,
9.Skimmed milk powder,
10.Partly skimmed milk powder 
11.Partly skimmed sweetened condensed milk.
12.Packaged Drinking water
13.Mineral water.

Note:
No person can manufacture, sell or exhibit for sale above mentioned foods except under the BIS certification mark on label.

References:
FSS(Prohibition and Restrictions on Sale ) Regulation,2011.

List of strains of microorganism approved as probiotic by FSSAI.

FSSAI recognised following strains of microorganisms as probiotic in the schedule VII of FSS(Health Supplements,Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food)Regulation,2016.

1. Lactobacillus acidophilus
2. Lactobacillus plantarum
3. Lactobacillus reuteri
4. Lactobacillus rhamnosus
5. Lactobacillus salivarius
6. Lactobacillus casei
7. Lactobasillus brevis
8. Lactobacillus johnsonii
9. Lactobacillus delbrueckii sub- sp. bulgaricus
10. Bacillus coagulans
11. Lactobacillus fermentum
12. Lactobacillus caucasicus

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

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.