FOOD SAFETY AND STANDARDS (FORTIFICATION OF FOODS) FIRST
AMENDMENT REGULATIONS, 2020
PREAMBLE
Whereas the draft of the Food Safety and Standards
(Fortification of Foods) Amendment Regulations, 2019, were published as
required under sub-section (1) of 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. REG/Fortification Amendment (1)/Notification/FSSAI-2018, dated
the 4th February, 2019, 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 Official Gazette containing the said notification
were made available to the public;
And whereas the copies of the said Gazette were made
available to the public on the 11th February, 2019;
And whereas the 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
clauses (e) of sub-section (2) of section 92 of the said Act, the Food Safety and
Standards Authority of India hereby makes the following regulations further to
amend the Food Safety and Standards (Fortification of Foods) Regulations, 2018,
namely:-
Regulation - 1. Short title and commencement.--
(1)
These regulations may be called the Food
Safety and Standards (Fortification of Foods) First Amendment Regulations,
2020.
(2)
They shall come into force on the date of
their publication in the Official Gazette and food business operator shall
comply with all the provisions of these regulations with effect from 1st July,
2021.
Regulation - 2.
In the Food Safety and Standards (Fortification of Foods)
Regulations, 2018 (herein after referred as said regulation)-
(A)
In regulation 2, in sub regulation (1), after
clause (d), the following clause shall be inserted, namely:-
"(da) "Fortified Processed Foods" means
processed foods (i.e., foods that have been altered from its natural state by
industrial processing methods) that have undergone the process of fortification
as per the provisions of these regulations. The same may have fortified staples
as raw materials and/or fortified with permitted micronutrients and additives
as specified under the Food Safety and Standards (Food Product Standards and
Food Additives) Regulation, 2011."
(B)
in regulation 3, after sub-regulation (4),
the following clauses shall be inserted, namely:-
"(5) Fortified Processed Foods may be
prepared from fortified food articles that may be cereals and/or milk;
(6) The Fortified Processed Food shall
provide 15-30% of the Indian adult RDA of micronutrient based on an average
calorie intake of 600 kcal from processed foods (approximately 1/3rd of daily
energy requirement for an adult);
(7) High Fat Sugar Salt (HFSS) Foods shall be
excluded from Fortified Processed Foods category. The definition of HFSS foods
shall have the same meaning as specified under the Food Safety and Standards
(Labelling and Display) Regulations, 2020."
(C)
in regulation 4, after sub-regulation (1),
the following sub-regulation shall be inserted, namely:-
"(2) Any manufacturer who fortifies any
processed food shall ensure that the level of micronutrients in such fortified
processed food shall fall within the range specified in Schedule-III."
(D)
in regulation 7, after sub-regulation (2),
the following proviso shall be inserted, namely:-
Provided that the requirements as specified in
sub-regulation (2) is not required in case of iodized salt (when fortified with
iodine).
(E)
in Schedule-I,-
(a)
for clause (3), the following shall be
substituted, namely:-
"3. Fortified Milk
Species identified milk (namely buffalo milk, cow milk,
goat milk, sheep milk and camel milk), full cream milk, toned milk, double
toned milk, skimmed milk and standardized milk, when fortified, shall be
fortified with the following micronutrients at the level given in the table
below, wherein the milk is to undergo the process of pasteurization,
sterilization, ultra high temperature sterilization/treatment or boiling:
|
S.
No. |
Nutrients/Source |
Level
of nutrient per litre of Species identified milk (namely buffalo milk, cow
milk, goat milk, sheep milk and camel milk)/full cream milk/toned milk/double
toned milk/skimmed milk/standardized milk |
|
1. |
Vitamin
A (?g RE)-Retinyl acetate or Retinyl palmitate |
270-450 |
|
2. |
Vitamin
D (?g) *Cholecalciferol or*Ergocalciferol (*Only
from Plant source) |
5-7.5 |
Note: Vitamin A (retinol): 1 IU= 0.3 ?g RE (Retinol
Equivalent); Vitamin D (Cholecalciferol or Ergocalciferol): 1 IU= 0.025
?g"
(b)
in clause (4), after the second table,
following statement shall be inserted, namely:-
"Multi-grain Atta may also be fortified with
vitamins and minerals at the same levels specified for 'Fortified Atta',
provided that the multigrain atta contains more than 50% as wheat flour in
it."
(F)
after Schedule-II, the following Schedule
shall be inserted, namely:-
"SCHEDULE-III
STANDARDS FOR FORTIFIED PROCESSED FOODS
[See sub-regulation (2) of regulation 4]
1.
Fortified Cereal Products:
(1)
Cereal products include Breakfast cereals,
Pasta and Noodles, when fortified, shall contain added iron, folic acid and
Vitamin B12 at the level given in the table below, namely:-
Table
|
S.
No. |
Nutrients/Source |
Level
of nutrient per 100 g |
|
1 |
Iron
(mg) Ferrous
citrate or Ferrous lactate or Ferrous sulphate or Ferric pyrophosphate or
electrolytic iron or Ferrous fumarate or Ferrous bis glycinate; or Sodium
Iron (III) Ethylene diamine tetra acetate, trihydrate (Sodium feredetate-Na
Fe EDTA); |
1.4-2.7 |
|
2 |
Folic
acid (?g) |
8-16 |
|
3 |
Vitamin
B12 (?g)-Cyanocobalamine, or Hydroxycobalamine; |
0.08-0.16 |
(2)
In addition, fortified cereal products, when
fortified, may also be fortified with following micronutrients, singly or in
combination, at the level in the table below, namely:-
Table
|
S.
No. |
Nutrient/Source |
Level
of nutrient per 100 g |
|
1. |
Zinc
(mg): Zinc Sulphate |
1.0-1.9 |
|
2. |
Vitamin
A (?g RE): Retinyl acetate or Retinyl Palmitate, |
48-96 |
|
3. |
Thiamine
(Vitamin B1) (mg): Thiamine hydrochloride or Thiamine mononitrate; |
0.1-0.19 |
|
4. |
Riboflavin
(Vitamin B2) (mg): Riboflavin or Riboflavin 5'-phosphate sodium; |
0.11-0.22 |
|
5. |
Niacin(Vitamin
B3) (mg): Nicotinamide or Nicotinic acid; |
1.3-2.6 |
|
6. |
Pyridoxine
(Vitamin B6) (mg): Pyridoxine hydrochloride; |
0.2-0.3 |
2.
Fortified bakery wares:
(1)
Bakery wares includes bread, biscuits, rusks
and buns, when fortified, shall contain added iron, folic acid and Vitamin B12
at the level given in the table below, namely:-
Table
|
S.
No. |
Nutrients/Source |
Level
of nutrient per 100 g |
|
1 |
Iron
(mg): Ferrous
citrate or Ferrous lactate or Ferrous sulphate or Ferric pyrophosphate or
electrolytic iron or Ferrous fumarate or Ferrous bisglycinate; or Sodium Iron
(III) Ethylene diamine tetra acetate, trihydrate (Sodium feredetate-Na Fe
EDTA); |
1.4-2.7 |
|
2 |
Folic
acid (?g) |
8-16 |
|
3 |
Vitamin
B12 (?g)-Cyanocobalamine, or Hydroxycobalamine; |
0.08-0.16 |
(2)
In addition, fortified bakery wares, when
fortified may also be fortified with following micronutrients, singly or in
combination, at the level in the table below:
Table
|
S.
No. |
Nutrient/Source |
Level
of nutrient per 100 g |
|
1. |
Zinc
(mg): Zinc Sulphate |
1.0-1.9 |
|
2. |
Vitamin
A (?g RE): Retinyl acetate or Retinyl Palmitate, |
48-96 |
|
3. |
Thiamine
(Vitamin B1) (mg): Thiamine hydrochloride or Thiamine mononitrate; |
0.1-0.19 |
|
4. |
Riboflavin
(Vitamin B2) (mg): Riboflavin or Riboflavin 5'-phosphate sodium; |
0.11-0.22 |
|
5. |
Niacin(Vitamin
B3) (mg): Nicotinamide or Nicotinic acid; |
1.3-2.6 |
|
6. |
Pyridoxine
(Vitamin B6) (mg): Pyridoxine hydrochloride; |
0.2-0.3 |
3.
Fortified Fruit Juices:
(1)
Fruit juices, when fortified, shall contain
Vitamin C at the level given in the table below:
Table
|
S.
No. |
Nutrient/Source |
Level
of nutrient per 100 m L |
|
1. |
Vitamin
C (mg): Ascorbic acid |
6-12" |