The Food Safety and Standards Authority of India (FSSAI) has proposed a Draft Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2017 relating to Foods for Infant Nutrition and Bakery Products.

These draft regulations will be finalized as soon as the suggestions and objections (if any) from all the stakeholders are received by FSSAI within the stipulated timeframe (30 days) from the date of this notification i.e. 18th April, 2017. These will come into force on the date of their final publication in the Official Gazette of India.

Regulations on Foods for Infant Nutrition and Bakery ProductsAI re

As per these Draft Regulations, the modifications made in the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 under regulation 2.1, relating to “Dairy Products and Analogues” in sub-heading “Infant Milk Substitutes” under sub-regulation 2.1.9 “Foods for Infant Nutrition”, the following should be noted:

Amendment, 2015

  • An amendment was made on 17th February 2015, termed as Safety and Standards (Food Product Standards and Food Additives) (Amendment) Regulations, 2015.

Salient Features of the Amendment 

  • After the heading “Foods for Infant Nutrition”, the sub-heading “Infant Milk Substitutes” was added.
  • In sub-regulation 2 relating to infant formula, after the second proviso, the following proviso was inserted, namely:
  • “Provided also that the lactose free or lactose and sucrose free or sucrose free infant milk substitutes shall conform to the following requirements, except the requirements of milk protein and milk fat, in the following manner, namely:

(a) Total protein% by weight must not be less than 10.0% and not more than 16%;

(b) Total fat% by weight must not be less than 18.0%; and

(c) The lactose in the product claimed to be lactose free must not exceed 0.05%.”

  • In Clause 3 before the words “milk cereal based complementary food”, the sub-heading “Infant Foods” was inserted.
  • In Clause 4 relating to processed cereal based complementary food, at the end, the following proviso was inserted, namely:
  • “Provided that the processed cereal based complementary foods for use in specific conditions, where protein needs to be restricted and where other cereals like wheat, soya, legumes and milk cannot be used, such processed cereal based complementary foods shall be prepared with single cereal like rice or ragi, which must have the minimum protein content of 6-9%, such products shall be conspicuously labelled, ‘Processed Mono Cereal Based Complementary Food for use in specific conditions under medical guidance only’.”

Amendment, 2016

  • An amendment was made on 13th July 2016, termed as Safety and Standards (Food Product Standards and Food Additives) 4th Amendment Regulations, 2016.

Salient Features of the Amendment 

In Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 in regulation 2.1, in sub-regulation 2.1.9, the following changes were made:

  • In Clause 2, after the first paragraph, the following paragraph was inserted, namely:
  • “It may contain algal and fungal oil as sources of Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA) from Crypthecodinium cohnii, Mortierella alpina, Schizochytrium sp., and Ulkenia sp. at the level of maximum 0.5%. DHA of total fatty acids and ratio of ARA: DHA as 1:1 minimum: Provided that DHA content shall not be less than 0.2% of total fatty acids, if a claim related to the addition of DHA is made.”
  • In Clause 5, after the first paragraph, the following paragraph was inserted, namely:
  • “It may contain algal and fungal oil as sources of Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA) from Crypthecodinium cohnii, Mortierella alpina, Schizochytrium sp., and Ulkenia sp. at the level of maximum 0.5%. DHA of total fatty acids and ratio of ARA: DHA as 1:1 minimum: Provided that DHA content shall not be less than 0.2% of total fatty acids, if a claim related to the addition of DHA is made.”

Salient Features of the Draft Regulations (2017)

As per the Draft Regulations (2017), under regulation 2.1, relating to “Dairy Products and Analogues” in sub-heading “Infant Milk Substitutes” under sub-regulation 2.1.9 “Foods for Infant Nutrition” the following points should be noted as a continuation of the previous amendments (2015 and 2016).

  • In para 1, after Sl. No. 37 and the entries thereto, the following proviso has been inserted, namely:
  • “Provided further that in ready to drink infant milk substitute, lecithin and ascrobyl palmitate may be used up to maximum limit of 0.5 g/100 ml and 1 mg/ 100 ml respectively.”
  • In para 2, after Sl. No. 38 and the entries thereto, the following proviso has been inserted, namely:
  • “Provided further that in ready to drink infant milk substitute, lecithin and ascrobyl palmitate may be used up to maximum limit of 0.5 g/100 ml and 1 mg/ 100 ml respectively.”

As per the Draft Regulations (2017), under regulation 2.4, relating to “Cereal and Cereal Products” in sub-regulation 2.4.15 “Bakery Products” the following points should be noted:

  • In para 1, after the third proviso, the following proviso has been inserted, namely:
  • “Provided also that biscuit may contain baker’s yeast at the levels required under “good manufacturing practices (GMP).”
  • In para 2, after the fourth  proviso, the following proviso has been inserted, namely:
  • “Provided also that bread may contain baker’s yeast at the levels required under “good manufacturing practices (GMP).”

Impact of the Draft Regulations (2017)

Under the sub-heading “Infant Milk Substitutes” it is evident that the FSSAI has fixed the limits of various fatty acids, thereby enhancing the nutritive value of the food product. Also, under the sub-regulation on “Bakery Products”, the FSSAI has given a directive to follow “good manufacturing practices (GMP)”, thereby ensuring high quality standards of the food product.