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 Special Dietary Food.                                                                                                    

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.

As per these Draft Regulations, the modifications made in the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 under regulation 2.9, relating to “Salt, Spices, Condiments and related Products” in sub-regulation 2.9.30, the following should be included:

  1. An extra clause (Clause 6) is to be added after Clause 5, which pertains to the Composition of Salt Substitutes, presented in the Table below:
  Salts Composition
(a) ·         Potassium sulphatePotassium, calcium or ammonium salts of the following acids:

·         Adipic

·         Glutamic

·         Carbonic

·         Succinic

·         Lactic

·         Tartaric

·         Citric

·         Acetic

·         Hydrochloric

·         Ortho phosphoric, or

 Not limited, EXCEPT:·         Phosphorus cannot exceed 4% m/m of the salt substitute mixture.

·         Ammonium 3% m/m of the salt substitute mixture.
(b) Magnesium salts of the following acids:·         Adipic

·         Glutamic

·         Carbonic

·         Citric

·         Succinic

·         Acetic

·         Tartaric

·         Lactic

·         Hydrochloric

·         Orthophosphoric

 

The above acids can be mixed with other Magnesium-free salt substitutes listed in (a), (c) or (d), or

 ·         Magnesium cannot be more than 20% m/m of the total of the Potassium, Calcium and Ammonium cations present in the salt substitute mixture.·         Phosphorus cannot exceed 4% m/m of the salt substitute mixture.
(c) Choline salts of the following acids:·         Acetic

·         Carbonic

·         Lactic

·         Tartaric

·         Citric

·         Hydrochloric

The above acids can be mixed with other Choline-free salt substitutes listed in (a), (b) or (d), or

 ·         Choline content cannot exceed 3% m/m of the salt substitute mixture.
(d) Following free acids:·         Adipic

·         Glutamic

·         Citric

·         Lactic

·         Malic

 Not limited.
  1. Salt substitutes may contain:
  • Colloidal silica or calcium silicate: not more than 1% m/m of the salt substitute mixture, individually or in combination.

(b)  Diluents must be safe and suitable nutritive foods as normally consumed e.g. sugars and cereal flour.

  1. Iodine-containing compounds added to salt substitutes in accordance with the Food Safety and Standards Regulations, 2011.
  1. Sodium content of salt substitutes should not be more than 120 mg/100 g of the salt substitute mixture.
  1. Salt substitutes should conform to the following specific labelling provisions in addition to the Food Safety and Standards (Packaging and Labelling) Regulations, 2011:

The following declarations should be present on the label:

  • “Low sodium salt substitute” or “low sodium dietetic salt”.
  • Amount of cations (i.e. sodium, potassium, calcium, magnesium, ammonium and choline/100 g (m/m) in the salt substitute mixture.

As per these Draft Regulations, the modifications made in the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 under regulation 2.11, relating to “Other Food Products and Ingredients”, after sub-regulation 2.11.8, the sub-regulation 2.11.9 is to be inserted:

Special Dietary Food with Low Sodium Content

  1. Special dietary food with low sodium content has special dietary value due to reduction, restriction, or removal of sodium, and must conform to the essential composition and standards as applicable to such food excluding salt substitutes as such.
  1. Low sodium and very low sodium food must conform to the respective provisions regarding maximum sodium content specified:
  • A special dietary food with low sodium content is processed without adding sodium salts.
  • Sodium content: Not more than one half of that of the comparable normal product as consumed.
  • Sodium content: Not more than 120 mg/100g of the final product as normally consumed.
  • A special dietary food with very low sodium content is processed without adding sodium salts.
  • Sodium content: Not more than one half of that of the comparable normal product as consumed.
  • Sodium content: Not more than 40 mg/100g of the final product as normally consumed.
  1. Addition of salt substitutes (as per Clause 6 of sub-regulation 2.9.30 pertaining to composition of salt substitutes) (above Table) to a special dietary food with low sodium content is permitted as long as it is limited by good manufacturing practice (GMP) as per the Food Safety and Standards Regulations, 2011.
  1. Special dietary food with low sodium content must conform to the following specific labelling provisions in addition to the Food Safety and Standards (Packaging and Labelling) Regulations, 2011:

Information to be displayed on Label:

  • The terms “low sodium” or “very low sodium”.
  • Sodium content to the nearest multiple of 5 mg per 100 g, as well as the amount of sodium normally consumed per serving.
  • Average carbohydrate, protein and fat content in 100 g of the product as normally consumed, and the kilocalorie (or kilojoule) value.
  • Added salt substitutes listed in Clause 6 of sub-regulation 2.9.30 pertaining to composition of salt substitutes (above Table).
  • Total amount of potassium (as mg cation per 100 g of the food as normally consumed) when a salt substitute is composed entirely or partially of a potassium salt.
  • The salt equivalent in terms of sodium chloride (NaCl) content per serving and the total amount of NaCl in the packet.
  • Any special storage conditions for the food.

Impact of Draft Regulations on Special Dietary Food

The Draft Regulations have been proposed under the following two sub-regulations:

  • Composition of Salt Substitutes
  • Special Dietary Food with Low Sodium Content

These regulations have highlighted the fact that the FSSAI is aiming for better quality salt products that will be welcomed by health conscious people. Importantly, these newer salt substitutes with low sodium content will be safer and healthier as these will be directly beneficial for people with hypertension (high blood pressure) and heart disease.