Food Safety Regulations for Proprietary Milk Products

As per section 2.12.1 of Food Safety and Standards Regulations (Food Products Standards & Food Additives) , 2011, ‘Proprietary Food’ means a food that has not been standardized under these regulations. Only 377 food products have the standards specified in the regulations. All other non-standardized food products comes under the category of proprietary food products.

Standards of some Dairy products and analogues have been specified in section 2.1 of FSSRS (Food Products Standards & Food Additives) Regulations. These are: milk, cream, malai, dahi or curd, chhena or paneer, cheese, dairy based deserts/confections, evaporated / condensed milk & milk products, foods for infant nutrition, butter, ghee & milk fats, chakka and shrikhand, fermented milk products, whey products and edible casein products.

Milk products other than these are considered as proprietary milk products since these are not been standardized under the regulations. As per section 22 of Food Safety and Standards Act, 2006, no person shall manufacture,distribute, sell or import these proprietary milk products which the Central Government may notify in this behalf. Until and unless standards of these products are notified by the Food Safety and Standards Authority of India, the proprietary milk products can not be manufactured, distributed, sold or imported. No license will be issued either by the Central or State governments.

Procedure of standards setting in FSSAI

Food Safety and Standards Authority of India (FSSAI)  has as many as sixteen scientific panels as of today. Standards of proprietary milk products are first considered and recommended by the concern scientific panel. Once recommended by the scientific panel, these standards are placed before the scientific committee of FSSAI. If recommended by the scientific committee, these standards are to be approved by the food authority. Standards of proprietary milk products approved by the food authority are forwarded to the ministry of health and family welfare, government of India. If satisfied, they send it to the law ministry for legal vetting. Once these formalities are complete, the draft notifications of standards are posted in FSSAI website for obtaining stake holders comment for 60 days. Final gazette notifications are done after obtaining comment from WTO.

Product approval advisory

In order to avoid the long drawn procedure of standards setting, FSSAI had introduced Product Approval Procedure and had issued advisories. As per the advisory, manufacturers / importers had to submit applications for No objection certificate or Product approval for proprietary food products and after obtaining No Objection Certificate or Product approval, manufacturers/ importers could start business of proprietary milk products. One of the most widely used proprietary dairy product is Dairy Whitener. In the absence of standards of Dairy Whitener in FSSRS, manufacturers of dairy whitener were advised to submit applications to FSSAI to obtain NOC/ Product Approval. Since ingredients of dairy whitener are mainly maltodextrin, sugar and skim milk powder, FSSAI had issued NOC / Product Approval to the applicants who had submitted applications for NOC / Product approval of Dairy whitener. Manufacturing of Dairy whitener as proprietary milk products started.

Other proprietary milk products like Cheese Card containing milk fat, salt, solid non fat, milk protein, residual lactose also granted product approval by FSSAI. Even low fat milk powder, butter milk powder which had no standards prescribed in FSSR, 2011 were granted product approval as proprietary milk products. However, the product approval procedure was rejected by the Supreme Court of India and stopped by FSSAI.

Standard setting for some proprietary milk products

FSSAI had also initiated standard setting of proprietary food products. Bureau of Indian Standards made standards for Dairy Whitener in 1998. In the 12th Food Authority meeting held on August 29, 2013, FSSAI decided to adopt the BIS  standards of Dairy Whitener. FSSAI also constituted a subcommittee of four members with Director, NDRI to finalize the standards.

Draft standards for Dairy Whitener was finalized and posted in FSSAI website on 23rd October,2015. FSSAI also started granting license for Dairy Whitener which conform to the prescribed standards of Dairy Whitener in the amended Food Safety & Standards Regulations ( Food Products Standards and Food Additives) , 2011, section 2.1.11.

Standard for dairy whitener

1) Description

The product prepared by spray drying of cow milk, buffalo milk or a mixture thereof containing carbohydrates such as sucrose, dextrose and maltodextrin. The fat or protein content, or both, of the milk may be adjusted by addition or withdrawal of milk constituents in such a way as not to alter the Whey Protein to Casein ratio of milk.

2) Essential Composition and Quality Factors

The product shall be white or light cream in colour, uniform in composition and free from lumps except those that break up readily under slight pressure and shall be free from extraneous matters and added colours.

The flavour of the product before or after reconstitution shall be pleasant and sweet. It shall be free from off flavours. It is recommended that the flavour and taste may be judged on the basis of their sensory characteristics.

If sugar is replaced with Milk Solid Non Fat i.e. Skimmed Milk Powder, ash content will proportionately increase and may be calculated as follows:

8. a) Calculated Ash Content: prescribed ash content + 8.2/100 (24 sugar % in the product)
9. b) Calculation for protein: Milk Protein % w/w is calculated from the proposed added sugar (as sucrose) i.e. 24 % w/w. Standard of 24% added sugar shall be reduced to 18% after two years from the date of notification. Dairy Whitener shall be free from vegetable oil, animal fat, mineral oil, thickening agents.

3) Food Additives

Only those additives permitted for Milk Powder as per Food Safety and Standards (Food products standards and Food Additives) Regulations, 2011 shall be used.

4) Hygiene

The products covered by this standards be prepared and handled in accordance with the appropriate provisions of the Schedule IV, Part II and III of the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011. The products covered under this standards shall conform the Microbiological requirements for milk and milk products of the Food Safety and Standards Regulations, 2011.

5) Contaminants

The products covered by this standards shall comply with the Maximum levels for contaminants specified in the Regulations Food Safety and Standards (Contaminants, Toxins and Residues) Regulations,2011.

6) Labelling

The products covered by this standard shall comply with the Food Safety and Standards (Packaging and Labelling) Regulations, 2011.

7) Methods of Sampling and Analysis

As provided in the Food Safety Standards Authority of India Manual of Method of Analysis of Food (2015) - Milk and Milk Products.

Other proprietary milk products

Standards for Fermented Milk , Flavoured fermented milks, Drinks based on Fermented milk, Concentrated Fermented milk are also notified by FSSAI on 23rd October,2015 . As a result, these proprietary milk products are now considered as standardized milk products.

Similarly, standards for Ice - Cream, Kulfi, Chocolate Ice Cream, Softy Ice Cream, Milk ice, Milk Lolly and dried Ice Cream mix also notified in Regulations 2.1.14. Standards for Frozen Deserts or Confections with added Vegetable oil or Fat or Vegetable Protein or both notified in regulations 2.1.15.

Since Food Safety & Standards Regulations, 2011 have specified standards for 377 food products, attempts are being made to make vertical standards as well as horizontal standards for proprietary food products. Harmonization with Codex Standards have been done in FSSAI so that proprietary food products are converted into standardized food products which is convenient for both the Food Business Operators as well as regulators.