Recently, FSSAI, under its new regulation notification issued on 27th April 2023, invited objections and suggestions from all persons likely to be affected by such provisional change i.e. only FSSAI certification would be mandatory for food products following the finalization of the amendments.
In February 2024, the FSSAI approved amendments to its regulations, removing the need for Bureau of Indian Standards (BIS), Indian Standards Institution (ISI), and Agricultural Marketing (AGMARK) certifications for food products. These regulations may be called the Food Safety and Standards (Prohibition and Restrictions on Sales) First Amendment Regulations, 2024, and come into force on the date 17th October 2024. This would certainly reduce the regulatory complication for the food business in India.
Understanding the Change
Food businesses had to get separate certifications from AGMARK, BIS, & ISI for certain food products, apart from the FSSAI license. AGMARK certification mark was mandatory for Edible oils, ghee, fat spread, etc. BIS certification mark for infant nutrition food, packaged drinking water & mineral water, whereas the Indian Standards Institution Certification Mark for Sweetened condensed milk and skim milk powder, including its manufacture, storage, or distribution. This usually results in increased costs and administrative burdens on business organizations.
With the new amendments, the FSSAI license is the only mandatory certification for food products. This means that businesses will no longer need to obtain separate certifications from AGMARK, BIS, & ISI, simplifying the regulatory process and reducing compliance costs.
What are the changes in the regulations?
In the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, in regulation 2.3 following changes are made:
A) sub-regulation 2.3.8 shall be omitted;
According to regulation 2.3.8, Ghee having a lower Reichert value or a different Butyro-refractometer reading at 40°C than what is prescribed for the place of sale cannot be sold or kept in that place of sale unless it bears an AGMARK seal.
Exceptions:
After opening the AGMARK-sealed container, this ghee can be sold in small quantities up to 2 kilograms at a time. It can also be used for preparing sweets or confectionery.
Declaration Requirement:
Anyone selling the ghee described above, or the confectionery prepared from this ghee, must make a declaration (in Form A) to the Food Safety Officer at the time of collection of the sample for analysis. The declaration shall also be given to any consumer desirous of having the sample of ghee or sweetmeat analyzed.
Analysis and Quality:
There would be no adulteration if the sample had been tested and passed by the quality standards of its place of origin, even though such ghee did not come up to the standards of the place of sale.
Now as the sub-clause is omitted, no AGMARK certification is required further, while FSSAI certification will be required for the sale of such products. The amendment regulations also omit the restriction on the sale of ghee having less Reichert value* than that specified for the area where such ghee is sold.
(* The Reichert Meissl value is used to detect adulteration of ghee with palm olein and sheep body fat, whereas the BR reading is used to detect vegetable oils in ghee. The Reichert Meissl value of ghee from animals fed cottonseed is lower than that of ghee from animals not fed cottonseed.)
B) in sub-regulation 2.3.14,- clauses (4) and (5) shall be omitted
As per clause 4, the BIS certification mark is mandatory for the manufacture, sale, or storage of infant milk food, infant formula, milk cereal-based weaning food, processed cereal-based weaning food, and follow-up formula.
Similarly, As per clause 5, the ISI certification mark is mandatory for sweetened Condensed milk, sweetened condensed skimmed milk, milk powder, skimmed milk powder, partly skimmed milk powder and partly skimmed sweetened condensed milk
Now by removal of this clause, the respective products can be manufactured, stored, or sold without BIS or ISI marks respectively, the only certification required is FSSAI.
C) in sub-regulation 2.3.14,- in clauses (11) & (13), the words “AGMARK certification mark bearing” shall be omitted;
As per clause(11), Blended Edible Vegetable Oils, cannot be sold loose, and must be sold in tamper-proof sealed packages, with a maximum weight of 15 liters. Such oil cannot be sold under the generic name oil used in blends. Instead, it must be labeled as “Blended Edible Vegetable Oil”. It should be an AGMARK certification mark-bearing package and include all necessary labeling as per the regulations.
Similarly, As per clause(13), Fat spread should not be sold loose. It must be sold in sealed packages weighing no more than 500 grams. The word “butter” cannot be used on the label. Like the other products, it must have the AGMARK certification mark-bearing package and proper labeling according to the regulations.
Now the revised regulations removed the Agmark certification mark for blended edible vegetable oils and fat spreads, the rest of the things need to be followed, with the FSSAI mark on it.
D) in sub-regulation 2.3.14,- clauses (17) and (18) shall be omitted
As per clauses (17) and (18), Both BIS certification & ISI mark are mandatory for Packaged drinking water and mineral water respectively. No person can manufacture or sell the said products without an ISI mark.
Now, ISI certification will no longer be required for the manufacture or sale of such products, only FSSAI certification is enough.
E) The Form A shall be omitted
Form A is a declaration form for selling of ghee under AGMARK, in revised regulations, AGMARK is not required for manufacture, storage or selling of ghee, so any such declaration is not required as well.
F) The amendment specifies that the restriction on the sale of a mixture of two or more edible oils as an edible oil will not apply to Multi-Source Edible Oil, as specified under clause 24 of sub-regulation 2.2.1 of regulation 2.2 of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. However, Multi-Source Edible Oil must not be sold in packages exceeding 15 liters.
Short summary:
- Agmark certification marks will no longer be required for packages of multi-source edible oils & fat spreads.
- Restriction on the sale of ghee with a lower RM value than the specified value for the area is removed.
- Removal of the declaration forms A for ghee samples.
- Removal of BIS certification mark for Manufacture, storage, or sale of infant nutrition food, packaged drinking water,r and mineral water.
- Removal of ISI certification mark for sweetened condensed milk and related variants.
- Restriction on sale of a mixture of two or more edible oils as an edible oil will not apply to Multi-Source Edible Oil
Main Advantages of the Amendment
Removal of BIS and AGMARK certification requirements will have the following benefits for food businesses:
Simplified regulations: No need for separate certification marks for certain products. So the only regulations to be followed are FSSAI.
Lower Costs: Removing the additional cost of certification will reduce the cost of business for most companies.
Faster Time to Market: The streamlined and singular process will enable companies to get their products to market at a faster pace.
References:
FOOD SAFETY AND STANDARDS (PROHIBITION AND RESTRICTIONS ON SALES) REGULATIONS, 2011
FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA NOTIFICATION, New Delhi, the 17th October, 2024
