FSSAI Guidelines on A1/A2 Cow's Milk and Ghee (Clarified Butter) etc.

[YAGAY andSUN]

The Food Safety and Standards Authority of India (FSSAI) is the governing body responsible for ensuring the safety and quality of food products in India. It sets the standards and regulations for food items, including milk and dairy products like A2 Cow's Milk and Ghee (Clarified Butter).

1. A2 Cow's Milk:

A2 Cow's Milk refers to milk that contains only the A2 beta-casein protein, which is considered to be easier to digest and potentially more beneficial compared to regular cow's milk that contains a mix of A1 and A2 proteins. A2 milk comes from cows that have only the A2 gene variant of the beta-casein protein.

FSSAI's Stance and Guidelines on A2 Milk:

• A2 Milk is Not Yet Officially Recognized by FSSAI as a Standardized Product: As of now, FSSAI does not have a specific legal definition or standardization for A2 Milk. While the market for A2 milk is growing due to the perceived health benefits, it is important to note that FSSAI has not yet issued a formal regulation to exclusively recognize A2 milk.
• Labeling and Claims:
  • If manufacturers or producers of A2 milk wish to label their product as "A2", they need to ensure that the claims are accurate. The product must contain only A2 protein, and testing must substantiate such claims.
  • The labeling of milk products claiming to be A2 should not be misleading. Producers should ensure they do not make unfounded health claims related to A2 milk unless substantiated by credible scientific evidence.
• Testing and Verification: The presence of A2 beta-casein in milk can be tested through methods like genetic testing of cows or protein analysis of the milk. These tests are necessary for producers to substantiate their claims about A2 milk.

2. Ghee (Clarified Butter):

Ghee is a popular dairy product made by clarifying butter, and it is widely consumed in India and other parts of the world. The purity and quality of ghee are paramount to consumer safety.

FSSAI's Guidelines on Ghee:

• Definition:
  • According to FSSAI, ghee is defined as clarified butter obtained from cow's milk, buffalo's milk, or a mixture of both. Ghee must be made by removing all water and milk solids, leaving behind the pure fat.
• Standards for Ghee:
  • Fat Content: Ghee should contain at least 99.5% of milk fat. It is mandatory that ghee produced and sold in India meets this criterion.
  • Moisture Content: The moisture content should not exceed 0.5%.
  • Free Fatty Acids: The free fatty acid content (expressed as oleic acid) should not exceed 0.5% in ghee.
  • Flavor and Aroma: Ghee should have a characteristic aroma and flavor of the cow or buffalo milk, depending on the origin. Any foreign or rancid odor is prohibited.
  • Color: The color of ghee should be uniform and golden yellow. However, it must not have any artificial color added to it.
• Packaging and Labeling of Ghee:
  • Hygienic Packaging: Ghee should be packed in clean, non-reactive containers that do not contaminate the product.
  • Labeling: Ghee packaging must clearly specify the source of milk (whether from cow, buffalo, or a mixture). It must also comply with general FSSAI labeling rules, including:
    • Ingredient list (if additives or preservatives are used)
    • Nutritional Information (including fat content, calorie count, etc.)
    • Best Before Date
    • Manufacturing Details: Name and address of the manufacturer.

3. Important Regulations on A2 Milk and Ghee under FSSAI:

• Standards of Identity and Quality (FSSAI):
  • FSSAI has set detailed standards under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. These regulations define what qualifies as ghee and the acceptable levels of various parameters such as fat, moisture, and flavor.
• Health Claims and Advertising:
  • Both A2 milk and ghee producers should ensure that their advertising does not make misleading claims about health benefits unless scientifically validated. This includes ensuring that A2 milk does not make exaggerated health claims that it can cure specific ailments unless such claims are supported by scientific evidence.
• Adulteration Prevention:
  • FSSAI has a strict stance on preventing adulteration in milk and ghee. The addition of harmful substances such as starch, detergents, synthetic milk, or other chemicals is prohibited.
• Traceability: FSSAI is focusing on traceability in dairy products. For A2 milk, traceability from the cow to the consumer is important, as it guarantees the purity of the milk. Testing and quality checks must be conducted to ensure that only genuine A2 milk is being sold in the market.

Summary Table of FSSAI Guidelines:

Product	Key FSSAI Guidelines
A2 Milk	- No formal standard for A2 milk.
	- Claims must be substantiated through testing (genetic/protein analysis).
	- Labeling should not be misleading.
Ghee	- Must contain at least 99.5% milk fat.
	- Moisture content must not exceed 0.5%.
	- Free fatty acids must not exceed 0.5%.
	- Must have a natural aroma and golden yellow color.
	- Must adhere to hygiene and packaging standards.
Health Claims	- No misleading health claims.
	- Claims must be supported by scientific evidence.

10 FAQs on A2 Milk and Ghee under FSSAI

1. What is A2 milk?
   • A2 milk comes from cows that produce only the A2 beta-casein protein, unlike regular milk, which contains both A1 and A2 proteins.
2. Is A2 milk certified by FSSAI?
   • No, FSSAI does not have a specific certification or regulation for A2 milk yet, but it can be marketed if the claims are substantiated.
3. Can A2 milk be tested?
   • Yes, genetic tests on cows and protein analysis of milk can verify whether the milk is A2.
4. What is the difference between A1 and A2 milk?
   • A1 milk contains both A1 and A2 proteins, while A2 milk contains only A2 proteins, which some studies suggest may be easier to digest.
5. What are the standards for ghee?
   • Ghee should contain at least 99.5% milk fat, with moisture not exceeding 0.5%.
6. Can artificial colors be added to ghee?
   • No, ghee should not have any artificial coloring.
7. Is A2 milk healthier than regular milk?
   • Some studies suggest A2 milk may be easier to digest, but there is no conclusive evidence that it is significantly healthier than A1 milk.
8. Can ghee be adulterated?
   • Yes, FSSAI regulations strictly prohibit adulteration in ghee with substances like starch, synthetic milk, or detergents.
9. What should be labeled on ghee packaging?
   • The source of milk (cow or buffalo), nutritional information, and manufacturer details must be clearly labeled.
10. Is ghee exempt from GST?
    • No, ghee is subject to GST at the applicable rate, typically 5%, unless it is unbranded or packed in a small container.

Clarification Regarding Selling/Marketing of Milk & Milk Products (Al & A2 Claims) by FBOs

File No: RCD-02004/1/2023-Regu1atory-FSSA1-Part(1) Food Safety and Standards Authority of India

(A Statutory body under Ministry of Health and Family Welfare)

(Regulatory Compliance Division)

FDA Bhavan, Kotla Road, New Delhi-110 002

Dated, the 21st August, 2024

To,

All E-Commerce Food Business Operators (FBOs)

Subject: -Clarification regarding Selling/ Marketing of Milk & Milk products such as Ghee, Milk etc in the name of Al & A2- reg.

It has come to the notice of FSSAI that several Food Business Operators are selling/ marketing Milk & Milk products such as Ghee, Butter, Curd etc in the name of Al & A2 under FSSAI License Number and/or Registration Certificate Number.

 In this regards, it may be noted that the matter has been examined by FSSAI and it is opined that Al and A2 differentiation of milk is essentially linked to difference in structure of protein (beta casein). Hence, use of any claims on milk fat products is misleading and not in conformance with the provisions laid down under FESS Act, 2006 and Regulations made thereunder,

 Further, Standards of milk as specified in Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011 do not mention/ recognize any differentiation of milk on the basis of Al and A2 types.

 Therefore, the FBOs are instructed to remove such claims from their products. E-Commerce FBOs are instructed to remove all the claims related to Al & A2 proteins from their websites immediately, Further, the concerned FBOs shall ensure strict compliance of the same with effect from the date of issuance of this direction. Although the F130s are permitted to exhaust the available pre-printed labels within 6 months from the date of issuance of this direction. No further extension and timeline will be granted to any FBO.

5.         This issues with the approval of the Competent Authority.

(Inoshi Sharma) Executive Director (CS)

Email: [email protected]

To.

 l . Commissioners of Food Safety of all States/UTs

2. Directors of all Regional Offices, FSSAI

 3. CTO, FSSAl-with a request for uploading on the FSSAI website

Copy for information to:

l . sr. ps to CEO, FSSAI

2. Advisor (S&S), FSSAI

Clarification Regarding Selling/Marketing of Milk & Milk Products (Al & A2 Claims) by FBOs

Summary of the Notice

The Food Safety and Standards Authority of India (FSSAI) has issued a clarification regarding the selling and marketing of milk and milk products (such as ghee, butter, curd, etc.) with claims related to the A1 and A2 types of milk. The notice was issued on 21st August 2024 and is aimed at E-Commerce Food Business Operators (FBOs).

Key Points:

1. Background:
   • FSSAI's Observation: Several FBOs have been selling and marketing milk products with claims like A1 and A2, under their FSSAI License Number or Registration Certificate.
   • FSSAI's Position: The differentiation between A1 and A2 milk is based on the difference in the structure of protein (specifically beta-casein). However, FSSAI has not recognized these claims in relation to milk or milk products like ghee, butter, or curd.
2. FSSAI's Regulatory Stand:
   • Misleading Claims: FSSAI considers the use of such claims (A1/A2 differentiation) as misleading, as it is not in line with the provisions of the Food Safety and Standards Act, 2006 and the relevant Regulations.
   • No Recognition of A1/A2 in Standards: The Food Product Standards and Food Additives Regulations, 2011 (under FSSAI) do not recognize or provide for the differentiation between A1 and A2 milk types in the context of milk products.
3. Instructions for Compliance:
   • Immediate Removal of Claims: All FBOs (including e-commerce platforms) are directed to remove any claims regarding A1 and A2 milk proteins from their websites and product listings immediately.
   • Exhaustion of Existing Labels: E-commerce FBOs are permitted to use up existing pre-printed labels that mention A1/A2 proteins, but this must be done within 6 months from the date of the issuance of this notice. No further extension will be granted beyond this timeframe.
   • Strict Compliance: FBOs must ensure strict compliance with this directive starting from the date the notice was issued.
4. Implication for E-Commerce FBOs:
   • FBOs should ensure they do not use A1/A2-related claims in the marketing, advertising, or sale of milk and milk products.
   • They should update their online listings, product descriptions, and packaging materials to comply with the directive.
   • Non-compliance can lead to regulatory action by FSSAI.

Summary Table:

Action	Details
Issue Date	21st August 2024
Target Audience	E-Commerce Food Business Operators (FBOs)
Key Concern	Misleading claims of A1 and A2 differentiation in milk and milk products.
Regulatory Position	FSSAI does not recognize A1 and A2 milk differentiation in milk products under current regulations.
Action Required	FBOs to remove A1/A2 claims from websites and marketing materials.
Timeline for Label Changes	Existing pre-printed labels can be used for up to 6 months from the date of the directive.
Final Compliance Deadline	After 6 months, no extension will be provided.

 

FAQs on FSSAI's Clarification on A1 & A2 Claims

1. Why is FSSAI issuing this clarification?
   • FSSAI has noticed misleading marketing practices regarding A1/A2 claims on milk products and aims to ensure that food business operators comply with the Food Safety and Standards Act.
2. What is A1 and A2 milk?
   • A1 and A2 refer to different forms of beta-casein protein found in cow's milk. A2 milk is promoted as being easier to digest, while A1 milk is considered to cause digestive discomfort in some individuals.
3. Does FSSAI recognize A1 and A2 milk differentiation?
   • No, FSSAI does not recognize the A1/A2 differentiation in the standards for milk products such as ghee, butter, and curd.
4. Can e-commerce platforms still sell A1 and A2 milk products?
   • E-commerce platforms can sell milk products, but they must not advertise them with A1/A2 claims. Any such claims should be removed immediately from the product descriptions.
5. What should FBOs do if their products have pre-printed labels with A1/A2 claims?
   • FBOs are allowed to use up the pre-printed labels within 6 months from the notice date but must remove A1/A2 claims from all new packaging and marketing materials.
6. Can FBOs be penalized for non-compliance?
   • Yes, failure to comply with this directive may result in regulatory actions from FSSAI.
7. Does this directive apply only to e-commerce platforms?
   • While the directive specifically mentions e-commerce platforms, it applies to all FBOs selling milk products with A1/A2 claims, whether online or offline.
8. What should be done if A1/A2 claims are on existing labels?
   • The existing pre-printed labels can be used up within the 6-month period. After that, such claims must be removed entirely.
9. What if a company has already removed the A1/A2 claims before the notice?
   • If a company has already complied with the removal of such claims, no further action is required, but the FBO should ensure continued compliance.
10. Are there any other regulations related to milk claims?

• FSSAI has detailed standards for milk and milk products under the Food Product Standards and Food Additives Regulations, 2011, which do not recognize the A1/A2 differentiation.

By adhering to these guidelines, FBOs can ensure they stay compliant with FSSAI regulations, avoid misleading marketing claims, and prevent regulatory penalties.

To further enhance clarity for users (e.g., dairy businesses, compliance officers, or marketing teams), here’s a concise executive summary and key compliance checklist:

📝 Executive Summary: FSSAI Guidelines on A1/A2 Milk & Ghee (Clarified Butter)

Topic	FSSAI's Position
A1/A2 Milk Claims	Not recognized under current FSSAI standards. Claims must be removed from product labels/websites.
A2 Milk Certification	No specific certification scheme yet. Claims (if made earlier) must be substantiated by testing.
Ghee Standards	Must contain ≥99.5% milk fat, ≤0.5% moisture, no artificial color, and a natural aroma.
Health Claims	Only permissible if backed by credible, scientific evidence.
E-Commerce FBOs	Must remove A1/A2 claims from digital platforms immediately; old labels allowed for 6 months.
Compliance Timeline	6-month transition from 21 August 2024; no extension beyond this.

✅ FSSAI Compliance Checklist for FBOs (As per 21-Aug-2024 Directive)

Compliance Requirement	Action
Remove A1/A2 claims from labels/marketing	✅ Required immediately
Use of pre-printed A1/A2 labels	✅ Permitted until February 21, 2025 only
Update product descriptions on e-commerce platforms	✅ Required immediately
Avoid making unscientific health claims	✅ Must be supported by clinical/scientific evidence
Ensure traceability and testing of A2 milk if claimed	✅ Use DNA testing of cow breeds or β-casein protein analysis
Comply with milk & ghee compositional standards	✅ Refer to Food Products & Food Additives Regulation, 2011
Label milk source and fat content	✅ Mandatory for ghee and milk products
Report compliance to FSSAI, if needed	✅ Keep communication ready for audit/inspection

🧠 5 Key Takeaways for Dairy Marketers

1. A1/A2 claims are no longer permissible — regardless of testing or cow breed, unless explicitly permitted by future notification.
2. Products can still be sold — but without highlighting A1/A2 differentiation.
3. Ghee must meet fat and aroma standards — and cannot use synthetic color or additives.
4. Health-based marketing is highly regulated — only scientific, peer-reviewed claims are acceptable.
5. Non-compliance may result in penalties — including withdrawal of license or product recall.