Hygiene Standards for FCM

10 Mins to read

Share
Dark
Light

Hygiene Standards for FCM

10 Mins to read

Share
Dark
Light

Article summary

Did you find this summary helpful?

Thank you for your feedback

Hygiene Standards for FCM
India

The below version control table serves to document all updates made to the report. The purpose is to ensure the information is always accurate and up-to-date.

Version Number	Content Creation Date	Publishing Date	Section(s) Updated & Reason(s) for Update
V0	06 Mar 2025	26 Mar 2025	N/A (new report)

Disclaimers

A) At RegASK, we are committed to providing our clients with the most up-to-date and accurate information on regulatory requirements and compliance. To ensure the highest level of accuracy and relevance, we regularly review and update our e-guidebooks at least twice per year to reflect the latest regulatory developments in the market. (Please contact us if you wish to activate this feature.) In the meantime, our RegAlerts service is designed to keep our clients notified of any regulatory updates that may impact their business.

B) The contents on this platform are exclusively intended for the use of RegASK and its authorized representatives. All materials herein are confidential and the sole property of RegASK. Any reproduction, distribution, or display of this content to others is strictly prohibited without the express written consent of RegASK.

1. Overview of relevant regulatory standards on hygiene standard for food contact materials

The hygiene standards for food contact materials (FCMs) are critical to ensure the safety and quality of food and beverages. These materials include containers, bottles, cans, packaging films and seals that directly interact with beverages. Various regulatory bodies, including FSSAI (Food Safety and Standards Authority of India), regulate the hygiene standards for FCMs to minimize contamination risks.

The hygiene standards for food contact packaging are defined in the Food Safety and Standards Act, 2006 [1], and the Food Safety and Standards (Packaging) Regulations, 2018 [2]. In addition, FSSAI Food Safety and Standards (Packaging and Labeling) Regulations, 2011 [3] outline general safety requirements for food contact materials, including glass, emphasizing non-toxicity, hygiene, and food-grade compliance. The Bureau of Indian Standards (BIS) provides specifications and standards for testing and manufacturing FCMs, including:

IS 2303: Standards for glass containers [4]
IS 15392: Guidelines for metal containers for food products [7]

Codex Standard applies in India along with local rules and provides benchmarks for food contact materials, including limits on heavy metals in glass [11].

Overall, packaging materials must be non-toxic, free from harmful chemicals, and prevent contamination of food and beverages. The use of food-grade materials (e.g., food-safe plastics, glass, or metals) is mandatory [2]:

Before being filled, FCMs must be free of residues, dust, and contaminants from previous handling or packaging processes. They must undergo cleaning, sanitization, and, where necessary, sterilization before use [1]. Liquor bottles imported into India must meet all relevant hygiene standards established by FSSAI. [4]

2. General Standards for Hygiene Requirements for Food Contact Materials

In India, liquor bottles, typically made of glass, plastic, or metal, are subject to strict regulatory standards to ensure that they do not contaminate the beverage and maintain its quality. The standards are guided by the Food Safety and Standards Authority of India (FSSAI) [1], Bureau of Indian Standards (BIS) [4], and related international benchmarks such as Codex Alimentarius Guidelines [11] and EU Regulation (EC) No 1935/2004.

The hygiene standards for food contact materials, including liquor bottles, are essential to ensure consumer safety and product quality. These standards govern the design, production, and handling of materials that come into direct contact with alcoholic beverages such as beer, whisky, and ready-to-drink products.

General Hygiene Requirements for Liquor Bottles [1]:

Material suitability:
1. Bottles must be made from food-grade materials safe for alcoholic beverages.
2. No toxic elements (e.g.: lead, arsenic, and cadmium) should leach into the contents.
Cleanliness
1. All liquor bottles must be free of contaminants, including dust, microbes, or residues from production or cleaning processes.
2. Proper washing and sanitization are mandatory before filing.
Migration testing
1. Liquor bottles should comply with specific migration limits (SML) for substances that may interact with alcohol, particularly for high-alcohol-content beverages.
Seal integrity
1. Bottles must have tamper-evident seals to prevent contamination after production [2].

Additional Hygiene Guidelines for Liquor Bottles [3]

Production Environment:
- Manufacturing facilities must comply with Good Manufacturing Practices (GMP) and maintain clean, sanitized production lines.
- Workers should follow hygienic practices, including wearing gloves and hairnets, during handling.
Filling and Sealing:
- Bottles must be sanitized before filling, using food-safe cleaning agents or steam.
- Automatic filling systems should minimize human contact to reduce contamination risks.
Labeling and Storage:
- Labels must use food-grade adhesives and non-toxic inks.
- Storage should be in clean, dry environments to avoid contamination or material degradation.
Testing and Certification:
- Bottles must be tested for organoleptic impact (taste, odor, and appearance of liquor).
- Certification from NABL-accredited laboratories is mandatory for compliance with FSSAI and BIS standards.

3. Specific Hygiene Requirements per Type of Food Contact Materials

3.1 Liquor bottles (B2C): Glass

In India, liquor bottles and their metal caps [7], typically made of glass, plastic, or metal, are subject to strict regulatory standards to ensure that they do not contaminate the beverage and maintain its quality. The standards are guided by the Food Safety and Standards Authority of India (FSSAI) [1], The Bureau of Indian Standards (BIS) [3], and related international benchmarks.

Table 1. Specific Hygiene Requirements by Material Type

Material	Applicable Standards/Regulations	Hygiene Requirements
Glass Bottles	IS 1993: 2006: Glass containers for packaging. [6]	- Smooth Surface: Free from cracks, bubbles, and chips that could harbor microbes or cause leakage. - Lead and Cadmium Limits: Compliance with BIS and international migration limits for lead and cadmium, especially for decorative or colored glass. - No glass particles in the product.
Plastic Bottles	IS 9833: 2018: Additives for plastic in contact with food. [8]	- Alcohol Resistance: Material must withstand high alcohol content without degrading or releasing substances like phthalates or antimony. - Hygienic Manufacturing: Produced and stored in clean environments to prevent microbial contamination.
Metallic Caps or Bottles	IS 15392: 2003: Food-grade metal containers. [7]	- Corrosion Resistance: No rusting or leaching of heavy metals like lead, tin, or cadmium. - Non-Toxic Coatings: Inner surfaces should be coated with food-grade materials if required to prevent interaction with alcohol. - Sealing Quality: Proper fit to prevent contamination.

3.2 Casks and barrels (B2B): Wood

Wooden casks and barrels are traditionally used for aging and storing beverages like whiskey, wine, and spirits [2]. To ensure safety and compliance in the B2B market, these casks must meet hygiene standards outlined by FSSAI (Food Safety and Standards Authority of India) and internationally recognized practices [1].

General Hygiene Requirements for Wooden Casks and Barrels [2]

Material Suitability:

Wood must be untreated or treated only with food-safe, non-toxic substances. Commonly used wood types include oak, which must be free from contaminants, mold, and decay.

Cleanliness and Maintenance:

Wooden casks must be clean and free from debris, insects, or residues from previous use. Regular inspection for microbial contamination, such as molds or fungi, is essential.

Seal ability:

Wooden casks must have tight-fitting seals to prevent contamination during storage or transportation.

Compliance with Food Safety Standards:

No harmful substances (e.g., heavy metals, toxic adhesives) should migrate into the contents.

Microbial Safety:

Due to the porous nature of wood, thorough cleaning and proper drying are essential to prevent microbial growth.

Specific Hygiene Practices for Wooden - Casks and Barrels

In India, specific hygiene practices for wooden casks and barrels [9] are guided by standards such as IS 11131:1984, issued by the Bureau of Indian Standards (BIS). These practices ensure the safety and quality of beverages stored in wooden containers.

Cleaning and Sanitization:
- Hot water or steam cleaning (85°C for 15–20 minutes): To eliminate microbial contaminants.
- Sulfur treatment (candles or tablets): Used to sterilize barrels for wine or spirits [10].
- Citric acid solutions: Can be used to neutralize odors and prevent contamination.
Inspection and Maintenance:
- Regular checks for cracks, splits, or areas where contamination might occur.
- Replace or repair damaged staves or hoops to maintain hygiene.
Storage Conditions:
- Store empty barrels in cool, dry environments to prevent mold or rot.
- Avoid high humidity, which can promote fungal growth.
Seasoning and Treatment:
- If barrels are toasted or charred (e.g., for whiskey), this must be done in food-safe environments to avoid introducing contaminants.
Reuse Practices:
- Reuse only barrels certified for food or beverage use.
- Ensure thorough cleaning and sanitization between uses, especially if switching contents.

Table 2: Specific Regulatory and Quality Requirements

Aspect	Hygiene Requirements	Relevant Standards
Type of Wood	Must be from food-safe species like oak; avoid woods treated with pesticides or non-food-grade preservatives.	BIS, FSSAI guidelines.
Surface Treatment	Interior surfaces may be toasted or charred but must not introduce harmful substances.	International standards such as Codex Alimentarius or EU guidelines.
Migration Testing	Testing for leaching of wood extracts, such as tannins, that may affect food safety.	NABL-accredited laboratory testing for migration limits.
Microbial Testing	Barrels must pass microbial tests for mold, yeast, and pathogens.	ISO 18593 or equivalent microbial swabbing and testing protocols.

Table 3: Migration and Contaminant Limits for Wooden Casks [9]

Substance	Limit	Testing Standard
Tannins and Phenolic Compounds	Must not impart off-flavors or exceed safe levels.	NABL migration testing.
Lead	≤ 1.0 ppm	FSSAI/BIS migration limits.
Residual Sulfites (from sterilization)	≤ 10 ppm	BIS or ISO standards.

3.3 Casks and barrels (B2B): Metal

Metal casks and barrels must comply with Food Safety and Standards Authority of India (FSSAI) regulations and relevant Bureau of Indian Standards (BIS) guidelines to ensure food safety and hygiene.

General Hygiene Requirements for Metal Casks and Barrels [2]

Food-Grade Materials:

Metal casks and barrels must be manufactured using food-grade metals such as stainless steel, aluminum, or food-safe alloys. These materials should not react with or contaminate the stored contents.

Corrosion Resistance:

Metals must resist corrosion, especially in contact with high-acidity or high-alcoholic beverages. Inner surfaces should be treated or coated with food-safe materials if necessary.

Smooth and Cleanable Surfaces:

All internal surfaces must be smooth, non-porous, and free of cracks to prevent microbial growth and allow for effective cleaning and sanitization.

Sealing and Closure:

Casks and barrels should have airtight closures to prevent contamination during storage or transportation. [15]

Migration Testing:

Mandatory testing for migration of heavy metals (e.g., lead, cadmium, tin) or other contaminants into food or beverages (see report on packaging requirement for food contact material in India).

Material Specific Requirement for Metal Casks and Barrels

To ensure safety, durability, and compliance, metal casks and barrels must meet specific material requirements for use in food and beverage industries [4].

Table 4: Material-Specific Requirements for Metal Casks and Barrels

Material Type	Applicable Standards	Key Hygiene Requirements
Stainless Steel (Preferred)	IS 5522: 1992 – Food-grade stainless steel. [16]	- Must be made from austenitic stainless steel grades (e.g., 304 or 316). - Corrosion-resistant and easy to sanitize. [16]
Aluminium	IS 15392 – Aluminum and aluminum alloys in contact with food.	- Non-reactive food-grade aluminum. - Protective coating if used for acidic or alcoholic contents.
Tin-Plated Steel	IS 1993: 2006 – Coated steel for food applications.	- Tin coating to prevent corrosion. - Coating must comply with FSSAI migration limits.
Alloys	Standards depend on specific alloy composition.	- Must meet heavy metal migration limits. - Coated internally to ensure non-reactivity.

Specific Hygiene Practices for Metal Casks and Barrels

Cleaning and Sanitization
1. Use food-grade cleaning agents and sanitizers. [12]
2. Steam or hot water cleaning is preferred to ensure thorough disinfection.
Inspection and Maintenance
1. Regularly inspect the dents, corrosion, or scratches that may compromise hygiene. [13]
2. Replace or recoat damaged barrels to prevent contamination.
Protective Coatings [14]
1. Use only food-safe coating approved by FSSAI or BIS for internal surfaces.
2. Coatings must withstand wear and alcohol exposure without leaching harmful substances.
Storage and Handling
1. Store empty barrels in a clean, dry environment to prevent contamination or rust formation.

4. Other Rules

The regulatory standards for hygiene and safety of food contact materials (FCMs) are governed by both central (as provided in the report) and state-level regulations. These ensure materials that come into contact with food, including those used in beer, RTDs, and whisky packaging, are safe and do not pose health risks.

5. Summary Table

Food contact materials	General legislation applicable	Specific legislation applicable
Glass bottle Casks and barrels (B2B): Wood Casks and barrels (B2B): Metal	FSSAI Act Overview Food Safety and Standards Act, 2006 [1]	Food Safety and Standards Act, 2006 [1]
		Food Safety and Standards (Packaging and Labeling) Regulations, 2018 [2]
	The Prevention of Food Adulteration Act, 1954 (PFA Act)	Prevention of Food Adulteration Act, 1954 (PFA Act)
	The Bureau of Indian Standards (BIS) Act, 1986 [4]	Food Safety and Standards (Food Additives) Regulations, 2011 [4]
	Food Safety and Standards (Import) Regulations, 2017 [5]	Bureau of Indian Standards (BIS) Regulations for Food Contact Materials
	The Consumer Protection Act, 2019	Indian Standard IS 15392: 2003 – Food-Grade Metal Containers [7]
	The Hazardous Waste (Management and Handling) Rules, 2016	BIS Standard IS 9833: 2018 – Food Contact Plastics [8]