Role of BIS Standards in Compliance with the PFA Act

Food safety in India relies on a robust regulatory framework where standardization plays a critical role. The Prevention of Food Adulteration (PFA) Act, 1954, was one of India’s foundational pieces of legislation designed to protect consumers from adulterated or unsafe food products. A key aspect of this framework was the integration of Bureau of Indian Standards (BIS) certification for specific food-related products, creating a dual layer of quality assurance that manufacturers had to meet before bringing products to market.

Understanding the PFA Act and its evolution 🔗

The Prevention of Food Adulteration Act was enacted in 1954 and came into force in June 1955. Its primary objective was to prevent the adulteration of food and beverage items intended for human consumption. The Act gave the Central Government several responsibilities, including setting up food standards committees, establishing central food laboratories, and organizing training programmes for officials involved in food safety enforcement.

Over the years, the PFA Act was amended multiple times-in 1964, 1976, and 1986-to strengthen its provisions and keep pace with changing food industry practices. However, in 2006, India took a significant step forward by enacting the Food Safety and Standards Act, 2006 (FSS Act), which consolidated multiple food-related laws under a single statutory body. This new Act repealed the PFA Act along with several other orders, including the Fruit Products Order (1955), Meat Food Products Order (1973), and Milk and Milk Products Order (1992).

The transition to FSSAI 🔗

The Food Safety and Standards Authority of India (FSSAI) was established on 5 September 2008 under the FSS Act, 2006. This body now serves as the single regulatory authority for food safety in India, eliminating the confusion that previously existed due to multiple food laws handled by various ministries. While the FSS Act replaced the PFA framework, the requirement for BIS certification for certain food products has continued under FSSAI regulations, maintaining the important connection between standardization and food safety.

The Bureau of Indian Standards: India’s quality guardian 🔗

BIS operates as the National Standards Body of India under the Ministry of Consumer Affairs, Food & Public Distribution. Established originally as the Indian Standards Institution (ISI) in 1947, it now functions under the Bureau of Indian Standards Act, 2016. The organization’s primary mandate includes developing and publishing Indian Standards across various sectors, including food and agriculture.

The BIS certification scheme allows manufacturers to use the well-known ISI mark on their products. This mark has become synonymous with quality and safety in the Indian market for over five decades. While the BIS certification scheme is generally voluntary in nature, the Indian Government has made certification mandatory for certain products through Quality Control Orders (QCOs) issued under various Acts and Regulations.

How BIS certification works 🔗

The certification process involves several steps that manufacturers must complete. First, an applicant submits Form-V along with required documents to BIS. The Bureau then arranges a factory visit to assess whether the manufacturer has the necessary infrastructure for producing quality products. Test results of the food products are reviewed to confirm compliance with relevant Indian Standards. Once BIS is satisfied with both the infrastructure and test results, it issues a license in Form-VIII, permitting the use of the BIS certification mark.

The license to use the Standard Mark (IS) is granted for a minimum of one year and a maximum of two years. Manufacturers can renew this license for further periods of one to five years, subject to continued compliance with standards.

Food products requiring mandatory BIS certification 🔗

Under the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, FSSAI has made BIS certification compulsory for Food Business Operators (FBOs) involved in manufacturing, selling, storing, or exhibiting certain food products. These include:

Infant nutrition products: This category includes milk cereal-based weaning food (IS 1656), infant formula (IS 14433), processed cereal-based weaning food (IS 11536), and follow-up formula (IS 15757). These products require mandatory certification due to the vulnerability of their target consumers-infants and young children whose health depends on receiving safe, nutritious food.

Packaged drinking water: BIS has published two Indian standards for this category: IS 13428 for Packaged Natural Mineral Water and IS 14543 for Packaged Drinking Water (other than natural mineral water). Both products fall under mandatory certification requirements.

Other essential food items: Certain milk products, edible oils, and fortified foods may also require BIS certification depending on specific regulatory requirements.

The role of BIS in packaging materials 🔗

Beyond finished food products, BIS standards extend to packaging materials that come into contact with food. This is crucial because there is always a possibility of migration of packaging material constituents into food items. The BIS standard IS 9845 specifically addresses the determination of overall migration of constituents from plastic articles intended to come into contact with foodstuff.

Metal containers used for preparation, packaging, and storage of food must conform to specific Indian Standard Specifications, including IS 20 (Specification for Cast Aluminium and Aluminium Alloy for Utensils) and IS 21 (Specification for Wrought Aluminium and Aluminium Alloy for Utensils). Paper-based packaging, plastics, and glass containers each have dedicated sectional committees within BIS responsible for formulating appropriate standards.

Why packaging standards matter 🔗

When packaging materials do not meet safety standards, harmful substances can migrate from the package to the packed material. Standards ensure that any substances that do migrate remain within prescribed limits and cause no hazards when consumed. This is particularly important for food products with long shelf lives or those stored under varying temperature conditions.

Benefits of BIS certification for manufacturers and consumers 🔗

BIS certification delivers multiple advantages. For manufacturers, it provides regulatory compliance, helping avoid legal penalties and product bans. The ISI mark on packaging signals to consumers that the product has undergone thorough testing and analysis, building trust and confidence that can translate into increased sales and customer loyalty.

For consumers, BIS certification provides third-party assurance of quality, safety, and reliability. It confirms that products meet stringent standards and have been manufactured under controlled conditions. This is especially important for sensitive products like infant food, where quality variations can have serious health consequences.

Compliance requirements for food business operators 🔗

FBOs manufacturing products under mandatory BIS certification must upload a copy of their BIS license when applying for an FSSAI license through the online FoSCoS system. They must also submit the BIS license document when applying for FSSAI license renewal. This dual requirement ensures that food businesses maintain both safety standards (through FSSAI) and quality standards (through BIS) simultaneously.

For products requiring mandatory certification, manufacturers must apply for a BIS license as per Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018. Test reports from third-party laboratories accredited by BIS must accompany the application.

Recent developments and the future of food standardization 🔗

The relationship between standardization bodies like BIS and regulatory authorities like FSSAI continues to evolve. In 2024, FSSAI in its 43rd meeting considered streamlining certification requirements, potentially reducing the need for separate BIS or AGMARK certifications for food products that already have FSSAI certification. Such changes aim to foster ease of doing business in the food sector while maintaining safety standards.

However, for now, certain categories-particularly infant nutrition products and packaged drinking water-remain under mandatory BIS certification requirements. Manufacturers should stay updated on regulatory changes by monitoring official notifications from both FSSAI and BIS.

Consequences of non-compliance 🔗

Failure to obtain required BIS certification can result in serious consequences. Products manufactured without mandatory certification are considered illegal and subject to penalties under both the BIS Act and the FSS Act. Repeated failures to maintain standards can lead to suspension or permanent discontinuation of certification, destroying product credibility and resulting in loss of market access. Additionally, consumers who encounter substandard products can initiate lawsuits under the Consumer Protection Act, leading to monetary compensation claims and reputational damage.

What do you think? Has the implementation of BIS standards under food safety laws effectively reduced the incidence of food adulteration in India? How might manufacturers better adapt to the evolving relationship between FSSAI and BIS certification requirements?

References

1. https://www.bis.gov.in/product-certification/products-under-compulsory-certification/?lang=en
2. https://fssai.gov.in/cms/food-safety-and-standards-act-2006.php
3. https://www.myfoodexpert.in/bis/
4. https://www.printweek.in/news/bis-standards-for-the-packaging-industry-42054
5. https://cleartax.in/s/fssai-bis-certificate