Regulation of Food-Contact Materials in India

Home to over 1.2 billion people, India has become a significant importer and exporter of food and food packaging, and an increasingly prominent member of the global marketplace. Recognizing the need to adapt to the rapid globalization of commerce, the government of India is in the process of reforming framework legislation pertaining to the safety of food and food-contact materials.[1]

Beginning with the adoption of the Food Safety and Standards Act of 2006 (FSSA, No. 34 of 2006), the Indian government’s goal has been to set forth the foundation for the integration and consolidation of pre-existing food laws and standards[2] into a single, science-based regulatory scheme intended to encompass the manufacture, storage, distribution, sale and import of food, as well as to ensure the safety of materials that may contact food intended for human consumption.

The FSSA establishes the creation of a new governmental agency, the Food Safety and Standards Authority of India (FSSAI).[3] FSSAI has been tasked with developing science-based standards and a methodology for the evaluation of food and food-contact materials, preparation of guidelines for the accreditation and certification of testing laboratories, and providing guidance with respect to emerging risks and appropriate response measures pertaining to food safety. In furtherance of the development of this new regulatory scheme, draft regulations were published by the Ministry of Health and Family Welfare in the Gazette of India Extraordinary, Part III, Section 4 on October 20, 2010, and were updated in early August 2011.[4] The regulations, titled "Food Safety and Standards," are divided into six individual legislative titles, including:

1. Contaminants, Toxins and Residues;
2. Food Products Standards and Food Additives;
3. Laboratory and Sample Analysis;
4. Licensing and Registration of Food Businesses;
5. Packaging and Labeling; and
6. Prohibition and Restriction on Sales

 The Packaging and Labeling Title defines packaged food broadly as "food, which is placed in a package of any nature, in such a manner that the contents cannot be changed without tampering it and which is ready for sale to the consumer."[5] The food packaging requirements are broad in nature, and reflect a recurring theme that food-contact materials shall not render the food unsafe for consumption. While the composition of the food-contact material is of importance in meeting this standard, significant emphasis is placed on the ability of the consumer to be able to make an independent determination that the content of the packaged food is safe for consumption through visual inspection.

As further evidence of the proposition that food-contact materials generally shall not render food unsafe, Section 2.1.1(3) sets forth certain requirements intended to ensure the integrity and suitability of packaging materials. For example, food packaging materials shall be: (1) securely packed and sealed; (2) free from major defects (including dents, rust, perforation, and seam distortions); and (3) free from leaks.

The Packaging and Labeling Title also sets forth the general requirements for utensils and containers which may be used in the "preparation, packaging and storing" of food. Section 2.1.1 states that products which are chipped, rusty, or improperly tinned are prohibited. Section 2.1.1(2) considers the use of plastics in contact with food, stating generally that "containers of plastic materials should confirm to the following Indian Standards Specification (IS), [when] used as appliances or receptacles for packing or storing whether partly or wholly, food articles."

The regulations refer to 10 types of plastic packaging materials which were previously defined by the Bureau of Indian Standards (BIS) and that may be used in contact with food, including:

• IS 10146 (Specification for Polyethylene in contact with foodstuffs);
• IS 10142 (Specification for Styrene Polymers in contact with foodstuffs);
• IS 10151 (Specification for Polyvinyl Chloride (PVC), in contact with foodstuffs);
• IS 10910 (Specification for Polypropylene in contact with foodstuffs);
• IS 11434 (Specification for Ionomer Resins in contact with foodstuffs);
• IS 11704 (Specification for Ethylene Acrylic Acid (EAA) copolymer);
• IS 12252 (Specification for Poly alkylene terephathalates (PET));
• IS 12247 (Specification for Nylon 6 Polymer);
• IS 13601 (Ethylene Vinyl Acetate (EVA));
• IS 13576 (Ethylene Metha Acrylic Acid (EMAA))

 We understand that it is the position of the Indian authorities that plastics used in food-contact applications should comply with the applicable IS Standard and meet any specifications and limitations set forth therein. Recognizing that many of these Standards have not been updated for some time, however, and further that the process for petitioning for amendment of these Standards remains somewhat ambiguous, and certainly very laborious and time consuming, many advancements in food-packaging composition and manufacturing technology which have taken place in recent years may not be covered by a relevant IS Standard.

Additional requirements for food packaging intended for specific applications are set forth in Section 2.1.2, and include:

• Milk and milk products (Section 2.1.2(1));
• Edible fats and oils (Section 2.1.2(2));
• Fruits and vegetables (Section 2.1.2(3));
• Canned meat products (Section 2.1.2(4)); and
• Bottled water (Section 2.1.2(5))

 Pursuant to Section 2.1.2(1), milk and milk-based products shall be mechanically heat-treated and sealed, where applicable. Repeat-use packaging for dairy products is restricted to such products that are "of a type which may be re-used after thorough cleaning and disinfecting."

The bottled water standards pertain to both packaged water and bottled mineral water, and require that such products are packed in "clean, hygienic… and tamperproof bottles/containers" composed of polyethylene conforming to IS: 10146, polyvinyl chloride conforming to IS: 10151, PET/PBT conforming to IS: 12252 or polypropylene (PP) conforming to IS: 10910. Polycarbonate and sterile glass bottles are also permitted for use in bottled water packaging, provided such products prevent adulteration or contamination of the water.

Finally, the Contaminants, Toxins and Residues Title pertains to the suitability of foods themselves, and states that food shall not contain chemicals identified in Chapter 2 of the provision in excess of the amount specified. Therefore, while we understand that this Title is not directly applicable to food-packaging per se, the composition of the packaging material should be designed such that migration of any of the specified contaminants would not render the food itself unfit for consumption. Contaminants are specified both by chemical composition, as well as by type of food product in which such substances may be present. For example, metal contaminants (including lead, copper, arsenic, tin, zinc, cadmium, mercury, chromium and nickel) are limited to specified values based on their potential presence in foods including fruit and vegetables, juice, infant formula, and in many instances, all "other foods." Limits are specified in parts per million (ppm) unless otherwise stated.

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As with any emerging regulatory scheme, and particularly given the scope of the Food Safety and Standards Act and applicable regulations, implementation and enforcement of specific provisions are expected to take some time. Nevertheless, the implementation of FSSA represents an important step toward increasing regulatory oversight and predictability pertaining to food safety in one of the world's largest markets.

[1] See, e.g., Prevention of Food Adulteration Act (PFA), 1954, available at http://dbtbiosafety.nic.in/act/PFA%20Acts%20and%20Rules.pdf (last visited October 11, 2011).

[2] Included in the consolidations are the Prevention of Food Adulteration Act the Fruit Products Order of 1955, the Meat Food Products Order of 1973, the Vegetable Oil products (Control) Order of 1947, the Edible Oils Packaging Order of 1988, the Solvent Extracted Oil and Edible Flour Order of 1967, the Essential Commodities Act of 1955, and the Milk and Milk Products Order of 1992.

[3] http://www.fssai.gov.in.

[4] See FSSAI > Gazetted Notification, available at http://www.fssai.gov.in/GazettedNotifications.aspx (last visited October 10, 2011). These Regulations became effective on August 5, 2011. Certain limited provisions went into effect six months following implementation, or February 5, 2012. The predecessor legislation, the Second Schedule of the Food Safety and Standards Act, 2006, and the Milk and Milk Products Regulation, 1992, was repealed on August 4, 2011 (see F. No. P-15025/41/2011-DFQC).

[5] See Chapter 1, Section 1.2.8.