Regulatory compliance and safety in packaging inks and coatings

Regulatory compliance and safety in packaging inks and coatings

As food safety concerns grow worldwide, the packaging industry faces increased pressure to meet stringent regulatory standards. Packaging inks and coatings, which can come into direct or indirect contact with food, must comply with safety regulations to ensure that no harmful substances migrate into food. This article explores key global and Indian regulations for packaging inks and coatings, emphasizing the importance of compliance for food safety and market access.

Regulatory framework in India

The Indian Food Safety and Standards (Packaging) Regulations, 2018, effective from July 2019, mandate food-grade packaging materials to ensure food safety by prohibiting toxic substances like phthalates, toluene, and heavy metals. IS 15495:2020 governs inks used in food packaging, banning specific harmful chemicals and providing guidelines for their use. The regulations also set migration limits for contaminants in plastic packaging materials and forbid the use of recycled plastics and newspapers. These standards promote consumer health, extended shelf life, and food security.

Global regulatory framework

European Union (EU)

The EU’s Regulation (EC) No 1935/2004 ensures food contact materials do not transfer harmful substances into food. Supported by the EU Plastics Regulation (EU No 10/2011), which sets migration limits, this framework governs inks used in food packaging. Additionally, the Good Manufacturing Practice (GMP) Regulation (EC No 2023/2006) requires all packaging materials, including inks, to be produced under stringent safety controls.

Germany

Germany’s Printing Ink Ordinance regulates substances used in inks for food packaging, setting migration limits and specifying a positive list of permitted substances. It ensures that harmful chemicals do not migrate into food, even in indirect contact situations.

Switzerland

Switzerland’s Ordinance on Food Contact Materials mirrors EU regulations, with a focus on migration limits and a positive list of substances allowed in packaging inks. This ensures that inks used for both direct and indirect food contact do not pose risks to consumers.

North American regulatory framework

United States

In the U.S., the Food and Drug Administration (FDA) governs packaging inks under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Inks are considered indirect food additives and must comply with strict migration limits. The FDA’s Food Contact Notification (FCN) system allows manufacturers to apply for new substances to be reviewed for safety.

Canada

Canada’s Health Canada oversees food packaging materials under the Food and Drugs Act. It evaluates inks through the Food Packaging Materials Assessment Program, ensuring compliance with strict migration limits and other safety requirements.

Regulatory landscape in Asia

China

China’s National Standard of Food Safety GB 9685 regulates additives in packaging materials, with migration limits in place to protect consumers. The GB 4806.1-2016 standard governs general safety requirements for food contact materials, ensuring that packaging inks do not release harmful substances.

Vietnam

Vietnam’s Food Safety Law, regulated by the Ministry of Health, covers packaging inks and coatings, enforcing strict migration limits and prohibiting harmful chemicals such as heavy metals.

South Asian Countries

Countries like Bangladesh and Sri Lanka are aligning their food safety regulations with global standards, banning hazardous substances like phthalates and heavy metals in packaging inks. They follow international guidelines to ensure the safety of food packaging inks and coatings.

Recent Developments in Regulatory Compliance and Safety

By the end of 2023, Vietnam’s Ministry of Science and Technology issued the National Standard TCVN 13928:2023, which prohibits the use of toluene in ink formulations for food packaging. This marks a significant step forward, as several printers and converters in Vietnam have already switched to safer alternatives. Bangladesh is also making strides with the development of packaging ink standards by BSTI, demonstrating the government’s commitment to enhancing consumer safety and raising regulatory standards. In Europe, the use of Food Safe coatings, which have low migration potential and are free from harmful substances such as mineral oils (MOSH, MOAH), heavy metals, and phthalates, is in compliance with regulations like EU No. 1935/2004, the Plastics Directive EU No. 10/2011, and the Swiss Ordinance (SR 817.023.21).

Manufacturers must now ensure that inks and coatings meet safety standards before entering the market, which involves rigorous testing and validation processes. The responsibility of ensuring safe formulations lies with manufacturers, who must obtain regulatory and safety data from their suppliers, such as through Food Contact Notifications (FCNs) or other substantiated determinations. In the US, recent developments include the FDA’s February 2024 ban on substances containing PFAS used as grease-proofing agents in food contact materials like paper and paperboard, signaling a continued effort to eliminate harmful substances in packaging materials. These regulatory changes across the globe reflect an increasing focus on the safety of packaging inks and coatings, encouraging safer, more sustainable alternatives in the industry.

Conclusion

Regulatory compliance is vital in the packaging inks and coatings industry, especially for food contact materials. Across India, the EU, the US, China, and other South Asian nations, strict safety standards govern the production and use of inks to prevent contamination and protect consumer health.

For GLS Speciality Chemicals, compliance with these global regulations is essential. The company’s state-of-the-art analytical lab ensures products meet safety requirements through rigorous testing. With its environment-friendly inks and coatings, GLS leads the industry in delivering safe, innovative, and sustainable packaging solutions. Through its commitment to transparency and regulatory adherence, GLS is well-positioned as a trusted partner in the global packaging industry.