China's New Standard for Adhesives: GB 4806.15-2024, Effective February 2025

The release of the GB 4806.15-2024, China's National Food Safety Standard for Adhesives in Food Contact Materials and Products, marks a significant development in the regulatory landscape governing food safety in China. This standard, which will become enforceable on February 8, 2025, introduces comprehensive guidelines that manufacturers must adhere to when producing adhesives that come into direct or indirect contact with food. The standard aims to ensure that these materials do not pose any risk to human health, thereby enhancing the overall safety of food products within China and for exports.

Scope and Application

The GB 4806.15-2024 standard is broad in its application, covering adhesives used in food contact materials and products. These materials can include packaging, containers, utensils, machinery, and other products that either directly or indirectly touch food during production, processing, storage, or packaging. The standard categorizes adhesives into two primary groups:

1. Adhesives for Direct Food Contact: These are adhesives used on surfaces that are expected to come into direct contact with food. Examples include adhesive layers in food packaging films or labels that are in direct contact with the food product.

2. Adhesives for Indirect Food Contact: These adhesives are applied to surfaces that do not directly touch food but are still part of the food contact material or product. Over time, substances from these adhesives may migrate into the food, making their regulation critical.

The differentiation between direct and indirect contact is crucial because it dictates the level of scrutiny and specific requirements that apply to each category.

Key Requirements for Adhesives

Basic Requirements

GB 4806.15-2024 establishes stringent basic requirements for adhesives used in food contact applications. These requirements are aligned with China's overarching food safety regulations, particularly GB 4806.1, which sets the general safety standards for food contact materials. Key stipulations include:

• Compliance with Safety Standards: Adhesives must meet the safety criteria set out in GB 4806.1, ensuring they do not release harmful substances that could contaminate food.

• Control of Safety Risks: Manufacturers are required to implement robust controls throughout the adhesive production process. This includes careful selection of raw materials, monitoring the production process, and ensuring that the final product is safe for its intended use.

• Minimization of Residual Adhesives: The amount of adhesive used should be minimized, especially for direct contact applications. This is to reduce the potential for any harmful residues that might migrate into the food.

Raw Material Specifications

The standard provides detailed guidelines on the types of raw materials that can be used in the production of adhesives for food contact. These materials are categorized based on their intended use—whether for direct or indirect contact with food.

• Direct Contact Adhesives: The raw materials for adhesives expected to come into direct contact with food must meet stricter criteria. These materials are listed in Appendix A of the standard, which outlines specific substances, their CAS numbers, and any usage restrictions. For example, certain monomers, oligomers, and additives must have specific migration limits to prevent contamination.

• Indirect Contact Adhesives: The materials used in indirect contact adhesives, while still regulated, are subject to slightly less stringent requirements. Appendix B of the standard lists these materials, along with their corresponding migration limits and other safety parameters.

Technical Requirements

Sensory, Physical, and Chemical Indicators

The GB 4806.15-2024 standard sets forth explicit sensory, physical, and chemical indicators that adhesives must meet to be considered safe for food contact applications.

• Sensory Indicators: For adhesives used in direct food contact, the sensory characteristics of the adhesive layer must not alter the sensory properties of the food. This means that adhesives should not impart any odor, color, or taste to the food they contact.

• Physical and Chemical Indicators: The standard specifies the maximum allowable limits for various chemical substances that can migrate from the adhesive into food. For instance, the total migration limit for any adhesive in direct contact with food is set at ≤ 10 mg/dm². Additionally, the amount of heavy metals, such as lead (Pb), must not exceed 1 mg/kg in acidic environments (e.g., when tested with 4% acetic acid at 60°C for 2 hours). Furthermore, the presence of aromatic primary amines, which are known to be hazardous, is strictly prohibited in any detectable amount.

Migration Tests and Limits

Migration testing is a critical component of the GB 4806.15-2024 standard. Adhesives must undergo rigorous testing to ensure that any substances that might migrate from the adhesive into the food remain within safe limits. The standard refers to GB 31604.1 for migration testing methods, which are designed to simulate real-world conditions under which the adhesive might interact with food.

• Specific Migration Limits (SML): These are set for individual substances based on their toxicological profile. For example, certain monomers and additives used in adhesives have specific migration limits that must not be exceeded.

• Overall Migration Limits (OML): The total amount of non-volatile substances that can migrate from the adhesive into food is capped at 10 mg/dm². This ensures that the cumulative exposure to potentially harmful substances is minimized.

Compliance and Safety Measures

Labeling and Identification Requirements

One of the essential aspects of GB 4806.15-2024 is its emphasis on proper labeling and identification. Adhesive products must clearly indicate whether they are intended for direct or indirect food contact. This labeling ensures that downstream users, such as food manufacturers and packaging companies, can make informed decisions about the suitability of the adhesive for their specific applications.

The standard also requires that all relevant safety information, including migration limits and any specific usage conditions, be provided with the adhesive product. This transparency is crucial for maintaining safety throughout the food production and supply chain.

Manufacturer Responsibilities and Best Practices

Manufacturers of adhesives for food contact materials bear significant responsibility under GB 4806.15-2024. They must implement comprehensive safety management systems that cover the entire production process, from raw material selection to final product testing. Best practices recommended by the standard include:

• Regular Testing and Verification: Manufacturers should regularly test their adhesives to ensure they remain compliant with the standard, particularly when there are changes in raw materials or production processes.

• Documentation and Traceability: Maintaining detailed records of raw materials, production batches, and testing results is essential. This documentation not only ensures compliance but also facilitates traceability in the event of a food safety issue.

• Collaboration with Supply Chain Partners: Adhesive manufacturers are encouraged to work closely with suppliers and customers to ensure that all parties understand and adhere to the requirements of GB 4806.15-2024.

Impact on the Food Industry

The implementation of GB 4806.15-2024 will have a profound impact on both domestic and international food manufacturers who export to China. Companies will need to evaluate their current adhesive products and production processes to ensure compliance with the new standards.

Implications for Domestic and International Manufacturers

For domestic manufacturers, the standard represents a shift towards stricter regulatory oversight, which will likely require investments in new testing equipment, updated production processes, and enhanced quality control measures. However, compliance with the standard will also open up opportunities for these companies to produce safer, higher-quality products that can compete more effectively in both domestic and international markets.

International manufacturers, particularly those exporting food products to China, will need to ensure that their adhesives meet the GB 4806.15-2024 requirements. This may involve reformulating products, sourcing new raw materials, or conducting additional testing to demonstrate compliance. Failure to comply could result in rejected shipments, recalls, and significant financial losses.

Adapting to the New Regulatory Landscape

As the enforcement date approaches, companies will need to take proactive steps to adapt to the new regulatory landscape. This includes:

• Conducting Compliance Audits: Companies should conduct thorough audits of their adhesive products to identify any gaps in compliance with GB 4806.15-2024.

• Engaging with Regulatory Experts: Partnering with regulatory consultants or food safety experts can provide valuable insights into navigating the complexities of the new standard.

• Training and Education: Educating staff and supply chain partners on the requirements of GB 4806.15-2024 will be crucial for ensuring smooth implementation and ongoing compliance.

Conclusion

The GB 4806.15-2024 standard represents a significant advancement in China's efforts to enhance food safety. By establishing clear guidelines and stringent requirements for adhesives used in food contact materials, the standard aims to protect consumers from potential health risks associated with chemical contamination.

As the February 8, 2025 enforcement date approaches, manufacturers must take decisive action to ensure their products comply with the new regulations. While the path to compliance may be challenging, the result will be a safer, more transparent food supply chain that benefits both consumers and businesses alike. The introduction of GB 4806.15-2024 is not just a regulatory requirement; it is an opportunity for the industry to reinforce its commitment to food safety and quality on a global scale.

For more detailed inquiries, stakeholders can connect directly with the National Health Commission of the People's Republic of China, the regulatory authority overseeing the implementation of GB 4806.15-2024, or utilize the SGS Digicomply platform for comprehensive insights and updates. Feel free to get in touch now to learn about implementing the Regulatory Intelligence Hub for your company. Or explore the demo and try this tool in action.