Because of their important role in overall food safety, food packaging products and materials are subject to regulations in most major jurisdictions around the world. In this article, we’ll provide a summary of the principle regulatory requirements for food packaging products and materials in the U.S., the European Union (EU), China and Japan.
How do food packaging products and materials impact food safety?
Packaging products and materials come in a variety of forms, such as bottles, cans, jars, cartons, bags and wrapping materials. They can be made of paper, plastic, petroleum-based substances, engineered products and recycled materials. Packaging materials based on agricultural ingredients like plant fibres, sugars and starches are also increasingly popular as an environmentally-preferable packaging option.
Food packaging products and materials usually contain additives, such as colourants and chemicals. Therefore, prolonged contact between food and packaging materials can result in the transfer of these additives from the packaging to a food product. In addition, recycled materials used in food packaging are often exposed to chemicals and other agents during the recycling process. Food packaging can also come in contact with potentially harmful substances during the production process or in storage, thereby cross-contaminating any enclosed food.
Food packaging product and materials regulations and standards
Regulations and requirements regarding food packaging products and materials are generally intended to preserve the physical, chemical and sanitary integrity of food products. However, in practice, regulations and standards intended to achieve this goal take a variety of different approaches. Following is a brief summary of the key regulations and standards applicable to food packaging products and materials in key global jurisdictions.
In the EU, requirements applicable to food packaging materials are detailed in Framework Regulation (EC) No. 1935/2004, which establishes minimum requirements applicable to most types of food packaging. These requirements mandate that all packaging materials:
- Are safe;
- Do not transfer components or chemicals to food so as to endanger human health, change food composition or adversely affect food taste or odour;
- Are produced consistent with good manufacturing practices, consistent with the requirements of Regulation (EC) No. 2023/2006;
- Are traceable through the production chain;
- Bear the EU’s ‘glass-and-fork” symbol or otherwise labelled to signify compliance with the requirements.
Under Regulation 1935/2004, packaging materials must be authorised by the European Food Safety Authority (EFSA) prior to being placed on the market. Food packaging materials that have been authorised are listed in a publically-available online database maintained by the EFSA.
Food packaging materials are also subject to the EU's Plastics Regulation (EU) No. 10/2011, which addresses the use of all plastic materials intended to come in contact with food. Importantly, Regulation 10/2011 establishes an overall migration limit (OML) for plastic products that come in contact with food, as well as specific migration limits (SMLs) and residual quantity in material (QM) limits for certain substances. Compliance with these limits is verified through a testing scheme described in the Regulation, and plastic food packaging materials are also subject to review and authorisation by the EFSA prior to be placed on the market.
In the U.S., regulations affecting food packaging products and materials are dictated by U.S. FDA regulatory requirements affecting each individual substance used in a given material. The FDA recommends the following approach to determine the regulations that apply to individual material substances, and the path to achieve compliance with its regulations:
- Consult 21 CFR (Code of Federal Regulations) 174-179 to determine if a substance used in a packaging material is a regulated indirect additive. Regulated additives can include adhesives and components of coatings, paper and paperboard components, polymers and irradiation used in the production process and handling of food.
- Consult 21 CFR 182-186 to determine if a substance used in a food packaging material is listed as "generally recognised as safe" (GRAS).
- Consult 21 CFR 181to determine if a substance used in a food packaging material is listed as "prior sanctioned."
- Consult the FDA's listing of Threshold of Regulation Exemptions to determine if a substance falls below the threshold of regulation and is therefore exempt.
- Consult the FDA's listing of Food Contact Substance (FCS) Notifications to determine if the FDA has previously been notified about a separate use of a given substance.
If a manufacturer determines that a specific food packaging product or material substance is not covered by any of the above regulations or listings, a manufacturer can either:
- submit a Threshold of Regulation exemption request;
- satisfy the criteria necessary for GRAS status; or
- submit an FCS Notification.
The FDA's FCS Notification route is generally the preferred method for obtaining agency clearance for previously unused food packaging substances. The FDA is required to complete its review of FCS Notification requests in not more than 120 days, significantly shorter than the period required for previous food additive petition processes. An FCS Notification is also proprietary to the manufacturer who has requested it, and is not applicable to the same substance produced by a different manufacturer.
Food packaging products and materials produced or used in China are regulated under the China Food Safety Law issued in 2009, which prohibits the importation, purchase or use of any food product that does not comply with the applicable Chinese food safety standards (formerly referenced as Guobiao (GB) or national standards). There are estimated to be more than 130 Chinese food safety standards applicable to food packaging materials, including standards that address food contact additives, specific food packaging products, and specific food packaging material groups such as paper, metal or ceramic.
One of the most important food safety standards is GB 9685, Hygienic Standard for Use of Additives in Food Containers and Packaging Materials. The standard includes a positive list of more than 1500 approved additives, as well as SML and QM limits. The standard also includes a negative list of food additives that are prohibited.
The process for obtaining approval for the use of new food packaging material additives is detailed in China's Management Rules for the Administrative Approval of New Varieties of Food-Related Products. Manufacturers seeking approval for new additives must be able to demonstrate that proposed substance has a clear scope of use, will not alter the structure, colour or flavour of the food it contains, and will not adversely affect human health under reasonably foreseeable uses. Testing is required to validate toxicology claims.
In addition to compliance with applicable food safety standards, manufacturers based in China that produce food packaging materials made of plastic or paper must hold a quality safety (QS) certificate issued by China's General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ).
Unlike some other industrialised countries, Japan does not require premarket review or approval of food packaging products and materials prior to their use. Instead, food packaging materials are expected to meet the general provisions of Japan's Food Sanitation Law, which prohibits the sale of packaging materials containing substances that could be harmful to human health. Enforcement is achieved through random inspection and testing of products, along with penalties for non-compliance.
Japan's Food Sanitation Law also authorises the Japanese Ministry of Health, Labour, and Welfare (MHLW) to develop specifications for food packaging materials. These specifications include general specifications that apply to all food packaging materials, material-specific specifications, and application-specific specifications.
In addition to MHLW specifications, food packaging material manufacturers must also be prepared to comply with voluntary industry standards and requirements promulgated by various Japanese trade organisations. The most important and influential trade organisations include the Japan Hygienic Olefin and Styrene Plastics Association (JHOSPA), the Japan Hygienic PVC Association (JHPA) and the Japan Paper Association (JPA). Frequently, Japanese food producers will require evidence of compliance with various standards produced by these and other trade organisations as a procurement condition.
Summary and conclusion
Food packaging products and materials are an important element in the overall effort to provide consumers worldwide with safe and nutritious food. However, packaging manufacturers must be prepared to deal with a complex global regulatory landscape, in which individual jurisdictions have adopted different regulatory frameworks for the review and approval of food packaging materials. Manufacturers seeking worldwide acceptance for their food packaging products and materials will benefit from a thorough understanding of all of the substances used in their products and materials, and a detailed analysis of the regulations and standards applicable to those substances.