Manufacturers and users of industrial packaging may not always be aware of a product’s final destination or end purpose, meaning it could become subject to regulations not considered in the original packaging selection or manufacturing process. The only time users become aware of the issue could be when requests for regulatory compliance statements are made. Packaging users and manufacturers should proceed with caution in how these requests are handled, as they can often be fraught with risk.
New regulatory demands in China may catch vendors by surprise: 2017 saw extensive revisions to Food Contact Packaging Standards. Like the EU regulatory structure, the standards are framed by a ‘General Safety’ standard with supporting Good Manufacturing Practice (GMP), Additive Positive List, Migration Test and Food Contact Materials standards. These National Standards, published by China’s National Health and Family Planning Commission (NHFPC) and known as ‘GB’ Standards, consolidate and normalize previous standards applicable to food contact materials to facilitate industry understanding and compliance, but there are several changes and the list of materials is still incomplete.
The main food contact packaging framework standards (GB9685-2016: Standard on the Uses of Additives in Food-Contact Materials and Articles and GB4806.1-2016: Standard on General Safety Requirements for Food-Contact Materials and Articles) have had major modifications. These include fundamental requirements mandating that there is “No migration” of packaging substances that creates a health problem. They also include requirement for safety assessment of “Non-Intentionally Added Substances” (NIAS) for food packaging materials and a most restrictive use model for multi-material packaging whereby the component with the greater limitations defines restrictions on the use of the entire mixture or article.
GB9685 is now helpfully organized with Appendices of Positive Additive Lists, including a new Plastic Materials and Articles (Appendix A, Table A.1) which will be widely applicable to the food packaging industry. It has several categorical clearances which allow use of some unlisted direct food ingredients in food contact packaging and articles if there is no technical effect on the food.
As part of wider, more comprehensive Product Information and Labeling Scheme, Chinese regulations now also require an ‘EU style’ Declaration of Compliance (DoC) for food packaging materials. Vendors should take caution, however, as positive listings of materials within the appendices of GB9685 does not equate to a statement of compliance. The DoC requires all elements of the Product Information and Labeling Scheme to be incorporated and this may require changes to existing customer notification systems before a compliance statement can be made.
The new Chinese General Safety Standard, GB4806.1, now allows substances not cleared for use in packaging to be included if the requirements of a functional barrier as detailed in the standards are met. A functional barrier Is defined as ‘a barrier in food-contact materials, made of one layer or multi-layer materials, that prevents the materials behind it from migrating to food to ensure that the migration of non-permitted substance to food is no more than 0.01 mg/kg”. As per EU regulations, substances behind such a barrier must not be a carcinogen, mutagen, reproductive toxin or nano substance. Although this brings the Chinese regulations more in line with other regulatory jurisdictions, the process for implementing and testing a functional barrier to produce a DoC is fraught and should only be undertaken with great care.
GMP is covered by China’s GB31603 and this is, in many ways, similar to the EU standard EC 2023-2006. Vendors should be aware, however, that the regulation has more specific requirements, including complete traceability and recall/withdrawal systems, which are more in line with the Global Food Safety Initiative (GFSI) Prerequisite Programs for food packaging. For companies certified under a GFSI scheme, a regulatory review procedure must be in place to track applicable changes in regulations for all markets into which a product is offered.
It is important that industrial packaging manufacturers and users understand the requirements of applicable regulations for their packaging types and markets and this is the focus at Industrial Pack 2018. It may come as a surprise when packaging is being used for a food contact article in a manner and/or under a regulatory regime that was not anticipated. When receiving requests for ‘blanket’ compliance statements of conformance, it may not be appropriate to issue these for a particular product or business strategy. Statements should be appropriate for products and markets and great care taken not to make uninformed statements of compliance without careful planning and review.
Industrial Pack 2018, April 4 & 5, takes place at the Cobb Galleria Centre, in Atlanta, Ga.. For more information, go to industrialpackexpo.com.