How Does FSMA Impact Food Packaging Manufacturers?
In FSMA, it is our understanding that if a "Food Facility" is registered, then the product in the "Food Facility" should be manufactured per the HACCP quality management system, and that the "Food Facility" will be subject to FDA audit. Does this include a facility that manufactures food contact substances such as film? Would it be subject to FDA audits under FSMA?
The Food Safety Modernization Act (FSMA) proposed rule for Preventive Controls for Human Food on current good manufacturing practice (cGMP) and hazard analysis and risk-based preventive controls (HACCP) for human food requires most registered food facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards. Since facilities manufacturing only food-contact materials are not subject to FDA food facility registration requirements, they also are not subject to this proposed rule.
This proposed rule could significantly impact the customers of food-contact material suppliers and some of those impacts may affect food-contact materials. While the revisions to the cGMP regulations add coverage of "food packaging materials" to certain regulations, they do not impose substantive requirements on manufacturers of food packaging materials. Instead, the revisions would apply to the proper handling and safe maintenance of food-contact materials in food facilities to ensure that these products are not contaminated or result in the adulteration of food.
In addition, while the HARPC provisions of the proposed rule also apply only to a "food facility" that is required to register with FDA, they could, in some cases, indirectly impact food-contact material suppliers. For example, as registered facilities develop written food safety plans and consider potential hazards that might relate to their packaging activities, packaging material suppliers may be requested to assist in developing plans to avoid some of these hazards.
For more information, see the PackaingLaw.com article, FDA's Proposed Rule to Implement FSMA's Hazard Analysis and Risk-Based Preventive Controls: Implications for Manufacturers of Food-Contact Materials.