Compliance with GMP Regulations for Food Contact Materials and Food Contact Final Articles
The safety of Food Contact Materials (FCM) and Food Contact Final Articles is ensured in multiple ways. In addition to regulations requiring that food contact materials and final articles are made from individual substances approved for food contact, many countries require that FCM are produced according to Good Manufacturing Practices (GMP). GMP requirements are designed to prevent contamination and ensure that food contact materials and articles are safe to contact food. GMP requirements for food contact materials and articles vary depending on the type of FCM being produced, as well as on the position of the FCM manufacturer in the supply chain. Generally, a GMP program follows the supply chain beginning with the approval and acceptance of raw materials and covering production, and shipment up to the point where the final article is brought into contact with food.
In the EU, food contact materials and articles must be compliant with Regulation (EC) No 1935/2004. Diese This regulation requires that both food contact materials and articles are manufactured in accordance with Regulation (EC) No 2023/2006, which further specifies the required GMP conditions for food contact materials and articles intended for the EU market. US regulation 21 CFR § 110 outlines GMP requirements related to manufacturing, packaging, or holding human food intended for the US market, including specific reference to food packaging.
• Key requirements for GMPs for FCM, in both the EU and US, include:
• Sanitation of facilities;
• Hygiene and training of personnel in the manufacturing facility;
• Documentation and traceability;
• Production and raw material specifications;
• Ensuring any subcontractors meet GMP requirements;
• Product recalls;
• Regular internal and supplier audits;
EU regulations also require the implementation of a quality control system establishing measures to ensure compliance of FCM with specifications. In the US, FCM are exempt from many sections of the Food Safety Modernization Act, although the US FDA has the discretion to access records and detain any food packaging that could cause serious adverse health consequences or death. Crucially, compliance with GMP are not only required for FCM facilities located in the EU or US, but any facility producing food packaging intended for the EU or US market. It is important for any food contact material and final article manufacturer selling products for these regions to be aware of the GMP requirements and ensure that they are implemented in their facilities.
To ensure that your food contact material and final article manufacturing facilities meet the EU and US GMP requirements, please contact the knoell FFCM team or get more information on our Food & Food Contact Materials page.