GMP-regulation (EU) 2023/2006

EU GMP Regulation 2023/2006 applies to all food contact material operators. This Regulation requires operators to have a documented quality management system in place to ensure good manufacturing practice. The objective of following good manufacturing practice is to ensure the chemical safety and compliance of materials and articles. In practice, the quality management system shall provide methodological guidelines for quality assurance and quality control. The management of documents demonstrating the compliance of raw materials and the final product, as well as the management of the operator's own process are relevant elements of quality assurance.

Good manufacturing practice (GMP) refers to methodological guidelines focusing particularly on preventing the set-off of printing inks and on the management of the recycled plastics process. The GMP Regulation does not lay down any other requirements for the content of the quality management system. Set-off refers to the transfer of ingredients of the printing ink from the printed surface to the non-printed surface when the contact material is stacked or reeled.

Finnish Food Authority's Guide 17018 on food contact materials contains instructions for operators with respect to the content of the quality management system. According to the Guide, the quality management system shall cover the following points

  • How to implement the management of the composition of the food control material?
  • A description of the manufacturing process of food contact materials, including establishment and monitoring of control points, as well as instructions for preventing the set-off phenomenon.
  • How to implement the testing of the safety of the final product
  • How to implement the labelling of the products (where consumer products are concerned)?
  • How to prepare the declaration of compliance?
  • How has traceability been verified?