Regulation (EY) 1935/2004 covering all food contact materials obligates contact material operators to manufacture contact materials according to good manufacturign practicies. In order to ensure a good manufacturing practicies and the safety of food contact materials, operators in the field must draw up a documented quality management system in accordance with Regulation (EC) 2023/2006, which includes both quality assurance methods and quality control methods. The quality management system must include both quality assurance procedures and quality control procedures. This requirement is in line with food industry operators’ own-check requirement.
The regulation does not exactly set any other requirements for the contents of the quality management system than the regulations about added requirements to the system caused by the use of printing inks and the recycled plastic process, mentioned in the regulation’s annex.
Ruokavirasto has given instructions on the contents of the quality management system in the food contact material control guidelines.
According to the guidelines, a quality management system should at minimum cover the following areas:
- General specifications of the quality system, such as document organisation, preparing for withdrawals, ensuring staff competence, etc.
- Managing the food contact materials’ composition (e.g. recipes or texture management, ingredient safety and related requirements and documents)
- Description of the producing process of the contact materials, risk assessment, process control and potential monitoring points and their bookkeeping, preventing set-off from printing inks, and requirements for additional information on recycled plastic (GMP regulation, Annex I)
- Testing for regulatory compliance of food contact materials, model calculations
- Food contact materials labelling (consumer products)
- Documents proving the regulatory compliance of food contact materials (model documents, principles for submitting and updating the documents).
- Procedures and documentation related to the traceability management of food contact materials
A quality management system can also be composed based on standards, and below are some of the standards that contact material operators use:
- SFS-EN 15593 standard: Packaging. Hygiene control in packaging production. Requirements.
- SFS-EN ISO 22000: Management systems for food industry. Requirements for all food industry chain organisations.
- BRC/IOP Global standard for packaging and packing materials
However, authorities do not insist that a quality management system should be based on standards, and it also does not need to be certified.
Different branches also have their own GMP guidelines that can be utilised in creating a quality management system.