10 Golden Rules for Food Contact Materials’ GMP Compliance in Europe

Under framework Regulation (EC) No. 1935/2004, the European Union (EU) states Food Contact Materials (FCM) must display the globally accepted glass/fork symbol before they can be sold in the EU, unless the articles are obviously intended to come into contact with food due to their characteristics. Similar to the European CE Mark, the glass/fork symbol specifies that food and drink in contact with the product will be safe for human consumption.

Regulation (EC) No. 1935/2004 also requires FCM to be manufactured to GMP. GMP therefore becomes the basic control measure and procedure manufacturers should pursue to produce safe and compliant FCM.

EU regulations that cover FCM include:

  • No. 1935/2004 – lineout of GMP requirements
  • No. 882/2004 – for officials looking at FCM compliance
  • No. 2023/2006 – for manufacturers. Defines scope, definitions, quality assurance (QA)/quality control (QC) systems, documentation
  • No. 282/2008 – amends No. 2023/2006

Stakeholders should note that, while Regulation (EC) No. 1935/2004 requires FCM to be manufactured to GMP, it is Regulation (EC) No. 2023/2006 that defines GMP for FCM. In Article 3 (a) it is defined as:

“‘Good Manufacturing Practice (GMP)’ means those aspects of quality assurance which confirm that materials and articles are consistently produced and controlled to confirm conformity with the rules applicable to them and with the quality standards suitable to their intended use by not endangering human health or causing an unacceptable change in the composition of the food or causing a deterioration in the organoleptic characteristics thereof.”

To implement GMP, manufacturers must implement a robust system of Quality Assurance (QA) and Quality Control (QC) – the building blocks of GMP – throughout the production chain. QA is a mechanism to support manufacturers control their procedures and QC supports them control quality.

The manufacturer is responsible for implementing a documented QA system that confirms:

  • Employees are suitably trained
  • Responsibilities are defined
  • Correct organization and procedures are in place
  • Traceability is assured
  • Suitability to manufacturing safe, compliant FCM
  • Technical know-how is in place to control:
    • Chemical procedures
    • Processing machine
    • Workplace conditions
    • Treatment of products

Central to achieving GMP is the correct choice of materials and suppliers, since they will have a major impact upon the management of the production procedure. The QC system must also be actual and suitable for controlling quality. It must run from raw materials and parts selection, through manufacturing, transportation, storage, and include supervision and corrective actions.

A robust QC system will allow:

  • Intervention in the production process
  • Corrective measures to confirm compliant production
  • Illustrate efficiency to authorities

Given the number of economic operators that can be included in the supply chain, it is vital for the manufacturer to confirm that each operator is individually compliant with their own legislative requirements, and that they are providing quality products to their clients.

The key to showing compliance with GMP, which cannot be tested, to authorities is documentation, which is commonly requested. To implement actual QA and QC systems, the manufacturer must create clear and exact documentation – either on paper or electronically. The system must contain supportive documents, including details of specifications, details of material composition, Declarations of Conformity and test report, and operative documents. These might include documents detailing:

  • Selection of materials
  • Registration of production data
  • Production controls – e.g. temperature records, cleaning charts
  • Procedure of corrective action
  • Control of finished product – e.g. testing
  • Personal training
  • Storage management
  • Distribution/Shipping protocols

To implement GMP, stakeholders should follow these ten golden rules to GMP compliance:

  • Get the facility design right from the start
  • Create good procedures and confirm they are followed
  • Validate the procedures
  • Recognize responsibilities and roles
  • Keep good records
  • Train and develop staff
  • Practice good hygiene
  • Maintain facility and equipment
  • Build quality into the lifecycle
  • Perform regular audits

Food Contact Materials Services

Global network of accredited laboratories can assist with testing and certifying FCM against local and regional regulations in Europe, North American, South American (Mercorsur) and the Asian Pacific. GMP certification for food packaging materials, based on BSI PAS 223, and GMP audits for management systems, based on FSSC 22000 part one and two.