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EC2023/2006 Regulation

Good Manufacturing Practice Regulation (EC) 2023/2006

Regulation EC2023/2006 of the European Parliament and of the Council.

“Good manufacturing practice for materials and articles intended to come into contact with food”

EC2023/2006 Regulation defines scope, definitions, quality assurance (QA) / quality control (QC) systems, and the documentation. Manufacturers should know that the EC1935/2004 Regulation defines the requirement for food contact material (FCM) to be manufactured to good manufacturing practice (GMP), however, the EC2023/2006 Regulation is the one that defines what good manufacturing practice is. Article 3 (a) states: “Good Manufacturing Practice (GMP), means those aspects of quality assurance which ensure that materials and articles are consistently produced and controlled to ensure conformity with the rules applicable to them and with the quality standards appropriate 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.”

What is the basic requirement for the EC2023/2006 Regulation?

The basis of the requirement for ‘good manufacturing practice’ in the production of materials and articles intended for contact with food, is compliance with Article 3 of the EC1935/2004 Regulation. Commission Regulation EC2023/2006 sets more specific requirements on good manufacturing practice, applicable to all food contact materials. In order to ensure that all relevant requirements are addressed properly, each individual company should carefully review the EC2023/2006 Regulation.

What does EC2023/2006 cover?

‘Good Manufacturing Practice’ for production of food contact materials and articles intended to come into contact with food starts with the approval and acceptance of the starting material for the production of polymers, which then moves on to the production, packaging, warehousing, and shipment and ends when the material actually comes into contact with food and meets legal compliance. These practices are intended as a guide on how to determine the consistent production of food contact materials.

What are the 2 stages of a ‘good manufacturing practice’?

The Framework Regulation obviously stresses that the safety, composition, and organoleptic entirety of the packaged food is a regulatory requirement. This element is repeatably mentioned in the definition of GMP EC2023/2006 Regulation. The whole composition of a food contact material or articles and its potential migrants require to be designed created and regularly kept up. This is in order for it to meet regulatory requirements in regard to the health, safety, and organoleptic properties of the packaged food are regularly guaranteed.

Two stages can be observed:

  • First stage – ‘design for compliance’ – an inert, safe, and organoleptically acceptable material is established with the intention of producing a final product that conforms to food contact regulatory requirements, through:
    • Regulatory compliance with EU10/2011 Regulation
    • Safety evaluation, fulfilling the EC1935/2004 Regulation requirements
    • Organoleptic controls of the food contact article
  • Second stage – Commercial Production – regulatory compliance of the composition and potential migrants of materials and articles must be regularly ensured. Primary importance procedures are those of very strict management of change procedures and effective prevention of contamination procedures.

Main 3 concepts for ‘Good Manufacturing Practice’

  • creating awareness across the board
  • retaining compliance of the composition and feasible migrants by effective prevention of contamination
  • retaining conformance of the composition and feasible migrants by effective supervision of change procedures suggesting potential composition changes or risk of contamination


Scope and guidance of ‘good manufacturing practice’

Article 2 of the EC2023/2006 Regulation sets out the scope as follows: “This Regulation shall apply to all sectors and all stages of manufacture, processing, and distribution of materials and articles, up to but excluding the production of starting substances.”

According to that, the scope could be broken down into:

Quality assurance system and quality policies

  • quality policy in place, which is adequate to regularly produce materials and articles intended for contact with food, compliant to the relevant regulations
  • active involvement of management and personnel as an effective quality assurance system
  • quality control department in place with authority to autonomously approve or reject all process materials

Management leadership and personnel 

  • responsibilities for GMP implementation assigned, defined, and documented
  • in order for the personnel to perform their assigned functions within the production or control of food contact materials and articles, education, training, and/or experience must be provided
  • good manufacturing practice should be included in personnel training

Hygienic policy (contingent on the supply chain positioning) – if relevant:

  • adequate and appropriate hygiene measures must be maintained for personnel, factories, warehouses, and transportation
  • the pest control program in place (or a documented explanation for lack of one)

Certification, labeling, record keeping, and traceability

  • documenting system for product formulation, operating procedures, operating windows, product release specifications, and any other crucial information
  • cross-contamination risks in case food contact materials are made in the same factory as non-food contact materials
  • traceability procedures (from incoming starting material through to outgoing food contact material), the procedures must also outline the use of raw material
  • the use of all major equipment, transfer lines, containers, and tanks that are used for processing, filling, or holding food contact materials; this could be done by labeling or electronic control systems to indicate contents, batch designation, control status, and other critical information
  • maintenance of the appropriate documentation on quality critical items


  • Raw / Starting material specifications and acceptance
    • procedure to approve suppliers
    • procedure to approve starting/raw materials
    • good technical quality of the starting materials for the intended use
    • verification for acceptance of the starting materials prior to use
    • prevention of mix-up or contamination by appropriate storage and handling
    • identification and control of materials not meeting the acceptance criteria
    • suitable quality of water coming into contact with food contact materials or articles
  • Prevention of contamination
    • adequate contamination prevention procedure
    • adequate set up of the equipment to prevent cross-contamination between material for food contact and those for non-food contact or their ingredients
    • procedures for an effective transition such as cleaning to avoid cross-contamination
    • segregation or a control system to divide raw materials from a non-conforming product or a product return
    • transfer, packaging, and loading procedures in place to avoid cross-contamination
  • Change management
    • documentation and establishment of operation procedures and process operating windows
    • management of change procedure in the event of operating procedures needing to be amended
    • the capability of the procedure to detect and indicate potential changes in the composition or increased risk of contamination
    • changes in product formulations – suppliers of the materials can be a subject of change
    • documented procedures for the impact of changes on the final product composition, quality, performance, and compliance
  • Storage, packing, warehousing, and transportation
    • well-managed and sufficient storage for starting materials
    • adequate storage conditions to prevent contamination
    • dedicated equipment for food contact materials or an effective measures procedure to ensure that the container doesn’t contain any contaminants not intended for food contact
    • procedures for correct labeling

Quality control and specifications

  • documented specification for raw material and finished products
  • monitoring of raw materials and finished products to verify conformance with regulations
  • one unique specification for every food contact material product code

Contracted out work 

  • any operation that is contracted out must be based on a written contract
  • any contracted out production should be carried out according to GMP

Complaint handling, product recall, incident management 

  • implementation of a recording and investigating system for complaints, which includes product recall
  • recommendations for corrective actions in place for all complaint investigations
  • procedure for contamination response
  • measures ensuring that non-conformance or recalled products aren’t released for food contact use without extensive investigation and adequate authorisation

Constant audits – internal and external

  • procedure for self-assessment and external audits


Article 3 of EC1935/2004 European Regulation defines the objective for materials and artivcles intended to come into contact with food: “Materials and articles intended to come into contact with food shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could:

  • endanger human health
  • or bring about an unacceptable change in the composition of the food
  • or bring about a deterioration of the organoleptic characteristics thereof.”

EC 2023/2006 Regulation, which focuses on good manufacturing practice, determines more specifically the requirements in regards to good manufacturing practice, as required by EC 1935/2004 Regulation.

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E & OE. M Barnwell Services endeavour to make sure that all content is correct. The information has been gathered from manufacturing partners and the EC2023/2006 Regulation. Information is for descriptive purposes only. For guidance visit