EuPIA Position on the Commission Regulation (EC) 2023/2006 on Good Manufacturing Practice for materials & Articles Intended to Come into contact with Food
The ‘GMP Regulation’ No 2023/20061 lays down rules on Good Manufacturing Practice for materials and articles intended to come into contact with food, which are listed in the Annex of the Framework Regulation (EC) No 1935/20042.
It introduces general rules for all business operators in the supply chain, and specifies that quality assurance and control systems are established and implemented. In addition, appropriate documentation is mandatory.
All printing inks intended for use on food packaging are in the scope of this Regulation.
This Regulation has an Annex which introduces detailed rules on Good Manufacturing Practice, but only applies to the application of printing inks to the non-food contact side of a material or article, and to the storage of the printed articles.
The Annex states:
Printing inks applied to the non food-contact side…shall be formulated and/or applied in such a manner that substances from the printed surface are not transferred to the food contact side.
In order to meet this requirement, there needs to be cooperation between the ink manufacturer and the rest of the supply chain, since this means that the ink manufacturer does not have an independent responsibility in this regard. However, those who actually apply the ink or coating are ultimately responsible for compliance with the Annex of the Regulation.
The cooperation between ink manufacturer and converter is managed by requirement specifications, e.g. by information about the substrate, type of food packed, printing and converting process parameters, storage and treatment conditions.
From this information, the ink manufacturer will supply ink(s) which, if used correctly, will allow the final package to meet these legal requirements.
Further to this the converter has the responsibility to ensure that, if there is any migration, it is not
.. in concentrations that lead to levels of the substance in the food which are not in line with the requirements of Article 3 of Regulation (EC) No 1935/2004.
The ‘GMP Regulation’ was published in the Official Journal in December 2006, and came into force on 1 August 2008 in all EU Member States, though there is still a need for guidelines for the various groups of materials and articles which are not yet covered by the detailed rules on good manufacturing practices.
EuPIA members believe that the supply of inks for food packaging which have been made using the concepts of the EuPIA GMP and Guideline, will give maximum support to the packaging manufacturers and other downstream members of the food packaging manufacturing chain to enable them to meet the criteria of the Framework and GMP Regulations.
However, the application of printing inks, as well as the handling and storage of printed materials, is an area of involvement for the printer/converter and accordingly they should also follow their relevant GMPs in order to meet the requirements as outlined in Regulation (EC) No 2023/2006.
(1) Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food, OJEU L384 of 29.12.2006
(2) Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC, OJEU L338 of 13.11.2004