ECMA Statement on Direct Food Contact Inks
ECMA and its members regularly receive questions about the conformity of printing inks on packaging which comes into direct contact with food and about the use of appropriate inks for such specific applications. Some legislation and the terminology used, can lead to confusion.
The GMP Regulation (EC) No 2023/2006 specifies in its Annex, detailed rules on good manufacturing practice for processes involving the application of printing inks on the non-food contact side of a material or article. These rules mention, the substances should not be transferred to the food contact side during processing or storage at levels which would not be in line with the Food Contact Framework Regulation (FCFR) (EC) No 1935/2004 and it is also stated the printed surfaces from such a printing processes shall not come into direct contact with food.
This does not mean direct contact between inks layers and food are not allowed. Specially designed inks, fulfilling very strict composition requirements in order to be compliant with Article 3 of the FCFR, are allowed on surfaces in direct contact with foodstuffs.
Similarly, the new German Ink Ordinance is covering both direct and indirect contact printing. For the Direct Food Contact (DFC) inks only the listed substances can be used, self-evaluated substances are not allowed.
Different documents available from the European Ink Manufacturers Association EuPIA (www.eupia.org) cover the specific guidance in relation to DFC applications. (EuPIA Guideline on printing inks applied to Food Contact Materials, EuPIA GMP, EuPIA Guidance on migration test methods for the evaluation of substances in printing inks and varnishes for food contact materials).
A second source of confusion is due to the naming of certain ink series. So-called "FCM (Food Contact Material) inks" are not suitable for direct contact printing. DFC inks are required for such applications. FCM inks are designed for use on food contact materials in cases where no functional barrier is present and on the surface which is not in physical contact with the food.
The EuPIA GMP further specifies, the presence of an overprint varnish does not change the contact character of the ink. With the presence of a DFC overprint varnish, it is still necessary to use a DFC ink on the direct contact side.