The regulatory framework requires that inks must be formulated and processed according to Commission Regulation (EC) No. 2023/2006 (GMP), so that substances are not released to food in quantities thst can generate situations not complying with the Article No. 3 of the Regulation (EC) No. 1935/2004 European Parliament and of the Council.
The Regulation on GMP of materials and objects intended to come into contact with food products, in relation to the specific rules on good manufacturing practices and in the case of «Processes involving the application of printing inks to the non-food contact side of a material or article» establishes that:
1. Printing inks applied to the non food-contact side of materials and articles shall be formulated and/or applied in such a manner that substances from the printed surface are not transferred to the food-contact side:
a) through the substrate
b) by set-off in the stack or the reel, 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.
For these reasons, risk assessment is necessary, related to the use of printing inks.
Based on this requirement, IRCPack and Sepack Lab developed a set-off evaluation protocol for printed materials with:
• solvent-based liquid inks on solvent material, study in collaboration with Giflex (Gruppo di Assografici, which brings together producers of flexible materials)
• UV inks on paper and flexible support, study in collaboration with RadTech Europe
• off-set inks
• digital printing inks
• water-based inks
The protocol provides:
• an analytical investigation based on screening methods for monitoring volatile, semi-volatile and non-volatile organic compounds contained in the inks by appropriate instrumental techniques based mainly on gas chromatography/mass spectrometry (GC/MS): the analytical investigation is focused both on the total material and on the side in direct contact with food.
• elaboration of the data obtained to verify the presence of “critical" definable compounds, by nature or quantity