Food packaging is very important for food producers. The visual aspect of packaging is a very powerful tool, so that consumers consider a brand name as an established value. In the process, the chosen varieties of ink play a crucial role. The choice may not only be based on marketing strategy. Still, the potential health risks that might result from the migration issues of the ink components have to be taken into account. Printing inks used in food packaging materials contain substances that might migrate, such as raw materials, photoinitiators and acrylates, by-products of hardeners, solvents or products of degradation and reaction between inks compounds under storage and application conditions. If you are a food manufacturer or packaging manufacturer, you need to comply with rules we describe below.
More than five thousand different chemicals can used in the production of printing inks. Some substances are evaluated by EFSA, Swiss Ordinance, German Printing Inks Ordinance or EuPIA, and restricted by a Specific Migration Level (SML). In addition, most of the printing ink chemicals on the industry inventory lists are not fully risk assessed and toxicological data may be unavailable. However, producers are obliged to demonstrate safety in use, and the public food inspection has to control it.
LEGAL REQUIREMENTS:
The ink itself does not need to be tested as such, since its composition may change during the printing process. In addition, the substrate influences the migration properties of the components of the ink. Regulation (EC) No. 1935/2004 requires that the finished article for food contact materials must be tested and / or evaluated under real conditions of use. In addition, the in-house control based on declarations of compliance and supporting documentation are important prerequisites for the limitation of this contamination and to ensure compliance with the EU legislation. This is a general point of quality assurance, even though the European legislation does not specifically regulate printing inks.
THE GENERAL AND BASIC REQUIREMENTS GIVEN BY THE ANNEX OF REGULATION EU 2023.20076 (GMP) ARE:
- 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.
- Printed materials and articles shall be handled and stored in their finished and semi-finished states in such a manner that substances from the printed surface are not transferred to the food-contact side:
- through the substrate or
- by set-off in the stack or the reel, in concentrations that lead to levels of the substance in the food are not in line with the requirements of Art. 3 of Regulation (EC) 1935/2004.
Transfer of printing ink components from a printed packaging material or article into food or food simulant may occur either directly as migration through the substrate, via contact to the reverse side in a reel or stack (known as “set-off migration”) or by gas phase transfer.
Migration of printing ink components depends on:
- ink and varnish formulation,
- substrate, shape and design of the packaging,
- printing process conditions (drying, speed, efficiency of lamps, etc.),
- real / intended usage (type of food, sterilization, pasteurization),
- storage conditions (temperature, time, pressure).
Invisible SET-OFF migration
Although it is not visible to the human eye, ink set-off can occur on the reverse side of printed articles, foils, containers, cups, and other packaging storage and transported in stacks or reels after printing. This creates a danger, that substances could be transferred to the unprinted inner side of the packaging that contact with the packed food. However, migration testing and/or Worst-Case Calculations can measure and quantify this phenomenon and verify safety of finished packaging.
EUROPEAN LEGISLATION:
- Framework legislation: Regulation (EC) No 1935/2004of 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,
- Regulation on Good Manufacturing Practices: Regulation (EC) No 2023/2006of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food,
- Plastic materials: Regulation (EU) No 10/2011of 14 January 2011 on plastic materials and articles intended to come into contact with food,
- Swiss Ordinance (SR 817.023.21) of the FDHA on materials and articles intended to come into contact with foodstuffs,
- 21st Amendment to the German Consumer Goods Ordinance (Printing Inks Ordinance), entered into force on December 8, 2021,
- EuPIA guidelines on printing inks for Food Contact Materials.
TESTING OFFER:
- Overall and Specific Migration into all food simulants
- Specific migration of:
- Primary Aromatic Amines (PAAs) and Annex II Metals
- Photoinitiators (UV initiators) and acrylates
- Plasticizers, antioxidants, monomers and other additives acc. EU 10/2011 Annex I and Swiss Ordinance
- Specific migration of Non-Intentionally Added Substances (NIAS):
- GC-MS/FID Screening
- LC-QToF-MS Screening
- Mineral oils (MOSH/POSH & MOAH)
- Hedsapace-GC/MS Screening (VOCs, solvents residual)
- Sensory analysis acc. DIN 10955, EN 1230-1/-2
- Simulation of SET-OFF storage effect in reels or stacks
- Worst-case calculations
