Switzerland introduced a positive list in 2010 (Swiss ordinance for printing inks SR 817.023.21) of all substances allowed in the manufacturing of printing inks for food contact packaging. The question arose, what is the legal situation of these materials within EU Member States?
Up to now, no specific EU harmonised legislation on printing inks for food packaging has been issued, with the exception of Directive 2007/42/EC relating to materials and articles made of regenerated cellulose film, which states
Article 5
Printed surfaces of regenerated cellulose film shall not come into contact with the foodstuffs.
Even if printing inks are applied on the non-food contact surface of packaging, as a component of the printed package, they must not prevent the final package from meeting the requirements of Regulation (EC) No 1935/2004 concerning materials and articles intended to come into contact with foodstuffs.
This Regulation requires that no food contact material (whether printed or not) should
Article 3(1)
- endanger human health
- bring about an unacceptable change in the composition of the food
- bring about a deterioration in the organoleptic characteristics thereof
This Regulation repealed Framework Directive 89/109/EEC and, as a Regulation, immediately came into force in the Member States on 3 December 2004.
In addition, Commission Regulation (EC) No 2023/2006 “on good manufacturing practice for materials and articles intended to come into contact with food” also makes specific reference to printing inks.
Annex
Processes involving the application of printing inks to the non-food contact side of a material or article
- 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:
- 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 which are not in line with the requirements of Article 3 of Regulation (EC) No 1935/2004. See above.
- 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 reelIn 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 193/2004. See above.
- The printed surfaces shall not come into direct contact with food.
In 2005, the Council of Europe (CoE) Committee of Ministers of the Partial Agreement in the Social and Public Health Field adopted the Resolution ResAP (2005)2 on “Packaging Inks Applied to the Non-Food Contact Surface of Food Packaging”. CoE Resolutions are not legally binding, but should be considered as statements of policy for national policy makers of the Partial Agreement member states. .
Up to now, Switzerland is the only member state of the CoE Partial Agreement who decided to translate the Resolution ResAP (2005)2 into its national legislation. In 2008 an amendment to the Swiss Ordinance on Materials and Articles (SR 817.023.21) was made, detailing certain provisions specific to food packaging inks. The core element of the new regulation is a list of “permitted substances”, identifying the only substances which may be used in the manufacture of food packaging inks marketed in Switzerland. This list, which has been established with the support of EuPIA and CEFIC, became applicable as from 1st April 2010. A revised list was published in February 2011 and came into force in May 2011.
Since late 2010, Germany has been developing an amendment to the German Ordinance on Materials and Articles, introducing printing ink-specific provisions.
The GMP directive (Commission Regulation (EC) No 2023/2006) defines the rules for good manufacturing practices for groups of materials and articles intended to come into contact with food, whilst the Swiss Ordinance-only applying to the Swiss market-details a positive list with substances which are allowed to be used in the production of printing inks in combination with clear regulation about accepted migration limits. Although there is still no European legislation regarding the use of printing inks for food packaging per se, these pieces of legislation gave a clearer picture to both brand owners and the packaging supply chain about their obligations.
Both pieces of legislation support brand owners with proving compliance with the framework directive (EC/1935/2004), which states that materials and articles, whether printed or unprinted, must be manufactured under GMP, so that under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could endanger human health, bring about an unacceptable change in the composition of the food, or bring about a deterioration in the organoleptic characteristics thereof. The legislation is very clear in that it applies to all types of packaging, regardless of the technology used and also clearly state that the responsibility for the compliance of the food package is the responsibility of the entire packaging chain. No one link in this chain can assume overall responsibility or take over the responsibility of another member of the packaging chain, should something go wrong.
Independent of these legal initiatives and in the absence of specific EU legislation, the European Printing Ink Association (EuPIA) has developed a Guideline setting out a mechanism for the selection of raw materials for food packaging inks. It is considered that this Guideline satisfies the current requirements of the food packaging chain. EuPIA has also developed a GMP in line with Regulation (EC) No 2023/2006.
While both of these documents are not legally binding, they give a good interpretation of the EU directives and regulations.
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