Regulation

European Commission Regulation (EC) No 2023/2006 on good manufacturing practice (GMP) for materials and articles intended to come into contact with food (this has an annex referring to printing inks).

Regulation (EC) 1935/2004 requires, in Article 3, requires that materials and articles in contact with food, do not transfer their constituents to food in quantities that could:

Endanger human health; or

Bring about an unacceptable change in the composition of the food; or

Bring about a deterioration in the organoleptic characteristics.

Responsibilities

Ink Makers

Commit to comply with the EuPIA GMP; ‘Good Manufacturing Practices for the Production of Packaging Inks for use on the non-food-contact surfaces of food packaging and articles intended to come into contact with food.’  This defines the practices around ink formulation such as hygienic manufacture, raw material control, production processes, quality control, traceability, storage and delivery.

Follow Appendix 1- ‘Selection scheme for packaging raw materials’ when selecting raw materials for inks.

Note: ‘The ink manufacturers’ responsibility is to supply products that are fit for the intended purpose as defined by members of the food packaging chain. They are not liable for any aspects of the production of food packaging once the packaging inks have left the manufacturing site. The manufacturer of the packaging and the filler are responsible for the properties of the food packaging and its compliance with legal requirements.’

‘The ink manufacturers are not able to issue certificates or declarations of compliance which cover all the legal responsibility of the entire packaging chain.’

All Others in the Packaging Chain

Need to take into account the application methods, designs, substrates and practical use of inks during the printing process that inevitably effect the final composition. In particular, UV curable products final composition is heavily dependent on the manner in which they have been printed and cured.  Hence the responsibilities as outlined above.

Also have an obligation under the GMP Regulation EC 2023/2006 to monitor and document all materials in their manufacturing, process control, storage and delivery processes to ensure consistent product quality and full traceability throughout the whole supply chain.

In light of the regulations set out above, Pulse Roll Label Products Ltd strongly recommend that converters and fillers evaluate migration as part of a risk assessment to confirm the packaging meets the required limits.

Pulse Roll Label Products Ltd have been working extensively with testing laboratories*, and from the results of these studies we are able to offer products that have been designed to reduce migration. Current product lines include: -

BB Series Low Odour UV Flexo Inks

SLM Series Low Odour High Adhesion UV Flexo Inks

PM Series Polymeric UV Flexo Inks

RLM Series Low Odour UV Flexo Metallic Inks

EL Range of Low Odour UV Flexo Varnishes and Laminating Adhesives

To support this we are happy to offer a complete declaration of composition, to a test laboratory under a NDA.

Pulse Roll Label Products Ltd are continuing to evaluate new raw materials in order to be able to respond to issues that may arise surrounding the use of chemicals used in printing inks. However, we are well aware that food packaging manufacturers are continuing to use inks, varnishes and additives, plus manufacturing, traceability and storage processes which will result in non-compliance to the EU regulations. This has already resulted in adverse media publicity and full product recalls. Pulse Roll Label Products Ltd strongly recommend that only low migratory inks, varnishes and processes, proven by the testing of the final package, are used in the manufacture of food packaging.

Note: It is important to note that the EuPIA Guideline recognises that the requirements are challenging and that there will be a need for a Continuous Improvement Strategy to control the potential migrants from packaging inks. It is envisaged that a significant period of time will be required in order to test, and where the required limits are not achieved, to generate an action plan that sets out a programme to ensure compliance within an agreed and manageable timescale.

* Food Packaging Test laboratories- refer to the BCF website on

http://www.coatings.org.uk/Sectors/Food_Packaging_Test_Houses.aspx

For further advice, please do not hesitate to contact us.