Good Manufacturing Practices for the Production of Packaging Inks formulated for Use on the Non-food-contact Surfaces of Food Packaging and Articles Intended to come into Contact with Food EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles Information leaflet: Printing Inks for food packaging

Raw Materials of Printing Inks for Packaging

Employ a common Exclusion List of raw materials that are to be avoided in the formulation, manufacture and supply of printing inks

Guideline on Printing Inks to the non-food contact surface of packaging materials and plastic articles specifies requirements that raw materials must meet in terms of purity, migration and toxicological properties

There needs to be co-operation with the suppliers of raw materials and knowledge of the needs of the customer

Raw materials are carefully selected to ensure that the components of the food packaging inks are of suitable quality

A name, reference number and batch/delivery number identify each raw material to ensure their traceability

Each raw material has a specification agreed between the supplier and food packing ink masterbatch manufacturer, which includes physical and chemical properties to maintain agreed upon quality and suitable end use

Where appropriate raw materials are tested in-house or alternatively are supported by a certificate of conformity from the supplier

Raw materials should be used on a first-in first-out basis

Raw materials must pass quality control procedures before their use to formulate final product

Inventory list –comprising packaging ink raw materials applied to the non-food contact surface of food packaging (December 2013)

EuPIA Suitability List of Photo-initiators for Low Migration UV Printing Inks and Varnishes

Printing ink industry contribution to German paper, paper converting and food industry initiatives to reduce mineral oil in paper and board packaging

Very detailed information, which also highlights the need for an exclusion list of raw materials and highlights the importance of communication between supplier and manufacturer.

Quality Assurance of Printing Inks for Packaging

Adequacy of the personnel:

The entire workforce, including all levels of management, is committed to the objectives of GMP

Training programmes and facilities are established to ensure that all personnel are fully aware of their functions and responsibilities and are competent to carry them out

The organisation of the premises and equipment:

1. Machinery and tools

The equipment used needs to be suitable to manufacture the products required and maintained in a good state

Equipment needs to be clean and calibrated, where necessary

All measuring equipment is tested and/or calibrated to ensure test results are accurate

2. Manufacturing processes

Product is identified with a descriptive title/trade name, reference number and a specific batch number

Where appropriate, each delivery of food packaging printing inks can be supported by a test certificate confirming that it meets agreed specification

Each product has data sheets detailing relevant chemical, physical and safety data and suitable end uses and methods of application

Packaging is selected to protect the food packaging ink during shipment and storage (and must be adequate based on the means of transport used and legal requirements for the nature and use of the product)

All products (including raw materials) are stored in conditions that prevent, as much as possible, their deterioration. Where appropriate a method exists to test products that have been held for some time to ensure their quality still remains adequate

The rejected stock is clearly marked and isolated so that it is not used accidentally

All products are delivered in clean and clearly labelled containers

Traceability of materials is required at all stages (including raw materials)

Presence of pre-established instructions for the procedures:

An instruction document (batch card) is issued for each batch of printing ink manufactured, which details the materials, quantities and equipment to be used and highlights any specific precautions to be followed

Product test specifications exist for each food packaging ink manufactured. They list the tests which are required during the manufacture and on completion, to ensure the batch meets the required specification and is fit for intended use

Manufacturing instructions are issued and followed for each batch, giving details of the raw materials, the quantities and the equipment to be used

Monitoring the implementation and achievement of GMP:

Implementation and achievement of GMP are regularly monitored by using a GMP-Audit Checklist. Corrective measures are identified to correct any failure to achieve GMP and are implemented without delay.

Requires testing food packaging ink samples at selected stages of the process to establish whether the product is meeting the required quality standard.

Final inspection and testing are key elements too, with specific test methods to be used

Corrective measures to remove any inefficiencies and non-compliance:

In the event of non-conformity at any stage in the process or a complaint, a procedure exists to take corrective and preventive action to find the cause, rectify the problem and if needed, make appropriate improvements to the manuals or other controls to prevent a recurrence

A person is appointed to accept responsibility for ensuring that any non-conformity issue is dealt with and corrective action completed.

Documentation:

Recording systems ensure that quality relevant stages can be verified for corrective action, with these systems having to be documented (covering the operations performed and specifications set out)

Very detailed and complete information, which highlights the importance of ensuring that the end-product is suitable for its required use and the need to highlight critical points of the production process and detail any subsequent stages of manufacture required on the delivered product. Also emphasizes the importance of correct storage to avoid misuse of non-compliant products and contamination.

Quality Control of Printing Inks for Packaging

Very detailed and complete information. Could possibly include information on the correct storage of products based on their compliance tests to prevent their contamination or mix-up.

Many inks are blended at converter plants from basic constituents and are labelled, given a brief description and given a reference and a batch number

If inks return from the print operation in their original state, they maintain the same description and batch number. If they are modified they need to be checked for suitability of re-use and if found to be suitable, they are given a new reference and a new batch number but keep their same description. If the inks are re-used or re-handled, modifications should be recorded, the product tested and the new product labelled accordingly