BLOG TOPIC: Identifying hazards and assessing exposure relating to printing ink production
RISK ASSESSMENT: Identifying hazards and assessing exposure relating to printing ink production
Printing inks are widely used in our society as it brings colour to our lives. Packaging and other materials are printed for communication or esthetical purposes. Especially for food packaging, we want to ensure that our printing inks are safe for its intended use. We therefore generate the information enabling our customers to perform a risk assessment in order to ensure safe use.
A risk assessment of printing ink ingredients is based on two fundamental elements: the hazard of a printing ink ingredient and the exposure to this ingredient upon use. In other words, the risk of an ingredient is a function of hazard and exposure.
Risk = Hazard x Exposure
When considering hazards, the question that should be asked is what health and environmental harm could be caused by substances in the printing ink. Identifying potential health effects in humans or the environment usually consists of collecting data from various human or animal studies, in vitro tests, and mathematical and statistical models.
How do we manage risk in our ink products?
The printing ink production process involves using substances with various toxicological properties. Flint Group aims to make the products safer by continuously reviewing our substances including the impurities. We are committed to carefully select raw materials based on the presence of detailed regulatory information to ensure the safe use of our products. If our products are intended for more sensitive applications (e.g. food contact materials), more comprehensive information is required to assess the potential risks.
Risk of migration with food contact materials
One of the most relevant risks associated with food contact packaging is the migration of ink ingredients from the packaging into the food. Consumers should be adequately protected against exposure of these substances in their daily consumption of food.
Migration depends on many factors - the physical-chemical properties, the amount of ink applied, the type of foodstuff and temperature. The most significant migration risk exists when there is no suitable barrier (also called a functional barrier) between the packaging and food. Other potential sources of contaminations in the food is the print production and handling (storage, transport or consumer end use). Therefore our products need to be handled and used in a correct way to avoid excessive migration.
What are specific migration limits?
Risk assessment in food packaging involves the identification of substances that may migrate (i.e. migrants). European Authorities or other national bodies have already performed safety assessments of substances being used in food contact applications. The result of the assessments is the establishment of a Specific Migration Limit (SML) – the maximum level of a substance allowed to migrate into food. If migration of the substance is below SML, the risk to the consumer is considered as adequately controlled.
If there is no official SML determined by the authorities, there is a possibility to perform your own risk assessment. Companies can define a self-derived SML, which is based on available toxicological data. Flint Group uses various databases to find studies on relevant toxicological endpoints. If such data are available and recognised as reliable, they are used to calculate a self-derived SML.
A tiered approach to exposure assessment
The exposure assessment of migrants is a stepwise approach, also called a tiered approach. The first tier is to make a worst-case calculation. It is an assumption that the total amount (100%) of substance that is present in a dry printing ink film is migrating into the food. If this assumption shows that a substance may exceed the SML, a second tier is applied - migration modeling using dedicated programs. The third tier is migration testing. The final tier is gathering food consumption data, which allows the estimation of exposure based on the daily consumption of food.
How does Flint Group support safety evaluation in food packaging?
Flint Group actively follow and apply principles and practices in printing ink associations. We support customers with regulatory and toxicology topics. It involves providing Statements of Composition, which include details of potentially migrating substances with Specific Migration Limits and other restrictions.
Flint Group’s Product Stewardship and Regulatory Affairs department is at the core of Flint Group and fostered throughout the company’s entire value chain. We strongly encourage customers to contact us at any time to discuss risk management, or other regulatory topics. Please email us at email@example.com.