If adhesives use "plastics" as a reference, what do films and paperboards use as a reference?
The largest positive list of evaluated substances is the Union list of the plastic regulation. So, all food contact materials for which no specific measures exist refer to the Union list. If substances are not listed there because they are not used for plastics, you have to check national legislation or you have to make your own toxicological assessment. For paper and boards, the German BfR recommendation 36 is used very often. In case of plastic films the plastic regulation can be applied, in case of celloluse the directive for regenerated cellulose can be used.
What organizations are you a part of to help understand these regulations?
We are member of the European adhesive association FEICA and therefore always informed about legislative issues. We can influence the draft forms of upcoming legislation and can discuss new legislation regarding the transfer on our products. Click here for more information.
REACH assessments are more likely to focus on the tox properties of a substance in relation to worker exposure - this may not include oral ingestion as would be the case for migration/food contact applications - how beneficial is any data from ECHA?
The main intention of REACH is to derive safe levels of exposure for workers but also for the general population. In that respect, toxicological tests have to reflect the main route of exposure. In fact, often the oral route is not the most relevant one. However, in principle we can often also use data obtained from inhalation or dermal studies. This is because in case of food contact the most important aspect is the dose, which becomes systemically available after oral ingestion. If there are data available from inhalation or dermal studies, we can use them if for example we have also toxicokinetic data showing how much of the respective substance becomes systemically available, e.g. by skin penetration. If no toxicokinetic studies are available, we can still work with the data but have to reflect this uncertainty by introducing additional safety factors.
Is there a distinction between direct and indirect contact? What about "incidental" direct?
In the European legislation there is no differentiation between direct and indirect food contact. As long as the specific limits are respected the food contact is allowed. If a migration limit of a certain substance is exceeded then the contact area must be modified.
How often do you re-assess products? What is your control plan?
When a product is assessed for food contact we block the formulation and we re-assess it when new raw material information are available, when the formulation was changed or when the legislation changes.
How do your adhesives impact regulatory documentation for food/ beverage companies?
The food packager and the beverage companies need our food contact statement to have "adequate information" in the supply chain for making their risk assessment for their products. Without the result of our risk assessment they cannot take their responsibility. There is also a white paper available on Food Contact Statements.
What is the receptivity of your raw material suppliers to the food safety topic? How can the supply chain collaborate to drive greater activity even further upstream?
Each member of the supply chain has to exchange information to improve the risk assessment. The better the information flow the better the risk assessment for the final product. The EU Guidance as regards information in the supply chain defines the roles and the responsibility of all members within the supply chain.