BASF Has a System to Control Risks Associated with NIAS

Many countries and regions have regulations governing which additives may be used in plastics that are intended to come into contact with food. But complying with those regulations isn’t always enough to manage potential risks.

Contamination by Non-Intentionally Added Substances (NIAS) is one of those risks, says David Horst, senior product steward at BASF. Additive suppliers might have conducted the required migration testing and toxicity testing, and obtained approval from regulators for use of their product. But NIAS can be introduced into the supply chain during manufacturing and use which can also impact compliance. “There could be residual solvents or impurities that arise from the manufacturing process,” says Horst. “Also, some products like stabilizers might transform chemically into something else during downstream processing and use.” Regulations also exist which address these aspects. Manufacturers have a primary responsibility to manage these risks and downstream users also have a role to play to evaluate possible effects from downstream processing.

In order to establish Fitness for Use in its products, BASF has been working to control NIAS that arise from the synthesis, from normal downstream processing and use, and from sources of potential cross-contamination in its facilities. To address the risk in their own facilities, BASF developed a system that makes it easy for plant managers to implement quality processes. “We’ve created guidance around sensitive applications. It’s a protocol that the sites know about and use and have bought into,” says Anne Christian, quality manager at BASF. “We’re not asking them to know all the rules around the regulations. We’ve translated those into quality processes.”

For example, plant managers are given the purity levels that have to be achieved for manufacturing products sold into sensitive applications. “The plants are always asking what do you want us to do? If you tell them to have a cleaning validation demonstrating a certain purity level, they’re very good at doing that,” says Christian. “Where these programs can fail is when product stewards state what they need in terms of regulations and it falls apart on the production side.”

Horst and Christian will talk about the program in detail during “Establishing Fitness for Use in a Global Plastic Additives Business,” a session at Stewardship 2017.

Horst points out that the key to success is working effectively with other business functions. For instance, imagine engineers are designing a new facility. “If they’re not thinking about the fitness for use requirements, an opportunity could be missed to organize the unit in a way that minimizes any issues with cross contamination,” he says. “In such a case, operations could be forced to have very expensive and time-consuming cleanouts that decrease the capacity of the equipment and add costs.” By bringing everyone together early, problems like this can be solved by designing plants and planning product siting for optimum overall efficiency.”

“You don’t want to solve these problems at the end of the pipeline. You want to identify and solve them before you make those big decisions,” says Horst.


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