Chemical substitution was the main topic of the second morning session at the fourth Food Packaging Forum (FPF) Workshop “Modern science to inform regulation of food contact materials in the circular economy” which took place on October 25, 2016 in Zurich, Switzerland.
Thomas Backhaus, Professor for Environmental Sciences at the University of Gothenburg, Sweden, introduced the substitution principle as it was defined by the Swedish Chemicals Agency in 2007. According to this definition, risks to the environment and human health and safety shall ideally be reduced by replacing chemicals of concern (COCs) with inherently safer chemicals, or by applying alternative non-chemical technologies instead. However, the principle recognizes that substituting COCs is only feasible if alternatives are available. Subsequently, Backhaus explained the application of the substitution principle under the European Chemicals Regulation (REACH) by detailing the authorization procedure and showing the numbers of chemicals at the respective steps of this procedure. He presented a general approach on how to identify possible alternatives that are both technically and economically feasible and lead to an achievable hazard and risk reduction. An example illustrating the successful replacement of popcorn bags containing fluorinated substances with non-fluorinated cellulose-based bags supported this approach (FPF reported). In the following part, Backhaus shortly discussed advantages and disadvantages of risk- versus hazard-based substitutions and how they affect data requirements, flexibility, communication, and regulation. Further, he illustrated the consequences of ‘regretful substitutions’ by discussing the replacement of bisphenol A (BPA, CAS 80-05-7) with structurally similar compounds. Finally, Backhaus showed that conflicting and changing goals as well as regulatory challenges complicate successful substitution of COCs (talk Backhaus).
Stephen Klump, Head of Packaging Quality and Safety at Nestlé based in Marysville Ohio, U.S., exemplified the practical challenges food producers are facing when they want to eliminate COCs. The identification of COCs, search for suitable alternatives, and the qualification of these alternatives are the main tasks, Klump stated. The identification of COCs shall not only be based on toxicological and food safety data and global regulations, but also on public concerns. Suitable alternatives need to be commercially available, allowed by regulators, be safe and perform the same way as the original chemical or material. In the second part, Klump explained what food producers need to consider when they want to substitute COCs by safer alternatives and how long these steps may take. The required steps include (i) the selection of alternative materials, (ii) a check of their regulatory status or regulatory compliance approvals, (iii) safety evaluations including migration analyses and identification of NIAS, (iv) production trials, and (v) shelf-life quality checks. Klump illustrated this procedure with two examples showing that chemical substitution can either be a straightforward process or a major technological challenge. The first example referred to Nestlé’s replacement of the photoinitiator isopropylthioxanthone (ITX, CAS 83846-86-0) in inks which was finished in less than one year, mainly because chemical alternatives were readily available. The second example showed that the substitution of BPA led to the elimination of the most commonly used can coatings without having comparable alternatives at hand. A time frame for new can coatings includes the development of new materials (3+ years), regulatory approval (+2 years), safety evaluation (up to 1 year), production trials (depending on the availability of the production line), and shelf-life checks (up to 2 years). Any failure of the new coating will lead to even longer development times before the new coatings can enter the market or to the loss of consumer trust, if the failure happens after introduction into the market, Klump concluded (talk Klump).
Thomas Backhaus (October 25, 2016). “Substitution of hazardous chemicals: Fundamental concepts, examples and challenges for FCMs.” (pdf)
Thomas Backhaus (October 25, 2016). “Substitution of hazardous chemicals: Fundamental concepts, examples and challenges for FCMs.” Youtube
Stephen Klump (October 25, 2016). “Food producer challenges to eliminate chemicals of concern in food packaging.” (pdf)
Stephen Klump (October 25, 2016). “Food producer challenges to eliminate chemicals of concern in food packaging.” Youtube
KEMI (2007). “The Substitution Principle.” Report Nr 8/07