The fourth Food Packaging Forum (FPF) Workshop “Modern science to inform regulation of food contact materials in the circular economy” took place on October 25, 2016 in Zurich, Switzerland. The morning session, chaired by Martin Scheringer from ETH Zurich, Switzerland, focused on the regulation of food contact materials. In his opening speech, Martin Scheringer, president of the Food Packaging Forum Foundation, described FPF’s role in structuring the issue on chemicals in food contact materials (FCMs) and enabling a science-based discussion. He noted the recent report by the European Parliament on FCM regulation in Europe as an important milestone (FPF reported).
The presentation by Gregor McCombie, Head of Department, Official Food Control Authority, Zurich, Switzerland, addressed the challenges and future developments in evaluating the compliance of FCMs, with a specific focus on analytical chemistry and enforcement of migration limits. McCombie emphasized that FCMs represent an underestimated and insufficiently characterized source of food contamination, with unknown migrants belonging to the group of so-called non-intentionally added substances (NIAS) being particularly challenging to measure and regulate.
When looking at all substances with potential to migrate from an FCM, McCombie suggested using the extracts (as opposed to specific migrants), particularly because the final use of an FCM is often unknown (i.e. which type of foods it will be brought in contact with), but also because the limit of detection is critical to ensuring a comprehensive analytical characterization. However, even with regards to the compounds which have specific migration limits (SMLs) set by the regulation (EU) 10/2011 for plastics, ensuring compliance is not always trivial because of the absence of pure analytical standards required for absolute quantification.
Regarding future developments, McCombie highlighted (i) the use of fewer substances (e.g. Swiss ordinance of printing inks lists 80 different photoinitiators); (ii) the use of bioassays for assessment of overall migrate or extracts of finished FCMs; (iii) establishing a list of evaluated NIAS and making the data contained in the dossiers submitted to the European Food Safety Authority (EFSA) publicly available; and (iv) introducing an FCM approval process where the final food contact article is relevant (talk McCombie).
The presentation by Joanna Griffiths, Packaging Technical Manager, BRC Global Standards, UK provided background information on migration testing, and described BRC’s involvement in writing standards for industry certification. Griffiths emphasized that in order to avoid migration controversy, industry should adhere to good practice. Specifically, consideration of possible migration issues should start with product development, and packaging manufacturers should be involved early on. Ultimately, the responsibility for compliance rests with the food manufacturer or packer, and not the supplier of the packaging itself, because the latter does not know what type of foods is going to be packed in their products. Food companies should maintain transparent communication channels with their packaging suppliers. Suppliers should be informed if the food product is changing, when considering a new product, and packaging should be considered when changing shelf-life or other product aspects. The benefits that a company will gain from the compliance efforts include not only consumer safety but also brand integrity, i.e. ensuring the prevention of image-damaging scandals such as those concerning mineral oil in chocolate (talk Griffiths).
The presentation by R. Thomas Zoeller, Professor of Biology, University of Massachusetts Amherst, U.S., presented the CLARITY-BPA study currently run by the U.S. National Toxicology Program (NTP) and partners from the regulatory bodies and academia. CLARITY-BPA stands for Consortium Linking Academic and Regulatory Insights on the Toxicity of BPA. This project was initiated due to concerns that guideline endpoints do not capture the whole complexity of the various estrogen-regulated processes occurring during development and in adulthood. Hence, a so-called “core” study, consisting of a two-year chronic exposure study in rats, performed according to regulatory guideline and comprising a full battery of guideline assays, was combined with other analyses performed by 13 academic partners on the exposed tissues sent to them randomized and blinded. Additionally evaluated endpoints included learning and behavior, breast cancer, prostate cancer, uterine cancer, male urogenital abnormalities, penile function, testis function/sperm counts, ovarian function, diabetes (blood glucose, pancreas, liver), obesity (adipose tissue), immune function, thyroid and brain anatomy, and cardiovascular effects. Currently, the results of all studies performed are being analyzed and prepared for publications expected by summer 2017.
Zoeller emphasized that the CLARITY-BPA project represents the first-ever attempt to “integrate data from university-based grantee studies with those of a guideline-compliant study to contribute to the safety assessment of [a chemical substance, in this case, bisphenol A (BPA, CASE 80-05-7)],” and we need to learn from it. In similar projects in the future, it would be advisable that a more detailed description of the animal and sample collection requirements be provided by the academic partners as early as possible, since this information is crucial for assessing the feasibility of the project and optimizing study design. The collaborative study approach pioneered by CLARITY-BPA could be employed in general to identify new endpoints to be included into guideline studies. Furthermore, it may even be possible to simultaneously evaluate the reliability of various endpoints. For this, blinded samples should be sent to triplicate labs (talk Zoeller).
Gregor McCombie (October 25, 2016). “Enforcing migration limits: Analytical chemistry challenges and future developments.” (pdf)
Gregor McCombie (October 25, 2016). “Enforcing migration limits: Analytical chemistry challenges and future developments.” Youtube
Joanna Griffiths (October 25, 2016). “Packaging and migration – Avoiding controversy.” (pdf)
Joanna Griffiths (October 25, 2016). “Packaging and migration – Avoiding controversy.” Youtube
R. Thomas Zoeller (October 25, 2016). “CLARITY-BPA: A model for integration of guideline and academic studies.” (pdf)
R. Thomas Zoeller (October 25, 2016). “CLARITY-BPA: A model for integration of guideline and academic studies.” Youtube
Heindel, J. et al. (2015). “NIEHS/FDA CLARITY-BPA research program update.” Reproductive Toxicology 58: 33-44.