Commentary of Seifeldin Raslan Mohamed, Aluminium Deutschland – Packaging, Recycling, Sustainability

Bisphenol A: A new TDI and regulatory proposal

Background

In the realm of food contact materials (FCMs), Bisphenol A (BPA) is a key component, notably used in coatings to line metal packaging like aluminium tubes, cans, lids, trays and as a component in the external coatings of plastic tubes. It is also present in inks and adhesives commonly used in the packaging industry.

The European Food Safety Authority (EFSA) has recently (April 2023) introduced a stricter Tolerable Daily Intake (TDI) of 0.2 nanograms per kilogram of body weight, a level 20.000 times lower than the previously adopted level. EFSA concluded that consumers of all age groups, whether exposed to BPA in average or high amounts, consistently surpass this new TDI, raising health concerns that might affect reproductive, developmental, and metabolic systems in the human body.

Additionally, the European Environment Agency (EEA) published a briefing on the results of an EU project dedicated to studying the BPA concentrations in EU citizens. The European human biomonitoring project, HBM4EU, conducted research from 2017 to 2022, aiming to create harmonized, continent-wide human biomonitoring data to assess the presence of chemicals in the European population and their health impacts. As part of the study, researchers measured three bisphenols, including Bisphenol A (BPA), as well as its substitutes, Bisphenol S and Bisphenol F, in urine samples from 2,756 adults across 11 European countries. These countries spanned north, east, south, and west Europe. The results concluded that: in the countries where biomonitoring for BPA was conducted, the level of exceedance ranged from 71% to 100%.

In response to these rising concerns, the European Commission is currently considering a legal act to ban intentional BPA use in FCMs.

Intentional vs. non-intentional presence of BPA in FCMs

BPA can be found everywhere around us, even in drinking water, so there is always a chance that residual traces of BPA may still be present in an FCM. Recent reports from the Commission suggest that they have no intention to punish manufacturers for non-intentional presence of BPA. However, this doesn’t mean that packaging with significant BPA concentrations will be completely free of any obligations, even if its presence is non-intentional. The Commission recommends robust monitoring, data sharing, analytical detection limits, and a harmonized approach among Member States.

In its recently published Q&A on the subject matter, the Commission asserted that although the main intention is banning BPA use and migration in materials used as FCMs, a de facto ban would apply also to external coatings. This is due to concerns over the vapor-phase transfer of BPA containing coatings that can contaminate the inner side of the packaging during application on the outer side. Additionally, a set-off between an outer layer of a tube with the inner side of another can occur, for example in the case of empty conical aluminium tubes, which are usually stacked in one other to facilitate their transport to filling facilities. Therefore, a complete ban on usage for the food and beverage sector is expected.

Heavy burden on tube manufacturers along with the entire supply chain

The quest for viable alternatives to Bisphenol A (BPA) in varnished or coated articles presents several challenges. It is a time-intensive process, with evaluation and testing of various suppliers and technologies increasing the costs needed to find suitable replacements. Each specific product type or food category requires separate qualification with the food business operator, considering the specific properties of the product and possible interactions with the coating. Even the raw material origin of a tube (primary vs secondary) can affect its reaction with the alternative coating.

Additionally, all these validation and verification processes involve a likelihood of failure, which would necessitate a repetition of the whole process. Not only this, but even if an alternative is deemed technically feasible, the availability of sufficient supply quantities along with its economic feasibility is still a big question mark.

Possible “spill-over effect”

Although the currently discussed legal act to ban BPA pertains solely to FCMs, there is a risk that similar bans might be adopted for packaging types used in other industries like the pharmaceutical or cosmetics sectors or even a blanket ban on BPA in all applications.

For example, Germany submitted a proposal for the inclusion of Bisphenol A, F, S, and AF in the “REACH Authorization List” in October 2022. Although the proposal was later temporarily withdrawn by the German authorities for revision of the scope, it is only a matter of time before they submit their restriction proposal again. If such a proposal was accepted, the manufacture and use of BPA-based materials would be completely prohibited in the EU after a specified “sunset date”.

Position and key demands of the food supply chain

The industry is astonished by the lack of interest from the EU-Commission to resolve the discrepancies between EFSA and other organizations such as the German Federal Institute for Risk Assessment (BfR) and the European Medicines Agency. Both organizations have significantly different opinions on the matter, nonetheless they were not considered as references for the expected legal act.

The packaging industry emphasizes that it has already made substantial efforts to develop alternatives, but numerous challenges persist, especially for external coatings. It advocates for extended examination and comment periods, along with clear definitions for “intentional” and “non-intentional” uses of BPA. It argues that a significant extension of the proposed 18-months transition period is crucial and warns against rushing untested coatings to the market, a measure that can compromise food security and consumer safety.