Why a group restriction of bisphenols is long overdue

2020-05-12

Two years ago, in spring 2018, CHEM Trust published the report “From BPA to BPZ: a toxic soup?”. It examined how industry is being allowed to replace the well-known hormone disrupting chemical bisphenol A (BPA), with very similar chemicals that may also be harmful, for example bisphenol S (BPS). The report argued that in order to avoid regrettable substitution of one problem chemical with another, restrictions on groups of chemicals need to be taken.

Following the publication of the report CHEM Trust sent letters to the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA) and the European Commission’s Health Commissioner, calling for accelerated regulatory action on the bisphenols group of chemicals. While all responses acknowledged the issue, no specific commitments to address the problem were made.

2 years on – where are we now?

In January 2020 an EU-wide ban of BPA in thermal paper entered into force. This ban was intended to motivate the industry to use alternatives to BPA in thermal paper products. CHEM Trust feared that only banning BPA would lead to regrettable substitution of BPA with BPS or similar bisphenols. Unfortunately, it seems this was justified. At the end of 2018 ECHA published a survey showing that from 2016 to 2017 the use of BPA in thermal paper increased 7% whereas the use of BPS increased 98%.

The replacement of BPA with other bisphenols seems to be taking place in other areas, too. Human biomonitoring studies have recently found a trend towards a decrease in human exposure to BPA and increased exposure to other bisphenols, including BPS.

So, it seems that the EU’s decision to phase out BPA, without also restricting the use of alternative bisphenols, has led to a likely increase in exposure to other bisphenols, including those where there is evidence that they may be harmful to human health, such as BPS.

Health impacts of the other bisphenols

This trend of regrettable substitution is very concerning. A new report published by the German Environment Agency (UBA) in February 2020 shows that nearly all of the tested alternatives to BPA may also have endocrine disrupting properties.

This UBA study looked for existing data on the endocrine disrupting potential of 44 BPA alternatives, including several bisphenols. They found that for 15 of the substances the potential to be endocrine disruptor was already described, whereas no data were available for 23 of the substances. All substances were then tested in various commercially available in-vitro test systems for endocrine activity. The researchers concluded that 33 of the BPA alternatives may have endocrine disrupting properties and that only one of the substances could be recommended as a substitute for BPA.

A recent review that included 20 potential BPA-alternatives, which are reported to be used in consumer products, confirmed a significant lack of data and also indications of endocrine disrupting properties for some of the bisphenol alternatives to BPA.

Are the other bisphenols being regulated?

The Belgian authorities have recently submitted a proposal for the EU to classify BPS as a ‘presumed human reproductive toxicant’ (Rep. Cat. 1B; CHEM Trust provided supportive comments), based on new testing provided by industry as part of a substance evaluation under EU chemicals law REACH. A final decision on the EU classification is expected in autumn 2020.

At the time of writing the “Toxic Soup” report none of the companies selling BPS suggested it may be a reprotoxicant. Only recently industry changed the self-classification of BPS as ‘Suspected human reproductive toxicant (Rep. Cat. 2), although this seems to have had been long warranted based on test results from 2000.

The French Agency for Food, Environmental and Occupational Health & Safety, Anses, concluded in October 2019 that bisphenol B (BPB) is an endocrine disruptor based on a systematic literature review and assessment according to the EU Guidance document on the criteria for endocrine disrupting biocides and pesticides. Anses has announced that it will submit a proposal for BPB to be identified as a Substance of Very High Concern under REACH by August 2020.

The Swedish Institute of Environmental Medicine published their conclusion in July 2019 that bisphenol AF showed endocrine disrupting properties when assessed according to the EU criteria and the ECHA/EFSA guidance.

In parallel, EFSA is working on a re-evaluation of BPA, and EFSA has discussed the outcome of the new testing for reproductive effects of BPS which is part of the substance evaluation with the Belgian authorities. However, no joint EU action on the group of bisphenols seems to have been taken. EFSA has recently finalised their own assessment of the result of these studies and concluded that they do not affect the authorisation or the specific migration limit for use of BPS in plastic food contact materials. However, EFSA also states that the agency is fully aware that other toxicological studies have been published since BPS authorisation.

The evidence to date illustrates that further bans for BPA and its bisphenol alternatives are needed, as they are still used in everyday consumer products, such as food contact materials and are ubiquitous in the general public, as human biomonitoring studies show.

ECHA has announced that they plan to address and regulate chemicals in groups to a much greater extent. CHEM Trust welcomes this announcement by ECHA and wants to see restriction of the bisphenols used as alternatives to BPA given the highest priority for this approach.

Dr Michael Warhurst, Executive Director of CHEM Trust said:

“Over the last two years new scientific findings continue to back up our 2018 Toxic Soup report which concluded that bisphenol alternatives to BPA also have similar impacts on human health and should be phased out. We need rapid action to restrict the bisphenols as a group, as the evidence shows that BPA is being replaced, in consumer products, with other problematic bisphenols. The European Commission must urgently request that EU chemicals agency ECHA prepares a group restriction on bisphenols”.

Some of the research published recently on bisphenols

New studies are being published all the time which highlight the harmful effects of other bisphenols:

A new study, looking for 15 different bisphenols including BPA and BPS plus other alternatives to BPA in biological samples from pregnant women in South China, showed that babies are exposed to unexpectedly high levels of these substances in the womb. BPA, BPS, BPAF and BPE and the derivative BPSIP were frequently detected in the samples (Pan et al., 2020).

In addition to BPA, BPS and BPF-exposures have also been associated with body mass outcomes in children (6-19 years). A recent study using US NHANES biomonitoring data showed that those with highest levels of BPS and BPF in the urine were more likely to be obese compared to children with lower levels. Although this study has some limitations, it suggests that BPS and BPF are correlated with obesity in children (Jacobson et al., 2019). In another paper also using NHANES data, BPA and BPF-exposures were also associated with obesity in children and particularly in boys (Liu et al., 2019).

BPS has slower skin uptake than BPA but research has found that when BPS is taken up in the body, it persists much longer and at much higher concentrations than BPA due to slower metabolism. This suggests that replacing BPA with BPS may lead to increased internal exposure to this endocrine disruptor (Liu & Martin, 2019; Gayrard et al., 2019).

A new study with pregnant mice showed that exposure to low doses of BPA, BPS and BPF in foetal life significantly increased blood pressure in the offspring, suggesting that even low-dose exposure to these chemicals during pregnancy may affect blood pressure later in life (Al Mansi et al., 2020).

An experimental study showed instant effects on mice heart function, with more potent effects for BPS and in females, when treating with BPA and BPS in amounts that mimicked typical human levels (Ferguson et al., 2019).

A recent paper suggests that current analytical methods to detect exposure to BPA (and other bisphenols) are likely to be underestimating the real human exposure (Gerona et al., 2019). This suggestion is currently under debate and is disputed by other scientists.

Chemtrust, 12 May 2020
; https://chemtrust.org/bisphenol_group/