Bisphenol A (BPA), a chemical used in coatings and certain plastics, has been controversial for many years as evidence has mounted of its endocrine disrupting effects. Two important events happened at the end of 2021 to increase the pressure on this chemical. Firstly, the EU food safety agency EFSA proposed a massive 100,000-fold reduction in the safe level for BPA in foodstuffs , and in addition, the European Court of Justice confirmed that BPA was correctly listed as a “substance of very high concern” in EU chemicals law REACH due to its endocrine disrupting properties for humans.
CHEM Trust welcomes these new developments which will clearly contribute to increased human health protection, but in our opinion the road to this has been unreasonably long, with the first scientific paper identifying BPA’s ability to interfere with the endocrine system being published in 1938.
Over the years, numerous scientific studies have pointed at serious impacts on the reproductive and nervous system after exposure to even very low doses of BPA. CHEM Trust has raised the alarm about the endocrine disrupting properties of BPA for many years, and highlighting that it is found in people and the environment. It has been detected in the urine of 96% of German children participating in a survey, and a recent Italian study has shown that even new-borns are polluted with BPA.
BPA is still in widespread use, only banned in a few products such as baby bottles and thermal papers. What’s even more concerning is the increasing use of similar bisphenols which add to the threat to human health and the environment.
The following section summarises the latest developments and subsequently draws three lessons learnt for the current reform of EU chemicals policy.
EFSA proposes massive cut in the safe level of BPA in food
When the European Food Safety Authority (EFSA) previously reassessed the risks to public health of BPA in foodstuffs in 2015 CHEM Trust criticised the assessment approach, highlighting that the evidence for many endocrine disrupting properties was not properly considered.
Now EFSA has assessed studies on BPA that have been published since 2013, including from the large US BPA CLARITY programme conducted by US authorities and academic scientists. Their conclusion is that the Tolerable Daily Intake (TDI) should be reduced by 100,000-fold to 0.04 nano g/kg. This is based on research which show effects on the immune system at low doses, and EFSA has consequently concluded that there is a health concern from dietary BPA exposure for all age groups.
CHEM Trust welcomes EFSA’s acknowledgement of the detrimental effects of very low doses of BPA, and we fully support the lowering of the TDI which will probably make it very difficult – if not impossible – to continue using BPA in materials in contact with food. However, it will be important to prevent the replacement of BPA by other bisphenols that are likely to have similar effects.
The draft is open for public consultation until 22nd February. CHEM Trust is concerned that pressure from industry might weaken the level of protection proposed.
European Court of Justice confirms (again) that BPA is an endocrine disruptor
In a separate development, the industry trade association Plastics Europe lost another EU court case on BPA just before Christmas, with the European Court of Justice confirming that BPA was correctly listed as a “substance of very high concern” (SVHC) in the EU’s REACH chemicals legislation due to its endocrine disrupting properties for human health. Since 2019, this industry association has also unsuccessfully challenged EU decisions to identify BPA as a SVHC based on its properties as toxic for reproduction and endocrine disrupting for the environment.
What can we learn and what needs to be changed?
The long history of the debate over the safety of BPA clearly demonstrates that there is a major problem with current hazard and risk assessment processes, and that a more precautionary approach is needed from the start of an assessment to fully meet the goal of zero-pollution for a toxic-free environment under the European Chemicals Strategy for Sustainability (CSS).
1. The burden of evidence is too high, preventing timely protection
It took more than 20 years and innumerable studies to be carried out before BPA was finally identified as an endocrine disruptor – throughout this period we and the environment continued to be exposed to BPA. This is the sad story of inaction on BPA.
The way forward for precautionary and timely protection is to:
- Change the focus in assessments from the ‘lack of evidence’ to the ‘available evidence for hazardous effects’, and lower the level of evidence required before regulatory action is taken. Regulators need to acknowledge the reality that their assessment only ever creates a ‘current estimate’ of hazard and risk, and this estimate is likely to change over time.
- Speed up assessment processes to avoid very long delays.
2. Grouping of chemicals in assessments and restrictions can quickly and effectively increase protection
To avoid the regrettable substitution of one problem chemical with another, restrictions on groups of chemicals need to be taken, as CHEM Trust highlighted in our ‘Toxic Soup’ report looking specifically at bisphenols. Unfortunately regrettable substitution from BPA to similar bisphenols was exactly what happened when BPA was banned in thermal paper from 2020, with the use of the similar Bisphenol S in thermal papers doubling in one year even before the restriction entered into force.
The way forward is to assess chemical substances based on a grouping approach and to rapidly control the use of groups of chemical substances. A very important development is the restriction proposal for BPA and structurally similar bisphenols which is currently under preparation by Germany. CHEM Trust also welcomes ECHA’s current work on grouping of chemicals for regulatory action.
3. Generic risk assessment and management is needed to ensure efficient protection, and consistency in regulation
The BPA saga also shows that enormous resources are diverted to demonstrate evidence for the hazardous properties of BPA by authorities from various regulatory sectors with different views on assessment approaches and regulatory measures. In addition, certain companies like to use delaying tactics by continuously arguing that more evidence is required before hazardous properties can be agreed, and by challenging regulatory decisions through courts. The overall result is that, decades after the debate on BPA started, it is banned for one consumer use but is still allowed for others – meaning our exposure continues.
The way forward is to:
- use hazard classification as the tool for consistent and more precautionary regulation, using grouping to accelerate this classification.
- apply the approach of generic risk assessment (GRA) in all relevant EU legislation, banning the most hazardous substances in consumer products, including articles like furniture and food packaging.
Ninja Reineke, Head of Science at CHEM Trust, says:
We have to learn from the failure of properly protecting health and wildlife from the impacts of the endocrine disruptor BPA. It is very concerning that all EU-citizens, including vulnerable foetuses and children, have been unnecessarily exposed to hazardous levels of BPA for so many years.
The current EU chemicals policy reforms need to ensure that scientific assessments will flag hazards faster and deal with substances in groups without always requiring new evidence for each group member. Only if these chemicals are then rapidly restricted in consumer products, including articles, will it contribute to making things cleaner and safer.
