As part of its work to assess the risks associated with exposure to bisphenol A, in 2011, the Agency issued a call for contributions to gather scientific data on the alternative products available and, if possible, on their safety and efficacy. A study report on the "Substitution of bisphenol A: review of alternatives to BPA, identification of the hazards of potential substitutes for bisphenol A" (ANSES, 2013) was published by the Agency in April 2013. It drew on the results of the call for contributions, on a major bibliographical review and on the collection of information from companies contacted outside the framework of the initial consultation. It is an inventory of potential alternatives to BPA, according to the different uses. This report does not aim to assess the technological issues of these substitutions or the health issues associated with the substitutes mentioned.
An initial detailed "identity card" of possible alternatives
A total of 73 possible alternatives to bisphenol A were identified: Four came directly from the industrial companies responding to the call for contributions, seven from industrial companies contacted outside of the framework of this call for contributions, and 62 others from the international literature.
There are many different ways of providing alternatives to bisphenol A:
- direct substitution of bisphenol A by another substance;
- substitution by another plastic material or another polymer having similar properties to the starting polymer;
- substitution by another material, or another type of packaging;
- substitution by a process.
For each of the identified alternatives, the regulatory framework, information on its uses and available toxicological data were reviewed by the Agency. Thus, for each alternative identified, the ANSES report specifies, to the extent that information is available:
- its identity;
- tts classification according to the regulatory framework relating to the classification, packaging and labelling of hazardous substances(1);
- tts status with regard to the European REACh Regulation (i.e. whether or not the substance is registered and any possible management measures the substance may be subject to);
- its status with regard to regulations on food contact materials (FCM) and products and materials in contact with drinking water (PDW), and more specifically its inclusion in or exclusion from Commission Regulation (EU) No 10/2011;
- its physico-chemical properties;
- the applications for which it can replace bisphenol A;
- the advantages and disadvantages associated with this alternative. Their descriptions are based on the available bibliographic data and/or data provided by the manufacturers who offered an example of substitution. This is presented for information only and cannot be regarded as either exhaustive or validated by ANSES, since it has not been assessed by the Agency;
- feedback from industrial companies when it is available and can be published.
The inventory drawn up by the Agency and described in the report on "the assessment of the risks associated with bisphenol A for human health, and on toxicological data and data on the use of bisphenols S, F, M, B, AP, AF and BADGE" (ANSES, 2013), made it possible to draw up an initial review of potential alternatives to bisphenol A and substitutions for bisphenol A by use.
Although scientific and technical information was collected for certain identified alternatives, it is important to stress that whilesome of these alternatives are currently in use both on European and non-European markets, others are still at an early stage of research and development. It should also be emphasised that the list of existing alternatives identified is probably not comprehensive.
On the basis of this initial work, it should be noted that no single alternative stood out for replacing bisphenol A for all of its uses. Some questions remain regarding the safety, feasibility and efficacy, in technical terms, of these alternatives.
The Agency’s objective in this work was solely to produce an inventory of existing potential alternatives to bisphenol A, and it by no means aimed to assess or validate the identified or submitted proposals, particularly with regard to the health risks. No assessment or value judgement was therefore made for the identified alternatives, whether on their technological feasibility, toxicology data, or their advantages and disadvantages.
In addition, the review of the available data on the toxicity of the potential alternatives to bisphenol A indicates that even though most of these chemical compounds have been (pre)registered under REACh, they have not yet undergone thorough toxicological testing, particularly relating to reproduction and/or their endocrine-disrupting qualities. Lastly, the search for alternatives is an evolving field and it is therefore necessary to update the information on this subject regularly.
(1) Directive 67/548/EC and the CLP Regulation (EC) No 1272/2008