Bisfenoler används för att framställa polymerer och hartser som sedan används för att tillverka plastmaterial. De utgör en stor familj med många ämnen med liknande kemiska strukturer och användningsområden. Några av de mest kända är bisfenol A (BPA) och bisfenol S (BPS).
På grund av bisfenolernas farliga egenskaper har användningen av vissa av dem begränsats eller är på väg att begränsas i EU för att skydda människors hälsa och miljön.
Bisphenols have been used in polycarbonate plastic and epoxy resin for decades.
Polycarbonate plastic is a strong and tough material that can be moulded at high temperatures. Products made of polycarbonate plastic include common consumer goods, such as re-usable plastic tableware and bottles for drinks, sports equipment, CDs and DVDs.
Epoxy resins are used to coat the insides of water pipes as well as food and drink cans to increase their shelf-life and avoid getting a metallic taste. They are also used in flooring, car body coatings and in adhesives.
Bisphenols are also used in thermal paper, inks, textiles, paper or in board.
Many bisphenols may damage fertility and disrupt the hormonal systems of both people and animals. They may also cause skin allergies.
The Candidate List of substances of very high concern (SVHC) contains three bisphenols.
BPA and BPB have been identified as endocrine disruptors for the environment and human health. BPA is additionally toxic for reproduction. 2,2-bis(4'-hydroxyphenyl)-4-methylpentane has been identified as toxic for reproduction.
Producers and importers of articles have to notify ECHA if their articles contain SVHCs.
BPA is classified in the EU as a substance that:
- causes toxic effects on our ability to reproduce (Repr. 1B);
- causes serious eye damage (eye dam. 1);
- may cause respiratory irritation (STOT SE 3); and
- may cause skin allergies (skin sens. 1).
ECHA’s Committee for Risk Assessment (RAC) supported proposals for additional harmonised classifications for BPA covering hazards for the aquatic environment (aquatic acute 1 and aquatic chronic 1) as well as proposals to classify BPS and bisphenol AF (BPAF) as toxic to reproduction (Repr. 1B). The opinions of RAC have been sent to the European Commission for decision.
2,2-bis(4'-hydroxyphenyl)-4-methylpentane may damage fertility and is very toxic to aquatic life. The substance also causes serious eye irritation.
In addition, many bisphenols are classified as skin sensitisers, and some are toxic to aquatic life.
Companies that supply bisphenols with harmonised classification – as well as any mixtures containing them – in the EU must classify and label them accordingly. This is to ensure that people and the environment are protected, and that safe handling and use is supported through consistent labelling that reflects the potential hazards.
To avoid situations where one hazardous bisphenol is replaced with another that may be equally harmful, ECHA and the Member States have assessed 148 bisphenols as a group.
To protect people and the environment, the authorities found that 34 bisphenols may need to be restricted under the EU’s chemicals legislation, REACH, as they may interfere with hormonal systems and affect reproduction. Either identification as substances of very high concern (SVHCs) or harmonised classification and labelling is proposed as a first step for these bisphenols to manage their risks. This number may change as more information is generated for these and other bisphenols that were lacking data.
There are also 26 bisphenols which are not suspected to be endocrine disruptors or toxic to reproduction. These bisphenols may still be regulated in consumer products because most of them are skin sensitisers
For many group members, more data is needed before their potential for endocrine-disrupting and reprotoxic properties can be assessed.
BPA has been restricted as a substance on its own and in mixtures intended for consumer use in the EU since March 2018. Its use in thermal paper has been restricted since January 2020.
However, companies have commonly used BPS to replace BPA in thermal paper. This is a concern as BPS is also suspected of damaging human reproductive and hormonal systems.
German authorities are preparing a proposal to restrict the use of BPA and other bisphenols with endocrine-disrupting properties for the environment. Once it is more clear which bisphenols the German proposal will cover, the Commission and ECHA will consider if further restrictions of bisphenols are necessary.
Coordination is also needed with the planned restriction of per- and polyfluoroalkyl substances (PFASs) as BPAF and its eight salts are defined as PFASs.
In addition, French and Swedish authorities have proposed to restrict over 1 000 skin sensitising chemicals in clothing, footwear and other articles with similar skin contact. Bisphenols that have been identified as skin sensitisers would be included in this restriction if the Commission decides to adopt it.
BPA can be used in food contact materials in the EU. However, only a limited amount (0.05 mg/kg) is allowed to leach from the material into food.
BPA has been banned in infant feeding bottles across the EU since June 2011 and in plastic bottles and packaging containing food for babies and children under three years since September 2018.
The European Food Safety Authority (EFSA) is re-evaluating the risks to public health related to BPA in foodstuffs and plans to finalise the updated assessment in 2022.
There is a limit on the amount of BPA that is allowed to leach out of toys for children up to the age of three and in any toys that are intended to be placed in a child’s mouth. This migration limit is 0.04 mg/l of BPA.
- Bisphenol A - European Food Safety Authority (EFSA)
- European Commission - Bisphenol A: EU ban on baby bottles to enter into force tomorrow, 31 May 2011
- Toy Safety in the EU - European Commission