Bisfenol A


El bisfenol A (BPA) es una sustancia química industrial utilizada con frecuencia desde los años 60. Se ha utilizado mayormente para fabricar plásticos y resinas de policarbonato.

Dadas sus propiedades peligrosas, el uso de BPA ha sido restringido o está siendo restringido en la UE para proteger la salud de las personas y del medio ambiente.

Where can you find it?

BPA has been used in polycarbonate plastic and epoxy resin for decades.

Polycarbonate plastic is strong and tough material that can be moulded at certain elevated 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 containing BPA are used to coat the inside of water pipes and the inside of cans for food and drink to increase their shelf-life and avoid getting a metallic taste on the food or drink.

BPA has also been used to develop dye in thermal paper for sales receipts and public transport and parking tickets. Since January 2020, such paper with BPA is no longer allowed on the EU market.

What are the concerns?

BPA may damage fertility and has been identified as a substance affecting the hormonal systems of humans and animals. In addition, it damages eyes and may cause allergic skin reactions and respiratory irritation.

What is the EU doing?
Harmonised classification and labelling
Bisphenol A is classified in the EU as a substance that:
  • causes toxic effects on our ability to reproduce (Repr. 1B);
  • may cause respiratory irritation (STOT SE 3);
  • causes serious eye damage (eye dam. 1); and
  • may cause skin allergies (skin sens. 1). 
Companies that supply BPA in the EU must classify and label the substance – as well as any mixtures containing it – according to the harmonised classification. This is to ensure that people and the environment are protected, and that safe handling and use is promoted through consistent labelling that reflects the potential hazards.
In addition to the existing classifications, the German authorities have proposed additional harmonised classifications covering hazards for the aquatic environment (aquatic acute 1 and aquatic chronic 1). ECHA’s Committee for Risk Assessment (RAC) supports their proposal. The European Commission decides whether to include the proposal for harmonised classification and labelling in Annex VI to the CLP Regulation, where all hazardous substances with harmonised classification and labelling are listed.
To tackle the potential concerns with bisphenol S (BPS), a commonly used alternative to BPA, Belgium made a proposal to harmonise its classification and labelling. RAC supported the proposal to classify bisphenol S as a substance that may damage fertility and the unborn child (repr. 1B and H360FD). The Commission will now decide whether to include the proposal in Annex VI to the CLP Regulation.
Substance of very high concern and REACH authorisation
BPA is listed in the Candidate List of substances of very high concern (SVHCs) due to its toxic for reproduction and endocrine-disrupting properties that may cause adverse effects to people’s health and to the environment. 
In October 2019, ECHA recommended BPA to be included in the REACH Authorisation List (Annex XIV to REACH). The decision on the Annex XIV inclusion is taken by the European Commission.
REACH restrictions

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. From this date, thermal paper with 0.02% or more of BPA by weight cannot be placed on the EU market.

The French and Swedish authorities have proposed to restrict over 1 000 skin sensitising chemicals in clothing, footwear and other articles with a similar skin contact. BPA, as a skin sensitiser, would be included in this restriction. The proposal is supported by ECHA’s scientific committees RAC and the Committee for Socio-economic Analysis (SEAC). The final decision will be taken by the Commission together with the Member States. 

In addition, German authorities are investigating the potential risks of BPA and other similar bisphenols to the environment. A call for evidence and information to support this work ran from October 2020 until mid-January 2021. They are expected to submit their restriction proposal to ECHA in April 2022.

Grouping approach
Since early 2020, ECHA supported by the Member States, has screened data on a large group of bisphenols such as BPA, BPS, BPF and their derivatives. Scrutinising similar substances in groups rather than one-by-one aims to speed up and increase the consistency of regulatory work, and to avoid hazardous chemicals being replaced by others that cause a similar concern. 
Restrictions in food contact materials
BPA can be used in materials that come into contact with food 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. France has banned BPA in all food packaging, containers and utensils.
The European Food Safety Authority (EFSA) is re-evaluating the risks to public health related to BPA in foodstuffs. This work is expected to conclude in late 2021 or early 2022.
Toy safety
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.