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BPA is toxic to reproduction says European Chemicals Agency

The Risk Assessment Committee of the European Chemicals Agency (ECHA) recommends that the chemical Bisphenol A (BPA) should receive an official EU classification as toxic to reproduction Category 1B.

The Risk Assessment Committee of the European Chemicals Agency (ECHA) has agreed that the chemical Bisphenol A (BPA) should receive an official EU classification as toxic to reproduction Category 1B.


The EU has a system of classification and labelling for certain hazardous chemicals, to inform workers and consumers of the dangers they present. The 2009 Classification, Labelling and Packaging Regulation requires the industry placing the chemicals on the market to identify risks to human health and the environment and classify and label them according to a legally-agreed set of hazards, hazard statements, and icons. For example, when a supplier identifies a substance as "acute toxicity category 1 (oral)", the label will say "fatal if swallowed", and "Danger" and have a pictogram of a skull and crossbones.

The majority of chemicals on the EU market are ‘self-classified’ by the chemicals industry, but some classifications are ‘harmonised’ at EU level. Since REACH came into force, proposals for harmonized classifications are discussed in the European Chemicals Agency’s Risk Assessment Committee (RAC), which is composed of Member State experts, and observers from various industries, trade unions and public interest NGOs. The RAC opinion on a harmonized classification is then taken forward to a Commission-Member State REACH Committee within the EU ‘Commitology’ procedure, which takes the final decision. Once a harmonized classification and labelling has been finally decided for a substance, the manufacturers or suppliers are obliged to use it.

Bisphenol A

For BPA, France proposed the harmonized category 1B reprotoxicant classification, and RAC agreed this due to its effects on fertility. Category 1B is ‘presumed’, based on animal experiment results, whereas category 1A is known, based on human evidence. The classification which BPA has held until now, Category 2, is suspected (human or animal evidence, possibly with other information).

There are several regulatory consequences if the REACH Regulatory Committee agrees with RAC. If BPA becomes officially recognized as toxic to reproduction 1B, it becomes eligible to be easily adopted as a REACH ‘Substance of Very High Concern’, although would still need to be proposed for this. As an SVHC, BPA present in consumer articles would need to be reported to consumers when they submit a right to know request to manufacturers or suppliers (Article 33 of REACH). Workers also then have the right to be notified about BPA throughout the supply chain.

Originally posted on 11 April 2014

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