Implications of RAC opinion to re-classify BPA:
BPA based products manufactured under EU standards are safe, and continue to remain safe
On 12 March 2014, the ECHA’s Risk Assessment Committee (RAC) adopted an opinion proposing to reclassify bisphenol A (BPA) as reprotoxic 1 B, i.e. ‘presumed human reproductive toxicant’, under the
EU Regulation on the classification, labelling and packaging of substances and mixture (CLP). BPA is
currently classified as reprotoxic 2, ‘suspected human reproductive toxicant’, under the CLP. The full
RAC opinion is currently not available. The following provides an initial explanation of the
implications of this decision.
BPA can continue to be used in food contact applications for consumers
BPA complies with both the Framework Regulation for all food contact materials (EU No.1935/2004)
and with the Regulation on plastics used as food contact materials((EU No 10/2011). The 1B
classification – when it is enforced – will not affect compliance with food legislation.
Exposure to BPA is very low, and far below the safety levels set by the authorities.
BPA is the chemical building block which is converted into the final material through
chemical reaction processes: during the production of the plastic material, the BPA
monomers firmly bind to each other, thus forming the polymer chain which then becomes
the final material, e.g. polycarbonate or epoxy resin. Only technically unavoidable trace
amounts of BPA remain in the polymer.
BPA was thoroughly risk assessed by the European Food Safety Authority (EFSA), who
calculated a maximum level of BPA that may be present in food. This level gives the limit at
which the requirements of the Framework Regulation for all food contact materials and the
Regulation on plastics used as food contact materials are met and takes into account a
significant margin of safety.
The re-classification of BPA by the RAC is based on a hazard assessment, i.e. on the intrinsic
properties of the substance. It is not a risk assessment, which looks at the actual exposure
to a substance. EFSA´s assessment of BPA as a component of food contact materials has
resulted in the establishment by the EU of a migration limit below which exposure to BPA is
considered safe and renders the food contact material to be inert.
Regulation on plastics used as food contact materials allows for many substances to be used
for food contact applications despite the fact that they carry a hazard labeling. Therefore, a
1B classification of BPA will not affect its approved use for food contact applications.
BPA not available to consumers, no consumer contact to BPA in mixtures
BPA is a raw material used to produce other materials and it is not available to consumers. During
professional uses, BPA is mainly used as an intermediate in the production of polymers, such as
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polycarbonate and epoxy resin. These professional uses of BPA are several manufacturing steps away
from the final article the consumer would be exposed to. Under REACH, an article is a product a
consumer can buy and use. Cars, mobile phones, food cans, furniture, paint etc. are articles in this
BPA may also be used in mixtures. The CLP regulation defines a mixture as “mixture or solution
composed of two or more substances” which don´t react with each other. There are no consumer
uses of mixtures made with BPA.
CLP sets hazard-related rules for labelling of substances classified as 1B but does not introduce
bans on the substances
CLP is the Regulation on classification, labelling and packaging of substances and mixtures. It aligns
previous EU legislation on classification, labelling and packaging of chemicals to the GHS (Globally
Harmonised System of Classification and Labelling of Chemicals). Its main objectives are to facilitate
international trade in chemicals and to maintain the existing level of protection of human health and
environment. The GHS is a United Nations system to identify hazardous chemicals and to inform
users about these hazards through standard symbols and phrases on the packaging labels and
through safety data sheets (SDS). The classification level defines the content of the warning label to
be placed on the product to guide its safe use.
Professional uses of BPA already strictly risk-managed under REACH
Handling of BPA during the production of polycarbonate and epoxy resin, processing of preparations
or mixtures and their conversion into a final article are examples of professional uses. Maintenance
work at home or on a car by a craftsmen company is also considered professional use. Product labels
as defined by CLP are designed to inform the users about the intrinsic properties of a substance,
about how to handle it safely, which personal safety protection to use, what to do in case of an
accidental contact, etc. For BPA, stringent risk management procedures are already in place and
included in the REACH dossier. Also with a 1B-classification, a ban or substitution of BPA in these
professional uses is neither foreseen nor necessary.
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Implications of RAC opinion to re-classify BPA: