Close Menu

BPA and authorisation under REACH

REACH*, the EU chemicals legislation, places duties on manufacturers, importers and users of
chemical substances. The REACH Regulation is implemented by EU Member States and applies to
almost all chemical substances.
Under REACH, “substances of very high concern” (SVHCs) may be subject to Authorisation in
order to ensure that the risks from these substances are properly controlled. For a comprehensive
explanation of the Authorisation process, please refer to the website of the European Chemicals
Agency (ECHA) at https://echa.europa.eu/addressing-chemicals-of-concern/authorisation.
In this document, the Polycarbonate/Bisphenol A industry group of PlasticsEurope examines
Authorisation under REACH and provides supplementary information on the manufacturing and
marketing of articles made from materials based on Bisphenol A (BPA).
CRITERIA FOR IDENTIFICATION AS AN SVHC
In order for a substance to be identified as SVHC, a so-called ‘Annex XV dossier’ has to be submitted
to ECHA that provides the justification for the proposal. REACH defines substances, which may be
subject to Authorisation, as:
Carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B;
Persistent, bio accumulative and toxic (PBT);
Very persistent and very bio accumulative (vPvB);
Showing scientific evidence of probable serious effects to human health or the environment
which give rise to an equivalent level of concern, such as substances with endocrine disrupting
properties.
APPLYING THE SVHC CRITERIA TO BPA
The EU Risk Assessment of BPA clearly states that BPA is neither persistent nor bio accumulative.
Therefore, BPA is neither a PBT nor a vPvB substance.
BPA is not an endocrine disruptor according to the WHO/IPCS criteria, which were presented by the
EU Commission in June 2016 as basis for the identification of Endocrine Disruptors. In its January
2015 opinion on BPA the EFSA expert panel concluded that “based on the WHO criteria, it is not
possible to conclude that BPA is an endocrine disruptor”. This is due to the fact that BPA does not
show any reproducible evidence of adverse effects through the endocrine system.

More broadly, the EU Risk Assessment of BPA has concluded that BPA presents
no risk to consumers or the environment in its intended applications. The
responsible authorities for consumer safety worldwide support this conclusion.
In August 2016, a reclassification of BPA as reprotox 1B entered into force
will apply from March 2018. Based on this 1B reprotoxic classification, the
French authorities submitted to ECHA an Annex XV dossier for BPA, proposing
the identification of BPA as a substance of very high concern (SVHC) under
REACH. Following the ECHA Member State Committee (MSC) agreement to
identify BPA as SVHC in December, Bisphenol A (BPA) has been included in the
REACH Candidate List of Very High Concern as of 12 January 2017, based on its
classification as reprotox 1B. Identification as an SVHC could be the entry point
into a potential authorization under REACH at a later stage.
INTERMEDIATES ARE NOT SUBJECT TO AUTHORISATION
Intermediates are substances that are converted during chemical processing.
Under REACH, Authorisation is not required for intermediates. BPA is
predominantly used as an intermediate in the manufacture of polycarbonate
plastic and epoxy resin. In fact, the overwhelming amount of all BPA produced
is converted into such polymers. BPA, as an intermediate, is therefore exempt
from Authorisation.
SUBSTANCES ON THE “CANDIDATE LIST”
Substances identified under REACH as SVHC are collected on the so-called Candidate List. The first
such Candidate List was published by ECHA in October 2008, it is since updated twice per year,
usually in June and December.
The identification of a substance as SVHC and the inclusion in the Candidate List triggers
communication and notification obligations for companies. These obligations refer not only to the
listed substance on its own or in mixtures but also to its presence in articles, pursuant to Article
33 of REACH:
Suppliers of articles which contain substances on the Candidate List in a concentration above
0.1% (w/w) have to provide sufficient information to allow safe use of the article to their
customers or upon request, to a consumer within 45 days of the receipt of the request. This
information must contain as a minimum the name of the substance.
Producers or importers of articles have to notify ECHA if their article contains a substance on the
Candidate List. This obligation applies if the substance is present in those articles in quantities
totalling over one tonne per producer or importer per year and if the substance is present in
those articles above a concentration of 0.1% (w/w). Of note, a notification is not required when
the producer can exclude exposure of humans and the environment during the use and disposal
of the article, or when the substance has already been registered for that use.

The predominant amount of all BPA produced
is converted into polymeric materials such as
polycarbonate and epoxy resin. BPA is firmly bound
into the structure and only technically unavoidably
trace levels of unreacted BPA may remain in the polymer
matrix. Such levels are usually far below the levels
that would trigger SVHC-related communication or
notification obligations. Therefore, for the vast majority
of BPA-based polymers, specifically polycarbonate
and epoxy resins, no direct obligations are expected
following the SVHC identification. Nevertheless it is
the responsibility of each company in the value chain
to evaluate, if their products (articles) fall under the
communication and notification obligations of REACH,
which are available under this link: https://www.echa.
europa.eu/candidate-list-obligations.
FOOD CONTACT MATERIALS
EU food safety legislation covers materials and articles that are intended to come into contact with
food. Food contact materials (FCMs) are regulated by the Framework Regulation for all food contact
materials (EC No 1935/2004) and the use of BPA as monomer for plastic FCMs is explicitly permitted
by the Regulation (EU No 10/2011). The SVHC-identification and inclusion in the Candidate List
does not impact compliance of BPA-based food contact materials with the respective legislation.
The European Risk Assessment concluded that BPA does not present a risk to consumers or the
environment in its intended applications. The January 2015 EFSA opinion on BPA concluded: “EFSA’s
comprehensive re-evaluation of bisphenol A (BPA) exposure and toxicity concludes that BPA poses
no health risk to consumers of any age group (including unborn children, infants and adolescents)
at current exposure levels. Exposure from the diet or from a combination of sources (diet, dust,
cosmetics and thermal paper) is considerably under the safe level (the “tolerable daily intake” or
TDI).”
CONCLUSION
Substances on the Candidate List are subject to a prioritisation driven by ECHA. If BPA was
prioritised among the substances on this list, it could ultimately mean that it may be subject to
Authorisation under REACH at a later stage.
A substance can be identified as an SVHC and be included on the Candidate List – however, this
implies neither a ban of the substance nor its automatic inclusion in Authorisation under REACH.
Uses as intermediate, such as BPA for polycarbonate and epoxy resin, are exempt from Authorisation
under REACH. Downstream users of BPA could therefore continue to use BPA-based materials such
as polycarbonate plastic and epoxy resin with confidence.

More information on BPA
is available at the following
Web sites:
ECHA:
https://echa.europa.eu/
support/guidance
https://www.echa.europa.
eu/web/guest/addressingchemicals-of-concern
https://echa.europa.eu/
addressing-chemicals-ofconcern/authorisation
https://www.echa.europa.eu/
candidate-list-obligations
EFSA:
http://www.efsa.europa.eu/en/
press/news/150121
PlasticsEurope:
www.bisphenol-a-europe.org
Or by contacting:
Jasmin Bird
Polycarbonate/Bisphenol-A
Group PlasticsEurope
Email:
Jasmin.Bird.consultant@plasticseurope.org