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Bisphenol A and REACH

INTRODUCTION
REACH, the EU chemicals legislation, places duties on manufacturers, importers and users
of chemical substances. In this document the Polycarbonate/Bisphenol A industry group of
PlasticsEurope answers questions about Bisphenol A (BPA) and REACH. Detailed information
about BPA and the Authorisation scheme under REACH is available in the separate fact sheet
“Authorisation under REACH: Information on BPA-based materials”.
WHAT IS REACH?
REACH stands for “Registration, Evaluation, Authorisation and Restriction of Chemicals”. REACH
became part of European law on 1 June 2007. It replaced several pieces of old legislation and
introduces new requirements. The REACH regulation came into operation in each EU Member State
at the same time and in the same way. However, EU Member States are free to set up national
enforcement processes according to their own laws and systems.
WHAT IS AN ARTICLE?
Although many people use the word “product” in a general way, it is not used in REACH. The
expression used in REACH is “article”, which is defined as “an object which during production is
given a special shape, surface or design which determines its function to a greater degree than
does its chemical composition”. Examples of articles made from BPA-based materials such as
polycarbonate and epoxy resin include CDs, transparent roofs, safety helmets, automotive parts,
housings for electronic equipment, windmill blades and epoxy coated articles such as lined cans.
WHO IS A DOWNSTREAM USER?
Downstream users are users of a chemical substance, either on its own or as preparation, in the
course of their industrial or professional activities. Downstream users of BPA typically include
manufacturers of BPA-based polymers (e.g. polycarbonate or epoxy resin), formulators of BPAcontaining chemical mixtures or preparations and producers of BPA-based reaction products.
Distributors and retailers are not regarded as downstream users under REACH. Their role is limited
to being recipients of a substance, preparation or article and to placing those on the market.

WHAT ARE THE BASICS OF REGISTRATION OF BPA?
REACH requires manufacturers and importers to act as registrants.
For a substance manufactured or imported in a quantity ≥1 tonne/
year they must compile a Technical Dossier on the physicochemical,
human health and environmental properties of that
substance. For a substance manufactured or
imported in a quantity ≥10 tonnes/year, like BPA,
a Chemical Safety Assessment must be carried
out and documented in a Chemical Safety Report
(CSR). Each registrant must submit a Registration
dossier including the Technical Dossier and the
CSR, where it is required, to the European Chemicals
Agency (ECHA). The deadline for Registration
depends on the tonnage manufactured or
imported. The leading manufacturers of BPA
have joined to prepare a consistent registration
dossier for BPA and have launched the BPA
REACH consortium. The registration dossier for BPA was submitted to ECHA
before the relevant deadline of 1 december, 2010. The secretariat of the BPA REACH
consortium can be contacted at consortium@reachcentrum.eu.
WHAT ARE THE DUTIES OF DOWNSTREAM USERS OF BPA AND BPA-BASED
POLYMERS IN THE REGISTRATION PROCESS?
The main obligations in the REACH Registration process fall upon the registrants
of BPA. It is they who must demonstrate the safety of BPA and BPA-based
materials for human health and the environment. As part of the Chemical Safety
Assessment, REACH requires downstream users to inform the registrants about the way they use
BPA. Users should provide sufficient information to allow the registrants to prepare a realistic
exposure scenario for each specific use of BPA. This will enable the registrant to include the use in
the CSR as an “identified” use and assure continued supply. The registrant is not obliged to include
in the CSR a use of BPA that he considers he cannot support. For uses of BPA not covered by the
CSR, downstream users must prepare their own Chemical Safety Assessment and CSR.
IS IT TRUE THAT POLYMERS ARE EXEMPT FROM REGISTRATION?
Yes, polymers are exempt from Registration, but the building blocks from which they are made, the
monomers, are not. In the case of polycarbonate and epoxy resin BPA is the monomer from which
they are manufactured.
DOES A PRODUCER OR IMPORTER OF AN ARTICLE HAVE TO REGISTER BPA?
It will be necessary for the producer or importer of an article to register the use of BPA in that article
only if BPA is intended to be released during normal and reasonably foreseeable conditions of use,
and if some additional conditions are met. We know of no article that is intended to release BPA
during use. Therefore, it is highly unlikely that any producer or importer of articles made from BPAbased materials will have an obligation to register BPA.
WHEN DOES A PRODUCER OR IMPORTER OF AN ARTICLE HAVE TO NOTIFY A SUBSTANCE?
Notification in the context of REACH means the requirement to inform ECHA of the presence and use
of a substance in an article. Notification of a substance in an article by the producer or importer of
that article is required if all of the following criteria apply:
The substance has been identified as a substance of very high concern (SVHC)
The substance has been included in the Candidate List for Authorisation
The substance is present in that article at a concentration exceeding 0.1% by weight
The total amount of the substance present in that article exceeds one tonne per producer or
importer per year
The substance has not yet been registered for that specific use.

Notification to ECHA shall be made at the latest six months after the substance has been included
on the Candidate List. However, there is no obligation to notify if the producer or importer of
the article can exclude exposure to humans or the environment during normal or reasonably
foreseeable conditions of use and disposal. Producers or importers of articles made from BPAbased materials like polycarbonate and epoxy resin are not expected to have an obligation to notify
the ECHA about BPA.
WHEN DOES THE “INFORMATION OBLIGATION UNDER ART. 33” APPLY TO A SUPPLIER OF AN
ARTICLE?
The obligations apply to articles that contain above 0.1% by weight of a substance which is on
the Candidate List. The supplier of such an article must “sufficiently inform” the recipient about
the substance to enable the safe use of the article. As a minimum requirement, the name of the
substance must be given. On request of a consumer, the supplier of the article must give the
same information to the consumer within 45 days of receipt of that request. The predominant
amount of all BPA produced is converted into polymeric materials such as polycarbonate. In
polycarbonate only technically unavoidable trace levels of BPA may remain in the polymer matrix.
For polycarbonate applications, if BPA would be included in the Candidate List, most probably no
information or notification obligation for suppliers and for producers or importers polycarbonate
articles would be expected, as the concentration of free (residual) BPA in the final product is usually
below 0.1%.
HOW CAN I FIND OUT ABOUT THE STATUS OF BPA REGISTRATION?
There is an active information flow from manufacturers and importers to downstream users about
the status and progress of the Registration process. Most recent information about registered
substances, substances on the Candidate List and substances proposed for inclusion on the
Candidate List can be found at the ECHA website.
WHERE CAN I GET MORE INFORMATION ON BPA AND REACH AND ITS EFFECTS ON MY BUSINESS?
For questions related to BPA which are not covered in our published information documents, please
contact the PC/BPA industry group of PlasticsEurope. For more general queries about REACH, your
own trade association will give you guidance or will refer you to the numerous websites operated
by ECHA, national authorities and industry organisations.

More information on BPA
is available at the following
Web sites:
ECHA:
https://www.echa.europa.eu/
regulations/reach/
PlasticsEurope:
www.bisphenol-a-europe.org
Or by contacting:
Jasmin Bird
Polycarbonate/Bisphenol-A Group
PlasticsEurope
Email:
Jasmin.Bird.consultant@plasticseurope.org