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Bisphenol A and Regulatory Assessments

WEIGHT OF SCIENTIFIC EVIDENCE SUPPORTS THE SAFETY OF BPA
Government and scientific bodies around the globe have extensively evaluated the weight of
scientific evidence on Bisphenol A (BPA) and have declared that BPA is safe for its intended uses,
including in materials which come into contact with food, such as reusable food-storage containers
and linings in metal cans.
Regulatory agencies that have recently ruled on the safety of BPA include
European Food Safety Authority (October 2016, January 2015, December 2011, September 2010)
German Federal Institute for Risk Assessment (February 2015, May 2011, July 2010)
U.S. Food and Drug Administration (November 2014, March 2013, January 2010)
HongKong Center for Food Safety (January 2013)
Food Standards Australia New Zealand (April 2012, July 2011, November 2010)
Health Canada (September 2012, March 2010, October 2008)
Japanese National Institute of Advanced Industrial Science and Technology (July 2011)
Swiss Federal Office of Public Health (June 2011, December 2011, February 2009)
German Society of Toxicology, Advisory Committee (April 2011)
WHO and FAO (September 2011/November 2010)
European Union (June 2008)
SAFETY OF BPA CONFIRMED BY REGULATORY AUTHORITIES AND SCIENTIFIC EXPERTS
European Food Safety Authority (EFSA)
In January 2015, following a comprehenssive re-evaluation of BPA exposure and toxicity, EFSA’s
scientific experts concluded that ”BPA poses no health risk to consumers of any age group
[including unborn children, infants and adolescents] at current exposure levels”. Going beyond
previous assessments, EFSA evaluated exposure to BPA not only from food, but also from a range
of other potential sources. EFSA found that exposure to BPA from all sources is very low and well
below the new safe limit of 4 microgram/kg body weight per day.

The 2015 EFSA opinion is the most recent one in a series of repeated assessments
the authority executed on BPA, namely from December 2011, September 2010,
July and October 2008, and January 2007. Each assessment incorporated
the available studies from the respective period, including exploratory and
non-GLPstudies, and applied a weight-of-evidence approach to the complete
database. In all assessments – including the most recent one of October 2016
which focussed specifically on some immunotoxicity studies – EFSA reached the
conclusion that BPA-based polycarbonate and epoxy resin food contact materials
are safe for their intended uses. Nevertheless, based on a highly precautionary
approach the EU Commission decided to restrict the use of BPA in baby bottles
as of June 2011 in Europe.
German Federal Institute for Risk Assessment (BfR)
In February 2015, the BfR supported the EFSA assessment of BPA and states
”no health risk for consumers from BPA esposure“.
U.S. Food and Drug Administration (FDA )
In November 2014, the US FDA updated its assessment of BPA. The FDA’s current
perspective, based on its most recent safety assessment, is that BPA is safe at
the current levels occurring in food. In another recent update, the FDA answered
the question ”Is BPA safe?“ with a clear answer: ”Yes.“
Food Standards Australia and New Zealand (FSANZ)
In April 2013, FSANZ reaffirmed the safety of BPA and stated: ”The weight of the scientific evidence
indicates that exposure to BPA in food does not present a significant human health and safety issue
at current exposure levels.“
Health Canada
In September 2012, Health Canada released an updated assessment of BPA. The experts concluded
that “current dietary exposure to BPA through food packaging uses is not expected to pose a health
risk to the general population, including newborns and young children.“
Advisory Committee of the German Society for Toxicology
In its April 2011 review published in Critical Reviews in Toxicology, the Advisory Committee
concluded, that “BPA exposure represents no noteworthy risk to the health of the human
population, including newborns and babies.” In its specific evaluation of studies reporting that low
doses of BPA cause adverse health effects in laboratory animals, the Committee found that these
studies “failed to meet minimal quality criteria for experimental design and statistical analysis” and
that their results were inconsistent with more robust studies on similar endpoints.
World Health Organization (WHO)
and Food and Agriculture Organization of the United Nations (FAO )
In September 2011, an international panel of experts organised by WHO and FAO released a report
on their review of all the latest scientific evidence on BPA and
concluded that ”initiation of public health measures against BPA
would be premature“. The experts also concluded that levels of
BPA in the human body “are very low, indicating that BPA is not
accumulated in the body and is rapidly eliminated.”

More information on BPA
is available at the following
Web sites:
EFSA:
https://www.efsa.europa.eu/en/
efsajournal/pub/3978
http://onlinelibrary.wiley.com/
doi/10.2903/j.efsa.2015.3978/full
https://www.efsa.europa.eu/en/
press/news/150121
http://www.efsa.europa.eu/en/
press/news/150121
FDA:
http://www.fda.gov/Food/
IngredientsPackagingLabeling/
FoodAdditivesIngredients/
ucm355155.htm
PlasticsEurope:
www.bisphenol-a-europe.org
Or by contacting:
Jasmin Bird
Polycarbonate/Bisphenol-A Group
PlasticsEurope
Email:
Jasmin.Bird.consultant@plasticseurope.org