Are the regulators in Denmark, France, Sweden and the EU basing their
regulations to ban BPA in plastic bottles for children on a risk assessment or
on a hazard classification and do you think that the regulation is justified?
Why or why not?
Requirements:
- Minimum of 15 peer-review references, can’t be those that are on the reading list
- 2,000 words
- Harvard referencing
- Show original analysis and critical thought
Readings:
1. EFSA – Bisphenol A
https://www.efsa.europa.eu/en/topics/topic/bisphenol
Timeline of events:
2006 – EFSA completes its 1st full risk assessment and sets a TDI of 0.05mg per bw/day- also
evaluate BPA intakes for infants and children and finds they are below the TDI
2008 – EFSA assesses a study by Lang et al – noting it doesn’t include information on long-
term exposure to BPA which is necessary to establish a correlation of the development of
chronic medical conditions
o Confirm that exposure to BPA is well below the TDI of 0.05mg/bw for both
adults and newborns – who can clear it from their bodies at levels far in
excess of the TDI
2009 – Address a study by Stump on the neurodevelopmental effects of BPA –
commissioned by ACC to address concerns raised by Canadian government – who had
banned the use of polycarbonate in baby bottles
2010 – requested by commission to take into account any new evidence and liase closely
with EU member state risk assessment bodies
- Update advice on BPA in September – CEP panel conclude they cannot identify any
new evidence that should lead them to revise the TDI for BPA of 0.05mg/kg body
weight set in 2006
2015 – comprehensive review of BPA exposure and toxicity concludes that BPA poses no
health concern
2016 – New data confirm EFSA’s previous conclusion that BPA might affect the immune
system in animals, but evidence is too limited to draw any conclusions for human health
2017 -
- First time a protocol is set up,
2. Bisphenol A and Risk Management Ethics (Resnik.D, 2015)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4115043/
- 8bn pounds of BPA are produced per annum = one of the most common industrial
products
, - Concern that it may cause adverse health effects at low doses, I,e: less than 5mg per
kg body weight per day (5)
o Vandenberg LN, Chahoud I, Heindel JJ, Padmanabhan V, Paumgartten FJR,
Schoenfelder G. Urinary, Circulating, and Tissue Biomonitoring Studies
Indicate Widespread Exposure to Bisphenol A. Environ Health Perspect.
2010; 118:1055–1070. [PubMed: 20338858]
- It effects the human body and is an endocrine disruptor compound as it can interfere
with estrogen receptors and impedes androgen receptors at higher doses
- FDA in 2010, declared BPA to be safe in 2008, stated they agreed with the National
Institute of Environmental Health Science (NTP’s) assessment of BPA
- EFSA and WHO concluded there is “insufficient evidence to conclude that BPA poses
risks to human health”
In 2010:
Denmark banned the use of BPA in manufacturing food containers for young
children (17)
Siva, op. cit., note 1.
Manufacturers called for it to be banned as they had already stopped using BPA
in baby bottles and children’s cups, but wanted an official ban to help bolster
consumer confidence (18)
o Tavernise S. F.D.A. Makes it Official: BPA Can’t be Used in Baby Bottles
and Cups. The New York Times. 2012 Jul 17.17:A15
In banning the product regulators need to compare the benefits, risks and costs
of allowing the use vs the benefits, risks and costs of not
o Are they alternatives to BPA better ? Bisphenol S – also acts as an
endocrine disruptor and has a nonmonotonic dose response curve
3. Commission Directive 2011/8/EU amending EU Directive 2002/72/EC as regards to
the restriction of the use of Bisphenol A in plastic infant feeding bottles
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32011L0008
29th March 2010 – Danish government informed the commission and states that it
had decided to apply the safeguard measures and temporarily ban the use of BPA for
the manufacture of plastic materials in contact with food intended for children aged
0-3 (5), risk assessment provided on 22nd March 2010
6th July 2010 – French Government informed the commission – and applied
measures provided by Article 18 of Regulation (EC 1935/2004) to ban the
manufacturer, import, export and placing on the market of feeding bottles
containing BPA (6)
o AFSSA issued opinion on 29th January 2010 and 7th June and report published
on 3rd June 2010 by the National Institute of Health and Medical Research
(INSERM)
The infant has sufficient capacity to eliminate BPA at worst-case exposure and EFSA’s
opinion points out that an infant’s system to eliminate BPA is not as developed as an adult
and reaches adult’s capacity during its first 6 months of life
regulations to ban BPA in plastic bottles for children on a risk assessment or
on a hazard classification and do you think that the regulation is justified?
Why or why not?
Requirements:
- Minimum of 15 peer-review references, can’t be those that are on the reading list
- 2,000 words
- Harvard referencing
- Show original analysis and critical thought
Readings:
1. EFSA – Bisphenol A
https://www.efsa.europa.eu/en/topics/topic/bisphenol
Timeline of events:
2006 – EFSA completes its 1st full risk assessment and sets a TDI of 0.05mg per bw/day- also
evaluate BPA intakes for infants and children and finds they are below the TDI
2008 – EFSA assesses a study by Lang et al – noting it doesn’t include information on long-
term exposure to BPA which is necessary to establish a correlation of the development of
chronic medical conditions
o Confirm that exposure to BPA is well below the TDI of 0.05mg/bw for both
adults and newborns – who can clear it from their bodies at levels far in
excess of the TDI
2009 – Address a study by Stump on the neurodevelopmental effects of BPA –
commissioned by ACC to address concerns raised by Canadian government – who had
banned the use of polycarbonate in baby bottles
2010 – requested by commission to take into account any new evidence and liase closely
with EU member state risk assessment bodies
- Update advice on BPA in September – CEP panel conclude they cannot identify any
new evidence that should lead them to revise the TDI for BPA of 0.05mg/kg body
weight set in 2006
2015 – comprehensive review of BPA exposure and toxicity concludes that BPA poses no
health concern
2016 – New data confirm EFSA’s previous conclusion that BPA might affect the immune
system in animals, but evidence is too limited to draw any conclusions for human health
2017 -
- First time a protocol is set up,
2. Bisphenol A and Risk Management Ethics (Resnik.D, 2015)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4115043/
- 8bn pounds of BPA are produced per annum = one of the most common industrial
products
, - Concern that it may cause adverse health effects at low doses, I,e: less than 5mg per
kg body weight per day (5)
o Vandenberg LN, Chahoud I, Heindel JJ, Padmanabhan V, Paumgartten FJR,
Schoenfelder G. Urinary, Circulating, and Tissue Biomonitoring Studies
Indicate Widespread Exposure to Bisphenol A. Environ Health Perspect.
2010; 118:1055–1070. [PubMed: 20338858]
- It effects the human body and is an endocrine disruptor compound as it can interfere
with estrogen receptors and impedes androgen receptors at higher doses
- FDA in 2010, declared BPA to be safe in 2008, stated they agreed with the National
Institute of Environmental Health Science (NTP’s) assessment of BPA
- EFSA and WHO concluded there is “insufficient evidence to conclude that BPA poses
risks to human health”
In 2010:
Denmark banned the use of BPA in manufacturing food containers for young
children (17)
Siva, op. cit., note 1.
Manufacturers called for it to be banned as they had already stopped using BPA
in baby bottles and children’s cups, but wanted an official ban to help bolster
consumer confidence (18)
o Tavernise S. F.D.A. Makes it Official: BPA Can’t be Used in Baby Bottles
and Cups. The New York Times. 2012 Jul 17.17:A15
In banning the product regulators need to compare the benefits, risks and costs
of allowing the use vs the benefits, risks and costs of not
o Are they alternatives to BPA better ? Bisphenol S – also acts as an
endocrine disruptor and has a nonmonotonic dose response curve
3. Commission Directive 2011/8/EU amending EU Directive 2002/72/EC as regards to
the restriction of the use of Bisphenol A in plastic infant feeding bottles
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32011L0008
29th March 2010 – Danish government informed the commission and states that it
had decided to apply the safeguard measures and temporarily ban the use of BPA for
the manufacture of plastic materials in contact with food intended for children aged
0-3 (5), risk assessment provided on 22nd March 2010
6th July 2010 – French Government informed the commission – and applied
measures provided by Article 18 of Regulation (EC 1935/2004) to ban the
manufacturer, import, export and placing on the market of feeding bottles
containing BPA (6)
o AFSSA issued opinion on 29th January 2010 and 7th June and report published
on 3rd June 2010 by the National Institute of Health and Medical Research
(INSERM)
The infant has sufficient capacity to eliminate BPA at worst-case exposure and EFSA’s
opinion points out that an infant’s system to eliminate BPA is not as developed as an adult
and reaches adult’s capacity during its first 6 months of life
