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BOSNA I HERCEGOVINA
БОСНА И ХЕРЦЕГОВИНА
Agencija za sigurnost hrane BiH
Агенција за безбједност хране БиХ
Food Safety Agency of Bosnia and Herzegovina
EVALUATION OF RISKS INDUCED BY BISPHENOL A
IN MATERIALS IN CONTACT WITH FOOD
Doc.dr.sc. Nihada Ahmetović
Doc.dr.sc. Sejad Mačkić
Food Safety Agency of Bosnia and Herzegovina
FOOD SAFETY
The European Union and member states have
put food safety at the top of political agendas
and priorities. Food Safety, initially viewed as
an isolated concept, because of its great
importance over time becomes a factor that is
embedded in all horizontal European policy.
Basic determinants of food security strategies
are: the legal framework for food safety and
food for animals, independent and public
opinion available to scientists, manufacturing
process control compliance with the legal
framework and freedom of choice for
consumers on the basis of available
information.
FOOD SAFETY
One of the results of the White Paper on food
safety is a European Commission Regulation
178/2002 (EC Regulation 178/2002), which is
called the General Food Law EU.
Food Law of B&H (Official Gazette of B&H ", no.
50/04) that is compliant with EC Regulation
178/02, governing the area of food safety in
Bosnia and Herzegovina.
Food Safety Agency of B&H, as a leading national
authority in the field of food safety, according to
the provisions of the Food Act initiates, prepares
and organizes the development of implementing
regulations under this Act.
RISK ANALYSIS FRAMEWORK
RISK ASSESSMENT
RISK MANAGEMENT
science based
policy based
RISK COMMUNICATION
interactive exchange of information
and opinions concerning risks
RISK ANALYSIS
RISK ASSESSMENT
The Codex Alimentarius Commission
defines risk assessment as: “A
scientificially based process consisting of
the following steps”
 hazard identification,
 hazard characterization,
 exposure assessment, and
 risk characterization.”
RISK MANAGEMENT
The process, distinct from risk
assessment, of weighing policy
alternatives in consultation with all
interested parties, considering risk
assessment and other factors relevant
for the health protection of consumers
and for the promotion of fair trade
practices, and, if needed, selecting
appropriate prevention and control
options.
RISK COMMUNICATION
The interactive exchange of information and opinions throughout the risk analysis
process concerning risk, risk-related factors and risk perceptions, among risk
assessors, risk managers, consumers, industry, the academic community and other
interestes parties, including the explanation of risk assessment findings and the
basis of risk management decisions.
Definitions
‘Risk’ means a function of the probability of an adverse
health effect and the severity of that effect, consequential
to a hazard;
‘Hazard’ means a biological, chemical or physical agent in,
or condition of, food or feed with the potential to cause an
adverse health effect;
Article 3 of Regulation (EC) No. 178/2002
FOOD SAFETY: The Holistic Approach
CONSUMERS
MEDIA
INDUSTRY
REGULATIONS
FOOD SAFETY
NATURE
ENVIRONMENT
AGRICULTURE
ECONOMY
CULTURE/
DEMOGRAPHY
SCIENCE AND
TEHNOLOGY
Bisphenol A (BPA, 2,2-bis(4-hydroxyphenyl) propane) is a chemical used
primarily in the manufacture of polycarbonate plastic, epoxy resins and as a
non-polymer additive to other plastics. Because of the extensive use of BPA in
the manufacture of consumer products, such as polycarbonate baby bottles,
epoxy-resin can liners, food containers and utensils, dental sealants, protective
coatings, flame-retardants, and water supply pipes, there is a widespread
human exposure to BPA.
BPA is permitted for use in food contact materials in
the European Union, under Commission Directive
2002/72/EC of 6 August 2002 relating to plastic
materials and articles intending to come into
contact with foodstuffs. It is also permitted for food
contact use in other countries such as the USA and
Japan.
Several risk assessment studies have been performed over the last 10 years by
different regulatory bodies in Europe, USA, Japan and Canada.
BPA has received considerable attention in recent years due to widespread
sources for human exposure, and its potential harmful effect on humans. BPA is
described as an endocrine disruptor (hormone like substance), since it has the
ability to bind to the nuclear oestrogen receptor and exert weak oestrogenic
effects. One of the main concerns is neurodevelopmental toxicity, based on the
concept that the developing brain of a human foetus or infant is inherently more
susceptible to injury from toxic agents than that of an adult. It is suggested that
metabolic disorders and carcinogenicity are other biological effects that might
be related to BPA exposure.
During the last 10 years regulatory bodies have undertaken hazard and risk
assessments of BPA Scientific Committee on Food (SCF; 2002), European
Chemicals Bureau (ECB; 2003, 2008); European Food Safety Authority (EFSA;
2006); US Food and Drug Administration (FDA; 2008), Environment Canada
and Health Canada (2008), and the Japanese National Institute of Advanced
Industrial Science and Technology (AIST; 2007). Hazard assessment data are
also published extensively in the scientific literature.
TOXICOKINETICS AND METABOLISM
• BPA is considered to be rapidly conjugated
into BPA glucoronide and BPA sulphate and
consequently eliminated from the human body
due to the water solubility of these
metabolites;
• Internal exposure to free BPA available for
biological activity within the body is therefore
expected to be very low;
• Recent data from measurements of unconjugated (free) BPA in human blood and
urine however suggest higher internal
exposure of humans to free BPA;
• Newborns are expected to be exposed to
higher internal BPA values due to immature
glucuronidation activity.
REPEATED DOSE TOXICITY
• The lowest overall NOAEL of 5
mg/kg bw/day for risk assessment
has been determined for liver
effects;
• Epidemiological studies suggest
correlations between BPA exposure
and heart diseases, liver toxicity and
metabolic syndrome (diabetes and
obesity); In vitro and in vivo studies
corroborate the findings, though
both, epidemiological and
laboratory studies have limitations.
CARCINOGENICITY
• BPA was not found to be carcinogenic in standard carcinogenicity studies;
• Concern has been expressed for increased susceptibility to precancerous changes
following in-utero or neonatal exposure to BPA in rats.
NEURODEVELOPMENTAL TOXICITY
• A recent guideline study found no evidence that BPA is a developmental
neurotoxicant.
• Many research studies report neurodevelopmental effects at very low
dose levels, however the effects seen are manifold and not consistent.
REPRODUCTIVE TOXICITY
• Guideline studies in compliance with GLP, using the oral
route of exposure, did not confirm the above mentioned low
dose effects of Bisphenol A on reproduction and
development.
EFSA role and ongoing work
In its risk assessment on BPA adopted in 2006, EFSA set a Tolerable Daily
Intake (TDI) of 0.05 mg/kg body weight for this substance. The TDI is an
estimate of the amount of a substance, expressed on a body weight
basis, that can be ingested daily over a lifetime without appreciable risk.
EFSA found that intakes of BPA through food and drink were well below
the TDI, even for infants and children.
EFSA role and ongoing work
In an opinion adopted in 2008, EFSA addressed the difference between
infants and adults in clearing BPA from the body. Results confirmed that
exposure to BPA was well below the TDI of 0.05 mg/kg bw for both
adults and newborns. Indeed, after exposure to BPA the human body
rapidly metabolises and eliminates the substance. Newborns can similarly
clear BPA at levels far in excess of the TDI. In its evaluation, EFSA took
into account both the previous and the most recent information and data
available, both from industry and from peer-reviewed scientific literature.
EFSA role and ongoing work
In September 2008 the European Commission asked EFSA to assess the
conclusions of a study by Lang et al. published in the Journal of the
American Medical Association (JAMA, 16 September 2008) that
suggested a link between raised levels of urinary BPA to increased
occurrence of serious medical conditions, including heart disease and
diabetes.
EFSA role and ongoing work
On 15 October 2009, EFSA received
On 8 March 2010 EFSA received a further
a request from the European
Commission to assess the relevance of
a new study on possible
neurodevelopmental effects of BPA
and, if necessary, to update the
existing TDI accordingly.
related request from the European
Commission to also take into account in its
risk assessment any other new scientific
evidence that may be available and to liaise
closely with EU Member States risk
assessment bodies on this issue
On 30 March 2010, EFSA received an urgent
request from the European Commission to review
scientific arguments supplied by Denmark in
support of the government’s decision to ban the
use of BPA in food contact materials for infants
aged from 0 to 3 years.
EFSA role and ongoing work
EFSA updated its advice on BPA in September 2010. Following a detailed
and comprehensive review of recent scientific literature and studies on
the toxicity of BPA at low doses, scientists of EFSA’s CEF Panel concluded
they could not identify any new evidence which would lead them to
revise the current TDI for BPA of 0.05 mg/kg body weight set by EFSA in
its 2006 opinion and re-confirmed in its 2008 opinion. The Panel also
stated that the data currently available do not provide convincing
evidence of neurobehavioural toxicity of BPA.
The Danish Government substantiated its safeguard measure with a risk
assessment provided on 22 March 2010 by the National Food Institute at
the Technical University of Denmark. The risk assessment covers the
evaluation of a comprehensive study carried out on animals exposed to
BPA in low doses monitoring the development of the nervous system
and the behaviour in newborn rats. DTU Food has also evaluated
whether the new data changes its previous evaluation of the toxic effects
on the development of the nervous system and behaviourpossibly
caused by BPA.
The French Government substantiated its safeguard measure with two
opinions issued by the French Food Safety Authority (AFSSA) on 29
January and 7 June 2010 and the report published on 3 June 2010 by the
National Institute of Health and Medical Research (INSERM).
On 23 September 2010 the EFSA adopted the opinion of its Panel on food
contact materials, enzymes, flavourings and processing aids on BPA
responding to the Commission’s request of 30 March 2010 as well as covering
the evaluation of the specific neurobehavioural study evaluated in the Danish
risk assessment and the review and evaluation of other recently published
studies on BPA.
In its opinion the Panel concludes that based on the comprehensive
evaluation of recent human and animal toxicity data, no new study could be
identified, which would call for a revision of the current tolerable daily
intake (hereinafter ‘TDI’) of 0,05 mg/kg bodyweight per day. This TDI is based
on the no adverse effect level of 5 mg/kg bodyweight per day.
The Panel noted that some animal studies conducted on developing animals
have suggested other BPA-related effects of possible toxicological relevance,
in particular biochemical changes in brain, immunomodulatory
effects and enhanced susceptibility to breast tumours. These studies have
many shortcomings. The relevance of these findings in relation to human
health cannot be assessed at present.
Taking into account that there are uncertainties in the present state of
scientific research with regard to the harmfulness of BPA exposure to infants
through polycarbonate infant feeding bottles that would need to be
clarified, the Commission is entitled to take a preventive measure
regarding the use of BPA in polycarbonate infant feeding bottles on the basis
of the precautionary principle which is applicable in a situation in which
there is scientific uncertainty, even if the risk, notably to human health, has
not yet been fully demonstrated.
Thus, it is necessary and appropriate for the achievement of the basic
objective of ensuring a high level of human health protection to obviate
sources of danger to physical and mental health that may be caused to
infants by BPA exposure through feeding bottles.
Member States shall apply the provisions referred to in paragraph 1 in
such a way as to prohibit from 1 March 2011 the manufacture of, and
from 1 June 2011 the placing on the market and importation into the
Union of, plastic materials and articles intended to come into contact
with foodstuffs and which do not comply with this Directive.
BOSNIA AND HERZEGOVINA
RISK ANALYSIS
RISK ASSESSMENT
RISK MANAGEMENT
RISK COMMUNICATION
BISPHENOL A
Bosnia and Herzegovina
BISPHENOL A
Bosnia and Herzegovina
Bosnia and Herzegovina
Thank you for your attention