EVALUATION OF RISKS INDUCED BY BISPHENOL A IN MATERIALS IN CONTACT WITH FOOD BOSNA I HERCEGOVINA БОСНА И ХЕРЦЕГОВИНА Agencija za sigurnost hrane BiH Агенција за безбједност хране БиХ 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 COMMUNICATION interactive exchange of information and opinions concerning risks RISK MANAGEMENT policy based RISK ASSESSMENT science based

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. 178/2002Definitions ‘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 FOOD SAFETY MEDIA CONSUMERS REGULATIONS INDUSTRY NATURE ENVIRONMENT CULTURE/ DEMOGRAPHY SCIENCE AND TEHNOLOGY ECONOMY AGRICULTURE

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.Commission Directive 2002/72/EC of 6 August 2002

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 un- conjugated (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 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. On 8 March 2010 EFSA received a further 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 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 BOSNIA AND HERZEGOVINA RISK ANALYSIS RISK ASSESSMENT RISK MANAGEMENT RISK COMMUNICATION

BISPHENOL A Bosnia and Herzegovina

BISPHENOL A Bosnia and Herzegovina

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