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Statements 2008-2009 and US regulatory out of presentations of the PC/BPA Group of PlasticsEurope

Statements 2008-2009 and US regulatory out of presentations of the PC/BPA Group of PlasticsEurope. National regulators statements re safety of BPA in food contact applications. Europe: BPA-based materials are safe for use. ECB (K. Aschberger) 2008:

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Statements 2008-2009 and US regulatory out of presentations of the PC/BPA Group of PlasticsEurope

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  1. Statements 2008-2009and US regulatory out of presentations of the PC/BPA Group of PlasticsEurope

  2. National regulators statements re safety of BPA in food contact applications BPA clipping overview

  3. Europe: BPA-based materials are safe for use ECB (K. Aschberger) 2008: „ We found that the margin of safety is high enough in relation to consumer exposure of BPA in plastic packaging and, as a result, there is no need for furtherinformation, testing or risk reduction measures beyond those which are being applied already“ EU risk assessment (2008) identified no concern regarding consumer products made from materials based on BPA; assessment included endocrinicity, low dose and neurodevelopment Link:http://ecb.jrc.it/documents/Existing-Chemicals/RISK_ASSESSMENT/ADDENDUM/bisphenola_add_325.pdf BPA clipping overview

  4. Europe: BPA-based materials are safe for use 2007, EFSA,based on the now available sound scientific data, increased the Tolerable Daily Intake increased by factor of 5 to 50 µg/kg b.w.„..low-dose effects of BPA in rodents have not been demonstrated in a robust and reproducible way“ Link: http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620835386.htm 2008,EFSA reaffirmed its conclusion that BPA is safe in food containers, baby bottles and water bottles and noted the established safe intake level for BPA“provides a sufficient margin of safety for the protection of the consumer, including foetuses and newborns.” Link: http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902017373.htm July and October 2008 EFSA reviewed new studies and concluded there is no basis to revise the current TDI. BPA clipping overview

  5. Switzerland: BPA-based materials are safe for use Feb 2009, Swiss Federal Office of Public Health re-evaluated BPA in light of recent research and confirmed that BPA is not a risk to human health in food contact applications: • “Das BAG hat die wissenschaftlichen Berichte verschiedener Lebensmittelsicherheitsbehörden ausgewertet und ist der Meinung, dass die Einnahme von Bisphenol A durch Lebensmittel kein Risiko für den Konsumenten darstellt. Dies gilt auch für Neugeborene und Säuglinge.” • “Ein Verbot von BPA würde unweigerlich dazu führen, dass die Hersteller von Verpackungen und Bedarfsgegenständen (Produkte für den Lebensmittelkontakt) auf andere Stoffe ausweichen müssten, deren Toxizität weniger gut bekannt ist. Das würde bedeuten, dass ein gut charakterisiertes Risiko durch ein deutlich schlechter einschätzbares Risiko ersetzt würde.” “After evaluating the scientific reports of various food safety authorities the SFOPH is of the opinion that the intake of bisphenol A from food represents no risk to the consumer. This also applies to newborns and infants.“ Link: http://www.bag.admin.ch/themen/lebensmittel/04861/06170/index.html?lang=de BPA clipping overview

  6. Netherlands: BPA-based materials are safe for use Nov 2008: Dutch Food and Consumer Product Safety Authority • “De onderzochte polycarbonaat babyflesjes hebben geen aantoonbare migratie van BPA naar de simulanten voor melk en voor vruchtensap. Dit betekent dat de flesjes in dit opzicht veilig zijn voor gebruik voor baby’s en kleine kinderen ten aanzien van BPA.” • “The researched polycarbonate baby bottles have no demonstrable migration of BPA into the simulants for fruit juice and milk. This means that the bottles are safe for use for babies and toddlers with respect to BPA. “ Link (Dutch only): http://www.vwa.nl/portal/page?_pageid=119,1639827&_dad=portal&_schema=PORTAL&p_file_id=31842 BPA clipping overview

  7. Denmark: BPA Case Used as Instrument in Political Debate • May, 2009: Left-wing “Red-Green Alliance” minority in Danish parliament puts forward proposal to demand the EU to ban all BPA-based consumer products and in the interim period impose stringent rules in Dk • Potential threat that proposal could be supported by a majority in the Danish Parliament as instrument to establish an example against the power of the EU in environmental and health issues in Denmark • No media attention so far • PC/BPA group closely following this topic and intensively providing adequate information: • Strategy to meet with spokespersons and MEPs* of relevant parties as well as regulators (Min. of Food, Agriculture and Fishery) and affected value chain partners in place * Members of Parliament BPA clipping overview

  8. Denmark: BPA-based materials are safe for use November 2008: Danish Environmental Protection Agency re-evaluated BPA in light of recent research and confirmed that BPA is not a risk to human health in food contact applications: • “The Environment Protection Agency has, in the light of this assessment concluded that these studies do not alter the decision in the EU assessment. It is therefore concluded that the differences in data for assessments in the EU and in particular the United States and Canada do not have any bearing on the overall assessment of bisphenol A.“ Link (in Danish only): http://www.folketinget.dk/samling/20081/spoergsmaal/s2148/svar/supplerende/20081112/609601.htm BPA clipping overview

  9. Germany: BPA-based materials are safe for use The German Federal Institute for Risk Assessment participated in the EFSA assessment and also re-evaluated BPA in light of recent research. BfR confirms that BPA is not a risk to human health in food contact applications (2006, 2007, 2008): • „Nach sorgfältiger Prüfung aller Studien, insbesondere auch der Studien im Niedrigdosisbereich von Bisphenol A, kommt das BfR in seiner wissenschaftlichen Bewertung zu dem Ergebnis, dass für Säuglinge und Kleinkinder aus der üblichen Verwendung von Polycarbonatflaschen kein gesundheitliches Risiko durch Bisphenol A resultiert.“ • „Die amtliche Lebensmittelüberwachung hat bei stichprobenartigen Untersuchungen im Inhalt haushaltsüblich erwärmter Babyfläschchen kein Bisphenol A nachweisen können. Eine Gesundheitsgefahr für Babys, die Nahrung aus Babyfläschchen aus Polycarbonat aufnehmen, sieht das BfR nicht. Einen Verzicht auf Polycarbonatfläschchen hält das Institut daher nicht für erforderlich.“ „…the presence of BPA in polycarbonate bottles poses no health risk to babies and infants during normal use.“ Link: http://www.bfr.bund.de/cd/7195 BPA clipping overview

  10. Germany: BPA-based materials are safe for use September 2008: “New studies with BPA do not challenge the current assessment“ – statement as reaction to specific assessment of the studies of Lang et al. (JAMA) and Leranth et al.”; • „Das Institut sieht unter Berücksichtigung der Daten aus beiden Studien keinen Anlass, die bisherige Risikobewertung für Bisphenol A zu ändern.“ • „Das BfR unterstützt die Bewertung der EFSA. Durch die bekannten Expositionen von Verbrauchern gegenüber Bisphenol A wird der TDI bei weitem nicht ausgeschöpft. Auch andere nationale und internationale wissen-schaftliche Gremien, so zum Beispiel die amerikanische Food and Drug Administration (FDA), vertreten die Auffassung, dass bei der derzeit bekannten Bisphenol A-Aufnahme über die Nahrung keine gesundheitsschädlichen Wirkungen für Verbraucher zu erwarten sind.“ Link: http://www.bfr.bund.de/cm/216/neue_studien_zu_bisphenol_a_stellen_die_bisherige_risikobewertung_nicht_in_frage.pdf BPA clipping overview

  11. France: BPA-based materials are safe for use Oct 2008: French Food Safety Authority re-evaluated BPA in light of recent research and confirmed that BPA is not a risk to human health in food contact applications: • …“when the contents of polycarbonate baby bottles are heated in the microwave under realistic conditions (heating time less than 10 minutes), the amounts of bisphenol A transferable to food are very low, and stay far short of the maximum migration value adopted by EFSA for its exposure calculation.“…“the conclusions of EFSA's 2006 opinion still apply to the specific cases of heating polycarbonate baby bottles in the microwave and do not justify any special conditions of use. Link: “http://www.afssa.fr/index.htm, http://www.afssa.fr/Documents/MCDA2008sa0141.pdf • “… recent in-depth studies by the AFSSA and the EFSA concluded that BPA-based baby bottles are harmless. Any residual levels of BPA are significantly inferior to the maximum limits fixed by health authorities … The precautionary principle becomes applicable when there are no reliable studies. Here (for BPA) these reliable studies are available, and on the basis of the scientific studies confirm no risk" for baby bottles produced with this substance... “The Canadian authorities decided on the ban on BPA as a result of public pressure not on the basis of valid scientific studies. The precautionary principle is a rational principle, not an emotional one." March and April 2009: French Minister of Health Roselyne Bachelot-Narquin confirms that BPA does not represent a health risk and accuses Canada of misusing the precautionary principle BPA clipping overview

  12. Asia/Pac: BPA is Safe in Food Containers Japan’s National Institute of Advanced Industrial Science and Technology confirmed no risk of BPA to human health, including infants and children (Nov 2005) March 2009: “FSANZ has assessed the risk to infants from exposure to BPA and concurred with conclusions reached by US FDA and EFSA that levels of exposure are very low and do not pose a significant health risk.”“The move by overseas manufacturers to stop using BPA in baby bottles is a voluntary action and not the result of a specific action by regulators.” Link: http://www.foodstandards.gov.au/newsroom/factsheets/factsheets2009/bisphenolabpaandfood4218.cfm BPA clipping overview

  13. Asia/PAC: reference to US and Europe Chinese National Food Hygiene Standard Committee, January 2009 • No new restrictions concerning BPA in the PC article hygiene standard as stated by National Food Hygiene Standard Committee. • Any new regulation not started by Committee before final decision from the US FDA Health Ministry of Malaysia, January 2009 • The Health Ministry of Malaysia will not issue a ban on plastic bottles made from polycarbonate after submission of information on BPA science by Global PC/BPA Group • “This is because the ministry had studies showing that the products were safe and not detrimental to health” Deputy Health Minister Datuk Dr Abdul Latiff Ahmad. National Environmental Protection AdministrationTaiwan, March 2009 • is looking into development of food standard on BPA (primarily focus is baby bottles) BPA clipping overview

  14. U.S. State and Local Activities State Activities (various, passed Minnesota) • Applications´ main focus: child care food and personal beverage containers • other applications like toys, cosmetics and food and beverage containers for all age groups affected by some proposed legislation • further discussion on labeling of all products containing BPA • Ages´ primary focus: infants and children, ages ranging from <3 to <14 years of age • Local Activities – Suffolk County (Long Island, NY), Chicago • Local legislature voted to ban children's beverage containers containing BPA for children age 3 and younger and county Executive signed law on April 2, 2009 The ACC PC/BPA global group in NAFTA is closely following the on-going issues in US with appropriate communication and advocacy measures. BPA clipping overview

  15. U.S. Federal Activities • Focus is on food containers, including beverage containers, that are composed in whole or in part of BPA, or that can release BPA into food. • Applies to: reusable food containers, which are empty containers, and other food containers, which contain food. Representative Markey has introduced a similar bill in the U.S. House of Representatives to Senator Feinstein's proposed bill Senator Schumer has introduced the “BPA-Free Kids Act of 2009” in the U.S. Senate • Bans children's food or beverage containers composed in whole or in part of BPA (bottle, cup, bowl, plate, straw, utensil, other container (except metal can)) designed or intended to be filled with any liquid, food, or beverage primarily for children 3 and younger. Senator Feinstein has introduced the "Ban Poisonous Additives Act of 2009" in the U.S. Senate BPA clipping overview

  16. U.S.-FDA: BPA is Safe in Food Containers 2008: “..despite extensive research world-wide, there is no conclusive evidence of a link between human reproductive health and exposure.. . ..levels of chemical migration are already strictly controlled within the EU. .. dietary exposure of infants and children is estimated to be well below TDI.” 2008: “Based on our ongoing review, we believe that there is a large body of evidence that indicates that FDA-regulated products containing BPA currently on the market are safe and that exposure levels to BPA from food contact materials, including for infants and children, are below those that may cause health effects. …At this time, FDA is not recommending that anyone discontinue using products that contain BPA…” 2008: “…FDA’s lowest calculated margins of safety are approximately 2,000 and 27,000 for infants and adults, respectively. FDA concludes that an adequate margin of safety exists for BPA at current levels of exposure from food contact uses, for infants and adults. “ Feb 2009:“[B]ased on all available evidence, the present consensus among regulatory agencies in the United States, Canada, Europe, and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.” Link:http://www.fda.gov/bbs/topics/NEWS/2009/NEW01955.html BPA clipping overview

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