WE Workshop

Workshop Safety of BPA based Polycarbonate “Free-Of” Marketing Claims

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September 2015 │ WE, Rome – M. Krieter

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Safety of BPA based Polycarbonate Regulatory Assessment / Update Consumer Exposure Our Position

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BPA – Regulatory Framework Regulation (EU) No. 10/2011

BPA authorized as monomer in plastic materials for food contact applications The use of BPA as a monomer is authorized under the Commission Regulation (EU) No. 10/2011 on plastics materials and articles intended to come into contact with food Current Specific Migration Limit (SML) = 0,6 mg/kg Not to be used for the manufacture of polycarbonate infant feeding bottles

Monomers have to be risk assessed by European Food Safety Authority (EFSA) (sets Tolerable Daily Intake TDI) and authorized by EU Commission (defines a SML) before their use in the manufacture of plastic materials and articles EFSA finalized updated risk assessment and confirms safety of BPA1 EU-COM to define/update risk management measure (SML) – still pending 3

September 2015 │ WE, Rome - Markus Krieter

1: European Food and Safety Agency (EFSA) January 2015; Scientific Opinion on the risks to public health related to presence of Bisphenol A(BPA) in foodstuffs

European Authority Safety Assessment EFSA confirms safety of BPA European Food Safety Authority (EFSA): “No consumer health risk from Bisphenol A exposure from foodstuff”1) (January 2015)

„BPA poses no risk to human health from foodstuff because current levels of exposure are well below the t-TDI of 4 µg/kg of bw/day. This also applies to pregnant women and to the elderly“2)

Further conclusions:2) Aggregated high exposure estimates (dietary and non dietary) is 3-5 times below the t-TDI Remaining uncertainties regarding health effects of BPA* have been quantified and factored into the TDI (*mammary gland, reproductive, metabolic, neurobehavioral and immune systems)

Available data do not provide evidence that BPA results in non-monotonic dose-response relationships (so called „low dose effects“) European Food and Safety Agency (EFSA) January 2015; Scientific Opinion on the risks to public health related to presence of bisphenol A(BPA) in foodstuffs 1): http://www.efsa.europa.eu/en/press/news/150121.htm?wtrl=01 2): http://www.efsa.europa.eu/en/corporate/doc/factsheetbpa150121.pdf 4

September 2015 │ WE, Rome - Markus Krieter

French position In contrast to the global consensus on BPA French ban of BPA in food contact materials in contrast to the most recent global regulatory consensus on BPA. End of 2012, the new French government drove the BPA legislation banning BPA in food contact materials.

French ban in force since January 2015. The same month EFSA confirmed the safety of BPA in its intended uses.

EFSA opinion will be basis for EU COM position and EU risk management.

2015-09-17 French constitutional court identified unjustified restriction of trade with French BPA ban.

The decision abrogates the French ban to manufacture and export BPA based food contact materials Inside France, the existing ban on import and marketing of such materials remains valid

PlasticsEurope will continue its legal proceedings at the French Council of State and at European level to argue that the French law should now be removed in its entirety.

The EU-Commission has opened an investigation procedure regarding a potential infringement proceeding.

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September 2015 │ WE, Rome - Markus Krieter

Consumer Exposure to BPA Based on recent EFSA BPA safety assessment EU authorities safety limits vs. typical exposure Intake above the safety limit* for BPA is clearly impossible Every day during his/her whole life

adult bodyweight

of 60 kg

300 l of water

A person weighing 60 kg would have to drink 300 liters of water from PC bottles, to reach the safety limit* 6

September 2015 │ WE, Rome - Markus Krieter

*according to the final EFSA opinion of 2015-01-21: http://www.efsa.europa.eu/en/efsajournal/pub/3978.htm

Covestro Position about BPA Safety

Covestro is convinced that there is currently no reasonable scientific basis for any health or safety concerns regarding Bisphenol A (BPA) when used as intended.

Covestro takes any concerns about its products very seriously Continuous evaluation of new studies through a team of toxicologists, with special focus on vulnerable human populations We shall react appropriately should any scientific proof of health risks related to BPA or Polycarbonate appear We are committed to Product Stewardship and take over responsibility for health, safety and environmental performance related to our products

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September 2015 │ WE, Rome - Markus Krieter

“Free-Of� Marketing Claims Based on a guideline from Plastics Europe

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“Free-of” Marketing Claims Additional Benefit or Increased Risk?

It may seem like a good idea at first…

Business as usual – we’ve always done it Demonstrates an advantage of one of our products vs. our competitors May be a response to a direct request from a customer Keeping up with competitor marketing/communication

but it never pays off in the long term!

Damages the reputation of the plastics industry and undermines our advocacy efforts & business Suggests that products which contain substance X are dangerous (‘free of’ appears safer) Implies support for unjustified bans or restrictions on chemicals Impossible to guarantee that a product does not contain a single molecule of a specific substance 9

September 2015 │ WE, Rome - Markus Krieter

Free-Of Claims push Chemo Phobia Which Products are next?

“Free-of" marketing can have unintended consequences!

"PVC-free!"

"Flame retardantfree!"

"Paraben-free!"

"BPA-free!"

"Phthalatefree!"

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September 2015 │ WE, Rome - Markus Krieter

„Plastic-free!“

Caution with alternatives !

You might lose more than what you win Performance of alternatives is often unknown "..products made of [alternative product] BPA-free material may not meet the superior quality expectations of [Company]. Based on these findings, we have decided to convert the above product offerings to polycarbonate in order to improve product performance and ensure we continue to serve the market with only the highest quality products."

Polycarbonate contains Bisphenol-A (BPA) however based on numerous scientific studies, use of plastics made with BPA for food contact applications has been and continues to be approved by the U.S. Food and Drug Administration.

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September 2015 │ WE, Rome - Markus Krieter

Key Learnings Using "free-of" marketing claims can be misleading, i.e. wrongly suggesting that a substance is dangerous or even prohibited.

Advertised alternative materials are not always well-known, and can have unexpected performance issues.

“Free-of” claims can be scientifically or technically uncertain.

“Free-of” claims can be in contrast to scientific evidence and regulatory safety assessment of chemicals.

“Free-Of” claims can harm an entire industry and bring further media criticism.

A valid alternative is to focus on the benefits of plastics for key applications.

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September 2015 │ WE, Rome - Markus Krieter

Thank you for your attention

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