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Updates on Global PET Regulations

ILSI Conference on Role of Packaging in Ensuring Food Security and SafetyKevin C. Kenny, J.D., LL.M., Chief Operating Officer, Decernis LLC

28 Feb 2017

European UnionRegulation (EU) 10/2011 Plastics Regulation (as amended)

ILSI Conference 28 Feb 2017

Major Country PET Regulation

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Monomers commonly used in making PET and copolyesters for food packagingMONOMER SML COMMENTTerephthalic acid (TPA) 7.5 mg/kg SML(T)Terephthalic acid, dimethyl ester (DMT) No SMLIsophthalic acid 5mg/kg SML(T)Isophthalic acid, dimethyl ester 0.05 mg/kg

Ethylene glycol (EG) 30 mg/kgSML(T); Alone or with diethylene glycol or stearic acid esters of ethylene glycol

Diethylene glycol (DEG) 30 mg/kgSML(T); Alone or with ethylene glycol or stearic acid esters of ethylene glycol

1,4‐Bis(hydroxymethyl)cyclohexane No SML

USA21 CFR 177.1630 Polyethylenephthalate polymers

and/or Food Contact Notifications (FCNs)

ILSI Conference 28 Feb 2017 3



MERCOSUR

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Status Substrate Restrictions GMC/RES Nº Title (Spanish)Positive List Monomers and Polymers 2/12

Reglamento técnico: Lista positiva de monómeros, otras sustancias de partida y polímeros autorizados para ... contacto con alimentos

2016 REVIEW Positive List of Additives 32/07

Lista positiva de aditivos para materiales plásticos ... en contacto con alimentos

General Requirements 56/92 Disposiciones generales (plasticos)

Migration Methods 32/10Reglamento técnico: Migración en materiales, envases y equipamientos plásticos destinados a estar en contacto con alimentos

Colorant and Pigment Additives 15/10

Reglamento técnico: Colorantes en envases y equipamientos plásticos destinados a estar en contacto con alimentos

Polymeric and Resinous Coatings 55/99

Reglamento técnico: Preparados formadores de película a base de polímeros y/o resinas destinados a recubrir alimentos

Fluorinated PE 56/98 Reglamento técnico: Polietileno flouradoRefillable PET Packages for Carbonated Non‐Alcoholic Beverages 16/93 Envases plásticos retornables (bebidas analcoholicas carbonatadas)Multilayer PET Packages Containing Recycled Material for Carbonated Non‐Alcoholic Beverages 25/99 Reglamento técnico: PET multicapa (único uso)Recycled PET for Food Packages (Mono/Multi) 30/07

Envases de Polietilentereftalato (PET) Postconsumo Reciclado Grado Alimentario (PET‐PCR Grado Alimentario)

Plastics

Japan

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Decernis has compiled a list of Associations with Voluntary Negative or Positive Lists:

Association Scope Established FormatJapan Hygienic PVC Association PVC 1967 Positive ListJapan Hygienic Association of Vinylidene Chloride

PVdC 1977 Positive List

Japan Hygienic Olefin and Styrene Plastics Association (JHOSPA)

PE, PP, PS, PC, PET, PBT, etc. 1973 Positive List

Japan Printing Ink Makers Association Inks 1952 Negative ListJapan Petrolatum Wax Industry Association Waxes 1974 Positive ListJapan Adhesive Industry Association Adhesives 1966 Negative ListJapan Rubber Manufacturers Association Rubbers 1950 Positive ListJapan Paper Association (JPA) Paper 1950 Negative List

Positive List (DRAFT)


30 Basic Polymers Covered by JHOSPA 1. Polyethylene （PE） 16. Polyacrylonitrile （PAN）2. Polypropylene（PP） 17. Fluorocarbon resins （FR）3. Polystyrene （PS） 18. Polybutylene-terephthalate （PBT）

4. AS resin （AS）19. Methylmethacrylate-Styrene Resin (MS

5. ABS resin （ABS） 20. Polyarylsulfone （PASF）6. Polymethylmethacrylate（PMMA） 21. Polyarylate （PAR）7. Polymethylpentene（PMP） 22. Polyhydroxybenzoic-acid （HBP）8. Butadiene resin （BDR） 23. Polyetherimide （PEI）

9. Nylon（PA）24. Polycyclohexylene-di-methylene-

terephthalate (PCT）10. Polybutene-1 （PB－1） 25. Polyethylene-naphthalate （PEN）

11. Polyethylene-terephthalate (PET) 26. Polyester-carbonate （PPC）

12. Polycarbonate （PC）27. Ethylene-tetracyclododecene copolymer

(E/TD）13. Polyvinylalcohol （PVA） 28. Polylactic-acid （PLA）14. Polyacetal （POM） 29. Polybutylenesuccinate （PBS）

15. Polyphenylene-ether （PPE）30. Ethylene-2-norbornene copolymer (E/NB)

JapanMajor Country PET Regulation


Countries Permitting PET (Positive List or Incorporation by Reference)

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COUNTRY INCORPORATES1 Albania2 Algeria3 Argentina Mercosur4 Armenia Eurasian Economic Union5 Aruba (Netherlands) European Union

6 Australia European Union/United States7 Austria European Union8 Azores (Portugal) European Union9 Bahrain GCC/GSO 10 Belarus Eurasian Economic Union11 Belgium European Union

12 Bermuda European Union/United States13 Bolivia Mercosur14 Bosnia‐Herzegovina15 Brazil Mercosur16 British Virgin Islands (UK) European Union17 Bulgaria European Union18 Canada19 China20 Colombia21 Croatia European Union22 Cyprus European Union23 Czech Republic European Union24 Denmark European Union25 Dominican Republic

COUNTRY INCORPORATES26 Ecuador27 Egypt28 Estonia European Union29 Fiji30 Finland European Union31 France European Union32 French Guiana (France) European Union33 French Polynesia (France) European Union34 Germany European Union35 Greece European Union36 Grenada37 Guadeloupe (France) European Union38 Guam United States39 Guatemala

40 Guyana European Union/United States41 Hong Kong42 Hungary European Union43 Iceland44 India45 Indonesia46 Iran47 Ireland European Union48 Israel49 Italy European Union50 Japan


Countries Permitting PET (Direct or Incorporation)

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COUNTRY INCORPORATES51 Kazakhstan Eurasian Economic Union52 Korea53 Kuwait GCC/GSO 54 Kyrgyzstan Eurasian Economic Union55 Latvia European Union56 Lithuania European Union57 Luxembourg European Union58 Madeira (Portugal) European Union59 Malaysia60 Malta European Union61 Marshall Islands United States62 Martinique (France) European Union63 Mayotte (France) European Union64 Mexico United States65 Netherlands European Union66 New Caledonia (France) European Union67 New Zealand European Union/United States68 Norway69 Oman GCC/GSO 70 Palestine71 Paraguay Mercosur72 Peru73 Philippines Japan/United States74 Poland European Union75 Portugal European Union76 Puerto Rico United States

COUNTRY INCORPORATES77 Qatar GCC/GSO 78 Réunion (France) European Union79 Romania European Union80 Russia Eurasian Economic Union81 Russia82 Saint Lucia United States83 Saint Martin (France) European Union84 Saudi Arabia GCC/GSO 85 Seychelles86 Slovakia European Union87 Slovenia European Union88 South Africa European Union/United States89 Spain European Union90 Sri Lanka91 Sweden European Union92 Switzerland93 Taiwan94 Thailand95 Turkey96 United Arab Emirates GCC/GSO 97 United Kingdom European Union98 United States99 Uruguay Mercosur100 US Virgin Islands United States101 Venezuela Mercosur102 Yemen GCC/GSO

• A handful of studies and articles have purported to identify potential safety issues. However:

• BPA is not used• PET neither contains nor needs phthalates of any kind.

• Despite the name, there are terephthalates and isophthalates in PET but they are not endocrine disruptors. In particular, PET does not contain diethylthexyl phthalate (DEHP), which is mainly used as a plasticiser for PVC

• Endocrine Disrupting Chemicals (EDCs) are neither used nor generated by PET containers.

• Even for high temperature studies, Antimony migrates at amounts below the tolerable daily intake level established by WHO/USA/EPA:

• WHO 20 μg/l 20 ppb Guideline value 0.02 mg/l• USEPA 6 µg/l Maximum contaminant level (MCL) of 6 ppb.• EU 5 µg/l Parametric value

• Not one Country or International Regulatory Body has tightened legislation on PET because of these studies.


Situation Stable:PET Contains No Hazardous Substances

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Paracelsus(1493-1541)

“All substances are poisons; there is none which is not a poison. The right dose differentiates a poison from a remedy.”

– Any substance, naturally occurring or man-made, is likely to produce some form(s) of harmful effect, if taken in sufficient quantity.


Dose-Response

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• PET is 100% Recyclable• In most countries PET bottles are approved for continual reuse.• Regulations in 70+ Countries also permit or require PET Recycling

and Post-consumer polyethylene terephthalate (PET) products• A few countries do not permit recycled PET in Food Contact or

Pharmaceutical Applications• Post-consumer polyethylene terephthalate (PET) Applications:

• Adhesives, Automotive Products, Clothing Products, Fabrics and Fibers, Coating Products, Construction Products, Fuel Products, Low-Molecular Weight Intermediate Products, Mattresses, Medical and Pharmaceutical Products, Plastic Blends and Composites, Printing Paper, Rubber Products, Thermoset and Thermoplastic Polyester Resins, Wind Turbines


PET Recycling

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INDIA• Plastic Waste Management Rules, 2016 • IS 14535: 1998 Guidelines for Recycled plastics • IS 14535: 1998: Indian Standard for Recycled plastics for the

manufacturing of products – DesignationUSA• US FDA Guidance for Industry: Use of Recycled Plastics in

Food Packaging: Chemistry Considerations (Aug 2006).


Recycling PET:Key Country Legislation & Guidance

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EUROPEAN UNION• Regulation (EC) No 282/2008 (Consolidated-2015-10-26):

Recycled plastic materials and articles intended to come into contact with foods

JAPAN• Container and Packaging Recycling Law 1995 (Consolidated-

2006-06-15):


Recycling PET:Key Country Legislation & Guidance

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Recycling PET:Country Legislation & Recycling Rates

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COUNTRYPET Bottle

Recycling Rate1 Argentina 30%2 Aruba (Netherlands) 59%3 Australia (deposit) 30%4 Austria (deposit) 70%5 Azores (Portugal)6 Bahrain 10%7 Belgium 81%8 Beliz9 Bolivia10 Brazil 52%11 British Virgin Islands (UK) 59%12 Bulgaria 59%13 Canada (deposit) 70%14 China 90%15 Colombia16 Costa Rica17 Croatia (deposit) 59%18 Cyprus 56%19 Czech Republic 70%20 Denmark (deposit) 59%21 Dominican Republic22 Ecuador (deposit) 112%23 Egypt 20%24 Estonia (deposit) 59%25 Faroe Islands (deposit)26 Fiji (deposit)

COUNTRYPET Bottle

Recycling Rate27 Finland (deposit) 59%28 France 67%29 French Guiana (France)30 French Polynesia (France)31 Germany (Deposit) 94%32 Greece 59%33 Guadeloupe (France)34 Hong Kong 30%35 Hungary 50%36 Iceland 42%37 India 80%38 Ireland 71%39 Israel (deposit) 61%40 Italy 58%41 Japan 72%42 Korea 49%43 Kuwait 10%44 Latvia 59%45 Lithuania (deposit) 59%46 Luxembourg 59%47 Madeira (Portugal)48 Malaysia 13%49 Malta 38%50 Martinique (France)51 Mayotte (France)52 Mexico (Voluntary) 35%

COUNTRYPET Bottle

Recycling Rate53 Netherlands (deposit) 71%54 New Caledonia (France)55 Norway (deposit) 83%56 Oman 10%57 Paraguay58 Poland 59%59 Portugal 59%60 Qatar 10%61 Réunion (France)62 Romania 59%63 Saint Martin (France)64 Saudi Arabia 10%65 Singapore 60%66 Slovakia 59%67 Slovenia 69%68 South Africa (Voluntary) 45%69 Spain 71%70 Sweden (Deposit) 85%71 Switzerland 81%72 Taiwan 73%73 Thailand 29%74 United Arab Emirates 10%75 United Kingdom 61%

76 United States (some deposit) 30%77 Uruguay

78 Venezuela 7%

79 Yemen 0%

• PET is most recycled plastic globally – 100% recyclable• Growing use of PET• Globally PET recycling doubling every 2-3 years• Capacity in some countries (US, China) growing faster than

collection rates.• Deposit/Return systems = 2.5 times more collection.


PET Recycling: Trends

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Extended Producer Responsibility – Now 46 Countries

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• Designed to promote the integration of environmental costs associated with goods throughout their life cycles into the market price of the products.

• EPR uses financial incentives to encourage manufacturers to design environmentally friendly products by holding producers responsible for the costs of managing their products at end of life.

Thank you!Special thanks to Forrest Bayer and Rich Lenoir for their inputs!

Kevin C. Kenny, J.D., LL.M.Chief Operating OfficerDecernis LL.C.1250 Connecticut Avenue NW, #200Washington, D.C. 20036E-Mail: [email protected]

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