Pragmatic risk assessment and mitigation for chemicals of concern in packaging - IoPP.pptx

Pragmatic risk assessment and mitigation for chemicals of concern in packaging - IoPP.pptx

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  Welcome to Today’s Webinar! Thursday, May1, 2025
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  CORPORATE PARTNERS PLATINUM GOLD
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  www.PackagingTechnologyAndResearch .com CREATED FOR: Spring 2025 Chemicals of Concern Pragmatic Risk Assessment and Mitigation for Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand - 3 Chemicals of Concern in Packaging
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  ABOUT PTR Dr. Claire Sandthinks “all packaging all the time” Claire’s enables a more sustainable food system with science & value chain innovations • 35+ years of food packaging experience • Ranks innovative packaging science and value chain solutions to extend shelf life • Generates implementation roadmaps and aligns business cases • IFT Fellow, Riester-Davis-Brody life-time achievement in food packaging award recipient • Doctorate in Food Science and Nutrition at the University of Minnesota • MS and BS in Packaging at Michigan State University Owner Columnist Current Leadership & Editorial Boards Awards Executive Boards Editorial Reviewer National Board Science Foundation Editorial Board Riester-Davis-Brody IFT Food Packaging Lifetime Achievement Award Fellow Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand - 2
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  Let’s Connect! Emily Smith,Project Manager at Civil & Environmental Consultants, Inc • Office: 866.312.2024 x 2620 • Mobile: 508.272.3833 • Email: easmith@cecinc.com Chemicals of Concern • Over 12 years of professional experience in the engineering and consulting industry • Specializes in environmental services including remediation, environmental assessments, and drinking water protection • Extensive experience with emerging contaminants of concerns including • Microplastics • PFAS • High-risk threats to sources of drinking water • BS in Chemical Engineering at the University of New Hampshire ABOUT CIVIL & ENVIRONMENTAL CONSULT ANTS, INC Emily Smith – Project Manager Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand - 5
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  1 Pragmatic risk assessmentand mitigation for CoCs in packaging - by Dr. Claire Sand - 6 3 2 Key Takeaways Why Packaging contains CoCs Why CoCs need to be Addressed Action! How to Mitigate CoCs
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  What are CoCs Pragmaticrisk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand - 7
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  Primary Packaging Secondary &Tertiary Packaging Ingredient Packaging Contamination from Production Environment Why all Packaging may contain CoCs Release Agents Forming Materials Improving Barriers Providing Grease & Oil Resistance For thermoforming, blowmolding plastic, metals, fibers Wetting and leveling agents, emulsifiers, foaming agents, or dispersants Fluorination of PE was approved in 1983 Dry end coatings on paperboard and corrugated, and paper Lower the surface tension Bond with functional groups such as acids and alcohols and/or take part in condensation polymers Prior use in forming of in HPDE, PP, PET blowmolded, thermoformed containers Wet end use on paperboard Polymers fluorinated with hexafluoropropylene (HFP), tetrafluoroethylene (TFE), vinylidene fluoride (VDF) polymers Coatings on hydroscopic polymers such as PLA, cellulose, starch, ethylenes, etc. Packaging for pet food, bakery, FOH fried foods PFAS Example Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand - 8
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  Why all Packagingcontainers may contain CoCs Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand - 9 - Despite Industry’s hard work Regrettable substitutions exist Regulations do not align with science Hodge-podge of legislation  Conflicted experts know that substitutions may be regrettable  This is a costly, and time-consuming game of whack-a-mole  GRAS status is dubious  Harmonious regulatory action is delayed  Reliance on voluntary abandonments Shape-shifting supply chain  Snapshots do not protect  NIAS vs IAS  State by State
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   Industry hasstrict chain of custody for specific applications  More testing of recycled packaging required by Brands  Making recycled content safe allows for more use of recyclate  Concerns  Lack of tight chain of custody does exist ■ Source, processing aids, inks, etc.  Standards do not relate to CoCs and subsequent use ■ Recyclable standards relate to the ability to handle recyclables in sorting systems and in existing machinery  Testing is snapshot of sources and amount of recycled content ■ > than status versus exact amount of recycled content Why Packaging with Recycled Content may contain CoCs Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand - 10
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  Why Packaging thatis Reused may contain CoCs  Industry is making excellent progress in using IoP to track and trace reuseable packaging  Concerns  Reuse approvals relate to actual reuse dynamics (number of washings) vs FDA food type and conditions of use  Reuse may expose layers not intended for direct food or medical contact  Prior use may not be known  Refilling process itself can cause abrasion ■ In reuseable larger PP woven totes Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand - 11
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   Confusion isbeing addressed  As municipalities add infrastructure, the end product of compostable packaging is increasingly distinguished from compost derived from food-scraps  Concerns  Standards for compostability do not define its use as compost ■ Compostable standards define degradation amount ■ Compostable standards do not define the subsequent appropriateness to use with or as food-scrap derived compost ■ Residual CoCs can exist in allowable (in regulations) X size pieces Why Compost from Compostable Packaging may contain CoCs Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand - 12
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  1 Pragmatic risk assessmentand mitigation for CoCs in packaging - by Dr. Claire Sand - 13 3 2 Why Packaging contains CoCs Why CoCs need to be Addressed Action! How to Mitigate CoCs Key Takeaways
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  Why CoCs needto be Addressed Food Brands and packaging suppliers need assurance that their packaging does not harm food, consumers and the environment Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand - 14
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  Financial Impact • Costof a recall • Brand damage • Revenue loss Market Demands • Major retailers requiring assurance • Consumer trust linked to compliance • Competitive advantage through assurance Regulatory Pressure • Increased inspection frequency • Higher penalties for violations • Enhanced traceability requirements Environmental • EPR • Standards define process of disposal not safety Assurance is a "need to do" vs a "nice to do” Why CoCs need to be Addressed Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand - 15
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  1 Pragmatic risk assessmentand mitigation for CoCs in packaging - by Dr. Claire Sand - 16 3 2 Why Packaging contains CoCs Why CoCs need to be Addressed Action! How to Mitigate CoCs Key Takeaways
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  Mitigate - Risk Assessment Define packaging that is high-risk for specific contaminant  Direct food contact  Presence of package protection ■ Grease and oil resistance ■ Products or ingredients that require packaging with high grease or oil protection ■ Value for Oil and grease testing (modified Cobb test)  Use of content with unknown chain of custody ■ Use of recycled or reusable content ■ Package formation-application of release agents during packaging production  Potential for cross-contamination  Environmental contamination and intended Disposal ■ Litter ■ Compostables ■ High Food Waste values PFAS Example Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand - 17
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  Partner Internally andExternally Safe Packaging Value Chain Internal Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand - 18 External Mitigate - Risk Assessment
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  Mitigate - RiskAssessment - Client Work Chemicals of Concern Process 1. Conduct risk assessment on 3 representative companies to identify sources of microplastics and PFAS in food from ingredient and consumer packaging and processing and production 2. Develop alternatives to mitigate microplastics and PFAS from packaging and production equipment so they would not enter into organics stream Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand - 19
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  Mitigate - ClientWork - Risk Assessment Results • Identified >75 sources of microplastics and PFAS from packaging and production equipment • Provided >50 solutions to mitigate microplastics and PFAS from packaging and production equipment • Shared results from representative brands to provide direction for other food processing and packaging operations to identify sources and mitigate microplastics and PFAS from packaging and production equipment Chemicals of Concern Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand - 20
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  Lower Potential Risks PET –polyethylene terephthalate; PE – polyethylene; PP – polypropylene; IBC – Intermediate Bulk Container; PC – polycarbonate Packaging Material Direct Food Contact PFAS Presence Microplastics Presence Litter Potential Potential to Enter Organics Stream Rationale Alternative Lower Risk Packaging Plastic Storage Container (PET, PE or PP) Yes Low Low Low Low Low temperature storage Releasing agents not required Minimal abrasion and limited contact time None recommended IBC (PET Blow Molded) Yes Low Low Low Low Single use Minimal fat resistance required Minimal abrasion Plastic Molding/Transportation Tray (PC) Yes Low Low Low Low PC is a rigid plastic High chemical resistance No releasing agents required Glass Jar Yes Low Low Low Low No releasing agent required Minimal plastic coating Plastic Tray (PET) Yes Low Low Low Low PET is not brittle High chemical resistance Jute Sack (Fiber) Yes Low None Low Low No oil or grease resistance Material does not contain plastic PFAS & Microplastics Example
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  Lower Potential Risks Packaging Material DirectFood Contact PFAS Presence Microplastics Presence Litter Potential Potential to Enter Organics Stream Rationale Alternative Lower Risk Packaging Coated Deli Paper (thin waxed paper) Yes Low Low High High Poor moisture barrier indicating absence of PFAS and plastic None recommended Production Bleached Recycled Content Paper No Medium Low High High Uncoated recycled paper content Consumer handling Non-recycled paper content Uncoated Presentation Paper Yes Low Low High High Uncoated packaging material None recommended PFAS & Microplastics Example
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  Increased Potential Risks PLA –polylactic acid; PET – polyethylene terephthalate Packaging Material Direct Food Contact PFAS Presence Microplastics Presence Litter Potential Potential to Enter Organics Stream Rationale Alternative Lower Risk Packaging Corrugated with Recycled Paperboard Yes Medium-High Low Low High Grease resistance Recycled content Minimal use of plastic coating Virgin paperboard; plastic free coated materials; reusable plastic/metal containers Coated Paper Cups Yes Low High High High No recycled paper content High oil and water resistance Potential plastic coating Paper coating easily removable More resistant plastic or metalized liner; plastic- free coating Recycled Content Kraft Paper Bag (PLA Composite) Yes Low Medium High High Uncoated packaging materials Certain conditions could potentially release microplastics Single-layer resistant polymer PFAS & Microplastics Example
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  PET – polyethyleneterephthalate; PE – polyethylene; PP – polypropylene; PLA – polylactic acid; LLDPE – linear low-density polyethylene Increased Potential Risks Packaging Material Direct Food Contact PFAS Presence Microplastics Presence Litter Potential Potential to Enter Organics Stream Rationale Alternative Lower Risk Packaging Plastic Lined Bag/Pouch (PET/LLDPE) Yes Low Medium High Low No releasing agents required; LLDPE is a soft polymer; Abrasion can generate microplastics More rigid food contact layer Bubble Wrap (PE/PP) No Low Low-Medium High Low No releasing agents required; Punctured bubbles can generate microplastics Integrate added cushioning into box design Multilayer Plastic Bag Yes Low Low-Medium Medium Medium No oil or grease resistance; Small filling operation; Limited contact time; Abrasion can occur during transport of product More rigid polymer; metalized film Food Scrap Liner (PLA and additives) Yes Low High Low High No recycled paper content; Certain conditions could potentially release microplastics No use of compost bags PFAS & Microplastics Example
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  Mitigate - DefineLevel of Protection needed 25 Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand -
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  Mitigate - EssentialProtection Chemicals of Concern • Experts conduct detailed collection and analysis, including identifying critical gaps and potential risks that basic attestations might miss, providing with a clear picture • Details include: • Multi-jurisdictional regulatory compliance (Including as the Coalition of Northeastern Governors (CONEG) Model Legislation for Packaging and Printing Materials, California Proposition 65, US Toxic Substances Control Act (TSCA) • Packaging allergen identification and risk assessment • FDA approval verification for specific food types and use conditions • Complete processing aid analysis (coatings, inks, adhesives) • Conduct a deep analysis of supplier attestations on Chemicals of Concern (COCs) • Define testing needs ESSENTIAL PROTECTION DELIVERABLE Certification within your existing internal tracking system for package material attestations, food-type authorizations for condition of use, and CoC identification 26 Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand -
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  Mitigate - Enhanced Protection Chemicalsof Concern ENHANCED PROTECTION DELIVERABLE: Documented certification within existing internal tracking system on test results and analysis for specified conditions of use and food types 27 Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand - • Coordinate conducting FDA-compliant testing protocols on select critical packaging components, providing scientific validation of safety and compliance for your specific food applications/intended use • The process includes: • Strategic test planning and execution to minimize costs • Multi-jurisdictional compliance verification (CONEG, Prop 65, TSCA) • Food-type specific FDA compliance validation • Processing aid safety assessment
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  Mitigate - ProactiveProtection Chemicals of Concern COMPLETE PROTECTION DELIVERABLE Documented certification within existing internal tracking system for strategic risk management of current known use of CoCs 28 Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand - • FDA or other governing bodies direction on COCs and SOIs and their safety is not a one-time assessment • Proactive monitoring of these pending FDA and other (state) regulations, changes in legislation, and consumer lawsuits requires companies to view food safety compliance as an ongoing procedure • This proactive approach allows you to ensure packaging aligns with the latest standards and address emerging threats before they escalate, safeguarding your brand reputation and minimizing your potential risks • Forward-looking CoC screening • Pending restriction analysis • Consumer litigation risk assessment • Competitive landscape evaluation • Legislative tracking and impact analysis
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  SITUATION $22 billion dollarBrand was exposed to lawsuits and lacked confidence in packaging SOLUTION 1. Developed a multi-phase Package Stewardship Assurance Process 2. Engaged with packaging suppliers and brokers to gain specific information on:  Food type and conditions of use for all packaging  Substances of interest  Allergens  Processing aid chemicals used in manufacturing and converting packaging materials 3. Defined required migration testing and reviewed results 4. Certified packaging after consideration of supplier letters of attestation, statements of compliance, and testing in a final review Client Work | Package Stewardship Assurance PTR CASE STUDIES Minimized internal workload by 20-75 hours per package component Coordinated efforts with 30+ existing packaging suppliers Issued Package Issued Stewardship Assurances for 1000+ packaging components RESULTS Chemicals of Concern Material Science Migration Complexities Global Food Company 29 Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand -
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  PTR CASE STUDIES NonprofitEnvironmental Advocacy SITUATION Client needed intelligence on what chemicals to prioritize for action from 600+ Intentionally (and Non- Intentionally) Added Substances (IAS & NIAS) used as Food Contact Chemicals (FCC) / in Food Contact Material (FCM) SOLUTION 1. Identified CoCs currently used for 20 direct food contact packaging materials via an industry survey 2. Defined 608 NAIS & IAS within food contact packaging materials Learn more about this project from a public article from Food Safety Magazine Client Work | Food Contact Materials Material Science Migration Complexities Output used in the development of the first-ever, free, and comprehensive tool for making food contact safety-based purchasing decisions for these products based on the latest available science: Understanding Packaging (UP) Scorecard RESULTS Chemicals of Concern 30 Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand -
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  Client Work |Migration from Packaging PTR CASE STUDIES European packaging company SITUATION Novel materials – Ovenable bags and CO2 emitting coolers - required legal food contact assessment and approval for North American market SOLUTION • Defined required testing need for USA and Canada • PTR reviewed data to determine if materials were in compliance • Assessed value chain for risk and means to mitigate risk ✔ Scientific assurance of material offering compliance ✔ Science-based risk mitigation methods RESULTS Process & Package Interactions Migration Complexities Chemicals of Concern 31 ClairPeraSgamnadtic risk a s s e s s m6e1 2n. 8t0a7n. 5d3 4m1 itigactlaioirne@fopracCkoaCgisngintecphancokloaggyianngdr-esbeyarDcrh..cColmaire SPaancdk a
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  ● Clear rationalefor 1 scenario/approach ● 5 Specific package design factors to employ to align with regulations ● 10+ Specific regulations that apply to the package ● 3 Ideas for new packages from this platform RESULTS Client Work | Food Safety and Packaging Regulations PTR CASE STUDIES European packaging company SITUATION Entry into USA market presented unknown regulatory and food safety hurdles SOLUTION • PTR provided clear direction on 2 scenarios/approach of delivery • PTR recommended package design changes for compliance Material Science Migration Complexities Chemicals of Concern 32 ClairPeraSgamnadtic risk a s s e s s m6e1 2n. 8t0a7n. 5d3 4m1 itigactlaioirne@fopracCkoaCgisngintecphancokloaggyianngdr-esbeyarDcrh..cColmaire SPaancdk a
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  1 Pragmatic risk assessmentand mitigation for CoCs in packaging - by Dr. Claire Sand - 33 3 2 Why Packaging contains CoCs Why CoCs need to be Addressed Action! How to Mitigate CoCs Key Takeaways
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  Dr. Claire Sand Founder& Owner Thank you Reach out to connect for a virtual coffee Pragmatic risk assessment and mitigation for CoCs in packaging - by Dr. Claire Sand - 34