H.B. Fuller on Food Safety May 6 2014

1. Ensuring Food Safety How to assess adhesives used in food contact packaging? May 6, 2014 Alexandra Ross Elizabeth Staab

3. ©2014 H.B. Fuller Company Agenda 3 1. Megatrends influence Packaging 1. Megatrends influence Packaging 2. Monitoring the Risk from Packaging Adhesives 3. Adhesive Assessment for Final Food Contact Application 4. Questions & Answers

8. Monitoring the Risk from Packaging Adhesives 8

9. ©2014 H.B. Fuller Company Food Contact Regulation & Control 9 Migration Monitoring & Control Kind and amount of substances Packaging Construction Barrier of the packaging Surface / Volume Ratio Contact time and Temperature Type of food

10. ©2014 H.B. Fuller Company Food Contact Regulation & Control 10 Migratio n Monitoring & Control Kind and amount of substances Packaging Construction Barrier of the packaging Surface / Volume Ratio Contact time and Temperature Type of food

11. ©2014 H.B. Fuller Company What is the Risk of Adhesives? 11 Possible migration into food should not endanger human health (Article 3, Regulation (EC) No 1935/2004) Hazard: Toxicity Exposure: Effective amount Risk = Hazard x Exposure

14. ©2014 H.B. Fuller Company Raw Material Data Gathering 14 Requested Information from RM Supplier 1.Date 2. Identification of Raw Material Supplier 3. Chemical Identification 4. Compliance Status 5. Compliance with Rejection List FEICA Source: FEICA Food Contact Guidance

15. Compliance Status 15 Information in the Supply Chain a. Regulation (EU) No 1935/2004 Traceability & Article 3 b. Regulation (EC) No 2023/2006 GMP c. Regulation (EU) No 10/2011 (Plastics Regulation): Substances on Union List Non-authorized substances Dual use additives d. Other: EU Member States Legislations or Recommendations e. Non-EU Legislations: FDA Sections (e.g. 175.105, 175.300, 176.170, 176.180, etc..) ©2014 H.B. Fuller Company

16. Rejection List FEICA 16 Examples of Rejected Substances Substances classified as CMR Regulation (EC) No 1272/2008 Substances containing heavy metals > 100 ppm Council Directive 94/62/EC Phthalates According to Annex XVII of Regulation (EC) No 1907/2006 Epoxy Derivatives Regulation (EC) No 1895/2005 Substances that deplete the ozone layer Regulation (EC) No 1005/2009 Dimethylfumarate Regulation (EU) No 412/2012 PBB & PBDE Directive 2011/65/EU (ROHS) ©2014 H.B. Fuller Company

18. ©2014 H.B. Fuller Company Toolbox for Raw Material Evaluation 18 Food Contact Status Declaration Adequate information Comp. A Comp. B Comp. C Comp. D Comp. E Comp. F Plastics Regulation (EU) No 10/2011 BfR Recommendation (e.g. XIV, XXV) FDA 175.105

19. ©2014 H.B. Fuller Company Food Contact Status Declaration by Adhesive Supplier 19 Adhesive Supplier Information Product Information Product Compliance Adhesive Supplier Recommendations Assessment of Suitability by DU Source: FEICA Food Contact Guidance

20. Adhesive Assessment for Final Food Contact Application 20

21. ©2014 H.B. Fuller Company Adhesive Evaluation by Downstream User 21 Source: FEICA Food Contact Guidance Evaluation of Packaging Evaluation of Migration Potential Migration Modeling / Test Worst-Case Approach

23. ©2014 H.B. Fuller Company Barrier Properties of Packaging Materials 23 Functional Barrier (Definition according to Regulation (EU) No 10/2011): A barrier consisting of one or more layers of any type of material which ensures that the final material or article complies with Article 3 of Regulation (EC) No 1935/2004 and with the provisions of this Regulation. Barrier against permeation of: Oxygen Water vapor Carbon dioxyde Nitrogen Acting as a barrier against migration of substances (functional barrier)

24. ©2014 H.B. Fuller Company Barrier and Migration Risks 24 BARRIER+ - EVOH – Laminates PET PVDC / PVC PA PE Corrugated Board Carton Paper Barrier Properties of Packaging Materials Could represent an absolute barrierGLASS, METAL, ALUFILM

26. ©2014 H.B. Fuller Company Typical Adhesive Applications 26 Application Adhesive Barrier Migration Risk Corrugated Hotmelt Water-based - Low, secondary packaging Carton Folding Box Hotmelt Water-based - Low Flexible packaging Laminated films Isocyanate-based +/- Medium Bottle-Labeling Water-based Hotmelt + Very low

27. ©2014 H.B. Fuller Company 32 cm 22 cm Calculation Example 1 – Snack Food 27 • Structure of laminate: OPP printed / met. OPP • Food: 150 g (dry) • Adhesive: Reactive, solventless; 0,28 g per bag Package • Identity: PM-Ref: 68320 • SML= 6 mg/kg Stabilizer A • 1 kg food = 6,66 bags • 0,28 g adhesive x 6,66 = 1,866 g / kg food • Stabilizer A = 0,00186 g / kg food Calculation • 1,86 mg is far below SML of 6 mg / kg • Calculation means 100% migrates • Assumed, no barrier in place Results

28. ©2014 H.B. Fuller Company Calculation Example 2 – Cereals 28 • Packaging: Carton & Inliner • Food: 375 g (dry) • Adhesive: Hotmelt; 1 g / box Package • Identity: PM-Ref: 93120 • SML(T) = 5 mg / kg Stabilizer B • 1 kg Cereals = 2,66 boxes • Adhesive = 2,66 g / kg food • Stabilizer B = 0,00266 g / kg food Calculation • 2,6 mg is far below SML of 5 mg / kg • Calculation means 100% migrates • Assumed, no barrier in place Results

29. ©2014 H.B. Fuller Company Key Learnings 29 RM • Evaluation of Raw Materials Used Barrier • Barrier Properties of Packaging Material Adhesive • Evaluation of Adhesive by Manufacturer & Downstream User Test • Migration Test if Required

30. This presentation is for informational purposes only and does not constitute an offer by H.B. Fuller to sell or a warranty of any kind. Thank you hbfuller.con/packaging-solutions