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Risk Assessment of Food Packaging Materials_2012

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  • 1. Risk Assessment of FoodRisk Assessment of Foodpackaging and Contact Materialspackaging and Contact Materialspackaging and Contact Materialspackaging and Contact Materials6th Asian Conference on Food and Nutrition Safety6th Asian Conference on Food and Nutrition SafetySingapore November 26thSingapore November 26th--28th, 201228th, 2012Dr. Forrest BayerFellow Packaging, Scientific andRegulatory Affairs
  • 2. Today’s TopicsToday’s TopicsReason for PackagingPackaging MigrationPackaging Types and MaterialsPackaging Materials Risk AssessmentThe Threshold of Toxicological ConcernThe Threshold of Toxicological ConcernThe Threshold of RegulationPackaging migrant issue - Bis-Phenol A
  • 3. Packaging DeliversSafe and Quality FoodExtends the shelf life of food productsPreserves the compositional integrity of foodPrevents microbial contaminationOffers physical protection during food handling andstorageWithout packaging we would loose a tremendous amountWithout packaging we would loose a tremendous amountof our food do to spoilageMeets consumer’s convenience requirementsProvides a tool to communicate with consumersNutrition informationCustomer engagement toolPromotion display
  • 4. FoodFoodPolymerPolymerPaper&BoardPaper&BoardPackage MigrationNo material is inert. When a material is put incontact with a foodstuffs, there is always arelease of substances from the material into thefoodstuffs.DP&BCt=0DPCF,t??????Kair/P&B KP&B/P KF/airKP/F
  • 5. Migration FactorsThis release will depend on:a) Type of material• Diffusion coefficients• Molecular weight of migrantsb) Type of foodstuffsb) Type of foodstuffs• Partition factorsc) Contact conditions-continuous or discontinuous-time-temperature
  • 6. Food Packaging MigrantsThe presence of trace packaging migrants in a food doesnot automatically imply that the food is unsafeMigration is taken into account by regulators whenapproving new food contact substancesToxicology studies are required by regulators prior toapproval of a new food contact substanceThe toxicological testing required incorporates the level ofmigration / dietary exposure from the food contactsubstance
  • 7. Risk Perception of FC MaterialsRisk perception for food contact materials maydiffer from scientific realityPress releases and media headlines may helpcreate a perceived riskSocial and cultural factors can outweigh thescientific evidencescientific evidenceAs analytical techniques improve, ultra-trace levelsof food contact substances are being detected andpresented sometimes out of contextLower consumer trust overall in science, industryand regulatorsOpportunities exist for proactive communicationand education programs
  • 8. Packaging Types and MaterialsPackaging Types and Materials
  • 9. Package TypesRigid and Flexible Plastics 38%Metal Containers 19%Glass 8%Paper/Paper Board 30%Other 5%Other 5%FilmBlisterSource: Pira International 2008
  • 10. Typical Polymeric Packaging MaterialsPolyolefinsPPHDPELDPELLDPEPETPETStyrenePVCNylonEVAABSPU
  • 11. Typical Additives to Polymeric PackagingAntioxidantsAnti-staticsAntifogging agentsAnti blocksPlasticizersPlasticizersSlip agentsThermal stabilizersLight (UV) stabilizersColorantsCarriers
  • 12. Packaging MigrantsPackaging Migrants
  • 13. Packaging MigrantsMonomersOligomersDecomposition ProductsThermalOxidativeOxidativePhotochemicalIonizableSolventsReaction ProductsImpurities (non-intentionally added substances(NIAS))
  • 14. RegulationRegulationof Food Contact Materials
  • 15. Regulatory ApproachesGeneral safety requirements – common to everycountryGeneral safety only – Mexico, some Asian and SouthAmerican countries, South AfricaMandatory positive lists – EU, MERCOSURMandatory positive lists – EU, MERCOSURVoluntary positive lists – Japan, GermanyNo objection or opinion letters –Canada, U.S. (forrecycled plastics)Combination approach – U.S.Pre-market registration – Argentina, Brazil, someEastern European countries
  • 16. Principal of “inertness” of the material and“purity” of the foodstuffs:Migration of substances shall notendanger human healthMigration cannot bring anGENERAL RULESAPPLICABLE TO ALL MATERIALSMigration cannot bring anunacceptable change in thecomposition of foodstuffsMigration cannot deteriorate theorganoleptic characteristics offoodstuffs
  • 17. US FoodContact RegulationsReflects an approach based on exposureassessmentVarious options exist to obtain authorizationThe Food Contact Notification program isbeneficial for both the FDA and industry – efficient,beneficial for both the FDA and industry – efficient,proprietary and it works‘Threshold of Regulation’ and ‘No Migration’principles are very useful in determining regulatorycompliance of substances with little or no migrationFood Additive Master File
  • 18. EuropeanFood Contact RegulationsIncomplete harmonization of regulationsPositive lists only exist for plastics, regeneratedcellulose and ceramicsHarmonization of plastics regulations is completeOther substances like paper, colorants andcoatings are regulated at member state levelcoatings are regulated at member state levelMaterials like printing inks and adhesives are notcovered by specific regulationsMutual recognition exists in principle, butinterpretation can be challengingAuthorization process for a new food contactsubstance can take 2-3 years
  • 19. MERCOSURFood Contact RegulationsBrazil, Argentina, Paraguay, UruguayPlastics are regulated through a combined approach of theFDA and EUPositive list of monomers is controlled through SMLs (similarto EU) and a partial positive list of additives is controlledto EU) and a partial positive list of additives is controlledthrough maximum use rates (similar to FDA)Resolutions exist for regenerated cellulose, plastics andpaper.Pre-registration requirements exist in some of the countries
  • 20. Asia/RussiaFood Contact RegulationsA very active region for rapidly evolving food contactregulationsChallenge for global companies is to monitor and ensurecompliance with the emerging regulationsChina’s food contact regulations are rapidly developing:China’s food contact regulations are rapidly developing:(updating GB-9685-2008, Hygienic Standard forAdjuvants and Processing Aids in Food Containers andPacking Materials). This went into effect June 2009.India is developing new food contact regulationsRussia is developing new food contact regulations
  • 21. JAPANTwo governing regulations governed byMinistry of Heath, Labor and Welfare (MHLW) &Industrial hygienic AssociationsFood Sanitation Law (1947)Food Safety Basic Law (2003)Article 4 DefinitionsArticle 4 DefinitionsUtensilsContainers/PackagesSpecifications by material15 polymer materials have “end usespecifications”Does not include a list of permitted additives
  • 22. JapanIndustrial Hygienic AssociationsIndustry groups (Hygienic Associations) haveestablished voluntary standards for variouspolymers & additivesJapan Hygienic Olefin and Styrene PlasticsAssociation (JHOSPA)Positive lists include permitted monomers, endPositive lists include permitted monomers, endtests and list of acceptable additives800 members: Resin & additive Mfgs, fabricators,converters, distributors and food companiesSet Voluntary Standards, certifications,registrationsConduct research & communicate withregulatory authorities
  • 23. Types ofTypes ofRegulatory Data Requirementsfor Approval
  • 24. Data Provided for Safety EvaluationChemistry data – for confirming identity of afood contact substance and for assessingpotential consumer exposure to the substanceand its impuritiesToxicology data – for use as basis forToxicology data – for use as basis forestablishing a safe level of consumer exposureto the substance and its impurities(Chemistry and toxicology data should be on substancesexpected to migrate to food under the intendedconditions of uses)Environment data – for consideration ofimpact on human environment25
  • 25. Chemistry InformationIdentityManufacturing processSpecificationsIntended use and technical effectIntended use and technical effectStabilityMigrationExposure assessment26
  • 26. Migration TestingMigration Testing
  • 27. 3% (w/v) acetic in aqueous solution10% (v/v) ethanol in aqueous solution50% (v/v) ethanol in aqueous solutionGENERAL FOOD SIMULANTSFor Migration TestingRectified olive oilHB 307Sunflower oilOther fatty food simulantsDetails in Chemistry Guidance:http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm081818.htm
  • 28. CONDITIONS OF CONTACT INACTUAL USETEST CONDITIONSContact Time Test Timet ≤≤≤≤ 0.5 hours0.5 h < t ≤≤≤≤ 1 hour1.0 h < t≤≤≤≤ 2 hours2.0 h < t ≤≤≤≤ 24 hourst > 24 hours0.5 hours1 hour2 hours24 hours10-30 daysContact Temperature Test TemperatureMIGRATION TESTING CONDITIONSt > 24 hours 10-30 daysContact Temperature Test TemperatureT ≤≤≤≤ 5°°°° C5°°°°C < T ≤≤≤≤ 20°°°° C20°°°°C < T ≤≤≤≤ 40°°°° C40°°°°C < T ≤≤≤≤ 70°°°° C70°°°°C < T ≤≤≤≤ 100°°°°C100°°°°C < T ≤≤≤≤ 121°°°°C121°°°°C < T ≤≤≤≤ 130°°°°C130°°°°C < T ≤≤≤≤ 150°°°°CT > 150°°°°C5°°°°C20°°°°C40°°°°C70°°°°C100°°°°C or reflux temperature121°°°°C*130°°°°C*150°°°°C**175°°°°C*** Use simulant C at reflux temperature** Use simulant D at 150°°°°C or 175°°°°C, in addition to simulants A, B & Cused as appropriate at 100°°°°C or at reflux temperature
  • 29. TOXICOLOGICAL TESTREQUIREMENTSREQUIREMENTS
  • 30. Toxicology Data RecommendationsToxicology data is needed for establishing a safelevel of consumer exposure to an FCSThe greater the expected exposure, the moretoxicity information required to support safetyExposure-driven tiered approach recommendedby FDA for safety testingby FDA for safety testingToxicology guideline is available on FDA’swebsite:http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm081825.htm31
  • 31. US FDA Toxicology Data Recommendations< 0.5 PPB dietary exposureNo testing neededPotential carcinogenicity should be discussed0.5 - 50 PPB Two genotoxicity tests:Bacterial gene mutation testin vitro mouse lymphoma tk± test50 PPB – 1 PPM Above plus:in vivo chromosomal damage rodent cells90-day subchronic rodent90-day subchronic non-rodent> 1 PPMChronic (2 yr) rodent studies1-yr feeding study in dogsMultigenerational studies in rats
  • 32. EU Toxicology Data Requirements< 50 PPB migration Three in vitro mutagenicity tests:Ames testin vitro gene mutation in mammalian cellsin vitro chromosomal aberration in mammalian cells50 PPB – 5 PPM Above plus:90-day oral toxicity study90-day oral toxicity studyData on potential for accumulation in man> 5 PPM Above plus:90-day oral toxicity study in 2nd speciesAbsorption/distribution/metabolism/excretion studyReproductive toxicity in one speciesDevelopmental toxicity in two speciesChronic toxicity / carcinogenicity in two species
  • 33. THRESHOLD OFTHRESHOLD OFTOXICOLOGICALCONCERN
  • 34. Paracelsus“All things are poison, and nothing is without poison, onlythe dose permits something not to be poisonous”Paracelsus: 1493-1541It’s the dose that makes the poison
  • 35. What does "TTC" Mean?"The Threshold of Toxicological Concern (TTC)concept is a principle that, through a probabilisticapproach, refers to the possibility of establishing humanexposure levels for chemicals below which there wouldbe no appreciable risk to human health."36be no appreciable risk to human health."-- ILSI, 2003
  • 36. What is the TTC Concept Based On?TTC concept was proposed in 1967 by Frawley, etal.Reliance on existing data on various chemicalclasses of substances to predict the toxicologicalpotential of substances of undetermined toxicity.37potential of substances of undetermined toxicity.Acceptance of the concept that the chemicalstructure defines potential for toxicity and thatstructural features can be used to groupsubstances into various categories of toxicologicalconcern-- ILSI, 2003
  • 37. Structural Alerts
  • 38. THRESHOLD OFREGULATIONREGULATION
  • 39. FDA’s Approaches to TTCThreshold of Regulation (TOR)– Established in 1995−specifies a limit 0.5ppb for projected dietaryexposure of food contact materials,− translating into a daily exposure of 1.5 ug/day forchemical without structural alerts for carcinogenicitychemical without structural alerts for carcinogenicity− A Tiered Approach to Threshold of Regulation –Cheeseman, et al, in 1999,−limit of 10 – 15ppb possible:−no structural alerts,−is negative in genotox tests− and acute toxicity (LD50) above 1000 mg/kg bw40
  • 40. Establishment of TOR Limit (1)First considered a level 1.0 ppbRequired level to be low enough to ensure publichealth protection, should the substance be found tobe a carcinogen41be a carcinogenAnalysis of 18,000 acute feeding studies in rats andmice showed that all acute toxic effects occurredabove 100 ppb
  • 41. Establishment of TOR Limit (2)Of 220 chemicals subjected to 2+ year feedingstudies, only 5 (pesticides) exhibited toxiceffects below 1000 ppb, but none were toxic atdietary levels of 100 ppb42Decided on 0.5 ppb: This is 2000 times lowerthan the level likely to cause non-carcinogeniceffects, and 200 times lower than chronicexposure levels at which toxic pesticidesinduce toxic effects
  • 42. TTC: Other Endpoints - ILSI EuropeSpecifically addressed the application of TTC topotentially sensitive endpoints:- Immunotoxicity- Developmental toxicity- Neurotoxicity / Developmental neurotoxicity43- Neurotoxicity / Developmental neurotoxicity- Endocrine active compounds- AllergenicityWith the exception of allergenicity, the TTC of 1.5 ug/dwas found to be conservative for all non-cancerendpoints
  • 43. Other TTC Exposure LimitsCramer Class* Number ofChemicals5th PercentileNOELTTC ExposureLimits**Cramer Class III(most toxic)137 0.15 mg/kg/d 90 ug/dCramer Class II(intermediate)28 0.91 mg/kg/d 540 ug/d44(intermediate)Cramer Class I(least toxic)447 3 mg/kg/d 1800 ug/d* Cramer, et al., 1978. Estimation of Toxic Hazard – A Decision Tree Approach. Fd. Cosmet. Tox. 16: 255** Munro, et al. 1996. Fd. Chem. Tox 34: 829
  • 44. Regulatory Acceptance of TTCU.S. FDA - Threshold of Regulationaccepted since 1995 for food packagingmaterialsGenotoxic impurities in pharmaceuticals45Genotoxic impurities in pharmaceuticalsEMEAFDA-CDERJECFA (Joint Expert Committee on FoodAdditives)EFSA (European Food Safety Authority)
  • 45. Draft opinion of EC Scientific Committees(SCCP/SCHER/SCENIHR*) on TTCGenerally supports the use of TTC for lowexposures to chemicals and outlines areas foradditional work.Expansion and validation of chemicaldatabases to support application to broader46databases to support application to broaderuse areas.Evaluating thresholds for local effects.Draft opinion issued by EFSA 2011.*SCCP – Scientific Committee on Consumer Products*SCHER – Scientific Committee on Health and Environmental Risks*SCHENIHR - Scientific Committee on Emerging and Newly Identified Health Risks
  • 46. BPA A CURRENTPACKAGING MIGRANTPACKAGING MIGRANTISSUE
  • 47. BPA: The Facts - ToxicologyBPA: The Facts - ToxicologyNot a carcinogenNo evidence of cancer in NTP bioassays intwo speciesNot mutagenicNo in vitro or in vivo genetic or chromosomaleffects in guideline studieseffects in guideline studiesNot a developmental toxicantDid not cause birth defects or malformationsNot a selective reproductive toxicantDid not reduce fertility or impair ability toreproduce at doses not toxic to the mother
  • 48. World Health Organization (WHO): Nov. 2010US FDA: Jan. 2010; Feb. 2009European Commission’s Institute for Health and ConsumerProtection: Feb 2010EU EFSA: Sept. 2010; July 2008; Jan. 2007 (Scheduled May 2103)FSNAZ: Food Stds. Australia New Zealand: March 2009; April 2012Global Regulatory AgenciesRecently Reviewing BPA ToxicologyFSNAZ: Food Stds. Australia New Zealand: March 2009; April 2012Canada Health Protection Branch: March 2009; Oct. 2008; Sept.2012German Federal Institute of Risk Assessment: July 2010; Oct.2009; Sept. 2008; Jan. 2006California Developmental and Reproductive Toxicant IdentificationCommittee (DARTIC): July 2009Japanese Ministry of Health: June 2011; March 2006UK Food Standards Authority: April 2001
  • 49. SummaryPackaging materials are complexPackaging migrants existsGlobal regulatory frameworks varyEU focuses on potential levels of migration tofoods and safety data to support those levelsU.S. and Canada focus on potential dietaryU.S. and Canada focus on potential dietaryexposures to substances and safety of thoseexposureConcepts such as the Threshold of ToxicologicalConcern can provide a conservative approach torisk assessmentDetailed toxicological assessment insures thesafety of packaging materials
  • 50. THANK YOUTHANK YOU

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