US1250 Connecticut Ave., NW, #200Washington, DC 20036+1 240-428-1800
Decernis GmbHJohann-Strauss-Str. 3565779 Kelkheim/Ts.Germany+49 6195 3709
ManagingGlobal Food Packaging
Compliance
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Managing Global Food Packaging Compliance
• Who am I??– Richard T. LeNoir– Chemical Engineer by training – University of Delaware– Hercules/Himont/Montell/Basell/LyondellBasell
– Almost 37 years– Salesman/R&D/Process Engineer/Plant Area
Supervision/Corporate HSE/Product Safety/Product Stewardship
– 25+ years in Product Safety, Product Stewardship, and Regulatory Affairs
14 October 2016 Overview 3
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Managing Global Food Packaging Compliance
• Challenges– Sales/marketing
• Defining the application– What is the packaging application
» Foods to be packaged» The conditions of use for the package
– Substance/Material selection for the package» Technical requirements» Regulatory status
• Where is product to be marketed/sold– Countries– Jurisdictions
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Managing Global Food Packaging Compliance
• Challenges– Sales/marketing
• Regulatory requirements in the places to be marketed• Defining customer regulatory needs
– Which regulations are important?» Is it only food contact?» Is REACh involved?» Any environmental requirements? Waste?
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Managing Global Food Packaging Compliance
• Challenges– Regulatory trends changing
• Governments around world have their own systems, not always referring to FDA or EU (e.g. China, Japan, Canada), not always covering all substances/components (e.g. Korea)
• Some are developing or changing systems• States & Municipalities creating confusion• Even FDA changing, with FSMA
– FSVP – affecting the import of food packaging, food packaging substances/materials
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Managing Global Food Packaging Compliance
• Challenges– Who decides?
• Blogs & interest groups replacing regulation• Retailors forcing changes:
– Walmart– Target– Nestle
– Science going by the wayside
Risk Analysis in the Food Contact Supply Chain
Courtesy: Jim Huang, Coca-Cola 8
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Managing Global Food Packaging Compliance
• Challenges– Getting supplier information
• What questions should be asked?• Everything but the “Kitchen Sink” questionnaires
– Some questions difficult to answer» Yes or No questionnaires are not easy
– Similarly, lists of thousands of chemicals» Does your product contain BPA?
• Better: Do you have BPA above 0.1% in your product?
» No one should be saying zero present, or none present; should say at what level of detection was testing
» Not used in the manufacture of product
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Managing Global Food Packaging Compliance
• Challenges– Getting supplier information (cont’d)
• Dependent on Answers across Multiple Levels of the Supply Chain
• Responsiveness of Suppliers• Reliability of Data
- “Form answers”- Skipped or unclear answers- Old data- No understanding of regulatory requirements
- Managing information• Organizing/Filing• Retrieving• Keeping current
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Managing Global Food Packaging Compliance
• Challenges– Misallocation of Resources
• Someone not familiar with regulations, asked to “make sense” of the situations
• Maybe even answer the questionnaires!!
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Managing Global Food Packaging Compliance
• So what can we do??🙏🙏 or
😱😱
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Managing Global Food Packaging Compliance
• Possible Solutions for consideration– Process of product development needs improvement
• Regulatory input• Determine information needed to comply• Where is product going
– Supplier information• What specific certifications needed• Determine what is really needed• Gather information• Frame questions better – ask for limits on chemicals
– e.g. Do you have phthalates above 0.1%• CAUTION: BE CAREFUL WHAT YOU ASK FOR!!
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Managing Global Food Packaging Compliance
• Possible Solutions for consideration– Personal Opinion:
• Consider A REGULATORY EXPERT!!!– To oversee the compliance effort– Has the knowledge/keeps current– Put processes in place– Engage a consultant if need be
– Look at SPI’s Project Passport
SPI “Project Passport”
Courtesy: Jim Huang, Coca-Cola8 June 2016 15
Project Passport Objectives:• Harmonize Questionnaires• Streamline Process
8 June 2016 Supply Chain Management/Article Compliance 16
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Result:
Managing Global Food Packaging Compliance
• Future Expectations– Some increasing Regional harmonization
• Regulations• Test Methods and Conditions• I think years away in future
– Increasing Communication in Supply Chain– Increasing Transparency to Consumer– Increasing Consumer Involvement
8 June 2016 Supply Chain Management/Article Compliance 18
Managing Global Food Packaging Compliance
• Echo Mitch’s Take Home Messages:– Determining and communicating compliance is complex and
getting more so.
– Understanding and monitoring issues of safety is a critical component of compliance monitoring and brand protection
– Mapping compliance strategy is critical to simplifying market entry
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Thank you!Richard T. LeNoirSenior ScientistDecernis LLC1250 Connecticut Avenue NW, #200Washington, D.C. 20036Office Tel.: +1 (240) 428-1800Mobile: +1 (302) 438-0988
E-Mail: [email protected]
208 June 2016
Supply Chain Management/Article Compliance
Products
gComply: web-based reference of 90,000+ regulations across 199 countries. 700-1000 new regulations per month!
gComply Plus: Rule-based Red Light/Green Light compliance analysis and reporting system; Can integrate with a company’s ERP and PLM systems for formulation checking.
News and Issue Management: Daily early warning for scientific and regulatory events. Track substances, flag events and push info to others.
Supply Chain Management: Manages all compliance documents including questionnaires, certificates, MSDSs, lab results etc. and enables gap analysis to identify missing or out-of-date documents. Provides a clear view of your supply chain.
14 October 2016 Overview 21
Decernis
Focus: Food, Consumer Products, Chemical Product Safety Compliance:
• 4,000+ users across 75 countries
• Covers 199 countries and 16 Economic Communities
• Clients:– Government (e.g. FDA, BfR, Swiss FSVO, EFSA, China,
Japan)– Upstream manufacturers (e.g., BASF, Dow, DSM,
DuPont)– Downstream manufacturers (e.g., Coca-Cola, HJ
Heinz, Mars, Nestlé)– Others (e.g., law firms, laboratories, universities)
14 October 2016 Overview 22
Client Overview
FOOD & CONSUMERPRODUCTS
BarillaBeam SuntoryCoca-ColaGodivaHersheyHeinzHPIllycaffèMarsMondelēzNestléPerfetti Van MellePernod RicardPhilip MorrisSC JohnsonStarbucksTempur-SealyWrigley
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POLYMERS
CHEMICALS & ADDITIVES
Arkema Akzo NobelAshland BASFBayer MS CelaneseCP Kelco DuPontEastman ExxonMobilHenkel IneosLanxess LucitMitsui Owens CorningSolvay TessenderloWacker Ultra Additives
PACKAGING AmcorAlcanClosure Systems IntCryovacHuhtamakiGraham PackagingLinpacPactivReynoldsSilganTetraPakWeidenhammer
MASTERBATCHES, COATINGS & PAPER
BostikClariantColorMatrixCabotEvergreenMead WestvacoMichelmanPolyOneSiegwerkStoraEnsoSunChemicalsVisko Teepak
REGULATORY AGENCIES, LAW FIRMS US FDA, BfR, EFSA, EU, Health Canada, OECDCONSULTANTS, LABS Keller & Heckman, Steptoe & Johnson, Intertek, TNO
Cray Valley Dow ChemicalsDow Corning DSMHuntsman Lyondell/BasellMitsui NovaPolymer Latex RepsolSABIC Shin-EtsuTotal Petrochem Ticona
INGREDIENTSAshlandCrodaFirmenichTIC GumsPrimeRoquette
BASF NutritionCP KelcoKerryPharmatonSensientSymrise
DECERNIS’ SUPPLY CHAIN MANAGEMENT
14 October 2016 Overview 24
Supplier Management
14 October 2016 Overview 25
Compliance Manager
Supplier 1
Supplier 2 Supplier
3
• Manage ALL supplier compliance documents & questionnaires• Material Acceptance Planning• Automated Questionnaire Management
Supplier Management:Workflow
14 October 2016 Overview 26
Product Certificates
Analyze Results using gComply Plus
Request
Create Project for Each Product
Auto-Email Requests for Missing Documents
Decernis-Experts
MSDS Laboratory Test Results
Completed Questionnaires Email Responses
Confirm All Docs Collected
MSDS CERT1 QUES LAB1 EMAILCERT2 LAB2
Auto-Validate Questionnaire Answers
Response
Convert Lab Results & Validate Compliance
Supplier Management Portal
Client Experts
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