Managing Global Food Packaging - aimcal.org · Managing Global Food Packaging ... Do you have BPA above 0.1% in your ... lab results etc. and enables gap analysis to identify missing

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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• 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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• 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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• 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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• 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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• 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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• 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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• 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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• So what can we do??🙏🙏 or

😱😱

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• 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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• 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:


• 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

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• 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

mailto:[email protected]

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.


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)


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


Supplier Management


Compliance Manager

Supplier 1

Supplier 2 Supplier

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• Manage ALL supplier compliance documents & questionnaires• Material Acceptance Planning• Automated Questionnaire Management

Supplier Management:Workflow


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