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Introduction to Food Contact Regulations

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[email protected] / www.assentcompliance.com / 1 866 964 6931 / © Assent Compliance 2017 1 Thank you for registering for today’s webinar! The presentation will begin shortly. We recommend you use either ear phones or a headset to listen to the webinar through your computer’s audio. If you prefer to call in to the webinar, click here and dial in using the details provided in the confirmation email you received from GoToWebinar. However, if you choose to call in, please note it is a Canadian number and long-distance or international charges will apply. You will be muted during the presentation, but able to submit your questions via the chat box. The presenter(s) will go through questions at the end of the presentation. If your question is not answered, someone will follow up with you directly following the webinar. You will receive a follow-up email with a copy of the recording and slides. If you have any questions about this webinar, please contact us at [email protected]. Your feedback is important to us. Please share with us how the webinar went at the end of the broadcast. Thank you for your patience and we hope you enjoy the webinar! Introduction to Food Contact Regulations
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Page 1: Introduction to Food Contact Regulations

[email protected] / www.assentcompliance.com / 1 866 964 6931 / © Assent Compliance 2017 1

Thank you for registering for today’s webinar!The presentation will begin shortly.■ We recommend you use either ear phones or a headset to listen to the webinar through your

computer’s audio.

■ If you prefer to call in to the webinar, click here and dial in using the details provided in the confirmation email you received from GoToWebinar.

□ However, if you choose to call in, please note it is a Canadian number and long-distance or international charges will apply.

■ You will be muted during the presentation, but able to submit your questions via the chat box. The presenter(s) will go through questions at the end of the presentation.

□ If your question is not answered, someone will follow up with you directly following the webinar.

■ You will receive a follow-up email with a copy of the recording and slides. If you have any questions about this webinar, please contact us at [email protected].

■ Your feedback is important to us. Please share with us how the webinar went at the end of the broadcast.

Thank you for your patience and we hope you enjoy the webinar!

Introduction to Food Contact Regulations

Page 2: Introduction to Food Contact Regulations

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Introduction to Food Contact Regulations

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Today’s Moderator

Madison AdamsAssent ComplianceCompliance Specialist

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Introduction

Page 5: Introduction to Food Contact Regulations

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Assent Product SuitesOur Market Leading Platform

Corporate Social Responsibility Product Compliance

Vendor Management Inspections

Page 6: Introduction to Food Contact Regulations

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Today’s Presenter

Bruce JarnotAssent ComplianceSenior Manager, Product Compliance

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Agenda

1 What Are Food Contact Materials?

2 How Are Food Contact Materials Regulated?

3 Good Manufacturing Practice (GMP)

4 Statutory vs. Migration Regulations

5 Demonstrating Compliance

6 Questions

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Feature Presentation

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It’s all about CONSUMER HEALTH!

Introduction to Food Contact Regulations

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Food contact materials include:

■ Any materials that have foreseeable contact with food■ Food packaging■ Kitchen utensils■ Domestic and commercial food processing equipment

What Are Food Contact Materials?

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Food contact materials are indirect food additives. For example:

■ Metals, alloys, glass and ceramics■ Polymers■ Paper and paperboard■ Coatings■ Adjuvants and production aids■ Adhesives■ Lubricants, wax and grease

What Are Food Contact Materials?

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Global food contact regulations are extremely complex. ■ North America■ Latin America■ Europe, the Middle East and Africa■ Northern and Southern Asia

How Are Food Contact Materials Regulated?

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■ Good Manufacturing Practice■ Statutory Regulations■ Migration Testing■ Risk Assessment

How Are Food Contact Materials Regulated?

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Good manufacturing practices for food contact materials:

■ Required for food contact materials throughout the world□ U.S. FDA 21 CFR 174.5□ EU Commission Regulation (EC) 2023/2006□ Etc.

Good Manufacturing Practice (GMP)

GMP includes:

■ Preventing contamination and cross-contamination■ Clearly defined and controlled manufacturing processes■ Clean manufacturing, packaging and storage facilities■ Operator training■ Corrective action plans■ Collection and retention of appropriate documentation■ Auditing, as needed

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Statutory regulations…

■ Primarily apply to North American compliance■ Are industry self-enforced, but open to government inspection■ Require statute-based compliance

□ U.S. FDA 21 CFR & GRAS substances “generally recognized as safe”□ Canada Safe Food for Canadians Act (SFCA)□ USDA & National Sanitation Foundation (NSF)

■ Based on positive (acceptable) and negative (unacceptable) substance lists■ Require GMP ■ Require documentation

Statutory vs. Migration-Based Regulations

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Migration-based regulations…

■ Primarily apply to European compliance■ Include positive (acceptable) and negative

(unacceptable) substance lists■ Require specific total and specific migration

testing

Statutory vs. Migration-Based Regulations

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Migration evaluates inertness…■ Migration tests the transfer of substances into food

Overall (total) vs. specific migration testing…■ Overall migration looks at total weight of extracted

substances■ Specific migration looks at material-specific restricted

substances□ Example: BPA extracted from polycarbonate

plastic□ Example: PAHs extracted from carbon black

Statutory vs. Migration-Based Regulations

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Migration testing conditions…

■ Based on intended and foreseeable product use conditions

□ Specified temperature□ Specified time□ Specified food simulant (Water,

Oil, 50% Alcohol…)

Statutory vs. Migration-Based Regulations

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Other regions/countries ■ Include elements of both statute- and migration-based compliance

Migration test conditions may vary from EU standards…■ China■ Japan■ Latin America (e.g. Mercosur countries)■ Others

Statutory vs. Migration-Based Regulations

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Food contact compliance cannot be demonstrated through a DSL. ■ The same CAS number may have different grades of purity

◻ Example: Salt (NaCl)◻ Example: Carbon black

■ Food contact materials require GMP, statutory and/or migration testing requirements■ Food contact Materials require documentation

Demonstrating Compliance

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Demonstrating Compliance

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Suppliers may offer food grade materials and formulants.■ Polymers■ Coatings■ Greases and waxes■ Other materials

Food grade is often a marketing claim.■ Sales literature, tech data sheets, etc.■ Should specify regulation(s) and section(s)

Religious certifications.■ Kosher■ Halal

Demonstrating Compliance

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Demonstrating Compliance

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How should I manage migration testing?■ Engage a third-party lab to assist with:

◻ Protocol design (important!)◻ Overall and specific migration testing

Consider testing the finished product or assembly…■ Provides most realistic use scenario■ Provides appropriate component exposure to

food simulant

Demonstrating Compliance

Page 25: Introduction to Food Contact Regulations

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What if the material is not specified as being food grade?

■ Ask the vendor if they have a food grade alternative■ Ask the vendor whether they have previously investigated food use■ Ask the vendor for a full formulation disclosure for third-party review

When should I consider a risk assessment?

■ If the material (e.g. ink) contains proprietary substances■ If the material is questionable for food safety ■ Should be performed by a competent third-party service

Demonstrating Compliance

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Questions/DiscussionConclusion

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Page 27: Introduction to Food Contact Regulations

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