DISPENSING MACHINES FDA FOOD

CONTACT COMPLIANCE

Jillian Salansky Conway

Manager Regulatory Services &
Business Development
AGENDA

01 Intertek Introduction

02 Dispensing Machines

03 How to Determine Compliance

04 Analytical Recommendation

Questions
05

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01
INTERTEK INTRODUCTION
OUR GLOBAL NETWORK AND CAPABILITIES
Global ATIC Business with over 42,000 Employees
Global Global
Market Market
Leader in Leader
Assurance in TIC

3,000 1,000+
laboratories
auditors
and offices

100,000 100+
audits countries

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DEPTH AND BREADTH OF OUR SERVICES

Assurance Testing Inspection Certification

• Management Systems • Softlines • Agriculture • Appliance & Electronic
• Benchmarking in Quality & • Hardlines • Asset Integrity • Aerospace & Automotive
Performance
• Automotive • Building Product • Building Product
• Sustainability & environment
• Biofuels • Chemical & Petrochemical • Conformity by Country
• Facility / Plant & Equipment
• Building Product • Electrical • Eco-Textile
• Legal & Regulatory
• Chemical & Pharmaceutical • Exporter & importer • Food & Food Service
• Product Development
• Electrical • Field Labelling • Hazardous Location
• Vendor Compliance
• Food • Industrial • HVACR
• Corporate Social
Responsibility • Health & Beauty • Mineral • Industrial Equipment

• Failure investigation • Mineral • Oil & Gas • IT & Telecom

• Laboratory Outsourcing • Packaging • Site Construction • Life Safety & Security

• Risk Management • focus

Intertek HERS has a strong Pharmaceutical • Textile
on the safety of any chemical applied, & Apparel
in all types • Lighting
of applications, and their approvals and compliance status
worldwide, for polymers, composites, additives, chemicals, fine chemicals, food and feed ingredients, Pharma & Healthcare, automotive , electrical,
• Supply Chain Assessment • Oil & Gas • Medical Device
packaging and more.

A global network with >200 scientists and technicians;

In Europe, ~40 regulatory specialists, toxicologists and consultants in
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Italy, UK, DE, NL, FR, UK, SWE, DK
 OUR SERVICES

• Worldwide Food Contact Notification

• Worldwide Chemical Notification
• Medical Device and Food Packaging
• Regulatory Compliance
• Regulatory Audits/Assessments
• Cosmetic Packaging
• MSDS, SDS, labels and GHS ; Hazard Classification
• RoHs, SVHS and restricted minerals
• Toxicological Services
• Regulatory Sustainability Services

© Intertek 2017. All Rights Reserved.

 TOXICOLOGICAL AND ECOTOXICOLOGICAL SERVICES

• Toxicology and Ecotoxicology Study Contracting

• Structure Activity Modeling and Predictive Toxicology
• Toxicology and Environmental Exposure Modeling and Risk Assessment
• Global Literature Search and Safety Data Compilation
• Cancer Risk Assessment
• Screening studies and theoretical assessments for endocrine disruptors
• In vitro and In vivo Biocompatibility studies for medical devices
• Toxicology and Ecotoxicology Safety Assessments to Support EPA PMNs
• Preparation of Food Safety Risk Assessments to Support FCN Food Contact Notifications

Client Examples: BASF, Valspar, RT Vanderbilt, King Industries, NextLife, 3M, Taylor, Medela, SK
Chemicals

© Intertek 2017. All Rights Reserved.

 SUSTAINABILITY AND REGULATORY COMPLIANCE

• FDA Approval for Use of Recycled Plastics in Food Packaging

• FDA Approval for Use of Recycled Paper in Food Packaging

• FDA Approval for Use of Biopolymers in Food Packaging

• Environmental impact Statements

• Eco-Assessment against “Standards of Sustainability”

© Intertek 2017. All Rights Reserved.

 Intertek Strength for Product Introduction and Compliance

Regulatory Toxicology

Global
Analytical Governmental
Reach

© Intertek 2017. All Rights Reserved.

02
DISPENSING MACHINES
EVOLUTION OF DISPENSING MACHINES

© Intertek 2017. All Rights Reserved.

COMMERCIAL DISPENSING MACHINES

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© Intertek 2017. All Rights Reserved.
DISPENSING MACHINE PARTS

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© Intertek 2017. All Rights Reserved.
03
HOW TO DETERMINE
COMPLIANCE
THE COMPLIANCE STRATEGY

• To understand FDA requirements

• Ensure each component is in compliance
• Determine if the end use of your product is covered
in this compliance
• If not, determine what could possibly migrate
• Conduct migration study, and if necessary
• Perform a literature search for available Tox data
• If all components are in compliance for the
intended use, the manufacturer or supplier could
claim that the product complies with FDA
requirements. If any of the components are not in
compliance for the intended use, an FCN (Food
Contact Notification) submission to the FDA is
necessary.

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DISPENSING MACHINE ASSEMBLY

inks
aluminum

polypropylene

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USA FDA PRODUCT COMPLIANCE - LISTINGS

Federal Register
Code of Federal Regulations
√ 21 CFR, Food and Drugs
“Inventory of Effective Premarket Notifications for FCS” – after
March 1, 2000
FDA website –
http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?r
pt=fcsListing
INTRODUCTION AND DEFINITIONS

FDA regulates “Food Additives“, i.e., substances which may by their intended use
become components of food, either directly or indirectly
 Direct Food Additive is added for a functional
purpose.
e.g. preservative or food coloring
 Indirect Food Additive (called Food Contact
Substance or FCS) is introduced into food via food
contact material and is not intended to have an effect|
on food.
FOOD CONTACT – DIRECT AND INDIRECT

• Direct food contact refers to a printing ink or coating that is intended by design
to be in contact with a food product
• Indirect food contact is a term inappropriately used in the printing industry to
describe a printing ink or coating that is not in contact with a food product
• The FDA has no specific guidelines for this scenario. The FDA regulates food
additives, not food contact. Both of the descriptions above can result in indirect
food additives

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FDA COMPLIANCE STRATEGY

• Understand the FDA requirements

• Ensure that all of the components of the product are in compliance
• Completed via compositional review
• Supplier statements of compliance
• Determine if the end-use of your product is covered in this compliance
• Conduct any required migration and testing studies
• If all components are in compliance for the intended use, the manufacturer or supplier could
claim that the product complies with FDA requirements.
If any of the components are not in compliance for the intended use, an FCN (Food Contact Notification)
submission to the FDA is necessary.
DEFINING END USE OF A PRODUCT

• Substrate (Polymer type, paper, etc.)

• Types of food with which the substance is intended to come in contact
• Whether the food contact material is intended for single or repeat use
• Maximum use temperature
 COMPLIANCE EVALUATION FLOW CHART

Confirm final product

Documentation and
composition (including Develop analytical and
compositional review Final certification and
available DOCs or complete testing
against applicable compliance report
chemical information) protocol (if needed)
regulations
and end use detail

© Intertek 2017. All Rights Reserved.

04
ANALYTICAL
RECOMMENDATION
FDA END-USE TESTING

•Can apply to a basic resin, prior to the addition of any adjuvants, and prior to the fabrication into the
final food-contact article
 Example: A polypropylene (PP) polymer as described in 21 CFR Part 177.1520
(c) specifications 1.1a
• End-use tests determine if the PP meets the polymer density specifications, maximum hexane extractables,
maximum xylene extractables
•Can also apply to the finished article
 Example: A polymeric coating as described in 21 CFR 175.300
• End-use tests determine if the coating formulation meets the maximum solvent (e.g., water, alcohol, heptane,
chloroform) extractables

• Several FDA regulations contain end-tests

• E.g. 21 C.F.R. Sections 175.300, 176.170
• These are quality control test methods, NOT migration protocols
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MIGRATION PROTOCOL DEVELOPMENT

**Only after completion of the regulatory review

• Different Parts require different simulating solvents

• Varying Food Contact Paths
• Varying Temperatures & Time Conditions
• Batch Testing
• Migration/Screening

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FDA COMPLIANCE: ANALYTICAL RESULTS (EXAMPLE) OF MIGRATION

Part &
description

Simulating
solvent
based on wetted
path

raw
material

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FDA COMPLIANCE: ANALYTICAL RESULTS (EXAMPLE) OF MIGRATION

Chemical detected
via screening

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FDA COMPLIANCE: ANALYTICAL RESULTS (EXAMPLE) OF MIGRATION

Chromatogram
showing peaks for
chemical
components
detected during
screening

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CONCLUSION & CERTIFICATION

• Regulatory Review
• Migration Testing
• Third Party Opinion Letter/Certification

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Jillian Conway
561.989.7294

Jillian.salansky@intertek.com

www.intertek.com/regulatory/food-contact/
FOOD CONTACT WEBINAR SERIES SCHEDULE
EU Food Contact: Regulation EU 10/2011 for Risk Assessments of Food Contact Materials that
plastic food contact materials fully into force on
01 January 1st 2016 07 Migrate into Food
November 28
October 3

US and Emerging Markets Food Contact China Food Contact Regulations

02 Regulations
October 17 08 December 5

Different Packaging Market: Compliance EU Food Contact Compliance for Paper and Board
03 throughout the Supply Chain
October 24 09 January 9

The Best Approach to Obtain FDA NO Objection

Letter (NOL) for Recycle Plastics and the Recycle EU Food Contact Compliance for Coatings
04 Impact on Lifecycle Analysis 10 January 16
October 31

Dispensing Machines FDA Food Contact GMP for Food Contact

05 Compliance
November 7 11 January 23

Inks and Colorants: Global Food Contact The Impact of the EU NIAS Regulations on the US
Regulations and Migration Studies Designed to
06 Ensure Safe Use in Packaging 12
FDA Final Articles Indirect Food Additives
Compliance
November 14 January 30
31
Register for our webinar series today! http://bit.ly/FC-series