THE BEST APPROACH TO OBTAIN FDA

NO OBJECTION LETTER (NOL) FOR

RECYCLED PLASTICS AND THE RECYCLE
IMPACT ON LIFECYCLE ANALYSIS

Jillian Salansky Conway

Manager Regulatory Services &
Business Development
AGENDA

01 Intertek Introduction

Sustainability and Recycle Process

02

Use of Recycled Plastics in Food Contact

03 Applications

FDA Regulations for Recycled Food Contact

04 Materials

05 Effective Approach to Obtain NOL

2
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

4
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
5
Italy, UK, DE, NL, FR, UK, SWE, DK
 OUR SERVICES

• Worldwide Food Contact Notification

• Worldwide Chemical Notification
• Medical and Food Packaging
• Regulatory Compliance
• Regulatory Audits/Assessments
• 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
SUSTAINABILITY AND
RECYCLE PROCESS
WHAT IS SUSTAINABILITY?
Industry
Sustainability is related to the quality of life in a community, where
the economic, social and environmental systems that make up the
community provide a healthy, productive, and meaningful life for all
community residents, present and future.
EPA
“Create and maintain conditions under which [humans] and nature
can exist in productive harmony, and fulfill social, economic and
other requirements of present and future generations of
Americans."
The most widely quoted definition internationally is the "Brundtland
definition"
“Meeting the needs of the present without compromising the
ability of future generations to meet their own needs."

© Intertek 2017. All Rights Reserved.

COMMON APPROACH TO PACKAGING SUSTAINABILITY

• Materials substitution
• Recyclable, reusable, biodegradable
• Broader view of packaging sustainability
• Cost reduction opportunity
• Greater impact in supply chain (LCA)

12
© Intertek 2017. All Rights Reserved.
03
USE OF RECYCLED PLASTICS
IN FOOD PACKAGING
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.

14
USE OF RECYCLED PLASTICS IN FOOD PACKAGING

Recycle and
Food Contact FDA Regulations

15
 FDA FOOD CONTACT SUBSTANCE REGULATIONS

• Any food additive should be

deemed unsafe unless it is used in
conformity with a regulation or
notification issued by the FDA.
• Suppliers and manufacturers are
ultimately held responsible for
ensuring that the food contact
substance and all of its
components comply with the FDA’s
requirements for safe use as
indirect food additives.

© Intertek 2017. All Rights Reserved.

 EPA RECYCLING PROCESS DEFINITION

In 1991, the Environmental Protection Agency (EPA) introduced a nomenclature that describes
the three distinct approaches to the recycling of plastic packaging materials.

Primary recycling (1°) refers to the use of pre-consumer industrial scrap and salvage to form
new packaging, a common practice in industry.

Secondary recycling (2°) refers to the physical reprocessing (e.g., grinding and melting) and
reformation of post-consumer plastic packaging materials

Tertiary recycling (3°) involves subjecting post-consumer plastic packaging to chemical

treatment whereby its components are isolated and reprocessed for use in manufacture

© Intertek 2017. All Rights Reserved.

 POST INDUSTRIAL VS. POST CONSUMER

Pre Consumer ( post industrial) Scrap material

Is defined as material generally in the production process before it has gone out of the
factory for its intended end use; examples would be "out of specification goods" or simply
unavoidable scrap such as edge trims.
In recycling post industrial materials, the primary need is to get the industrial scrap back
in to a form that can be reused in the production process.

Post Consumer
Is defined as material that has been used for its original intended use; examples would
include used bottles from curbside pickup and used carpeting.
In recycling post consumer materials, the primary need is cleaning and separation of the
desired materials from undesirable materials

© Intertek 2017. All Rights Reserved.

04
FDA REGULATIONS FOR
RECYCLED FOOD CONTACT
MATERIALS
FDA SAFETY CONCERNS

FDA's main safety concerns with the use of recycled plastic materials in food-contact
articles are:
1.That contaminants from the post consumer material may appear in the final food-
contact product made from the recycled material.
2.That recycled post-consumer material not regulated for food-contact use may be
incorporated into food-contact packaging.
3. That adjuvant in the recycled plastic may not comply with the regulations for food-
contact use.

© Intertek 2017. All Rights Reserved. 20

FDA REQUIREMENTS FOR A NOL FOR THE USE OF RECYCLED PLASTICS IN
FOOD CONTACT

• It is necessary to either show that there has been no possibility of contamination

with substances other than food or to demonstrate that the process will remove any
of theses contaminations.
• A description of the proposed conditions of use of the plastic (e.g., information on
intended temperature of use, type of food with which the plastic will come into
contact, the duration of the contact, and whether the food-contact plastic will be
for repeated or single-use applications.)

© Intertek 2017. All Rights Reserved. 21

FDA RECOMMENDATIONS FOR SECONDARY PROCESSING

Examples in which Recyclers address these concerns are:

• Implementing controls on the source of the post-consumer polymer
• Adequate sorting procedures for the incoming post-consumer material
• Use limitations on the finished recycled packaging (such as use at room
temperature or below), or
• Food-type restrictions (such as dry or aqueous foods only).
• In any submissions to FDA regarding 2° recycling processes, a discussion of these
types of actions would be very helpful in FDA's evaluation of the processes.

© Intertek 2017. All Rights Reserved. 22

FDA REQUIREMENTS FOR A NOL FOR THE USE OF RECYCLED PLASTICS IN
FOOD CONTACT

• A complete description of the recycling process, including

- Description of the source of the recyclable plastic
- Description of any source controls in place
- Description of any steps that are taken to ensure that the recyclable plastic is not
contaminated at any point in the process

• The results of any tests performed to show that the recycling process removes
possible contaminants.

© Intertek 2017. All Rights Reserved. 23

USE OF RECYCLED PLASTICS IN FOOD CONTACT APPLICATIONS

•Recycled plastics could not be notified to FDA using the FCN process
•Using recycled plastics in food contact applications has to comply with all FDA regulations
•The recycled plastics can be used in applications that is not regulated by FDA as long as all its
content will not become a indirect food additives.
•The recycled plastics could be used in food contact application if a functional barrier exist between
the plastic and the food.
•The recycled plastics could be used in food contact applications by self determination of the safe
use of the plastics and the determination that recycle polymer will not contaminate the food.
•The recycled plastics could be used in food contact application by obtaining a No Objection Letter (
NOL) from FDA for the recycled plastics and the recycled process.

24
USE OF RECYCLED PLASTICS IN FOOD PACKAGING: CHEMISTRY
CONSIDERATIONS
MAXIMUM ALLOWABLE LEVEL OF CONTAMINATE RESIDUE

**To recommend a maximum acceptable level for chemical contaminants in recycled food-contact articles that can form the basis of
Good Manufacturing Practice with respect to recycled material, FDA has determined the residual concentration of a contaminant that
corresponds to an acceptable upper limit of dietary exposure. Using the scientific analysis supporting the Threshold of Regulation
approach to evaluating indirect food additives as a basis (see 21 CFR 170.39), FDA believes that EDIs of contaminants from recycled
food-contact articles on the order of 1.5 micrograms/person/day (0.5 ppb DC) or less are generally of negligible risk.
25
FDA EXAMPLE - MINIMUM CONCENTRATIONS OF
CONTAMINANTS IN A SURROGATE COCKTAIL

26
FDA RECOMMENDED CHALLENGE TEST SOLVENTS

27
05
EFFECTIVE APPROACH TO
OBTAIN A NOL
FDA NO OBJECTION LETTER FOR RECYCLING PROCESS

• If the recycled plastics are originally in compliance with FDA requirements for the
safe use in the intended food contact applications, no FCN is required
• FDA recommends a submission of the recycling process to obtain a No Objection
Letter (NOL)
• FDA issued a favorable opinion on the suitability of a specific process for producing
post-consumer recycled (PCR) plastic to be used in the manufacturing of food-
contact articles.
• FDA web site has a list of no objection letters
• This is a recommendation and is not required by law

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OBTAINING NOL WITHOUT THE CHALLENGE TEST

• Materials Source are FDA food contact compliant

• Materials are from Consistent Source
• Controlled and Measurable Contamination
• Effective recycle process

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NON-CURBSIDE POST CONSUMER MATERIALS

• Hangers
• Trays
• Lunch Boxes
• Retail Bags
• Office Polycarbonate Water Bottles
• In process equipment

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ANALYTICAL PROTOCOL

• Analysis of three incoming batches (prior to the recycle process)

• Analysis of the same batched in process
• Analysis of the same batches as final products (post recycle process)

Analytical Methods Applied

• In Polymer Analysis
GC/MS, LC/MS, GPC
• Metals Analysis
ICP, ICP/MS, XRF
• Migrations Analysis
CFR end use test

32
CASE STUDY: POLYSTYRENE ANALYSIS

1. Determination of Metals
2. GPC Molecular Weight Distribution
3. HS-GC-MS for volatile organic compounds
4. HPLC/MS for none volatiles
5. Additive Screening
6. FDA 21 CFR 177.1640 (styrene content)

33
ANALYTICAL: SOLVENT ANALYSIS

34
ANALYTICAL: 21 CFR 177.1640

35
ANALYTICAL: VOLATILES COMPARISON

36
FUNCTIONAL BARRIER

37
QUESTIONS?

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
39
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