A Globally Harmonized Repository:

Enabling interoperability, scalability, and better chemistry

CSW & NCAC-SOT Joint Symposium

April 30, 2019

Stacy Glass

Executive Director

Agenda

Introduction

1.0 The call for a globally harmonized repository

2.0 Harmonized, GHS-based methodology

3.0 Third-party Verification

4.0 Actionable Information

5.0 What’s Next

Who We Are

MaterialWise is a non-profit, value chain collaboration.

We believe that data underpins the pathway to safer

products, and that increased use of chemical hazard profiles

for proactive decision making will lead to safer products for

all.

Our mission is to be the most-trusted source for cost-

effective, verified, chemical hazard information.

● Stacy GlassExecutive Directorstacy@materialwise.org

● Lauren Heine, PhDDirector of Safer Materials & Data Integritylauren@materialwise.org

● Josh FordTechnical Directorjosh@materialwise.org

Leadership Team

Co-Design Partners

INNOVATION

When a safe solution is not

possible with existing

chemistry, innovation is

needed to rethink and

redesign how specific

performance requirements

are met.

TRANSPARENCY

Visibility into the supply

chain and chemicals used

in products. Without

accurate information about

what is in a product, change

cannot begin.

CHEMICAL MANAGEMENT

From regulatory compliance

and RSLs to proactive

toxicological assessments,

data are used to ensure a

product is safe for humans

and the environment.

Reliable chemical data underpins the entire pathway to safer, healthier products

Theory of change

List Screening

Chemical Hazard Assessments

1.0 The call for a globally harmonized repositoryof chemical hazard assessments

UN Environment - Global Chemical Outlook II

Some Findings

● An enormous volume of chemicals are released to the environment every year, most unregulated and toxic

● Concentrations of hazardous chemicals are ubiquitous in all media in all regions of the planet and in all human bodies.

● In high consumer economies, the largest source of hazardous chemical exposures come from the products they purchase.

● Given current trends, we will not meet the UN goal of sound chemical management by 2020 and there is a significant need for more aggressive global action.

https://wedocs.unep.org/bitstream/handle/20.500.11822/27651/GCOII_synth.pdf?sequence=1&isAllowed=y

To Achieve SDG’s: Actions beyond 2020

3. Assess and communicate hazards

Fill global data and knowledge gaps, and enhance international collaboration to advance chemical hazard assessments, classifications, and communication by:

● sharing existing hazard data and assessments globally, and increasing the mutual acceptance of testing data and hazard assessments across countries based on accepted methods and scientific criteria;

● developing a global database of assessed and classified chemicals for information-sharing and promoting harmonization of classifications; and

● setting targets to fill data gaps to fully understand globally the hazards of substances in commerce, and assessing progress.

Circular Economy Solution

Google + Ellen MacArthur Foundation

What’s next and where can industry go collectively?

1. Increase access to high-quality chemical hazard assessment data

2. Create a demand signal for safer material innovation

3. Drive innovation in recycling technology and infrastructure

https://storage.googleapis.com/gweb-environment.appspot.com/pdf/Role-of-SafeChemistry-HealthyMaterials_CircularEconomy.pdf

Certification Program Needs

For programs with a CHA component, there is a need to:

● Ensure consistency between

assessors (reasonable toxicologists will disagree)

● Eliminate redundant work

● Lower cost for users

This began as an internal initiative of the C2C Products Innovation Institute to bolster quality assurance and lower the cost of material health assessments in the certification program.

● Comprehensive chemical hazard assessments are expensive, duplicative and protected on private systems

● Chemical hazard assessment schemes are not harmonized therefore data are not portable

● Chemical profiles are not peer reviewed or validated by an independent panel

● The majority of companies don’t have chemists on staff to make sense of CHA’s

Non-profit clearinghouse

Challenge Solution

3rd-party verified

Harmonized, GHS-based input,to allow for multiple outputs

Translation to actionable information

User-Centered Research Insights Interviews with 48+ retailers, brands, and manufacturers across industry and up and down the supply chain revealed:

Programs that start with CHA;s and may have additional criteria need to require the use of a GHR to ensure consistency, eliminate redundant work, and lower costs for users

Certification Programs

✓ ✓ ✓

Call for non-profit clearing house of cost-effective, verified, actionable chemical hazards assessments

Industry

UN Environment call to develop a global database of assessed + classified chemicals for information-sharing and promoting harmonization of classifications

Policy Organizations

Call for a Globally Harmonized Repository

Globally Harmonized Repository of CHAs

Harmonized, GHS-based criteria one profile per CASRN, third-party verified

2.0 Harmonized, GHS-based methodology

Requirements

● Portable data that supports many users and program needs;

● Grounded in science-based practice;

● Quality and current data as a priority;

● Definitive profile per CASRN; and

● Supports any/all GHS-based programs.

All-in-one World Travel AdapterInspiration from Meg Whittaker

Universal Adapter for CHA’s

Google and USGBCSponsored

Goals:• Better products into the

marketplace

• Simplify process for manufacturers

• Make selection and specification of healthy materials easier

• Speed adoption of LEED v4 Material Health credits

http://www.usgbc.org/resources/material-health-evaluation-programs-harmonization-opportunities

SCSCGHSC2C GS SC

Globally

Harmonized

Method

C2C

C2C

C2C

C2C

GHS

GHS

GHS

GHS

GS

GS

GS

GS

SC

SC

SC

SC

GHS

GHS

GHS

GHS

GHS

C2C

C2C

GS

GS

SC

SC

SC

GHSC2C GS SC

C2C

C2C

C2C

GHS

GHS

GHS

GS

GS

GS

SC

SC

SC

Globally

Harmonized

Method

Mapping Leading Programs

1st Attempt Better Approach

Benefits

● Efficiencies lower the cost for users;

● Data can meet multiple customer and/or reporting requirements;

● Increased confidence in data;

● Better investment for users;

● Improves quality of existing programs;

● Fair and equitable

Harmonized GHS-based input

Win

Win Win

3.0 Third-party VerificationStructured peer review

Third-Party Verification

What does success look like?

● Single, harmonized source for chemical hazard classifications

● Trusted third-party verification process for accepting profiles

● Credible, continuous improvement process for resolving inconsistencies or disagreements

● Affordable, accessible, and easy to use for all participants

Criteria

Verified CHA’s will be:

● Complete. According the MaterialWise GHS-based input method and guidance;

● Current. Updated regularly according to MaterialWise program requirements (currently every three years);

● Best available. Based on data that are as relevant, reliable and adequate as feasible;

● Accurate. In applying classification or rating criteria to existing data;

● Transparent and Appropriate.○ In applying expert judgment in the evaluation of existing data, especially when various

data streams differ; and○ In supplementing test data with New Approach Methods (NAMs) for filling data gaps

for hazard classification needs.

Process

Continual Improvement Technical Challenge (CITC)

Process accommodates new information and data, and differing interpretations

● Any aspect of a MW CHA may be subject to a CIT Challenge.

● Any MW user, MW Assessor, or NGO partner may submit a CIT Challenge.

● Challenge must be well documented including a written a rationale for the dissenting opinion and supporting data that will be provided to the Assessor and the Verifier. Challenges that are not well documented or justified may be rejected.

● CIT Challenges will first undergo Facilitated Discussion.

● If Facilitated Discussion does not result in resolution, then the CIT Challenge may move to Technical Arbitration.

CIT Challenge Process

4.0 Actionable Information

Next wave. Innovators like Nike, Levis, and Method have been leading the way, using assessment data and scored chemistry to proactively optimize their products. But how do we scale and activate the next wave of adoption?

Different needs. Early adopters and beyond represent a large market opportunity but they have different needs than innovators. They don’t have chemists on staff. They will need meaningful interpretation of assessment data. This is a pain point MaterialWise can help solve.

innovators

late majority

laggards

early majority

early adopters

Expanded Market

Formulation-level insight. This is where most downstream users are making (or driving) decisions about safer chemistry. Providing assessment-based guidance on formulation (and perhaps even trade-name) chemistry offers the most relevance and value to users.

Interpretation. Next adopters (and even innovators) would benefit from an index of chemistry options that have been “scored” based on a best-practice, transparent method and premised on high-quality underlying data.

Portfolios of better alternatives. It’s becoming easy to find what not to use, but the next question is, what to use instead? Curated portfolios help to accelerate the adoption of better alternatives and avoid regrettable substitutions

Opportunities

Identify high demand chemistries

We start with the most needed, worst in class chemicals based on regulation, RSL/MRSL’s and candidate lists

Research better alternatives

We convene and/or coordinate with existing working groups, review perforamce data, and reach out to suppliers, to identify a short list of functional options

Conduct assessments on alternatives

Qualified assessors use an enhanced GHS-based input to compile a complete human and environmental toxicological report

Verify assessments

Third-party review by expert toxicologists to ensure quality and channel constructive challenges

Post a dynamic portfolio

Our cloud-based platform accelerates industry transformation with an accessible, shared evidence-base of better chemistry that grows over time

Creating CHA Alternatives PortfoliosProblem Statement. Regulations and RSLs indicate what not to use, but the next question is what to use instead. Without robust, high-quality data, this question cannot be answered and everyone in the value chain is vulnerable to regrettable substitutions.

Suppliers submitbetter alternatives

SubscriptionPage

Portfolio Overview

Product Overview

Chemical Detail

5.0 What’s Next

What We Do

1. Build a globally harmonized repository of CHAshousing one 3rd-party verified profile per CASRN enabling a foundation of

consistency for CHA-based programs, eliminating redundant work, and

lowering the cost for users.

2. Create chemical hazard alternative assessment portfoliosfor high priority, pre-competitive chemistry in a cost-sharing model to

accelerate sector transformation toward safer chemistry.

Pilot

In Q1 2019 MaterialWise launched a series of pilots to test and refine the current single chemical platform and to design for handling the roll-up of single chemicals into formulations.

Pilot 1: Alternatives to Ortho-Phthalate Plasticizers

Pilot 2: Alternatives to Per and Poly-Fluoroalkyl Substances(PFASs) in Durable Water Repellents

Pilot 3: Alternatives to Dimethyl formamide (DMF)in the Manufacture of Synthetic Leather

To test:

● Globally Harmonised System of Classification and Labeling (GHS)-based harmonized input;

● Verification and peer review process;

● Digital output (GHS, C2C, and other);

● Approach to analyzing and reporting results for hazards associated with chemical formulations; and

● A transaction model for fair and equitable compensation for the assessors.

Goal of Pilots

CHAA Pilot Timeline

APR: Finalize alternatives to be considered

Secure supplier participation

Send RFP to qualified Assessors

MAY: Assessors work with suppliers under NDA to

Protect IP and provide transparency on hazards

Harmonized, verified assessments posted on MaterialWise

JUNE: Results to MW Co-Design Partners

Evaluate pilot projects and refine for future use

Follow our progresswww.MaterialWise.org

Visualizing GHS

Creating the Globally Harmonized RepositoryProblem Statement. Reliable chemical data underpins the pathway to safer, healthier products and better inputs for a circular economy. But access to this data is not scalable in the current system where CHA’s are expensive, duplicative, protected on private systems, and schemes are not harmonized. Lack of peer reviewed or validated CHA’s breeds inconsistency and undermines confidence.

Fair, equitable

A process for

challenges allows for

transparent dialogue

and additional data

review. Our fee

structure promotes

equitable

compensation to

assessors.

Third-party verification

Expert independent toxicologists review each CHA to ensure they are current, comprehensive, and credible. They also assist w/ challenges

Harmonized, portable data

An enhanced GHS-based input provides documentation to meet multiple industry standards creating flexibility for users

World-class experts

Quality assurance begins with well qualified assessors, we approve organizations with the highest level of expertise, capacity, and experience

Trusted repository

A cloud-based, secure

platform holds one

profile per CASRN,

eliminating duplicative

work, ensuring

consistency, and

lowerings costs for

users

Technical Challenge process allows for continuous improvement

Globally Harmonized Repository Value Proposition

Trusted source. A repository of third party verified chemical hazard classifications

Harmonized, portable data. An enhanced GHS-based input that provides documentation to meet multiple industry standards

Definitive profile, lower fees. A single profile per CASRN eliminates redundant work and creates efficiencies throughout the system.

Continuous improvement, living data. An evolving resource with CHAs that are maintained by assessors and where technical challenges that are professionally managed.

Fair and equitable. A transaction model that creates a win/win/win for users, assessors, and the platform.

CHA Alternatives Portfolios Value Proposition

Trusted source. A repository of third party verified chemical hazard classifications

Harmonized, portable data. An enhanced GHS-based input that provides documentation to meet multiple industry standards

Aggregated demand, lower fees. An innovative cost-sharing model that eliminates duplicative efforts while maintaining equitable compensation to assessors

Respect for IP, essential transparency. A partnership process that encourages maximum disclosure while allowing protection of critical formulation-level information

Actionable information. A system that simplifies complex scientific dossiers into accessible reports for all user levels.

Dynamic knowledge repository. A living, evolving resource with CHAs that are maintained by assessors and AA portfolios that grow with additions from suppliers.