Responsibly Managing Supply Chain Chemical Compliance in the Decade of Regulatory Affairs ©baytouch...

Responsibly Managing Supply

Chain Chemical Compliance

Malcolm Pollard – CEO, Baytouch Ltd

© Baytouch Ltd 2014

Agenda

Baytouch

Supply Chain challenges

Solutions

2© Baytouch Ltd 2014

About Baytouch

Based in Manchester, England with UK, EU and USA clients

Cloud-based IT provider of regulatory management and compliance

solutions:

• ReachSuite: For company Lead Registrants and REACH Consortia with SIEF

Management / Communications, SIEF cost allocation and sharing with online

Letters of Access Contracts

• PSMmonitor: Workplace Safety - EHS and PSM in high hazard chemical

handling sites

• ProductTraq: Product regulatory data storage and management solution

Common thread to what Baytouch does is “robust”, information-rich

change management regulatory affairs solutions


Clients and Partners

Large, influential trade associations leading REACH

registrations

• Lower Olefins, Higher Olefins, CONCAWE, European Aluminium, Polyester

Monomers, Petrol Additives, Grease Thickeners, etc.

Lead registrant and chemical-using corporate clients

• Kemira, IFF, Kimberly Clark, Shell, Eastman, Arkema

Consultancy Services and Expertise Partners

• Caleb Management Services, Ernst & Young (Netherlands), Jongerius Consult,

Penman Managed Services, WSP Environmental

Cloud-based solutions with tens of thousands of users and <2

hours unplanned downtime in the last 365 days


Chemical Industry Trends

1970s

1980s

1990s

2000s

2010

onwards

Bulk chemical manufacture predominates

Small number of large companies making everything

Centralised regulatory affairs resource

Speciality chemicals

Post-Bhopal, Responsible Care and Process Safety Management evolve

Downsizing/rightsizing to adjust to the rise of the east

Quality Management / Assurance, Responsible Care et al become entrenched

MBOs/MBIs, divestments and the emergence of VC power

Industry fragmentation to VCs resulting in lots of small companies making “a

few things”

Loss of technical resource

The rise of REACH and global regulatory uptake – the decade of Regulatory

Affairs..?


Statement of the obvious…

REACH is burdensome!And so are the many other emerging and evolving formal and “informal”

regulatory drivers:

• e.g. China, Korea, etc. and NGO black lists such as the ChemSec

SIN List, California DTSC and others

REACH is here to stay and needs to be in the core of your business processes

Size is irrelevant


But I’m a (small?)DownstreamUser (DU), what has REACH got to do

with me?No duty to register products - not classed as a manufacturer

BUT not removed from duties under REACH

Participation in supplying information up and down the supply

chain

Only use substances registered with your intended uses

Provide Safety Datasheets (SDS) with your products

Ensure supplier SDS are made available to all who need them

Implement the necessary Risk Management Measures (RMM)


Compliance Challenges

Multiple SDS from different suppliers of the same product

• Review and re-edit before making available to customers

Managing multiple conformity declarations

• By supplier; product; batch; etc.

• Could include SVHC presence (Article 33), Intermediates status

(REACH Article 17/18), Conflict Mineral, Halal and Kosher, ROHS,

WEEE, etc.

Cyclic activity examples

• SVHC Candidate list updated 6-monthly

• Halal, Kosher only valid for 12 months


Spreadsheets & filing cabinets…


Hardly translates into “Best Available Technology”

Fast forward 5 years…..a Competent Authority Inspection

Robust processes are key!Supply Chain Compliance Transparency

• What Information required to validate product

compliance

• How does THIS translate to product compliance

• How is it updated / maintained

• Benchmarks, supplier trust rankings, KPIs, etc.

Processes ensuring all compliance

information is collected, validated, stored

and current, and communicated effectively

Structured data storage and management

with robust Management of Change

processes10© Baytouch Ltd 2014

Typical Current Processes

Small regulatory team

Frequently manual processing

Supplier information formats inconsistent – manual and/or

electronic

Periodic updates often required, probably not automated!• “We bother them until we get what we want, if we can

remember…”

Consolidated overview of compliance status hard to discern,

metrics not easily acquired


Dedicated to the Regulatory Team

Or the hard-pressed individual!

As the list of chemicals of concern grows,

• How will you check that your business is on track?

• What will your REACH compliance statement actually mean?

• Will you have sufficient information to support your Article 33 or 17/18

declarations? (SVHC, Intermediates)

• How will you deal with the changes to the Candidate and other Lists?

• What will you do if something goes wrong?

SVT – how will you efficiently and accurately capture

substance import volumes


Efficient processes to focus on

Collect, store and update supplier information as well as

product specs and testing results would be a start

• Flexibility to collect supplier data in multiple formats

• “Management of Change” to keep the business aligned with its

compliance requirements

Information securely shareable internally and with

trusted service providers, stakeholders and supply chain

Compatibility with enterprise systems is desirable

De-skill as many processes as possible to free up high

value regulatory expertise


Short term pain versuslong term gain

Regulatory Affairs are rapidly becoming key to business’

licence to operate (both to manufacture and to sell)

Businesses that excel at managing regulatory affairs will

grow at the expense of others that don’t

Business systems and document management must

accommodate and integrate Regulatory Affairs to survive

and prosper:

Procurement - Manufacturing - Sales and Marketing -

R&D - Strategic Planning


Conclusions

Structured document handling and systematic

approaches are necessary for requesting, receiving and

forwarding supply chain information:

• Ensures timely response levels to information changes

• Improves change management

• Supports best practice and demonstrates leadership in chemical

handling management

• Contributes to a Compliance dashboard leading to supplier

benchmarking

• Lowers risk which promotes corporate sustainability and a

positive image


To coin the words of the great Leonardo Da

Vinci: "Simplicity is the ultimate sophistication".

This is precisely what we at Baytouch have

strived for in bringing ProductTraq to the

market, all your compliance data 2-clicks

away….

17

All your compliance data just two clicks away!

Manufacturers & Importers

Formulators

Distributors

Retailers

A comprehensive supply chain

record management system for:

www.ProductTraq.com


19

Questions

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Responsibly Managing Supply Chain Chemical Compliance in the Decade of Regulatory Affairs ©baytouch...

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