REACH management in the supply chain Webinarmedia.simplicityweb.com/chemicalwatch/CW-REACH-a… · · 2014-11-07REACH management in the supply chain Webinar 5 November 2014,

REACH management in the supply chain Webinar

5 November 2014, 3:00pm GMT

Today’s webinar aims

• This webinar will discuss how the various changes in the regulatory status of substances (e.g. evaluation, authorisation, classification), are linked to each other and how they impact on business continuity;

• Reflect on experiences learned by The REACH Centre whilst working extensively with both multinationals and SMEs in a variety of industry sectors, and explore mitigation strategies and industry best practice;

• Get insights from industry representatives on practical steps to implementation of a workable chemicals management system.

Speakers

• Dr Sandra Meijer, Director of Business Development, The REACH Centre

• Caroline Haycock, Director of Ethical Trade & Corporate Responsibility, Debenhams

• Douglas Leech, Technical Director, Chemical Business Association

Chair: Geraint Roberts, Global Content Editor, Chemical Watch

Questions

• Please submit questions during the webinar using your chat box

• Any unanswered questions can be raised on our Forum following the webinar: http://forum.chemicalwatch.com/

http://forum.chemicalwatch.com/

“a value driven approach to regulatory compliance…”

Chemical Watch Webinar

REACH Management in the Supply Chain- strategies and lessons learned

Sandra Meijer5th November 2014

WWW.THEREACHCENTRE.COM

Leading global provider of Regulatory, Scientific Services and Training in Chemicals Management

• Accomplished team of regulatory and scientific specialists in chemicals management• Head office based in the UK at Lancaster University’s prestigious environmental research centre• High investment in collaborative research for chemicals management and nanotechnologies • Providing services to global industries, trade bodies and governments worldwide

http://www.THEREACHCENTRE.COM


Regulatory Services

• EU REACH Regulation (Lead /Joint Registrations)• Nano, Biocides, Cosmetics, Detergents, Toys, RoHS• Global Notification Systems • SIEF/Consortia Management

Scientific and Analytical

• Analytical Characterisation and Testing• Phys/Chem Analysis• (Eco)Toxicology, Modelling Techniques• Exposure Assessment

Chemicals Management

• chemtrac® - Global Chemicals Regulatory Reference Tool• Chemicals Management Systems, Policies & Procedures• SDS Authoring and Management Systems• Regulatory and Supply Chain Audits

Training• Multiple User Online Learning Environment• Modular Classroom Training – up to 15 participants • Virtual Classroom – Cost Effective 1-to-1 Training Online• Bespoke Workshops – tailored by request

HazardsCommunication

• Classification• Safety Data Sheets and extended SDS• Exposure Scenarios• Labeling & Packaging

OUR SERVICES



REACHEvaluationAssessment of

dossiers /substances

AuthorisationControl and

substitution of most hazardous substances

Registration (and notification)M/I submit dossiers to

ECHA

RestrictionEU wide control on certain hazardous

chemicals

REACH



ENFORCEMENT

Areas for enforcement (as per “Forum” strategy)

1. Registration related duties• REACH registration, notification• C&L notification

1. Use related duties• Following guidance on safe use• Implementing Exposure Scenarios

1. Supply chain related duties• Authorisation, Restrictions• CLP requirements to label and package



ROLES AND OBLIGATIONS

Formulator

Non-EU EU

OR

e.g. cosmetics, cleaning products, paints, adhesive, building materials

Procurement of raw materials

Importer?

Registration/ notification

Formulation of mixtures

User of chemicals

Safe use of chemicals (eSDSimplementation)

Supply of mixtures

Supplier

Supply chain communication (eSDS provision)

Suppliers Customers

ACTIVITY

ROLE

OBLIGATION



SUBSTANCE INVENTORY

Determine your obligations: -

• Regulatory status (e.g. restricted / banned / exempt)• Classification (impacts on regulatory status)• Tonnage (will change over time)• Source (EU vs non-EU)• Your role (may change depending on source / activity)

MONITOR CHANGE!



EFFECTS OF REACH

Restriction

ClassificationChange

Authorisation

SubstanceEvaluation

Product Labelling

SVHCs

REACHRegistration

Removed from Market



BUSINESS RISK

RISK

Non-Compliance

Loss of Raw Materials

Usage Ban or Restricted

Hazardous Materials

identified by Customers

Company Reputation

Compromised

ReformulationCosts

FinesEnforcement Notices

ProductPerformance

Issues

IncreasedMaterial Costs

OccupationalClaims

Loss of Sales



CHEMICALS MANAGEMENT SYSTEM

Implement a fit-for-purpose Chemicals Management System to include: -

• Policy

• Procedures and responsibilities

• Internal and external communication templates

• Live inventory of substances within your supply chain

• REACH impact assessment for new activities

• Training

• REACH regulatory monitoring tools



SUCCESSFUL REACH MANAGEMENT

Culture

Resources

Tools

• Senior management support/promotion• Buy-in from all impacted departments• Integration into day-to-day working practices

• Chemicals Management Team• Financial Budget• SHE/Finance/Operations/Purchasing/Sales/ICT

• Regulatory monitoring systems• Access to data from ERP systems• Inventory management systems



SUCCESSFUL REACH MANAGEMENT

• Compliance typically driven by a REACH/CLP champion – SHE manager

Stage 1

• Knowledge/ responsibilities begin to be cascaded to other departments/managers

Stage 2 • REACH/CLP becomes integrated into business management systems

Stage 3

Management of REACH/CLP is an evolving process!



CASE STUDY: RETAILERFocus on safe consumer products. Regulatory compliance is an essential aspect of this but most go further.

• Restricted substances list (black/grey lists)– Adopt one limit (lowest global threshold?)– Compare and monitor global requirements

• SVHC management challenge… an article is often like a “black box”. “Bill of Substances” or risk-based approach?

– Product Risk Assessment• Bill of materials• Identify high-risk substances/suppliers• Supplier auditing• Testing strategies



CASE STUDY: PERSONAL CARE AND CLEANING PRODUCTS

Compliance risk and business risk for mixture ingredients driven by regulatory changes.

• Restrictions, re-classification, other regulations– Active monitoring of regulatory status– Horizon scanning

• Supply chain communication– Preparation of eSDS for mixtures– Product labelling



CASE STUDY: AUTOMOTIVE MANUFACTURER

IMDS only looks at chemicals that end up in a car!

• Business risk of raw material supply• CMRs not registered• Authorisation / restriction

• Substance Inventory• Ranking of substances on business risk• Substitution



Substance Database

• Track the regulatory status of chemicals• Find essential data on over 150,000 substances• View key global chemicals regulations and

stakeholder lists• Upload and share key information across the

organisation and supply chain• View regulatory guide with direct links to the

legislation• Actively maintained with changes in regulations

Product Risk Assessor

• Evaluate the risk of non-compliance• Identify high-risk products• Provide testing strategies

Substance Alerts

• Monitor substances of specific concern• Track latest regulatory amendments• Systematic and regular updates


Thank you

Sandra Meijers.meijer@thereachcentre.comwww.thereachcentre.comtwitter.com/thereachcentre

“a value driven approach to regulatory compliance…”

mailto:[email protected]

http://www.thereachcentre.com

© Copyright CBA 2014 | www.chemical.org.uk

UNDERSTANDING DOWNSTREAM IMPACTS

OF CLASSIFICATION

http://www.chemical.org.uk

THE LEGISLATIVE LANDSCAPE…


REACH

CLP

BIOCIDES

PESTICIDES

NANOTECH

BIOTECH

IS EVOLVING…


OVERLAPPING LEGISLATION


RE

AC

H • Registration• Testing

Proposals• SVHC

Candidate list• Restrictions• Authorisation• Substance

Evaluation

Cla

ssifi

catio

n an

d La

belli

ng • Reclassification• CLH

Harmonised Classification

• CLP notification

• Cosmetics• Medical devices• RoHS• Toys• Detergents• Fertilisers• Biocides• Food Contact

Materials• Food• Product Safety• Water• Waste• MORE…….

Links more

complex


GHS CYCLE


UPDATED EVERY TWO YEARS:

GHS Rev.1• Adopted

• December 2004

• Published• 2005


• December 2006



• December 2008



• December 2010



• December 2012

• published• 2013

GHS Rev.6• Biennium

started • January

2013


GHS REVISIONS IMPACT CLP…


ADAPTATION TO TECHNICAL PROGRESS (ATP)

• Introduced changes to Annex VI tables 3.1 & 3.2 - Lists of substances1st ATP

•Updated CLP to apply changes within the 3rd revised edition of GHS into CLP2nd ATP

• Introduced changes to Annex VI tables 3.1 & 3.2 - Lists of substances3rd ATP

•Updated CLP to apply changes within the 4th revised edition of GHS4th ATP

• Introduced changes to Annex VI tables 3.1 & 3.2 - Lists of substances5th ATP

• Introduced changes to Annex VI tables 3.1 & 3.2 - Lists of substances• Inclusion of Croatia ‘H’ and ‘P’ statements6th ATP

•Forwarded to World Trade Organisation (WTO) prior to adoption•Updates CLP to apply changes in the 5th revised edition of GHS7th ATP



DSD/DPD UNDERWENT NUMEROUS UPDATES

NOTHING NEW…


Chemical Business Association

BUSINESS IMPACTS



CHANGES HAPPEN…


THE TRICK IS…

• To have internal processes in place to:• Monitor

o The landscape• Identify

o Issues and changes• Update

o documentation• Communicate

o Internally and externally


THEY LOOK THE SAME????




RoHS Restrictions on Electronic Equipment

Restrictions

Evaluation

Registration

LEGISLATIVE LINKS



Restrictions

Cat. 1A & 1B CMRsCosmetics

Food and Food packagingToys directive

CLP Harmonised Classification

Biocides Review

LEGISLATIVE LINKS



• CLP (EC) 1272/2008 Regulation• Implements GHS into EU

o Two phases§ December 2010

• Substances§ June 2015

• Mixtures

• New data results in new end pointso Reclassification may lead to new duties§ Authorisation§ Restriction§ Cosmetics§ Biocides

LEGISLATION IMPACTS



HARMONISED(CLH)

SELF-CLASSFIED

CLASSIFICATION



CLH Dossier generated

RAC debates and forms opinion• Committee for Risk Assessment - ECHA

Opinions forwarded to Commission by ECHA annually

Commission publish CLP ATP proposal and forward to WTO

New classification adopted into CLP Annex VI, tables 3.1 & 3.2• Implementation date assigned

CLH PROCESS



CLH Opinion

CLP / DPD• Annex VI

• Table 3.1 • Table 3.2

Substance and Mixture classification• Labelling• SDS

Impacts other legislation• COMAH• TOYS• Biocides• Cosmetics

WHY ARE WE TELLING YOU THIS?


NITRIC ACID EXAMPLE


RAC OPINION

• May 2013• Assigned toxicity

classificationso DSD / DPD§ T+; R26

o CLP§ Acute Tox. Cat 1 (Inhalation)

• H330§ Ox. Liq. 2 > 99%

• H272


IMPACTS FOR COMPANIES


• TRANSPORT• May reopen

classification for transporto Require new packaging

or restrict others§ Such as not in IBCs

• OTHER IMPLICATIONS• SEVESO/COMAH• EXPOSURE

CONTROLo COSHH

• Food / Feed etc

Concentration Classification LT thresholdUT/TT

threshold

<2% Acute Tox. Category 4

N/A N/A

2% to <10% Acute Tox. Category 3 (Inhalation)

50 tonnes 200 tonnes

10% to <40% Acute Tox. Category 2

50 tonnes 200 tonnes

≥40% Acute Tox. Category 1

5 tonnes 20 tonnes


LEGISLATION IMPACTS


Environmentally Hazardous• Never tested before• Changes to classification• Introduction of ‘M’ factor

Seveso • R50; R50/53

• 100 tonnes Lower Tier Threshold• 200 tonnes Upper Tier Threshold

• R51/53• 200 tonnes Lower Tier Threshold• 500 tonnes Upper Tier Threshold

RECLASSIFICATION DUE TO NEW DATA


Chemical Business Association © Copyright CBA 2014 | www.chemical.org.uk

QUESTIONS


2007 – Reg EU 1907/2006

• Understanding the Regulation & legislation• Met with 3rd party service providers • BRC collaborative brands reviewing how to

approach & manage Reach• Risk & Impacts of waiting for a perfect

solution • Programme to capture (Bill of Substance)

BOS, declarations, weight, CAS numbers

Risk Assessment Considerations• Business model – complexity of being a department

store• Supply base – FOB, landed, International brands• Reputation, Litigation, prosecution• Scale of high – medium – low risk products• Dedicated team • Expertise – knowledge & understanding of chemicals • Understanding the regulations• Industry research• Keeping up to date with legislation & changes to

regulations

Risk Assessment – Partner with a 3rd

party

• Ensure adherence with the regulation• Technical support & advice, SVHC’s & chemicals• Consumer expectation & confidence• 45 day ruling for Reach enquiries• Consumer protection• Drive to significantly restrict & prohibit the use of

SVHC’s & other harmful chemicals globally

The Changing world, industry &Reputation

• Awareness of the damage caused & on-going impacts of using dangerous chemicals

• Human health & the environment• Industry – alternative solutions• Careful consideration of new and med-long term

suppliers• Assessment and risk mapping• Brand reputation• Investors – sustainable investment

Impacts to Health - examplesHeavy Metals –Nickel• Agent can trigger dermatitis if in prolong contact with skin• Affect central nervous systemChromium• Chromium (VI) and certain Chromium (VI) compounds are known

carcinogens• Chromium (VI) can also be corrosive to skin and can cause allergic

reactions

Phthalates• Risk to human health and environment• Bio-accumulative• Endocrine disruptor• Carcinogenic pHFabrics with extreme pH value can easily damage the skin and cause allergic reaction

Suppliers & Manufacturers

• Formal roll-out of Reach programme• Provide training & support for suppliers• Primary responsibility lies with the Importer• Mandatory requirement for BOS to be submitted• Declarations – spot checks• Due-diligence testing• On-going updates and seminars• Annually review programme & SOP

Reach Enquiry – product management

• If a enquiry is received essential to follow the documented procedure in SOP.

• Gain maximum information as possible about the complaint

• Find out if other complaints have been received• Seal the product in a polythene bag – ensure its

airtight and minimise handling• Identify if a production sample (‘gold’ seal)

product is available for reference

On-going Due-Diligence & Best practice

• Be prepared for up & coming regulation • Ensure a comprehensive well-proven tool for

chemical management • Audit your SOP• Engage regularly with suppliers & manufacturers • Test results, BOS data, corrective actions• Constantly encourage full transparency • Maintain on-going supply-chain communication,

internally & externally

Product Testing

• Article vs component• Degree of risk, product & laboratory• Frequency of testing & supplier collaboration• Consistent testing• Solvent extraction• Mixtures, timings, industry – Reach needs a

regulated consistent test standard• Risk with individual interpretation

Industry Guidance

• BRC, Chemical Watch, chemtrac-ReachCentre, BV, ITS, SGS, Satra etc

• Ensure internal Reach team trained with on-going guidance & support

• Training• Research• Reach towards 2020 & beyond

International Standards & regulations• Korea REACH• Taiwan -Toxic Chemical Substance Control Act

• China - Measures for the Environmental Administration of New Chemical Substances; 58 priority chemicals; presentation of an elimination and restriction list announced for 2015

• Russia - Federal Law About Technical Regulation on Safety of Chemical Regulation

• Philippines - Philippine Inventory of Chemicals and Chemical Substances • Turkey - Chemicals Management Regulation (bridge to REACH) • Australia - Industrial Chemicals Act - NICNAS • South Korea - Toxic Chemicals Control Act

• EU - REACH, product directives (toys, cosmetics, RoHs) • Japan - Chemical Substances Control Law

The damage is real

• March 2014 – Herald Sun.com.au

Thank you for attending

What did you think about the webinar? Please take part in our email survey (in your inbox now)A downloadable recording of this presentation (with slides) will be available shortly. If you have any questions, please contact Lorna ([email protected])

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Documents

REACH management in the supply chain Webinarmedia.simplicityweb.com/chemicalwatch/CW-REACH-a… · · 2014-11-07REACH management in the supply chain Webinar 5 November 2014,