Navigating the Complex World of GHS / CLP and its Impact on Product Compliance Catherine Bland Technical Sales Support Manager EMEA

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Agenda • GHS Overview • Product Safety and Stewardship Challenges • Implementing Effective Processes to Meet Impending Deadlines • Summary & Questions

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GHS Overview

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Global Adoption – Asia Pacific • • • • • • • • • • • •

New Zealand Japan Korea Taiwan Singapore Vietnam China Indonesia Australia Thailand Malaysia Philippines

– Europe • • • • •

EU Russia Switzerland Serbia Turkey

– Americas • • • • •

USA Mexico Brazil Uruguay Ecuador

– MEA • South Africa • Abu Dhabi

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Challenges of GHS • GHS is a voluntary agreement rather than a law – Each country/region adopted GHS into its own national legal mechanism on its own timeline – Each country was able to chose which hazard classes and categories (i.e. building blocks) to implement • And add additional hazard classes for hazards not covered by the UN Purple Book model. For example: – EU = Ozone – USA = Combustible liquids

• Financial costs to implement – Personal resource, changing labels – printing and application, updating SDS, outreach to customers, software, …………… etc. ©2015, 3E Company, All Rights Reserved

Imminent GHS Deadlines • Countries implementing GHS in 2015: – Taiwan (phase III list) = January 1 – Singapore update 4th Ed. (subs = March 7 -> July 1; mixtures = July 1) – Philippines = late March – Malaysia (substances & mixtures) = April 17 – EU (mixtures), Switzerland = June 1 – Serbia (mixtures) = June 1 – Turkey (substances) = June 1 – USA (substances & mixtures) = June 1 – Brazil (mixtures) = June 1 ©2015, 3E Company, All Rights Reserved

Upcoming GHS Deadlines • Countries implementing GHS in 2016+: – – – – –

Vietnam (mixtures) = March 30, 2016 Turkey (mixtures) = June 1, 2016 Indonesia (mixtures) = Dec 31, 2016 South Africa (mixtures) = tbc, 2016 Thailand = 2017

3E solutions:  Monthly Newsletter & Webinars  WebInsight – GHS Comparison Chart; Regulatory alerts by region / topic; GHS Tools  Classification support – expert authoring services, MSDgen, SAP EHSM Expert rules & SDS templates ©2015, 3E Company, All Rights Reserved

Building Block Approach

Source: 3E Ariel WebInsight ©2015, 3E Company, All Rights Reserved

Industries Affected “Since all chemicals in commerce are made in a workplace (including consumer products), handled during shipment and transport by workers, and often used by workers, there are no complete exemptions from the scope of the GHS for any particular type of chemical or product.” Chemicals, Food contact & Cosmetics Consumer products Pharmaceuticals Electronics & Medical devices Food & Flavours Healthcare Industrial, Automotive & Heavy Equipment Automotive – oil, anti-freeze, paints Oil, Gas & Petrochemicals Retail Utilities – power, water, sewage treatment ©2015, 3E Company, All Rights Reserved

Product Safety and Stewardship Challenges

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Product Life Cycle • All participants impacted – Each stage needs to effectively communicate GHS information downstream – Users = Industrial, Professional, Consumer

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Access to Data Product Data Regulatory Data

• Physical & Chemical • Composition • Tox / ecotox

• Classifications • Health Data • Restricted Substances

Supplier Data • Full 100% composition • Reliable C&L; reliable tox/ecotox?

SDS obtainment Integrated data

Dangerous Goods

PCTEC

• Physical & Chemical • Toxicity • Eco-Tox

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• International Data • Country Specific Lists

GHS asks a lot of a few people

Few companies have access to regulatory attorneys, PhDs, chemists, toxicologists, industrial hygienists, and chemical engineers! 3E solutions: Legal & Regulatory experts Chemists, Biologists, Biochemists, Toxicologists, Environmental Science experts, … Multilingual capabilities ©2015, 3E Company, All Rights Reserved

Product Distribution / Sales Map • Where will your product be: – Manufactured – Warehoused – Sold

• Each different region/country a product passes through can affect: – – – – – –

Exact classification system in use Documentation required Labels to be applied Inventory status checks Product notifications / registrations Regulatory reporting ©2015, 3E Company, All Rights Reserved

Product Lifecycle Management 1. New Product - Concept Initial composition – R&D & Sales, also Product Safety, Toxicology, Industrial Hygienists, Manufacturing

2. New Product Development Finalise composition; intended markets; defined sales region.

3. New Product Launch All required documentation available.

4. Existing Product Change Control Communicate changes of raw material supplier/compositions, manufacturing composition spec, warehousing arrangements, transportation mode, packaging materials, sales / shipping countries, etc.

5. Product Removal from Range Decide process = temporary or permanent; select countries or global; inventory to be run down or immediate – agree dates. ©2015, 3E Company, All Rights Reserved

IT Tools Inefficient data repositories will cause time delays: • Databases – Maintain data once, in one location  consistency; one source of truth

• Document libraries – Sufficient access to appropriate personnel – Automatic link to original source eases maintenance

Document design software: either internal or 3rd party • SDS templates • Label design ©2015, 3E Company, All Rights Reserved

Implementing Effective Processes to Meet Impending Deadlines

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CLP Timeline – Key Dates Currently SDS: Substances = CLP&DPD format; Mixtures = CLP&DPD or DPD only Labels: Substances = CLP only; Mixtures = CLP or DPD

2015

By 1st June 2017 SDS: CLP only format Labels: CLP only

2016

2017

From 1st June 2015 SDS: Substances = CLP only format; Mixtures = CLP only (new SDS), CLP&DPD (existing SDS) Labels: Substances = CLP only; Mixtures = CLP only (new stock), DPD permitted (existing stock already available to market) ©2015, 3E Company, All Rights Reserved

Engage Stakeholders • Communicate compliance obligations (and document) • Outline potential business risks of non-compliance – Official = Inspections, enforcement actions – notice to comply, fines, sales ban – Customers = loss of reputation, find alternate supplier

• Gain buy-in on project scope, resource allocation, budget commitment (e.g. new label stock, packaging, printers, IT software, access to regulatory databases, consultancy support, SDS authoring services, etc.) • Impacts across many functions not just Product Safety – Sales; Marketing; R&D; Purchasing; Manufacturing; Logistics; Customer services; IT ©2015, 3E Company, All Rights Reserved

GHS – Entire Company Effort Procurement Product Safety

Manufacturing

Marketing & Sales

Logistics & Distribution

IT

R&D

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Project Management • Assign a Project Manager – Essential = The ‘do-ers’ will be too busy performing the tasks. One person needs a complete overview of the project, pulling all functions together when necessary and ensuring deadlines are achieved – Assign responsibilities for individual tasks and schedule deliverables – Monitor the project and ensure it stays on track

• Regular meetings to raise issues • Leverage core strengths of team • Maintain positive morale ©2015, 3E Company, All Rights Reserved

Evaluate, Rationalise & Prioritise • 100% compliance for all products, in all regions by June 1st – potentially unlikely • Evaluate product portfolio – Substances – already EU compliant; potentially easier to expand to other regions – Mixtures – group into product families of similar chemistry

• Rationalise based on sales revenue or geography – Which are your top selling products? – Products for key accounts – Countries with limited sales

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Data Gap Analysis • Data from your suppliers: – Need to know full composition – SDS s.3 may not be enough – Obtain CoA; request inventory status and non-hazardous declarations – Beware of concentration ranges – must classify on worst case scenario

• Data on your products: – Physical / chemical data: external test houses if internal facilities not available

• In absence of all necessary data to GHS classify in full: – Use CLP Annex VII conversion table: DPD  CLP – Document product data gaps and efforts made to fill them – Plan and implement review process for when data gaps filled and true GHS classification possible

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Labelling • Design – Required content occupies more room • Each pictogram = 1/15th label surface area for Article 17 content • H & P statements generally longer than R & S phrases

– Minimum label dimensions: 2nd ATP to CLP (No. 286/2011, Table 1.3) – Less space for multiple languages  more label variants

• Printing – Multi-colour printers vs. pre-printed stock • Empty red diamonds are not permitted

• Label application control – Labels will look very similar but may have different content ©2015, 3E Company, All Rights Reserved

Inventory Assessment • How much existing stock at each location? – Non-EU ≠ label change transition periods

• EU: Re-label or stock exhausted before 1st June 2017? – – – –

Manual handling Stock rotation Customer acceptance Remaining lifespan of product ©2015, 3E Company, All Rights Reserved

Distribution of SDS Downstream • Workers shall be granted access by their employer to SDS for the substances or mixtures that they may use or be exposed to in the course of their work. (REACh, Article 35) • The supplier of a substances or mixture shall provide the recipient with an SDS. (REACh, Article 31) • The SDS shall be supplied in an official language of the Member State(s) where the substance or mixture is placed on the market. (REACh, Article 31) • In addition, provide SDS to: – Poison centres, Emergency response providers, 3rd party warehouses ©2015, 3E Company, All Rights Reserved

Self-audit & Product Review • Classification summary documentation per product – The supplier shall assemble and keep available all the information used by that supplier for the purposes of classification and labelling … for a period of at least 10 years … (CLP, Article 49)

• Process to evaluate new information and address any impacts – Updated SDS from Suppliers – Regulatory listings for substances / Changes to regional GHS schemes

• Plan visits to manufacturing locations & warehouses to audit labelling ©2015, 3E Company, All Rights Reserved

Timeline Summary Audit manufacturing/labelling locations

Product prioritisation & grouping Obtain vendor SDS CAS # regulatory data Classify all products to GHS/CLP

Data gap analysis – obtain own product data Review impact of suppliers SDS updates Audit/update own product GHS classifications Document decisions made New labels on stock for non-EU destinations

2015

2016

2017

Author SDS variants Provide SDS updates to customers

Distribution map  label matrix Design/create labels Distribute labels to locations ©2015, 3E Company, All Rights Reserved

Re-label any DPD stock Re-author SDS: CLP-only

GHS Implementation Summary • GHS is becoming global standard – its fulfilling purpose to improve hazard communication and streamline international trade • GHS affects every hazardous chemical material • Heavy burden upon upstream and downstream companies – many companies will have responsibilities in both areas • Structured adoption plans will ensure a smooth transition and help to achieve GHS compliance • No need to “reinvent the wheel” – many tools available to assist with the transition

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Thank you for your attention. Any questions?

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