no data no market- meeting the 2018 reach registration deadline part two
TRANSCRIPT
[email protected]/ www.assentcompliance.com / 1 866 964 6931 / © Assent Compliance 2017
PART TWO
No Data No Market - Meeting the 2018 REACH Registration Deadline
[email protected]/ www.assentcompliance.com / 1 866 964 6931 / © Assent Compliance 2017
Today’s Moderator
Valerie KuntzAssent ComplianceSubject Matter Expert
[email protected]/ www.assentcompliance.com / 1 866 964 6931 / © Assent Compliance 2017
INTRODUCTION
[email protected]/ www.assentcompliance.com / 1 866 964 6931 / © Assent Compliance 2017
Assent Product SuitesOur Market Leading Platform
Ethical Sourcing
Materials Management
Supplier Information Management
InspectionsConfigurable Surveys & Declarable Substance
Lists
March 14, 2017
2018 REACH Deadline for Registration
Agenda• Intro to Tetra Tech
• Explaining REACH
• Supply Chain Coverage
• Associated Risks
• Plan for Success
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Tetra Tech OverviewTetra Tech is a leading provider of consulting, engineering and technical services worldwide.Employees: 16,000Revenue: $2.4 billion (FY 2015)NASDAQ Symbol: TTEKOffices: 400 worldwide
75%Water & Environment
15%Infrastructure
10% Energy
5% International
15% U.S. State &
Local
45%U.S.
Federal
35%U.S.
Commercial
Customer Mix
Business Mix
Material Compliance Sectors
∙ Electronics (WEEE/RoHS)∙ Automotive (ELV/IMDS)∙ Multiple Industries (REACH)∙ EU Packaging∙ Energy Using Products (EuP)∙ Life Cycle Assessments∙ Design for Environment∙ Green Procurement / Green Supply Chain
Continued Assessment and Planning
Supplier Training and Management
Suppliers
Manufacturer
Purchasing
Sales
Engineering, Materials Customers
IT Solution
Mana
gem
ent
Quali
ty BOMsLegislative Monitoring
Data Extraction, Review and Entry
IT Solutions and Systems Integration
Internal Training and Communication
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Material Compliance – 7 Areas We Focus On
Reporting5
What is REACH?Quick overview of the Regulation
Registration, Evaluation, Authorization and Restriction of Chemicals▪ Regulation (EC) No 1907/2006,
– Initial regulation is over 700 pages– Several thousand additional pages of guidance
▪ Administered by the European Chemical Agency (ECHA)
Requires industry to be responsible for the safe manufacture and use of chemical substances
▪ Registration of substances by manufacturers/importers▪ Communication of substances of very high concern (SVHC)- articles▪ Authorization and Restrictions on chemicals posing unacceptable risk
Obligations exist for nearly all products, parts, substances and mixtures manufactured or imported in Europe
• EU manufacturers and importers of substances on their own or in mixtures in quantities of one tonne or more per year.
• EU producers and importers of articles in case that the article contains a substance in quantities over 1 tonne per year and the substance is intended to be released under normal or reasonably foreseeable conditions of use.
• ‘Only representatives’ established in the EU and appointed by a manufacturer, formulator or article producer established outside the EU to fulfil the registration obligations of importers.
Who Can Register?
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Solutions to Registration
1. Exit the from EU Market
2. Self- Registration by Importer
3. Coverage Letter from Supplier (or Only Representative, OR)
Legal Context is unclear and guidance not published.
• Stop Importation • If market is re-entered maintain tonnage to <1 MT per
importer• Still keep track in case of audit.• Maintain flow of Safety and Hazard information
Exit from Market
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Information to be normally provided in each dossier is listed in Annex VI of REACH. So-called ‘standard information requirements’ depend on the tonnage band and are detailed in column 1 of Annexes VII through X and ‘specific rules’ for their adaptation are given in column 2 of these Annexes (see Section 5.2).
Abbreviated version of Registration process and building Dossier
• Confirm ID of substance and align with proper SIEF. (assumes substance is already pre-registered)
• Join SIEF and purchase LOA based on import volume
• Utilize LOA information, specific use, analytical data, import data and SDS information to create dossier via IUCLID 6 utility tool
• File dossier via REACH-IT with ECHA and pay ECHA fees
• Insure importers and supply chain knowledgeable on hazards of substance (SDS distribution)
• Maintain data on annual import volumes and substance safety information.
Self Registration as Importer/Manufacturer
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Your supplier and/or Substance Manufacturer will register the substance for REACH and will report your companies imports under their import volumes
Example:
YOUR COMPANY buys 100MT/yr of MeOH from Oakmont Chemical.
Oakmont has registered MeOH at >1000 MT.
Your Company enters into an OR Contract with Oakmont and they report your import information with their own and other customers data.
Coverage from Supply Chain
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Pros:▪ No cost for registration▪
Cons:▪ Bound to that specific Supplier▪ May be limited to Suppliers import volume restrictions▪ Must pass along information of who your importers are (unless being handled
by 3rd party i.e, OR)▪ Reliant upon Supplier gaining Registration by Deadline (May 31st, 2018).
Same:▪ Still required to track and report substance import information
Coverage from Supply Chain
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•Penalties from EU•Public image•Market loss•Worker exposure
Risk of Non-Compliance
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•Does your documentation cover the risk•Quality Suppliers
•Responsive•Dependable
•Levels of documentation•Audits
What is the Appropriate Due Diligence
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• The registration number for each substance is listed on the letter (verify in REACH-IT and check to see whether the number is valid)
• The specific tonnage amounts purchased from the supplier are listed for each of the past three calendar years• The communication is on company letterhead and signed by a senior individual• The company is specifically mentioned as a covered party• The years of coverage are mentioned. For example, “this coverage is valid from Jan 1st, 2018 through Dec 31st,
2019” • The product’s relevant uses are mentioned as covered. This would only require the uses of the product in the
EU as those outside the EU are not subject to the REACH Regulation• The commitment is referenced in the company’s Supplier Terms and Conditions, or other contractual
instrument, and defines the consequences of failure to perform. For example, consequential damages for loss of EU market sales
Gold Standard (Best Practice)
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• A pre-registration number is provided
• A verbal commitment to register by May 31st, 2018 is provided, along with some type of commitment to immediately notify the company if that decision is reversed
• The tonnage band for which the company will be supported is mentioned. Otherwise it is possible the registration may not cover all exported/imported volumes, and a portion of the product will be non-compliant and not entitled to be imported into the EU
• The chemical ingredients are mentioned
• The communication is on company letterhead, signed and contact information is provided for any questions
• The company is specifically mentioned as a covered party
Silver (OK for Now)
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• No registration nor pre-registration numbers have been provided but there is at least an assertion the chemicals have been pre-registered and will be registered
• The company is not mentioned and the communication is addressed “To Whom It May Concern.” The registration might not necessarily document any coverage that is of use to the company and its supply chain
• No mention of tonnage bands makes it unclear how much of the product is covered• It is clear the communication came from the supplier, but it is not clear who the
contact person is, what level they are in the company and how to contact that person to obtain more details
Bronze (Unsuitable)
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• The letter says the supplier will be “REACH compliant” but makes no commitment to any actions to ensure that occurs
• One or more of the chemicals purchased are not mentioned
• The verbiage is very high level, vague and does not demonstrate any specific understanding of the requirements of the regulation
• Supplier uses language designed to shed its liability, such as a disclaimer statement
Paper (High Risk)
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• Able to clearly identify and confirm registration status• System in place to track volume and import locations• Is your supply chain protected?
• Will you be able to get covered product?
• Do you require confidentiality?▪ Only Representative may be an option
Where does you REACH Compliance Stand?
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• Find another supplier• Register
▪Yourself▪Only Representative
• Reformulate• Prepare to exit market
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If you answered No to any of the previous:
How Tetra Tech and Assent Can Help
• Chemical assessment and management of the data (formulations, substance and import information)
• Supply Chain Risk Assessments
• Authorization and registration dossier services
• Only Representative
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How To Get Started with Tetra Tech and Assent
Now is the time to take the right steps to ensure your market access after the 2018 deadline. Contact Tetra Tech for help with your REACH Registration processes, and Assent Compliance to assist with your REACH compliance program.
Contact Tetra Tech’s REACH Consulting Services Group at [email protected] or 734.213.4095.
Contact Assent Compliance at [email protected].
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[email protected]/ www.assentcompliance.com / 1 866 964 6931 / © Assent Compliance 2017
Q&A Discussion
Questions?