No Data No Market- Meeting the 2018 REACH Registration Deadline Part One

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PART ONE

No Data No Market - Meeting the 2018 REACH Registration Deadline

mailto:[email protected]



http://www.assentcompliance.com



Today’s Moderator

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Valerie KuntzAssent ComplianceSubject Matter Expert







INTRODUCTION

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Assent Product SuitesOur Market Leading Platform

Ethical Sourcing

Materials Management

Supplier Information Management

InspectionsConfigurable Surveys & Declarable Substance

Lists

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March 1, 2017

2018 REACH Deadline for Registration

Agenda• Intro to Tetra Tech

• Explaining REACH

• Who Is Responsible

• Deadline

• 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

http://www.tetratech.com/

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


3 Phases of REACH1. Restriction

2. Authorization

3. Registration


Restrictions limit or ban the manufacture, placing on the market or use of certain substances that pose an unacceptable risk to human health and the environment.

• Current list of 63 chemicals banned for use

• Each substance has Conditions of Restrictions that apply

• Very small window of exemption and concentration limits. Will vary substance to substance

• Restriction exemptions granted by specific use and only by applicant

Understanding REACH Restrictions

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BenzeneConditions of Restriction

1. Shall not be used in toys or parts of toys where the concentration of benzene in the free state is greater than 5 mg/kg (0,0005 %) of the weight of the toy or part of toy.

2. Toys and parts of toys not complying with paragraph 1 shall not be placed on the market. 3. Shall not be placed on the market, or used, — as a substance, — as a constituent of other

substances, or in mixtures, in concentrations equal to, or greater than 0,1 % by weight. 4. However, paragraph 3 shall not apply to:

(a) motor fuels which are covered by Directive 98/70/ EC; (b) substances and mixtures for use in industrial processes not allowing for the emission

of benzene in quantities in excess of those laid down in existing legislation;(c) natural gas placed on the market for use by consumers, provided that the

concentration of benzene remains below 0,1 % volume/volume.

Restriction Examples

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2. Authorization

3. Registration


This section generates two lists of substances that must be addressed by importers:

▪ Candidate List (SVHC)

▪ Authorization List (Annex XIV)

Understanding REACH Authorization

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SVHCs in the context of the REACH Regulation are:• CMRs category 1 or 2 in accordance with Directive 67/548/EEC4• PBTs and vPvBs meeting the criteria of Annex XIII and• Substances, such as those having endocrine disrupting properties or

those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of Annex XIII, for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points 1 and 2 and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59

Substances of Very High Concern (SVHC)

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Identifies Substances of Very High Concern (SVHC)▪ List of over 173 substances. ▪ New additions every 6 months▪ Precursor list for the Authorization List▪ Determine if substance is in article / material▪ Communicate if concentration is over 1000 ppm in article

Understanding REACH - SVHCs

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The REACH Regulation sets up a system under which the use of substances with properties of very high concern and their placing on the market can be made subject to an authorization requirement. • Such substances are included in Annex XIV of the Regulation• Cannot be placed on the market or used without an authorization after

the sunset date• The authorization requirement ensures that risks from the use of such

substances are either adequately controlled or outweighed by socio-economic benefits

• An analysis of alternative substances or technologies will be a fundamental component of the authorization process

Authorization

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Annex XIV List of substances which require the Authorization process

• Currently at 39 substances, ID’d by CAS number

• Require submittal of Authorization dossier to ECHA for use on the market

• Each substance has established sunset date ▪ Some have passed, other upcoming▪ Still can submit past sunset date, but cannot sell on market until

approval given

Authorization List

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2. Authorization

3. Registration


Understanding REACH Registration

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• Knowledge on hazards and uses of substances is a prerequisite for responsible action

• REACH puts the burden of proof to individual companies. They must demonstrate their substances can be used safely

• Companies collect information, analyze it and document their conclusions in a registration dossier

• Information from registrations is used by authorities and published by ECHA on its website

Registration of chemicals already in the European market in a stepwise manner:Nov 2010 - ≥1000t of import or CMR cat 1 or 2 and ≥ 1t or R50/53 and ≥100tJune 2013 - >100t of importMay 31st, 2018 - > 1t of import

** There are numerous exemptions pre-registration and phase-in requirements that may apply

Registration Phase–In Period

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Understanding REACH Registration

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• 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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You should look at each of these three factors for every substance you deal with:

• Your role in the supply chain: do you need to register your substance or is it an obligation for another actor in your supply chain?

• Scope and exemptions: does your substance need to be registered or is it exempted from registration?

• Volume: do you reach the one tonne per year threshold? (3-year rolling average)

If only one of these factors does not apply, you do not need to register that substance under REACH.

Understanding REACH – Responsibility of Importer

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Import is NOT based on product, but substance!Example:

Product A = 0.8 MT x 80% MeOH = .64 MTProduct B = 0.4 MTx 50% MeOH = .20 MTProduct C = 0.7 MTx 90% MeOH = .63MT

1.47MT

You are importing MeOH above the threshold and must register

Importance of Import Volume Tracking

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An importer is any natural or legal person established within the Community who is responsible for import (Article 3(11) of the REACH Regulation). Import means the physical introduction into the customs territory of the Community (Article 3(10)).

Examples▪ Distributer (depends who makes purchasing decision)▪ Own warehouse▪ Customer▪ Sales Agency

Understanding REACH – Who Is an Importer?

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Import volume based on IMPORTER

Example:

Product A = 0.8 MT x 80% MeOH = .64 MT

Product B = 0.4 MT x 50% MeOH = .20 MT

Product C = 0.7 MT x 90% MeOH = .63MT

1.47MT

Importer #1 = 0.37 MT



Number of Importers

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Import volume based on IMPORTER

Example:

Product A = 0.8 MT x 80% MeOH = .64 MT

Product B = 0.4 MT x 50% MeOH = .20 MT

Product C = 0.7 MT x 90% MeOH = .63MT

1.47MT


Importer #2 = 1.1MT = Registration

Number of Importers

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Registration Deadlines

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• Third and last registration deadline for phase-in substances• Concerns: Companies that manufacture/import substances between 1 to

100 tonnes/year and have pre-registered them• What is new?

▪ Higher % of SMEs

▪ Many SMEs might consider becoming lead registrants for the first time▪ Many small SIEFs/registrants alone in their SIEF▪ Less information → need to generate new data▪ Different levels of sector organizations▪ New economical and political contexts

• Registration can occur Upstream▪ Your suppliers▪ Manufacturer of substance/material

• Registration can occur downstream▪ EU distributor▪ EU manufacturer▪ Anywhere down the supply chain as long as it is an EU entity▪ Only Representative (OR)

• Risks - Who controls the Registration?

Coverage of Your Imports

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• Determine if existing SIEF (substance information exchange forum) exists for you substance

• Has a Lead Registrant been established?

• Does a Letter of Access (LOA) exist?

• If no Lead or LOA, then determine what information is required based upon your import volumes and query industry to see what information exists

▪ Extensive testing may be required▪ Hire consultant to assist with dossier creation▪ Potentially a 12-18 month process

Registration Process

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• Purchase Letter of Access• Determine applicable downstream “uses” of your substance• Create Safety Guidance and Chemical Safety Report specific to use• Obtain analytical information to properly identify your substance• Create Dossier in REACH-IT or IUCLID 6• Upload documentation into REACH-IT and pay ECHA registration

cost• Maintain tracking on import volumes, importers substance

classifications and SDS distribution

Registration- Creation of Dossier

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What Does All This Mean for You?

• Understand Your Imports▪ Products down to substance level▪ Do they contain any restricted substances

– How are they used▪ Contain any Authorization Substances

– When is sunset date– Are you prepared to provide user warning for SVHC

▪ How much are you importing and where is it going.

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Ask Your Supply Chain

• Ask your suppliers if the substance you are buying and importing is registered?

• If not, will it be?

• Is it in process?

• Is there a lead determined?

• Please send me documentation for verification

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In the next webinar, we will review the answers you should be receiving from your suppliers

There Are Various Stages of Assurance1. Coverage letter from the supplier clearly

states REACH compliance, meaning you are safe for the 2018 deadline

2. The letter shows excellent promise of registration

3. There is a good chance of registration4. Time to start thinking of a changePlease send your examples for the next webinar

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Q&A Discussion

Questions?







[Webinar] Transitioning from a Regulatory to a Programmatic MindsetWednesday, March 8th | 1PM EST

[Webinar] No Data No Market - Meeting the 2018 REACH Registration Deadline Part 2Tuesday, March 14th | 1PM EST

Upcoming ConferencesExecutive SummitMay 22 | Chicago, IL

Responsible Business Summit Europe June 7 | London, England

Supplier Relationship ForumJune 8 | Chicago, IL

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No Data No Market- Meeting the 2018 REACH Registration Deadline Part One