Preparing for Increased European Union Regulatory Enforcement in 2020

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 Preparing for Increased
European Union Regulatory
Enforcement in 2020
Today’s Presenters

COMPANY NAME COMPANY NAME COMPANY NAME

Travis Miller Steve Andrews Raj Takhar

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Agenda
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Introduction
Our Market-Leading Platform
Assent Products

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Overview

75%

300k

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Registration is now open

supplychaininsight.com ARIZONA GRAND HOTEL

PHOENIX, ARIZONA
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Feature
Presentation
Format of the Presentation
▪ perspective
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The Situation
Your Company, ACME, Has Just Been Contacted by a Customer Indicating That the Product Is
Non-Compliant With the REACH Regulation and RoHS Directive

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Our Regulator Today

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First Some Thoughts
▪ “Great Unseen”

▪ different in every EU member state

▪ exchange information

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So Are Chemicals/Hazardous Substances in Product Laws
Being Enforced?
EU Product Recalls: Chemicals in Products Is the Number One Reason for Product Recalls
So What Happened to Willie Coyote’s Product?
An Example of the EU Enforcement Authorities Approach

risk assessment

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▪ Random Selection.

XRF

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Next Steps
Technical Documentation

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Next Steps
Outcome

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▪ Product withdrawal from the EU market

Due Diligence

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Our Representative From Industry

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We Don’t Make Anything Inside the EU

▪
suppliers were responsible for providing RoHS
certifications and conformance data on EU REACH.

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We Thought We Had All the Bases Covered (i)

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We Thought We Had All the Bases Covered (ii)

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Our Representative From Legal

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My Persona
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Here Is How I Am Going to Interpret This Problem
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I want to know what the customer and customs is saying
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What Do We Do
Now?
Best Practices for Managing an EU
Enforcement Action
Acme Is in a Bind
The Next Steps the Company Takes Will Dictate the Impact

Let’s Discuss

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List of Harmonised EU Product Regulations (i)
Current List of Regulations

Regulation (EC) No 1907/2006 EU REACH.

Regulation (EC) No 1272/2008 classification, labelling and

packaging of substances and mixtures.
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List of Harmonised EU Product Regulations (ii)
Current List of Regulations

Directive 2011/65/EU restriction of the use of certain

hazardous substances in electrical and electronic
equipment.

Regulation (EU) No 528/2012 biocidal products.

Directive 2012/19/EU waste electrical and electronic
equipment (WEEE).

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List of Harmonised EU Product Regulations (iii)
Current List of Regulations

Regulation (EU) 2017/745 MDR.

Regulation (EU) 2017/746 IVDR.

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Under EU 2019/1020 for Member Market Surveillance Authorities

▪ non-compliant products

▪ unannounced

▪ unannounced

▪ enforce actions

▪ enforce actions

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Under EU 2019/1020 for Member Market Surveillance Authorities

▪ products removed

▪ warning messages

▪ Additional powers

▪ recover costs

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2020-21
A Big Year for Change — Start to Plan for It Now!

▪ Union Product Compliance Network — January 1,

2021, go live date.

▪ ECHA SCIP Database — January 5, 2021

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▪ RoHS Phthalates Restriction

— July
22, 2021
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Comes into force in January & July 2021.

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Upcoming Events
Webinars
Expanding Requirements & Substance List: The State of
RoHS in 2019

Product Compliance Essentials: What Chemicals Are in Your

Supply Chain?

Conferences

Electrical and Electronic Equipment and the Environment

Conference

Supply Chain Insight

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Questions
/Discussion
Conclusion
Lots of different regulations
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EU 2019/1020 (i)
Regulation (EU) 2019/1020 on market surveillance and compliance of products

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EU 2019/1020 (ii)
Key Elements

Union
Economic Market Product New
Operator Surveillance Compliance Powers
Network
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▪ 25th June 2019

▪ 16th July 2021.

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What is an Economic Operator? (i)
Definition of an economic operator

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What is an Economic Operator? (ii)
Obligations

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What is an Economic Operator? (iii)
Non-EU economic operators and EU based ‘fulfillment service provider’ roles

▪ non-EU economic operators come into the scope of the market surveillance
and therefore all 70 regulations when an economic operator sells products by any means
to a EU member state market.

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What is Market Surveillance? (i)

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▪

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 Information and
Testing facilities Communication Mutual Assistance Training
System

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