Presented by:Bruce CalderVP of Consulting Services

REACH SVHC Definition of an ArticleOpinion of the Advocate General of the ECJ

Agenda• Introduction

• Opinion of Advocate General of ECJ- Context

- Ruling

- Summary

• Managing change in article definition- Practical impact

- Problems with ‘grind’ based testing

- Risk based assessment and testing

- Example product

• Summary

• Q&A

Webinar is 50 minutes with 10 minutes of Q&A

(hopefully)

Claigan - Restricted Materials Services

• Restricted Materials Services- RoHS (EU and China)

- REACH SVHC and Article 67

- Conflict Minerals

- California Proposition 65

- Global requirements

- EMC Testing

• Capability- Consulting

- Laboratory testing

- Data gathering

- Technical files and declaration

- Auditing

Website Updatedhttp://www.claigan.com

Global Support - Claigan Program

Each month(or quarter)

Written Report

Interactive Webmeeting

On demand

Example Topics from Past Months• New Proposed California Proposition 65 warnings

• Amendment to RoHS Recast (phthalates)

• New China RoHS standard

• Two New REACH SVHCs for consultation

• REACH enforcement using mobile apps

• Opinion on Articles (ECJ)

• Recent Proposition 65 prosecutions including DINP

• CoRAP List Update

• Addition of Styrene to Proposition 65

REACH SVHC Opinion - Articles• France has applied to the European Court of Justice

(ECJ) regarding the definition of an article

• Difference of opinion- France

• Components of an article are also articles

- European Chemical Agency (ECHA)• Article is the final product

• The ECJ has referred the issue to the Advocate General of the ECJ for a legal opinion.

- One of the steps for the ECJ to issue a ruling

- The ruling would apply to all EU member states

REACH SVHC Opinion - Articles• Summary of opinion

- "The supplier of an entire article consisting of component articles which, despite being integrated into an entire article, retain a shape, surface or design of their own is required to provide information to recipients and, on request, consumers under Article 33 of the REACH Regulation on a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) if it is present in a component article above a concentration of 0.1% weight by weight (w/w) and relevant information is available to the supplier."

• Long story short- SVHCs above 0.1 % w/w in components in an article would need

to be communicated to customers

REACH SVHC Opinion - In Practice• Implementation

- The opinion is only an opinion by the legal service of the ECJ. The ECJ still has to rule

• Ruling is months away

- ECJ’s ruling will have enforceability on all EU member states

• Ruling - Expected before summer

REACH SVHC Opinion - In Practice• Compliance change

- Grind testing of full products would no longer be feasible

- Risk based engineering evaluation and testing would have more ‘follow up’ tests for specific materials

• example - small PVC cable bundles that would normally be ignored for phthalates due to inconsequential size would need to be checked for phthalates

- REACH SVHC declarations are expected to have more ‘best efforts’ and similar statements

Grind Testing for REACH SVHCs• Source of most of the incorrect declarations reviewed or

received by Claigan- Grind of full product and test for SVHC

• Not an effective compliance method (even now)- Metals, plastics, and circuit boards are ground separately then re-

combined

- Different solubilities of different plastics make the resulting powder incompatible with many test methodologies

- Cannot identify the part that caused the issue• i.e. No ability to replace the offending part

• Which is a serious issue with the four phthalates being added to RoHS

• New potential article definition- Measured values would be for full finished products and not for articles

in an article

Risk Based Methodology• Claigan standard approach

- Risk based evaluation of materials

- Segregation of materials into high risk / low risk

- Testing of high risk materials for specific substances

• Advantages- Higher accuracy

- Lower cost

- No false fails

- Specific parts or materials at cause of the failure can be identified and replaced

Risk Based Assessment and Testing• Example process / product

• Random product purchased locally

Product Articles - Group 1• First set of articles (old rules)

• Eight (8) articles (don’t forget the twist tie)

Product Articles - Group 2• Second set of articles (old rules)

• Four (4) more articles (for a total of 13 - outer box too)

Dismantling of Main Unit for Assessment• Dismantling of main article

• Other articles happen to be low risk (including tie)• Uncoloured ABS, PE, paper, and cardboard

Except

External plastic over 20% of unit weight

UV 320UV 328

High Risk Parts - Old Rules

External plastic over 20% of unit weight

UV 320UV 328

PVC Cable over 0.33% w/w of unitDEHP (and other

phthalates)

Additional High Risk Parts - New Opinion

PVC jacketed wireDEHP

(and other phthalates)

PVC tubeDEHP

(and other phthalates)

Summary of Evaluation• Kitchen electronic product

- Old definition of an article - high risk materials needing testing

• UV stabilizers (UV 320, UV 328)

• External white ABS plastic

• Transparent accessory plastic

• DEHP (and other phthalates)

• Power cord

- New definition of an article - high risk materials needing testing

• All of the above and

• DEHP (and other phthalates)

• Black wire, blue wire, and transparent tube.

Overall Summary• Advocate General to the ECJ formed opinion on

definition of an article- Components of an article would qualify as separate articles

• Enforceability- Actual ruling would originate from ECJ directly

- Likely out before summer

• Practical implications- Grind and test a full product is no longer remotely practical

- Risk based assessment is applicable• Number of high risk parts will increase if the definition changes

Global Support - Claigan Program

Each month(or quarter)

Written Report

Interactive Webmeeting

On demand

Claigan - Restricted Materials Services• Restricted Materials Services

- RoHS (EU and China)

- REACH SVHC and Article 67

- California Proposition 65

- Conflict Minerals

- Global requirements

- EMC Testing

• Experience- Consulting

- Laboratory testing

- Data gathering

- Technical files and declaration

- Auditing

Q&A

Website Updatedhttp://www.claigan.com