REACH SVHC Definition of an Article Opinion of the Advocate General of the ECJ Presented by: Bruce Calder VP of Consulting Services
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 Updated http://www.claigan.com
Global Support - Claigan Program Interactive Webmeeting Each month (or quarter) On demand Written Report
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 recombined - 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 320 UV 328
High Risk Parts - Old Rules External plastic over 20% of unit weight UV 320 UV 328 PVC Cable over 0.33% w/w of unit DEHP (and other phthalates)
Additional High Risk Parts - New Opinion PVC jacketed wire DEHP (and other phthalates) PVC tube DEHP (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 Interactive Webmeeting Each month (or quarter) On demand Written Report
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 Website Updated http://www.claigan.com Q&A