REACH SVHC Compliance

Transcription

1 REACH SVHC Compliance How we do it Presented by: Bruce Calder VP of Consulting Services

2 Overview - Agenda Introduction REACH SVHC Requirements Article definition Compliance Process Risk assessment High risk materials Option 1 - Onsite Evaluation and Declaration Process Declaration Option 2 - Laboratory Testing at Claigan Process Persistent Organic Pollutants Summary Webinar is 50 minutes with 10 minutes of Q&A (hopefully)

3 Claigan Overview Principal Services - Consulting - Laboratory testing - Data gathering Experience - Wide range of professional, medical, industrial, and consumer companies RoHS, REACH SVHC, REACH Registration, Conflict Minerals, Batteries, Packaging, Persistent Organic Pollutants, Proposition 65, California Transparency in Supply Chains, UK Modern Slavery, and more.

4 Claigan - Update Services Monthly or Quarterly Updates - Custom webinar - On the changes in requirements - Impacts to your specific products - Monthly or Quarterly - Interactive

5 REACH SVHC Declaration Article 33 of REACH Regulation (1907/2006) - Suppliers of articles must communicate REACH Substances of Very High Concern (SVHC) > 0.1% w/w in an article they provide to their customer - Suppliers of consumer products to the end consumer only need to supply a declaration within 45 days of a consumer request Based on the decision by the European Court of Justice (ECJ) - Component articles of complex articles are articles and require declaration

6 Summary - What is an Article? Component requires an MSDS - Not an article - Examples - solder, glue, paint - REACH SVHC communication requirements do not apply until added to an article Component does not require an MSDS - Article - Examples - resistor, screw, wire - REACH SVHC communication requirements apply

7 Article Re-Visited Requires an MSDS Not an article Does not require an MSDS Article Any SVHC over 0.1% w/w needs to be communicated to customers in the EU

8 Commonly Declared SVHCs under Old Definition Phthalates (DEHP, BBP, DBP, DnHP, DHNUP) - Plasticizers - Common between 5% to 30% w/w in PVC, buna-n, buna-s, vinyl, sealants 1, 2-dimethoxyethane (EGDME) - Common between 1% to 4% w/w in Lithium manganese batteries UV stabilizers (UV-320, 327, 328, and 350) - in outdoor / UV rated plastics Flame retarded polyurethane - Tris(2-chloroethyl)phosphate (TCEP)

9 Some Specific Impacts Component types more likely to be declarable under the new definition - Internal PVC hook up wires (phthalates) - Buna-n or PVC gaskets (phthalates) - PVC labels (phthalates) - Electrical (vinyl) tape (phthalates and TXP) - Label adhesives (NPEO) - Buzzers / transducers (PZT) - MHHPA (ICs) - DMAC (Kapton & Spandex)

10 Grind Testing for REACH SVHCs Grind testing - Grinding up an entire complex product into a single powder - Testing the powder for SVHCs Not compliant!

11 Risk Based Methodology Testing every component for every SVHC is cost prohibitive A better plan - Risk based assessment and testing - Risk based evaluation of materials - Segregation of materials into high risk / low risk - Testing of select high risk materials for specific substances

12 Claigan Approach Master reference document of REACH SVHC High Risk Materials Based on results from Test results Statements by manufacturers (declarations and SDS) Government agencies

13 High Risk Material Approach Consistent with the ECHA report published this week - Proposed Materials Information Platform (MIP) - Proposed high risk materials database by ECHA

14 Identifying Materials Likely to Contain SVHCs High risk of SVHCS To be tested* Review and separate the materials into 3 piles Low risk of SVHCS Solved Unknown materials To be solved and re-classified low or high risk * for a specific SVHC or set of SVHCs. Can also be solved by supplier declaration

15 How We Do It - In Practice Two Options Laboratory Testing Onsite at your site

16 Option 1 - Onsite REACH Evaluation Onsite REACH SVHC Evaluation (at your site) - by Plan - Education and explanation of process - Evaluation and declaration of one of your products - by Claigan - Evaluation and declaration of a second product - by you aided by Claigan

17 REACH SVHC Evaluation - Onsite High Risk Create Declaration Review Components Onsite Assign Low / High Risk Low Risk From inventory or for specific products Unknown Materials Review with Engineering to Identify Materials

18 REACH SVHC Evaluation - Onsite High Risk Create Declaration Based on Materials Risk Review Components Onsite Assign Low / High Risk Low Risk Unknown Materials Review with Engineering to Identify Materials

19 REACH SVHC Evaluation - Onsite High Risk Create Declaration Review Components Onsite Assign Low / High Risk Low Risk Create a declaration based on identified high risk materials and related SVHCs Unknown Materials Review with Engineering to Identify Materials

20 REACH SVHC Declaration Declaration based on what product does or may contain Acceptable Release REACH SVHC Declaration Business Decision Not Acceptable Identify, Reduce, and Control High Risks

21 Business Decision Is current declaration acceptable to the business? - is declarable may contain specific SVHCs acceptable to the business? If acceptable - Declaration can be released for use If not acceptable - Further works needs to be performed to - Evaluate, reduce, and control the risk Acceptable Release REACH SVHC Declaration Business Decision Not Acceptable Identify, Reduce, and Control High Risks

22 Evaluate, Reduce, and Control Risks Next steps - Identify actual REACH SVHC in product through a combination of - Testing - Supplier data gathering - Reduce - Remove due to test result or supplier data, or - Replace part or material - Control - Implement control of SVHC in that part or materials Acceptable Release REACH SVHC Declaration Business Decision Not Acceptable Identify, Reduce, and Control High Risks

23 Option 2 - Claigan Laboratory Offsite REACH SVHC Evaluation and Testing - at Laboratory testing - Evaluations, screening, and follow up testing at Claigan - Normally in parallel to other regulations - RoHS, RoHS 3, California Proposition 65, EU Persistent Organic Pollutant

24 EU Persistent Organic Pollutants Regulation (EC) No 850/2004 Updated in November by Regulation 2015/2030 #1 cause of EU product recalls (related to restricted materials) Primarily in cheap PVC or vinyl New specification (November 2015) Articles containing SCCPs in concentrations lower than 0,15 % by weight shall be allowed.

25 SCCP Typical Recall Roughly 2 to 3 recalls per week All above 0.15% Example below

26 POP - Short Chain Chlorinated Paraffins Another SCCP Recall - January Power cable

27 Option 2 - Claigan Laboratory Process - Product level evaluation, screening, and testing at Claigan - Normally for multiple regulations at once - REACH SVHC, RoHS, RoHS 3, POP, Prop 65 Product Screening Engineering Evaluation Follow Up Testing (GC-MS) Final Report Screening with XRF FTIR High / Low Risk Assessment Testing of High Risk Materials for Specific SVHCs Final Report with Declarable SVHC

28 Summary REACH SVHC Declaration - Risk based assessment - Does involve business decisions Option 1 - Onsite - Excellent starting point - Excellent for legacy products - Provides education and declarations Option 2 - Offsite Testing at Claigan - Excellent for new products or representative products - Multiple regulations in same assessment / testing - More definitive

29 Claigan - Update Services Monthly or Quarterly Updates - Custom webinar - On the changes in requirements - Impacts to your specific products - Monthly or Quarterly - Interactive

30 Claigan Overview Principal Services - Consulting - Laboratory testing - Data gathering Experience Q&A - Wide range of professional, medical, industrial, and consumer companies RoHS, REACH SVHC, REACH Registration, Conflict Minerals, Batteries, Packaging, Persistent Organic Pollutants, Proposition 65, California Transparency in Supply Chains, UK Modern Slavery, and more. info@claigan.com