RoHS in Regulatory changes in China RoHS and EU RoHS. Presented by: Bruce Calder VP Consulting Services

Transcription

1 RoHS in 2019 Regulatory changes in China RoHS and EU RoHS Presented by: Bruce Calder VP Consulting Services

2 Overview - Agenda Introduction China RoHS Overview First batch catalog Products under scope Tables and labels EU RoHS 2015/863 Challenges Conformity assessment Compliance plan Summary Q&A Webinar is 50 minutes with 10 minutes of Q&A (hopefully)

3 Claigan - Restricted Materials Services Laboratory Testing and Consulting EU RoHS China RoHS California Proposition 65 REACH SVHC REACH Restrictions EU Persistant Organic Pollutants WEEE EU Medical Device Regulation Healthy Hospitals Initiative and many other global restricted materials requirements

4 Claigan Environmental - Difference Claigan s focus - Compliance - End Deliverables If a step or process does not contribute to compliance or end deliverables, then it needs to be justified

5 China RoHS First Catalog Presented by: Bruce Calder VP Consulting Services

6 China RoHS China RoHS Law (Management Methods for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products) Mandatory labelling of content and recyclability Packaging marking if mandatory standard exists Standard only recommended Restriction of substances if catalog exists 1st Catalog (Batch) released March 2018 SJ/T Product Labelling Standard (Marking for the restriction of hazardous substances in electrical and electronic products) GB/T Package recycling marking Restriction Catalogs Products and Exemptions

7 China RoHS Catalog released - March Into effect - March Two documents - List of products with EU RoHS restrictions for ( First Batch ) - Pb, Cd, Hg, Cr6+, PBB, and PBDE - Applicable exemptions

8 China RoHS Doc #1 - Products in Scope (First Batch) 1. Refrigerators 2. Air conditioners 3. Washing machine (up to 10 kg load of clothes) 4. Water heaters 5. Printers 6. Copiers 7. Fax machine 8. TVs 9. Monitors 10. Computers (including laptops, PDAs, and tablets) 11. Cell phones 12. Home phones With certain scope limitations

9 China RoHS - Doc #2 - Exemptions Identical to EU RoHS Annex 3 except - numbers are different - ie. 6(c) Pb in copper allows is 7.3 in China RoHS - open ended limits are listed as infinite value - ie Ceramics and Glass: For Electronics Other Than Dielectric Ceramic Capacitors - no explicit renewal dates / cycles - may not update in sync with EU RoHS

10 China RoHS - Conformity Assessment No specific method for conformity assessment yet identified - expected to be similar to other international methods such as - EN 50581

11 China RoHS - Table and Label Table and label are unchanged from previous requirements - table of hazardous materials needed if any substance is above 1,000 ppm (or 100 ppm for Cd) - irrespective of whether a product is in scope of the first batch catalog or not - product in the first batch still requires a table and label. ie. - if in the first batch - still needs table and label - if not in the first batch - still needs table and label

12 China RoHS - Summary First catalog ( First batch ) - EU RoHS Restrictions to 11 specific categories of electronics - Includes EU RoHS exemptions - with numbering changes Table and labels requirement - Unchanged Into effect - March Conformity assessment - No specific process at this time

13 EU RoHS 2019 Directive 2015/863 on phthalates Presented by: Bruce Calder VP Consulting Services

14 EU RoHS Update In 2015, the restrictions in Article IV of RoHS Recast were updated Delegated Directive 2015/ L0863 Change - Additional of low molecular weight orthophthalates - DEHP, BBP, DBP, DIBP - Restricted at 1,000 ppm in homogenous materials

15 Deadline Required for products placed on the market after Categories 1-7,10,11 - July Categories 8,9 (medical, IVD, monitoring and control) - July Placed on the market simplified - Date of custom clearance from importation into the EU

16 Why were the phthalates added? RoHS is related to the safety of the recycling workers and their environment - Not related to consumer safety Low molecular weight phthalates - Category 1b Reproductive Toxins - Found to be in the blood stream of recycling workers, in the air / dust in the facilities, and in the environment surrounding the facility - Justified restrictions

17 What is wrong with these phthalates? These substances are - Endocrine disruptors - (recent classification from the REACH process) Their metabolites are estrogenic endocrine disruptors - DEHP is not dangerous - Its metabolites (ie. MEHP) are

18 Endocrine Disruptors Key note - The only method that EDCs are categories at this time is through - the EU REACH SVHC process Summary - All EDCs will be REACH SVHCs

19 BPA(Bisphenol-A) - Estrogenic EDC Details - Endocrine disruptor - Estrogenic Estrogenic feature - ie. makes animals or fish more female Male outcomes - Anxiety (commonly referred to as attention deficit) - Reduced fertility (sperm count) Female outcomes - Precocious puberty (early onset) - Ovarian cysts BPA Estradiol Other estrogenic EDCs - nonylphenol ethoxylates, DEHP, BBP, DBP, and DIBP. MEHP

20 EDCs and Autism There is increasing data linking estrogenic EDCs to autism - ECHA publication - _cldee=cgf0cmljaweuy2fszgvyqgnsywlnyw4uy29t&recipientid=leade8d5fcd4c0e0e71180fa b31-706c50de1ffa f4d099f34&es id=3d761fc e811-80fc b31&urlid=21 Believed to be hormonal affects in pregnancy or pre-pregnancy - such as thyroid disfunction - science is still in process Furthering expectation of more regulations of EDCs - the addition of BPA to RoHS in the next 5 years would not be a surprise

21 Where are phthalates used? Rigid plastics - example - PVC Phthalates create flexibility - by getting in between the vinyl chloride strand and forcing them apart - leading to weaker forces of attraction - creating fluidity (flexibility)

22 High Risk Materials Principal high risk materials - Flexible PVC - Neoprene - Nitrile rubber - SBR rubber - Adhesives - Toughened or rubberized ABS Concentrations - 1,000 to 300,000 ppm

23 High Risk Components Typical high risk components - wires and cables - strain relief - o-rings, gaskets - sealed radial bearings - motor belts - stickers (PVC) - soft rubber components - synthetic leather - soft covers

24 Challenges - RoHS 2015/863 Principal compliance challenges - Data not readily available - The data is not reliable at all - The ask is not clear - RoHS 3? RoHS 10? RoHS / phthalates? - RoHS compliant including directive 2015/863 on phthalates - Product re-design - Controls are not in place to maintain compliance

25 Conformity Assessment EN 50581:2012 So, do I need to re-gather the data for all of my parts? Well, no. EN The manufacturer is required to - determination what information is needed - collect that information - evaluate the validity of that information - keep the information up to date - manage the risk of the data being incorrect

26 EN 50581:2012 Determination of Required Information The manufacturer is required to determine - what information is required Examples - phthalates cannot be in metals - An RoHS 2 declaration for metals is sufficient for RoHS 3 / 2015/863 - a supplier level declaration can encompass all parts provided by the supplier - a test report for the product meets the conformity assessment requirement for the product

27 Is Data Gathering Successful? In making an RoHS compliant product? - Not most days. Risk mitigation - In 2017, 60% of finished electronic products that used data gathering as their compliance method failed RoHS 2 under test - and initial results for RoHS 3 are worse

28 Data Gathering After the Fact Data gathering after the fact is a very bad idea. Good questions to ask yourself - Do you buy a stand off and then measure to see if it is 10 cm high? or - Do you buy a 10 cm stand off and then potentially measure it to make sure it is 10cm? - Do you have an enclosure made and then ask afterwards was it aluminum? or - Do you specify in the enclosure s drawing that it has to be aluminum and then potentially verify the first article when it arrives? Then why are you treating RoHS any different?!?

29 A More Effective Plan Create a restricted materials specification - That can be referenced in drawings - That can be provided separately to suppliers - That can be used as a reference by designers - That can be updated and revision controlled Acquire commitment from suppliers that they are building, buying, designing, and providing to that specification Test representative products to ensure the process is working.

30 Non-Compliance Event If you have a non-compliance event in the EU - The national authority will ask for your test report You may be able to get by with a supplier data and an explanation, but it will be tough From lots of experience with national authorities on RoHS, if you have a test report - even if you are noncompliant in the future, the penalties are reduced - Normally to a corrective action

31 Claigan One of our most effective strategies - Map your current compliant state (EMC, restricted substances, etc..) - Then map a future state for - new designs - engineering change orders - Apply the tools to representative legacy products - Create standard compliance outputs to provide to customers - Be on-call to support unique or confusing requests

32 Remember Better than average chance that - even with your best efforts, your product will not be RoHS 2 or 3 compliant A more effective plan - make RoHS (and restricted substances in general) part of the design requirement - confirm acceptance of the spec at the supplier level - verify with testing of representative products

33 Summary - EU RoHS 2019 New restricted substances - July 2019 (except medical and monitoring and control) - DEHP, BBP, DBP, DIBP Data gathering - data gathering after the fact is not very effective Compliance plan - create a restricted materials specification - ensure acceptance by suppliers - test representative products to confirm compliance

34 Claigan - Restricted Materials Services Laboratory Testing and Consulting EU RoHS China RoHS California Proposition 65 REACH SVHC REACH Restrictions EU Persistant Organic Pollutants WEEE EU Medical Device Regulation Healthy Hospitals Initiative Q&A bruce.calder@claigan.com and many other global restricted materials requirements