Presented by:Bruce CalderVP Consulting Services

RoHS in 2019Regulatory changes in China RoHS and EU RoHS

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)

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

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

Presented by:Bruce CalderVP Consulting Services

China RoHSFirst Catalog

China RoHS

China RoHS Law(Management Methods for the Restriction

of the Use of Hazardous Substances in Electrical and Electronic Products)

SJ/T 11364-2014Product Labelling Standard(Marking for the restriction of hazardous

substances in electrical and electronic products)

Mandatorylabelling of content and recyclability

Packaging marking if mandatory standard exists

GB/T 18455-2010Package recycling marking

Standard only ‘recommended’

Restriction of substances if catalog exists

1st Catalog (Batch) released March 2018

Restriction CatalogsProducts and Exemptions

China RoHS

• Catalog released- March 15 2018

• Into effect- March 15 2019

• Two documents- List of products with EU RoHS restrictions for (‘First Batch’)

- Pb, Cd, Hg, Cr6+, PBB, and PBDE

- Applicable exemptions

China RoHS Doc #1 - Products in Scope (First Batch)

1. Refrigerators2. Air conditioners3. Washing machine (up to 10 kg load of clothes)4. Water heaters5. Printers6. Copiers7. Fax machine8. TVs9. Monitors10. Computers (including laptops, PDAs, and tablets)11. Cell phones12. Home phones

• With certain scope limitations

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. 8.3.1 Ceramics and Glass: For Electronics Other Than Dielectric Ceramic Capacitors

- no explicit renewal dates / cycles

- may not update in sync with EU RoHS

China RoHS -Conformity Assessment

• No specific method for conformity assessment yet identified

- expected to be similar to other international methods such as

- EN 50581

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

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 15 2019

• Conformity assessment- No specific process at this time

Presented by:Bruce CalderVP Consulting Services

EU RoHS 2019Directive 2015/863 on phthalates

EU RoHS Update• In 2015, the restrictions in Article IV of RoHS Recast

were updated

• Delegated Directive 2015/863- http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:

32015L0863

• Change- Additional of low molecular weight orthophthalates

- DEHP, BBP, DBP, DIBP

- Restricted at 1,000 ppm in homogenous materials

Deadline• Required for products placed on the market after

• Categories 1-7,10,11- July 22 2019

• Categories 8,9 (medical, IVD, monitoring and control)- July 22 2021

• Placed on the market simplified- Date of custom clearance from importation into the EU

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

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

• 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

Endocrine Disruptors

• Details

- Endocrine disruptor

- Estrogenic

- 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

• Other estrogenic EDCs

- nonylphenol ethoxylates, DEHP, BBP, DBP, and DIBP.MEHP

BPA(Bisphenol-A) - Estrogenic EDC

BPA

Estradiol

Estrogenic feature

• There is increasing data linking estrogenic EDCs to autism- ECHA publication

- https://newsletter.echa.europa.eu/home/-/newsletter/entry/how-chemicals-can-result-in-autism-and-iq-loss-in-developing-children?_cldee=cGF0cmljaWEuY2FsZGVyQGNsYWlnYW4uY29t&recipientid=lead-e8d5fcd4c0e0e71180fa005056952b31-706c50de1ffa46808469593f4d099f34&esid=3d761fc9-8611-e811-80fc-005056952b31&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

EDCs and Autism

• 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)

Where are phthalates used?

• Principal high risk materials- Flexible PVC

- Neoprene

- Nitrile rubber

- SBR rubber

- Adhesives

- ‘Toughened’ or rubberized ABS

• Concentrations- 1,000 to 300,000 ppm

High Risk Materials

• 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

High Risk Components

• 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

Challenges - RoHS 2015/863

• So, do I need to re-gather the data for all of my parts?

• Well, no.

• EN50581 -- 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

Conformity Assessment EN 50581:2012

• 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

EN 50581:2012Determination of Required Information

• 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

Is Data Gathering Successful?

• 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?!?

Data Gathering After the Fact

• 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.

A More Effective Plan

• 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 non-compliant in the future, the penalties are reduced

- Normally to a corrective action

Non-Compliance Event

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

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

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

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

Q&Abruce.calder@claigan.com