Upcoming Commission Delegated Directive · 2015-12-09 · Commission Delegated Directive 2015/XXXX • If you want to be absolutely accurate, the CoC should read - “Compliant with

Presented by:Bruce CalderVP Consulting Services

Upcoming Commission Delegated DirectiveAddition of DEHP, BBP, DBP, and DIBP to RoHS Restrictions

Agenda - RoHS / Phthalates Restrictions• Introduction

• RoHS- Commission delegated directive

- Timelines

• Phthalates- Uses

- Migration

• Main challenge

• CoCs and technical files

• Near term recommendations- 6 recommendations

• Additional recommendations

• Summary

• Q&A

Webinar is 50 minutes with 10 minutes of Q&A

(hopefully)

Claigan - Services

• RoHS / REACH SVHC- Consulting / Program Development - Review

- Data gathering from suppliers

- Laboratory testing

- Technical files

• Related services- Proposition 65

- Conflict minerals

- EMC testing

Commission Delegated Directive• In April of 2015, the EU Council approved two

amendments to the RoHS Directive • Maximum of 1,000 ppm in homogenous materials of

• DEHP

• BBP

• DBP

• DIBP

• The related Commission Delegated Directive should be published in the Official Journal of the EU in the second half of June• Unless delayed by the EU Parliament (unlikely)

• Likely to be referred to colloquially as ‘RoHS3’

Timelines• Publication

- Expected to be in second half of June 2015

- Commission Delegated Directive 2015/XXXX

- where XXXX will likely be ~1000

• Implementation in national legislation - 31 December 2016

• Compliance deadlines- Most products currently under scope of RoHS Recast

- July 22 2019

- Monitoring and Control Instruments & Medical / IVD Devices

- July 22 2021

Where Are Phthalates Used?• Phthalates

• Principal use is as a ‘plasticizer’

• To increase the liquidity / plasticity of a material

• i.e. make a material more flexible

• Function• A plasticizer is a chemical which is added to a polymer

to increase its flexibility. The plasticizer gets between the polymer chains and keeps them further apart which reduces the forces of attraction between them and makes the material more flexible.

PVC• The principle use of phthalates is as a plasticizer in

PVC

• Concentration depends on flexibility of PVC• 0% to 60% (0 to 600,000 ppm)

• Phthalates are present in virtually all flexible PVC• Typically 20% (200,000 ppm)

• Other names for flexible PVC• vinyl

• synthetic rubber

Other Common Uses• Buna-N and Buna-S

• Acrylonitrile butadiene rubber (Buna-n or NBR)

• Styrene-butadiene rubber (SBR)

• Both commonly use phthalates as the plasticizer

• Epoxies / sealants• Phthalates (DEHP, BBP, DBP, DIBP) are also commonly used

in epoxies

• Which include epoxies used in surface mount components

• like polymer resistors

Migration• DEHP and other phthalates have tremendous ability to

migrate from one material to another

• High risk situation for electronics• ESD mats

• commonly • either PVC or buna-n

• with high concentration of phthalates (~20%)

• phthalates migrate into adjoining plastics (including PVC, polystyrene, and other plastics)• can migrate up to 10,000 ppm into contacting material

• faster in situations with heated plastics

• http://www.sciencedirect.com/science/article/pii/S0165237003001311

The Challenge - Two Different RoHS• The largest challenge of the new commission

delegated directive

• First time that there are two active forms of RoHS• i.e. RoHS compliant can mean two different things

• Different RoHS’s• RoHS compliant

• RoHS compliant including commission delegated directive 2015/XXXX

• Just from a database perspective

• Database needs to be able to hold two different RoHS compliance flags

• Not to mention supplier confusion, contract manufacturers, designer confusion, etc…

CoC Updates• CoC (Certificate of Compliance)

- RoHS compliant NOT satisfactory

- CoC needs to be compliant with RoHS including Commission Delegated Directive 2015/XXXX

• If you want to be absolutely accurate, the CoC should read- “Compliant with the materials restrictions of Article 4 of

RoHS Recast including Commission Delegated Directive 2015/XXXX”

• However, compliant with RoHS including Commission Delegated Directive 2015/XXXX should be sufficient

Technical File Updates• Technical File

- Finished products only

- Technical file needs to be completely updated

• Updates- Update criteria for acceptable supporting documentation

- Documentation specification

- Update supporting documents for applicable parts

- Update of risk assessment

- Update of any testing performed

- Update of compliance statement by final integrator

What To Do Now?• Should I go out and collect new data tomorrow?

• Well … no.

• Details• The legislation is not published yet and, therefore, there is

no specific legislation to request compliance to.

• Your suppliers will not be ready

• And data you are able to collect will not be reliable

• and you will just have to regather it

• But your customers might not know that

• What can I do?• Create a plan

• (and possibly a budget)

1. Develop a Communication for Customers• Chances are

- At least one of your customers will come asking about RoHS3.

• Recommendation- Create an initial communication in customers stating

- You are committed to compliance with RoHS including the upcoming Commission Delegated Directive regarding phthalates

- You will provide a compliance timeline before the end of 2015

- Or some other reasonable date

- Include contact information (possibly to a generic email address such as [email protected])

- Develop a plan to be able to provide a more concrete statement and timeline

2. Develop a New RoHS Specification• Supplier / part specification

- First step to compliance to the phthalate restrictions

- Update your ‘ask’ or specification

• Questions to resolve- What is your new compliance requirement?

- including wordage such as the name of the new delegated directive

- How are you going to update your part specification?

- What are you going to do about drawings?- If you used statements such as ‘Must be RoHS compliant’

- A separate environmental spec is recommended

- How are you going to store / mark compliance?- Remember - two different and valid RoHS’s at once

3. Develop a Plan to Implement in New Products• Your first internal ‘customer’ will be the people

designing your new products- They will not want to re-design a product in three years

• Implementation in new products will include- Update of design specification

- Implementation of new specification

- Training of design team on new requirements

4. Develop a Plan to Update ECO Process• ECO

- Engineering Change Order process (or similar)

• If you are changing parts, it would be helpful if you do not have to change the parts again in three years

• Implementation- Recommend leveraging new part specification

- Implement with operations

- May require training of operations / design / procurement

- Often more difficult with contract manufacturers

5. Develop a Timeline and Budget for Product Conversion• Next step

- When are your products going to be compliant with the delegated directive?

• Recommendation- Finished products

- Before 2019 (or 2021 for m/i instruments and medical)

- Components / assemblies- Before the end of 2016

- Or earlier if possible

• Component suppliers will have- A short timeline (in practice)

- More risk of being designed out of products- But less so if timeline is clearly communicated

6. Update Customer Communication• Now that you have a timeline

- Update customer communication regarding conversion timeline

- Re-emphasize to management

- Customer demands

- Risks of non-compliance

- Not going to be easy or free

• Next step- Doing the work

Summary of Near Term Steps1. Develop a communication for customers

2. Develop a new RoHS specification

3. Develop a plan to implement in new products

4. Develop a plan to update ECO process

5. Develop a timeline and budget for product conversion

6. Update Customer Communication

• And then the work really starts….

Recommendations - Leverage REACH SVHC Work• But do not rely on it

- RoHS and REACH have different standards

- Homogenous materials versus articles

- Restriction versus communication

- And, phthalate work for REACH SVHC by suppliers has been ‘inconsistent’

• But it will provide you a good starting point regarding- Parts requiring replacement

- Exemptions you may need

Recommendations - Identify if any exemptions needed• The new delegated directive will have no exemptions

- To start with

• Many critical uses of DEHP are in consumables- Such as a catheter tubes

- Which are not under scope of RoHS

• But you may have other critical uses that cannot be replaced

• Applying for an exemption- Standard RoHS process

- Take 1.5 to 2 years on average for an exemption to be accepted

- You should start early

Recommendations - Identify ‘No Risk’ Materials• ‘No Risk’ materials

- Some materials cannot use phthalates at all

- Example

- metals and metal alloys

• Under EN 50581:2012 - 4.3.2 Determine the information needed - Manufacturer can determine that certain part types do not

require additional documentation / information

- Such as 100% metal parts

- Metal parts compliant with original RoHS can be assumed to be compliant with RoHS including commission delegated directive 2015/XXXX

- Which should somewhat reduce compliance work

Challenges with Maintaining Compliance• Currently

- Over 50% of products our laboratory tests for RoHS still fail

- Supplier control of phthalates is far worse than it is for Pb

• Sources of error- Even if DINP is used, we commonly find DEHP over 1,000

ppm in the same material

- Lack of controls in the supply chain

- Higher cost of DEHP testing compared to Pb testing

- Legacy materials

- cables (i.e. we still see Pb in PVC cables)

- labels

• More risk based testing will be needed to maintain compliance

Full Material Declaration• This is likely the year that many people finally realize

that any full material declaration information they collected turns out not to be very useful- Non-standardized data

- phthalates are an additive and do not need to be declared in polymers

- i.e. polymer and epoxies declared at the CAS number which does not require declaration of plasticizers

- Most phthalate containing materials are in part types that rarely have full material declarations

- custom components, cables, rubber feet, labels

- A lot of suppliers just made up most of the non-RoHS data.

Summary• Commission Delegated Directive

- Expected to be published in later June 2015

- Products need to be compliant by

- July 22 2019 - most products under scope of RoHS

- July 22 2021 - medical / IVD / monitoring and control

• Main recommendations- No point gathering data until later 2015 or early 2016

- Develop

- customer communication

- specification

- implementation plan

- Expect lower supplier competence / accuracy than observed for standard RoHS

Claigan - Services

• RoHS / REACH SVHC- Consulting / Program Development - Review

- Data gathering from suppliers

- Laboratory testing

- Technical files

• Related services- Proposition 65

- Conflict minerals

- EMC testing

Q&A