rohs & reach: impact on the automotive...

RoHS & REACH:

Impact on the Automotive Industry

Oct. 11, 2016

Nikki Johnson, Total Parts Plus

Agenda

• ELV Requirements

• RoHS Requirements

• RoHS Updates

• REACH Requirements

• REACH Updates

• Impacts to Automotive Suppliers

ELV Requirements

• Every year, end-of-life vehicles (ELV) generate between 7 and 8 million tonnes of waste in the European Union which need to be managed correctly

• The ELV directive sets clear quantified targets for reuse, recycling and recovery of the ELVs and their components

• It also pushes producers to manufacture new vehicles without hazardous substances (in particular lead, mercury, cadmium and hexavalent chromium)

ELV Requirements

ELV Substance Restrictions

Substance Concentration

Lead (Pb) 0.10%

Mercury (Hg) 0.10%

Hexavalent Chromium (Cr6+) 0.10%

Cadmium (Cd) 0.01%

ELV Requirements

• Exemptions defined in Annex II allow for the continued use of hazardous substances in specific applications

• 7th Revision of Annex II released May 2016

• Many exemptions expired and are now only available on spare parts for vehicles already on the market

• Automotive suppliers must remain diligent to insure sufficient time is allotted for development of alternate technology to replace uses no longer exempted

RoHS Requirements

• The Restriction of Hazardous Substances Directive (RoHS) took effect in 2006 and restricts the use of 4 heavy metals and 2 brominated flame retardants in homogeneous materials

• RoHS applies to EEE as defined by the WEEE categories

• Categories 8 and 9 of the WEEE directive (medical devices and monitoring and control instruments) were given more time to comply

• RoHS directive updated in 2011 (RoHS2) and new substances added in 2015

RoHS Requirements

When to comply?

• All WEEE categories except 8 & 9: July 1, 2006

• Category 8-medical devices: July 22, 2014

• Category 8-monitoring and control devices: July 22,2014

• Category 8-In vitro diagnostic medical devices: July 22, 2016

• Category 9-Industrial monitoring and control devices: July 22, 2017

• All EEE except those explicitly excluded: July 22, 2019

RoHS Requirements

Substances Currently Restricted by RoHS


Lead (Pb) 0.10%

Mercury (Hg) 0.10%

Hexavalent Chromium (Cr6+) 0.10%

Cadmium (Cd) 0.01%

Polybrominated biphenyls (PBB) 0.10%

Polybrominated diphenyl ether (PBDE) 0.10%

RoHS Updates

• Exemptions defined in Annex III and Annex IV allow for the continued use of hazardous substances in specific applications

– Annex III exemptions apply to all products on a material level (ex. Pb in copper alloy)

– Annex IV exemptions apply to category 8 and 9 products on a product level (ex. Pb in x-ray test objects)

• All Annex III exemptions set to expire July 2016 unless an application received for extension

• Exemption applications analyzed in Packs by the Oko-Institute and recommendations sent to the EU

– Some final reports issued, Pack 9 still ongoing

RoHS Updates

• On June 4, 2015 the EU published Directive (EU) 2015/863 which added 4 phthalates to the list of RoHS restricted substances

• These substances become restricted on July 22, 2019 for all EEE except categories 8 & 9

• Restricted for categories 8 & 9 on July 22, 2021

RoHS Updates

New RoHS Substances


Bis(2-Ethylhexyl) phthalate (DEHP) 0.10%

Benzyl butyl phthalate (BBP) 0.10%

Dibutyl phthalate (DBP) 0.10%

Diisobutyl phthalate (DIBP) 0.10%

RoHS Requirements

• 4 phthalates are already REACH SVHCs

• DEHP, BBP, DBP and DIBP are primarily used as plasticizers to soften plastics

• Not always declared on material declarations as plastic compositions are often considered proprietary

• Need to begin research now to ensure the substances are removed from products prior to the restriction date

REACH Requirements

• Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) addresses the production and use of chemical substances, and their potential impacts on both human health and the environment.

• Requires all companies manufacturing or importing chemical substances into the European Union in quantities of one tonne or more per year to register these substances with the European Chemicals Agency (ECHA)

• Restricts the use of substances found in Annex XVII

• Article 33 requires the presence of Substances of Very High Concern (SVHCs) be reported when present over the threshold

REACH Requirements

SVHCs • Substances added to the Candidate List for Authorization

• SVHC list updated every 6 months (currently 169 substances)

• Once moved from the Candidate List to the Authorized list (Annex XIV), SVHCs are given a “Sunset Date” for their use

– After the Sunset date the SVHCs can’t be imported, placed on the market, manufactured or used to manufacture within the EU

– Articles containing the SVHC can still be imported to the EU as long as they were manufactured outside the EU

REACH Updates

• Previous Industry definition of REACH SVHC threshold was based on the weight percentage of the finished product

• On September 10, 2015, the Court of Justice of the European Union ruled that this definition did not meet the intent of the regulation

• New definition states ‘Once an article, always an article’

• Previous definition allowed for the presence of SVHCs to be negated by the mass of the finished product

• New definition requires that the SVHC concentration be known for each component in the product

– Still some discussion as to what defines an article

Impacts to Automotive Suppliers

• Need to ensure that components comply with ELV as well as RoHS and REACH, when applicable

• Different reportable lists for different Industries (GADSL for Automotive, IEC62474 for EEE)

• IMDS used for automotive Industry vs IPC 1752a for EEE

• Exemptions allowed for RoHS differ from those for ELV

• Need to ensure all SVHCs are known at the Article Level instead of the product level

• Suppliers providing components to both the automotive Industry and EEE have to ensure their products comply to all legislation

Questions??

Thank You!

Nikki Johnson Environmental Compliance Programs Manager

Total Parts Plus

[email protected]

Presented By:

Kirsten Wallerstedt Senior Regulatory Analyst

EU Legislative

Updates

EU Legislative Updates

EU Updates – what you need to know now:

I. REACH

II. Nano

III. Biocides

R each

REACH Updates

Preparing for REACH 2018

Deadline: May 31, 2018

Who: Companies manufacturing or importing substances (including in a mixture) in a quantity 1-100 tons/year.

REACH Updates


If your substance is already registered by others, you must do a Joint Registration. Do a sameness check ASAP to ensure you are in the right Substance Information Exchange Forum (SIEF).

If your substance is not registered, start SIEF ASAP to determine who can take the lead and to agree on sameness.

REACH Updates


Tip: You can still “late pre-register” your substances if manufacturing or importing 1-100 tons/yr until 31 May 2017.

REACH Updates


Non-EU Companies:

The European Chemicals Agency (ECHA) provides support for non-EU companies (echa.europa.eu/contact/helpdesk-contact-form/enquiry-on-reach-from-non-eu-countries)

REACH Updates

Take steps now to ensure the continuity of your supply in 2018: • Review your chemical inventory • Identify substances that are not yet registered

by your suppliers • Check REACH registration database to see if

another supplier has registered the substance • Check with your sector organization about

registration of substances for your sector • Check that registrants are aware about how

your sector uses their substances

Advice for

downstream

users


ECHA’s Approach (echa.europa.eu/reach-2018)

1 • Know your portfolio

2 • Find your co-registrants

3 • Get organized with your co-registrants

4 • Asses hazard and risk

5 • Prepare your registration

6 • Submit registration dossier

7 • Keep your registration up to date

REACH: 3rd Registration Deadline

Communication flow in the supply chain

Communication on uses to the

registrant

Communication on safe use to downstream users

Registrant (CSR) Manufacturer/ Importer

Formulator

Formulator

DU DU

DU

End user

Source: ECHA

REACH Updates

Recent EU REACH Headlines: • ECHA Publishes List of Substances with Lead Registrants (Sept 28)

– Will help with 2018 Registration deadine

• EU Amended the REACH Regulation’s Skin Sensitization Testing Guidelines (Sept 20)

• ECHA Updated the List of Substances which may be Subject To Compliance Checks (Sept 7) – Added 14 substances

– Update your dossiers by mid-Nov (if needed)

EU: Developments on Horizon

• New harmonized classification for

Bisphenol A (BPA) (category 1B

reproductive toxicant) valid from March 2018

• Significant because under REACH, category 1 CMRs can be nominated as SVHCs and placed on Candidate List

• Therefore, BPA may eventually be placed on REACH Annex XIV – Annex XIV = list of substances flagged for phase out from EU market, barring

authorization for specific use

REACH & Brexit

Impacts on:

Companies’ use of UK companies as representatives under REACH

Importers of biocidal products

UK as an Evaluating Member State

Looking Forward

2019: European Commission reviews

‒ See Article 138 for required reviews

2020: All SVHCs on Candidate list

2022: ECHA draft decisions complete for testing proposals on registrations submitted for the 1 June 2018 deadline

B iocides

Biocidal Products Regulation (BPR)

Wood paneling

• Effective 1 September 2015

• Fines up to 40,000 Euros

Biocidal Products Regulation (BPR)

Companies need authorization before they

can place a b.p. on the market

Active substances must be approved for the relevant

Product Type

Your Active Substances suppliers must be on the

Article 95 list

The BPR applies to the whole article even if only

one part is classified as biocidal

EU Biocides

Updates on Biocides in Europe

Upcoming deadlines: • All active substance and product-type

combinations have deadlines to apply for Union authorization. Apply in time to keep your product on the market.

• Treated Articles (TAs), e.g. cars, may not be marketed after March 1, 2017 unless approved, or until 180 days after rejection of application.

• See also: https://echa.europa.eu/regulations/biocidal-products-

regulation/upcoming-deadlines

ECHA

https://echa.europa.eu/regulations/biocidal-products-regulation/upcoming-deadlines







EU Biocides


Defining Endocrine Disruptor Chemicals (“EDCs” or “ED") • Proposed scientific criteria in a draft legal act in

June 2016.

• The act defines how active substances are to be identified as having ED properties, as well as the scientific protocols which are to be used.

How to

define

EDCs

EU Biocides


EDC Impact: Biocidal Products Regulation

Substances having ED properties which may cause adverse effects will not be approved (unless there is negligible risk).

How to

define

EDCs

EU Biocides


EDC Impact: REACH • One way Authorization is allowed is if the socio-

economic benefits outweigh the risks to humans/environment.

• The EC will assess whether this basis for authorization should be extended to EDCs.

• Will publish their review by end of 2017.

How to

define

EDCs

EU Nano

EU updates: Nanomaterial regulation

REACH compliance: ECHA’s compliance checks have noted that information on the nano-form of a substance should be included on registration dossiers.

Expect: Framework for more specific requirements for nanomaterials under REACH & CLP.

Update: EU indicated that it will not create an EU register.

National nanomaterial registries

France

Norway

Denmark

Belgium – Note upcoming deadline 1 Jan 2017 for mixtures

Italy (voluntary)

Sweden – proposed

EU Nano

Moratorium on updates to REACH until after the 2018 deadline --Notably, does not apply to Nano.

EU Nano

Other nanomaterial updates

ECHA published “Guidance on Information Requirements and Chemical Safety Assessment” in Feb 2016. (Ongoing publication of such guidance documents)

CEN Committee questionnaire on disposal practices for manufactured nano-objects in waste. (Closed 5 Sept. 2016)

EU Nano

CEN = European Committee for Standardization

Other nanomaterial updates

ECHA published “Usage of (eco)toxicological data for bridging data gaps between and grouping of nanoforms of the same substance: Elements to consider” in March 2016.

EU Nano

https://echa.europa.eu/documents/10162/13630/eco_toxicological_for_bridging_grouping_nanoforms_en.pdf







OECD ‒ July 2016: Summary reports on 4

nanomaterials

‒ Feb 2016 Report: “Categorization of Manufactured Nanomaterials”

‒ Feb 2016 report evaluating the physical-chemical properties of nanomaterials including methods used during testing

‒ Series on the Safety of Manufactured Nanomaterials

EU Nano

http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2016)9&doclanguage=en

http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2016)9&doclanguage=en

Other EU nanomaterial headlines:

Germany Set Out a Long-term National Research Strategy on Nanomaterials (Sept. 2016)

EU Nano

C onclusions

Conclusions

What to Keep in Mind • May 31, 2018 registration deadline for 1-100 tons

under REACH

• REACH registration dossiers must include information on the nanoform of the substance (if applicable)

• March 1, 2017 deadline for TAs on the EU market under the Biocidal Products Reg

• Jan 2017 deadline for reporting nanomaterials in mixtures in Belgium

REACH

Nano

Biocides

What to Expect Ongoing development of nano-specific

requirements under REACH

Conclusions on EDC definition will affect both REACH and Biocides regulations

Continual additions of nano guidance documents from ECHA and other EU committees

BPA may become an SVHC

REACH

Nano

Biocides

Conclusions

Kirsten Wallerstedt

Senior Regulatory Analyst

T hank You!

Material Manufacturer, Impact of New Regulations, IT-Systems and Standards

on Polymer Material Manufacturer

Stefan Dully

Abridged History of DuPont Biomaterials History of DuPont

– Founded in 1803 as an explosives company.

– Diversified into cellulose-based materials in early 1900s. Developed first “nylon”, PA510, in 1934.

This was a biobased nylon derived from caster beans. PA66 from petroleum sources was later

developed to reduce costs.

– Built world-leading petro-based materials businesses during the 20th century through R&D and

acquisition.

– Commercialized a portfolio of new biobased engineering polymers in the last several years.

– In addition to biobased materials/polymers, DuPont biotechnology is leading the world in biofuels

with cellulosic ethanol and biobutanol. DuPont enzymes are used across a wide range of industries

to improve products and make processes more sustainable.

© Rick Bell – DuPont Performance Materials

Environmental Protection

Mega-Trend Environmental Protection:

– Definition of Mega-Trends

• half-life of less than 50 years

• subject to economy, ecology,

politics and daily life

• global character

– Mega-Trend „Neo-Ecology“

• Lack of Resource, CO2 Emission,

¨Corporate Social Responsibility, Sustainability, Consumer Awareness, …

• This topics won’t be pushed back on a long term and therefore it is seen as a Mega-Trend

and will be one of the leading topics within the next years.

Markets

Technology

Civilization

Source of idea of Megatrends:

2010 Horx Zukunftsinstitut GmbH

Environmental Protection Main Topics of Regulations in Europe

– Emission Management

– Worker Protection

– Waste Management

– Hazardous Management

– Environmental-friendly Products

New Aspects

– Consideration of more impact categories

– Holistic sustainability approach

– No data no market

Initial Situation

Industry Regulatory

56

Without contact to

environment

With contact to

environment

With contact to humans

In human beings

Automotive

Electronics

Food Packaging

Cosmetic Packaging

Construction

Negative Lists

Positive Lists

Tests with Labs

Contracts

Tests

Disclosure

Systems

Initial Situation

IMDS

CDX

CAMDS

BomCheck

Documents

Customer-

specific

3third Party Cert.

Current Challenges

… still a way to go

Different standards/

systems

Intellectual Property

Environmental friendly design

Intelligent use of Information

Challenge: Different Systems and Standards

– Current Standards

– IPC, IEC, IMDS-Format, …

– Current Systems

– IMDS, CDX, BomCheck, …

Solution:

– Focus on standards rather than on systems

and on formal rules of systems.

– Focus on a way for a quick update

of standards.

– No customer specific requirements.

Challenge and Solution

Challenge: Intellectual Property

– Current systems want to get more and more

information from material manufacturer.

Material composition is essential know how

of material manufacturers.

Solution:

– Focus on hazardous substances within

the environment.

– Focus on quick update of negative lists

and updates of information from

your suppliers.


Challenge: Intelligent use of Information

– In different systems a lot of information is

integrated. This information could be used

in a more holistic way.

Solution:

– Use all information in the system.

– If you don’t use all information you can use

standards instead of online systems.


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Challenge: Environmental-Friendly design

- Main objective should be environmental-friendly design.

- Detailed Life Cycle Assessment are very expensive

- Difficult within automotive industry, because of

increasing functionalities weight etc. is increasing.

Solution:

– Develop strategies and projects to increase eco innovations



Harmonization of Regulations:

- TTIP

- CETA

- …

Impact on:

- Internal Processes

- Environmental Protection

- Standards

- Costs

Thank you

Stefan Dully

[email protected]

mailto:[email protected]