rohs & reach: impact on the automotive...
TRANSCRIPT
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
Substance Concentration
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
Substance Concentration
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
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
Preparing for REACH 2018
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
Preparing for REACH 2018
Tip: You can still “late pre-register” your substances if manufacturing or importing 1-100 tons/yr until 31 May 2017.
REACH Updates
Preparing for REACH 2018
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
Preparing for REACH 2018
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
EU Biocides
Updates on Biocides in Europe
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
Updates on Biocides in Europe
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
Updates on Biocides in Europe
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
N ano
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
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
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 and Solution
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.
Challenge and Solution
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Challenge and Solution - Example
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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
Challenge and Solution
Challenge and Solution
Harmonization of Regulations:
- TTIP
- CETA
- …
Impact on:
- Internal Processes
- Environmental Protection
- Standards
- Costs
Challenge and Solution