REACH & Co
Overview on current discussions and relevant ACEA initiatives
CLEPA Materials Regulations Event
17th of May 2017
Reutlingen
Timo Unger
Manager Environmental Affairs
Hyundai Motor Europe R&D
Content
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Hyundai Motor Europe Tech. Center GmbH
• Updates on REACH
–
–
–
–
–
2018 Registration Deadline
New (and old) Restrictions
Exemptions under Authorisation
O5A
AIG on REACH
• Updates on ACEA Projects on Materials & Substances
– Sustainable Substitution
– GRMS2
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2018 Registration Deadline
Yes
Hyundai Motor Europe Tech. Center GmbH
Substances
*1 CMR: Carcinogen, Mutagen, Reprotoxic
(Chemicals)
*2 R50/53: Very toxic for aquatic organisms
Substances
of very high concern
(CMRs*1)
Authorization
No
>100 t/a
Evaluation
1-100 t/a
Registration
Transition Period (only for Pre-Registered Substances):
Deadline for
Pre-Registration
(Pre-Reg =12-18 month after entry into force)
06/2007
REACh enters
into force
12/2008
12/2010
06/2013
Registration & Evaluation Registration & Evaluation
- of Substances>1000t/a
of Substances
- of Substances>100t/a which
100-1000t/a
are classified as R50/53*2
+S
ubstances for Authorization
06/2018
Registration of
Substances
1-100t/a
Registration for all substances > 1t/a, NOT been pre-registered!
optional
mandatory
2018 Registration Deadline
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Question:
• What may happen, if a material manufacturer / importer will not register
in 06/2018
– Possible reasons: registration costs/efforts > expected profit;
company is unaware of its obligations; ...)
• but the (low volume) substance however is crucial to our industry (e.g.
additive for tiny applications)
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Size of the problem
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• How likely is such a scenario?
vs.
• Nobody really knows because there is no tool or other possibility to check
the real risk and justify concrete countermeasures.
• But there are “simple” things everybody can do to
– Get a better understanding on the real size of the problem
– Be prepared and avoid worst case scenarios
Countermeasures / Recommendations
• Proposal to Automotive Industry
– Distribute either the letter or a modified
copy of the wording to your suppliers
– Ask for feedback in case there is an issue
– Provide such feedback also to your
customers
See also:
Latest IMDS Newsletter under
https://public.mdsystem.com/documents/10906/26775/imds_newslett
er_45.pdf/e0debd81-3e45-4d29-9583-2dda810f7fb9
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SVHC Roadmap: Tackle all known SVHCs
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500++
• Timeline: Until 2020 ~ 500
Substances on the Candidate List
173
Update: 2/year
Today
2020
• Progress is on track:
– All substances for which there is sufficient information on the hazard properties
have already been addressed.
• 173 SVHCs on the Candidate List for Authorisation
• > 200 substances with a harmonised classification
• 20 new Annex XVII Restriction
– The focus now is on getting more data on other substances of potential
concern
– > 500 Substances currently under investigation for need of further regulation
• For 159 substances a RMOAs was / is done
• For 67 substances the RMOA-conclusions have been published
– ~50% of these Substances were identified as SVHC
REACH Authorisation
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Examples from REACH Annex XIV
Hyundai Motor Europe Tech. Center GmbH
• Today, there are 31 Substances included, such as:
Examples (Substances with upcoming Sunset Date)
Sunset date
Latest application date
Formaldehyde, oligomeric reaction products with aniline
(technical MDA)
22/08/2017
22/02/2016
Arsenic acid
22/08/2017
22/02/2016
Bis(2-methoxyethyl) ether (diglyme)
22/08/2017
22/02/2016
Chromium trioxide and it’s acids, ammonium dichromate,
Potassium (di)chromate, Sodium (di)chromate
21/09/2017
21/03/2016
1,2-dichloroethane (EDC)
22/11/2017
22/05/2016
2,2′-dichloro-4,4′-methylenedianiline (MOCA)
22/11/2017
22/05/2016
Dichromium tris(chromate), Strontium chromate,
Potassium hydroxyoctaoxodizincatedichromate, Pentazinc
chromate octahydroxide
22/01/2019
22/07/2017
Substances suggested for Annex XIV
Hyundai Motor Europe Tech. Center GmbH
• And there are many more to come…
7th Suggestion for inclusions into Annex XIV
(published on the ECHA website on 10/11/2016)
1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear
Dihexyl phthalate
Trixylyl phosphate
Sodium perborate; perboric acid, sodium salt; Sodium peroxometaborate
Tetralead trioxide sulphate; Pentalead tetraoxide sulphate; Orange lead (lead tetroxide);
Lead monoxide (lead oxide)
Substances suggested for Annex XIV
Hyundai Motor Europe Tech. Center GmbH
• ... and more ...
Draft 8th recommendation Annex XIV
(published on the ECHA website on 02/03/2017)
5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-secbutyl-2-(4,6dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering
any of the individual stereoisomers of [1] and [2] or any combination thereof] (karanal group)
1-Methyl-2-pyrrolidone (NMP)
2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)
2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327)
2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350)
2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320)
1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and
hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5)
Current Developments
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• So far, no Application for Authorisation has ever been rejected
• However, this does not mean that this trend remains stable
– Chromates authorisation: Still no decision on those applications being most
important to Automotive Industry
– Bad precedence because no planning certainty for industry
• Legal disputes at the European Court of Justice to be expected
– E.g. on the granted Authorisation for DEHP in recycled PVC
• Sunset date for spare parts “legacy” to be extended by 3 years
– In the meantime, EC will work out a Commission Decision on a simplified
authorisation for LSPs; Outcome is unpredictable.
• Simplification of procedure for small amounts (< 100 kg)
– legal problems solved; Commission proposal expected soon.
• Dossiers expected to be more slim in future
Clarification / Reminder
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• Please note that an Annex XIV listed substances is NOT automatically
restricted
• Still misleading requests / requirements in the automotive supply chain
• Please be careful when
defining your company
and supplier requirements
REACH Restrictions
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Restriction of four phthalates in articles
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(DEHP, DIBP, DBP, BBP)
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The following uses will be prohibited under the Restriction proposal:
a) any (indoor or outdoor) articles whose phthalate containing material may
be mouthed or is in prolonged contact with human skin or any contact
with mucous membranes
– No current articles in a vehicle that contains one of the four Phthalates and
giving rise to prolonged skin contact during regular use.
– Only a very small number of spare parts would have potential for prolonged skin
contact. These parts are not safety critical and volumes are so low that
substitution for these spare parts would be possible.
– No exemption for spare parts is required.
b) any phthalate containing articles that are used (including stored) in an
indoor space where people are present under normal and reasonably
foreseeable conditions and potentially exposed via inhalation.
– Results from VIAQ testing's:
Well below an interior threshold of 100µg/m3.
– Exposure to DEHP is well below the DNEL of 0.034mg/kg/
bw/day under normal and reasonably foreseeable conditions.
– No impact by the exposure by inhalation
= No exemption required.
Phthalates: Timeline and latest status
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• Conclusion:
– No need for a specific exemption
– We however would like to note that if the finalized restriction would cover parts
that have not been considered in the current draft text (i.e. parts where no prolonged
skin contact occurs), then we may be required to revisit the impact upon spare parts.
• Timeline:
ACEA Input
Recommendation:
• Phase Out the four Phthalates
• Check if conclusions are correct also for your business
• Follow up the legal developments and check for possible changes
Restriction on Nickel
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• The nickel restriction has been in place under EU legislation for many years
(REACH Annex XVII, Entry 27).
– The aim was to reduce consumer dermal exposure to nickel to prevent nickel
sensitisation (nickel allergy) and nickel allergic reactions (contact dermatitis).
– To this purpose, the current Regulation states that Nickel and Nickel compounds
shall not be used:
• (a) in body piercing unless the Ni release […] is less than 0,2 μg/cm2/week
• (b) in articles intended to come into direct and prolonged contact with the skin such
as: earrings, necklaces, bracelets and chains, anklets, finger rings, wrist-watch cases,
watch straps and tighteners, rivet buttons, tighteners, rivets, zippers and metal marks,
when these are used in garments, if the Nickel release rate from the parts of these
articles coming into direct and prolonged contact with the skin is greater than 0,5
μg/cm2/week.
• Articles cannot be placed on the EU market (produced
within EU or imported) unless they comply with this
requirement.
Which typical articles are in the scope of the
restrictions?
What is the definition of “prolonged contact
with the skin”?
Restriction on Nickel
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EC has requested ECHA to develop a guidance which should provide
• A non legally binding interpretation of “prolonged skin contact”
– Prolonged contact with the skin is interpreted as contact with the skin of
potentially more than either
- 10 minutes on three or more occasions within two weeks, or
- 30 minutes on one or more occasions within two weeks.
– The skin contact time of 10 minutes applies when there are three or more
occasions of skin contacts within a two-week time period. The skin contact time
of 30 minutes applies when there is at least one occasion within a two-week time
period.
• Two non-exhaustive lists of articles to be considered as falling in / outside
the scope of the restriction
• The draft guidance is available here:
https://echa.europa.eu/documents/10162/5dea96fd-1db4-4b64-1572-19858939d8fd
Restriction on Nickel -Impact on Automotive Industry
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• Two automotive applications were explicitly
mentioned
• Others may fall under the same principle (e.g.
Chromated parts)
• The REACH TF has commented that both
examples do not fulfill the mentioned
requirements from a prolonged skin contact
Justification: While driving the car, you are
required to hold the steering wheel with two
hands
• Result of discussion is still open
Recommendation:
If not already done though, phase out Nickel in such
applications asap!
Restriction on DecaBDE
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• The restriction decabromodiphenyl ether (decaBDE) was published in the
EU's Official Journal on 10 February 2017 (EC 2017/227)
• It restricts the manufacture, use and the placing on the market of the
substance decabromodiphenyl ether (decaBDE) as a substance and as a
constituent of other substances, or in mixtures, if the concentration is
equal or greater than 0.1 % by weight.
• Derogations include:
– (b) the production of spare parts for either of the
following: (i) an aircraft produced before
2 March 2027; (ii) motor vehicles within the scope
of the Directive 2007/46/EC, …
• The measure will enter into force on 2 March 2017
and is becoming effective 2 years later
= on 2nd March 2019
Recommendation:
If not already done though, phase out DecaBDE
latest by Mid of 2018!
Restriction on DecaBDE vs Stockholm Convention
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• In parallel, Norway was submitting c-decaBDE to the Stockholm Convention.
• The decision to list DecaBDE in Annex A of the SC was taken at COP-8.
• The whole DecaBDE REACH Restriction will be withdrawn as soon as
DecaBDE is added to Annex 1 of the EU POP Regulation.
• The very broad exemptions for Legacy Spare Parts under the current
Restriction will then be narrowed down to the exemptions as listed in the SC.
• But the individual parties (e.g. Germany) may decide not to make use of any
/ all exemptions.
• This is likely to happen earliest by mid of 2019 / beginning of 2020 but can
also happen later depending on the process in the ratifying countries
Deca BDE used in:
the running production
the production of Legacy Spare Parts
Already produced parts (on Stock)
Imported vehicles or components
UN Stockholm Convention
/ EU POP Regulation
Banned by
~mid of 2019-2020
Several exemptions
Exempted ?
Banned after
~mid of 2019-2020
(But parts produced before the
entry into force can be further
placed on the market until ~end of
2019-2020)
REACH Annex XVII
Banned after 03 / 2019
Exempted
Exempted
Banned after 03/ 2019
REACH TF Information letters to suppliers
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1. ON THE PHASE OUT OF DECABROMODIPHENYL ETHER
See http://www.acea.be/uploads/publications/20160704_Information_Letter_to_Suppliers_on_DecaBDE.pdf
2. ON REACH RESTRICTION FOR PERFLUOROOCTANOIC ACID (PFOA)
See http://www.acea.be/uploads/publications/20160704_INFORMATION_LETTER_TO_SUPPLIERS_ON_PFOA.pdf
3. ON REGULATORY ADVICE ON TDCP
See http://www.acea.be/uploads/publications/Information_letter_
to_suppliers_on_TDCP_phase_out_from_REACH_TF_experts.pdf
Recommendation:
If you are still using automotive parts that contain
one of the above substances
• carefully evaluate these uses and
• contact your customer as soon as possible to
understand their requirements
Restriction on Isocyanate
•
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The European Chemicals Agency published the restriction proposal for diisocynates
under the REACH regulation on 7 October 2016
– Industry opinion: The proposal is generally fair and balanced
•
•
Proposal is not a typical ban but intends to make the use of products containing
Isocyanates safer
Downstream users will only be able to purchase isocyanates from raw materials
suppliers if
– they can prove that their workforce has been trained according to the specifications of the
restriction in order to safely handle the substances or
– if the product/use combination is considered as intrinsically safe and is exempted from
specific training obligations
•
•
As far as flexible polyurethane foam is concerned, this has no impact on the
automotive industry, since there are no free isocyanates in cured PU foam
But it will impact the in-house production if isocyanates are used directly or in
mixtures in your own production processes (as adhesives, sealants, for coatings,
for the production of wood panels...)
Recommendation:
If you have an own PUR production (e.g.
Production of instrument panels), make sure
that you fulfill the training requirements
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Restriction on DBTO – An Update
Hyundai Motor Europe Tech. Center GmbH
Background:
• DBTO Restriction is already is force since 2012
– use in articles for supply to the general public (= cars, spare parts, A/S
products) if the concentration in the article, or part thereof, is > 0,1 % by weight
of tin.
• As the term “parts thereof” is not specified under REACH, the REACH TF
has made its own definition, based on legal advise
– See ...
• However, BAuA is now challenging the current definition of “parts thereof”
Industry
Interpretation
Latest BAuA*
Interpretation
On the overall weight of
the sub-component
On the weight of the coating
on the sub-component
Calculation
of the 0.1%
Tin content
*
BAuA: Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (German REACH Authority)
Restriction on DBTO – An Update
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Impact on Automotive Industry:
• If BAuA interpretation will be adopted, many parts will be incompliant
– Investigation of one OEM: > 150,000 Components!!!
Countermeasures:
• Discussions started at REACH Task Force and IMDS Steering Committee
• Contacts established to chemical industry and BAuA
– CEPE (European Council of the Paint, Printing Ink and Artists' Colours Industry) will approach the
EU COM and ask for clarification.
Recommendation:
•
No actions required yet but depending on the outcome of the discussion, countermeasures
will be required.
•
The REACH TF will inform the automotive supply chain via the IMDS Newsletter
ECJ Judgement on the REACH Article-Definition (O5A)
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• The current ECHA SiA draft
guidance (chapter 5.1.2) does :
– acknowledge the difficulty of
data collection and the need
for pragmatic solutions
(Due diligence based approach)
– indicate that the exact parts composition is not required to fulfill the obligations
(full IMDS Data)
• In the ECHA Partner Expert Group (PEG) meeting
– it was accepted that some sectors need to get acceptance for a certain level of
aggregation (=Rec019)
– Industry was invited to develop own guidance documents considering the industry
specifics
• Based on that, the REACH TF has concluded that
– There will be an update of the AIG incl. new chapters on Art 7.2 & 33
• After release this will be shared with the EU COMM / ECHA.
– There is no need to change the Rec019 reporting in IMDS, in order to fulfill the
(new) obligations caused by the ECJ Judgement.
• The current Rec019 reporting enables users to fulfill their communication duties in line
with the judgement, if the overall Rec019 principles are applied...
Main principles of Rec019 Communication
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• Companies must have available all data on the exact material composition of
their purchased electronic components
• Companies are committed to take the required measures to verify / update their
Rec019 data on a regular base (e.g. GADSL changes)
– By doing so, a company knows those components that are subject to legal
regulations, e.g. phase out of exemptions, REACH-SVHC
– Can react accordingly to stay compliant in terms of the parts themselves but as well
to related documentation (e.g. IMDS)
– If specific components are not
covered by Rec019 but needs
reporting acc. to O5A, they can
be added as separate declaration
=> Fulfillment of the
ECJ – Judgement
© Robert Bosch GmbH 2016. All rights reserved, also regarding any disposal, exploitation, reproduction, editing,
distribution, as well as in the event of applications for industrial property rights.
AIG Chapters on Art 33 / 7.2
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• The AIG will elaborate on questions such as:
– Which article must be considered for the calculation of the 0,1%-threshold?
– Are there exemptions regarding the calculation of the 0,1%-threshold?
– Is really the lowest level of parts (in IMDS) necessary, or can certain parts/assemblies, like
printed circuit boards, chosen as relevant calculation level?
– Is it possible to summarize some small articles/parts into larger groups (modules, how e.g.
engine), if customers do not come into contact with the materials?
– Which information must be provided to the customers?
Name of the model type / module / part number / complete part path / article / SVHC sufficient?
– What languages are required?
• Do we need to translate the existing information of IMDS data into all EC languages?
• Do we have to re-name cryptic article names (Bezel Q80V1 colored – porcelain) in to clear article
names (bracket)?
– If a complex product contains an SVHC in several articles, is it necessary to specify all?
– Is it necessary to specify the detailed position of an article in the complex product?
– Is a general information for all vehicles of a model type sufficient?
E.g. vehicle with basic configuration, reference vehicle or 150%-vehicle?
– Do we have to provide commercial and private customers the same information or could
these be different?
– Are in-house users of vehicles (drivers of company cars) commercial users, who must be
informed about SVHC automatically too?
– Is it sufficient to inform with a link to a web page for further investigation by the customer or
do we have to provide the complete O5A story in hardcopy actively to the customer?
– ...
Announcement- The Automotive Industry Guideline (AIG) V4.0
Since the publication of the last AIG in
2012, the REACH discussions where
continuing on both Industry as well as
on COM / Authority side.
Some of the outcomes are heavily
impacting our business.
V4.0 of the AIG is providing guidance
for all critical subjects
Scheduled release date: 08/2017
Translations foreseen into
• English
• German
• Chinese
• French
• Korean
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• Sustainable Substitution - Problem Description
NMP
PFOS
Penta & OctaBDEs
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NEP
PFOA
DecaBDEs or HBCD
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Concrete actions of the EU Automotive Industry
• Sustainable Substitution Project
• Global Monitoring Project
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New process proposal
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Minimum requirements for acceptable substitutes
Proposed Criteria: The chosen substitute should
*
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...
 Have a completed registration under REACH – preferable high volume registration
 Be listed in all global legally binding chemical inventories (e.g. TSCA, IECSC, KECI,
ENCS, PICCS,…)
 Be a substance (incl. impurities, additives) that does not meet the SVHC criteria and is
not expected to meet them
 Not be already regulated or in the regulatory pipeline in the EU or other global regions
 Not to be considered as regulated are obligations on registration, inventories etc.
 Not be listed on GADSL / GLAPS
 Not belong to the same substance group as the original substance (e.g. NXPs like NMP
and NEP)
 In case of the same substance group: Assessment whether the substitute has the
same hazard profile (classification by analogy approaches or QSAR) and verification
by testing.
 Be “less hazardous” than the original substance (to be defined case by case)
 Be available or have the potential to be made available in amounts sufficient to supply
customers needs
 Fulfil technical customer requirements
* If criteria are not met, customers of the automobile industry should be contacted for further
discussion (according to the process-chart).
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Regulatory compliance challenge
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Our
Solution
Key
Challenges
GRMS2
Benefits
Global monitoring system
of chemical substances
Efficiency
Monitoring
An external service provider takes over
regulatory monitoring of global
chemicals (draft) legislations
Harmonized activities
Planning certainty
Reliability & Costs
Assessment of relevance
Impact Assessment by Service Provider:
Based on defined criteria
No complete overview and process
existing to monitor relevant chemical
regulation on a global basis
Database
Legislation are stored in a database, incl.
legislations’ fact sheet, substance ID,
etc
Sector/ Business specific
Impact Assessment
Process stability
Strengthen industry position
Compliant products
Increasing
GRMS2
•
•
•
•
- Status
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Budget is approved
Service provider is almost selected
Other sectors already have announced willingness to team up
Project will start soon