REACH & CoOverview on current discussions and relevant ACEA initiatives

Timo Unger

Manager Environmental Affairs

Hyundai Motor Europe R&D

CLEPA Materials Regulations Event

17th of May 2017

Reutlingen

Hyundai Motor Europe Tech. Center GmbHContent

• 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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Hyundai Motor Europe Tech. Center GmbH

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Substances (Chemicals)

Substances

of very high concern

(CMRs*1)

Authorization RegistrationEvaluation

Yes No

>100 t/a 1-100 t/a

Transition Period (only for Pre-Registered Substances):

REACh enters

into force

12/2010

Registration & Evaluation

- of Substances>1000t/a

- of Substances>100t/a which

are classified as R50/53*2 +S

ubstances for Authorization

06/2013

Registration & Evaluation

of Substances

100-1000t/a

06/2018

Registration of

Substances

1-100t/a

*1 CMR: Carcinogen, Mutagen, Reprotoxic

*2 R50/53: Very toxic for aquatic organisms

Deadline for

Pre-Registration(Pre-Reg =12-18 month after entry into force)

06/2007 12/2008

optional mandatoryRegistration for all substances > 1t/a, NOT been pre-registered!

2018 Registration Deadline

Hyundai Motor Europe Tech. Center GmbH2018 Registration Deadline

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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Hyundai Motor Europe Tech. Center GmbHSize of the problem

• How likely is such a scenario?

• 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

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vs.

Hyundai Motor Europe Tech. Center GmbHCountermeasures / 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 underhttps://public.mdsystem.com/documents/10906/26775/imds_newsletter_45.pdf/e0debd81-3e45-4d29-9583-2dda810f7fb9

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Hyundai Motor Europe Tech. Center GmbHSVHC Roadmap: Tackle all known SVHCs

• Timeline: Until 2020 ~ 500 Substances on the Candidate List

• 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

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Today 2020

173

500++

Update: 2/year

Hyundai Motor Europe Tech. Center GmbHREACH Authorisation

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Hyundai Motor Europe Tech. Center GmbHExamples from REACH Annex XIV

• Today, there are 31 Substances included, such as:

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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, Pentazincchromate octahydroxide

22/01/2019 22/07/2017

Hyundai Motor Europe Tech. Center GmbHSubstances suggested for Annex XIV

• 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)

Hyundai Motor Europe Tech. Center GmbHSubstances suggested for Annex XIV

• ... 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-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [coveringany 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)

Hyundai Motor Europe Tech. Center GmbH

• 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

Current Developments12

Hyundai Motor Europe Tech. Center GmbHClarification / Reminder

• 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 companyand supplier requirements

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Hyundai Motor Europe Tech. Center GmbHREACH Restrictions

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Hyundai Motor Europe Tech. Center GmbHRestriction of four phthalates in articles (DEHP, DIBP, DBP, BBP)

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.

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Hyundai Motor Europe Tech. Center GmbHPhthalates: Timeline and latest status

• 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:

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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

ACEA Input

Hyundai Motor Europe Tech. Center GmbHRestriction 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”?

Hyundai Motor Europe Tech. Center GmbHRestriction 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

Hyundai Motor Europe Tech. Center GmbHRestriction 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 contactJustification: 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!

Hyundai Motor Europe Tech. Center GmbHRestriction 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!

Hyundai Motor Europe Tech. Center GmbHRestriction 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: UN Stockholm Convention / EU POP Regulation

REACH Annex XVII

the running productionBanned by

~mid of 2019-2020Banned after 03 / 2019

the production of Legacy Spare Parts Several exemptions ExemptedAlready produced parts (on Stock) Exempted ? Exempted

Imported vehicles or components

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)

Banned after 03/ 2019

Hyundai Motor Europe Tech. Center GmbHREACH TF Information letters to suppliers

1. ON THE PHASE OUT OF DECABROMODIPHENYL ETHERSee 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

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Hyundai Motor Europe Tech. Center GmbHRestriction on Isocyanate

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• The European Chemicals Agency published the restriction proposal for diisocynatesunder 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

Hyundai Motor Europe Tech. Center GmbHRestriction on DBTO – An Update

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”

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* BAuA: Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (German REACH Authority)

IndustryInterpretation

Latest BAuA* Interpretation

Calculation of the 0.1% Tin content

On the overall weight of the sub-component

On the weight of the coating on the sub-component

Hyundai Motor Europe Tech. Center GmbHRestriction 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

Hyundai Motor Europe Tech. Center GmbHECJ Judgement on the REACH Article-Definition (O5A)

• 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...

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Hyundai Motor Europe Tech. Center GmbHMain principles of Rec019 Communication

• 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 legalregulations, 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

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© 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.

Hyundai Motor Europe Tech. Center GmbHAIG Chapters on Art 33 / 7.2• 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?

– ...

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Hyundai Motor Europe Tech. Center GmbHAnnouncement- 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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Hyundai Motor Europe Tech. Center GmbH• Sustainable Substitution - Problem Description

NMP NEP

PFOS PFOA

Penta & OctaBDEs DecaBDEs or HBCD

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Hyundai Motor Europe Tech. Center GmbHConcrete actions of the EU Automotive Industry

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• Sustainable Substitution Project

• Global Monitoring Project

Hyundai Motor Europe Tech. Center GmbHNew process proposal

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Hyundai Motor Europe Tech. Center GmbHMinimum requirements for acceptable substitutes

Proposed Criteria: The chosen substitute should * ...

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

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* If criteria are not met, customers of the automobile industry should be contacted for further

discussion (according to the process-chart).

Hyundai Motor Europe Tech. Center GmbHRegulatory compliance challenge

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No complete overview and process existing to monitor relevant chemical regulation on a global basis

Monitoring

An external service provider takes over regulatory monitoring of globalchemicals (draft) legislations

Assessment of relevance

Impact Assessment by Service Provider: Based on defined criteria

Database

Legislation are stored in a database, incl. legislations’ fact sheet, substance ID, etc

Efficiency

Harmonized activities

Planning certainty

Reliability & Costs

Process stability

Strengthen industry position

Compliant products

Increasing

GRMS2 Global monitoring system of chemical substances

Our

SolutionKey

ChallengesBenefits

Sector/ Business specific Impact Assessment

Hyundai Motor Europe Tech. Center GmbHGRMS2 - Status

• Budget is approved

• Service provider is almost selected

• Other sectors already have announced willingness to team up

• Project will start soon

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