Friday, 20 April 2018

The Automotive Industry Task Force on REACH–

REACH – An update for 2018

CLEPA MATERIAL REGULATION EVENT 2018

STUTTGART, 18. – 19.4.2018

Timo Unger

2018 REGISTRATION DEADLINE • History of the discussion (s. CLEPA Event 2017)

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• Issue has been presented to ECHA (August 2017) oUnderstanding of our situation oSolution developed with the Directors Contact Group (not sure if this will cover our issues!) oECHA / COM Statement:

There will be a solution to avoid stop of production… Size of the problem, probably is overestimated…

• Still only very few cases known of substance obsolescence in the AI

LARGEST RISK

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Quality issues: Standard requirement in the Automotive Industry: If substances = materials change, usually a new PPAP is required.

Largest Concern: • Will substances be substituted without duly

OEM-testing / -approval / -knowledge? • Will IMDS be always updated? • Risk of malfunctions

oReliability issues oSafety issues oRecalls….

AUTHORISATION

SUBSTANCES ADDED TO ANNEX XIV IN 2017

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8TH RECOMMENDATION: SUBSTANCES PROPOSED BY ECHA TO BE ADDED TO ANNEX XIV IN 2018

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AUTHORISATION TIMELINE

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March 2017 June 2017 Feb 2018 ~ May 2018 ~ End 2018 / Beginning 2019

APPLICATIONS FOR AUTHORISATION – PROCESS AND TIMELINE

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THE MISUNDERSTANDING

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If once an authorisation has been granted, everything is solved and there are no further problems to be expected…

o Start substitution if possible If not, collect reasons why

o Start preparing for the next round o Notif your authorised uses to ECHA…

ART 66 DUTIES – NOTIFICATION OF ANNEX XIV SUBSTANCES

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• If you use an Annex XIV substance after the sunset date, you have to notify ECHA (via REACH IT) within 3 month after delivery o Obligation starts with the publication date of the authorisation decision in the OJ

• Background: Check / Monitor if the substances are used as authorised • Information to be notified:

o Information on your company and the concernd locations (incl. contact data) o Authorisation number o Data proofing the fullfilment of the authorisation conditions

(e.g. Workplace meassurements) o Annual amount of the Annex XIV substance o Number of employees that are using the substance. o Short description of the usage o Activities to substitute the substance

ART 66 NOTIFICATION – SOME OFFICIAL NUMBERS

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Notifications (in numbers) Notifications (per country)

Source: ECHA

If you use Annex XIV substances, after the sunset date (e.g. DEHP, Cr6+, …) you have to notify!

UPDATE

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• Sunset date for spare parts “legacy” have been extended by 3 years for several substances o In the meantime, EC will work out a Commission Decision on a simplified authorisation for LSPs;

Outcome is unpredictable; No progress yet (known).

• Still, no Application for Authorisation has ever been rejected • However, this does not mean that this trend

remains stable o Chromates authorisation: Still no decision on those

applications being most important to Automotive Industry Bad precedent because no planning certainty for industry Increasing preasure on EC but still no indication on direction…. Industry still hopes to get a long review period (12 years)

4 years 12 years

Serious technical/scientific uncertainties reg. the impact on human & environment if authorisation is granted

The usage of alternatives requires the availability of legal approvals / certifications to guarantee the safe use of the product Possible cases: Pharma, Aerospace, Automotive!

The socio-economic use is exceeding the risk on health / environment only marginal and the assumptions include uncertainties

Remaining risks on health/environment are low, the socio economic benefit is high and this is not expected to change within the next decade

All conditions for 12 years are fulfilled!

MISSING SUBSTANCE IDENTIFIERS

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There is an increasing number of SVHCs without any unique identifier (CAS/EC number) falling under authorisation, restriction, etc: Aluminosilicate Refractory Ceramic Fibres Zirconia Aluminosilicate Refractory Ceramic Fibres 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated Nonylphenol ethoxylates Phenol, 4-nonyl-, branched and linear covering all individual isomers …

Industry is not able to perform a proper investigation on the usage of

these SVHCs (especially not within the given timeframe). Usually, Industry systems and processes (IMDS, GADSL) are CAS# based

Annex XIV

Automotive Industry Proposal to ECHA & EC (in 2013): Help industry to easily find the corresponding substance identifiers

(CAS / EC number) in all relevant documentations 13

ECHA OPINION

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ECHA is aware but saying, that…:

o these entries are representing group entries with more than just one identifier o numerical identifiers are not mandatory for substance identification and will only

be provided if they are available or appropriate. o sufficient information has been provided to enable users of substances to

determine whether they fall within the definition of that group. o they acknowledge that this requires a sufficient knowledge of the

chemistry and the naming of a substance which is not necessarily available in all SMEs.

o To fulfill the obligations under Art 33 (Communication) it is however sufficient to only provide the name of the substance. o the given information therefore is fully in line with the scope and aim of REACH.

o Thus it is justified not to include EC and CAS numbers for certain entries on the CL and Annex XIV.

GERMAN BAUA & BMU OPINION

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• Acc. to the German government (BAuA & BMU), the Art 33 obligations are not limited to only those CAS numbers listed on the Candidate List (ECHA Webpage) but also to all related numbers (e.g. mentioned in the Annex XV dossiers)

• This has been also confirmed by ECHA on ACEA request (Jan 2018) • A reporting only based on the officially published numbers on the ECHA CL-Page would

lead to incompliance

AUTOMOTIVE INDUSTRY APPROACH

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• In order to improve the quality of information, the TF REACH has reviewed the documents on the ECHA webpage in order to get clearer understanding of those CAS numbers that are directly or indirectly included in the candidate (and other) lists.

• The approach has tried to find CAS numbers o for entries without such CAS numbers

o where not all numbers were mentioned compared to the Annex XV dossiers,

o for substances which might have multiple CAS numbers for e.g. Isomers

o for entries of so called chemicals of unknown or variable composition (UVCB).

• Position paper and list have been sent to ECHA in 12/2017 o ECHA response (11.01.2018): Will check our list and provide comments

• The results have been (and will be) communicated to the supply chain o IMDS BSL updated

o GADSL updated

Suppliers have to report acc. to these defined identifiers!

RESULTS • The REACH TF CAS# lists today is based so far only on the CL (RMOA will follow soon) • Other relevant lists (e.g. Annex XVII) will be evaluated later • It contains 453 CAS numbers for the 174 CL entries:

• Download of latest version available under: http://www.acea.be/news/article/reach-substances-without-unique-identifier

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REQUEST & PROPOSAL

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• Request to suppliers: Please check the list and make your reporting following the listed substances

• Interface with other sectors: o What is the negative consequence for the chemical industry because of unjustified

black listing? o What happens if each industry is defining its own list and if the results are different?

Discussions started with cross industry groups (e.g. BDI, RCSG)

REACH TF has started discussions with other industries to find consensus on a commonly used list

• Where a CL substance in an article that you supply (either on its own or as part of a complex object, such as a vehicle or vehicle part) exceeds the 0.1% w/w threshold, you must ensure that you provide information available to you to ensure the safe use of the article in any subsequent life cycle phases.

• To evaluate what safe use information may be required, you should typically consider the following life cycle phases: o Manufacturing or assembly operations in the article’s

downstream supply chain; o Use of the vehicle/part by a professional user or consumer; o Maintenance and repair of the vehicle/part; o Reuse, remanufacturing, recycling or disposal of the vehicle/part.

AIG-REACH: CHAPTER 5.10 – COMMUNICATION SUMMARY OF MAIN OBLIGATIONS ON ART 33

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But what is the definition of “Article”

BACKGROUND: SUBSTANCES IN ARTICLES (SIA)

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• 2012: AIG-REACH recommends calculation of CL substance % w/w in articles based on complete object (e.g. a car)

• 2015: European Court of Justice judgment defined the principle known in the AI as “Once An Article, Always An Article”, or “O5A”

• 2016/17: AI participated in ECHA PEG to develop V4 Guidance – ECHA encourages sector specific guidance for complex objects o The REACH TF has decided to update the AIG e.g. with sector specific recommendations on Art 33 & 7.2

• June 2017: ECHA published V4 Guidance o Even after the SiA Guidance publication, there is a lot of confusion in the industry

• Up to Sept 2017: AI revises AIG-REACH incl. SiA sections o AIG is not fully aligned with the ECHA SiA guidance document

Source: http://www.zseries.in/electronics%20lab/passive%20components/resistors/#.WsXtJi5ubmE

RED: Not covered by ECHA Guidance or different interpretation of REACH TF

AIG-REACH: CHAPTER 5.10 – COMMUNICATION

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Provision of Safe Use Information (SUI) (Article 33.1 & 33.2) • You must consider any and all information available to you, including SUI from your

supplier; information known to your technical experts and product safety specialists. • But, you only have to include those parts of the available SUI that remain relevant

to the safe use of the article that you place on the market. • You may reference existing SUI already made available to your customers, such as

vehicle owner manuals, part service/repair instructions, and disposal/dismantling information.

• If existing referenced SUI is sufficient to ensure safe use, or if no information at all is required for the safe use of the article, than it is sufficient to “only” provide the name of the CL substance.

• Usually the name of the substance is sufficient SUI to satisfy the law

• In special cases however, also further information can be required, e.g. o Location, Safe Use Instructions, …

• The SUI may also change.

No need to automatically forward it down the chain o IMDS is not useful

SAFE USE INFORMATION (SUI) DOWN THE SUPPLY CHAIN

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AIG-REACH: CHAPTER 5.10 – COMMUNICATION

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Provision of Safe Use Information (Article 33.1 & 33.2) • AIG-REACH includes templates (Annex M1, M2 & M3) for providing consistent and sufficient

SUI. • Providing SUI for a vehicle will not usually be feasible for each vehicle configuration (i.e. by

Vehicle Identification Number or VIN). o AI recommends providing SUI based on the master parts list (known as the 150% BOM).

• SUI should be made available in the local EEA language of the customer receiving the article. • But it is not necessary to translate the data collected via IMDS (except if specific SUI is

required). • SUI may be provided by hard copy and/or by electronic means, for example by providing the

customer with a direct link to the relevant SUI (e.g. on an online catalogue), which is updated in response to CL changes for products that remain in production.

• Acc. to the REACH TF assessments, IMDS Rec019 is still fulfilling all requirements. No change of IMDS is required

THE ECJ JUDGEMENT IN REALITY…

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• Analysis of a real vehicle acc. to the O5A principle:

Part-Weight # of parts <0,1g 82 <1g 24 <5g 25 >=5g 26 Total 157

o In Total 157 articles contain a SVHC > 0,1 % w/w

o 106 Articles have a weight < 1g o Only 26 Articles have a weight > 5g o Zero articles were SUI would make sense

Large concerns at industry (esp. complex article manufacturers) because of unrealistic expectations to disclose the name and description of the exact location of each article falling under Art 33 Lead Solder PCB Display Navigation System Kia Ceed; 2WD; Spirit; VIN XXX

8A CPU SUB ASSY-LHD AUTO 9HP 48 QX AMP NGPTSQ 12 JNVSM Screw

• Example for an IMDS-Article Descriptions: o IMDS data structure is not usable o Would require either new IMDS data or

separate collection o Possible costs of XXX Million Euro

• Complex Data Structure:

WHATFORE & WHY ?

CONCRETE EXAMPLE

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http://www.opel.de/reach/uebersicht.html

IMDS SOLUTION FOR ELECTRONIC COMPONENTS

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• Common solution from German electronic industry (ZVEI) und automotive industry (since 2003) • For electric components, standard datasheets are published in IMDS which break down the Printed Circuit

Board Assembly “PCBA” into key materials IMDS Recommendation 019 • A detailed declaration at the level of each individual

article (e.g. the pin of the resistor) would not provide added value for the Art 33 objectives (health and environment or for informed purchase decision-making)

• NOTE: If the CL substance content of the relevant Rec 019 PCBA Material Data Sheets does not match the actual component CL substance content, the respective component must be reported individually.

Plus + Simplified calculation + Avoids the reporting of very small / irrelevant electronic components + An overload of unnecessary information is avoided =

REACH ECJ ARTICLE JUDGEMENT HOW TO DEAL WITH PRINTED CIRCUIT BOARD ASSEMBLIES?

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• The REACH TF has concluded that there is no need to change the Rec019 reporting in IMDS, in order to fulfill the (new) obligations caused by the ECJ Judgement. o The current Rec019 reporting enables users to fulfill their communication duties in

line with the judgement, if the overall Rec019 principles are applied... o …and if the calculation of the CL substance threshold is based on the homogenous

material

We all can relax, if you(r supplier) do the Rec019 reporting correctly

Challenge: The REC019 reporting sometimes is not done appropriately

LATEST UPDATE OF DISCUSSIONS

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• Automotive Guidance on Art 33 & 7.2 has been presented to ECHA during a webinar on 27.11.17 o ECHA understands our approach and the rational behind but also has

reservations, especially on Our interpretation that the location of the article needs not to be described Our way of dealing with electronics (IMDS REC019)

• ECHA does not know yet how to proceed o Upload / reference of sector guidance's on ECHA webpage?

• ECHA will start discussions at CARACAL in June 2018 o ACEA will try to participate and defend positions

• In a worst case, the current O5A strategy needs to be adapted

REACH RESTRICTIONS

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ECHA ENFORCEMENT REPORT ON RESTRICTIONS

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• In Feb 2018, ECHA has published the “FORUM REF-4 PROJECT REPORT on the Harmonized Enforcement Project on Restrictions”

• Objectives: o to raise awareness of restrictions, o to identify non-compliance in the EU-market, o to follow-up with enforcement action and o to achieve a greater degree of compliance and thus

a greater degree of health and environmental protection

• 5 625 product checks (for 17 substances, 1 009 mixtures and 4 599 articles).

ECHA ENFORCEMENT REPORT ON RESTRICTIONS

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• It covered 14 different entries: o Non-compliance rate

18 % -> Very High!!! o Most problematic: Phthalates in Toys PAHs Cadmium in brazing fillers Chrome(VI) in Leather Asbestos in Used-Materials Nickel in metal parts of clothings

o Conclusions So far no incompliant cases in the auto industry They will extend audits and especially look at imports.

REACH TF ANNEX XVII EVALUATION LIST

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• The Annex XVII today includes 70 Restrictions entries • The interpretation of their wording is challenging

o And so it is to define the potential relevance on the automotive business

• The REACH TF has developed an Evaluation matrix on each individual entry o Art: Relevance for Articles and/or spare parts o PC: Relevance for Process Chemicals and/or A/S Products o Merchandising Products and untypical A/S products are not in the evaluation scope

• See Annex K of the AIG V4.0

DEFINITION OF “PARTS THEREOF” History:

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Countermeasures: • Discussion started with chemical industry, ECHA, EC

o ECHA & EC already have indicated support of automotive industry position o ECHA will issue a related FAQ in Q4/2017 Q1/2018 Q2/2018?

Impact on Automotive Industry: • If BAuA interpretation will be adopted, many parts

will be incompliant o Investigation of one OEM: > 150,000 components!!! o Paint Industry: Even more concerned!?

• Similar impact also on other restrictions with similar wording (Phthalates, DecaBDE)

Position of REACH TF: 1. The ECJ Judgement is applicable for complete REACH and not only for Art 33 / 7.2 2. The “parts thereof” phrase has to be removed from the applicable restrictions

RESTRICTION ON NICKEL

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• The REACH TF has commented that both examples do not fulfill the requirements from a prolonged skin contact with the following justification: o Car keys are usually covered by a plastic housing

o While driving the car, you are required to hold the steering wheel with two hands

• Based on the input received, ECHA has deleted both examples from the draft guidance o Note: Keychains, keyrings, key fobs are still included!

• However, if a vehicle interior part contains nickel and fulfills the “prolonged skin contact” criteria, it is highly recommended to be re-developed!

Recommendation: If not already done though, phase out Nickel in such applications asap!

OUTLOOK / NEXT STEPS

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• ECHA will work to update the draft Guideline • It is expected that ECHA will present a revised version of the draft

Guideline, for discussion and possible approval, at the next CARACAL meeting (in June 2018, tbc);

• Once endorsed by CARACAL, the ECHA Guideline will be made available and posted on the ECHA website, in the section on Q&As on the REACH restrictions, under Entry 27 (Nickel and its compounds): o https://echa.europa.eu/support/qas-support/browse/-

/qa/70Qx/view/scope/REACH/Restrictions

UPDATE: RESTRICTION OF FOUR PHTHALATES IN ARTICLES (DEHP, DIBP, DBP, BBP)

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Exemption for • Articles for industrial use or in open air use

o If no contact with human mucous membranes or prolonged contact with human skin

• M, N & O vehicles placed on the market before ~2023

• Spare parts for these vehicles (w/o deadline)

Draft Restriction (WTO Notification on March 29, 2018)

2018

PFOA, ITS SALTS AND PFOA-RELATED COMPOUNDS

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• Publication of Restriction: 13.07.2017 • Application date: 04.07.2020 • Concentration limit:

o 25 ppb for PFOA and its salts and o 1 000 ppb for one or a combination of PFOA-related

substances o Limits were also requested by REACH TF

• PFOA has been almost completely replaced by C6 chemicals (e.g. PFHxA)

• Recommendation to the COP: list PFOA, its salts and PFOA-related compounds in Annex A or B with no specific exemptions for automotive

• ACEA comments to the SC secretariat: o In commercial C6 chemicals (e.g. PFHxA), which are typically

used as substitutes for C8 chemicals (e.g. PFOA), a low level of impurities of such C8 chemicals is technically unavoidable. These impurities however don´t exceed the very low threshold of 25 ppb

o BUT materials or components purchased in China could potentially contain higher concentrations of PFOA substances

o Proposal is based on a non-exhaustive lists of substances without full CAS# provision >> No certainty for industry

Recommendation: Replace PFOA as soon as possible Check especially non-EU (China!) imports for C8 (PFOS & PFOA) contaminations

Carc. 2; H351 Repr. 1B; H360D Lact.; H362 Acute Tox. 4; H332 Acute Tox. 4; H302 STOT RE 1; H372 Eye Dam. 1; H318

METHANOL

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• In Jan. 2015, Poland has proposed a restriction of Methanol in Windshield Washer Fluid

• The REACH Committee has approved the related COM proposal (max. concentration: 0.6% w/w)

• Proposal is proved by Council and Parliament until 10.2.18 • Publication in the OJ expected very soon

o Transitional Period: 12 Month after publication

Recommendation: Make sure that MeOH is not used in WWF in vehicles potm after 2019

Note: Similar requirement also in Korea

MICRO PLASTICS

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• ECHA call for evidence on the intentional uses of microplastic particles in products of any kind o Is there a need for a restriction on the

placing on the market and/or use of ‘intentionally added’ microplastic particles in products or uses that ‘intentionally release’ microplastic particles to the environment?

o What are all possible intentional uses of microplastic particles in products?

• Scope: Theoretically everything but o Many plastic articles only ‘unintentionally release’ microplastics during their life-cycles through

abrasion (e.g. tyre wear or washing of synthetic fibres) or weathering. o ECHA has not been requested by the EC to include these in the scope of the investigation (yet).

No direct impact on our sector yet but careful monitoring is required !

http://www.alternativenergia.hu/a-tengerek-oriasait-veszelyeztetik-a-muanyag-mikroszemcsek/81775

ANNOUNCEMENT- THE AUTOMOTIVE INDUSTRY GUIDELINE (AIG) V4.0

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• 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

incl. new chapters on Art 33 & 7.2 • Scheduled release date: Q2/2018 • Translations foreseen into

o English o German? o Chinese o French o Korean

WHAT ELSE…?

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• SVHC proposal for Lead Metal • Restriction on Siloxanes (D4, D5 & D6) • Restriction on CMRs in Textiles • Restriction on Cobalt Salts • REACH REFIT • Waste Framework Directive

o ECHA to develop an Art 33 database for waste sector

• Quality of SDSs o ACEA Guidance on SDS quality / plausability checks:

>1,500 Downloads; Available in 5 languages

o Participation at ENES & PEG on SDS quality

o Electronic transfer of SDSs

• Brexit……….

Thank you for your attention www.acea.be @acea_eu