The Automotive Industry Task Force on REACH-REACH - An update for 2018 - STUTTGART, 18 19.4.2018 - clepa
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The Automotive Industry Task Force on REACH– REACH – An update for 2018 CLEPA MATERIAL REGULATION EVENT 2018 STUTTGART, 18. – 19.4.2018 Timo Unger Friday, 20 April 2018
2018 REGISTRATION DEADLINE
• History of the discussion (s. CLEPA Event 2017)
• Issue has been presented to ECHA (August 2017)
o Understanding of our situation
o Solution developed with the Directors Contact Group (not sure if this will cover our issues!)
o ECHA / 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
2
LARGEST RISK
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….
3
AUTHORISATION
SUBSTANCES ADDED TO ANNEX XIV IN 2017
5
8TH RECOMMENDATION:
SUBSTANCES PROPOSED BY ECHA TO BE ADDED TO ANNEX XIV IN 2018
6
AUTHORISATION TIMELINE
~ End 2018 /
March 2017 June 2017 Feb 2018 ~ May 2018
Beginning 2019
7
APPLICATIONS FOR AUTHORISATION –
PROCESS AND TIMELINE
8
THE MISUNDERSTANDING
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…
9
ART 66 DUTIES – NOTIFICATION OF ANNEX XIV SUBSTANCES
• 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
10ART 66 NOTIFICATION – SOME OFFICIAL NUMBERS
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!
11UPDATE
• 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
4 years 12 years
• However, this does not mean that this trend
Serious technical/scientific The usage of alternatives
remains stable uncertainties reg. the requires the availability of
impact on human & legal approvals /
o Chromates authorisation: Still no decision on those environment if certifications to guarantee
applications being most important to Automotive Industry authorisation is granted the safe use of the product
Possible cases: Pharma,
Bad precedent because no planning certainty for industry Aerospace, Automotive!
Increasing preasure on EC but still no indication on direction…. The socio-economic use is Remaining risks on
Industry still hopes to get a long review period (12 years) exceeding the risk on health/environment are low,
health / environment only the socio economic benefit
All conditions for 12 years are fulfilled! marginal and the is high and this is not
assumptions include expected to change within
uncertainties the next decade
12MISSING SUBSTANCE IDENTIFIERS
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 Annex XIV
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
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
13ECHA OPINION
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.
14GERMAN BAUA & BMU OPINION
• 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
15AUTOMOTIVE INDUSTRY APPROACH
• 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!
17RESULTS
• 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
18REQUEST & PROPOSAL
• 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
19AIG-REACH: CHAPTER 5.10 – COMMUNICATION
SUMMARY OF MAIN OBLIGATIONS ON ART 33
• 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.
But what is the definition of “Article”
20BACKGROUND: SUBSTANCES IN ARTICLES (SIA)
• 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” Source: http://www.zseries.in/electronics%20lab/passive%20components/resistors/#.WsXtJi5ubmE
• 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
RED: Not covered by ECHA Guidance or different interpretation of REACH TF
21AIG-REACH: CHAPTER 5.10 – COMMUNICATION
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.
22SAFE USE INFORMATION (SUI) DOWN THE SUPPLY CHAIN
• 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
23AIG-REACH: CHAPTER 5.10 – COMMUNICATION
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
24THE ECJ JUDGEMENT IN REALITY…
• Complex Data Structure:
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
• Example for an IMDS-Article Descriptions:
8A CPU SUB ASSY-LHD AUTO o IMDS data structure is not usable
9HP 48 QX o Would require either new IMDS data or
AMP NGPTSQ 12 separate collection
JNVSM
o Possible costs of XXX Million Euro
Screw
• Analysis of a real vehicle acc. to the O5A principle:
Part-Weight # of parts o In Total 157 articles contain
5g & WHY ?
Total 157 o Zero articles were SUI would make sense
25CONCRETE
EXAMPLE
http://www.opel.de/reach/uebersicht.html
27IMDS SOLUTION FOR ELECTRONIC COMPONENTS
• 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
Plus
= + Simplified calculation
+ Avoids the reporting of very small / irrelevant electronic components
+ An overload of unnecessary information is avoided
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.
28REACH ECJ ARTICLE JUDGEMENT
HOW TO DEAL WITH PRINTED CIRCUIT BOARD ASSEMBLIES?
• 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
Challenge:
The REC019 reporting sometimes is not done appropriately
We all can relax, if you(r supplier)
do the Rec019 reporting correctly
29LATEST UPDATE OF DISCUSSIONS
• 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
31REACH RESTRICTIONS
32ECHA ENFORCEMENT REPORT ON RESTRICTIONS
• 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).
33ECHA ENFORCEMENT REPORT ON RESTRICTIONS
• 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.
34REACH TF ANNEX XVII EVALUATION LIST
• 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
35DEFINITION OF “PARTS THEREOF”
History:
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
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?
36RESTRICTION ON NICKEL
• 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!
37OUTLOOK / NEXT STEPS
• 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
38UPDATE: RESTRICTION OF FOUR PHTHALATES IN ARTICLES
(DEHP, DIBP, DBP, BBP)
2018
Draft Restriction (WTO Notification on March 29, 2018)
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)
39PFOA, ITS SALTS AND PFOA-RELATED COMPOUNDS
Carc. 2; H351
Repr. 1B; H360D
Lact.; H362
Acute Tox. 4; H332
Acute Tox. 4; H302
STOT RE 1; H372
Eye Dam. 1; H318
• Publication of Restriction: 13.07.2017 • Recommendation to the COP: list PFOA, its salts
• Application date: 04.07.2020 and PFOA-related compounds in Annex A or B
• Concentration limit: with no specific exemptions for automotive
o 25 ppb for PFOA and its salts and • ACEA comments to the SC secretariat:
o 1 000 ppb for one or a combination of PFOA-related o In commercial C6 chemicals (e.g. PFHxA), which are typically
substances used as substitutes for C8 chemicals (e.g. PFOA), a low level of
o Limits were also requested by REACH TF impurities of such C8 chemicals is technically unavoidable.
These impurities however don´t exceed the very low threshold
• PFOA has been almost completely replaced by C6 of 25 ppb
chemicals (e.g. PFHxA) 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
Recommendation: without full CAS# provision >> No certainty for industry
Replace PFOA as soon as possible
Check especially non-EU (China!) imports for C8 (PFOS & PFOA) contaminations
41METHANOL
• 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
42MICRO PLASTICS
• 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 http://www.alternativenergia.hu/a-tengerek-oriasait-veszelyeztetik-a-muanyag-mikroszemcsek/81775
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 !
43ANNOUNCEMENT-
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
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
46WHAT ELSE…?
• 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……….
47Thank you for your attention www.acea.be @acea_eu
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