2016 REACH Update Matthew Griffin Jaguar Land Rover

REACH Screening Process

REACH Regulatory Options

SVHC Identification: Candidate List Substance developments

New SVHC Substances The number of SVHC substances is now 169 

6 substances added since last year’s conference: 

Benzo(a)pyrene, CAS# 50-32-8



1,3-propansultone, CAS# 1120-71-4*



UV-327, CAS# 3864-99-1



UV-350, CAS# 36437-37-3*



Nitrobenzene, CAS# 98-95-3



Perfluorononan-1-oic-acid and its sodium and ammonium salts



These substances must be included in your IMDS submissions if >0.1% in the material



SVHC List - https://echa.europa.eu/candidate-list-table



* are new additions to GADSL (Feb 2016) – “Declarable”

SVHC Developments Recent European Court of Justice Ruling on “Once an Article, Always an Article” (O5A) 

0.1% Threshold applies to sub-components, as well as the final article (automobile).



REACH Guidance being developed by Partner Expert Group (PEG) and the German

BDI  Potentially need to communicate down to smallest article – resistor on a circuit board?  This could generate 150+ pages of useless information for car customer.  Need to bring a little bit of common sense to the discussions……

REACH Regulatory Options

Annex XIV Authorisation

Recap 2013 – AFA to Authorisation

Phthalates  DEHP (Sunset Date Feb 2015)

 18 months after the Sunset Date.  Still no decision on Authorisation!

 Being overtaken by REACH Restriction proposal….

Hexavalent chromium compounds  Chromium (VI) Compounds (Sunset Date September 2017)

 RAC / SEAC Opinion expected to be published this year.

Next Annex XIV Priorities Substance Name Dichromium tris(chromate) Strontium chromate Pentazinc chromate octahydroxide Potassium hydroxyoctaoxodizincatedichromate 2,2'-dichloro-4,4'-methylenedianiline (MOCA) 1,2-Dichloroethane (EDC) Acids generated from chromium trioxide and their oligomers Potassium chromate Sodium dichromate Ammonium dichromate Sodium chromate Potassium dichromate Chromium trioxide Formaldehyde, oligomeric reaction products with aniline (technical MDA) Bis(2-methoxyethyl) ether (Diglyme) Arsenic acid Trichloroethylene

EC Number 246-356-2 232-142-6 256-418-0 234-329-8 202-918-9 203-458-1 231-801-5, 236-881-5 232-140-5 234-190-3 232-143-1 231-889-5 231-906-6 215-607-8 500-036-1 203-924-4 231-901-9 201-167-4

CAS Number 24613-89-6 7789-06-2 49663-84-5 11103-86-9 101-14-4 107-06-2 7738-94-5, 13530-68-2 7789-00-6 7789-12-0; 10588-01-9 7789-09-5 7775-11-3 7778-50-9 1333-82-0 25214-70-4 111-96-6 7778-39-4 79-01-6

Sunset date 22/01/2019 22/01/2019 22/01/2019 22/01/2019 22/11/2017 22/11/2017 21/09/2017 21/09/2017 21/09/2017 21/09/2017 21/09/2017 21/09/2017 21/09/2017 22/08/2017 22/08/2017 22/08/2017 21/04/2016

Latest application date 22/07/2017 22/07/2017 22/07/2017 22/07/2017 22/05/2016 22/05/2016 21/03/2016 21/03/2016 21/03/2016 21/03/2016 21/03/2016 21/03/2016 21/03/2016 22/02/2016 22/02/2016 22/02/2016 21/10/2014

Hexabromocyclododecane (HBCDD), alpha-hexabromocyclododecane, beta-hexabromocyclododecane, gamma-hexabromocyclododecane Tris(2-chloroethyl)phosphate (TCEP) 2,4 – Dinitrotoluene (2,4-DNT) Diarsenic pentaoxide Lead sulfochromate yellow (C.I. Pigment Yellow 34) Diarsenic trioxide Lead chromate Lead chromate molybdate sulphate red (C.I. Pigment Red 104) Bis(2-ethylhexyl) phthalate (DEHP) Dibutyl phthalate (DBP) Diisobutyl phthalate (DIBP) Benzyl butyl phthalate (BBP) 5-tert-butyl-2,4,6-trinitro-m-xylene (Musk xylene) 4,4'-Diaminodiphenylmethane (MDA)

221-695-9, 247-148-4 204-118-5 204-450-0 215-116-9 215-693-7 215-481-4 231-846-0 235-759-9 204-211-0 201-557-4 201-553-2 201-622-7 201-329-4 202-974-4

3194-55-6, 25637-99-4, 134237-50-6, 134237-51-7, 134237-52-8 115-96-8 121-14-2 1303-28-2 1344-37-2 1327-53-3 7758-97-6 12656-85-8 117-81-7 84-74-2 84-69-5 85-68-7 81-15-2 101-77-9

21/08/2015 21/08/2015 21/08/2015 21/05/2015 21/05/2015 21/05/2015 21/05/2015 21/05/2015 21/02/2015 21/02/2015 21/02/2015 21/02/2015 21/08/2014 21/08/2014

21/02/2014 21/02/2014 21/02/2014 21/11/2013 21/11/2013 21/11/2013 21/11/2013 21/11/2013 21/08/2013 21/08/2013 21/08/2013 21/08/2013 21/02/2013 21/02/2013

Next Annex XIV Priorities  7th Recommendation for the inclusion onto the candidate list published Name

EC Number

CAS Number

Recommendation Year

1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear

271-093-5

68515-50-4

7th Draft (September 2015)

Cyclohexane-1,2-dicarboxylic anhydride [1], cis-cyclohexane-1,2-dicarboxylic anhydride [2], trans-cyclohexane-1,2-dicarboxylic anhydride [3] [The individual cis- [2] and trans- [3] isomer substances and all possible combinations of the cis- and trans-isomers [1] are covered by this entry]

201-604-9"236-086-3"238009-9

85-42-7"13149-00-3"14166-21-3

7th Draft (September 2015)

Dihexyl phthalate

201-559-5

84-75-3

7th Draft (September 2015)

Hexahydromethylphthalic anhydride [1], Hexahydro-4-methylphthalic anhydride [2], Hexahydro1-methylphthalic anhydride [3], Hexahydro-3-methylphthalic anhydride [4] [The individual isomers 247-094-1"243-072-0"256[2], [3] and [4] (including their cis- and trans- stereo isomeric forms) and all possible combinations 356-4"260-566-1 of the isomers [1] are covered by this entry]

25550-51-0"19438-60-9"48122-14-1"5711029-9

7th Draft (September 2015)

Lead monoxide (lead oxide)

215-267-0

1317-36-8

7th Draft (September 2015)

Orange lead (lead tetroxide)

215-235-6

1314-41-6

7th Draft (September 2015)

Pentalead tetraoxide sulphate

235-067-7

12065-90-6

7th Draft (September 2015)

Sodium perborate; perboric acid, sodium salt

239-172-9"234-390-0

Sodium peroxometaborate

231-556-4

7632-04-4

7th Draft (September 2015)

Tetralead trioxide sulphate

235-380-9

12202-17-4

7th Draft (September 2015)

Trixylyl phosphate

246-677-8

25155-23-1

7th Draft (September 2015)

7th Draft (September 2015)

REACH Regulatory Options

Annex XVII Restriction

Annex XVII Developments Automotive relevant Restriction Proposals

 Methanol – “RAC/SEAC Opinion Published”  DecaBDE – “RAC/SEAC Opinion Published”  PFOA and related substances – “RAC/SEAC Opinion

Published”

Annex XVII Methanol Restriction proposed Poland 

Consultation finished 19th Feb, 2016.

Restriction Proposal: Shall not be placed on the market for supply to the general public: 

as a component of windshield washing fluids in concentration equal to, or greater than 0.6% by weight [Note: original proposal was 3.0%]



as a component of denaturated alcohol (methylated spirit, brennspiritus) in concentrations equal to, or greater than 0.6% by weight [Note: original proposal was 3.0%]



Member State may maintain any existing and more stringent restrictions for methanol..

Annex XVII Developments Automotive relevant Restriction Proposals 

DecaBDE:

 2015 - “Opinion Development”  2016 – Final draft to be approved 20/21st September  Will then go to EU Parliament for final approval  Automotive position – vehicles produced before July 1st, 2018 and spare parts for these are exempt.

 Stockholm convention looking to reduce spare part exemption to safety critical and powertrain applications only….  EU POP legislation will overwrite EU REACH…..

Annex XVII PFOA Restriction proposed Germany and Norway for PFOA and related substances 

Deadline for comment was 17th June, 2015.



Deadline to comment on SEAC opinion was 16th November, 2015

Annex XVII PFOA SEAC Proposed Restriction:

Annex XVII PFOA SEAC Proposed Restriction:

Biocidal Product Regulation (BPR) Automotive Task Force – Biocides • Supported by members from ACEA, CLEPA, JAMA, JAPIA, KAMA • Chair: Jonathan Swindell ([email protected]) Automotive Industry Guideline on the BPR (AIG-BPR) http://www.acea.be/materials&substances/Biocides • Details on key terms and definitions (esp. related to treated articles) • Dates and deadlines • Structured approach to BPR compliance in 8 steps • Automotive industry examples (e.g. textiles, A/C cores, air ionisers) • Role-specific summaries for five automotive industry key roles: • Supplier/Distributor/Retailer of BP e.g. aftermarket supplier of antibacterial fabric cleaner • Professional User of Purchased BP e.g. anti-microbial additive for metalworking fluids • Professional User of In Situ BP e.g. water treatment by in situ generation of chlorine dioxide • Supplier/Distributor/Retailer of TA e.g. textiles, A/C cores, air ionisers, air filters, pet fleeces • Importer of TAs into the EU (see following slides…) AS = Active Substance; BP = Biocidal Product; PT = Product-Type; TA = Treated Article

Biocidal Product Regulation (BPR) Role Obligations Summary: Importer of TAs into the EU Step

Scenario

Identify any TA that you import into the EU

1 2

Role Obligations

You import TA into the EU

Identify PT applicable to your/your customers’ uses Confirm your role and obligations as a TA importer

3 AS on Annex I; OR AS approved on Union List

4

AS in the Review Programme before 1 September 2016; AND No decision made AS not on Annex I; AND not approved on Union List; AND not in the Review Programme before 1 September 2016

Non-approval decision on AS/PT was made

The TA may be imported for the relevant PT

Stop import of TA after 1 March 2017, unless a new AS/PT application is approved

Stop import of TA after 1 March 2017 or 180 days after nonapproval decision, whichever is later, unless a new AS/PT application is approved

AS = Active Substance; BP = Biocidal Product; PT = Product-Type; TA = Treated Article

Biocidal Product Regulation (BPR) Role Obligations Summary: Importer of TAs into the EU Step

5

Scenario

Role Obligations

AS substitution/elimination is required (according to AS Status in Step 4 above)

Coordinate elimination/substitution with supplier/ customer so that TA (or alternative) may continue to be imported

TA incorporates a BP; AND a biocidal claim is made regarding the TA 6

7

8

TA incorporates a BP; AND the contained AS requires TA labelling as a condition of approval

Provide TA labelling; confirm that any biocidal property shown on the label is substantiated

TA placed on the market is a hazardous substance or mixture

Provide SDS in EU format (REACH Annex II)

TA placed on the market is substance or mixture that is non-hazardous

Recommended to provide information in SDS-format

TA placed on the market is an article

No SDS obligations apply

TA is placed on the market

Maintain relevant records in case required by the EU Competent Authority

AS = Active Substance; BP = Biocidal Product; PT = Product-Type; TA = Treated Article

Points to take away today  Do you, your supplier or your customer need to Notify (O5A)?

 Authorisation – is this your best management option?  Restrictions – changes to GADSL declaration limits required.  Restrictions - they apply to the Article and Imports

Thank You! Matt Griffin [email protected]