1. The Candidate List and SVHCs
Jim Casper
March 2011

2. The Candidate List and SVHCs2

3. SVHC process SVHC suspicion => annex XV dossier
Annex XIV
Authorisations/ restrictions
Proposals for authorisation list
Candidate list
Consultation process
SVHC suspicion => annex XV dossier

4. High Hazard Substance Controls
REACH has a number of processes for controlling exposure to high hazard chemicals
Substances of Very High Concern (SVHC)
The “CANDIDATE LIST” is the first step in the process
Authorities nominate substances that they consider pose risks
Specific action required when these substances are present
Annex XIV – Authoristation
Controls the use of a substance
Use only allowed when authorisation granted
“sunset date” when non-authorised uses must stop
Annex XVII – Restrictions
Formerly “Marketing & Use Directive”

5. High Hazard Substance Controls
Defined process to manage each step in the process
Controlled by ECHA
Proposals to be made by Member State or EU Commission – Annex XV dossier
Public consultation at each stage
– 2 Consultations per year
Full visibility at ECHA CHEM

6. Overview 1. Overview Does substance meet SVHC criteria?
No further action No
Yes
Candidate list
Yes
ECHA: risk managed preferably via Authorisation?
Annex XIV

7. Candidate List: Actions
Substance suppliers
Provide Safety Data Sheet to customers.
Mixture suppliers
Provide Safety Data Sheet if the mixture contains at least one substance on the Candidate List at >0.1% (w/w)
Article suppliers (if the article contains 0.1% Candidate list substance):
Provide information to customers, who should use it in their work.
Provide, on request, within 45 days equivalent information to consumers.
Provide a Notification to ECHA if the substance is present in those articles (at > 1 tonne an > 0.1%), and not yet registered for that specific use.
Required by 1 June 2011 for substances added to the Candidate list before 1 December 2010
Required no later than 6 months after inclusion on the Candidate List for subsequent additions to the list

8. Authorisation List: action required
Stop using the substance by the SUNSET date, unless applying for Authorisation
Authorisation must be requested
by each registering or using company
for specific uses.
by the date specified in Annex XIV
Authorisations are
limited in time.
subject to review
Authorisations will be granted if
Use is considered safe as long as the risks are adequately controlled, and the conditions of the authorisation are met, or
Use can be demonstrated to be so important on socio-economic grounds that continued use outweighs the risks to human health and the environment

9. Questions to ask
Are substances on the Candidate /Authorisation list contained in your products?
Are substances on the Candidate/Authorisation list contained in your products?
No further action necessary No
Yes
What’s the plan:
What?
Who?
When?
Review the “actions required” (earlier slides)
& ECHA Guidance

10. Monitoring/later action
Monitor evolution of the Candidate List, Annex XIV, including formal and informal proposals for additions
Review the substances added to the list and:
Determine if you use of substance
Understand customer/stakeholder requirements
– reporting/de-selection.
Determine what action is necessary:
Reformulation / Obsolete / Continue and report
Work with suppliers to seek authorisation where appropriate.
Respond to requests from customers/other stakeholders for information
Use standard letters to facilitate response to customers

11. The current situation 11 11

12. Candidate List (1)
Ref
Substance name
EC number
CAS number 1
Bis(tributyltin)oxide (TBTO) 2
5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) 3
Dibutyl phthalate (DBP) 4
Benzyl butyl phthalate (BBP) 5
4,4'- Diaminodiphenylmethane (MDA) 6
Bis (2-ethylhexyl)phthalate (DEHP) 7
Anthracene 8
Diarsenic pentaoxide 9
Diarsenic trioxide 10
Cobalt dichloride 11
Lead hydrogen arsenate 12
Sodium dichromate / 13
Hexabromocyclododecane (HBCDD) and all major diastereoisomers identified:
and /
Alpha-hexabromocyclododecane
( )
Beta-hexabromocyclododecane
( )
Gamma-hexabromocyclododecane
( ) 14
Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins) 15
Triethyl arsenate
October 2008 List

13. Candidate List (2)
Ref
Substance name
EC number
CAS number 16
Diisobutyl phthalate 17
Tris(2-chloroethyl)phosphate 18
2,4-Dinitrotoluene 19
Lead sulfochromate yellow (C.I. Pigment Yellow 34) 20
Lead chromate 21
Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 22
Pitch, coal tar, high temp. 23
Anthracene oil 24
Anthracene oil, anthracene paste 25
Anthracene oil, anthracene-low 26
Anthracene oil, anthracene paste, anthracene fraction 27
Anthracene oil, anthracene paste,distn. lights
January 2010 List 28
Acrylamide
March 2010 addition

14. Candidate List (3)
Ref
Substance name
EC number
CAS number 29
Trichloroethylene 30
Disodium tetraborate, anhydrous
/ / 31
Sodium chromate
03/11/7775 32
Potassium dichromate 33
Potassium chromate 34
Ammonium dichromate
05/09/7789 35
Boric acid / / 36
Tetraboron disodium heptaoxide, hydrate
June 2010 List 37
Cobalt(II) diacetate 38
2-Methoxyethanol 39
2-Ethoxyethanol 40
Cobalt(II) carbonate 41
Chromium trioxide 42
Chromic acid,Oligomers of chromic acid and dichromic acid, / /
Cobalt(II) sulphate 44
Cobalt(II) dinitrate
December 2010 List

15. Candidate List (4) Current Consultation
Ref
Substance name
EC number
CAS number 1
Cobalt dichloride 2
2-ethoxyethyl acetate 3
strontium chromate   4
1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters 5
Hydrazine 6
1-methyl-2-pyrrolidone (NMP) 7
1,2,3-trichloropropane 8
1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich
February 2011 List

16. Authorisation List 6 substances added to Annex XIV in February 2011
Ref
Substance name
CAS number
EC number
Latest application date
Sunset date 1
5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) 2
4,4'- Diaminodiphenylmethane 3
Hexabromocyclododecane (HBCDD) 4
Bis (2-ethyl(hexyl)phthalate) (DEHP) 5
Benzyl butyl phthalate 6
Dibutyl phthalate
Correct at 3/3/11
6 substances added to Annex XIV in February 2011
The countdown has started for “sunset date”

17. How to seek an Authorisation17 17

18. Applying for authorisation

19. Applying for authorisation
STEPS IN THE PROCESS:
Prepare application for authorisation
Notification and pre-submission discussions
Submit the application
Prepare the invoice
Pay the invoice
Check conformity
Public consultation on the uses applied for
Require additional information on alternatives
Prepare draft opinions of RAC and SEAC
Comment draft opinions
Adopt RAC and SEAC final opinions
Prepare, adopt and publish the authorisation decision
Comply with the authorisation
Register of the notifications of Downstream users

20. Applying for authorisation
FURTHER DETAILS ON ECHA WEBSITE:

21. End 21 21