by Alexis Sumner
9 July 2018
In the first step of the Authorisation process, substances that meet certain criteria within the REACH and Classification, Labelling and Packaging (CLP) Directive (Regulation (EC) No 1272/2008) are identified and added to the Candidate List of Substances of Very Highs Concern (SVHC) for authorisation. Substances that are carcinogens, reproductive toxins, germ cell mutagens, sensitisers, those that are persistent, bioaccumulative and toxic (PBT) to the environment or very persistent and very bioaccumulative (vPvB), and those that have a similar concern, e.g. endocrine disrupting properties, are all subject to inclusion on the Candidate List. The current list now contains 191 entries.
As of June 27, 2018, ten new substances have been added to the Candidate List
Identifier Chemical Name
CAS: 556-67-2 Octamethylcyclotetrasiloxane (D4)
CAS: 541-02-6 Decamethylcyclopentasiloxane (D5)
CAS: 540-97-6 Dodecamethylcyclohexasiloxane (D6)
CAS: 7439-92-1 Lead
CAS: 12008-41-2 Disodium octaborate
CAS: 191-24-2 Benzo[ghi]perylene
CAS: 61788-32-7 Terphenyl hydrogenated
CAS: 107-15-3 Ethylenediamine (EDA)
CAS: 552-30-7 Benzene-1,2,4-tricarboxylic acid 1,2 anhydride (trimellitic anhydride) (TMA)
CAS: 84-61-7 Dicyclohexyl phthalate (DCHP)
Substances on the Candidate list present in >0.1% must be identified in Section 3 of the SDS and additional regulatory information can be listed in Section 15. Furthermore, if used within an article, there are additional notification and communication obligations for a manufacturer/importer.
Of particular concern for those in the silicone industry is the listing of D4, D5 and D6. Please see the official statement published by CES – Silicones Europe. https://www.silicones.eu/uploads/Modules/Newsroom/svhc-listing_decision-statement_june_2018_final.pdf
Recommended Action Items
- Review the substances against your portfolio and identify the uses associated with each substance.
- Monitor additions to REACH Annex XIV of substances that become subject to Authorisation.
- Potentially investigate suitable replacement substances.
References and Resources:
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) – Regulation (EC) No 1907/2006: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1530725613116&uri=CELEX:02006R1907-20180509
ECHA webpage – Candidate List of substances of very high concern for Authorisation: https://echa.europa.eu/candidate-list-table