ECHA Announces 7 Substances That May Be Included in the Authorization List
Following the publication of a REACH Substances of Very High Concern (SVHC) candidate list of 15 substances on October 29, 2008, the European Chemicals Agency (ECHA) published a draft list on January 16, 2009, of substances selected from the SVHC candidate list that require ECHA authorization for use. According to this draft, seven substances were initially included in the authorization list (Annex 14).
The seven substances included in the list are as follows (the original list published by ECHA can be downloaded from the attachment):
| | Substance name | toxicity | EC No. | CAS No. |
| 1 | Musk xylene卅二甲苯麝香 | vPvB | 201-329-4 | 81-15-2 |
| 2 | 4,4’-Diaminodiphenylmethane卅4,4’-二胺基二苯甲烷 | Carcinogenicity: Cat. 2 | 202-974-4 | 101-77-9 |
| 3 | Short Chain Chlorinated Paraffins卅短鏈氯化石蠟 | PBT & vPvB | 287-476-5 | 85535-84-8 |
| 4 | HBCDD卅六溴環十二烷 | PBT | 247-148-4 | 25637-99-4 |
| 5 | DEHP卅鄰苯二甲酸二(2-乙基丁基)酯 | Reproductive toxicity Cat.2 | 204-211-0 | 117-81-7 |
| 6 | BBP卅鄰苯二甲酸丁苯酯 | Reproductive toxicity Cat.2 | 204-622-7 | 85-68-7 |
| 7 | DBP卅鄰苯二甲酸二丁酯 | Reproductive toxicity Cat.2 | 201-557-4 | 84-74-2 |
Under the REACH regulation, companies must apply for a license to use substances listed in the authorized list. Applicants must demonstrate that the risks of using the substance can be adequately controlled, or that the socio-economic benefits outweigh the risks, and that there are no substitutes or corresponding alternative technologies.
ECHA stated that it assesses whether to include these chemicals in the REACH Authorization List based on the inherent characteristics, intended use, and approved dosage of the products. All stakeholders were required to respond to the consultations by April 14, 2009, specifically providing recommendations regarding whether exemptions from authorization applications should be granted. ECHA would finalize the authorization list by June 1, 2009. ECHA also recommended that authorization applications be submitted within 24–30 months of the inclusion of these substances in Annex XIV of REACH. These substances will be prohibited from use for 42–48 months after being added to the list.
ECHA also recommended that substances exempted under special conditions under Directive 76/769/EEC should be included in the assessment. ECHA stated that it will consider comments received during the consultations and opinions from Member State committees, and may amend the draft before submitting the proposal to the European Commission for review. Regarding whether to authorize the inclusion of eight substances onions, cobalt chloride, arsenic pentoxide, arsenic trioxide, sodium dichromate dihydrate, bis(tributyltin) oxide, lead arsenate, and triethylarsenate on the SVHC list, ECHA indicated that it will consider this at a later date.
ECHA recommends that downstream companies promptly check whether they are using raw materials listed in the SVHC authorization list, regularly audit suppliers (provide safety information sheets to raw material suppliers when necessary), and gradually replace SVHC raw materials within the specified period.
– Reference sources: ECHA website & China Chemical Industry News, February 20, 2009. Other related documents downloads:
draft_recom_annex_xiv.pdf
