EU REACH adds 2 new substances of very high concern, the candidate list of substances has increased to 163
The European Chemicals Agency (ECHA) added two Substances of Very High Concern (SVHCs) to its list on June 15. One is an alkyl ester containing more than 0.3% dihexyl phthalate, added to the SVHC candidate list due to its reproductive toxicity. Such substances are often used as plasticizers or lubricants in applications including adhesives, coatings, building materials, and cables. The other substance was added due to its very persistent and very bioaccumulative (vPvB) properties; its primary use is as a key component of the flavoring agent "karanal." With these two additions, the total number of SVHCs as of June 15, 2015, reached 163.
The following SVHC data has been added:
| Serial number | Reference Chinese name | English Name | EC number | CAS number | Reasons for inclusion in SVHC |
| 162 | 1,2-苯二甲酸二 C6-10 烷基 酯； 1,2-苯二甲酸混合癸與己和辛 二酯，包含≥0.3%的鄰苯二甲 酸二己酯(DNHP，EC No. 201-559-5，CAS No. 84-75-3) | 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5) | 271-094-0 | 68515-51-5 | Reproductive toxicity |
| 272-013-1 | 68648-93-1 |
| 163 | 包含以下[1]與[2]之所有單獨 立體異構物與其組成。 [1] 5-二級丁基-2-(2,4-二甲基環 己-3-烯-1-基)-5-甲基-1,3-二 【口咢】【口柬】 [2] 5-二級丁基-2-(4,6-二甲基環 己-3-烯-1-基)-5-甲基-1,3-二 | 5-sec-butyl-2-(2,4-dimethylcyclohex-3- en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3- en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof] | – | – | Extremely persistent and highly bioaccumulative (vPvB) |
Substances of High Concern in Finished Products
From the date of inclusion on the list of Substances of Very High Concern (SHC), suppliers of finished products in the EU or EEA region whose finished products contain SHC at a concentration of 0.1% (w/w) or higher must proactively or upon customer request (within 45 days of request) provide information on the safe use of the finished products, at least providing the name of the substance. Furthermore, manufacturers and importers of finished products in the EU or EEA are obligated to notify ECHA if their finished products contain SHC and meet the following conditions:
1. The substance is a substance of very high concern listed in the Authorization Candidate List (Article 57); and
2. The total annual amount of a substance in the finished product of an individual manufacturer or importer exceeds 1 ton; and
3. The concentration of the substance in the finished product exceeds 0.1% (w/w); and
4. When the finished product is used normally or reasonably intended, including during disposal, it cannot be ruled out that human beings and the environment will be exposed to the substance of high concern.
The notification of Substances of Very High Concern (VHC) in finished products has been in effect since 2011. New VHCs must be notified to the competent authority six months after being publicly announced. Furthermore, when the finished product is normally or reasonably intended for use, including disposal, and the possibility of human and environmental exposure to VHCs cannot be ruled out, the manufacturer or importer must provide appropriate instructions for the finished product. Notification information includes the company name, substance identification, classification, labeling information, and a description of the substance's use in the finished product and the intended use of the finished product itself. However, if the intended use of the finished product is already registered, notification is exempt. Therefore, before planning to notify, manufacturers should confirm with their suppliers and/or trading partners whether the intended use of the finished product is registered.
The EU's REACH policy is particularly relevant to Taiwanese SMEs in terms of the transparency requirements for substances of very high concern (SVCs) in finished products. Although Taiwanese SMEs rarely have their own brands and export to the EU, they often play the role of upstream suppliers in the international supply chain. In order to meet the concerns of numerous downstream customers regarding SVCs in components, Taiwanese SMEs are urged to conduct early checks on the content and safety information of SVCs in their products in order to comply with the international supply chain's requirements for transparent disclosure of hazardous substances.
Please refer to the attachment for the latest updated list of Substances of Very High Concern (SVHCs): European Chemicals Agency Announcement List of Substances of Very High Concern (SVHCs) (Chinese Version) _ 20150615
Sources:International Chemicals Policy Promotion Network (2015-06-16) Attachment file:European Chemicals Agency Announcement: List of Substances of Very High Concern (SVHCs) (Chinese Version) _ 20150615.pdf
