EU REACH adds 2 new substances of very high concern, the candidate list of substances has increased to 163
The European Chemical Agency added two new substances of very high concern (SVHC) on June 15. One is an alkyl ester containing more than 0.31 TP3T dihexyl phthalate, which is included in the SVHC candidate list due to its reproductive toxicity properties. Such substances are mostly used as plasticizers or lubricants, including bonding, painting, building materials, cables and other uses. Another substance was included in the list due to its very persistent and very bioaccumulative (vPvB) properties and its main use is as a main component of the fragrance raw material "karanal". After adding these two SVHCs, there are a total of 163 SVHC substances as of June 15, 2015.
The newly added SVHC information is as follows:
| serial number | Reference Chinese name | English name | EC number | CAS number | Reasons for including SVHC |
| 162 | Di-C6-10 alkyl 1,2-phthalate; 1,2-phthalic acid mixed decyl and hexane and octyl diesters, containing ≥0.3% of dihexyl phthalate (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 esters 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 | Including all individual stereoisomers and their compositions of the following [1] and [2]. [1] 5-Secondary butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-bis【口璢】【口 Cambodian】 [2] 5-Secondary butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-di | 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] | – | – | Very persistent and very bioaccumulative (vPvB) |
Substances of very high concern in finished products
From the date of inclusion in the list of substances of very high concern, suppliers of finished products in the EU or EEA region should take the initiative or upon customer request (within 45 days as required) if their finished products contain substances of very high concern with a concentration of 0.1% (w/w) or above. , provide relevant information on the safe use of the finished product, at least the name of the substance should be provided. In addition, manufacturers and importers of finished products in the EU or EEA are obliged to notify ECHA when their finished products contain substances of high concern and meet the following conditions:
1. The substance is a substance of high concern included in the authorization candidate list (Article 57); and
2. The annual total amount of substances in the finished products 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. It cannot be ruled out that the human body and the environment are exposed to substances of high concern during normal or reasonably expected use of the finished product, including disposal.
The notification of substances of very high concern in finished products has been effective since 2011. New substances of very high concern must be notified to the competent authority 6 months after the announcement. And when the normal or reasonably expected use of the finished product, including disposal, cannot exclude human and environmental exposure to substances of very high concern, the manufacturer or importer must provide appropriate finished product instructions. The notified information includes company name, substance identification, classification, labeling information, as well as a description of the use of the substance in the finished product and the use of the finished product itself. However, if the intended use of the finished product has been registered, notification is exempted. Therefore, before manufacturers plan to notify, they should first confirm with their suppliers and/or trading partners whether the intended use of the finished product has been registered.
The EU REACH is more relevant to China's small and medium-sized enterprises mainly because of the information transparency requirements for substances of high concern in finished products. Although Taiwan's small and medium-sized enterprises rarely have their own brands and export to the EU, domestic companies often act as upstream suppliers in the international supply chain. Role, in order to respond to the numerous downstream customers' concerns about substances of high concern contained in parts and components, we call on China's small and medium-sized enterprises to conduct early inspections of the content and safety information of substances of high concern in their products in order to cope with the international supply chain's requirements for transparent disclosure of hazardous substances information. .
For the latest updated list of substances of very high concern, please refer to the attachment: European Chemicals Agency Announcement of the SVHC List of Substances of Very High Concern (Chinese version)_20150615
Source:International Chemical Policy Advocacy Network (2015-06-16) Attachment file:The European Chemical Agency announces the SVHC list of substances of very high concern (Chinese version)_20150615.pdf
