SAFEGUARDS | Consumer Products NO. 097/18
On June 27, 2018, the European Chemical Agency (ECHA) added ten new SVHCs to the Candidate List . The addition of the new SVHCs brings the total number of entries to 191.
Obligations for article producers and importers
According to Article 33 of REACH, European Union (EU) and European Economic Area (EEA) manufacturers and importers of articles are required to provide information to allow the safe use of products by the recipients upon supply, and to consumers within 45 days upon request, when the concentration of the SVHC in the article exceeds 0.1% (w/w). For articles that contain an SVHC in which the concentration is above 0.1%, with the quantity over one tonne per year, a notification shall be submitted to ECHA by the manufacturers or the importers under Article 7 of REACH. The notification of SVHCs in an article must be made within six months of their inclusion on the List. The notification deadline for the ten new SVHCs added to the Candidate List is December 27, 2018.
Ten New SVHC Candidates
Three SVHCs are cyclic polydimethylsiloxanes – octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane and dodecamethylcyclohexasiloxane (i.e. D4, D5 and D6 respectively) – which are considered having PBT and vPvB properties. Recently, the EU published a regulation restricting D4 and D5 in wash-off cosmetic products to a limit of 0.1% by weight, with the restriction becoming effective on February 1, 2020 .
Benzo[ghi]perylene is the fifth polyaromatic hydrocarbons (PAHs) included as an SVHC, owing to its classification as having PBT and vPvB properties. It is not produced intentionally but occurs, together with other PAHs, as a constituent of coal and petroleum stream UVCB substances.
Hydrogenated terphenyl is another vPvB substance included as an SVHC. It is a UVCB substance used in coatings, adhesives, sealants, heat transfer fluid and as an additive in plastic applications.
Two SVHCs are respiratory sensitizers – ethylenediamine and benzene-1,2,4-tricarboxylic acid 1,2-anhydride (TMA) – which are used in the manufacture of polymers, esters, and epoxy resins
Lead and disodium octaborate are both classified as toxic for reproduction for inclusion as SVHCs. Lead is mainly used in lead-acid batteries and in lead sheets used in the construction industry. Lead is also used as shots and bullets for ammunition and for alloying steel, in soldering alloys, cable sheathing and to produce oxides, pigments, stabilisers and other lead compounds. Lead is strictly restricted in jewellery and accessible parts of articles under REACH Annex XVII. Meanwhile, there are two restriction proposals on regulating lead in shot for shooting in wetlands, and its compounds in PVC articles as a stabilizer . Disodium octaborate has wide dispersive uses in the manufacturing industry, the building sector, in refractory mixtures, as micronutrient fertilizers, and for indoor and outdoor facilities.
The remaining new SVHC is dicyclohexyl phthalate, which is the fifteenth phthalate included in the Candidate List. It is used as plasticizer in plastisol and in PVC, rubber and plastic articles.
The potential uses of the ten SVHCs are summarized in Table 1.
Table 1. Possible uses of the new SVHCs in the Consultation List published by ECHA on June 27, 2018
|No.||Substance||CAS No./ EC No.||Classification||Potential uses|
|1||Benzo[ghi]perylene||191-24-2/ 205-883-8||PBT, vPvB||
|2||Octamethylcyclotetrasiloxane (D4)||556-67-2/ 209-136-7||PBT, vPvB||
|3||Decamethylcyclopentasiloxane (D5)||541-02-6/ 208-764-9||PBT, vPvB||
|4||Dodecamethylcyclohexasiloxane (D6)||540-97-6/ 208-762-8||PBT, vPvB||
|5||Terphenyl, hydrogenated||61788-32-7/ 262-967-7||vPvB||
|6||Ethylenediamine||107-15-3/ 203-468-6||Respiratory sensitizing properties||
|7||Benzene-1,2,4-tricarboxylic acid 1,2-anhydride (TMA)||552-30-7 / 209-008-0||Respiratory sensitizing properties||
|8||Lead||7439-92-1/ 231-100-4||Repr. 1A||
|9||Disodium octaborate||12008-41-2/ 234-541-0||Repr. 1B||
|10||Dicyclohexyl phthalate||84-61-7 / 201-545-9||Repr. 1B, ED (environment)||
ED: Endocrine disrupting properties
PBT: Persistent, bioaccumulative and toxic
PVA: Polyvinyl alcohol
PVC : Polyvinyl chloride
Repr. 1A: Toxic for reproduction category 1A
Repr. 1B: Toxic for reproduction category 1B
UVCBs: Substance of unknown or variable composition, complex reaction products or biological materials
vPvB: Very persistent and very bioaccumulative
The notification of the new SVHCs shall be submitted by December 27, 2018.
SVHCs may be introduced into various consumer products due to the complexities of both the supply chain and production process. Identifying high risk products or materials, or having a test strategy, can also be a smart way to ensure compliance and save costs. If you would like to learn more about how SGS can support your REACH compliance activities please contact us at email@example.com or visit www.sgs.com/reach
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