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On June 27, 2018, the ECHA added ten new SVHCs to the Candidate List. The addition of these new SVHCs brings the total number of entries to 191.

SAFEGUARDS | Consumer Products NO. 097/18

SGS CTS SafeGuardS various solutions in beakers on shelf

On June 27, 2018, the European Chemical Agency (ECHA) added ten new SVHCs to the Candidate List [1]. 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 [2].

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 [3]. 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
  • Not produced intentionally but occurs as a constituent or impurity in coal and petroleum stream substances
2 Octamethylcyclotetrasiloxane (D4) 556-67-2/ 209-136-7 PBT, vPvB
  • As intermediate for production of silicone polymers
  • In washing & cleaning products, cosmetics and personal care products, polishes and waxes
  • For manufacture of chemicals, rubber products, plastic products, mineral products (e.g. plasters, cement) and electrical, electronic and optical equipment
3 Decamethylcyclopentasiloxane (D5) 541-02-6/ 208-764-9 PBT, vPvB
  • As intermediate for production of silicone polymers
  • In washing & cleaning products, cosmetics and personal care products, polishes, waxes, paints, fragrances and air fresheners
  • In textile treatment products and dyes, polymers and adhesives and sealants
4 Dodecamethylcyclohexasiloxane (D6) 540-97-6/ 208-762-8 PBT, vPvB
  • In production of polysiloxane polymers and resins
  • In washing & cleaning products, cosmetics and personal care products, polishes, waxes, pharmaceuticals and medical devices
5 Terphenyl, hydrogenated 61788-32-7/ 262-967-7 vPvB
  • As additive in plastic applications
  • In coatings, inks, adhesives, sealants and heat transfer fluid
6 Ethylenediamine 107-15-3/ 203-468-6 Respiratory sensitizing properties
  • In epoxy, PU, adhesives, coatings and other polymers
  • As polymerization inhibitor, hydrogen sulphite scavenger, neutralizing corrosion inhibitor
  • As processing aid
7 Benzene-1,2,4-tricarboxylic acid 1,2-anhydride (TMA) 552-30-7 / 209-008-0 Respiratory sensitizing properties
  • As a synthesis of plasticizer in PVC resin
  • As a reactant in wire and cable insulation enamels and polyester resins in powder coatings
  • As an epoxy curing agent, textile sizing agent, rubber curing accelerator, electrostatic toner binder, and vinyl cross-link agent
8 Lead 7439-92-1/ 231-100-4 Repr. 1A
  • In lead-acid batteries, lead sheets and solder
  • For production of oxides, pigments, stabilizers and other lead compounds
  • In lead articles (e.g. cast, rolled and extruded products, ammunition and lead shot)
9 Disodium octaborate 12008-41-2/ 234-541-0 Repr. 1B
  • In micronutrient fertilizers and in refractory mixtures
  • In cellulose insulation, paints and coatings, construction materials, and borate PVA solutions
10 Dicyclohexyl phthalate 84-61-7 / 201-545-9 Repr. 1B, ED (environment)
  • As plasticizers in plastisol and in PVC, rubber and plastic articles
  • As phlegmatizer and as a dispersing agent for formulations of organic peroxides
  • In fillers, putties, plasters and modelling clay
  • In adhesives, sealants, coatings and paints, thinners, paint remover and finger paints

Abbreviations

ED: Endocrine disrupting properties

PBT: Persistent, bioaccumulative and toxic

PU: Polyurethane

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

Next step:

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 reach@sgs.com or visit www.sgs.com/reach

For enquiries, please contact:

Emily Lam
Corporate Research & Development
t: +852 2204 8339 ext.1339

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