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On 8 July 2021, the European Chemical Agency (ECHA) added 8 new Substances of Very High Concern (SVHC) to the REACH Candidate List for Authorization. This brings the list to 219 SVHC substances. The new SVHC are used in consumer products such as cosmetics, scented articles, rubber and textiles. Others are used as solvents, flame retardants or to manufacture plastics products. Most have been added to the Candidate List because they are hazardous to human health as they are toxic for reproduction, carcinogenic, respiratory sensitisers or endocrine disruptors. The eight newly added substances are as follows:
1) 2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers (CAS 80-54-6; EC 201-289-8)
- Toxic for reproduction (Article 57 c)
- Use(s): Cleaning agents, cosmetics, in scented articles, polishes and wax blends
2) Orthoboric acid, sodium salt (CAS 13840-56-7; EC 237-560-2)
- Toxic for reproduction (Article 57 c)
- Use(s): Not registered under REACH. May be used as solvent and corrosion inhibitor
3) 2,2-bis(bromomethyl)propane1,3-diol (BMP); (CAS 3296-90-0; EC 221-967-7); 2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA) (CAS 36483-57-5; EC 253-057-0); 2,3-dibromo-1-propanol (2,3-DBPA) (CAS 1522-92-5; 96-13-9; EC 202-480-9);
- Carcinogenic (Article 57 a)
- Use(s): BMP: manufacture of polymer resins and in one component foam (OCPF) application. TBNPA: polymer production manufacture of plastics products, including compounding and conversion and as an intermediate. DBPA: registered as an intermediate
4) Glutaral (CAS 111-30-8; EC 203-856-5)
- Respiratory sensitising properties (Article 57f - human health)
- Use(s): Biocides, leather tanning, x-ray film processing, cosmetics
5) Medium-chain chlorinated paraffins (MCCP) (UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17) (CAS None; EC None)
- vPvB (Article 57e); PBT (Article 57d)
- Use(s): Flame retardants, plasticising additives in plastics, sealants, rubber and textiles
6) Phenol, alkylation products (mainly in para position) with C12-rich branched alkyl chains from oligomerisation, covering any individual isomers and/ or combinations thereof (PDDP) (CAS None; EC None)
- Toxic for reproduction (Article 57c); Endocrine disrupting properties (Article 57f - human health and environment)
- Use(s): Preparation of lubricant additive materials and of fuel system cleaners.
7) 1,4-dioxane (CAS 123-91-1; EC 204-661-8)
- Carcinogenic (Article 57a) Equivalent level of concern having probable serious effects to the environment (Article 57f -environment) Equivalent level of concern having probable serious effects to human health (Article 57f –human health)
- Use(s): Solvent
8) 4,4'-(1-methylpropylidene)bisphenol (CAS 77-40-7; EC 201-025-1)
- Endocrine disrupting properties (Article 57f - human health and environment)
- Use(s): Not registered under REACH. May be used in manufacture of phenolic and polycarbonate resin
This addition may impact your company if your company produces or is involved with the manufacturer or is a downstream user of any of the following:
- Cleaning agents
- Corrosion inhibitor
- Flame retardants
- Intermediate chemicals
- Leather Tanning
- Phenolic resins
- Plastics products
- Plasticizing additives
- Scented articles
- Wax Blends
- X-Ray Film processing
If you fall into any of these categories, you may need to revisit your compliance obligations. A successful approach to compliance requires data, systems, expertise and an executable process that starts with 3E’s “3 I’s”:
- Identification - Do you currently use these substances on their own, or as part of mixtures or articles?
- Impact Analysis - Complying depends on the use of the substance as it relates to concentration, annual import/export quantities, current registered uses, and exposure exclusions.
- Information Collection and Distribution - Make sure you can provide documentation and information up and down your supply chain. Consumers are entitled to complimentary information within 45 days of their original request, and ECHA must be conditionally notified no later than 6 months after a substance is listed.
Companies must follow their legal obligations and ensure the safe use of these chemicals. They also have to notify ECHA under the Waste Framework Directive if their products contain substances of very high concern. This notification is submitted to ECHA’s SCIP database and the information will later be published on the Agency’s website.
Verisk 3E can help with interpreting, managing and executing on these requirements. Discover how Verisk 3E can support supply chain material compliance and receive technical information on the recent SVHC additions and explore best practices.