Substances of very high concern
Chemical substances that meet certain REACH criteria– such as being carcinogenic, toxic for reproduction, or persistent in the environment- may be proposed as SVHC (substance of very high concern). The listing of a substance as an SVHC by the European Chemicals Agency (ECHA) is the first step in the procedure for authorisation procedures or restriction of the use of a chemical.
Although these high-concern substances can be considered unwanted due to their hazardous nature, they are used (and in the past in large quantities) due to their flame retardant, stabilizing, or other functional properties in plastics, furniture, building materials, and electronics.
Currently, manufacturers or suppliers have to comply with REACH and must identify and monitor SVHC substances in their products. In addition to identifying potential SVHC substances, companies must check whether applied substances appear on the REACH list of restrictions (called REACH Annex XVII) and/or the REACH authorization list (called REACH Annex XIV).
To avoid SVHC substances from ending up in toys, agriculture, clothes, or food packaging made from recycled feedstock it is important that these chemicals can be tracked from manufacturing to waste. In doing so, the waste processors and secondary manufacturers (recyclers) know if a waste product contains one or more of these substances and how to safely extract them from the waste streams.
If you are an EU article supplier and your product contains SVHC > 0.1% w/w, you must communicate information on it along the supply chain. As a minimum, the name of the SVHC has to be passed on. If requested by a consumer you must supply them with the SVHC safe use information within 45 days. In addition to the communication responsibility, EU article producers and importers have to notify ECHA if the total quantity of SVHC in articles is greater than 1 tonne per year. Additionally, manufacturers need to pay attention of the growing number of SVHC substances on the Annex XIV list for authorization. Manufacturers without authorization for a specific substance use must carefully watch the latest application and sunset dates to comply with REACH requirements on allowed SVHC use. If you are an EU supplier of mixtures for consumers, you may need to provide a Safety Data Sheet if the mixture contains a SVHC ≥ 0.1% w/w, upon request by downstream users or distributors. This requirement is in addition to the obligations in accordance to the dangerous preparation Directive (EC) 1999/45C and the CLP Regulation (EC) 1272/2008.
Fulfill notification obligations
- Assess your products
- Implement a system for identifying and tracking SVHC substances in your articles
- Collect information (e.g. REACH certificates) from your suppliers
- Assess if the concentration of SVHC reaches the 0.1 % threshold
- Create a SCIP notification dossier (an IUCLID template will be available for this)
- Submit your notification dossier.
What is an article
Under REACH an article is an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition does. Examples of articles are plastic packaging or cloths
There are also Complex objects which may be made of several individual articles. This can be something as complex an e-bike consisting of hundreds of different articles (frame, battery, electronics, tyres etc).
The SCIP Communication obligations on SVHC substances in articles also apply to every article incorporated in a complex object.
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