How do I recognize a new substance?

  • Substances with an EC-Nr. beginning with 2 or 3 are existing substances (EINECS)
  • Substances with an EC-Nr. beginning with 4 (ELINCS) are new substances
  • Substances with an EC-Nr. beginning with 5 are no-longer polymers (NLP) and considered being new substances, too
  • Those with a list number beginning with 6, 7, 8 or nine are mostly new substances, too (unless the manufacturer can prove that the identity corresponds to a substance listed in EINECS).
The Swiss manufacturer (definition includes the importer) has to define himself his substance’s identity in terms of self-regulation (art. 5 ChemO). For this purpose, he has to procure all accessible information. ECHA’s “Guidance for identification and naming of substances under REACH and CLP” can be useful
 
If the manufacturer notices that the substance is a new substance, he has to notify it prior to placing the substance onto the market above 1 tpa (art. 24 and 26 ChemO, Swiss quantity), if no other exemption pursuant to art. 26 applies
If the manufacturer is of the opinion that it is an existing substance, he does not need to notify. However, in case of a control by enforcement authorities or if being asked by the notification authorities, he must be able to prove it (scientific arguments, analysis data, statements by the chemical manufacturer or an EU authority).
 
The notification authority may decide – where necessary after consultation with the evaluation units – about individual cases, if all available data and sufficient information is submitted.
 

Last modification 06.12.2018

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