According to article 4, paragraph 1, letter a of ChemA, new substances are defined as those which are not existing substances. Thus, new substances are those (no longer) fully registered under REACH in the EU. New substances are therefore substances
• which are not (or no longer) fully registered in the EU under REACH
• are only registered as intermediates (except monomers)
• are placed on the market in a higher quantity category than they are registered in the EU
If the substance is sourced from the EEA, the importer can obtain confirmation from the chemical manufacturer in the EU that the substance is registered in the EU with the registration type "Full" or "NONS" and the registration status "active", stating the registered tonnage category. This is proof that the substance is an existing substance.
If a substance is manufactured in Switzerland or purchased from a non-EEA country or received via the EU as transit goods, the manufacturer (including the importer) must check whether the substance falls under the above-mentioned existing substance definition of the ChemO.
Three criteria must be met:
1. the substance is registered
2. the substance is not registered exclusively as an intermediate.
3. the substance may not be placed on the market without notification in a higher quantity category than it is registered in the EU.
There are two ways to check this
1. on the website of the European Chemicals Agency (ECHA)
Using the CAS or EC/List number, one can search for the registration status of the substance on https://echa.europa.eu/de/information-on-chemicals/registered-substances and on https://echa.europa.eu/de/information-on-chemicals (see section "How to search for registered substances on the ECHA homepage?" in the "existing and new substances" guidance document).
2. An Excel list of substances registered in the EU with registration type "Full" or "NONS" and registration status "active" is available on the website of the Notification Authority for Chemicals as an aid, indicating the registered tonnage category. On this list the registered substances can be searched. The time of the registration status corresponds to the update date of the list: if the manufacturer does not find a substance, he must search for the substance on the ECHA website as part of fulfilling his self-regulation obligation.
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 https://echa.europa.eu/documents/10162/2324906/substance_id_en.pdf/.
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 (https://www.anmeldestelle.admin.ch/chem/en/home/themen/pflicht-hersteller/stoffe/neuer-stoff/ausnahmen-anmeldepflicht.html). 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.