Who has an obligation to notify the chemical under Swiss Chemical regulation?

The new substances should be notified before placing into the market by

  • Swiss manufacturer,
  • Importer
  • Only Representative can notify the substances on behalf of Non Swiss Manufacturer

  • The ChemO has also adopted GHS by requiring suppliers to classify, label and package hazardous substances and preparations in accordance with EU CLP regulation.
  • In the meantime, manufacturers and importers are required to submit the classification and labelling info of hazardous substances (including <1t/y new substances and exempt new substances) and preparations to the Swiss authority within 3 months after first placing them on the Swiss market.

This obligation is called registration. It is similar to C&L notification under CLP regulation

  • Substances with an EC-Nr. beginning with 4 (ELINCS) are new substances
  • 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).
  • Substances with an EC-Nr. beginning with 5 are no-longer polymers (NLP) and considered being new substances, too. 

A steering committee is appointed for the Notification Authority. It is composed of the directors of the following federal offices:

  • the FOPH, for matters concerning the protection of human life and health;
  • the FOEN, for matters concerning the protection of the environment and indirect protection of human beings;
  • SECO, for matters concerning the protection of workers.

Manufacturer must classify, package and label substances and preparations and prepare exposure scenarios and compile safety data sheets in accordance with this Ordinance

Manufacturers of a new substance or their only representative must notify the new substance to the Notification Authority before placing it on the market for the first time

Polymers (but not the monomers) are exempted from the notification obligation under ChemO and from registration obligation under REACH. Within the scope of self-regulation, the notifier must check this (in case of uncertainty, it may ask his supplier).

  • Polymer means a substance consisting of molecules characterized by the sequence of one or more types of monomer units and comprising:
  1. simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant and
  2. less than a simple weight majority of molecules of the same molecular weight; these molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units;

If the substance quantity placed on the market is 1 tonne per year or more and if the new substance is exempt from notification ,the manufacturer or his only representative must declare the new substance to the Notification Authority before placing it on the market for the first time

The declaration must be written in an official language or in English and be submitted electronically in the format required by the Notification Authority.

Notification Authority may request the manufacturer or only representative to furnish test reports that are relevant for the assessment of the substance, provided that they are available and can be obtained with reasonable effort.

The Substances and preparations that are hazardous or PBT/vPvB or on Swiss SVHC candidate list;even if quantity is <1 MT ,the company has to submit registration to the authority

No deadline specified in the regulation

New Substances: The new substance >1 MT has to be notified before placing into the market

PPORD substances: The new substance >1 MT has to be declared before placing into the market

Registration: The hazardous substances that are already on market (including <1MT),registration need to be done