Switzerland Reach Regulation for Various Sectors

Switzerland is not a member of the EU or the European Economic Area (EEA) and all new substances must be notified, registered and/or declared in Switzerland before they are placed on the market. This is so even if they are already registered in the EU under REACH, have to be registered according to the Swiss Ordinance on Protection against Dangerous Substances and Preparations (Chemicals Ordinance; ChemO, SR 813.11, 4th Revision).

Switzerland has moved towards implementation of REACH through partial revision of the Swiss Chemical Ordinance on February 1, 2009. Switzerland has decided to move toward Reach implementation. The partial revision of the Swiss Chemicals Ordinance (ChemO, RS 813.11) came into force on February 1, 2009.

A new substance is defined a substance that is not listed on EINECS (European Inventory of Existing Commercial Chemical Substances). This inventory includes chemical substances deemed to be on the European Community market between January 1, 1971 and September 18, 1981.

There is no official Swiss chemical inventory. Switzerland also uses EINECS as their existing chemical substance inventory. A substance that is listed on EINECS may still require registration under the Swiss Chemicals Ordinance.

If the new substance is placing on the market it has to be notified or declared under the regulation.

Following substances will be treated as New substance Swiss REACH:

• 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. Pursuant to art. 26 par. 1 let. c there is no notification obligation for these (classified NLP however must be registered)

• 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.

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

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

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 either on its own or as a constituent in a preparation or object from which the substance is intended to be released under normal or reasonably foreseeable conditions of use.

The substances and preparations that are hazardous or PBT/vPvB or on Swiss SVHC candidate list,and even if qunatity is <1 MT,registration need to be done along with the details of substance identity, classification & labelling, uses, quantity, and chemical safety report

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;

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