Obligation to report preparations
Introduction
The reporting requirements for substances and preparations under Articles 48–54 of the Chemicals Ordinance (ChemO; SR 813.11) were introduced in Switzerland in their current form with the chemicals legislation in 2005 and have since been regularly updated. They arose from the notification requirements for products under the toxic substances legislation.
The reporting of new substances as specified in Art. 26 para. 3 ChemO is described in the “Guidelines for notification, reporting and declaration of new substances in accordance with the Swiss Chemicals Ordinance”.
Separate guidance is available for reporting in accordance with the Ordinance on Biocidal Products (OBP; SR 813.12) and the Chemical Risk Reduction Ordinance (ORRChem; SR 814.81).
With the 2018 and 2022 revisions of the ChemO, certain elements of the reporting requirements were aligned with Annex VIII to Regulation (EC) No 1272/20081 (CLP Regulation). However, marked differences still remain between the regulations in Switzerland and the EU with regard to the scope of the obligation to report and the requirements concerning reporting (Annex VIII to the CLP Regulation uses the term “notification”).
Reports are submitted to the product register for chemicals (RPC: register des produits chimiques) via an electronic application provided free of charge by the Notification Authority for Chemicals (www.rpc.admin.ch).
This guidance is addressed to those required to submit reports, and to the federal and cantonal employees concerned. It describes in detail the reporting requirements specified in Articles 48–54 ChemO. Use of the electronic application (RPC) is described in a separate document.
1Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, OJ L 353, 31.12.2008, p. 1; last amended by Commission Regulation (EU) 2017/776, OJ L 116, 5.5.2017, p. 1.
1. Purpose of reporting
2. Who is required to submit reports?
3. When must a report be submitted?
4. Which substances and preparations have to be reported?
5. What information on substances and preparations has to be reported?
The requirements for reporting of substances and preparations are specified in Art. 49 ChemO and additionally, for the extended report for preparations, in Art. 50 ChemO. To be included in all reports are: the name and address of the manufacturer in Switzerland.17
6. In what format are reports to be submitted?
In Switzerland, electronic reports can be submitted manually via www.rpc.admin.ch. Also now available is a mass registration interface.28
7. When do submissions have to be updated?
Art. 52 ChemO indicates when submissions have to be updated:
Simplification of the registration application procedure for preparations
Since July 1, 2015, it is no longer necessary to report the classification of each ingredient when reporting preparations. All the information is provided below.
Voluntary reporting of a preparation in the Chemicals Product Register (RPC)
Voluntary reporting (within the meaning of Art. 48 ff. ChemO, SR 813.11) of chemical preparations not subject to reporting in the Product Register for Chemicals (RPC)
Remarks concerning the notification of a preparation with labelling EUH208
If a preparation is labelled exclusively with one or more EUH phrases (e.g. EUH208 Contains [name of the sensitiser]. May produce an allergic reaction), the chemical is not considered dangerous according to the Chemicals Ordinance (ChemO). However, if the preparation contains a substance mentioned in Art. 19 letter d ChemO above the concentration limit, the product is a dangerous preparation. I.e. the product it must be notified in the register for products (RPC) and a safety data sheet must be prepared for supply to professional users.
