Chemicals Ordinance (ChemO)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Chapter 1 Taking Account of new Information Releva
Art. 44 Reassessment of substances, preparations and objects
Manufacturers must reassess or further assess substances, preparations and objects containing dangerous constituents and, where necessary, reclassify, relabel and repackage them if: a. they are to be supplied for different purposes; b. they are to be used in a different way; c. they are to be used in much larger quantities than before; d. variations arise in the nature and quantity of impurities, which could have adverse effects on human health or the environment; e. the assessment of the risks they pose to human health or the environment needs to be modified in the light of practical experience, new data or new information.
Art. 45 Updating and retention of documents
1 Manufacturers are required to update documents continuously with new information relevant to health and the environment for as long as they continue to place on the market the substance, preparation or object containing dangerous constituents. 2 They must retain or ensure the availability of the main documents used in the assessment and classification, together with the results of the assessment and classification, for at least ten years after the products are last placed on the market. They must retain samples and specimens for as long as their condition allows them to be analysed.
Chapter 2 Updated Information and Additional Test
Art. 46 Updated information
1 Notifiers must inform the Notification Authority in writing without delay if: a. there are any changes in the information referred to in Article 27 paragraph 2 letter b numbers 1–6 or Article 35 paragraph 2; b. the quantity placed on the market is likely to have reached one of the thresholds laid down in Article 47 paragraph 1; in this case, notifiers shall specify which tests they intend to conduct in order to produce the additional information specified in Article 47 paragraph 1; c. the quantity placed on the market has increased or decreased by a factor of more than two compared with the quantity last notified; d. new information comes to their attention regarding the effects of the substance on human health or the environment; e. they place the substance on the market for a new use or become aware that this substance is being used for purposes other than those indicated to the Notification Authority; f. they compile, or have compiled for them, test reports going beyond the techni
Art. 47 Quantity-based information requirements
1 Notifiers must provide the Notification Authority with the following additional information based on the quantity placed on the market: a. for quantities of 10 tonnes per year or more: the information specified in Annex 4 number 9 letter b and number 10 letter b and a chemical safety report in accordance with Article 28; b. for quantities of 100 tonnes per year or more: the information specified in Annex 4 number 8 letter b, number 9 letter c and number 10 letter c and a chemical safety report in accordance with Article 28; c. for quantities of 1,000 tonnes per year or more: the information specified in Annex 4 number 9 letter d and number 10 letter d and a chemical safety report in accordance with Article 28. 2 After receiving the information specified in Article 46 paragraph 1 letter b, the Notification Authority shall, in accordance with Article 31 paragraph 3, inform the notifier of the data that it already holds. 3 If the risks associated with a given substance cannot be adequat
Para. 2 — The reference was amended on 1 March 2018 pursuant to Art. 12 para. 2 of the Publications Act of 18 June 2004 (SR 170.512).
Chapter 3 Obligation to Report
Art. 48 Substances and preparations subject to reporting requirements
1 Manufacturers must report the following substances and preparations to the Notification Authority within 3 months after first placing them on the market: a. the substances and preparations specified in Article 19, irrespective of whether a safety data sheet has to be compiled for them; b. nanomaterials, other than those referred to in letter a, which specifically contain biopersistent fibres or tubes exceeding 5µm in length. 2 Materials with a water solubility of less than 100mg per litre or with a half-life in the lungs of 40 days or more are considered to be biopersistent.
Art. 48 — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801).
Art. 49 Content of the report
1 The report must include the following information: a. the manufacturer’s name and address; b. the name of the person responsible for placing the substance or preparation on the market in the EEA in accordance with Article 17 paragraph 1 letter a of the CLP Regulation, if the manufacturer’s identity is not mentioned on the label; c. in the case of substances: 1. the chemical name in accordance with Article 18 paragraph 2 letters a–d of the CLP Regulation, 2. the CAS number, 3. the EC number, 4. the classification and labelling, 5. the intended uses, 6. in the case of substances dangerous to the environment: the quantity likely to be placed on the market annually according to one of the following categories: less than 1 tonne, 1–10 tonnes, 10–100 tonnes, more than 100 tonnes, 7. in the case of nanomaterials: – the composition, particle form and mean particle size and, where available, the number size distribution, specific surface area by volume, crystal structure, aggregation status,
Para. 1 let. b — See footnote to Art. 2 para. 4. Para. 1 let. c let. 7 — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801). Para. 1 let. d let. 1a — Inserted by No I of the O of 31 Jan. 2018 (AS 2018 801). Amended by Annex No 1 of the O of 18 Nov. 2020, in force since 1 Jan. 2022 (AS 2020 5125). Para. 1 let. d let. 7 — Amended by Annex No 1 of the O of 15 Nov. 2023, in force since 1 Jan 2024 (AS 2023 709). Para. 2 let. b — Inserted by No I of the O of 11 March 2
Art. 50 Extended report
In the case of dangerous preparations sold to private users, the Notification Authority must be informed of the full composition. Constituents which are not deemed to be dangerous under Article 3 may be designated by a name that identifies the most important functional groups.
Art. 50 — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801).
Art. 51 Form of the report and extended report
The report and extended report shall be submitted as follows: a. electronically in the format required by the Notification Authority; b. in an official language or in English.
Art. 52 Modifications
1 Any modifications to the information specified in Articles 49 and 50 must be reported within 3 months. 2 If the quantity of substances and preparations dangerous to the environment actually supplied in a year falls outside the reported category of quantities placed on the market, the quantity placed on the market in the previous year must be reported by 31 March of the following year in accordance with the categories specified in Article 49 paragraph 1 letter c number 6 and letter d number 6.
Para. 2 — The reference was adapted in application of Art. 12 para. 2 of the Publications Act of 18 June 2004 (SR 170.512) on 1 May 2022.
Art. 53 Special form of compliance with the obligation to report
The requirements to report preparations in accordance with Article 48 are deemed to have been met if a request to use an alternative chemical name (Art. 15) has been submitted and the Notification Authority possesses the information required under Article 49 paragraph 1 letters a, b and d and, if applicable, Article 50.
The reference was adapted in application of Art. 12 para. 2 of the Publications Act of 18 June 2004 (SR 170.512) on 1 May 2022.
Art. 54 Exemptions from the obligation to report
1 The reporting requirements specified in this Chapter do not apply to: a. intermediates that: 1. are not given to third parties, 2. do not leave the manufacturing site, or 3. are placed on the market in quantities less than 100kg per year; b. substances and preparations which are placed on the market solely for the purposes of analysis, research or development; bbis. substances that are placed on the market solely for training purposes; c. substances and preparations used exclusively for foodstuffs, therapeutic products or animal feedingstuffs; d. … e. explosives and pyrotechnic devices which require authorisation under the Explosives Ordinance of 27 November 2000; f. substances obtained in Switzerland; g. preparations obtained in Switzerland and supplied in packaging other than that provided by the original manufacturer, provided that: 1. the trade name, composition, the UFI and the intended use are unchanged, and 2. the name of the original manufacturer is also indicated; h. gas mix
Para. 1 let. a — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801). Para. 1 let. b — Amended by No I of the O of 11 March 2022, in force since 1 May 2022 (AS 2022 220). Para. 1 let. bbis — Inserted by No I of the O of 11 March 2022, in force since 1 May 2022 (AS 2022 220). Para. 1 let. d — Repealed by Annex 5 No II 1 of the O of 1 Nov. 2023 on Placing Fertilisers on the Market, with effect from 1 Jan. 2024 (AS 2023 711). Para. 1 let. e — SR 941.411 Para. 1 let.
