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 Self-Regulation
Section 1 Principles
Art. 5
1 The self-regulation system introduced by Article 5 of the Chemicals Act and Article 26 of the EPA requires manufacturers to assess whether substances or preparations may endanger human life or health or the environment. To this end, manufacturers must classify, package and label substances and preparations and prepare exposure scenarios and compile safety data sheets in accordance with this Ordinance. 2 In the case of objects containing dangerous substances, substances considered PBT or vPvB, or substances listed in Annex 3, self-regulation under Article 26 of the EPA requires manufacturers to assess whether these substances may endanger the environment or indirectly endanger human health when these objects are used as intended, or in a foreseeable manner, or when they are appropriately disposed of. 3 In the case of objects containing substances listed in Annex 3, manufacturers must assess whether these substances may endanger human health when these objects are used as intended, or
Section 2 Classification of Substances and Prepara
Art. 6 Classification of substances
1 Manufacturers must classify substances in accordance with Articles 5, 7–13 and 15 of the CLP Regulation. 2 If a harmonised classification is specified for a substance in Annex VI to the CLP Regulation, in the applicable version referred to in Annex 2 number 1, the manufacturer must additionally classify this substance in accordance with Article 4 paragraph 3 of the CLP Regulation. 3 Classification must be based: a. in the case of existing substances: on data collected in accordance with Article 5 paragraph 4; b. in the case of new substances: on the data as specified in Article 5 paragraph 4 and on data in the technical dossier as specified in Article 27 paragraph 2 letter b. 4 The Federal Department of Home Affairs (FDHA), in consultation with the Federal Department of the Environment, Transport, Energy and Communications (DETEC) and the Federal Department of Economic Affairs, Education and Research (EAER), may prescribe a harmonised classification and the associated labelling for c
Para. 1 — See footnote to Art. 2 para. 4. Para. 3 let. b — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801).
Art. 7 Classification of preparations
Manufacturers must classify preparations in accordance with Articles 6–15 of the CLP Regulation.
See footnote to Art. 2 para. 4.
Section 3 Packaging and Labelling of Substances an
Art. 8 Packaging
Manufacturers making available or supplying dangerous substances or preparations to third parties must package them in accordance with Article 35 of the CLP Regulation.
See footnote to Art. 2 para. 4.
Art. 9 Packaging of aerosol dispensers
Aerosol dispensers not covered by the FoodA are subject both to the packaging provisions of this Ordinance and to Articles 1 and 2, and points 2.1, 2.3, 3, 4, 5 and 6 of the Annex to Directive 75/324/EEC.
SR 817.0 See footnote to Art. 2 para. 4.
Art. 10 Labelling
1 Manufacturers making available or supplying dangerous substances or preparations to third parties must label them in accordance with the following provisions: a. Article 17 paragraph 1, Article 18 with the exception of the last sentence of paragraph 2, Articles 19–23, Article 25 paragraphs 1, 3 and 4, Articles 26–28, Article 29 paragraphs 1–4, Article 31 and Article 32 paragraphs 1–5 of the CLP Regulation; b. the specific rules for labelling of outer packaging, inner packaging and single packaging set out in Article 33 of the CLP Regulation. 2 Preparations with particular hazards referred to in Article 4 paragraph 7 of the CLP Regulation must additionally be labelled in accordance with Article 25 paragraph 6 of the CLP Regulation. 3 In addition to paragraphs 1 and 2, the labelling must meet the following requirements: a. The name, address and telephone number of the manufacturer are to be included. b. The labelling must be in an official language of the location at which the substanc
Para. 1 let. a — The correction of 24 April 2023 relates to the French and Italian texts only (AS 2023 193). Para. 1 let. a — See footnote to Art. 2 para. 4. Para. 3 let. b — Amended by No I of the O of 11 March 2022, in force since 1 May 2022 (AS 2022 220). Para. 3 let. c — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801). Para. 3bis — Amended by No I of the O of 11 March 2022, in force since 1 May 2022 (AS 2022 220). Para. 3bis let. b — Inserted by No I of th
Art. 10a Official languages
The official languages are German, French and Italian.
Art. 10a — Inserted by No I of the O of 11 March 2022, in force since 1 May 2022 (AS 2022 220). The correction of 24 April 2023 relates to the French and Italian texts only (AS 2023 193)
Art. 11 Labelling of aerosol dispensers
1 Aerosol dispensers not covered by the FoodA are subject both to the provisions of this Ordinance and to Articles 1, 2 and 8 paragraphs 1 and 1a, and points 1.8, 1.9 and 1.10, the introductory provision of number 2, and points 2.2 and 2.3 of the Annex to Directive 75/324/EEC. 2 In the case of aerosol dispensers not deemed to be dangerous under Article 3, the manufacturer’s name and address must be indicated. If such an aerosol dispenser is imported from an EEA member state, the manufacturer’s name may be replaced by the name of the person responsible for placing it on the market in the EEA.
Para. 1 — SR 817.0 Para. 1 — See footnote to Art. 2 para. 4. Para. 1 — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801).
Art. 12 Derogations from labelling requirements
1 The Notification Authority may, after consultation with the assessment authorities, permit derogations from the labelling requirements for certain substances or preparations, or for certain groups of substances or preparations, and allow these not to be labelled or to be labelled in some other suitable form if: a. the packages are too small or otherwise unsuitable for labelling in accordance with Article 10; b. the substance or preparation is supplied in such small quantities that, taking the particular hazards into account, it poses no risk to humans or the environment; or c. the substance or preparation does not fall within the scope of the CLP Regulation. 2 It shall issue a ruling in response to a justified application or issue a general ruling. 3 It shall maintain a list of the derogations that have been permitted and publish this on its website.
Para. 1 let. c — See footnote to Art. 2 para. 4.
Art. 13
Repealed by No III 1 of the O of 22 March 2017, with effect from 1 May 2017 (AS 2017 2593).
Art. 14 Use of an alternative chemical name
1 Manufacturers of preparations may use an alternative chemical name for a substance if: a. they demonstrate that disclosing the name of the substance on the label or in the safety data sheet would put the confidential nature of their business, in particular their intellectual property rights, at risk; and b. the substance meets the criteria specified in Section 1.4 of Annex I to the CLP Regulation, in the applicable version referred to in Annex 2 number 1. 2 The alternative chemical name shall be a name that identifies the most important functional groups or serves as an alternative designation. 3 If the European Chemicals Agency has approved the use of an alternative chemical name in accordance with Article 24 of the CLP Regulation, the use of the name is deemed approved in Switzerland from the date on which the Notification Authority acknowledges the following documents and data: a. the decision of the European Chemicals Agency; b. details of the substance identity in accordance wit
Para. 3 let. b — Amended by Annex No 1 of the O of 15 Nov. 2023, in force since 1 Jan. 2024 (AS 2023 709). Para. 3bis — See footnote to Art. 2 para. 2 let. f. Para. 3bis — Inserted by Annex No 1 of the O of 15 Nov. 2023, in force since 1 Jan. 2024 (AS 2023 709). Para. 6 let. b — Amended by Annex No 1 of the O of 15 Nov. 2023, in force since 1 Jan. 2024 (AS 2023 709). Para. 7 — Inserted by Annex No 1 of the O of 15 Nov. 2023, in force since 1 Jan. 2024 (AS 2023 709).
Art. 15 Requests to use an alternative chemical name
1 Requests to use an alternative chemical name for a substance in a preparation must be written in an official language or in English and be submitted electronically in the format required by the Notification Authority. The accompanying letter must be written in an official language. 2 Requests must contain: a. the manufacturer’s name, address and telephone number; b. the following information relating to the substances whose identity is to remain confidential on the label: 1. the chemical name, 2. the Chemical Abstracts Service (CAS) registry number, 3. the EC number; c. the alternative name of the substance; d. the reasons for the request; e. the trade name or designation of the preparation; f. the information on the constituents in accordance with the provisions relating to the safety data sheet; g. the classification of the preparation; h. the labelling of the preparation; i. the intended uses of the preparation; j. the physical state; k. if applicable, the safety data sheet. 3 The
Para. 2 let. b let. 2 — The CAS registry number can be accessed free of charge on the European Chemicals Agency website: http://echa.europa.eu/information-on-chemicals/ec-inventory
Art. 15a Unique formula identifier
1 If a manufacturer places a preparation on the market which is classified as dangerous because of the physical or health hazards it poses, the manufacturer must label the preparation with a unique formula identifier (UFI). 2 He must generate the UFI using the electronic system provided by the Notification Authority. Generating the UFI using the electronic system is not required if the preparation already has a UFI that has been generated on the basis of the CLP Regulation. 3 The UFI, preceded by the acronym "UFI:" in capital letters, must be printed or affixed in a clearly visible, legible and indelible manner in the following location: a. on the label in the section for supplemental information in accordance with Article 2525 of the CLP Regulation; or b. on the inner packaging together with the other label elements; if the inner packaging is of such a nature or so small that the UFI cannot be printed or affixed thereon, it may be printed or affixed with the other label elements on th
Art. 15a — 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. 2 — See footnote to Art. 2 para. 4.
Section 4 Exposure Scenarios and Safety Data Sheet
Art. 16 Obligation to prepare exposure scenarios
1 The manufacturer of an existing substance that fulfils the criteria specified in Article 14 paragraph 4 of the REACH Regulation and is supplied on its own to third parties in a total quantity of 10 tonnes per year or more must prepare an exposure scenario for each identified use of the substance. 2 Any person who obtains a substance for which exposure scenarios have been prepared and supplies it to third parties on a commercial basis in quantities of 1 tonne per year or more as a substance or in a preparation for a use not described in the safety data sheet must prepare an exposure scenario for this use. 3 Paragraph 2 does not apply in cases where: a. the exposure scenario for the new use would exclusively cover conditions described in an exposure scenario included in the safety data sheet; b. the substance is present in the preparation in a concentration below the limits referred to in Article 27 paragraph 3; or c. the substance is used for purposes of product and process-orientated
Para. 1 — See footnote to Art. 2 para. 4.
Art. 17 Requirements for the preparation of exposure scenarios
The exposure scenarios must be prepared in accordance with the provisions of Section 5.1 of Annex I to the REACH Regulation.
See footnote to Art. 2 para. 4.
Art. 18 Purpose of the safety data sheet
Safety data sheets are designed to enable professional users or traders to take the measures required for health protection, occupational safety and environmental protection.
Art. 19 Obligation to compile a safety data sheet
Where the provision of a safety data sheet is required under Article 21, the manufacturer must compile a safety data sheet for the following substances and preparations: a. dangerous substances and preparations; b. PBT or vPvB substances; c. substances listed in Annex 3; d. preparations which are not dangerous within the meaning of Article 3 and contain at least one of the following substances: 1. a substance that is dangerous to health or to the environment in an individual concentration of ≥1.0 per cent by weight (non-gaseous preparations) or ≥0.2 per cent by volume (gaseous preparations), 2. a category 2 carcinogenic substance, a category 1A, 1B or 2 toxic for reproduction substance, a category 1 skin allergen, a category 1 inhalation allergen, a substance having effects on or through lactation, or a PBT or vPvB substance in an individual concentration of ≥0.1 per cent by weight, 3. a substance listed in Annex 3 in an individual concentration of ≥0.1 per cent by weight, 4. a substan
let. b — Correction of 4 June 2019 (AS 2019 1647). let. d let. 2 — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801). let. d let. 4 — Amended by Annex No 1 of the O of 18 Nov. 2020, in force since 15 Dec. 2020 (AS 2020 5125). let. d let. 4 — Commission Directive 2000/39/EC of 8 June 2000 establishing a first list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC on the protection of the health and safety of workers
Art. 20 Requirements for the compilation of safety data sheets
1 Safety data sheets must be compiled in accordance with the technical provisions referred to in Annex 2 Number 3. 2 The exposure scenarios prepared in accordance with Article 16 or included in the chemical safety report (Art. 28) must be attached to the safety data sheet; the information in sections 1, 7, 8 and 13 of the safety data sheet must correspond to the uses described in the exposure scenarios. 3 The FDHA may, in consultation with DETEC and the EAER, define the technical expertise required for the compilation of safety data sheets.
Art. 21 Obligation to provide safety data sheets
1 Anyone who supplies substances or preparations as specified in Article 19 to professional users or traders in a commercial capacity must provide them with a current safety data sheet. In retail outlets, the safety data sheet must be provided on request. 2 The safety data sheet must be provided: a. when supplying a substance or preparation as specified in Article 19 letters a–c: at the latest at the time it is first supplied and on request with subsequent deliveries; b. when supplying a preparation as specified in Article 19 letter d: on request. 3 Safety data sheets must be provided as follows: a. free of charge; b. in the official languages requested by the professional user or trader or, by mutual agreement, in another language; the annex to the safety data sheet may be written in English; c. on paper or in electronic form; the safety data sheet is to be provided on paper if this is requested by the professional user or trader.
Art. 22 Updating of safety data sheets
1 If important new information on a substance or preparation becomes available, the manufacturer must update the safety data sheet without delay. 2 The supplier must make the updated safety data sheet available to all professional users or traders supplied with the substance or preparation concerned within the previous twelve months. 3 Paragraph 2 does not apply to safety data sheets provided through retail outlets.
Art. 23 Obligation to retain safety data sheets
Professional users or traders are required to retain the safety data sheet for as long as the substance or preparation concerned continues to be handled at their workplace.
Chapter 2 Notification and Declaration of New Subs
Section 1 Notification of New Substances
Art. 24 Obligation to notify
1 Manufacturers of a new substance or their exclusive representative must notify the new substance to the Notification Authority before placing it on the market for the first time: a. on its own; b. in a preparation; or c. in an object from which the new substance may be released under normal or reasonably foreseeable conditions of use. 2 If a new substance is contained in a polymer as a monomer or as another substance in the form of monomer units or chemically bound, paragraph 1 applies for the substance on its own. 3 The Notification Authority may require the notification of a substance contained in an object if it has reason to believe that the substance may be released when the object is used.
Art. 25 Substances that are no longer registered
If a substance is subject to the obligation to notify because it is no longer registered in accordance with Article 5 of the REACH Regulation, the manufacturer may continue to place it on the market without notification until the end of the calendar year following that in which its registration status changes. The Notification Authority may extend the period by a maximum of two years in response to a justified request.
Art. 25 — Amended by No I of the O of 11 March 2022, in force since 1 May 2022 (AS 2022 220, 273). The correction of 5 May 2022 concerns the French text only (AS 2022 273). See the footnote to Art. 2 para. 2 let. f.
Art. 26 Exemptions from the obligation to notify
1 Notification is not required for: a. polymers or substances contained as monomer units or chemically bound to the polymer in a concentration of less than 2 per cent by weight; b. … c. substances placed on the market in quantities of less than 1 tonne per year; d. substances placed on the market by a manufacturer: 1. exclusively for product and process-orientated research and development purposes, 2. in quantities not exceeding those required for the specified purpose, and 3. for a period not exceeding five years; in response to a justified request, the Notification Authority may, in consultation with the assessment authorities, extend this period by an additional five or ten years; e. substances used exclusively as raw materials, active ingredients or additives in foodstuffs, therapeutic products and animal feedingstuffs; f. substances obtained in Switzerland; g. intermediates, provided that they are not monomers; h. substances listed in Annex IV or Annex V to the REACH Regulation; i
Para. 1 let. b — Repealed by No I of the O of 11 March 2022, with effect from 1 May 2022 (AS 2022 220). Para. 1 let. h — Amended by No I of the O of 11 March 2022, in force since 1 May 2022 (AS 2022 220). Para. 1 let. h — See footnote to Art. 2 para. 2 let. f. Para. 1 let. j — Inserted by No I of the O of 11 March 2022, in force since 1 May 2022 (AS 2022 220). Para. 3 — Amended by No I of the O of 11 March 2022, in force since 1 May 2022 (AS 2022 220).
Art. 27 Form and content of the notification
1 The notification must be written in an official language or in English and be submitted electronically in the format required by the Notification Authority. The accompanying letter must be written in an official language. 2 The notification must contain the following information and documents: a. the quantity which the notifier intends to place on the market; b. a technical dossier with the following information further specified in Annex 4: 1. the identity of the notifier, 2. the identity of the substance, 3. information on manufacture and use, 4. classification and labelling, 5. guidance on safe use, 6. exposure assessment, 7. robust study summaries and further data on the physical and chemical properties, 8. robust study summaries with regard to the properties dangerous to health, 9. robust study summaries with regard to the properties dangerous to the environment; c. if the quantity placed on the market amounts to 10 tonnes per year or more: a chemical safety report in accordance
Para. 2 let. a — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801). Para. 2 let. c — Expression in accordance with No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801). This change has been made throughout the text. Para. 2 let. e — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801). Para. 3 let. a — See footnote to Art. 2 para. 4. Para. 4 — Repealed by No I of the O of 31 Jan. 2018, with effect from 1 March 2
Art. 28 Chemical safety reports
The chemical safety report contains the chemical safety assessment in accordance with Annex I to the REACH Regulation. A chemical safety assessment includes the following steps: a. a human health hazard assessment; b. a human health hazard assessment of physicochemical properties; c. an environmental hazard assessment; d. PBT and vPvB assessment; e. if the substance fulfils the criteria specified in Article 14 paragraph 4 of the REACH Regulation: 1. an exposure assessment, covering all identified uses, 2. a risk characterisation, covering all identified uses.
See footnote to Art. 2 para. 4.
Section 2 Use of Data from Previous Notifiers and
Art. 29 Use of data from previous notifiers
1 If the Notification Authority finds that a new substance has already been notified in Switzerland, it shall inform the notifier of the names and addresses of the earlier notifiers. 1bis The Notification Authority may refer to data from a previous notifier instead of data produced by the notifier if: a. the new notifier proves with a letter of access from a previous notifier that the latter agrees to the Notification Authority consulting its data; or b. the data protection period has expired. 2 The notifier must not refer to data from previous notifiers regarding: a. the identity and purity of the substance and the nature of any impurities; b. action to render the substance harmless. 3 The rules of competition and intellectual property law are not affected by the provisions of this section.
Para. 1 — Inserted by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801). Para. 1bis let. b — Originally: para. 1.
Art. 30 Data protection period
1 The data protection period is 12 years. 2 For additional data which must be submitted in accordance with Article 47, the protection period is 5 years. If the data protection period specified in paragraph 1 has not yet expired, the protection period for additional data is extended accordingly.
Para. 1 — Amended by No I of the O of 11 March 2022, in force since 1 May 2022 (AS 2022 220).
Art. 31 Mandatory advance enquiries to avoid tests on vertebrates
1 Anyone planning tests on vertebrates for notification purposes must contact the Notification Authority to enquire whether data from such tests is already available. The enquiry must be made in the format stipulated by the Notification Authority. 2 This enquiry must contain information on: a. the identity of the substance in accordance with Article 27 paragraph 2 letter b number 2; b. the quantity of substance the applicant intends to place on the market. 3 If the Notification Authority already has adequate data from previous tests on vertebrates, and none of the conditions of Article 29 paragraph 1bis is met, then: a. it shall notify the former notifiers of the intended use of the data by the new notifier and of his name and address, and b. it shall disclose the names and addresses of the former notifiers to the new notifier. 4 Studies on tests with vertebrates may not be repeated.
Art. 31 — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801). Para. 1 — Amended by No I of the O of 11 March 2022, in force since 1 May 2022 (AS 2022 220).
Art. 32 Right to remuneration for sharing of data from previous tests on vertebrates
1 The previous notifiers are entitled to receive fair remuneration from the new notifier for the use of their data from previous tests on vertebrates if the term of protection for such data has not yet expired. 2 The notifiers shall take steps independently to reach an agreement on data sharing and remuneration. They may seek an arbitrator’s report. 3 If no agreement is reached, the new notifier may apply to the Notification Authority for a ruling on the amount of the remuneration; the request may be made no earlier than four months after receipt of the notification referred to in Article 31 paragraph 3. The new notifier shall inform the previous notifiers of his/her application. 4 The Notification Authority shall issue a ruling on the amount of the remuneration no later than 60 days after the request referred to in paragraph 3. If an arbitrator’s report has been submitted, the Notification Authority is bound by it unless the parties raise objections within 30 days in terms of Article
Art. 32 — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801). Para. 4 — SR 272
Art. 33 Use of data from previous tests on vertebrates
The Notification Authority shall use data from previous tests on vertebrates for notification under Article 24, unless otherwise agreed between notifiers, as soon as: a. the new notifier and the previous notifiers have concluded an agreement on the sharing of data and the remuneration, or the Notification Authority has issued a corresponding ruling, and b. the new notifier pays the remuneration or has undertaken to do so by acknowledgement of debt confirmed by signature.
Art. 33 — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801).
Section 3 Declaration of New Substances for Produc
Art. 34 Obligation to make a declaration
If the substance quantity placed on the market is 1 tonne per year or more and if the new substance is exempt from notification under Article 26 paragraph 1 letter d, the manufacturer or his exclusive 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.
Art. 35 Form and content of the declaration
1 The declaration must be written in an official language or in English and be submitted electronically in the format required by the Notification Authority. The accompanying letter must be written in an official language. 2 The declaration must contain the following information and documents: a. the name and address of the manufacturer; b. if the manufacturer has imported the substance: the name and address of the foreign manufacturer; c. essential data relating to the identity of the substance; d. the intended uses; e. the amount of the substance that the manufacturer expects to place on the market each year in Switzerland; f. proposed classification and labelling; g. the research programme and a list of the people to whom the substance is to be supplied; h. in the case of dangerous substances or PBT or vPvB substances: a proposed safety data sheet. 3 The Notification Authority may request the manufacturer or exclusive representative to furnish test reports that are relevant for the
Section 4 Procedure for Notification and Declarati
Art. 36 Confirmation of receipt and forwarding of the documents
1 The Notification Authority shall confirm to the manufacturer or the exclusive representative the date on which the notification or declaration was received. 2 If the documents are not obviously incomplete, the Notification Authority shall forward them to the assessment authorities.
Art. 37 Review of the notification or declaration
1 The assessment authorities, within their area of competence, shall assess whether: a. the submission is complete or if not, whether the reasons given by the notifier are valid; b. the data is scientifically plausible; c. the test reports are based on tests meeting the requirements specified in Article 43. 2 If, when reviewing the notification dossier, an assessment authority determines that a substance poses a particular risk for human health or the environment, on account of its dangerous nature, its properties, its foreseeable use or the quantity placed on the market, the authority may conduct a targeted risk assessment before accepting the notification. 3 The assessment authorities shall report the results of their review to the Notification Authority.
Art. 38 Additions to the documents
1 If the Notification Authority determines that the documents are obviously incomplete, it shall inform the manufacturer or exclusive representative accordingly without delay. 2 If an assessment authority determines that the documents are incomplete or inaccurate, or that further data or tests are required for an assessment of the hazards and risks associated with the substance, it shall inform the Notification Authority accordingly. The Notification Authority shall request the manufacturer or exclusive representative to submit additions or corrections. 3 If a robust study summary in accordance with Article 27 paragraph 2 letter b numbers 7–9 does not permit an independent assessment of a specific test, the Notification Authority may request the full study report. 4 The Notification Authority shall confirm to the manufacturer or exclusive representative the date of receipt of additions and corrections.
Art. 39 Acceptance of the notification or declaration
1 In consultation with the assessment authorities, the Notification Authority shall issue a ruling on the acceptance of the notification or declaration if the review has shown that the notification or declaration documents are complete and sufficient to permit assessment of the hazards and risks associated with the substance. 2 If a targeted risk assessment was conducted, the ruling shall include the risk mitigation measures ordered.
Section 5 Authorisation to Place Substances on the
Art. 40 Placing substances subject to notification requirements on the market
Substances subject to notification requirements may be placed on the market if: a. the Notification Authority has accepted the notification thereof; or b. 60 days have elapsed since the confirmed date of receipt of the notification and of any additions or corrections required thereafter, without the Notification Authority having issued any response.
Art. 41 Placing substances subject to declaration requirements on the market
Substances subject to declaration requirements may be placed on the market if: a. the Notification Authority has accepted the declaration thereof; or b. 30 days have elapsed since the confirmed date of receipt of the declaration and of any additions or corrections required thereafter, without the Notification Authority having issued any response.
Chapter 3 Requirements for Tests
Art. 42 Principle
1 Manufacturers must ensure that the conduct of the tests required for assessment of the hazards and risks of substances and preparations, the methods used and the assessment of test results are in accordance with the current state of scientific and technical knowledge. 1bis They must not carry out tests on vertebrates if the hazards can be assessed by other methods or if the test is not necessary from a scientific point of view. 2 The FDHA, DETEC and the EAER may regulate technical details in their respective areas of competence.
Para. 1bis — Inserted by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 801).
Art. 43 Requirements
1 Tests designed to determine the properties of substances and preparations must be carried out in accordance with the test methods specified in the technical provisions referred to in Annex 2 number 2. 2 Other test methods may be used if: a. no method is specified in accordance with paragraph 1; b. the manufacturer can show that a specified method is not suitable for the determination of a given physicochemical property; or c. the method is recognised in the EU in accordance with Article 13 paragraph 3 of the REACH Regulation. 3 If other test methods are used, the manufacturer must show that they: a. produce valid results; and b. take due account of animal protection in the case of tests on animals. 4 Non-clinical tests designed to determine properties dangerous to health or the environment must be carried out in accordance with the principles of Good Laboratory Practice (GLP) specified in the Ordinance of 18 May 2005 on Good Laboratory Practice. 5 If certain tests do not, or do not f
Para. 2 let. c — See footnote to Art. 2 para. 4. Para. 4 — SR 813.112.1
