813.11
Ordinance
on Protection against Dangerous Substances and Preparations
(Chemicals Ordinance, ChemO)
of 5 June 2015 (Last amended on 1 December 2025)
Preamble
The Swiss Federal Council,
based on Article 19 paragraphs 2 and 3 of the Animal Welfare Act of
16 December 20051,
on the Chemicals Act of 15 December 20002 (ChemA),
on Article 26 paragraph 3, 29, 30a–30d, 38 paragraph 3, 39 paragraph 1, 41 paragraph 3, 44 paragraphs 2 and 3, 46 paragraphs 2 and 3 and 48 paragraph 2 of the Federal Act of 7 October 19833 on the Protection of the Environment (EPA),
and on Article 9 paragraph 2 letter c, 27 paragraph 2 and 48 paragraph 2 of the Waters Protection Act of 24 January 19914,
and in implementation of the Federal Act of 6 October 19955 on Technical Barriers to Trade,6
ordains:
Title 1 General Provisions
Art. 1 Aim and scope
This Ordinance regulates:
the determination and assessment of dangers and risks that substances and preparations may pose to human life and health and to the environment;
the conditions under which substances and preparations that may endanger people or the environment are placed on the market;
the handling of substances and preparations that may endanger people or the environment;
the way in which data relating to substances and preparations is processed by the enforcement authorities.
This Ordinance applies to biocidal products and the active substances contained therein, and to plant protection products and the active substances and co-formulants contained therein, insofar as they are referred to in the Ordinance of 18 May 2005 on Biocidal Products7 or the Ordinance of 20 August 20258 on Plant Protection Products.9
This Ordinance applies to tobacco products and electronic cigarettes in terms of Article 3 letters a–f of the Tobacco Products Act of 1 October 202110 and for similar products that are deemed equivalent thereto in accordance with Article 3 of the Tobacco Products Ordinance of 28 August 202411 (TabPO) insofar as they are referred to in the TabPO.12
This Ordinance applies to radioactive substances and preparations, excluding effects attributable to the radioactive nature of these substances and preparations.
Only Articles 5–7 and 81 apply to cosmetic products within the meaning of Article 53 paragraph 1 of the Ordinance of 16 December 201613 on Foodstuffs and Utility Articles in the form of finished products intended for private or professional users, and only with regard to environmental protection and to classification or assessment in relation to risks to the environment.14
This Ordinance does not apply to:
the transport of substances and preparations by road, rail, water, air or pipelines, with the exception of Article 10 paragraph 1 letter b;
the transit of substances and preparations under customs supervision, provided that this does not involve any processing or transformation;
substances and preparations in the form of finished products ready for supply to private and professional users that fall into the following categories:15
16foodstuffs as defined by Article 4 of the Foodstuffs Act of 20 June 201417 (FoodA),
medicinal products as defined by Article 4 paragraph 1 letter a and medical devices as defined by Article 4 paragraph 1 letter b of the Therapeutic Products Act of 15 December 200018,
animal feedingstuffs as defined by Article 3 paragraph 1 of the Feedstuffs Ordinance of 26 October 201119;
weapons and ammunition as defined by Article 4 paragraphs 1 and 5 of the Weapons Act of 20 June 199720;
substances, preparations and objects which are waste according to Article 7 paragraph 6 of the EPA.
Articles 57, 62 and 67 apply to imported substances and preparations that are simply relabelled and then exported without alteration.21
Dangerous substances and preparations that are exported are also governed by the PIC Ordinance of 10 November 200422.23
Art. 2 Definitions and applicable legislation
By way of clarification of the definitions given in the Chemicals Act, in this Ordinance:
substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;
manufacturer means:
any natural or legal person domiciled in Switzerland or with a registered office or branch in Switzerland, who manufactures, extracts or imports substances, preparations or objects in a professional or commercial capacity, and
24any person who obtains substances, preparations or objects in Switzerland and supplies them on a commercial basis, without altering their composition:
– under his own name, without specifying the name of the original manufacturer,
– under his own trade name,
– in packaging other than that provided by the original manufacturer,
– for a different intended use, or
– at a location where the labelling in accordance with Article 10 paragraph 3 letter b has not been applied in the official language by the original manufacturer,
25a person is deemed to be the sole manufacturer if he arranges for the manufacture of a substance, preparation or object in Switzerland by a third party, and if he is domiciled or has a registered office or branch in Switzerland; if he has neither his domicile, a registered office or branch in Switzerland, the third party is the sole manufacturer.
In addition, in this Ordinance:
professional user means:
any natural or legal person who obtains substances, preparations or objects in Switzerland for use in professional activities,
also deemed to be a professional user is:
– any natural or legal person who obtains substances, preparations or objects in Switzerland for use in the course of training or for research purposes,
– any legal person who obtains substances, preparations or objects in Switzerland for use in charitable activities;
private user means any natural person who obtains or uses substances, preparations or objects for non-professional purposes;
trader means any natural or legal person who obtains substances, preparations or objects in Switzerland and supplies them unchanged on a commercial basis;
exclusive representative means any natural or legal person that is authorised by a manufacturer whose domicile or registered office is located abroad to notify a substance in Switzerland and represents several importers designated by that manufacturer;
object means an article, consisting of one or more substances or preparations, which during production is given a special shape, surface or design which determines its end use function to a greater degree than does its chemical composition;
26existing substance means the substance that is registered in accordance with Article 5 of Regulation (EC) No 1907/2006 (REACH Regulation)27, with the exception of substances that:
28are placed on the market in larger quantities than those registered in the European Economic Area (EEA), or
are registered solely as intermediates, unless they are monomers;
polymer means a substance consisting of molecules characterised by the sequence of one or more types of monomer units and comprising:
a 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
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;
monomer means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process;
monomer unit means the reacted form of a monomer substance in a polymer;
intermediate means a substance manufactured and used solely for chemical processing during which it is transformed into one or more other substances;
secondary product means any substance formed by chemical or biochemical transformation during the storage, use or disposal of a substance or preparation;
scientific research and development means any scientific experimentation, analysis or chemical research carried out under controlled conditions and involving quantities of less than 1 tonne per year;
product and process-orientated research and development means any scientific development related to product development or the further development of a substance on its own, in preparations or in objects in the course of which pilot plant or production trials are used to define the production process or test the fields of application of the substance;
robust study summary means a detailed summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an independent assessment of the study, minimising the need to consult the full study report;
exposure scenario means the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer controls, or recommends customers to control, exposures of humans and the environment. These exposure scenarios may cover one specific process or use or several processes or uses as appropriate;
hazard class means the nature of the physical, health or environmental hazard;
nanomaterial means a material containing particles in an unbound state or as an aggregate or as an agglomerate, where one or more external dimensions is in the size range 1–100 nm, or a material where the specific surface area by volume is greater than 60 m2/cm3. A material is only considered to be a nanomaterial if it is deliberately produced to utilise the properties arising from the defined external dimensions of the particles it contains, or from the defined surface area by volume of the material. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm are considered to be nanomaterials;
29colorants means substances and preparations that primarily contain colouring agents, colour pigments and effect-producing pigments which are added solely for the purpose of colouring or producing effects.
Any other terms which are used in various senses in the legislation underlying this Ordinance are used here as defined in the Chemicals Act.
The equivalence of expressions between the REACH Regulation, Regulation (EC) No 1272/2008 (CLP Regulation)30 and Directive 75/324/EEC31, and this Ordinance as specified in Annex 1 number 1 applies.32
If in this Ordinance reference is made to provisions of the REACH Regulation, the CLP Regulation or Directive 75/324/EEC which in turn refer to other provisions of these acts, these other provisions also apply; the applicable version of the act in question is that specified in the footnote to paragraph 2 letter f or, as applicable, paragraph 4 or, in the case of references to annexes to the CLP Regulation or the REACH Regulation, the version specified in Annex 2 number 1 or, as applicable, Annex 4 number 3. An exception are provisions referred to in provisions of the REACH Regulation and the CLP Regulation, as specified in Annex 1 number 2; here, the provisions of the Swiss legislation listed in Annex 1 number 2 apply instead.33
If in this Ordinance reference is made to provisions of the REACH Regulation or the CLP Regulation which in turn refer to other EU legislation, the Swiss legislation specified in Annex 1 number 3 applies instead of the EU legislation.
The provisions of the Nagoya Ordinance of 11 December 201534 are reserved with respect to the placing on the market of substances and preparations the development of which is based on the use of genetic resources or on traditional knowledge associated therewith.35
Art. 3 Dangerous substances and preparations
Substances and preparations are dangerous if they fulfil the criteria for classification of physical, health, environmental or other hazards specified in the technical provisions referred to in Annex 2 number 1.
Art. 4 Persistence, bioaccumulation and toxicity
Substances are considered persistent, bioaccumulative and toxic (PBT) if they fulfil the criteria defined in Sections 1.1.1–1.1.3 of Annex XIII to the REACH Regulation36.
Substances are considered very persistent and very bioaccumulative (vPvB) if they fulfil the criteria defined in Sections 1.2.1 and 1.2.2 of Annex XIII to the REACH Regulation37.
Title 2 Marketing Requirements
Chapter 1 Self-Regulation
Section 1 Principles
Art. 5
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.
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.
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 in a foreseeable manner, or when they are appropriately disposed of.
Manufacturers must collect all available data of relevance to the obligations referred to in paragraphs 1 and 2.
Any person importing substances, preparations or objects with dangerous constituents in a professional or commercial capacity must comply with the obligations listed under paragraphs 1 and 2 before supplying them to a third party for the first time or, if they are for the importer’s own use, before using them for the first time.
Section 2 Classification of Substances and Preparations
Art. 6 Classification of substances
Manufacturers must classify substances in accordance with Articles 5, 7–13 and 15 of the CLP Regulation38.
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.
Classification must be based:
in the case of existing substances: on data collected in accordance with Article 5 paragraph 4;
39in 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.
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 certain hazard classes of a substance if, for the substance in question, a harmonised classification is not specified for the relevant hazard class in Annex VI to the CLP Regulation, in the applicable version referred to in Annex 2 number 1.
Art. 7 Classification of preparations
Manufacturers must classify preparations in accordance with Articles 6–15 of the CLP Regulation40.
Section 3 Packaging and Labelling of Substances and Preparations
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 Regulation41.
Art. 9 Packaging of aerosol dispensers
Aerosol dispensers not covered by the FoodA42 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/EEC43.
Art. 10 Labelling
Manufacturers making available or supplying dangerous substances or preparations to third parties must label them in accordance with the following provisions:
44Article 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 Regulation45;
the specific rules for labelling of outer packaging, inner packaging and single packaging set out in Article 33 of the CLP Regulation.
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.
In addition to paragraphs 1 and 2, the labelling must meet the following requirements:
The name, address and telephone number of the manufacturer are to be included.
46The labelling must be in an official language of the location at which the substance or preparation is supplied to private or professional users. With the agreement of individual professional users, a substance or a preparation for supply to these users may be labelled in another official language or in English.
Where labelling is in languages other than those required under letter b, all information shall be given in all languages used.47
In the case of substances or preparations imported from a member state of the EEA, the manufacturer’s name may be replaced on the labelling by the name of the person responsible for placing on the market in the EEA, if the substances or preparations:48
are not intended for distribution to private users; or
are supplied to private users, are contained in an inner packaging in portions of no more than 125ml or g and are marked on the outer packaging with the name, address and telephone number of the manufacturer.49
If further label elements are required in order to comply with other legislation, these are to be included in the section for supplemental information in accordance with Article 25 of the CLP Regulation.
Where the name in the IUPAC nomenclature50 exceeds 100 characters, another name may be used, provided that the report in accordance with Article 49 includes both the name given in the IUPAC nomenclature and the other name used.
The requirements of paragraph 1 are deemed to have been met if the inner packaging is labelled before the application of or immediately after the removal of the transport packaging. Responsibility for packaging and labelling rests with the manufacturer.
Art. 10a51 Official languages
The official languages are German, French and Italian.
Art. 11 Labelling of aerosol dispensers
Aerosol dispensers not covered by the FoodA52 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/EEC53.54
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.
Art. 12 Derogations from labelling requirements
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:
the packages are too small or otherwise unsuitable for labelling in accordance with Article 10;
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
the substance or preparation does not fall within the scope of the CLP Regulation55.
It shall issue a ruling in response to a justified application or issue a general ruling.
It shall maintain a list of the derogations that have been permitted and publish this on its website.
Art. 1356
Art. 14 Use of an alternative chemical name
Manufacturers of preparations may use an alternative chemical name for a substance if:
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
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.
The alternative chemical name shall be a name that identifies the most important functional groups or serves as an alternative designation.
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:
the decision of the European Chemicals Agency;
details of the substance identity in accordance with Article 49 letter c numbers 1–3.57
Where the name and identification number in the classification and labelling inventory in accordance with Article 42 of the CLP Regulation is used when the chemical name in accordance with Article 18 paragraph 2 letter b of the CLP Regulation is used, if the Notification Authority so requests, the substance identity in accordance with Annex VI Sections 2.1–2.3 of the REACH Regulation58 must be provided.59
The use of an alternative chemical name may be requested for a preparation:
in a specific composition;
with a specific trade name or a specific designation; and
reserved for certain uses.
Authorisation to use an alternative chemical name is granted to the manufacturer and is non-transferable.
The use of an alternative chemical name by the manufacturer and professional users in the same supply chain is permitted without authorisation for the first six years after:
the reporting, declaration or notification of a new substance;
the registration of a substance that falls under Article 119 paragraph 2 letter f of the REACH Regulation and in respect of which proof of registration and details of the substance identity in accordance with Article 49 letter c numbers 1–3 are submitted to the Notification Authority.60
If no request to use an alternative chemical name and no decision from the European Chemicals Agency nor the information in accordance with paragraph 3 are submitted within the period specified in paragraph 6, on expiry of the period the chemical name in accordance with Article 18 paragraph 2 of the CLP Regulation must be used.61
Art. 15 Requests to use an alternative chemical name
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.
Requests must contain:
the manufacturer’s name, address and telephone number;
the following information relating to the substances whose identity is to remain confidential on the label:
the chemical name,
the Chemical Abstracts Service (CAS) registry number62,
the EC number;
the alternative name of the substance;
the reasons for the request;
the trade name or designation of the preparation;
the information on the constituents in accordance with the provisions relating to the safety data sheet;
the classification of the preparation;
the labelling of the preparation;
the intended uses of the preparation;
the physical state;
if applicable, the safety data sheet.
The Notification Authority shall decide on the request in consultation with the assessment authorities.
Art. 15a63 Unique formula identifier
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).
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 Regulation64.
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:
on the label in the section for supplemental information in accordance with Article 2525 of the CLP Regulation; or
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 the outer packaging.
In the case of preparation that are not packaged, the UFI must be indicated on the safety data sheet or, in the case of supply to private users, in a copy of the label elements in accordance with Article 29 paragraph 3 of the CLP Regulation, together with the other label elements.
Paragraphs 1–4 do not apply if the preparation is not subject to the obligation to notify in accordance with Article 54.
Section 4 Exposure Scenarios and Safety Data Sheet for Substances and Preparations
Art. 16 Obligation to prepare exposure scenarios
The manufacturer of an existing substance that fulfils the criteria specified in Article 14 paragraph 4 of the REACH Regulation65 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.
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.
Paragraph 2 does not apply in cases where:
the exposure scenario for the new use would exclusively cover conditions described in an exposure scenario included in the safety data sheet;
the substance is present in the preparation in a concentration below the limits referred to in Article 27 paragraph 3; or
the substance is used for purposes of product and process-orientated research and development.
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 Regulation66.
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:
dangerous substances and preparations;
67PBT or vPvB substances;
substances listed in Annex 3;
preparations which are not dangerous within the meaning of Article 3 and contain at least one of the following substances:
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),
68a 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,
a substance listed in Annex 3 in an individual concentration of ≥0.1 per cent by weight,
69a substance for which an occupational exposure limit value has been laid down in Directives 2000/39/EC70, 2006/15/EC71, 2009/161/EU72 (EU) 2017/16473 or (EU) 2019/183174.
Art. 20 Requirements for the compilation of safety data sheets
Safety data sheets must be compiled in accordance with the technical provisions referred to in Annex 2 Number 3.
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.
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
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.
The safety data sheet must be provided:
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;
when supplying a preparation as specified in Article 19 letter d: on request.
Safety data sheets must be provided as follows:
free of charge;
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;
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
If important new information on a substance or preparation becomes available, the manufacturer must update the safety data sheet without delay.
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.
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 Substances
Section 1 Notification of New Substances
Art. 24 Obligation to notify
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:
on its own;
in a preparation; or
in an object from which the new substance may be released under normal or reasonably foreseeable conditions of use.
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.
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. 2575 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 Regulation76, 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. 26 Exemptions from the obligation to notify
Notification is not required for:
polymers or substances contained as monomer units or chemically bound to the polymer in a concentration of less than 2 per cent by weight;
77…
substances placed on the market in quantities of less than 1 tonne per year;
substances placed on the market by a manufacturer:
exclusively for product and process-orientated research and development purposes,
in quantities not exceeding those required for the specified purpose, and
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;
substances used exclusively as raw materials, active ingredients or additives in foodstuffs, therapeutic products and animal feedingstuffs;
substances obtained in Switzerland;
intermediates, provided that they are not monomers;
78substances listed in Annex IV or Annex V to the REACH Regulation79;
substances already notified and exported by the manufacturer, and re-imported by the same or another manufacturer in the same supply chain who can show that:
the substance being re-imported is the same as the exported substance,
he has been provided with a safety data sheet in accordance with Article 20 for the exported substance, if this is required under Article 19;
80substances listed in Annex 7, up to the maximum quantity specified therein.
If there are reasons to suppose that a given substance that is exempt from notification in accordance with paragraph 1 may endanger humans or the environment, the Notification Authority shall, if so requested by an assessment authority, require the manufacturer to present certain test reports. The information required for these test reports must not go beyond that which must be submitted for the technical dossier in accordance with Annex 4 number 8 letter a, number 9 letter a and number 10 letter a.
Dangerous substances and PBT or vPvB substances that are exempt from the obligation to notify in accordance with paragraph 1 letters a, c, g, h and j must be reported in accordance with Article 48.81
Art. 27 Form and content of the notification
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.
The notification must contain the following information and documents:
82the quantity which the notifier intends to place on the market;
a technical dossier with the following information further specified in Annex 4:
the identity of the notifier,
the identity of the substance,
information on manufacture and use,
classification and labelling,
guidance on safe use,
exposure assessment,
robust study summaries and further data on the physical and chemical properties,
robust study summaries with regard to the properties dangerous to health,
robust study summaries with regard to the properties dangerous to the environment;
if the quantity placed on the market83 amounts to 10 tonnes per year or more: a chemical safety report in accordance with Article 28;
a proposed safety data sheet in the case of dangerous substances or PBT or vPvB substances;
84all available documents and information on the properties, exposure and the adverse effects of the substance on humans and the environment, insofar as these are not already apparent from the technical dossier referred to in letter b.
Paragraph 2 letter c does not apply to new substances that are placed on the market in the form of preparations if the concentration of the substance is lower than the following values:
the cut-off values in accordance with Article 11 paragraph 3 of the CLP Regulation85; or
0.1 per cent by weight for PBT or vPvB substances.
...86
The Notification Authority may request the notifier to furnish test reports that go beyond the technical dossier and are relevant for the assessment of the substance, provided that they are available and can be obtained by the notifier with reasonable effort.
Art. 28 Chemical safety reports
The chemical safety report contains the chemical safety assessment in accordance with Annex I to the REACH Regulation87. A chemical safety assessment includes the following steps:
a human health hazard assessment;
a human health hazard assessment of physicochemical properties;
an environmental hazard assessment;
PBT and vPvB assessment;
if the substance fulfils the criteria specified in Article 14 paragraph 4 of the REACH Regulation:
an exposure assessment, covering all identified uses,
a risk characterisation, covering all identified uses.
Section 2 Use of Data from Previous Notifiers and Data Protection Period
Art. 29 Use of data from previous notifiers
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.88
The Notification Authority may refer to data from a previous notifier instead of data produced by the notifier if:
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
the data protection period has expired.89
The notifier must not refer to data from previous notifiers regarding:
the identity and purity of the substance and the nature of any impurities;
action to render the substance harmless.
The rules of competition and intellectual property law are not affected by the provisions of this section.
Art. 30 Data protection period
The data protection period is 12 years.90
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.
Art. 3191 Mandatory advance enquiries to avoid tests on vertebrates
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.92
This enquiry must contain information on:
the identity of the substance in accordance with Article 27 paragraph 2 letter b number 2;
the quantity of substance the applicant intends to place on the market.
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:
it shall notify the former notifiers of the intended use of the data by the new notifier and of his name and address, and
it shall disclose the names and addresses of the former notifiers to the new notifier.
Studies on tests with vertebrates may not be repeated.
Art. 3293 Right to remuneration for sharing of data from previous tests on vertebrates
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.
The notifiers shall take steps independently to reach an agreement on data sharing and remuneration. They may seek an arbitrator’s report.
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.
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 189 paragraph 3 of the Civil Procedure Code94. In the absence of an arbitrator’s report, the Notification Authority shall take particular account in its ruling of:
the costs incurred by the previous notifiers in obtaining the test results;
the remaining period of protection for the data concerned.
Art. 3395 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:
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
the new notifier pays the remuneration or has undertaken to do so by acknowledgement of debt confirmed by signature.
Section 3 Declaration of New Substances for Product and Process-orientated Research and Development
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
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.
The declaration must contain the following information and documents:
the name and address of the manufacturer;
if the manufacturer has imported the substance: the name and address of the foreign manufacturer;
essential data relating to the identity of the substance;
the intended uses;
the amount of the substance that the manufacturer expects to place on the market each year in Switzerland;
proposed classification and labelling;
the research programme and a list of the people to whom the substance is to be supplied;
in the case of dangerous substances or PBT or vPvB substances: a proposed safety data sheet.
The Notification Authority may request the manufacturer or exclusive 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.
Section 4 Procedure for Notification and Declaration
Art. 36 Confirmation of receipt and forwarding of the documents
The Notification Authority shall confirm to the manufacturer or the exclusive representative the date on which the notification or declaration was received.
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
The assessment authorities, within their area of competence, shall assess whether:
the submission is complete or if not, whether the reasons given by the notifier are valid;
the data is scientifically plausible;
the test reports are based on tests meeting the requirements specified in Article 43.
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.
The assessment authorities shall report the results of their review to the Notification Authority.
Art. 38 Additions to the documents
If the Notification Authority determines that the documents are obviously incomplete, it shall inform the manufacturer or exclusive representative accordingly without delay.
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.
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.
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
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.
If a targeted risk assessment was conducted, the ruling shall include the risk mitigation measures ordered.
Section 5 Authorisation to Place Substances on the Market
Art. 40 Placing substances subject to notification requirements on the market
Substances subject to notification requirements may be placed on the market if:
the Notification Authority has accepted the notification thereof; or
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:
the Notification Authority has accepted the declaration thereof; or
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
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.
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.96
The FDHA, DETEC and the EAER may regulate technical details in their respective areas of competence.
Art. 43 Requirements
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.
Other test methods may be used if:
no method is specified in accordance with paragraph 1;
the manufacturer can show that a specified method is not suitable for the determination of a given physicochemical property; or
the method is recognised in the EU in accordance with Article 13 paragraph 3 of the REACH Regulation97.
If other test methods are used, the manufacturer must show that they:
produce valid results; and
take due account of animal protection in the case of tests on animals.
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 200598 on Good Laboratory Practice.
If certain tests do not, or do not fully, comply with GLP principles, the person submitting the test reports must state the reasons. The Notification Authority, in consultation with the assessment authorities, shall decide whether to accept these test results.
Title 3 Obligations of the Manufacturer after Placing on the Market
Chapter 1 Taking Account of new Information Relevant to Assessment, Classification and Labelling
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:
they are to be supplied for different purposes;
they are to be used in a different way;
they are to be used in much larger quantities than before;
variations arise in the nature and quantity of impurities, which could have adverse effects on human health or the environment;
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
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.
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 Reports on new Substances
Art. 46 Updated information
Notifiers must inform the Notification Authority in writing without delay if:
there are any changes in the information referred to in Article 27 paragraph 2 letter b numbers 1–6 or Article 35 paragraph 2;
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;
the quantity placed on the market has increased or decreased by a factor of more than two compared with the quantity last notified;
new information comes to their attention regarding the effects of the substance on human health or the environment;
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;
they compile, or have compiled for them, test reports going beyond the technical dossier referred to in Article 27 paragraph 2 letter b for the substance in question;
they are able to obtain other test reports going beyond the technical dossier referred to in Article 27 paragraph 2 letter b.
The updated information in accordance with paragraph 1 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.
Only representatives must ensure that they have access to updated data, particularly as regards the quantities of substances imported annually by the importers they represent.
Importers represented by an exclusive representative in the notification of a new substance must inform the representative annually of the quantities of the substance imported.
Art. 47 Quantity-based information requirements
Notifiers must provide the Notification Authority with the following additional information based on the quantity placed on the market:
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;
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;
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.
After receiving the information specified in Article 46 paragraph 1 letter b, the Notification Authority shall, in accordance with Article 31 paragraph 399, inform the notifier of the data that it already holds.
If the risks associated with a given substance cannot be adequately assessed, the Notification Authority shall, if so requested by an assessment authority, require the notifier to submit additional information or carry out additional tests relating to the substance or its transformation products.
The Notification Authority, after consulting the notifier and with the agreement of the assessment authorities, shall draw up a timetable for the performance of the additional tests.
If the notifier fails to submit the additional test reports by the specified deadline, the Notification Authority may arrange for the required tests to be carried out at the notifier’s expense and, if necessary, prohibit the notifier from continuing to place the substance on the market.
Chapter 3 Obligation to Report
Art. 48100 Substances and preparations subject to reporting requirements
Manufacturers must report the following substances and preparations to the Notification Authority within 3 months after first placing them on the market:
the substances and preparations specified in Article 19, irrespective of whether a safety data sheet has to be compiled for them;
nanomaterials, other than those referred to in letter a, which specifically contain biopersistent fibres or tubes exceeding 5µm in length.
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. 49 Content of the report
The report must include the following information:
the manufacturer’s name and address;
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 Regulation101, if the manufacturer’s identity is not mentioned on the label;
in the case of substances:
the chemical name in accordance with Article 18 paragraph 2 letters a–d of the CLP Regulation,
the CAS number,
the EC number,
the classification and labelling,
the intended uses,
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,
102in 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, surface coating and surface functionalisation, and
– the quantity expected to be placed on the market annually according to one of the following categories: less than 1 kilogramme, 1–10 kilogrammes, 10–100 kilogrammes, 100–1000 kilogrammes, 1–10 tonnes, 10–100 tonnes, more than 100 tonnes,
an indication of whether the substance is considered to be PBT or vPvB,
the chemical safety report available in the EEA, provided that it can be obtained by the manufacturer with reasonable effort;
in the case of preparations:
the trade name,
1a. 103the UFI,
data relating to the constituents in accordance with the provisions concerning the safety data sheet,
the classification and labelling,
the intended uses,
the physical state,
in the case of preparations 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,
104in the case of preparations containing nanomaterials: the following data, provided they are specified in the safety data sheet: the composition of the nanomaterials, their particle form and mean particle size and, where available, the number size distribution, specific surface area by volume, crystal structure, aggregation status, surface coating and surface functionalisation.
If the constituents in terms of paragraph 1 letter d number 2 that are added to the preparation are solely a perfume or a colorant, the generic product identifier «perfume» or «colorant» may be indicated provided the following conditions are met:
The following concentrations are not exceeded:
for perfumes: a total of 5 per cent by weight,
for colorants: a total of 25 per cent by weight;
Substances of very high concern in accordance with Annex 3 in an individual concentration of ≥ 0.1 per cent by weight are indicated in the notification.105
Art. 50106 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. 51 Form of the report and extended report
The report and extended report shall be submitted as follows:
electronically in the format required by the Notification Authority;
in an official language or in English.
Art. 52 Modifications
Any modifications to the information specified in Articles 49 and 50 must be reported within 3 months.
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 1107 letter c number 6 and letter d number 6.
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 1108 letters a, b and d and, if applicable, Article 50.
Art. 54 Exemptions from the obligation to report
The reporting requirements specified in this Chapter do not apply to:
a. 109intermediates that:
are not given to third parties,
do not leave the manufacturing site, or
are placed on the market in quantities less than 100kg per year;
b. 110substances and preparations which are placed on the market solely for the purposes of analysis, research or development;
bbis. 111substances that are placed on the market solely for training purposes;
c. substances and preparations used exclusively for foodstuffs, therapeutic products or animal feedingstuffs;
d. 112…
e. explosives and pyrotechnic devices which require authorisation under the Explosives Ordinance of 27 November 2000113;
f. substances obtained in Switzerland;
g. preparations obtained in Switzerland and supplied in packaging other than that provided by the original manufacturer, provided that:
114the trade name, composition, the UFI and the intended use are unchanged, and
the name of the original manufacturer is also indicated;
h. gas mixtures consisting exclusively of reported gases;
hbis. 115gases and gas mixtures that are classified in the «gases under pressure» hazard category;
i. preparations not deemed to be dangerous under Article 3 which are in packages containing no more than 200 ml, if they are manufactured in Switzerland and supplied directly to professional or private users;
j. preparations placed on the market in quantities of less than 100 kg per year and intended exclusively for professional users;
k. 116substances notified by the manufacturer in accordance with Article 24;
l. 117paints formulated on demand in limited quantities for an individual consumer or professional user at the point of sale by tinting or mixing colours, provided that:
the requirements of Article 25 paragraph 8 of the CLP Regulation118 are complied with, or
the potentially hazardous colorants are indicated in the notification of the base colour in the maximum concentration in which they are added; in this case, the product must be labelled with the UFI of the base colour;
m. 119fresh and ready-mix concrete, plaster and cement that correspond to the standard formulations in Annex VIII Part D of the CLP Regulation and that bear the UFI required by the Notification Authority.
Not exempted from the reporting requirements of this chapter are:
intermediates in accordance with paragraph 1 letter a in the form of monomers that are new substances;
preparations in accordance with paragraph 1 letters b, c, h, i and j that have a UFI.120
Title 4 Rules for Handling of Substances, Preparations and Objects
Chapter 1 General Provisions
Art. 55 Taking account of the information provided by the manufacturer
Substances, preparations and objects may be promoted, offered or supplied professionally or commercially only for the uses and methods of disposal stated by the manufacturer.
The information and instructions given on the package and labelling and in the safety data sheet must be taken into account.
Art. 56 Environmental release
Substances and preparations may be released directly into the environment only to the extent that is necessary for the intended use.
To this end, users must:
use equipment allowing correct and accurate application;
take measures to prevent substances and preparations, as far as possible, from entering surrounding areas or waterbodies; and
take measures to ensure that, as far as possible, animals, plants, their biological communities and habitats are not threatened.
Preparations may be released directly into the environment only for the uses specified by the manufacturer.
Art. 57 Storage
When substances and preparations are stored, the information and instructions given on the package and labelling and, if applicable, in the safety data sheet must be taken into account.
Dangerous substances and preparations and their containers must be protected against hazardous, especially mechanical, impacts.
Dangerous substances and preparations must be clearly identifiable and kept separate from other goods. No foodstuffs, animal feedingstuffs or therapeutic products may be kept in the immediate vicinity.
Paragraphs 1–3 also apply to objects from which substances or preparations are released in quantities that may endanger human health or the environment.
Substances and preparations that may react dangerously with each other must be stored separately.
Dangerous substances and preparations may only be filled into and stored in containers which meet the following requirements:
They must not be capable of being confused with packaging containing foodstuffs, cosmetics, therapeutic products or animal feedingstuffs.
The name of the substance or preparation must be given in the labelling of the containers.
They must comply with the requirements of Article 35 paragraphs 1 and 3 of the CLP Regulation121.
Their design must not be likely to attract or arouse the curiosity of children.
Art. 58 Special obligations with regard to the supply of substances and preparations
Anyone who supplies a substance or preparation in a commercial capacity and is required to provide a safety data sheet must be familiar with and capable of interpreting the content of the safety data sheet.
Art. 59 Chemicals contact person
Commercial and educational establishments must notify the cantonal enforcement authorities of their chemicals contact person, designated under Article 25 paragraph 2 of the Chemicals Act.
The FDHA shall regulate mandatory notification in accordance with paragraph 1; it shall define the form and content of the notification.
It shall define the requirements that the chemicals contact person must meet, particularly with regard to technical qualifications and operational responsibilities.
Art. 60 Advertising
Advertising for substances, preparations and objects must not give a misleading impression as to the risks posed to human health and the environment or as to their environmental acceptability, and must not encourage inappropriate or illegitimate use or disposal.
Terms such as «degradable», «not harmful to the environment», «non-polluting» and «non-water-polluting» may be used in advertising only if the properties thus described are at the same time explained in more detail.
Anyone who advertises dangerous substances or preparations that private users can purchase without seeing the labelling beforehand must indicate their hazardous properties in a comprehensible and clearly legible or audible manner.
Paragraph 3 also applies to preparations labelled in accordance with Article 25 paragraph 6 of the CLP Regulation122.
Substances and preparations must not be promoted for uses for which they are not to be placed on the market.
Chapter 2 Handling Substances and Preparations in Groups 1 and 2
Art. 61 Substances and preparations in Groups 1 and 2
Substances and preparations are deemed to belong to Group 1:
if their labelling in accordance with the CLP Regulation123 contains at least one element specified in number 1.1 of Annex 5 to this Ordinance; or
if they are not yet labelled in accordance with the CLP Regulation and their labelling contains at least one element specified in number 2.1 of Annex 5 to this Ordinance.
Substances and preparations are deemed to belong to Group 2:
if their labelling in accordance with the CLP Regulation contains at least one element specified in number 1.2 of Annex 5 to this Ordinance; or
if they are not yet labelled in accordance with the CLP Regulation and their labelling contains at least one element specified in number 2.2 of Annex 5 to this Ordinance.
Art. 62 Storage
For the storage of substances or preparations in Groups 1 and 2, Article 57 applies.
Anyone who stores substances or preparations in Groups 1 and 2 must ensure that they are not accessible to unauthorised persons.
Substances and preparations in Groups 1 and 2 may only be filled into and stored in containers if these are labelled with the appropriate danger symbols or hazard pictograms.
Art. 63 Exclusion of self-service
Substances and preparations in Group 2 which are intended for private users must not be offered on a self-service basis.
The prohibition specified in paragraph 1 does not apply to motor fuels.
Art. 64 Supply restrictions
Substances and preparations in Group 1 must not be commercially supplied to private users.
Substances and preparations in Groups 1 and 2 may be commercially supplied only to persons having capacity to act.
Substances and preparations in Groups 1 and 2 may be supplied to minors if they are capable of judgement and have to handle these substances or preparations in the course of their training or in a professional or commercial capacity.
The supply restrictions specified in paragraphs 1 and 2 do not apply to motor fuels.
Art. 65 Special obligations with regard to supply
Anyone who commercially supplies a substance or preparation in Group 1 to professional users or traders must, at the time of supply, explicitly inform them of the precautions required and the correct method of disposal.
Anyone who commercially supplies a substance or preparation in Group 2 to private users must, at the time of supply, explicitly inform them of the precautions required and the correct method of disposal.
Substances and preparations may be supplied in accordance with paragraph 2 only to persons who can be assumed by the supplier to be capable of judgement and able to comply with the duty of care specified in Article 8 of the Chemicals Act and the requirements set out in Article 28 of the EPA.
The obligations specified in paragraphs 1 and 2 do not apply to the supply of motor fuels.
Art. 66 Knowledge required to supply
Special knowledge is required by anyone who, in a commercial capacity:
supplies substances and preparations in Group 1 to persons who obtain them in order to use them professionally, but without placing them on the market in a different form;
supplies substances and preparations in Group 2 to private users.
The FDHA may regulate:
how the knowledge requirements are to be met; in this connection, it shall take professional training and experience into account;
the content, duration and organisation of courses for people seeking to acquire such knowledge.
Articles 10 and 11 of the Chemical Risk Reduction Ordinance of 18 May 2005124 (ORRChem) apply mutatis mutandis.
Paragraph 1 does not apply to motor fuels.
Art. 67 Theft, loss, erroneous placing on the market
In the event of theft or loss of substances or preparations in Group 1, the person suffering the theft or loss must notify the police without delay.
The police must inform the cantonal authority responsible for enforcing this Ordinance as well as the Federal Office of Police.
Anyone who erroneously places on the market a substance or a preparation in Group 1 or 2 must immediately inform the cantonal authority responsible for enforcing this Ordinance and provide the following information:
all the data required for precise identification of the substance or preparation;
a comprehensive description of the danger which the substance or preparation may pose;
all the available information as to the source from which the substance or preparation was obtained and to whom the substance or preparation has been supplied;
the measures taken to avert any danger, such as warnings, suspension of sales, withdrawal from the market or recall.
The cantonal authority shall decide whether and in what way the public needs to be warned of any danger.
Art. 68 Samples
Substances and preparations in Groups 1 and 2 may be provided for promotional purposes only to professional users or traders.
Art. 69 Substances and preparations intended for self-defence
For the handling of substances and preparations intended for self-defence, Article 62, Article 64 paragraphs 2 and 3, Article 65 paragraphs 2 and 3, Article 66 paragraph 1 letter b, Article 67 paragraphs 3 and 4 and Article 68 apply mutatis mutandis.
Substances and preparations intended for self-defence must not be offered on a self-service basis.
Chapter 3 Handling of Substances of Very High Concern
Art. 70 List of substances of very high concern
Substances referred to in Article 57 of the REACH Regulation125 are deemed to be of very high concern if they are included in Annex 3 (candidate list).
The Federal Office for the Environment (FOEN) shall decide, in consultation with the Federal Office of Public Health (FOPH) and the State Secretariat for Economic Affairs (SECO), whether a candidate list substance listed in Annex XIV to the REACH Regulation is to be included in Annex 1.17 to the ORRChem126.
Art. 71 Objects containing substances of very high concern
Anyone who commercially supplies an object containing a substance of very high concern in a concentration greater than 0.1 % by weight must provide the following information:
the name of the substance concerned;
all the information required to allow safe use of the object, insofar as this is available to the supplier.
This information must be provided free of charge:
to professional users or traders: without being so requested;
to private users: on request within 45 days.
Title 5 Data Processing
Art. 72 Register of products
The Notification Authority shall maintain a register of substances and preparations that fall within the scope of the following Ordinances:
this Ordinance;
the ORRChem127;
the Biocidal Products Ordinance of 18 May 2005128;
129the Plant Protection Products Ordinance of 20 August 2025130;
131Fertilisers Ordinance of 1 November 2023132.
The data collected in accordance with Article 27 paragraph 1 TabPO on preparations shall also be entered in the register of products.133
The register shall be compiled on the basis of data:
134that has been collected or produced by a Swiss authority under one of the ordinances cited in paragraph 1 or 1bis;
that is made available by foreign authorities or by international organisations.
Art. 73 Confidential data
The enforcement authorities shall treat data as confidential when an interest in its confidentiality is worthy of protection, unless there is an overriding public interest in its disclosure.
The Notification Authority shall designate the confidential data in consultation with the assessment authorities. It shall do so before passing it on to the competent cantonal or federal authorities specified in Article 75 paragraph 2.
In particular, shall be deemed worthy of protection the interest in maintaining commercial/manufacturing secrecy, including:
information on the identity of intermediates;
the complete composition of a preparation;
the quantities of a substance of a preparation placed on the market;
the information on nanomaterials referred to in Article 49 paragraph 1135 letter c, 7 and letter d, 7.136
If the Notification Authority discovers that data deemed to be confidential has subsequently been lawfully disclosed, this data shall no longer be treated as confidential.
The following are not deemed confidential under any circumstances:
the trade name;
the name and address of the person subject to notification, declaration or reporting requirements;
the physicochemical properties;
procedures for proper disposal, for possible recycling or reuse, and for other ways of rendering materials harmless;
the summary of results of toxicological and ecotoxicological tests;
the degree of purity of a substance and the identity of the impurities and additives that are relevant for classification;
recommendations regarding precautions during use and emergency measures in the event of an accident;
137information that appears in the safety data sheet, with the exception of the identity of intermediates;
suitable analytical methods for determining the exposure of human beings and presence in the environment.
The Notification Authority and assessment authorities may publish data in the register of products which is not deemed confidential under any circumstances.
Art. 74 Data to be passed on to the Notification Authority and the assessment authorities
At the request of the Notification Authority, the authorisation body for plant protection products and the assessment authorities, and if it is necessary for the enforcement of this Ordinance, the following data concerning substances, preparations and objects must be passed on:138
139data collected by the FOAG under:
the Fertilisers Ordinance of 1 November 2023140,
the Animal Feedstuffs Ordinance of 26 October 2011141,
142data collected by the FSVO under:
the Plant Protection Products Ordinance of 20 August 2025143,
the Ordinance of 27 May 2020144 on the Implementation of Foodstuffs Legislation;
data collected by the Federal Office for Customs and Border Security145 from customs declarations;
data collected by SECO, by the Swiss National Accident Insurance Fund (SUVA) or by cantonal employment inspectorates under legislation on the protection of workers;
data collected by the poisons information centre (Art. 79);
data collected by examining bodies under Article 12 paragraph 3 of the ORRChem146;
data collected by cantons in connection with the enforcement of this Ordinance or of other legislation governing the protection of human health or the environment against substances, preparations or objects.
Art. 75 Exchange of information and data
The Notification Authority and assessment authorities shall, insofar as is required for the performance of their duties, make available to each other the data that they have collected or have had collected on their behalf under this Ordinance or any other legislation governing the protection of human health or the environment against substances, preparations or objects. To this end, they may establish automated retrieval procedures.
They shall make available to the cantonal and federal authorities responsible for enforcing legislation governing the protection of human health or the environment against substances, preparations or objects the data required for the performance of their duties.
They may make data concerning manufacturers and the substances or preparations that they have placed on the market accessible via retrieval procedures to the authorities listed below, if these authorities require the data for enforcement purposes:
the customs authorities;
the authorities specified in paragraph 2;
the poisons information centre (Art. 79).
They may, in special cases, pass on data relating to substances, preparations and objects to bodies other than those specified in paragraph 2, if these bodies require the data in order to perform their duties.
With regard to confidential data relating to the composition of preparations, the following applies:
In the retrieval procedure, the data may only be made available to the cantonal authorities in accordance with paragraph 2 and only for the purpose of verifying the UFI.
Disclosure to the authorities and bodies in accordance with paragraphs 2, 3 and 4 is only permitted if:
it is required by a criminal prosecution authority;
it serves to answer medical queries, particularly in cases of emergency; or
it serves to answer medical queries, particularly in cases of emergency or to prevent an imminent danger to human life or health or to the environment.147
The cantons shall inform the FOPH of the results of surveys and analyses regarding the quality of indoor air and pass on available data on indoor air to the FOPH.
Art. 76 Data to be passed on to other countries and to international organisations
The Notification Authority and assessment authorities may pass on data that is not confidential to foreign authorities and institutions, and to international organisations.
They may pass on confidential data if:
this is required by international agreements or decisions of international organisations; or
it is necessary to prevent an imminent danger to human life or health or to the environment.
Title 6 Enforcement
Chapter 1 Confederation
Section 1 Organisation
Art. 77 Notification Authority and steering committee
The Notification Authority is administratively attached to the FOPH.
A steering committee is appointed for the Notification Authority. It is composed of the directors of the following federal offices:
FOPH;
FOAG;
FOEN;
SECO;
148FSVO.
The steering committee has the following duties and powers:
appointing the management of the Notification Authority;
defining the strategy of the Notification Authority;
inspection and application rights concerning the budget of the Notification Authority.
The steering committee makes decisions by consensus.
Art. 78 Assessment authorities
The assessment authorities are:
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.
Art. 79 Poisons information centre
The poisons information centre established under Article 30 of ChemA is Tox Info Suisse.
The FOPH shall enter into an agreement with Tox Info Suisse setting the amount of remuneration that it receives for services provided under Article 30 paragraph 2 of ChemA.
Section 2 Review of Existing Substances
Art. 80
The assessment authorities may review any existing substances which:
149may represent a particular risk to human life or health or to the environment, owing to the quantities manufactured or placed on the market or owing to their dangerous nature or the dangerous nature of their secondary products or wastes; or
are included in an international existing substances programme.
If an existing substance is to be reviewed, the Notification Authority, at the request of an assessment authority, shall require all the manufacturers concerned to provide the following information:
the name and address of the manufacturer, and the name and address of the foreign manufacturer if the manufacturer imports the substance;
all documents used in assessing and establishing the hazardous properties of the substance;
the known uses;
information on the quantities placed on the market by the manufacturers;
the registration dossier submitted to the European Chemicals Agency, provided it is available and can be obtained by the notifier with reasonable effort.
If requested by an assessment authority, the Notification Authority shall request one of the manufacturers to carry out investigations or studies. The costs incurred by the manufacturer shall be borne jointly by all the manufacturers concerned.
Section 3 Review of Self-Regulation and Monitoring
Art. 81 Review of self-regulation
The assessment authorities shall review, in their area of competence, for substances, preparations and objects:
the assessment and classification;
the information that appears in the safety data sheet.
They may instruct the Notification Authority:
to verify the composition and the physicochemical properties of substances, preparations and objects;
to ask cantonal enforcement authorities to take samples.
If there is reason to suppose that assessment or classification has not been carried out or has not been carried out correctly, the Notification Authority, at the request of an assessment authority, shall require the manufacturer concerned to provide:
all the documents used in establishing the hazardous properties or in the assessment;
the safety data sheet, if appropriate.
At the request of an assessment authority, the Notification Authority shall require the manufacturer to perform tests or additional assessments if there are indications that:
substances or preparations and their secondary products or wastes may endanger human health or the environment;
objects, their secondary products or their wastes may endanger the environment.
Moreover, the enforcement authorities have the powers assigned to them by Article 42 of the Chemicals Act and, in the case of a danger to the environment, also Article 41 of the Chemicals Act.
If a manufacturer does not comply with an official order, the Notification Authority shall, if so requested by an assessment authority, prohibit it from continuing to supply the substances, preparations or objects concerned.
As regards cosmetic products, and raw materials and additives intended exclusively for these products, the body responsible for these products shall order the necessary measures. The participation of the FOEN is governed by Articles 62a and 62b of the Federal Act of 21 March 1997150 on the Organisation of the Government and the Administration.
Art. 82 Monitoring with regard to national defence
In matters concerning national defence, the Notification Authority shall examine, in consultation with the assessment authorities, whether the provisions of this Ordinance are being respected.
Art. 83 Monitoring of imports and exports
Customs offices shall, at the request of the Notification Authority, check whether substances, preparations or objects comply with the provisions of this Ordinance
The assessment authorities may call upon the Notification Authority to submit a request in accordance with paragraph 1.
In cases of suspected infringement, the customs offices are authorised to detain goods at the border and call in the other enforcement authorities in accordance with this Ordinance. These authorities shall carry out further investigations and take the necessary measures.
Section 4 Adaptations of technical provisions and of the candidate list
Art. 84
In consultation with the FOEN and SECO, the FOPH shall adapt the following annexes:
Annex 2:
It shall specify the applicable version of the annexes to the CLP Regulation151.
152It shall take into account amendments to the Guidelines for the Testing of Chemicals drawn up by the Organization for Economic Cooperation and Development (OECD) and specify the applicable version of Regulation (EC) No 440/2008153, and of the UN Manual of Tests and Criteria154.
It shall specify the applicable version of Annex II to the REACH Regulation155.
Annex 3 (candidate list). It shall take into account amendments to the list of substances for eventual inclusion in Annex XIV to Regulation (EC)
No 1907/2006 in accordance with Article 59 paragraph 1 of the REACH Regulation.
Annex 4. It shall take into account amendments to Annexes III and VII–XI to the REACH Regulation.
156Annex 7. It shall take into account developments in Europe.
Section 5 Delegation of Duties and Powers to Third Parties
Art. 85
The competent federal bodies may delegate to appropriate public corporations or private persons all or some of the duties and powers assigned to them by this Ordinance.
To the extent that enforcement of health protection is concerned, delegation is limited to the following:
review of self-regulation;
assessment as part of a review of notification and updated information;
provision of information under Article 28 of the Chemicals Act;
risk assessment under Article 16 of the Chemicals Act.
Section 6 Charges
Art. 86
The obligation to pay charges and the calculation of charges for administrative actions by the federal enforcement authorities in accordance with this Ordinance are based on the Chemical Charges Ordinance of 18 May 2005157.
Chapter 2 Cantons158
Art. 87 Duties of the cantonal enforcement authorities
By means of random sampling, the cantonal enforcement authorities shall inspect substances, preparations and objects placed on the market.
Within the framework of these inspections, the cantonal enforcement authorities shall verify:
that the notification, declaration and reporting requirements (Articles 24, 34, 48, 52, 53) and the provisions governing updated information (Art. 46) have been respected;
that packaging conforms to the provisions on packaging (Articles 8 and 9);
159that the labelling and the UFI conform to the provisions on labelling (Articles 10–13) and on the UFI (Art. 15a);
that the requirements concerning the provision, updating and retention of the safety data sheet (Articles 21–23) are being complied with and that the information in the safety data sheet is not obviously incorrect;
that the provisions on advertising (Art. 60) and samples (Art. 68) are being respected;
that the requirement to provide information when supplying objects containing substances of very high concern (Art. 71) has been complied with.
Art. 88 Cooperation between the cantonal and federal enforcement authorities
The Notification Authority, on its own initiative or at the request of an assessment authority, shall instruct the cantonal enforcement authorities to inspect certain substances, preparations or objects, especially in accordance with Article 81 paragraph 1.
The cantonal enforcement authorities shall collect samples at the request of the Notification Authority.
If the inspections identify serious concerns, the authority that performed the inspections shall inform the Notification Authority and the authorities responsible for orders in accordance with Article 90a.160
If there are grounds for suspecting incorrect classification, the authority that performed the inspections shall inform the Notification Authority.
Art. 89161
Art. 90 Monitoring of Handling and Promotion of Environmentally Sound Practices162
The cantonal enforcement authorities shall monitor compliance with the specific provisions relating to handling (Articles 55–59, 61–67 and 69). Article 25 paragraph 1 second sentence of the Chemicals Act applies accordingly.
The cantons shall promote environmentally sound practices.
Art. 90a163 Measures taken by the cantonal enforcement authorities
If the inspection reveals infringements of the provisions referred to in Articles 87 paragraph 2, 88 paragraph 1 and 90 paragraph 1, the competent authority of the canton in which the infringing party is domiciled or has its registered office shall order any necessary measures. In the case of infringements of the provisions referred to in Article 90 paragraph 1, the competent authority in the canton in which the infringement took place may also issue the order. The cantons shall coordinate the required measures.
Title 7 Final Provisions
Chapter 1 Repeal and Amendment of other Legislation
Art. 91 Repeal of other legislation
The Chemicals Ordinance of 18 May 2005164 shall be repealed.
Art. 92 Amendment of other legislation
The amendment of other legislation is regulated in Annex 6.
Chapter 2 Transitional Provisions
Art. 93
For preparations that were packaged and labelled in accordance with Articles 35–50 of the Chemicals Ordinance of 18 May 2005165 before the commencement of this Ordinance, the following transitional provisions apply:
They may be supplied until 31 May 2017 if a safety data sheet was compiled for them in accordance with Article 19 of this Ordinance and they were reported in accordance with Article 48 of this Ordinance; if the preparations concerned are liquid laundry detergents contained in soluble packaging for private users which do not meet the requirements of Regulation (EU)
No 1297/2014166, they may only be supplied until 31 December 2015.
Double labelling in accordance with Articles 35–50 of the Chemicals Ordinance of 18 May 2005 and with Article 10 of the present Ordinance is not permissible.
For handling, the provisions of Title 4 of this Ordinance apply.
Aerosol dispensers that were packaged and labelled before the commencement of this Ordinance, do not fall within the scope of the FoodA167 and do not meet the requirements of Articles 9 and 11 may be supplied until 31 May 2017.
If a preparation that was labelled in accordance with Articles 39–50 of the Chemicals Ordinance of 18 May 2005 in the version of 1 December 2012 before the commencement of this Ordinance is refilled from the original packaging into smaller packages, without the composition or the intended use being changed, it may also be supplied in these smaller packages with the existing labelling until 31 May 2017.
For substances that are placed on the market in quantities of 10 to 100 tonnes per year, the manufacturer must comply with the obligation to prepare exposure scenarios in accordance with Article 16 by 1 June 2018.
Art. 93a168 Transitional provisions to the amendment of 31 January 2018
Manufacturers of substances, preparations and nanomaterials referred to in Article 48 which have already been placed on the market at the date of entry into force of the amendment of 31 January 2018 and which are placed on the market again after the entry into force of the amendment of 31 January 2 shall comply with the notification requirement laid down in Articles 48–54 no later than three months after they are placed on the market again.
...169
Art. 93b170 Transitional provision to the Amendment of 18 November 2020
Manufacturers may continue to place the following preparations on the market until 31 December 2025 at the latest without indicating the UFI in accordance with Article 15a, notwithstanding that these do not have a UFI on 1 January 2022:
preparations intended for professional users;
preparations intended for private users that are placed on the market before 1 January 2022.
Art. 93c171 Transitional provision to the Amendment of 11 March 2022
Substances and preparations may be supplied to third parties with the previous labelling until 31 December 2025.
If a manufacturer intends to conduct tests on vertebrates, it must by 31 October 2023 comply with the advance enquiry obligation in accordance with Article 31 paragraphs 1 and 2 for any substance that was placed on the market before this amendment comes into force and which is now subject to the notification obligation. If it complies with this obligation, it may continue to place the substance on the market without notification until 30 April 2027. The Notification Authority may extend the period by a maximum of two years. If two or more manufacturers intend to give notification of the same substance, the Notification Authority shall inform the manufacturers of this immediately on expiry of the deadline for the advance enquiry. Article 31 paragraph 4 applies by analogy.
New substances for which notification was not given before this amendment comes into force and which do not fall under paragraph 2 may continue to be placed on the market without notification until 30 April 2024. The Notification Authority may extend the period by a maximum of one year.
The following applies to existing substances for which notification was given before this amendment comes into force:172
173The notifier is not bound by the obligations in Articles 46 and 47, and the exclusive representative and the importer are not bound by obligation in Article 46.
The exemption in Article 54 paragraph 1 letter k does not apply.
Chapter 3 Commencement
Art. 94
This Ordinance comes into force on 1 July 2015.
Correspondences between expressions and applicable legislation
(Art. 2 para. 4, 5 and 6)
1
The following expressions of the REACH Regulation174, the CLP Regulation175 and Directive 75/324/EEC176, and this Ordinance correspond as follows:
EU | Switzerland |
|---|---|
a. German expressions: | |
Hersteller, Lieferant, Importeur, nachgeschalteter Anwender | Herstellerin in accordance with Article 2 paragraph 1 letter b |
Inverkehrbringen | Inverkehrbringen nach in accordance with Article 4 paragraph 1 letter i ChemG |
Gemisch | Zubereitung |
Erzeugnis | Gegenstand |
Zwischenprodukt | Zwischenprodukt in accordance with Article 2 paragraph 2 letter j |
Verbraucher, Endverbraucher | private Verwenderin |
Öffentliche Beratungsstelle | Tox Info Suisse (Art. 79) |
b. French expressions: | |
fabricant, fournisseur, importateur, utilisateur en aval | fabricant selon l’art. 2, al. 1, let. b |
mise sur le marché | mise sur le marché selon l’art. 4, al. 1, let. i LChim |
mélange | préparation |
article | objet |
intermédiaire | produit intermédiaire selon l’art. 2, al. 2, let. j |
consommateur | utilisateur privé |
organisme consultatif officiel | Tox Info Suisse (art. 79) |
c. Italian expressions: | |
Fabbricante, fornitore, importatore, utilizzatore a valle | Fabbricante ai sensi dell’articolo 2 capoverso 1 lettera b |
Immissione sul mercato | Immissione sul mercato ai sensi dell’articolo 4 capoverso 1 lettera i LPChim |
Miscela | Preparato |
Articolo | Oggetto |
Sostanza intermedia | Prodotto intermedio ai sensi dell’articolo 2 capoverso 2 lettera j |
Consumatore | Utilizzatore privato |
Organismo di consulenza ufficiale | Tox Info Suisse (art. 79) |
d. English expressions: | |
Manufacturer, supplier, importer, downstream user | Manufacturer as defined by Article 2 paragraph 1 letter b |
Placing on the market | Placing on the market as defined by Article 4 paragraph 1 letter i ChemA |
Mixture | Preparation |
Article | Object |
Intermediate | Intermediate as defined by Article 2 paragraph 2 letter j |
Consumer | Private user |
Official advisory body | Tox Info Suisse (Art. 79) |
2
If in this Ordinance reference is made to provisions of the REACH Regulation or the CLP Regulation which in turn refer to one of the following provisions of these two acts, the following provisions of Swiss legislation shall apply instead:
Provisions of the REACH Regulation or the CLP Regulation | Provisions of Swiss legislation |
|---|---|
Art. 13 of the REACH Regulation | Art. 43 para. 2 of this Ordinance |
Art. 31 of the REACH Regulation | Art. 20 of this Ordinance |
Art. 59 of the REACH Regulation | Annex 3 of this Ordinance |
Art. 17 para. 2 of the CLP Regulation | Art. 10 para. 3 let. b of this Ordinance |
Art. 23 let. e of the CLP Regulation | Legislation on explosives |
Art. 24 of the CLP Regulation | Art. 14 of this Ordinance |
3
If in this Ordinance reference is made to provisions of the REACH Regulation or the CLP Regulation which in turn refer to other EU legislation, the following Swiss legislation shall apply instead of the EU legislation:
EU legislation | Swiss legislation |
|---|---|
Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes, OJ L 358 of 18.12.1986, p. 1 | Animal Protection Act of 16 December 2005177 |
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, OJ L 167 of 27.6.2012, p. 1 | Biocidal Products Ordinance of 18 May 2005178 |
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, OJ L 309 of 24.11.2009, p. 1 | Plant Protection Products Ordinance of 20 August 2025179 |
Rules on the transport of dangerous goods | Regulations concerning transport by post, rail, road, air, water and pipelines |
Commission Decision of 12 July 1995 setting up a Scientific Committee for Occupational Exposure Limits to Chemical Agents, OJ L 188 of 9.8.1995, p. 14 | Art. 50 para. 3 of the Ordinance of 19 December 1983180 on Accident Prevention |
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work, OJ L 131 of 5.5.1998, p. 11 | Legislation on the protection of workers |
Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work, OJ L 158 of 30.4.2004, p. 50 | Legislation on the protection of workers |
National occupational exposure limit values | List of occupational exposure limit values published by SUVA181 |
Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment, OJ L 399 of 30.12.1989, p. 18 | Ordinance of 19 May 2010182 on Product Safety |
Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives, OJ L 312 of 22.11.2008, p. 3 | Waste Management Ordinance of 4 December 2015183 and Ordinance of 22 June 2005184 on the Movement of Wastes |
Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer, OJ L 286 of 31.10.2009, p. 1 | Annex 1.4 ORRChem185 |
Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC, OJ L 158 of 30.4.2004, p. 7 | Annexes 1.1, 1.9 and 1.16 ORRChem |
Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals, OJ L 201 of 27.7.2012, p. 60 | PIC Ordinance of 10 November 2004186 |
Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of major-accident hazards involving dangerous substances, amending and subsequently repealing Council Directive 96/82/EC, OJ L 197 of 24.7.2012, p. 1 | Major Accidents Ordinance of 27 February 1991187 |
Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC, OJ L 39 of 15.2.1980, p. 40 | Measurement Act of 17 June 2011188 and associated ordinances in the area of weights and measures |
Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents, OJ L 104 of 8.4.2004, p. 1 | Annexes 2.1 and 2.2 ORRChem |
List of applicable technical provisions
(Art. 2 para. 5, 3, 6 para. 2 and 4, 14 para. 1 let. b,
20 para. 1, 43 para. 1 and 84 let. a)
1 Technical provisions for classification, labelling and packaging of substances and preparations
For classification, labelling and packaging of substances and preparations, Annexes I–VII to the CLP Regulation189 apply. The following amendments to the CLP Regulation are authoritative for Switzerland:
Amendments to the CLP Regulation authoritative for Switzerland | Reference in the Official Journal of the EU (OJ.) | Summary |
|---|---|---|
Commission Regulation (EC) | OJ. L 235 of 5.9.2009, p. 1 | 1st adaptation of the CLP-Regulation to technical progress (ATP) |
Commission Regulation (EC) | OJ. L 83 of 30.3.2011, p. 1 | 2nd ATP |
Commission Regulation (EC) | OJ. L 179 of 11.7.2012, p. 3 | 3rd ATP |
Commission Regulation (EC) | OJ. L 149 of 1.6.2013, p. 1 | 4th ATP |
Commission Regulation (EC) | OJ. L 216 of 10.8.2013, p. 1 | Corrections in Annex VI |
Commission Regulation (EC) | OJ. L 261 of 3.10.2013, p. 5 | 5th ATP |
Commission Regulation (EC) | OJ. L 167 of 6.6.2014, p. 36 | 6th ATP |
Commission Regulation (EC) | OJ. L 350 of 6.12.2014, p. 1 | Protection against liquid caps |
Commission Regulation (EU)2015/1221 of 24 July 2015 | OJ. L 197 of 25.7.2015, | 7th ATP |
Commission Regulation (EU)2016/918 of 19 May 2016 | OJ. L 156 of 14.6.2016, p. 1 | 8th ATP |
Commission Regulation (EU)2016/1179 of 19 July 2016 | OJ. L 195 of 20.7.2016, | 9th ATP |
Commission Regulation (EU)2017/776 of 4 May 2017 | OJ. L 116 of 5.5.2017, p. 1 | 10th ATP |
Commission Regulation (EU)2018/669 of 16 April 2018 | OJ. L 115 of 4.5.2018, p. 1 | 11th ATP |
Commission Regulation (EU)2019/521 of 27 March 2019 | ABl L 86 of 28.3.2019, p. 1 | 12th ATP |
Commission Regulation (EU)2018/1480 of 4 October 2018 | OJ. L 251 of 5.10.2018, p. 1 | 13th ATP |
Commission Delegated Regulation (EU)2020/217 of 4 October 2019 | OJ. L 44 of 18.2.2020, p. 1 | 14th ATP |
Commission Delegated Regulation (EU)2020/1182 of 19 May 2020 | OJ. L 261 of 11.8.2020, p. 2 | 15th ATP |
Commission Delegated Regulation (EU)2021/643 of 3 February 2021 | OJ. L 133 of 20.4.2021, p. 1 | 16th ATP |
Commission Delegated Regulation (EU)2021/797 of 8 March 2021 | OJ. L 176 of 19.5.2021, p. 1 | Correction |
Commission Delegated Regulation (EU)2021/849 of 11 March 2021 | OJ. L 188 of 28.5.2021, | 17th ATP |
Commission Delegated Regulation (EU)2021/1962 of 12 August 2021 | OJ. L 400 of 12.11.2021, | Correction of substance entries in Annex VI |
Commission Delegated Regulation (EU)2022/692 of 16 February 2022 | OJ. L 129 of 3.5.2022, p. 1 | 18th ATP |
Commission Delegated Regulation (EU)2023/1434 of 25 April 2023 | OJ. L 176 of 11.7.2023, | 19th ATP |
Commission Delegated Regulation (EU)2023/1435 of 2 May 2023 | OJ. L 176 of 11.7.2023, | 20th ATP |
Commission Delegated Regulation (EU)2023/707 of 19 December 2022 | OJ. L 93 of 31.3.2023, p. 7. | ATP ‘New hazard classes’ |
Commission Delegated Regulation (EU)2024/197 of 19 October 2023 | OJ. L, 2024/197, 5.1.2024 | 21st ATP |
Commission Delegated Regulation (EU)2024/2564 of 19 June 2024 | OJ. L, 2024 /2564, 30.9.2024 | 22nd ATP |
Commission Delegated Regulation (EU)2025/1222 of 2 April 2025 | OJ. L, 2025 / 1222, 20.6.2025 | 23rd ATP |
2 Methods for testing the properties of substances and preparations
Tests designed to determine the properties of substances and preparations shall be carried out in accordance with:
the test methods specified in Regulation (EC) No 440/2008190;
the OECD Guidelines for the Testing of Chemicals, in the version dated 25 June 2025191; or
the test methods specified in the UN Manual of Tests and Criteria192.
3 Requirements for the Safety Data Sheet
3.1 The safety data sheet must comply with the requirements specified in Annex II to the REACH Regulation193; the foregoing does not apply to the requirements for nanomaterials and nanoforms
3.2 Where Annex II to the REACH Regulation requires reference to be made in sections 1, 7, 8, 13 and 15 of the safety data sheet to national law, the relevant provisions of Swiss law must be indicated. In Section 1 the Swiss manufacturer and the telephone number of Tox Info Suisse must be indicated.
4 Transitional Provisions
4.1 Preparations that do not meet the requirements of Regulation (EU) No 286/2011194 (2nd Adaptation to Technical Progress [ATP] of the CLP Regulation) may be supplied until 31 May 2017 if they were packaged and labelled before the commencement of this Ordinance.
4.2 Preparations that do not meet the requirements of Regulation (EU) No 487/2013195 (4th ATP) and of Annex I to Regulation (EU) No 944/2013196 (5th ATP) may be supplied until 31 May 2017, if they were packaged and labelled before the commencement of this Ordinance
5 Transitional Provision to the Amendment of 2 November 2015
5.1 Substances listed in Regulation (EU) 2015/1221197 (7th ATP) and preparations that contain such substances may, if their classification and labelling do not meet the requirements of the said Regulation, be supplied until 31 December 2016.
5.2 For substances and preparations for which a safety data sheet was compiled under existing law before the Amendment of 2 November 2015 came into force, a safety data sheet must be compiled in accordance with the requirements of the EU REACH Regulation by 1 June 2017.
6 Transitional Provision to the Amendment of 1 November 2016
6.1 Substances and preparations that do not meet the requirements of Regulation (EU) 2016/918198 (8th ATP) may be supplied until 31 January 2020 is they were packaged and labelled before 31 January 2018.
6.2 Substances that are listed in Regulation (EU) 2016/1179199 (9th ATP) and preparations that contain such substances may if their classification and labelling do not meet the requirements of the said Regulation, be supplied until 28 February 2018.
7 Transitional provision to the amendment of 5 February 2018
Substances which have been reclassified by Regulation (EU) 2017/776200 (10th ATP) in Annex VI to the CLP Regulation or which have been newly included in it, and preparations containing such substances may be supplied until 30 November 2018 if their classification and labelling do not meet the requirements of the above-mentioned Regulation.
8 Transitional provision to the amendment of 31 October 2018
In the case of substances and preparations whose labels must under Article 18 paragraphs 2 and 3 of the CLP Regulation include the substance name (Art. 10 para. 1 let. a), substance names that differ from the official substance names contained in Regulation (EU) 2018/669201 (11th ATP) in Annex VI of the CLP may continue to be used until 31 May 2020.
9 Transitional provision to the amendment of 23 May 2019
9.1 Substances and preparations that do not meet the requirements of Regulation (EU) 2019/521202 (so-called 12th ATP) may be supplied until 31 December 2020.
9.2 Substances that are listed in Regulation (EU) 2018/1480203 (13th ATP), and preparations that contain such substances may be supplied until 30 April 2020 if their classification and labelling do not meet the requirements of the said Regulation.
10 Transitional provision to the amendment of 21 February 2020
Substances that are listed in Regulation (EU) 2020/217204 (14th ATP), and preparations that contain such substances may be supplied until 30 September 2021 if their classification and labelling do not meet the requirements of the said Regulation.
11 Transitional provision to the amendment of 19 November 2020
11.1 Substances that are listed in Regulation (EU) 2020/1182205 (15th ATP), and preparations that contain such substances may be supplied until 28 February 2022 if their classification and labelling do not meet the requirements of the said Regulation.
11.2 For substances and preparations for which a safety data sheet has been compiled in accordance with the previous law before the amendment of 19 November 2020 comes into force, a safety data sheet in accordance with Annex II to the EU REACH Regulation must be compiled by 31 December 2022 at the latest.
12 Transitional provision to the amendment of 4 August 2021
Substances that are listed in Regulation (EU) 2021/849206 (17th ATP) and preparations that contain such substances a may be supplied until 16 December 2022 if their classification and labelling do not meet the requirements of the said Regulation.
13 Transitional provision to the amendment of 9 August 2022
Substances that are listed in Regulation (EU) 2022/692207 (18th ATP) and preparations that contain such substances may be supplied until 30 November 2023 if their classification and labelling do not meet the requirements of the said Regulation.
14 Transitional provision to the amendment of 5 September 2023
Substances that are listed in Delegated Regulation (EU) 2023/1435208 (20th ATP) and preparations that contain such substances may be supplied until 31 January 2025 if their classification and labelling do not meet the requirements of the said Regulation.
15 Transitional provision to the amendment of 22 July 2024
15.1. Substances that do not meet the requirements of Delegated Regulation (EU) 2023/707209 (ATP New Hazard Classes) may be supplied until 31 October 2026.
15.2. Preparations that do not meet the requirements of Delegated Regulation (EU) 2023/707 (ATP New Hazard Classes) may be supplied until 30 April 2028.
15.3. Substances that are listed in Delegated Regulation (EU) 2024/197210 (21st ATP), and preparations that contain such substances, may be suppled until 31 August 2025 if their classification and labelling do not meet the requirements of the said Regulation.
16 Transitional provision to the amendment of 31 July 2025
16.1. Substances listed in Delegated Regulation (EU) 2024/2564211 (22nd ATP) and preparations that contain such substances may be suppled until 30 April 2026 if their classification and labelling do not meet the requirements of the said Regulation.
16.2. Substances listed in Delegated Regulation (EU) 2025/1222212 (23rd ATP) and preparations that contain such substances may be suppled until 31 January 2027 if their classification and labelling do not meet the requirements of the said Regulation.
List of substances of very high concern (candidate list)213
(Art. 5 para. 2 and 3, 19 let. c and d, 70 para. 1 and 84 let. b)
Technical dossier
(Art. 2 para. 5, 26 para. 2, 27 para. 2 let. b, 47 para. 1 and 84 let. c)
1 General provisions
1.1 The information in the technical dossier may be submitted in a form approved by the European Chemicals Agency. In this case, certain expressions may differ from those prescribed in this Annex.
1.2 Whether the information specified in numbers 7–10 is required depends on the quantity placed on the market.
1.3 In the case of references to Annexes VII–XI of the REACH Regulation214, the requirements in relation to nanomaterials and nanoforms need not be complied with.
2 General notifier information
2.1 The identity of the notifier is to be indicated, in particular:
Name, address, telephone number and e-mail address;
Contact person;
Location of the notifier’s production site(s), as appropriate.
2.2 If the notifier is an exclusive representative, the following information is to be additionally provided:
Name and address of the foreign manufacturer;
Location of the production site(s);
Authorisation from the foreign manufacturer stating that it has designated the notifier as its exclusive representative;
Names and addresses of the importers represented;
the substance quantities that each importer expects to import annually.
3 Identification of the substance
The following information on the substance is to be provided:
data specified in Section 2 of Annex VI to the REACH Regulation;
for nanomaterials: data on composition and, where available, surface coating and surface functionalisation.
4 Information on manufacture and use
The following information is to be provided:
the estimated overall quantity to be placed on the market by the notifier in the calendar year of the notification;
the quantities for the notifier’s own use;
the form or physical state in which the substance is made available;
a brief description of the identified use(s);
information on waste quantities and composition of waste resulting from manufacture of the substance, the use in objects and identified uses;
uses advised against (Section 1.2 of the safety data sheet).
5 Classification and Labelling
The following is to be indicated:
the classification of the substance in accordance with Article 6 paragraph 1 for all hazard classes and categories in the CLP Regulation215; if no classification has been given for a hazard class or differentiation of a hazard class, the reasons are to be provided;
the labelling of the substance in accordance with Article 10;
any specific concentration limits resulting from the application of Article 10 of the CLP Regulation.
6 Guidance on safe use
The following information is to be provided; it must be consistent with that in the safety data sheet, where such a safety data sheet is required in accordance with Article 19:
first-aid measures (safety data sheet, No 4);
fire-fighting measures (safety data sheet, No 5);
accidental release measures (safety data sheet, No 6);
handling and storage (safety data sheet, No 7);
transport information (safety data sheet, No 14);
exposure controls/personal protection (safety data sheet, No 8);
stability and reactivity (safety data sheet, No 10);
disposal considerations: information on recycling and methods of disposal for industry and for the public (safety data sheet, No 13).
7 Information on exposure (1–10 tonnes per year)
For substances where the quantity placed on the market is between 1 and 10 tonnes per year, the following information on exposure is to be provided:
Main use categories:
professional use,
industrial use,
private use;
Specification for industrial and professional use:
use in a closed system,
use resulting in inclusion into or onto matrix,
non-dispersive use by a restricted number of persons,
dispersive use;
Significant routes of exposure:
human exposure: oral, dermal and inhalatory,
environmental exposure: water, air, solid waste and soil,
pattern of exposure: accidental/infrequent, occasional or continuous/ frequent.
8 Information on physicochemical properties
The following information is to be provided:
for the quantities placed on the market of 1 tonne per year or more:
robust study summaries with regard to the information specified in Section 7 of Annex VII to the REACH Regulation,
for nanomaterials: the particle form and mean particle size and, where available, the number size distribution, specific surface area by volume and aggregation status;
for the quantities placed on the market of 100 tonnes per year or more: in addition to the information specified in letter a, robust study summaries with regard to the information specified in Section 7 of Annex IX to the REACH Regulation.
9 Toxicological information
Robust study summaries are to be provided with regard to the following information:
for quantities of 1 tonne per year or more: the information specified in Section 8 of Annex VII to the REACH Regulation;
for quantities of 10 tonnes per year or more: in addition to the information specified in letter a, the information specified in Section 8 of Annex VIII to the REACH Regulation;
for quantities of 100 tonnes per year or more: in addition to the information specified in letters a and b, the information specified in Section 8 of Annex IX to the REACH Regulation;
for quantities of 1,000 tonnes per year or more: in addition to the information specified in letters a–c, the information specified in Section 8 of Annex X to the REACH Regulation.
10 Ecotoxicological information
Robust study summaries are to be provided with regard to the following information:
for quantities of 1 tonne per year or more: the information specified in Section 9 of Annex VII to the REACH Regulation;
for quantities of 10 tonnes per year or more: in addition to the information specified in letter a, the information specified in Section 9 of Annex VIII to the REACH Regulation;
for quantities of 100 tonnes per year or more: in addition to the information specified in letters a and b, the information specified in Section 9 of Annex IX to the REACH Regulation;
for quantities of 1,000 tonnes per year or more: in addition to the information specified in letters a–c, the information specified in Section 9 of Annex X to the REACH Regulation.
11 Omission of certain tests
Certain tests specified in numbers 8–10 may be omitted if, according to the criteria specified in Annex XI to the REACH Regulation:
testing does not appear scientifically necessary;
testing is technically not possible;
the exposure assessment makes it possible for certain tests to be omitted.
Substances and preparations in Groups 1 and 2
(Art. 61)
1 Substances and preparations labelled in accordance with the CLP Regulation216
1.1 Group 1
a. |  in conjunction with | H300217: Fatal if swallowed, or H310: Fatal in contact with skin, or H330: Fatal if inhaled, or combinations of the above hazard statements |
b. |  | |
c. | Substances and preparations labelled as follows in accordance with Annex 1.10 to the ORRChem218: | |
 in conjunction with | H340: May cause genetic defects, or H350: May (if inhaled) cause cancer, or H360: May damage fertility or the unborn child |
1.2 Group 2
a. | in conjunction with | H301: Toxic if swallowed, or H311: Toxic in contact with skin, or H331: Toxic if inhaled, or combinations of the above hazard statements |
b. | in conjunction with | H370: Causes damage to organs, or H372: Causes damage to organs through prolonged or repeated exposure |
c. |  in conjunction with | H314: Causes severe skin burns and eye damage. (Preparations that must be classified as "Skin Corr. 1C" and labelled H314 solely because of their lactic acid content [CAS No 79-33-4] are not deemed to be Group 2 preparations) |
d. | Containers with a content of more than 1 kg labelled as follows: | |
 in conjunction with | H410: Very toxic to aquatic life with long lasting effects. (Substances and preparations in Group 2 are those that must be labelled H410, because they are classified as «Aquatic Chronic 1».) | |
e. |  in conjunction with | H250: Catches fire spontaneously if exposed to air, or H260: In contact with water releases flammable gases which may ignite spontaneously, or H261: In contact with water releases flammable gases |
f. | H230: May react explosively even in the absence of air, or H231: May react explosively even in the absence of air at elevated pressure and/or temperature, or EUH019: May form explosive peroxides, or EUH029: Contact with water liberates toxic gas, or EUH031: Contact with acids liberates toxic gas, or EUH032: Contact with acids liberates very toxic gas |
2 Substances and preparations not yet labelled in accordance withthe CLP Regulation
2.1 Group 1
a. |  in conjunction with | R28219: Very toxic if swallowed, or R27: Very toxic in contact with skin, or R26: Very toxic by inhalation, or combinations of the above R phrases |
b. |  | |
c. | Substances and preparations labelled as follows in accordance with Annex 1.10 to the ORRChem: | |
in conjunction with | R46: May cause heritable genetic damage, or R45: May cause cancer, or R49: May cause cancer by inhalation, or R60: May impair fertility, or R61: May cause harm to the unborn child |
2.2 Group 2
a. | in conjunction with | R25: Toxic if swallowed, or R24: Toxic in contact with skin, or R23: Toxic by inhalation, or combinations of the above R phrases |
b. | in conjunction with | R39: Danger of very serious irreversible effects, or R48: Danger of serious damage to health by prolonged exposure |
c. |  in conjunction with | R35: Causes severe burns, or R34: Causes burns |
d. | Containers with a content of more than 1 kg labelled as follows: | |
 in conjunction with | R50/53: Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. | |
e. |  in conjunction with | R17: Spontaneously flammable in air, or R15: Contact with water liberates extremely flammable gases |
f. | R6: Explosive with or without contact with air, or R19: May form explosive peroxides, or R29: Contact with water liberates toxic gas, or R31: Contact with acids liberates toxic gas, or R32: Contact with acids liberates very toxic gas. |
Amendment of other legislation
(Art. 92)
The following legislation shall be amended as follows:
...220
List of new substances for which notification is not required221
(Art. 26 para. 1 let. j and 84 let. d)
Transitional Provision of 9 August 2022
The substances “Pigment Red 3100 (TKP 50106)”, “Fadex (MU05004) AS PK” and “FSM-004Y”, which were deleted from Annex 7222 by the Amendment of 9 August 2022, may continue to be placed on the market without notification until 31 December 2023.