Federal Act on Protection against Dangerous Substances and Preparations

(Chemicals Act, ChemA)

of 15 December 2000 (Status as of 1 January 2024)

The Federal Assembly of the Swiss Confederation,

based on Articles 95 paragraph 1, 110 paragraph 1 letter a and 118 paragraph 2 letter a of the Federal Constitution¹,
and having considered the Dispatch of the Federal Council dated
24 November 1999²,

ordains:

Chapter 1 General Provisions and Principles

Section 1 General Provisions

Art. 1 PurposeOpen annotations

This Act is intended to protect the lives and health of human beings against harmful effects arising from substances and preparations.

Art. 2 ScopeOpen annotations

1. This Act applies to the handling of substances and preparations.
2. The handling of microorganisms is deemed equivalent to the handling of substances and preparations in so far as they are used in biocidal products or plant protection products.
3. The Federal Assembly may by means of an ordinance extend the scope of this Act or of individual provisions to include:
   1. organisms that have, or may have, dangerous properties within the meaning of this Act;
   2. the protection of the lives and health of farm and household animals.
4. The Federal Council shall provide for exemptions from the scope or from individual provisions of this Act in cases where:
   1. lives and health are adequately protected by other federal legislation against harmful effects arising from substances and preparations;
   2. substances and preparations are intended solely for through transit or export;
   3. general defence or the tasks of the police and customs authorities necessitate such exemptions.

Art. 3 Dangerous substances and preparationsOpen annotations

1. Substances and preparations are deemed dangerous if they are capable of presenting a hazard to life or health as a result of physico-chemical or toxic effects.
2. The Federal Council shall specify the properties deemed dangerous and define categories of danger.

Art. 4 DefinitionsOpen annotations

1. In this Act: a. substances means chemical elements and their compounds in the natural state or obtained by any production process. A distinction is drawn between existing and new substances: 1. substances shall be deemed to be existing substances if they are designated as such by the Federal Council, 2. all other substances shall be deemed new; b. active substances means substances and microorganisms including viruses which on account of their action are designed to be used as biocidal products or plant protection products; c. preparations means mixtures or solutions composed of two or more substances; d. biocidal products means active substances and preparations that are not plant protection products and which are designed to: 1. deter, render harmless, destroy or otherwise control harmful organisms, or 2. prevent damage from being caused by harmful organisms; e. plant protection products means active substances and preparations that are designed to: 1. protect plants and plant products against harmful organisms or prevent the action of such organisms, 2. influence the life processes of plants other than as a nutrient, 3. preserve plant products, 4. destroy unwanted plants or parts of plants, or 5. control the undesired growth of plants; f. manufacturer means any natural or legal person who, by way of profession or trade, produces or extracts substances or preparations, or imports them for professional or commercial purposes; g. notifier means any natural or legal person who notifies new substances to the notification authority, submits documentation on existing substances under review, or requests authorisation for active substances or preparations; h. notification authority means the federal authority that receives in particular notifications of new substances, documentation on existing substances under review, or requests for authorisation for active substances and preparations, as well as other submissions, coordinates the procedures and issues the necessary rulings; i. placing on the market means providing for or supplying to third parties and importing for professional or commercial purposes; j. handling means any activity in connection with substances or preparations, in particular, production, import, export, placing on the market, storage, keeping, transport, use or disposal.
2. The Federal Council may define more precisely the terms specified in paragraph 1, as well as other terms used in this Act, draw further distinctions, and, in the light of new scientific and technological knowledge and in line with international developments, make adjustments and grant exemptions.

Section 2 Principles for the Handling of Substances and Preparations

Art. 5 Self-regulation

1. Any manufacturer who places substances or preparations on the market shall be responsible for ensuring that they do not endanger life or health. In particular, the manufacturer shall:
   1. assess and classify substances and preparations according to their properties;
   2. package and label them in accordance with the type of hazard concerned.
2. The Federal Council shall issue regulations on the nature, extent and review of self-regulation. In particular, it shall specify:
   1. test methods, the principles of Good Laboratory Practice (GLP) and the criteria for assessment and classification;
   2. packaging and labelling requirements.

Art. 6 Placing on the market

Having completed the appropriate self-regulation procedures, the manufacturer shall be entitled to place substances and preparations on the market without the prior consent of the authorities. The following exceptions apply:

1. notification is required for placing new substances on the market as such or as a constituent of a preparation (Art. 9);
2. authorisation is required for placing biocidal products or plant protection products on the market (Art. 10 and 11).

Art. 7 Obligation to inform purchasers

1. Any person who places substances or preparations on the market must inform purchasers about properties and hazards relevant to health, and about the appropriate precautions and protective measures.
2. The Federal Council shall issue regulations concerning the nature, content and scope of such information, in particular the distribution and content of a safety data sheet.

Art. 8 Duty of careOpen annotations

Any person involved in the handling of substances or preparations must pay due regard to their dangerous properties and take any measures necessary to protect life and health. In particular, due consideration must be given to the relevant information provided by the manufacturer.

Chapter 2 Notification of and Authorisation for Specific Substances and Preparations

Art. 9 Notification of new substances

1. The notification authority shall review and assess the documents submitted in conjunction with the federal authorities responsible for the technical matters in question (assessment authorities) and shall inform the notifier of the outcome within a period specified by the Federal Council.
2. A substance for which notification has been submitted may be placed on the market if the notification authority has accepted the notification or if it has not requested any further documents or information concerning the notification within the above-mentioned period.
3. The Federal Council shall issue regulations on the requirements and the procedure for the notification of new substances. It shall specify any exemptions from mandatory notification, taking into account in particular the intended use, the type of substance or preparation and the quantities that are to be produced or placed on the market.

Art. 10 Authorisation for biocidal productsOpen annotations

1. The notification authority shall review and assess the documents submitted in conjunction with the assessment authorities and shall issue its decision – taking the risk assessment into consideration (Art. 16) – within a period specified by the Federal Council.
2. Authorisation shall be granted for a biocidal product in particular if, when used as intended:
   1. it is sufficiently effective;
   2. it does not have any unacceptable adverse effects on the health of humans or of farm or household animals.
3. Authorisation may be withheld or revoked if the health risks give rise to concern and if another active substance is available for which authorisation has been granted for biocidal products of the same type, which is associated with a considerably lower health risk and which does not entail any significant economic or practical disadvantages for users.
4. The Federal Council shall specify the types of authorisation and the authorisation procedures, as well as any exemptions from mandatory authorisation for biocidal products. Authorisation shall be granted for limited periods.

Art. 10a Duty to notify for biocidal products

1. Any person who places biocidal products on the market is required to notify the Confederation of the data on their placing on the market.
2. The Federal Council shall regulate in particular the data that must be recorded and the office to which notice must be given.

Art. 11 Authorisation for plant protection productsOpen annotations

1. Authorisation shall be granted for a plant protection product in particular if, when used as intended, it does not have any unacceptable adverse effects on the health of humans or of farm or household animals.
2. In other respects, the types of authorisation and the authorisation procedures, as well as any exemptions from mandatory authorisation for plant protection products, shall be determined by the relevant agricultural legislation. When issuing the appropriate implementing regulations, the Federal Council shall give due consideration to the protection of health within the meaning of this Act.

Art. 12 Obligation to request information in advance

Before notifiers conduct the animal experiments required for notification or authorisation, they must enquire at the notification authority as to whether the substance or preparation concerned has already been notified or authorisation has already been granted.

Art. 13 Second notification and second authorisation

1. Notification or authorisation in accordance with Articles 9–11 shall also be required in cases where substances or preparations subject to mandatory notification or authorisation have already been notified by another notifier or authorisation has already been granted to another notifier.
2. The Federal Council shall establish a special procedure for second notification or authorisation and, giving due consideration to the interests of the original notifier, shall specify the conditions under which:
   1. the second notifier may refer to notification documents already submitted;
   2. the original notifier, in the interests of animal welfare, has to accept the use of its notification documents.

Art. 14 Use of documents

Subject to the provisions of Article 13 paragraph 2, the federal authorities involved in the notification or authorisation procedure shall not be entitled to use information or documents provided by a notifier for the benefit of a different notifier without the former’s consent. The Federal Council shall specify the period of protection and determine any exemptions, giving due consideration to the confidentiality of the information concerned.

Art. 15 Review of existing substances

1. The Federal Council shall issue regulations concerning the review and assessment of individual existing substances.
2. The notification authority may request manufacturers to carry out investigations or tests or to provide documents relating to existing substances that:
   1. in view of the quantities produced or placed on the market or in view of their dangerous character may pose a particular risk to life or health; or
   2. are being reviewed in connection with international efforts and programmes.

Art. 16 Risk assessment

1. The notification authority, in conjunction with the assessment authorities, shall identify possible hazards presented by substances or preparations (risk assessment). For this purpose, the notifier may be requested to provide additional information and, if necessary, to carry out further tests.
2. A risk assessment shall be required for:
   1. new substances (Art. 9);
   2. substances and preparations subject to mandatory authorisation (Art. 10 and 11);
   3. existing substances under review in accordance with Article 15 paragraph 2 letter b.
3. On the basis of the risk assessment, having first consulted the notifier, the notification authority may recommend or order that the notifier should take measures to reduce the risks.
4. If no measures can be taken to reduce the risks or if the risks cannot be adequately reduced by such measures, the authorities responsible shall take appropriate steps to amend the relevant legal regulations.
5. Risk assessments shall be reviewed and, if necessary, revised in the light of new findings. In addition, reviews shall be carried out periodically in the case of biocidal products and plant protection products.

Art. 17 Supplementary information

The notifier must inform the notification authority without delay and if necessary submit new documents if new findings emerge relating to the substance or preparation concerned or if significant changes occur with regard to essential points such as properties, intended use, or the quantities produced or placed on the market.

Chapter 3 Special Provisions concerning the Handling of Substances and Preparations

Art. 18 Reporting the details of substances and preparations

1. In cases where dangerous substances or preparations not subject to a mandatory notification or authorisation procedure are placed on the market, the manufacturer shall inform the notification authority of the following:
   1. the name and address of the manufacturer;
   2. the essential details concerning the identity of the product;
   3. the classification and labelling;
   4. the substances relevant to the classification.
2. In the case of certain substances and preparations, the Federal Council may waive, in part or in full, the requirement to provide such information, particularly if:
   1. on account of their properties or the intended use, information on the substances or preparations concerned is of little importance for the identification of risks or for prevention;
   2. they are supplied exclusively to professional or commercial users; or
   3. they are supplied in small amounts to a restricted circle of users.
3. It may, if this is important for the identification of risks or for prevention:
   1. stipulate that additional details be reported for certain substances and preparations, specifically concerning their composition;
   2. extend the scope of mandatory reporting to include preparations that are not dangerous but contain dangerous substances.

Art. 19 Regulations concerning substancesOpen annotations

1. The Federal Council may issue special regulations:
   1. for certain substances and preparations that may endanger life or health;
   2. for articles containing substances or preparations as specified under letter a that may endanger life or health when they are used as intended or in a foreseeable way.
2. It may:
   1. impose restrictions on the way in which they are handled, and in particular produced, placed on the market and used;
   2. impose restrictions on the intended use for which a substance or preparation is placed on the market, and on the quality and form thereof;
   3. prohibit any handling if life and health cannot otherwise be protected;
   4. attach special conditions to exports;
   5. require articles to be labelled if certain substances are contained in or may be released from them;
   6. require certain poisonous plants and animals to be labelled as such if they are placed on the market;
   7. specify the classification and labelling of individual dangerous substances and set threshold concentrations for the classification and labelling of preparations that contain these substances.

Art. 20 Advertising

1. The promotion and offering for sale of dangerous substances and preparations, and of preparations containing dangerous substances, must not give rise to misapprehensions regarding the hazards or encourage inappropriate handling. In the case of biocidal products, no misleading claims may be made regarding efficacy.
2. The Federal Council shall issue regulations on how reference is to be made to the hazards in such promotion and offering for sale.

Art. 21 Keeping, storageOpen annotations

Dangerous substances and preparations shall be kept and stored securely according to the type of hazard involved. In particular, they must:

1. be protected against hazardous external influences;
2. be inaccessible to unauthorised parties;
3. be kept or stored in such a way as to prevent any risk of confusion, specifically with foodstuffs, or of their being used by mistake.

Art. 22 Obligation to return and to accept returns

1. Any person who supplies dangerous substances or preparations shall be obliged to accept them when returned by non-commercial users for appropriate disposal. Small quantities shall be returnable free of charge.
2. In the case of particularly dangerous substances and preparations, the Federal Council may stipulate that they are to be returned by the owner for disposal.

Art. 23 Theft, loss, inadvertent placing on the market

The Federal Council shall issue regulations concerning the measures that are to be taken when dangerous substances or preparations have been stolen, lost, or placed on the market by mistake.

Art. 24 Regulations concerning personal and technical qualifications

1. The Federal Council shall specify the personal and technical qualifications required by persons wishing to handle substances and preparations with particularly dangerous properties or in specific categories of danger or carrying special risks. It shall establish a licensing requirement if this is necessary to protect life and health.
2. It shall specify how the necessary expertise may be acquired.

Art. 25 Measures required in commercial and educational establishmentsOpen annotations

1. Any person who is involved in the handling of substances and preparations by way of profession or trade shall be obliged to take such measures to protect the life and health of employees as are necessary in the light of experience, practicable according to the state of technological development and appropriate to the circumstances of the establishment concerned. Subject to the provisions of Articles 42 and 45, the present provision shall be implemented in accordance with the Labour Law of 13 March 1964³and the Federal Law of 20 March 1981⁴on Accident Insurance.
2. In commercial and educational establishments where dangerous substances or preparations are handled by way of profession or trade, a person is to be designated who is responsible for questions of appropriate handling and who can provide the enforcement authorities with the necessary information (Art. 42 Para. 2). This person shall be required to have the necessary technical qualifications and operational authority. The cantonal authority responsible for enforcement shall be notified of the name of the person designated.

Art. 25a Reducing the risks of biocidal product use

1. The risks to human beings, animals and the environment of using biocidal products shall be reduced and the quality of drinking water, surface waters and the groundwater shall be improved.
2. The Federal Council shall by 2023 specify:
   1. the relevant risk areas;
   2. the targets for reducing unacceptable risks in these areas;
   3. the methods to be used to measure whether the targets have been achieved.

Chapter 4 Documentation and Information

Art. 26 Documentation

1. The notification authority shall be responsible for the management of cross-sectoral documentation on substances and preparations. To this end, it shall maintain a product register.
2. The assessment authorities shall be responsible for obtaining the documentation required to fulfil their tasks.

Art. 27 Product register

1. The product register shall contain the information on substances and preparations that:
   1. has been acquired or compiled by the notification authority and the assessment authorities in the course of the notification or authorisation procedure as specified in Chapter 2;
   2. has been reported by the manufacturer in accordance with Article 18.
2. The Federal Council shall regulate the processing of data contained in the product register, particularly its use and disclosure, giving due consideration to the interests of the manufacturer; it shall specify the type of information that may be disclosed to enforcement authorities implementing regulations on substances and preparations on the basis of other legal instruments.

Art. 28 Information

1. The federal government shall inform the public and authorities about the risks and hazards involved in handling substances and preparations and shall recommend measures to reduce the risks.
2. It shall issue technical guidelines and publish the lists of substances and preparations that are required for the application of this Act.
3. The cantons shall provide information within their areas of responsibility.

Art. 29 Information on indoor air

The federal government shall provide information on hazards arising from indoor pollutants. It may in particular issue recommendations on the limitation or prevention of exposures hazardous to health and on the improvement of indoor air quality.

Art. 30 Poisons information centre

1. The Federal Council shall establish a poisons information centre and ensure that it is financially compensated for carrying out the tasks assigned to it.
2. The information centre shall provide information on the prevention and treatment of poisoning and shall recommend appropriate measures; to this end, it shall collect and process the necessary information, including details of cases of poisoning.
3. It shall have unrestricted access to the data in the product register (Art. 27) and shall be entitled to request the manufacturer directly to provide any additional information on substances and preparations that may be required for the fulfilment of its tasks.
4. The Federal Council shall take appropriate measures to ensure that the data made available in accordance with paragraph 3 is treated confidentially and that commercial and industrial secrets are protected. It shall specify in particular the conditions under which and the extent to which the information centre may, for medical purposes of a preventive or curative nature, disclose details of the composition and properties of substances and preparations.

Chapter 5 Enforcement

Section 1 Cantons

Art. 31 Enforcement

1. In so far as the federal government is not responsible, this Act shall be enforced by the cantons. They shall ensure that the authorities responsible for enforcing this Act coordinate their activities with the enforcement authorities responsible for workplace safety and for environmental protection.
2. They shall implement decisions issued by the federal authorities, when requested to do so by the latter.

Art. 32 Cantonal regulations

The cantons shall issue the organisational regulations for enforcement and shall notify the federal government thereof.

Section 2 Federal Government

Art. 33 Supervision

1. The federal government shall supervise the enforcement of this Act.
2. It shall coordinate cantonal enforcement measures in so far as uniform enforcement is deemed desirable. To this end, it may in particular:
   1. impose a duty on the cantons to inform the federal government about enforcement measures;
   2. prescribe measures to ensure uniform enforcement by the cantons;
   3. in exceptional circumstances, order the cantons to take specific enforcement measures;
   4. ⁵ support continuing education and training for the enforcement authorities.

Art. 34 Enforcement powers of federal government

1. The federal government shall enforce:
   1. Article 5 paragraph 1 letter a (assessment and classification of substances and preparations) and the requirements based on Article 5 paragraph 2 letter a;
   2. Article 7 (manufacturer’s obligation to inform purchasers);
   3. Articles 9–17 (notification of and authorisation for specific substances and preparations);
   4. Article 18 (reporting of details of substances and preparations);
   5. Article 19 paragraph 2 letter d (exports);
   6. Articles 26–30 (documentation and information), with the exception of Article 28 paragraph 3.
2. It may delegate responsibility to the cantons for individual parts of the tasks specified in paragraph 1 or request their participation in specific parts of tasks.
3. The federal government is responsible for enforcement with regard to the following matters:
   1. installations, activities, substances and preparations required for the purposes of national defence;
   2. imports, through transit or exports.

Art. 35 Coordination

1. The Federal Council shall determine which assessment authorities are to be involved in the procedures and reviews specified in Chapter 2.
2. If under different items of legislation substances or preparations must be notified to or authorisation granted by more than one federal authority, it shall designate a joint notification authority.
3. The Federal Council shall regulate the cooperation between the federal authorities involved.

Art. 36 Delegation of enforcement tasks

The Federal Council may delegate enforcement tasks to public or private organisations and persons.

Art. 37 Scientific requirements, research

1. The federal government shall ensure that the scientific requirements necessary for the application of this Act are fulfilled.
2. It may carry out surveys itself or in cooperation with the cantons, or with appropriate institutions or experts.
3. Within the framework of international cooperation, it may finance investigations of substances and preparations in whole or in part.
4. It shall promote scientific teaching and research in the field of dangerous properties of substances and preparations.

Art. 38 Federal Council implementing provisions

The Federal Council shall issue the implementing provisions. Where possible, it shall combine these with the implementing provisions for other federal acts if the latter include provisions relating to substances and preparations.

Art. 39 Adoption of internationally harmonised regulations and standards

1. When issuing its provisions, the Federal Council shall give due consideration to internationally harmonised guidelines and recommendations, and internationally harmonised technical regulations and standards.
2. It may declare certain internationally harmonised technical regulations and standards to be applicable in connection with this Act. It may authorise the relevant federal office to make subsequent adjustments to technical details of minor importance in the regulations and standards that have been declared applicable.
3. In exceptional cases, it may decide that the regulations and standards declared applicable are to be published in a special form and that translation into the official languages is not required.

Art. 40 International cooperation

1. By way of amendment to the provisions of Article 18 of the Federal Act of 6 October 1995⁶on Technical Barriers to Trade (TBA), the Federal Council may approve the recognition in particular of tests, inspections or assessments carried out abroad and of foreign reports or certificates.
2. Within the scope of the authority granted by this Act, it may conclude international agreements over and above the provisions of Article 14 paragraph 1 TBA.
3. The federal authorities shall cooperate with foreign authorities and institutions, and with international organisations.

Art. 41 Safeguard clause

If the notification authority has good reason to believe that substances or preparations represent a health hazard, although they comply with the requirements of this Act, in particular if their classification, packaging or labelling is no longer appropriate, it may, having first consulted the manufacturer, provisionally reclassify the substances or preparations, prohibit their placing on the market or make them subject to special conditions. In such cases, the measures required to amend the regulations concerned shall be taken without delay.

Section 3 Special Regulations on Enforcement

Art. 42 Powers of enforcement authorities

1. In order to monitor compliance with the provisions of this Act, the enforcement authorities shall be authorised to test substances, preparations and articles as specified in Article 19 paragraph 1 letter b and to examine procedures for the handling thereof.
2. For this purpose, they shall be authorised to request that any persons involved in the handling of such substances, preparations or articles should, free of charge:
   1. provide the necessary information;
   2. carry out or submit to investigations;
   3. grant access to production and storage facilities;
   4. permit sampling or provide samples on request.
3. They shall be authorised, at the expense of the person responsible, to take any measures necessary to remedy irregularities with regard to such substances, preparations or articles. In particular, they shall be authorised to:
   1. prohibit any further handling of such substances, preparations or articles;
   2. order them to be recalled or returned;
   3. order them to be rendered harmless or destroyed;
   4. order their seizure.

Art. 43 Secrecy

Any person carrying out tasks in accordance with this Act is bound to maintain secrecy.

Art. 44 Confidentiality of information

1. Information shall be treated as confidential if its disclosure would be detrimental to an interest deemed worthy of protection. In particular, one such interest is that of manufacturers in the preservation of their commercial and industrial secrets.
2. The Federal Council shall define the types of information for which preservation of secrecy cannot be asserted to be an interest deemed worthy of protection.

Art. 45 Data exchange among enforcement authorities

1. If several different federal authorities are involved in enforcement, they shall be responsible for ensuring that data is exchanged in so far as this is necessary for the fulfilment of their tasks.
2. The Federal Council may approve the exchange of data with additional authorities or with public or private organisations and persons if this is necessary for the enforcement of this Act.
3. The federal authorities shall disclose to the relevant cantonal enforcement authorities any data required for the fulfilment of their enforcement tasks.
4. The cantonal enforcement authorities shall communicate to the relevant federal authorities any data that they have collected in accordance with this Act.
5. For the purposes of data exchange, automated recall procedures may be established. In this case, the Federal Council, giving due consideration to the interests of the parties concerned deemed worthy of protection, shall determine who is permitted to call up data, what data may be called up, and for what purposes.

Art. 46 Data exchange with foreign countries and with international organisations

1. The Federal Council shall establish responsibilities and procedures for the exchange of data with foreign authorities and institutions and with international organisations.
2. Confidential information may only be disclosed to foreign authorities and institutions or to international organisations if:
   1. this is required by international agreements or the resolutions of international organisations; or
   2. it is imperative in order to avert an imminent hazard to life or health.

Art. 47 Fees

The Federal Council shall set the Fees to be levied for enforcement by the federal authorities. It may grant exemptions from the liability to pay fees.

Chapter 6 …

Art. 48

Chapter 7 Criminal Provisions

Art. 49 Felonies and misdemeanours

1. Manufacturers who wilfully:
   1. place substances or preparations on the market for a use that poses an immediate threat to life or health, if they are aware or should be aware of this fact (Art. 5 para. 1);
   2. fail to correctly classify, package or label substances or preparations (Art. 5 para. 1), fail to produce a safety data sheet, or include inaccurate or incomplete information in such a sheet (Art. 7);
   3. place substances or preparations on the market:
   1. without having notified them (Art. 6 and Art. 13 para. 1), 2. before the notification has been accepted or the specified period has elapsed (Art. 9 para. 2), 3. without authorisation having been granted (Art. 6 and Art. 13 para. 1); d. withhold information on substances or preparations from, or give false information to, the authorities responsible (Art. 9 para. 3, Art. 10 para. 4, Art. 11 para. 2, Art. 15 para. 2, Art. 16 para. 1, Art. 17, Art. 30 para. 3 and Art. 42 para. 2); e. infringe regulations concerning substances (Art. 19 para. 2 let. a–c, e and g); f. contravene measures ordered pursuant to the safeguard clause (Art. 41)

shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.⁷

2. …⁸

3. Any person who wilfully:

1. places dangerous substances or preparations on the market without duly informing the purchaser about the properties thereof or the appropriate precautions and protective measures, or without supplying the purchaser with a safety data sheet (Art. 7);
2. breaches the duty of care in the handling of dangerous substances and thereby knowingly endangers human life or health (Art. 8, Art. 21, Art. 23 and Art. 25 para. 1);
3. contravenes the obligation to request information in advance (Art. 12);
4. infringes regulations concerning substances (Art. 19 para. 2 let. a and c);
5. infringes regulations concerning exports (Art. 19 para. 2 let. d);
6. handles substances or preparations without due authorisation (Art. 24 para. 1);
7. supplies dangerous substances or preparations to unauthorised parties (Art. 19 para. 2 let. a and Art. 24 para. 1);
8. breaches the duty of secrecy (Art. 30 para. 4, Art. 43 and Art. 44);
9. contravenes measures ordered pursuant to the safeguard clause (Art. 41),

shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.⁹

4. If human life is severely endangered as a result of the offences specified in paragraph 3, the penalty shall be a custodial sentence not exceeding ten years or a monetary penalty.¹⁰

5. Any person who commits the foregoing offence through negligence shall be liable to a monetary penalty.¹¹

Art. 50 ContraventionsOpen annotations

1. Any person who wilfully:
   1. infringes the provisions concerning self-regulation (Art. 5);
   2. breaches the duty of care in the handling of substances or preparations (Art. 8, Art. 21, Art. 23 and Art. 25 para. 1);
   3. fails to report details of substances or preparations or gives false information (Art. 18);
   4. contravenes the labelling requirements for poisonous plants and animals (Art. 19 para. 2 let. f);
   5. infringes the regulations concerning advertising (Art. 20);
   6. refuses to accept the return of dangerous substances or preparations (Art. 22 para. 1);
   7. breaches the duty to provide information to the cantonal enforcement authorities (Art. 25 para. 2);
   8. breaches the duty to provide information or misinforms the enforcement authorities (Art. 42 para. 2);
   9. contravenes an injunction issued with specific reference to the sanctions of the present article,

shall be liable to a fine not exceeding 20,000 Swiss francs.¹²

2. In cases of negligence, the penalty shall be a fine.

3. For an infringement of implementing regulations that does not constitute an offence under paragraph 1 or Article 49, the Federal Council may impose:

1. a fine of up to 20,000 Swiss francs for wilful acts, or
2. a fine in cases of negligence.¹³

4. Attempts and aiding and abetting are also offences.

5. and⁶…¹⁴

Art. 51 Offences in commercial establishments

Articles 6 and 7 of the Federal Act of 22 March 1974¹⁵on Administrative Criminal Law apply to offences under this Act.

Art. 52 Criminal prosecution and complaints

1. The cantons shall be responsible for the prosecution and adjudication of offences.
2. If there are adequate grounds to suspect that an offence has been committed within the area of federal enforcement, the federal agency responsible shall report this to the cantonal authority. In particularly minor cases, a complaint may be dispensed with.

Chapter 8 Final Provisions

Art. 53 Repeal and amendment of existing legislation

The repeal and amendment of existing legislation is regulated in the Annex.

Art. 54 Transitional provisions

1. Data collected under existing legislation by the Toxicology Documentation Office (Art. 18 of the Toxic Substances Act of 21 March 1969¹⁶), in particular that included in the list of toxic substances (Art. 4 of the Toxic Substances Act), may be included in the product register (Art. 27) and continue to be used, in so far as it is relevant to the enforcement of this Act.
2. After the commencement of this Act, substances and preparations that are packaged and labelled in accordance with existing legislation may still be placed on the domestic market by the manufacturer for one year and may be supplied to final users for two years. For these substances and preparations, the preparation and supply of safety data sheets shall be governed by existing law.
3. For substances and preparations subject to mandatory notification or authorisation that are already on the market when this Act comes into force, the Federal Council shall specify a facilitated notification or authorisation procedure. At the same time, for such cases, it shall grant an appropriate extension of the periods specified in paragraph 2.
4. Authorisation procedures for substances and preparations which are pending when this Act comes into force shall be pursued and concluded by the federal authority that is responsible under this Act in accordance with the provisions of this Act.
5. The Federal Council shall determine to what extent and for how long persons licensed to deal with toxic substances under existing law are entitled to handle dangerous substances and preparations.

Art. 55 Referendum and commencement

1. This Act shall be subject to an optional referendum.
2. The Federal Council shall set the commencement date.

Commencement date: 1 August 2005¹⁷
Art. 19 para. 2 let. a and d, 34 para. 1 let. e, 38, 49 para. 3 let. e and Annex No II 2
(Art. 39 para. 1^bisof the Environmental Protection Act): 1 January 2005¹⁸

Repeal and Amendment of Current Legislation

I

The Toxic Substances Act of 21 March 1969¹⁹is repealed.

II

The Federal Acts listed below are amended as follows:

.²⁰

Footnotes

1. SR 101 ↩

2. BBl 2000 687 ↩

3. SR 822.11 ↩

4. SR 832.20 ↩

5. The amendment in accordance with the Federal Act of 20 June 2014 on Continuing Education and Training, in force since 1 Jan. 2017 relates only to the French and Italian texts (AS 2016 689;BBl 2013 3729). ↩

6. SR 946.51 ↩

7. Amended by No I 31 of the FA of 17 Dec. 2021 on the Harmonisation of Sentencing Policy, in force since 1 July 2023 (AS 2023 259;BBl 2018 2827). ↩

8. Repealed by No I 31 of the FA of 17 Dec. 2021 on the Harmonisation of Sentencing Policy, with effect from 1 July 2023 (AS 2023 259;BBl 2018 2827). ↩

9. Amended by No I 31 of the FA of 17 Dec. 2021 on the Harmonisation of Sentencing Policy, in force since 1 July 2023 (AS 2023 259;BBl 2018 2827). ↩

10. Amended by No I 31 of the FA of 17 Dec. 2021 on the Harmonisation of Sentencing Policy, in force since 1 July 2023 (AS 2023 259;BBl 2018 2827). ↩

11. Amended by No I 31 of the FA of 17 Dec. 2021 on the Harmonisation of Sentencing Policy, in force since 1 July 2023 (AS 2023 259;BBl 2018 2827). ↩

12. Amended by No I 31 of the FA of 17 Dec. 2021 on the Harmonisation of Sentencing Policy, in force since 1 July 2023 (AS 2023 259;BBl 2018 2827). ↩

13. Amended by No I 31 of the FA of 17 Dec. 2021 on the Harmonisation of Sentencing Policy, in force since 1 July 2023 (AS 2023 259;BBl 2018 2827). ↩

14. Repealed by No I 31 of the FA of 17 Dec. 2021 on the Harmonisation of Sentencing Policy, with effect from 1 July 2023 (AS 2023 259;BBl 2018 2827). ↩

15. SR 313.0 ↩

16. [AS 1972 430, 1977 2249No I 541; 1982 1676Annex No 10; 1984 1122Art. 66 No 4; 1985 660No I 41; 1991 362No II 403; 1997 1155Annex No 4; 1998 3033Annex No 7] ↩

17. O of 18 May 2005 (AS 2005 2293). ↩

18. FCD of 10 Nov. 2004. ↩

19. [AS 1972 430, 1977 2249No I 541, 1982 1676Annex No 10, 1984 1122Art. 66 No 4, 1985 660No I 41, 1991 362No II 403, 1997 1155Annex No 4, 1998 3033Annex No 7] ↩

20. The amendments may be consulted underAS 2004 4763. ↩