Federal Act
on Protection against Dangerous Substances and Preparations
(Chemicals Act, ChemA)

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.

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.

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.

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.

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.

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.

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.

Any person who places biocidal products on the market is required to notify the Confederation of the data on their placing on the market.

The Federal Council shall regulate in particular the data that must be recorded and the office to which notice must be given.

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.

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.

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.

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.

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.

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.

The Federal Council shall issue regulations concerning the review and assessment of individual existing substances.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The Federal Council shall issue regulations on how reference is to be made to the hazards in such promotion and offering for sale.

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.

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.

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.

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.

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.

It shall specify how the necessary expertise may be acquired.

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 1964⁴ and the Federal Law of 20 March 1981⁵ on Accident Insurance.

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.

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.

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.

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.

The assessment authorities shall be responsible for obtaining the documentation required to fulfil their tasks.

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.

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.

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.

It shall issue technical guidelines and publish the lists of substances and preparations that are required for the application of this Act.

The cantons shall provide information within their areas of responsibility.

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.

The Federal Council shall establish a poisons information centre and ensure that it is financially compensated for carrying out the tasks assigned to it.

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.

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.

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.

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);

4. 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);

5. infringe regulations concerning substances (Art. 19 para. 2 let. a–c, e and g);

6. 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.¹¹

…¹²

Any person who wilfully:

• a. 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);

• b. 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);

• c. contravenes the obligation to request information in advance (Art. 12);

• d. infringes regulations concerning substances (Art. 19 para. 2 let. a and c);

• e. infringes regulations concerning exports (Art. 19 para. 2 let. d);

• f. handles substances or preparations without due authorisation (Art. 24 para. 1);

• g. supplies dangerous substances or preparations to unauthorised parties (Art. 19 para. 2 let. a and Art. 24 para. 1);

• h. breaches the duty of secrecy (Art. 30 para. 4, Art. 43 and Art. 44);

• i. 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.¹³

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.¹⁴

Any person who commits the foregoing offence through negligence shall be liable to a monetary penalty.¹⁵

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.¹⁶

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

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.¹⁷

Attempts and aiding and abetting are also offences.

and ⁶ …¹⁸

Articles 6 and 7 of the Federal Act of 22 March 1974¹⁹ on Administrative Criminal Law apply to offences under this Act.

The cantons shall be responsible for the prosecution and adjudication of offences.

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.

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

Data collected under existing legislation by the Toxicology Documentation Office (Art. 18 of the Toxic Substances Act of 21 March 1969²⁰), 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.

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.

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.

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.

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.

This Act shall be subject to an optional referendum.

The Federal Council shall set the commencement date.

Commencement date: 1 August 2005²¹
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^bis of the Environmental Protection Act): 1 January 2005²²