Chemicals Act (ChemA)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
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 products
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: a. it is sufficiently effective; b. 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 au
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. 10a — Inserted by No I 1 of the FA of 19 March 2021 on Reducing the Risks of Pesticide Use, in force since 1 Jan. 2024 (AS 2022 263; 2023 708; BBl 2020 6323, 6569).
Art. 11 Authorisation for plant protection products
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: a. the second notifier may refer to notification documents already submitted; b. 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: a. 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 b. 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: a. new substances (Art. 9); b. substances and preparations subject to mandatory authorisation (Art. 10 and 11); c. 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, revise
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.