Switzerland's Chemical Regulation: ChemO and REACH Alignment

On 14 April 2025, Switzerland notified the World Trade Organization (WTO) of two proposed amendments to its chemical safety regulations. These amendments aim to enhance public health protection by restricting the availability of certain hazardous substances to the general public and aligning Swiss regulations more closely with the European REACH and CLP frameworks.

Key Provisions of the Amendments

Restriction on CMR Substances for Consumer Use

The draft amendment to the Ordinance on the Reduction of Risks Related to the Use of Particularly Dangerous Substances, Preparations, and Articles (ORRChim) prohibits the supply of substances classified as carcinogenic, mutagenic, or toxic to reproduction (CMR) to the general public. This applies to substances listed in Annex 1 to 6 of Annex XVII of the EU REACH Regulation, as well as mixtures containing these substances when their mass concentration exceeds the threshold defined in the EU CLP Regulation.

These substances may no longer be supplied to the general public in Switzerland after 31 August 2025.

Updates to Classification, Labelling and Testing Requirements

The amendment to the Ordinance on the Protection against Dangerous Substances and Preparations (OChim) updates Annexes 2 and 3 to reflect the latest EU regulations. This includes:

• Incorporation of the 22nd and 23rd Adaptations to Technical Progress (ATPs) under the EU CLP Regulation.

• Updated references to testing methods under Regulation (EC) No 440/2008, OECD Test Guidelines (as of June 2025), and the UN Manual of Tests and Criteria, 8th revised edition with the 2025 amendment.

• Transitional periods allowing the continued supply of noncompliant substances until 30 April 2026 (for the 22nd ATP) and until a future date to be determined for the 23rd ATP.

Expanded Candidate List of Substances of Very High Concern

Following developments at EU level, seven new entries are being added to Annex 3 of ChemO, Switzerland’s list of substances of very high concern (SVHCs). In addition, one existing entry is being updated. The revised list will contain 247 substances and groups of substances, effective 1 August 2025.

Effective Date

Both amended ordinances are scheduled to enter into force on 1 August 2025.

These changes reflect Switzerland's commitment to aligning its chemical safety regulations with the EU's REACH and CLP frameworks to enhance protection for the general public against particularly hazardous substances.

For more detailed information, you can access the full notifications here and here.

The Federal Office of Public Health (FOPH), in collaboration with the Federal Office for the Environment (FOEN) and the State Secretariat for Economic Affairs (SECO), has announced significant amendments to the Ordinance on the Protection against Dangerous Substances and Preparations (ChemO). These amendments were notified to he World Trade Organization (WTO) on May 27, 2024. The amendments, The aim of the amendments which will come into force on September 1, 2024, is to improve safety standards for chemical products in Switzerland.

Key Amendments

Updates to Annex 2:

• Classification, Labelling, and Packaging: The European Union’s CLP Regulation (Regulation (EC) No 1272/2008) Annexes I to VII are now applicable to Swiss standards. This alignment ensures that the classification, labelling, and packaging of substances and preparations are consistent with international guidelines.

• New EU Hazard Classes: The new EU hazard classes according to Delegated Regulation (EU) 2023/707 for endocrine disruptors and chemicals that are persistent, bioaccumulative, or may reach surface water, groundwater or drinking water due to their mobility, will become applicable in Switzerland. These hazard classes will become mandatory in stages, first for substances, and subsequently for preparations.

• Testing Methods: The testing methods for determining the properties of substances and preparations have been updated. Acceptable methods include those defined in EU Regulation (CE) No. 440/2008, OECD Guidelines for the Testing of Chemicals (as of June 2024), and the UN Manual of Tests and Criteria.

Updates to Annex 3:

• List of Substances of Very High Concern: Seven news entries have been added to the list and one entry has been updates. This list, effective September 1, 2024, contains 240 substances and groups of substances that have been identified as being of very high concern due to their hazardous properties. This update aims to improve the safety of public health and the protection of the environment by regulating these high-risk chemicals.

Transitional Provisions

In order to facilitate a smooth transition, the Ordinance provides for specific deadlines for compliance:

• Non-compliant substances: Substances that do not comply wjth the new regulations can be marketed until October 31, 2026.

• Non-compliant preparations: Preparations that do not meet the new criteria can be marketed until April 30, 2028.

• Harmonized classification and labelling: Substances listed in Delegated Regulation (EU) 2024/197 and their preparations must comply by August 31, 2025.

Implementation and Compliance

The FOPH emphasizes that these amendments are essential to align Swiss chemical safety standards with international regulations, thereby improving the protection of human health and the environment. Companies dealing with chemical substances and preparations are advised to review the updated requirements and ensure compliance by the specified deadlines to avoid disruptions in their operations.