Switzerland Aligns with REACH Through Chemicals Ordinance

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.

In November 2023 the Swiss Federal Office of Public Health (BAG) published a revision of the Biocidal Products Ordinance. The revision implements changes to the Chemicals Act (ChemG), which has been adapted to reduce the risks from the use of pesticides. The revised ordinance will enter into force on 1 January 2024.

Obligation to report the quantities of biocidal products

The revision of the Biocidal Products Regulation introduces a new obligation to report annually on the quantities of biocidal products placed on the market. This will allow better tracking of sales volumes. This reporting obligation must be fulfilled by the person who first places a biocidal product on the market in Switzerland. This mainly concerns authorisation holders, manufacturers, and Swiss importers. Dealers, direct sales points, professional and commercial users are not affected.

The first report for data from 2024 must be submitted by 31 May 2025 and thereafter by 31 May each year.

Introduction of Indicators

Indicators based on measurements in aquatic environments have been established to assist in the assessment and mitigation of risks associated with biocidal products. If the values specified in the Water Protection Ordinance are consistently exceeded, authorisations for biocidal products may be altered or revoked if necessary.