Switzerland Regulatory News

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 amendme...

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 a...

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.

The Federal Office of Public Health, Switzerland, on 28 June 2022 published a draft amendment of Annexes 2, 3, 4, and 7 of the Ordinance on Protection against Dangerous Substances and Preparations (Ch...

The Federal Office of Public Health, Switzerland, on 28 June 2022 published a draft amendment of Annexes 2, 3, 4, and 7 of the Ordinance on Protection against Dangerous Substances and Preparations (Chemicals Ordinance).

Annex 2 is the technical regulations for the classification, labelling and packaging of substances. It will be updated and adapted to technical progress in the EU from November 23, 2023. The draft revises the list of harmonized classifications and updates it to include 39 substances, amends 17 existing entries and one existing entry was split into two. Also, the newest developments in test methods for substances and preparations (OECD) are adopted in this draft revision.

For Annex 3, four substances are added to the candidate list of substances of very high concern (SVHC). The requirements in Annex 4 (technical dossier for notifications) are updated based on the specifications for registrations in the EU. And three entries are eliminated from Annex 7, the list of new substances for which notification is not required.

With these revisions, the agency aims to protect human health and the environment and reduce trade barriers to enhance trade in Switzerland. The last day for comments is July 15, 2022, and the proposed date of adoption is July 29, 2022. The changes are expected to come into force on September 1, 2022.

After identifying 388 Food Contact Chemicals (FCCs) as “of concern” substances, Swiss researchers from the Food Packaging Forum (FPF) called for such substances to be phased out. These substances ...

After identifying 388 Food Contact Chemicals (FCCs) as “of concern” substances, Swiss researchers from the Food Packaging Forum (FPF) called for such substances to be phased out. These substances that are listed as being “intentionally added” to Food Contact Materials (FCMs) in the FPF’s FCC database (FCCdb) include:

• Carcinogenic, Mutagenic or Reprotoxic substances (CMRs),
• Endocrine Disrupting Chemicals (EDCs), and
• Persistent and Bioaccumulative substances (PBs). 

The database for the migrating and extractable FCCs, FCCmigex as labeled by FPF, has also listed some of the aforementioned substances, where 97 of such chemicals were found evidently migrating from FCMs. Part-funded by environmental NGO Zero Waste Europe, the research league including colleagues at ETH Zurich and the Swiss Federal Institute of Aquatic Science and Technology spotted the need to investigate a wider range of FCCs in extraction and migration experiments; the ultimate calling is that no untested substances and no hazardous chemicals shall be present in FCMs.

On the 13th of February, Switzerland had a vote to decide if full animal testing should be banned or not. This includes animal testing for both scientific and medical research.If voted for, the ban ...

On the 13^th of February, Switzerland had a vote to decide if full animal testing should be banned or not. This includes animal testing for both scientific and medical research.

If voted for, the ban would include:

·       a ban on the importation of products created through animal testing,

· a ban on human experiments, and 

· A certainty that non-animal testing will receive a level of support from the state that is almost the same as the support provided for animal experiments’ research.

During the voting process, 21% of the participants voted in favour while 79% voted against. Otherwise, Switzerland would have become the first country to fully ban animal testing. In 2017, Switzerland banned cosmetics that contain ingredients tested on animals.

However, Julia Baines from PETA UK said the rejection of the full ban does not equal approval of animal testing as this is collectively aimed at human clinical trials as well as the manufacturing, export and import of products tested on animals.

Switzerland has adopted new disclosure obligations for some synthetic fibrous or tubular nanomaterials and intermediate chemical products.

Switzerland has updated the list of substances notified or registered in the country, with 385 additions in June. New substances manufactured or imported into the country, in a volume greater than one...

Switzerland has updated the list of substances notified or registered in the country, with 385 additions in June. New substances manufactured or imported into the country, in a volume greater than one tonne per year, must be notified to the Swiss chemicale Notification Authority before they on to the market.