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On 5 April 2023 the Swiss Federal Council amended the 2005 Chemicals Risk Reduction Ordinance. The purpose of the amendment is to codify temporary exemptions for the use of substances of very high concern regulated in Annex 1.17 concerning substances listed in Annex XIV of Regulation (EC) No. 1907/2006 on the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH Regulation).
The amendment comes into force on 1 May 2023.
Annex 1.17 of the 2005 Chemicals Risk Reduction Ordinance (2005 ChemRRV) regulates certain substances of very high concern; these substances are listed in Annex XIV to the EU REACH Regulation. A ban on the use of these substances applies in principle throughout the EU as well as in Switzerland. However, the European Commission and federal authorities are permitted to grant temporary exceptions to the ban on these substances under particular circumstances. The exemptions are often deployed when a company is unable to find an effective substitute substance that is less hazardous or to utilize another process that does not require the use of these banned substances.
In its meeting on 5 April 2023, the Federal Council determined that an additional procedural simplification regarding the substances listed in Annex 1.17 was necessary in order to facilitate certain chemical and pharmaceutical activities. The new provisions allow the chemical-pharmaceutical industry to use a substance regulated in Appendix 1.17 of the 2005 ChemRRV for the manufacture of chemicals, pharmaceuticals, and medical devices under certain conditions. Specifically, these substances are only permitted for use in a closed system that ensures the prevention of environmental and human exposure to the chemicals.
In addition, the Federal Council added a further exception to the 2005 ChemRRV that permits the use of substances listed in Annex 1.17 needed for the maintenance of Swiss Air Force aircraft. In its announcement of these changes, the Federal Council notes that “these changes to the regulations do not affect the level of protection for health and the environment.”
The 2005 ChemRRV serves as the primary regulatory instrument through which restrictions and prohibitions on the use of certain chemicals in certain applications is articulated for Switzerland. Switzerland is not an EU member state; however, the Swiss began harmonizing their chemical control regime with that of the EU in 2005. While it does recognize several aspects of the REACH Regulation and the related Regulation (EU) 1272/2008, the restrictions in this legislation are specific and unique to Switzerland. The procedural simplifications for the temporary use of these substances should relieve some of the regulatory burden on companies that require exemptions.
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