On September 17, 2021, the Federal Council passed a partial revision of the Chemicals Control Ordinance, which came into force on November 1, 2021. The revision simplified the licensing procedures for the manufacture of certain chemicals for research, medical and pharmaceutical purposes.
- New powers for issuing licenses and new deadlines
- New declaration deadlines for plant locations
- ICP requirement
The Chemical Weapons Convention (CWC) is an international disarmament and control treaty that came into force in 1997. In addition to the ban on chemical weapons, the CWC contains an extensive declaration and control system for the production, processing and consumption, as well as trade in (dual-use) chemicals that can be misused to produce chemical weapons. In Switzerland, the Goods Control Act (GKG) forms the legal basis for the implementation of the GWÜ. The corresponding implementation provisions are contained in the Chemicals Control Ordinance (ChVV). On September 17, 2021, the Federal Council passed a partial revision of the KVV, which came into force on November 1, 2021. The main revision points are listed below.
Under the previous regulation, the Federal Council was responsible for issuing licenses for the production, processing and consumption of List 1 chemicals in all cases requiring a license. In practice, this meant that the Federal Council also had to approve the manufacture of small quantities of Schedule 1 chemicals as part of the manufacture of pharmaceuticals. To relieve the burden on the Federal Council, the State Secretariat for Economic Affairs (SECO) will issue licenses for the production of list 1 chemicals up to 100 g per year and company once the revised VVK comes into force. The Federal Council remains responsible for issuing licenses for production, processing and the consumption of Schedule 1 chemicals in quantities of more than 100 g per year and company. There will thus be a shift in competence from the Federal Council to SECO.
The 200-day deadline for submitting the license application still applies to licenses that fall within the competence of the Federal Council. The period of validity of these permits is determined by the Federal Council itself.
From the entry into force of the revised ChVV, the deadline of 40 days for the submission of license applications for the manufacture of List 1 chemicals will apply, as already applies to license applications for the import and export of List 1 chemicals by SECO in consultation with the Spiez Laboratory be assessed. The period of validity of the permits issued by SECO has been set at five years.
Under the previous legal situation, the Spiez Laboratory set the annual declaration deadlines for plant locations. From the entry into force of the revised ChVV, the deadlines for the annual reports to the Spiez Laboratory are expressly anchored in the ChV and specified in such a way that the CWC National Agency can submit the reports required under the CWC in good time to the Organization for the Prohibition of Chemical Weapons (OPCW).
Finally, adjustments were made to align the wording of the ChVV with the wording of the Goods Control Ordinance (WVV).
The application for a license under the ChVV now requires proof of a functioning internal control system (Internal Compliance Program or “ICP”), which ensures compliance with Swiss export control regulations (new Art. 19a Para. 2 ChVV). The reasons for the refusal of approval were also those according to Art. 6 GCO.
The Federal Council also took the revision of the ChVo as an opportunity to make a long-overdue adjustment to the WMO. While an ICP certificate has been required for permits under the Goods Control Ordinance since 2016 (cf. Art. 5 Para. 2 WVO), there was previously no corresponding permit requirement in the War Material Ordinance. This requirement has now been expressly set out in Art. 12a para. 2 of the WMO.
Legal entities who would like to receive authorizations in accordance with the ChCO or WMO must adjust their ICP and their supporting documents accordingly and submit a new confirmation to SECO.