On 17 September 2021, the Federal Council adopted a partial revision of the Chemicals Control Ordinance, which entered into force on 1 November 2021. With the revision, the licensing procedures for the production of certain chemicals for research, medical and pharmaceutical purposes have been simplified.
- New competencies for granting licenses and new deadlines
- New declaration deadlines for plant sites
- ICP Requirement
The Chemical Weapons Convention (CWC) is a disarmament and control treaty under international law that entered into force in 1997. In addition to the ban on chemical weapons, the CWC contains an extensive declaration and inspection system for the production, processing and consumption, as well as trade in (dual-use) chemicals that can be misused for the manufacture of chemical weapons. In Switzerland, the Goods Control Act (GCA) forms the legal basis for the implementation of the CWC. The corresponding implementing regulations are contained in the Chemicals Control Ordinance (ChCO). On 17 September 2021, the Federal Council adopted a partial revision of the ChCO, which entered into force on 1 November 2021. The main revision points are set out below.
New competencies for granting licenses and new deadlines
Under the previous regulation and with regard to the production, processing and consumption of Schedule 1 chemicals, the Federal Council was responsible for issuing licenses in all cases where a license is required. In practice, this meant that the Federal Council also had to authorize the production of very small quantities of Schedule 1 chemicals within the framework of the production of medicines. To relieve the Federal Council, the State Secretariat for Economic Affairs (SECO), as from the entry into force of the revised ChCO, issues licenses for the production of Schedule 1 chemicals up to 100 g per year and establishment, whereas the Federal Council remains responsible for issuing licenses for the production, processing and consumption of Schedule 1 chemicals in quantities of over 100 g per year and establishment. There is thus a shift of competence from the Federal Council to SECO.
As before, the 200-day deadline for submitting the license application applies to licenses that fall within the competence of the Federal Council. The period of validity of these licenses is determined by the Federal Council itself.
As from the entry into force of the revised ChCO, the deadline of 40 days, as it already exists for license applications for the import and export of Schedule 1 chemicals, will apply to the submission of license applications for the production of Schedule 1 chemicals to be assessed by SECO, in consultation with the Spiez Laboratory. The period of validity of licenses issued by SECO has been set at five years.
New declaration deadlines for plant sites
Under the previous legal situation, the annual declaration deadlines for plant sites were set by the Spiez Laboratory. As from the entry into force of the revised ChCO, the deadlines for the annual declarations to the Spiez Laboratory are expressly anchored in the ChCO and are fixed so as to enable the National Authority CWC to submit in due time the required declarations under the CWC to the Organisation for the Prohibition of Chemical Weapons (OPCW).
Finally, amendments were made in order to align the wording of the ChCO with the wording of the Goods Control Ordinance (GCO).
In order to apply for a license under the ChCO, proof of a functioning internal control system (Internal Compliance Program or “ICP”) that ensures compliance with the Swiss export control regulations is henceforth required (new art. 19a para. 2 ChCO). The reasons for license refusals have also been aligned with those pursuant to art. 6 GCO.
The Federal Council has also taken the revision of the ChCO as an opportunity to undertake a long overdue amendment of the WMO. While proof of an ICP had already been required for licenses under the goods control regulations since 2016 (see art. 5 para. 2 GCO), a corresponding licensing requirement was previously missing in the war material regulations. This requirement has now been expressly stated in art. 12a para. 2 of the WMO.
Legal persons that wish to obtain licenses under the ChCO or WMO must adapt their ICP as well as their proof of such ICP accordingly and submit a new confirmation to SECO.