Comments on the legal situation regarding disinfectants

The designated use of a disinfectant basically determines the law to which it is subject. The designated use also determines the authority with which the disinfectant must be registered.

The following breakdown is designed to help manufacturers and distributors work out which authority a disinfectant must be reported to.

Products for wound treatment and preoperative skin disinfection fall under the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA, SR 812.21).
Products for the specific treatment of medical devices (surgical instruments, dialysis equipment, etc.) are subject to the terms of the Medical Devices Ordinance (MedDO) and must undergo a conformity assessment (Medical Devices Ordinance, MedDO, SR 812.213). This conformity assessment must be carried out by a conformity assessment body. As soon as the products bear the CE marking, they can be marketed in Switzerland and throughout the European Union. Swissmedic is responsible for market surveillance, but not for an approval.
The Ordinance on Biocidal Products (OBP, SR 813.12), which entered into force on 1 August 2005, regulates a large percentage of products used to combat living organisms, from viruses to dust mites and mammals. All products must be authorised. Biocidal products are divided into 22 different product types, with disinfectants falling into the first five.

Products for hand disinfection (hygienic and surgical disinfection) or hygienic hand washing are subject to the OBP.

Also subject to the OBP are products for disinfecting surfaces, instruments (excluding medical devices), swimming pools (surfaces and water) and drinking water. The OBP applies to hospitals, people, laboratories, the food industry (abattoirs, production facilities, restaurants and kitchens), veterinary and private spaces, cooling facilities, etc.

Multiple types of authorisation are possible, and forms are available in the procedures and forms section of the notification authority’s website.

Under the applicable law, products for disinfecting medical devices that are also used for other purposes, for example for disinfecting surfaces, equipment or facilities, must undergo a conformity assessment for medical devices and meet the requirements stipulated in the OBP and the Chemicals Ordinance.
Article 74 of the Ordinance on Epizootic Diseases (OFE, SR 916.401) is applicable if the disinfectant is used to combat animal epidemics (epizootic diseases). The Federal Food Safety and Veterinary Office (FSVO) has drawn up a positive list.

Overview of the legal basis and authorities with which disinfectants must be authorised in Switzerland