Authorisation procedure for biocidal products with proof of efficacy
The procedure to obtain authorisation AN for a biocidal product is described on the page Application for Authorisation AN.
Biocidal products are evaluated before being authorised. The evaluation of disinfectants consists of several stages, and includes testing for toxicity and efficacy, and documentation on the product. In some cases the risk posed to users or third parties is assessed.
Disinfectants must undergo an efficacy assessment (Article 13 of the Ordinance on Biocidal Products, OBP). However, products for specific uses do not require proof of efficacy if their efficacy is plausible. In this case the applicant is responsible for demonstrating the efficacy of its product to customers.
Chemical disinfectants can reduce the number of microorganisms by destroying their structure or metabolism. But not all substances and formulas are equally effective against the different types of pathogen. For this reason a series of expert opinions must be obtained for each formula to determine the range of effects.
To assure appropriate efficacy, the designated use, concentrations and contact time duration of use must be specified on the label or in the directions. This information is taken from the expert opinions.
The dossier for proof of efficacy must show what pathogens the marketed formula has an effect against. The expert reports should contain details of the effect concentrations and required contact time.
When evaluating a product, the FOPH reads these expert reports and makes sure that the information on efficacy provided on the label and in the directions (or on technical information sheets) of the product tally with the results of the tests.
If the requirements are met, the disinfectant is authorised and is given an authorisation number, and the applicant is sent an official authorisation. The applicant is responsible for ensuring that all the documentation relating to the product (labels, directions, information, advertising, website, etc.) is adapted in accordance with this authorisation. All information, including classification, data on efficacy, and protective and precautionary measures, must correspond to the ordinances and the authorisation.
Last modification 13.02.2017