Simplified examination AN on the basis of the revised Ordinance on Biocidal Products
In the latest revision to the Ordinance on Biocidal Products (OBP), which entered into force on 15 December 2020, the internal assessment procedure was adjusted by the authorities for applications for AN authorisation. (OBP and explanatory report).
For these time-limited transitional authorisations, the authorities conduct a summary risk assessment to check whether:
• the documentation is complete;
• the active substances are approved for the use of the biocidal product as intended. In particular the authorities check whether the active substances contained in the biocidal product are legally compliant for the product type applied for;
• insofar as they are intended for the general public, biocidal products have none of the properties mentioned in Art. 11d of the OBP;
• no obviously inappropriate applications are approved, for example dermal application of a product rated by the applicant as skin irritating or sensitising for product type 19;
• biocidal products for disinfection of drinking water (product type 5) additionally meet the requirements of the FDHA ordinance on drinking water and water in publicly accessible baths and showers (TBDV/OPBD/OPPD);
• no banned applications are approved, for example algae and moss control agents;
• the correct proofs of efficacy have been submitted for disinfectants (product types 1 to 4);
• there is proof of the efficacy of wood preservatives;
• the use of insecticides (product type 18) has no negative effects on aquatic organisms, bees/pollinators or livestock.
The contents of AN authorisation under the new summary procedure thus differ from previous AN authorisations. AN authorisation contains only that which has been checked by the authorities.
All requirements under the OBP that have not been checked by the authorities for AN authorisation are subject to self-regulation. For example classification and labelling are no longer part of the decision. Correct classification and labelling and all other biocidal product requirements under the OBP not covered by the authorisation are subject to self-regulation for the limited duration of the AN authorisation and can at any time be controlled downstream by the cantonal enforcement authorities or the authorities responsible for authorisation.
All available documents as per Annex 8 of the OBP must still be submitted to enable the potential risks to humans and the environment to be assessed by the authorities on the basis of the available data and for any measures to be taken to reduce the risk.
Given that somewhat less work is required on the part of the authorities, the new fees are as follows:
• Summary procedure without the involvement of the assessment authorities: CHF 350
• Summary procedure involving an assessment authority (biocidal products of type 1, 2, 3 [teat disinfection], 4, 5, 8 and 19): CHF 600
• For the in-depth review and renewed authorisation (for example products checked in the course of market inspections necessitating a correction and thus a new authorisation): CHF 1,000
• For the "Authorisation procedure AN for in situ generated active substances", the fees are increased by a factor of 1.5 due to the complexity
As before, CHF 50 will be charged for each query owing to an incomplete dossier.