Authorisation AN

This type of authorisation applies to products that contain at least one notified active substance, for which a decision on inclusion in the list in Annex 1 or 2 of the Ordinance on Biocidal Products (OBP; SR 813.12) is still outstanding.

The other active substances of the product are included in one of these lists (notified active substances or Lists of Annex 1 or 2).

Important: If the last notified active substance of a biocidal product has been approved (included in the Lists of Annex 1 (XLS, 133 kB, 07.10.2021) or Annex 2 (XLS, 828 kB, 01.09.2022) of the OBP), then the authorisation owners of an authorisation A_N have various options that are presented under the Transitional regulation (Link to Transitional regulation).

Important: The composition must be 100% and must include all components. Applications with incomplete compositions cannot be processed.

Procedure

An application for authorisation A_N must be submitted to the Notification Authority for Chemicals via the Chemicals Register RPC using the electronic form. The applicant must be domiciled in Switzerland or have a registered office or branch in Switzerland. Explanations for the electronic form may be found in the guidance document guidance for electronic applications Authorization AN (PDF, 4 MB, 30.08.2023). On the “Documents” tab in the RPC the following documents should be uploaded:

Please note: documents with confidential content should have an access level “author & federal authorities”. The access level can only be assigned after the document has been uploaded.

a. Signed printout of the last page¹ of the confirmation from the product register as a PDF
b. a draft label (incl. description and instructions for use)
c. safety data sheet
d. if applicable proof of efficacy (disinfectants and wood preservatives)
e. possible evidence for the labelling of the product
f. The completed document “Additional information (RTF, 68 kB, 30.08.2023)”
g. Provision of proof of the source of the active substance in accordance with Art. 95 EU-BPR, either with the following form or by enclosing a letter of conformity from the supplier. Form Declaration Art. 95 BPR (PDF, 73 kB, 16.11.2022). See also : article 95 (of the EU biocidal product regulation, BPR)

After transmission of the completed electronic form via the Chemicals Register, an email with the following information has to be sent to the Notification Authority for Chemicals (cheminfo@bag.admin.ch):

Trade name and the CPID number of the biocide
Specifying, that the application concerns a first application A_N

Processing period

Complete applications are generally processed and a decision given within 60 days. Please note the legal holidays (among others from 15 July to and with 15 August, art. 22a APA).

Period of Validity

The authorisation is valid for 6 months after the last active substance of the biocidal product is included in the lists of Annex 1 or 2 OBP. Thereafter the product may still be placed on the market for up to 360 days and supplied to end consumers for additional 360 days. Professional or commercial use is not limited insofar there is not an unacceptable effect on humans, animals and the environment. Should the product still remain on the market (Transitional provisions).
If a decision is taken by the EU Commission to deny the inclusion of the active substance into the Annex 1 BPR or into the Union lists of approved active substances, then the authorisation will be revoked by the Notification Authority. After the decision of the Commission the product can be placed on the market for up to 360 days and supplied to end consumers for additional 360 days. Professional or commercial use is not limited insofar there is not an unacceptable effect on humans, animals and the environment.

Fees

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.

Additional fees will be charged for incomplete applications.